FCC ID: PQC-OBRTBV1 Wireless Transducer

 

Instructions for Use Avalon Fetal Monitor FM20/30, FM40/50, Avalon CL Release J.3. with Software Revision J.30.xx Patient Monitoring 1Table of Contents 1 Introduction Who this Book is For Confirm Fetal Life Before Using the Monitor Introducing the Avalon Family of Fetal Monitors 2 What's New What's New in Release J.3 What's New in Release G.0 3 Basic Operation Supported Measurements Avalon FM20 and FM30 Avalon FM40 and FM50 Avalon CL Transducer System Getting to Know Your Avalon FM20/FM30 Getting to Know Your Avalon FM40/FM50 Transducers Getting to Know Your Avalon CL Cableless Transducers CL Pods Operating and Navigating Operating Modes Automatic Screen Layouts Settings Preparing to Monitor Switching the Monitor to Standby After Monitoring Disconnecting from Power Power On/Power Off Behavior Monitoring After a Power Failure Troubleshooting 4 FM20/30 Battery Option External Power Supply M8023A Using Batteries Optimizing Battery Performance 5 Alarms Alarm Mode Nurse Call Systems 9 9 10 11 29 29 32 35 35 36 39 40 40 43 45 47 51 55 56 63 64 64 67 98 98 99 99 99 100 101 102 102 105 109 110 110 3 Visual Alarm Indicators Audible Alarm Indicators Acknowledging Alarms Acknowledging Disconnect INOPs Alarm Reminder Pausing or Switching Off Alarms Alarm Limits Reviewing Alarms Latching Alarms Testing Alarms Alarm Behavior at Power On 6 Patient Alarms and INOPs Alarm Messages Technical Alarm Messages (INOPs) 7 Admitting and Discharging Admit/Discharge on the Monitor New Patient Check OB TraceVue/IntelliSpace Perinatal 8 Non-Stress Test Timer Setting NST Autostart/Autostop Viewing the NST Timer Timer Expiry Notification Accessing the NST Setup Pop-up Keys 9 Non-Stress Test Report Setting Up an NST Report NST Report Status Window NST Criteria Non-Reassuring Report Non-Reactive NST Test 10 Cross-Channel Verification (CCV) Misidentification of Heart Rates Cross-Channel Verification Functionality Overview of Cross-Channel Comparisons Coincidence Examples Recommended Actions for INOP Coincidence 11 Monitoring FHR and FMP Using Ultrasound Technical Description Limitations of the Technology Misidentification of MHR as FHR What You Need 4 110 111 114 114 114 115 117 118 118 120 121 123 123 126 137 137 139 139 141 141 141 142 142 145 145 146 148 149 149 151 151 152 152 154 156 157 157 158 158 158 Cableless Monitoring - Important Considerations Preparing to Monitor Selecting Fetal Heart Sound Changing the Fetal Heart Sound Volume Fetal Movement Profile Troubleshooting Additional Information Testing Ultrasound Transducers 12 Monitoring Twin FHRs Important Considerations Monitoring Twins Externally Monitoring Twins Internally Separating FHR Traces Troubleshooting 13 Monitoring Triple FHRs Important Considerations Monitoring Triplets Separating FHR Traces

"Standard" Separation Order

"Classic" Separation Order Switching Trace Separation On and Off When Trace Separation is On When Trace Separation is Off Troubleshooting 14 Fetal Heart Rate Alarms Changing Alarm Settings Changing Signal Loss Delay 15 Monitoring Uterine Activity Externally What You Need External Toco Monitoring Toco Sensitivity Troubleshooting Testing Toco Transducers 16 Monitoring Uterine Activity Internally What You Need Internal (IUP) Monitoring Troubleshooting 17 Monitoring FHR Using DECG Misidentification of MHR as FHR What You Need 159 160 161 161 163 165 166 173 175 175 176 177 177 181 183 183 184 184 184 185 186 187 188 188 191 191 192 193 193 194 195 195 195 197 197 199 199 201 201 203 5 Making Connections Monitoring DECG Suppressing Artifacts Troubleshooting Testing DECG Mode 18 Monitoring Noninvasive Blood Pressure Introducing the Oscillometric Noninvasive Blood Pressure Measurement Preparing to Measure Noninvasive Blood Pressure Starting and Stopping Measurements Enabling Automatic Mode and Setting Repetition Time Enabling Sequence Mode and Setting Up The Sequence Choosing the Alarm Source Assisting Venous Puncture Calibrating NBP Troubleshooting 19 Monitoring Maternal Temperature Measuring Tympanic Temperature 20 Monitoring SpO2 Selecting an SpO2 Sensor Applying the Sensor Connecting SpO2 Cables Measuring SpO2 SpO2 Signal Quality Indicator (Fast SpO2 only) Assessing a Suspicious SpO2 Reading Understanding SpO2 Alarms Setting Up Tone Modulation Setting the QRS Volume 21 Monitoring Maternal Heart / Pulse Rate Priority for Maternal Heart / Pulse Rate Misidentification of MHR for FHR MHR from MECG Electrodes Monitoring MECG Wave Pulse Rate from Toco MP Pulse Rate from SpO2 Adjusting the Heart Rate / Pulse Alarm Limits Average Pulse Rate from Noninvasive Blood Pressure Testing MECG Mode 6 205 206 208 209 209 211 211 212 214 215 215 216 216 216 217 219 219 227 227 227 228 228 229 230 230 231 231 233 233 234 235 238 240 241 241 242 242 22 Printing the ECG Waveform 23 Paper Save Mode for Maternal Measurements 24 Recovering Data Recovering Traces on Paper Recovering Traces on an OB TraceVue/IntelliSpace Perinatal System Recording Stored Data 25 Care and Cleaning General Points Cleaning and Disinfecting Cleaning and Disinfecting Monitoring Accessories Cleaning and Disinfecting the Tympanic Temperature Accessories Sterilizing 26 Maintenance Inspecting the Equipment and Accessories Inspecting the Cables and Cords Maintenance Task and Test Schedule Recorder Maintenance Cleaning the Print Head Disposing of the Monitor 27 Accessories and Supplies Information on Latex Avalon CL Base Station Transducers Fetal Accessories MECG Accessories Noninvasive Blood Pressure Accessories SpO2 Accessories Tympanic Temperature Accessories Recorder Paper Batteries 28 Specifications and Standards Compliance Environmental Specifications Physical Specifications Performance Specifications Recorder Specifications Compatible External Displays: FM40/FM50 Only Manufacturer's Information Trademark Acknowledgment Regulatory and Standards Compliance Environment 243 249 251 251 252 252 255 255 256 257 258 258 259 259 259 260 260 265 266 267 267 268 268 268 270 270 273 277 277 277 279 279 281 285 294 296 296 296 297 306 7 Monitoring After a Loss of Power ESU, MRI and Defibrillation Cardiac Pacemakers and Electrical Stimulators Fast Transients/Bursts Symbols on the System 29 Default Settings Appendix Alarm and Measurement Default Settings Recorder Default Settings Index 307 307 307 307 308 311 311 314 317 8 1 1Introduction Who this Book is For This book is for trained healthcare professionals using the Avalon FM20, FM30, FM40 and FM50 Fetal/Maternal monitors, and the cableless monitoring system Avalon CL. It describes how to set up and use the monitor and transducers. Familiarize yourself with all instructions including warnings and cautions before starting to monitor patients. Read and keep the Instructions for Use that come with any accessories, as these contain important information about application and care and cleaning that is not repeated in this book. You should be:

For information on how to configure and service the monitor, see the Configuration Guide and the Service Guides, or contact your authorized service provider. Your monitor may not have all of the features and options described in this guide. The exact appearance of the monitor may differ slightly from that shown in the illustrations. In this guide:

A warning alerts you to a potential serious outcome, adverse event or safety hazard. Failure to Trained in the use of fetal heart rate (FHR) monitors. Trained in the interpretation of FHR traces. Familiar with using medical devices and with standard fetal monitoring procedures. observe a warning may result in death or serious injury to the user or patient. A caution alerts you to where special care is necessary for the safe and effective use of the product. Failure to observe a caution may result in:

minor or moderate personal injury, damage to the product or other property, possibly in a remote risk of more serious injury. Monitor refers to the entire fetal/maternal monitor. Display refers to the physical display unit. Screen refers to everything you see on the monitor's display, such as measurements, alarms, patient data, and so forth. FM30 Whenever a monitors identifier appears to the left of a heading or paragraph, it means that the information applies to that monitor only. Where the information applies to all models, no distinction is made. 9 1 Introduction Avalon CTS Avalon CL Whenever one of these identifiers appear to the left of a heading or paragraph, it means that the information applies to that cableless monitoring system. Where the information applies to both systems, no distinction is made. Confirm Fetal Life Before Using the Monitor Fetal monitoring technology available today is not always able to differentiate a fetal heart rate (FHR) signal source from a maternal heart rate (MHR) source in all situations. Therefore, you should confirm fetal life by independent means before starting to use the fetal monitor, for example, by palpation of fetal movement or auscultation of fetal heart sounds using a fetoscope, stethoscope, or Pinard stethoscope. If you cannot hear the fetal heart sounds, and you cannot confirm fetal movement by palpation, confirm fetal life using obstetric ultrasonography. Continue to confirm that the fetus is the signal source for the FHR during monitoring. Be aware that:

an MHR trace can exhibit features that are very similar to those of an FHR trace, even including accelerations and decelerations. Do not rely solely on trace pattern features to identify a fetal source. Fetal Movement Profile (FMP) annotations on a fetal trace alone may not always indicate that the fetus is alive. The body of a deceased fetus can move and cause the monitor to annotate fetal body movements. Here are some examples where the MHR can be misidentified as the FHR. When using an ultrasound transducer:

It is possible to pick up maternal signal sources, such as the aorta or other large vessels. Misidentification may occur when the MHR is higher than normal (especially when it is over 100 bpm). When using a fetal scalp electrode:

Electrical impulses from the maternal heart can sometimes be transmitted to the fetal monitor through a recently deceased fetus via the spiral scalp electrode cable, appearing to be a fetal signal source. The recorded MHR (and any artifact) can be misinterpreted as an FHR (especially when it is over 100 bpm). When Fetal Movement Profile (FMP) is enabled:

FMP annotations in the absence of fetal life may be a result of:

Movement of the deceased fetus during or following maternal movement. Movement of the deceased fetus during or following manual palpation of fetal movement

(especially if the pressure applied is too forceful). Movement of the ultrasound transducer. The ultrasound transducer detecting a maternal movement source, such as the mother coughing. See also Monitoring FHR and FMP Using Ultrasound on page 155 and Monitoring FHR Using DECG on page 195. To reduce the possibility of mistaking the MHR for an FHR, it is recommended that you monitor both maternal and fetal heart rates. The monitor's cross-channel verification (CCV) facility can help by automatically detecting when an MHR coincides with an FHR. For further details, see Cross-Channel Verification (CCV) on page 149. 10 1 Introduction Introducing the Avalon Family of Fetal Monitors The Avalon family of fetal monitors consists of the Avalon FM20, FM30, FM40 and FM50. While the FM20/FM30 and the FM40/FM50 have different form factors, the method of operation is very similar for all monitors. The Avalon fetal monitors also share transducers, accessories, software, and are compatible with the Avalon CL, and Avalon CTS Cableless Fetal Transducer Systems. Intended Use The Philips Avalon FM20 (M2702A), FM30 (M2703A), FM40 (M2704A) and FM50 (M2705A) Fetal/

Maternal Monitors are intended for:

non-invasive monitoring of fetal heart rates and movements. non-invasive monitoring of maternal heart rates, maternal pulse rates, uterine activity, maternal noninvasive blood pressure, maternal oxygen saturation, and maternal temperature. invasive monitoring of fetal Direct ECG and intrauterine pressure and for displaying and recording of fetal and maternal ECG waves. (FM30 and FM50 only). displaying, storing, and recording patient data and parameter values, and for generating alarms from fetal and maternal parameters. transmitting patient data and parameter values to a patient information and surveillance system used by trained health care professionals. use in antepartum testing areas, in labor and delivery rooms, and during postpartum recovery in the hospital environment. They are not intended for use in intensive care units or operating rooms. monitoring in a bath or shower. (Avalon CL cableless transducers Toco+ MP, Ultrasound, and ECG/IUP only) transport situations in healthcare facilities, for healthcare facilities outside hospitals, such as doctors offices, and for use in private households. (FM20 and FM30 only) WARNING The fetal/maternal monitors are not intended for:

ECG measurements on patients connected to electrical stimulator or with cardiac pacemakers. use during defibrillation, electro-surgery, or magnetic resonance imaging (MRI). use of the invasive measurements IUP and fetal DECG, use of the patient module (M2738A) and use of the Avalon CL system in domestic establishments and those connected directly to the public low-voltage supply network that supplies buildings used for domestic purposes. WARNING No modification of the fetal monitors, transducers, and the Avalon CL base station is allowed. CAUTION US federal law restricts this device to sale by, or on the order of, a physician. 11 1 Introduction Connecting the Monitor to AC Mains WARNING Always use the supplied power cord with the earthed mains plug to connect to an earthed AC mains socket. Never adapt the mains plug from the fetal monitor to fit an unearthed AC mains socket. Check that the line frequency is correctly configured in the Global Settings menu. FM20/FM30 only: The protective earth conductor is required for EMC purposes. It has no protective function against electric shock. Double and/or reinforced insulation protects this device against electric shock. Do not use AC mains extension cords or multiple portable socket-outlets. Indications for Use Avalon Fetal/Maternal Monitor FM20 Indicated for use by trained health care professionals whenever there is a need for monitoring of the physiological parameters uterine activity, heart rate, oxygen saturation, noninvasive blood pressure, pulse rate, and temperature of pregnant women and the fetal heart rates of single fetuses, twins, and triplets in labor and delivery rooms, in antepartum testing areas, in private households and during transports in healthcare facilities. Avalon Fetal/Maternal Monitor FM30 Indicated for use by trained health care professionals whenever there is a need for monitoring of the physiological parameters uterine activity, heart rate, ECG, oxygen saturation, noninvasive blood pressure, and pulse rate and temperature of pregnant women and the fetal heart rates of single fetuses, twins, and triplets in labor and delivery rooms, in antepartum testing areas, in private households and during transports in healthcare facilities. Avalon Fetal/Maternal Monitor FM40 Indicated for use by trained health care professionals whenever there is a need for monitoring of the physiological parameters uterine activity, heart rate, oxygen saturation, noninvasive blood pressure, and pulse rate and temperature of pregnant women and the fetal heart rates of single fetuses, twins, and triplets in labor and delivery rooms and in antepartum testing areas. Avalon Fetal/Maternal Monitor FM50 Indicated for use by trained health care professionals whenever there is a need for monitoring of the physiological parameters uterine activity, heart rate, ECG, oxygen saturation, noninvasive blood pressure, and pulse rate and temperature of pregnant women and the fetal heart rates of single fetuses, twins, and triplets in labor and delivery rooms and in antepartum testing areas. Safety Information In this guide:

A warning alerts you to a potential serious outcome, adverse event or safety hazard. Failure to observe a warning may result in death or serious injury to the user or patient. A caution alerts you to where special care is necessary for the safe and effective use of the product. Failure to observe a caution may result in minor or moderate personal injury or damage to the product or other property, and possibly in a remote risk of more serious injury. 12 1 Introduction WARNING The fetal/maternal monitors are not intended for:

ECG measurements on patients connected to electrical stimulator or with cardiac pacemakers. use during defibrillation, electro-surgery, or magnetic resonance imaging (MRI). use of the invasive measurements IUP and fetal DECG, use of the patient module (M2738A) and use of the Avalon CL system in domestic establishments and those connected directly to the public low-voltage supply network that supplies buildings used for domestic purposes. WARNING No modification of the fetal monitors, transducers, and the Avalon CL base station is allowed. CAUTION US federal law restricts this device to sale by, or on the order of, a physician. WARNING Always use the supplied power cord with the earthed mains plug to connect to an earthed AC mains socket. Never adapt the mains plug from the fetal monitor to fit an unearthed AC mains socket. Check that the line frequency is correctly configured in the Global Settings menu. FM20/FM30 only: The protective earth conductor is required for EMC purposes. It has no protective function against electric shock. Double and/or reinforced insulation protects this device against electric shock. Do not use AC mains extension cords or multiple portable socket-outlets. WARNING To avoid magnetic interference affecting the mode of the pacemaker, ensure that the Avalon CL base station does not come into close contact with implanted pacemakers. This equipment generates, uses, and radiates radio-frequency energy, and if it is not installed and used in accordance with its accompanying documentation, may cause interference to radio communications. Operation of this equipment in a residential area may cause interference, in which case the users must take whatever measures may be required to correct the interference. 13 1 Introduction WARNING Do not change the date and time setting, if the fetal monitor is connected to a Philips OB TraceVue/

IntelliSpace Perinatal system via a LAN -setup. The monitor uses the OB TraceVue/IntelliSpace Perinatal system date and time, including daylight saving time changes. As long as the fetal monitor is connected to the OB TraceVue/IntelliSpace Perinatal system via the LAN-setup (locomotive icon displayed on the monitor's screen), the option to change the date and time settings at the fetal monitor are disabled, this is not valid for RS232 connections, or the connection to other systems. WARNING Short range radio connections are subject to interruption due to interference from other radio sources in the vicinity, including microwaves, bluetooth devices, WLAN devices (802.11b,g,n) and cordless phones. Depending on the strength and duration of the interference, the interruption may occur for an extended period. A loss of connection, due to moving out-of-range, interference, or for other reasons, is indicated with a No Host Monitoring INOP (here the host is the fetal monitor) on the NBP or SpO2 Pods, or a cl NBP Disconnect or cl SpO Disconnect INOP at the fetal monitor. Correct channel configuration is important, refer to the Configuration Guide for details. CAUTION Check the fetal monitors housing for damage before you start to monitor as part of your safety precautions. WARNING When connecting devices for acquiring measurements, always position cables and NBP tubing carefully to avoid entanglement or potential strangulation. CAUTION Using recorder paper that is not approved by Philips can result in accelerated paper fading and can damage the thermal line printhead. This type of damage is not covered by warranty. WARNING Never immerse the base station in liquid. You must protect it against water sprays or splashes. Place the base station where there is no chance of contact with, or falling into water or other liquids. 14 1 Introduction CAUTION Avoid the use of pulsating water jets in the bath or shower while monitoring, as these can be misinterpreted as an incorrect (or totally artificial) heart rate. Toco Baseline drift: The accuracy specified for baseline drift cannot be guaranteed for underwater usage. When using transducers under warm water the temperature increase causes a significant baseline change due to internal pressure increase. The depth under water at which the Toco transducer is used also has an effect on the Toco baseline, as the water pressure increases with depth. After immersion, allow one to two minutes for the pressure to stabilize, then adjust the Toco baseline (between contractions), and check it frequently. When using the transducers underwater, the radio transmission range is reduced, and signal loss may occur. WARNING Always use the supplied power cord with the earthed mains plug to connect the external power supply M8023A (option #E25) to an earthed AC mains socket. Never adapt the mains plug from the power supply to fit an unearthed AC mains socket. Do not use AC mains extension cords or multiple portable socket-outlets. If a multiple portable socket-outlet without an approved isolation transformer is used, the interruption of its protective earthing may result in enclosure leakage currents equal to the sum of the individual earth leakage currents, so exceeding allowable limits. Do not connect any devices that are not supported as part of a system. Any non-medical device placed and operated in the patients vicinity must be powered via an approved isolation transformer that ensures mechanical fixing of the power cords and covering of any unused power outlets. WARNING Do not touch the charging contacts for the cableless transducers at the Avalon base station while you are touching the patient.) CAUTION Condition the battery with a monitor not currently in use. The monitor switches off automatically when there is no battery power left. 15 1 Introduction WARNING Use only Philips batteries part number M4605A. Use of a different battery may present a risk of fire or explosion. Do not open batteries, or dispose of them in fire, or cause them to short circuit. They may ignite, explode, leak or heat up, causing personal injury. If battery leakage should occur, avoid contact with skin. Refer to qualified and authorized service personnel. Dispose of used batteries promptly and in an environmentally-responsible manner. Do not dispose of the battery in normal waste containers. Consult your hospital administrator to find out about local arrangements. Do not expose batteries to liquids. Do not crush, drop or puncture batteries - mechanical abuse can lead to internal damage and internal short circuits which may not be visible externally. If a battery has been dropped or banged against a hard surface, whether damage is visible externally or not:

Keep batteries out of the reach of children. discontinue use dispose of the battery in accordance with the disposal instructions above. CAUTION Do not disassemble, heat above 100C (212F) or incinerate the batteries, to avoid the risk of fire and burns. Keep batteries out of the reach of children and in their original package until you are ready to use them. If battery leakage should occur, use caution in removing the battery. Avoid contact with skin. Refer to qualified and authorized service personnel. Do not install or use pre-damaged batteries. WARNING Alarm systems of the monitor and those of the connected OB system are independent and not synchronized. WARNING In INOP only mode, no fetal/maternal patient alarms are enabled or indicated. 16 1 Introduction WARNING Do not rely exclusively on the audible alarm system for fetal monitoring. Adjustment of alarm volume to a low level or off during monitoring may result in a dangerous situation. Remember that the most reliable method of fetal monitoring combines close personal surveillance with correct operation of monitoring equipment. WARNING Be aware that the monitors in your care area may each have different alarm settings, to suit different scenarios. Always check that the alarm settings are appropriate before you start monitoring. CAUTION In order to ensure that the settings are reset to user defaults for a new patient, always discharge the previous patient from the fetal monitor. WARNING Performing ultrasound imaging or Doppler flow measurements together with ultrasound fetal monitoring may cause false FHR readings, and the trace recording may deteriorate. CAUTION Never use ultrasound transducers connected to more than one fetal monitor on the same patient. 17 1 Introduction WARNING Ensure that the conductive parts of the fetal scalp electrode and the maternal leg plate electrode do not contact other conductive parts, including earth. Indication of the heart-rate may be adversely affected by the operation of cardiac pacemaker pulses or by cardiac arrhythmias. During ambulant FHR monitoring, the chance of losing the signal or detecting the maternal heart rate is higher than during stationary monitoring. The frequency of the patient's walk may be detected, and mistaken for a FHR signal. Check the mothers pulse periodically during monitoring and compare this with the FHR signal. Beware of mistaking a doubled maternal heart rate for FHR. In the case of a dead fetus, there is a risk that the maternal heart rate is monitored and misinterpreted as the fetal heart rate. Therefore, the simultaneous monitoring of maternal heart rate (preferably, the maternal ECG) is encouraged. Do not interpret maternal movements as fetal movements. Artifacts: FMP artifacts are generated during fetal heart rate searching by changing the transducer position, therefore Philips fetal monitors enable the FMP only after detecting a valid heart rate signal for several seconds. FMP is not recommended when the mother is likely to move, and you should disable Fetal Movement Profile (FMP) at the fetal monitor (FMP Off) if the mother is walking. Gaps and maternal heart rate detection can occur:

if the transducer is not correctly positioned. due to the pulsation of uterine blood vessels. if the fetus moves. CAUTION Using ultrasound gel not approved by Philips may reduce signal quality and may damage the transducer. This type of damage is not covered by warranty. WARNING Periodically compare the mother's pulse with the signal coming from the monitor's loudspeaker to ensure that you are monitoring fetal heart rate. Do not mistake a doubled or elevated MHR for FHR. WARNING Do not catheterize if placenta previa is diagnosed, or if uterine bleeding from an undetermined source is present. 18 1 Introduction WARNING Never attempt to connect the fetal scalp electrode to anything other than the correct DECG adapter cable. WARNING The fetal/maternal monitor is not a diagnostic ECG device. In particular, the display of fetal/maternal ECG is intended only for evaluating signal quality for fetal/maternal heart rate as derived from the ECG waveform. When in doubt, it can be used to identify sources of compromised signal quality, such as noise or muscle artifacts. It can subsequently be used to verify the result of measures taken to resolve them (e.g. checking ECG cable connections or adapting the fetal ArtifactSuppress configuration). The safety and effectiveness of the displayed fetal/maternal ECG waveform (i.e. P, QRS and T segments) for evaluation of fetal/maternal cardiac status during labor have not been evaluated. WARNING Intravenous infusion: Do not use the NBP cuff on a limb with an intravenous infusion or arterial catheter in place. This could cause tissue damage around the catheter when the infusion is slowed or blocked during cuff inflation. Skin Damage: Do not measure NBP in cases of sickle-cell disease or any condition where skin damage has occurred or is expected. Unattended measurement: Use clinical judgment to decide whether to perform frequent unattended blood pressure measurements in cases of severe blood clotting disorders because of the risk of hematoma in the limb fitted with the cuff. WARNING Do not use the thermometer in the presence of flammable anesthetics, such as a flammable anesthetic mixture with air, oxygen or nitrous oxide. 19 1 Introduction WARNING Never apply the probe to the patient when the probe is not connected to the unit. Always use a single-use probe cover to limit patient cross-contamination. Measurement errors or inaccurate readings may result when:

probe covers other than the specified probe covers are used (see Tympanic Temperature Accessories on page 267) Insert the probe slowly and carefully to avoid damage to the ear canal and the tympanic membrane. Inspect the probe for damage, holes, tears, or sharp edges to avoid injuring the skin. Always ensure that the used probe cover is removed before attaching a new probe cover. CAUTION Do not immerse the probe in fluids, or drop fluids on the probe. Do not use a probe cover that has been dropped or is damaged. Do not autoclave. To prevent damage to the unit, probe and accessories, refer to the cleaning procedures in the Cleaning and Disinfecting on page 246 chapter. CAUTION Do not use OxiCliq disposable sensors in a high humidity environment, or in the presence of fluids, which may contaminate sensor and electrical connections causing unreliable or intermittent measurements. Do not use disposable sensors when there is a known allergic reaction to the adhesive. WARNING Proper Sensor Fit: If a sensor is too loose, it might compromise the optical alignment or fall off. If it is too tight, for example because the application site is too large or becomes too large due to edema, excessive pressure may be applied. This can result in venous congestion distal from the application site, leading to interstitial edema, hypoxemia and tissue malnutrition. Skin irritations or lacerations may occur as a result of the sensor being attached to one location for too long. To avoid skin irritations and lacerations, periodically inspect the sensor application site and change the application site regularly. Venous Pulsation: Do not apply sensor too tightly as this results in venous pulsation which may severely obstruct circulation and lead to inaccurate measurements. Ambient Temperature: At elevated ambient temperatures be careful with measurement sites that are not well perfused, because this can cause severe burns after prolonged application. All listed sensors operate without risk of exceeding 41C on the skin if the initial skin temperature does not exceed 35C. Extremities to Avoid: Avoid placing the sensor on extremities with an arterial catheter, an NBP cuff or an intravascular venous infusion line. 20 1 Introduction WARNING For fully conscious pediatric or adult patients, who have a normal function of perfusion and sensory perception at the measurement site:

To ensure skin quality and correct optical alignment of the sensor, inspect the application site when the measurement results are suspicious or when the patient complains about pressure at the application site, but at least every 24 hours. Correct the sensor alignment if necessary. Move the sensor to another site, if the skin quality changes. For all other patients:

Inspect the application site every two to three hours to ensure skin quality and correct optical alignment. Correct the sensor alignment if necessary. If the skin quality changes, move the sensor to another site. Change the application site at least every four hours. Injected dyes such as methylene blue, or intravascular dyshemoglobins such as methemoglobin and carboxyhemoglobin may lead to inaccurate measurements. Inaccurate measurements may result when the application site for the sensor is deeply pigmented or deeply colored, for example, with nail polish, artificial nails, dye or pigmented cream. Interference can be caused by:

High levels of ambient light (including IR warmers) or strobe lights or flashing lights (such as fire alarm lamps). (Hint: cover application site with opaque material.) Another SpO2 sensor in close proximity (e.g. when more than one SpO2 measurement is performed on the same patient). Always cover both sensors with opaque material to reduce cross-interference. Electromagnetic interference, especially at perfusion indicator values below 1.0 or signal quality indicator below medium. Excessive patient movement and vibration. WARNING With pulse oximetry, sensor movement, ambient light (especially strobe lights or flashing lights) or electromagnetic interference can give unexpected intermittent readings when the sensor is not attached. Especially bandage-type sensor designs are sensitive to minimal sensor movement that might occur when the sensor is dangling. CAUTION If you measure SpO2 on a limb that has an inflated noninvasive blood pressure cuff, a non-pulsatile SpO2 INOP can occur. If the fetal monitor is configured to suppress this alarm there may be a delay of up to 60 seconds in indicating a critical status, such as sudden pulse loss or hypoxia. 21 1 Introduction WARNING The fetal/maternal monitor is not a diagnostic ECG device. In particular, the display of fetal/maternal ECG is intended only for evaluating signal quality for fetal/maternal heart rate as derived from the ECG waveform. When in doubt, it can be used to identify sources of compromised signal quality, such as noise or muscle artifacts. It can subsequently be used to verify the result of measures taken to resolve them

(e.g., checking ECG cable connections). The safety and effectiveness of the displayed fetal/maternal ECG waveform (i.e., P, QRS and T segments) for evaluation of fetal/maternal cardiac status during labor have not been evaluated. WARNING The fetal/maternal monitor is NOT intended for use during defibrillation, electro-surgery, or MRI. Remove all transducers, sensors, and accessories before performing electro-surgery, defibrillation, or MRI, otherwise harm to the patient or the user can result. WARNING No alarm is possible when Toco MP or CL Toco+ MP transducer is the source of the pulse rate. No QRS tone is audible when Toco MP or CL Toco+ MP transducer is the source of the pulse rate. The Toco MP or CL Toco+ MP transducer signal is significantly less reliable if the patient is up and moving about, or is pushing during the second stage of labor. WARNING No alarm is possible when noninvasive blood pressure is the source of the pulse rate. CAUTION Only use Philips paper. Using paper other than Philips paper may result in the failure to recover traces. CAUTION Ensure that you admit each patient by name, including other patient identification information, and discharge the patient when you have finished monitoring, so that you can identify which trace period

(entry in the patient list) refers to which patient. 22 WARNING Do not operate the monitor if it is wet. If you spill liquid on the monitor, contact your service personnel or Philips service engineer. 1 Introduction Do not perform underwater monitoring (for example, in a bath or shower) using wired transducers. Place the monitor where there is no chance of contact with, or falling into water or other liquid. Do not dry equipment using heating devices such as heaters, ovens (including microwave ovens), hair dryers and heating lamps. Do not put equipment or accessories in autoclave (for sterilization). CAUTION Solutions: Do not mix disinfecting solutions (such as bleach and ammonia) as hazardous gasses may result. Skin contact: To reduce the risk of skin irritations, do not allow a cleaning or disinfecting agent to leave residues on any of the equipment surfaces - wipe it off with a cloth dampened with water, after allowing the appropriate time for the agent to work, or before applying to a patient. Hospital policy: Disinfect the product as determined by your hospital's policy, to avoid long term damage to the product. Local requirements: Observe local laws governing the use of disinfecting agents. Touch display: To clean and disinfect the touch-enabled display, disable the touch operation by switching off the monitor during the cleaning procedure, or by selecting and holding the Main Screen key until the padlock symbol appears on it, indicating that touch operation is disabled. Select and hold again to re-enable touch operation. WARNING Do not put device and accessories in autoclave (for sterilization). WARNING Schedule: Failure on the part of the responsible individual hospital or institution employing the use of this equipment to implement a satisfactory maintenance schedule may cause undue equipment failure and possible health hazards. In case of problems: If you discover a problem with any of the equipment, contact your service personnel, Philips, or your authorized supplier. Electric shock hazard: Do not open the monitor housing. Refer all servicing to qualified service personnel. 23 1 Introduction WARNING To avoid contaminating or infecting personnel, the environment or other equipment, make sure you disinfect and decontaminate the monitor appropriately before disposing of it in accordance with your country's laws for equipment containing electrical and electronic parts. For disposal of parts and accessories such as thermometers, where not otherwise specified, follow local regulations regarding disposal of hospital waste. WARNING Reuse: Disposable accessories and supplies intended for single use, or single use only, and are indicated as such on their packaging. Never reuse disposable accessories and supplies, such as transducers, sensors, electrodes and so forth that are intended for single use, or single patient use only. Approved accessories: Use only Philips-approved accessories. Packaging: Do not use a sterilized accessory if its packaging is damaged. Protection against electric shocks: The transducers and accessories listed in this chapter are not defibrillator proof. Electro-Surgery, Defibrillation and MRI: The fetal/maternal monitors are not intended for use during defibrillation, electro-surgery, or MRI. Remove all transducers, sensors, and accessories before performing electro-surgery, defibrillation, or MRI, otherwise harm can result. WARNING Explosion Hazard: Do not use in the presence of flammable anesthetics, such as a flammable anesthetic mixture with air, oxygen, nitrous oxide, or in oxygen rich environment. Use of the devices in such an environment may present an explosion hazard. WARNING Do not use additional AC mains extension cords or multiple portable socket-outlets. If a multiple portable socket-outlet is used, the resulting system must be compliant with IEC/EN 60601-1 A1:

2012. Do not connect any devices that are not supported as part of a system. Do not use a device in the patient vicinity if it does not comply with IEC/EN 60601-1 A1: 2012. The whole installation, including devices outside of the patient vicinity, must comply with IEC/

EN 60601-1 A1: 2012. Any non-medical device, including a PC running an OB TraceVue system, placed and operated in the patient's vicinity must be powered via a separating transformer

(compliant with IEC/EN 60601-1 A1: 2012) that ensures mechanical fixing of the power cords and covering of any unused power outlets. Do not use USB devices with own power supplies unless an appropriate separation device is used

(either between USB interface and device or between device and power). 24 1 Introduction CAUTION FM20/FM30 only: Although this is an electrical Class II device, it has a protective earth conductor which is needed for EMC purposes. Always use the supplied power cord with the three-prong plug to connect the monitor to AC mains. Never adapt the three-prong plug from the power supply to fit a two-slot outlet. CAUTION The use of accessories, transducers and cables other than those specified may result in increased electromagnetic emissions or decreased electromagnetic immunity of the device. WARNING Do not use cordless/mobile phones or any other portable RF communication system within the patient vicinity, or within a 1.0 m radius of any part of the fetal monitoring system. WARNING For paced patients: The radiated SRR power of the CL SpO2 and NBP Maternal Cableless Measurement Devices, the CL Transmitter, and other sources of radio-frequency energy, when used in very close proximity of a pacemaker, might be sufficient to interfere with pacemaker performance. Due to shielding effects of the body, internal pacemakers are somewhat less vulnerable than external pacemakers. However, caution should be exercised when monitoring paced patients. In order to minimize the possibility of interference, avoid positioning and wearing the Cableless Measurement Devices in very close proximity to a pacemaker. Consult the pacemaker manufacturer for information on the RF susceptibility of their products CAUTION Fetal parameters, especially ultrasound and ECG, are sensitive measurements involving small signals, and the monitoring equipment contains very sensitive high gain front-end amplifiers. Immunity levels for radiated RF electromagnetic fields and conducted disturbances induced by RF fields are subject to technological limitations. To ensure that external electromagnetic fields do not cause erroneous measurements, it is recommended to avoid the use of electrically radiating equipment in close proximity to these measurements. CAUTION The device should not be used adjacent to, or stacked with, other equipment unless otherwise specified. 25 1 Introduction WARNING Leakage currents: If several items of equipment used to monitor a patient are interconnected, the resulting leakage current may exceed allowable limits. ECG electrodes: NEVER allow ECG electrodes to contact other electrical conductive parts, including earth. WARNING The fetal/maternal monitors are NOT intended for use during defibrillation, electro-surgery, or MRI. Remove all transducers, sensors, and accessories before performing electro-surgery, defibrillation, or MRI, otherwise harm to the patient or the user can result. WARNING The fetal/maternal monitors are not intended for use for ECG measurements on patients connected to external electrical stimulator or with cardiac pacemakers. 26 1 Device Classification and Names within this Manual New cableless measurements for fetal and maternal monitoring supplement the Avalon fetal monitor family. The Avalon CL solution consists of the Avalon CL base station, the Avalon CL transducers, and the IntelliVue CL Pods. The IntelliVue CL Pods are only used for maternal measurements within the Avalon CL solution. To differentiate between the CL transducers and the CL Pods, the CL Pod are also referred to as maternal measurement Pods. The following table provides an overview of all the devices within the solution. Avalon FM20/FM30 and FM40/

FM50 Wired Transducers Avalon CL Base Station Avalon CL Transducers IntelliVue CL Pods FM20/

FM30 FM40/

FM50 US transducer wired M2702A and M2703A Avalon CL Base Station M2704A and M2705A 866074 Avalon CL Toco+ MP Transducer cableless IntelliVue CL NBP Pod cableless M2736A 865216 866075 27 1 Introduction Avalon FM20/FM30 and FM40/

FM50 Wired Transducers Avalon CL Base Station Avalon CL Transducers IntelliVue CL Pods IntelliVue CL SpO2 Pod cableless 865215 Avalon CL US Transducer cableless Avalon CL ECG/IUP Transducer cableless Toco/ Toco MP transducer wired Toco+

transducer with ECG/

IUP capability wired Patient Module for ECG/IUP M2734A and M2734B M2735A M2738A 866076 866077 28 2What's New 2 What's New This section lists the most important new features and improvements to the fetal monitors and their user interface introduced with Release J.3. You may not have all of these features, depending on the fetal monitor configuration purchased. What's New in Release J.3 Avalon CL Transducer System The Avalon CL system provides cableless monitoring with the Avalon FM20/FM30 and FM40/FM50 with the same functionality and performance as the wired measurement devices (e.g. twin and triplets monitoring). The Avalon CL has a straight-forward handling and operating concept. The cableless transducers are assigned by simply docking them at the base station, no further configurations are necessary. The Avalon CL system includes the following features:

Cableless monitoring of twins and triplets Cableless maternal measurement Pods CL SpO2 and CL NBP Maternal pulse from a CL Toco+ MP (Smart Pulse) transducer A cableless ECG/IUP transducer measuring IUP and fetal/maternal ECG Watertight cableless transducers that can be used to monitor in water Patient call that pages an ambulating mother with an audible signal emitted by the worn CL transducers. Out of range audible signal emitted by the worn CL transducers to inform an ambulating mother that she is approaching the limit of the active signal area of reach. A transducer finder LED on all cableless transducers to help identify the assigned transducer Support For Use of Maternal Cableless Measurement Devices The IntelliVue measurement pods are patient-worn, battery powered measurement devices for SpO2 and NBP. The devices provide measurement values on the built-in display and communicate them to the fetal monitor using the wireless short range radio (SRR) interface of the Avalon CL base station. Maternal Temperature Measurement To measure maternal temperature, the new optional Tympanic Temperature device (866149) is available for the Avalon fetal monitors. The measurement data is:

fully documented at the local recorder and the OB system, can be displayed as a numeric on the screen, and is printed out on the recorder trace strip. 29 2 What's New Manually Entered Maternal Temperature Measurements Manually measured temperatures can be entered manually into the fetal monitor and stored in the database. They are also displayed as a numeric on screen, and are printed out on the recorder trace if required. New Design for the User Interface The user interface for the fetal monitors has been redesigned to bring the presented information into the foreground, letting the structural elements such as keys and frames retreat into the background. Additionally special regard was given to making the "look and feel" similar to that of standard software products. New SmartKeys The Start ECG SmartKey is renamed to Record ECG . With the Call Patient SmartKey you can now page patients who are ambulating wearing cableless transducers. With the Tele Info SmartKey you can call up the Tele Info window on the fetal monitor display. In the Tele Info window you can control and view the status of the cableless transducers from the connected Avalon CL system. With the Enter Temp SmartKey a pop-up window opens showing a numeric pad for entering externally measured maternal temperature values. Coincidence INOP Tone When the cross-channel verification detects that the signal of the maternal heart rate coincides with the fetal heart rate, the Coincidence INOP is issued with a tone at the fetal monitor. The Coincidence INOP tone has a configurable delay. Increased Internal Back-up Memory The internal back-up memory is now able to store data at least 3 hours. USB Interface An optional USB interface allows the use of USB printers, bar code readers, and input devices such as a keyboard or mouse. Flexible Nurse Call Interface An optional Flexible Nurse Call interface allows now the connection of a nurse call device to the fetal monitors. DHCP Support The DHCP support offers an alternative to BOOTP. DHCP (dynamic host configuration protocol) enables the fetal monitors to request an IP address (internet protocol address) from the connected network (OB TraceVue/IntelliSpace Perinatal) automatically. 30 2 What's New Data Export Support You can now export measurement values from the monitor to other devices via the LAN or RS232 interface. NBP Configurable Measurement Sequence Up to four measurement cycles can be set up which will run consecutively. For each cycle you can set the number of measurements and the interval between them. By setting the last cycle to run continuously you can have regular measurements continue after the sequence has run. Alarms Enhancements In addition to the standard blue INOPs, some INOPs can now be configured as red or yellow INOPs to provide a severity indication (ECG Leads Off, NBP Cuff Overpress, Cuff Not Deflated). A small number of INOPs are always yellow or red to indicate a severity corresponding to red and yellow alarms. For the invasive pressure measurement, the extreme pressure alarms Extreme High and Extreme Low can be made available for your monitor in Configuration Mode and are additional to the standard High and Low limit alarms. The Review Alarms window now shows when the monitor was switched on (after being switched off for longer than 1 minute) and any changes made to the Standby and paired status. In order to improve alarming on asystole under certain conditions, you can set Asystole Detect. in Configuration Mode to Enhanced. In enhanced mode an asystole alarm will be suppressed for up to five seconds if a valid beat-to-beat Pulse is detected from a Pressure. Alarm Reminder In Configuration Mode you can set now an Alarm Reminder. The Alarm Reminder emits an audible reminder of alarm conditions that remain active after the alarm is acknowledged. This reminder may take the form of a repetition of the alarm tone for a limited time, or an unlimited repetition of the alarm tone (this is the same as a new alarm). The interval between silencing the alarm and sounding the reminder tone can be set to one, two, or three minutes. Auto Free In Configuration Mode you can now set an Auto Free setting which discharges a patient automatically when the fetal monitor is powered off, or is in standby mode for a set time. Only the demographic patient data is deleted, the trace data is not affected. What's New in Release G.0 Battery Option and Patient Transport Improvements for the Avalon FM20 and FM30 For the FM20/FM30, you can now switch between battery-powered and mains-powered operation without interrupting monitoring. The monitor is connected to the AC mains power with the external power supply. Traces of multiple patients can be recorded during transport and can automatically be uploaded to OB TraceVue/IntelliSpace Perinatal (Rev. G or higher) when reconnected. 31 2 What's New A bed hanger is available as a mounting option, especially for patient transport purposes within healthcare facilities. Maternal Pulse from Toco MP Transducer The new Toco MP transducer can measure the maternal pulse rate, in addition to the other available sources; MECG, SpO2, and NBP. With sensors built-into the bottom cover of the Toco MP transducer, and using a measurement technology similar to SpO2, it automatically gives you an additional maternal pulse source for Cross-Channel Verification (CCV). The new Toco MP transducer is standard for the whole product family, Avalon FM20 to FM50. Non Stress Test (NST) Analysis as Clinical Decision Support (CDS) Application The optional NST Report Trace Interpretation feature allows you to automatically interpret FHR traces and to generate a printed NST report, equivalent to the NST report functionality in OB TraceVue Rev. F and based on the NICHD guidelines from 1997. The application can be adapted to domestic or hospital guidelines. A report of the NST analysis can be printed automatically or on demand. This software option is available for the whole product family, Avalon FM20 to FM50. FHR Sound Source A newly-connected fetal measurement (FHR or DFHR) automatically becomes the FHR sound source, without the need for manual intervention. If you prefer the previous behavior, this can be changed in Configuration mode (Audio Select setting). FHR Numeric Display The FHR numeric display shows changes in fetal heart rate faster and is updated more frequently. Improved FHR and DFHR Label Concept A DFHR numeric (fetal heart rate from DECG measurement) now also has a unique number (DFHR1, DFHR2, or DFHR3) to allow easier identification of the related trace in OB TraceVue/IntelliSpace Perinatal. New SmartKeys You can control fetal heart sound volume directly with the configurable SmartKeys (FHR Vol. Up and FHR Vol.Down) on the monitors screen. Now the Toco Baseline SmartKey automatically turns into the Zero IUP SmartKey when switching to IUP measurement. Trace Separation On/Off Operation Now you can switch the Trace Separation on or off in every FHR setup menu. NBP 32 To prevent the NBP measurement from being switched on or off accidentally, this operation is now only available in Configuration Mode. 2 You can enter the NBP setup menu by touching the NBP numeric (on the screen) before the first measurement is taken. Algorithm enhancements (more tolerant of movement artifacts). Alarms There is an individual Alarm Tone Volume setting for Yellow, Red and Cyan alarms. The new alarm settings available in Configuration Mode are:

AutoIncrease Vol and IncreaseVolDelay AlarmsOffAtStart ConfirmAlarmsOff For a detailed description of the settings see the Configuration Guide. CCV INOP There is a new INOP (technical alarm) Coincidence after 1 minute of persistent coincidence warning. New Demographic Fields Date of Birth and Gestational Age can be entered for complete documentation in an NST Report

(supporting the optional NST Trace Interpretation software feature). A Middle Name field is now available in the admission form - whether it appears is configurable. Two additional ID fields Lifetime ID and Encounter ID can also be configured to appear, and their names can be customized to fit hospital requirements. The default label of the Lifetime ID is MRN. Recorder It can now be configured whether the recorder speed can only be adjusted in Configuration mode, or also in Monitoring mode. When recorder speed is changed, a new trace header is printed. Date and/or time changes are annotated in real time recording. Stored Data Recording Printing progress is shown while printing a trace from the internal back-up memory. FHR Sound Volume Volume steps are optimized in the low range to allow finer FHR sound volume adjustments. Avalon CTS An antenna symbol is displayed next to MECG waves if an Avalon CTS is used. 33 2 What's New 34 3Basic Operation 3 Basic Operation This chapter gives you an overview of the monitor and its functions. It tells you how to perform tasks that are common to all measurements (such as entering data, switching a measurement on, changing some monitor settings, and setting up the recorder). The alarms section gives an overview of alarms. The remaining sections tell you how to perform individual measurements, and how to care for and maintain the equipment. Supported Measurements The following Fetal measurements are supported:

Fetal Monitor or Model FM20 FM30 FM40 FM50 Fetal Heart Rate

(FHR) via US

(including Twins) Standard Optional Standard Optional Standard Optional Standard Optional Triple FHR via US Optional Optional Optional Optional) Optional Optional Optional Optional Toco FHR via Direct ECG

(DECG) Intrauterine Pressure (IUP) Standard Standard Standard Standard Standard Standard Standard Standard

Standard Standard Standard Standard

Standard Standard Standard Standard 35 3 Basic Operation The following Maternal measurements are supported:

Fetal Monitor or Model Maternal Heart Rate (MHR) via Maternal ECG Electrodes Standard Standard FM20 Maternal ECG

(MECG) Wave Maternal Pulse from Toco

Standard Standard Standard Standard Standard FM30 Standard Standard Standard FM40 Standard Standard

Standard Standard Standard Standard Standard Non-invasive Blood Pressure with Pulse Rate Optional (built-in) Pulse Oximetry

(Maternal SpO2) with Pulse Rate

Maternal Temperature Optional

(Interface cable and manual entry) Optional

(cableless) Optional (built-in) Optional (built-in) Optional Optional

(cableless)

(Interface cable and manual entry) Optional

(cableless) Standard (built-in) Standard (built-in) Optional Optional

(cableless)

(Interface cable and manual entry) Optional

(cableless) Standard (built-in) Standard (built-in) Optional Optional

(cableless)

(Interface cable and manual entry) Standard Standard Standard FM50 Optional

(cableless) Optional

(cableless)

Avalon FM20 and FM30 This section outlines the capabilities of your monitor. 36 3 Basic Operation Avalon FM20 The Avalon FM20 fetal/maternal monitor provides a solution for external fetal monitoring applications, and optional noninvasive maternal vital signs. You can monitor fetal heart rates (FHRs) externally using ultrasound, uterine activity and maternal pulse using an external Toco transducer, and the maternal heart rate (MHR) with maternal ECG electrodes, and optionally, noninvasive blood pressure and maternal oxygen saturation (SpO2). Measurements are displayed on a 6.5-inch color display as numerics. The display is a touchscreen, and you operate the monitor using this touchscreen interface. The integrated recorder documents fetal and maternal measurements as well as the user-defined annotations. You can connect the monitor to an OB TraceVue/IntelliSpace Perinatal system via the RS232 connection, or over a LAN connection (with OB TraceVue Revision E.00.00 and later, or IntelliSpace Perinatal Revision H.0 and later). Avalon FM30 The Avalon FM30 fetal/maternal monitor offers a solution for both external and internal fetal monitoring applications, and optional noninvasive maternal vital signs. The Avalon FM30 shares all the features and capabilities of the Avalon FM20. In addition, you can monitor one FHR internally with a direct fetal electrocardiogram (DECG), uterine activity internally using an intra-uterine pressure (IUP) catheter together with a Toco+ transducer or patient module. The Avalon FM30 carries the IP label, indicating that it is capable of intrapartum monitoring. FM20/30 with Battery Option

#E25 Only The battery option for the FM20/30 provides support for the in-transport monitoring of all measurements when disconnected from a power supply. Existing data storage is automatically uploaded to OB TraceVue or IntelliSpace Perinatal after reconnecting it to the system. Trace printing during transport is also possible. 37 3 Basic Operation Avalon FM40 and FM50 This section outlines the capabilities of your monitor. Avalon FM40 The Avalon FM40 fetal/maternal monitor provides a solution for external fetal monitoring applications, and noninvasive maternal vital signs. You can monitor fetal heart rates (FHRs) externally using ultrasound, uterine activity using an external Toco transducer, and the maternal heart rate (MHR) via maternal ECG electrodes, and non-invasive blood pressure and maternal oxygen saturation (SpO2). Measurements are displayed on a 6.5-inch color display as numerics. The display is a touchscreen, and you operate the monitor using this touchscreen interface. The integrated recorder documents fetal and maternal measurements as well as the user-defined annotations. You can connect the monitor to an OB TraceVue/IntelliSpace Perinatal system with the RS232 connection, or over a LAN connection (with OB TraceVue Revision E.00.00 and later, or IntelliSpace Perinatal Revision H.0 and later). Avalon FM50 The Avalon FM50 fetal/maternal monitor offers a solution for both external and internal fetal monitoring applications, and noninvasive maternal vital signs. The Avalon FM50 shares all the features and capabilities of the Avalon FM40. In addition, you can monitor one FHR internally with a direct fetal electrocardiogram (DECG), and uterine activity internally using an intra-uterine pressure (IUP) catheter together with a Toco+ transducer or patient module. The Avalon FM50 carries the IP label, indicating that it is capable of intrapartum monitoring. 38 Avalon CL Transducer System 3 Basic Operation The Avalon CL Fetal Transducer System lets you monitor the patient continuously with cableless transducers during the antepartum period, labor, and delivery. You can monitor the fetal heart rate

(FHR) using noninvasive CL Ultrasound transducers, or invasively using the CL ECG/IUP transducer with the direct electrocardiogram (DECG). The uterine activity can be monitored using an external CL Toco+ MP transducer. The fetal and maternal parameters are measured and transmitted via radio frequency from the CL transducers to the CL base station, eliminating the need for patient cables. With the Avalon CL Transducer System you can monitor a single fetus, twins and triplets. The Avalon fetal monitor (FM20-FM50) connected to the CL base station displays and records the parameters. All the CL transducers are watertight. You can continuously monitor patients in a bath or shower using the CL Toco+MP and the CL Ultrasound transducers. The system should only be used by, or under the direct supervision of, a licensed physician or other health care practitioner, who is trained in the use of FHR monitors and in the interpretation of FHR traces. Getting to Know Your Avalon FM20/FM30 Overview Touchscreen Display (tilt and fold) Power LED Paper Drawer Paper Drawer release 1 2 3 4 5 Connectors 39 3 Basic Operation Right Side with Battery Option Left Side 1 On/Off Switch 2 Power Connector 1 On/Standby Switch 2 MSL Connector SpO2 Socket (optional) 1 2 Noninvasive Blood Pressure Socket

(optional) Fetal Sensor Sockets 3 Each of the fetal sensor sockets accepts any fetal transducer, one Avalon CL or one Avalon CTS Cableless Fetal Transducer System base station, or an event marker. 40 Bottom 3 Basic Operation LAN/RS232 system interface There are five optional interfaces available for the Avalon FM20/30 monitor:

Dual PS/2 interface MIB/RS232 interface USB port You can use two of the five optional interfaces at the same time. Flexible Nurse Call Optional Interfaces Description Flexible nurse call interface card USB ports 1 LAN/RS232 system interface 2 Dual PS/2 system interface 41 3 Basic Operation Rear 1 Display Release 2 Carrying Handle 3 Built-in Stand Getting to Know Your Avalon FM40/FM50 Front Touchscreen color display 1 2 Transparent paper guide with tear-off edge Paper eject button Power LED 3 4 5 On/Standby switch 6 Recorder paper table 7 Fetal sensor sockets 8 Noninvasive blood pressure socket 9 SpO2 socket Connect any fetal sensor or patient module at the fetal sensor sockets, including an Avalon CL or an Avalon CTS via interface cable (with red connector). 42 Rear 3 Basic Operation 1 Reserved for future use: protective earth intended for use in system installations. 2 Equipotential grounding point 3 4 5 Power cord connector Loudspeaker Slot 01 for optional LAN/RS232 system interface (for connection to an obstetrical information and surveillance system) Slot 03 reserved for future use 6 7 Video output (VGA) 8 Telemetry interface 9 Slot 02 for optional interfaces: Either dual PS/2 system interface (A) for mouse and keyboard connection) Or MIB interface (B) for external touch screen connection. Two Avalon CL, or one Avalon CTS can be also connected to the Telemetry interface sockets using the interface cable (with black connector). Additional Optional Interfaces Optional Interfaces Description Flexible nurse call interface card USB ports 43 3 Basic Operation Transducers 1 2 Transducer finder LED - lights up on the transducer providing the measurement source

"MP" for M2734B "Toco MP"

transducers (additionally capable of providing the maternal pulse measurement) 3 Belt Button 1 Cable - connects to any of the four fetal sensor sockets on the monitor The M2736AA US transducer is identical to the M2736A US transducer, including all specifications 1 Connector - for connecting ECG/IUP adapter cables

(M2735A Toco+ transducer only) Toco (M2734A) and Toco MP Transducer (M2734B) Ultrasound Transducer (M2736A) Toco+ Transducer with ECG/IUP capability

(M2735A) 44 3 Basic Operation 1 Butterfly belt clip (shown fitted;

for use with belts without button holes) 2 Close-up of MECG adapter cable connected to Toco+ transducer 3 Close-up of active finder LED 1 Connector - for connecting ECG/

IUP adapter cables (same as for Toco+ transducer) 2 Cable - connects to any of the four fetal sensor sockets on the monitor Patient Module for ECG/IUP (M2738A) 45 3 Basic Operation Getting to Know Your Avalon CL Front Transducer docking slots 1 2 On/Standby button with power LED 3 Device label 4 LED for optional cableless pods 5 Docking slots for cableless pods WARNING To avoid magnetic interference affecting the mode of the pacemaker, ensure that the Avalon CL base station does not come into close contact with implanted pacemakers. This equipment generates, uses, and radiates radio-frequency energy, and if it is not installed and used in accordance with its accompanying documentation, may cause interference to radio communications. Operation of this equipment in a residential area may cause interference, in which case the users must take whatever measures may be required to correct the interference. 46 3 Basic Operation Docking Slot for Cableless Transducers The Avalon CL base station has three docking slots to mechanically hold the CL transducers. The flexible electronic contacts identify the transducer type after docking. The transducers are charged while docked. The base station has a built-in radio interface with an integrated antenna to communicate with the transducers for assignment, configuration, and for transducer firmware updates. The transducers can be controlled with the base station and the fetal monitor. On/Standby Button Pressing the On/Standby button switches the Avalon CL base station between the two modes On and Standby. 1 On/Standby button If you switch the base station to On, the LED button lights up green. The base station is ready for use. The CL transducers are charging. When the transducers are picked up from their docking slot, the base station sets up the radio communication to the CL transducer automatically. Wired transducers connected to the fetal monitor are disabled, and the antenna symbol for the CL transducer is displayed on the screen of the fetal monitor. If you switch the base station to Standby, the LED button turns off. The base station is now in Standby mode. The docked CL transducers continue charging. No radio communication occurs, any existing radio communication is stopped. If the LED of the On/Standby button turns red, it indicates a technical problem has occurred that needs your attention. Check your monitor for a possible related INOP message. 47 3 Basic Operation Docking Slots for Cableless Measurement Pods The Avalon CL base station has one docking slot to mechanically hold an IntelliVue CL pod. The electronic contacts identify the CL pod type after docking. The CL pod is charged while docked. The LED under the docking slot indicates the battery status of the CL pod. The base station has a built-in short range radio interface with an integrated antenna to communicate with the CL pod for assignment and configuration. The CL pod can be controlled with the base station and the fetal monitor. 1 Docking slot for CL pods WARNING Short range radio connections are subject to interruption due to interference from other radio sources in the vicinity, including microwaves, bluetooth devices, WLAN devices (802.11b,g,n) and cordless phones. Depending on the strength and duration of the interference, the interruption may occur for an extended period. A loss of connection, due to moving out-of-range, interference, or for other reasons, is indicated with a No Host Monitoring INOP (here the host is the fetal monitor) on the NBP or SpO2 Pods, or a cl NBP Disconnect or cl SpO Disconnect INOP at the fetal monitor. Correct channel configuration is important, see the Configuration Guide for details. 48 Rear and Bottom 3 Basic Operation 1 Name plate 1 Manufacturer label 2 Cable reel 49 3 Basic Operation Cableless Transducers The cableless Avalon CL transducers have a built-in radio interface with an on-board, integrated antenna. The fetal monitor connected to the Avalon CL base station can control the transducer using radio communication. The transducer transmits measured values, alarms, and status information to the fetal monitor. The cableless transducers are assigned by simply docking them at the Avalon CL base station. If they are picked up from their docking slot at the base station, they are automatically activated. CAUTION To ensure the correct assignment of CL transducers to the fetal monitor in use, always dock them at the base station connected to that fetal monitor before use. This is particularly important when you add an additional CL transducer that was previously docked at another base station. 1 Transducer finder LED - lights up on the transducer providing the measurement source. 2 CL Toco+ MP transducers

(additionally capable of providing the maternal pulse measurement) 3 Belt button CL Ultrasound transducer 50 3 Basic Operation CL ECG/IUP transducer Radio Range of CL Transducers The CL transducers have a operating range around the base station of at least 70 m in the line of sight. Obstructions as walls, metal doors, elevators and other environment structures can lead to signal loss. The Tele symbol indicator and the Tele Info window on the monitor's display (see Screen Elements on page 56 and Tele Info Window on page 92) provide information on the status of the signal strength. When a patient is approaching the end of range, the US sound is replaced by an artificial QRS sound

(like DECG), and the DECG and MECG waves are no longer displayed on the monitor. Connector Cap for the CL Toco+ MP Transducer The CL Toco+ MP transducer is delivered with a connector cap covering the MECG/DECG/IUP connector. The connector cap is designed to cover the connector, not to protect it from water. (The connector itself is water-proof and may be immersed in water). You can reorder lost connector caps in a kit of 10 (989803184841). 51 3 Basic Operation Cableless Transducer LED Indication The cableless transducers have a multi-color LED that indicates the status of the transducer with specific colors. This LED remains visible when the transducer is correctly attached to the transducer belt (Philips standard belt). 1 LED LED Status White White one short blink Green Yellow Red Cyan Meaning The LED lights up to identify the US transducer among other US transducers, and to easily verify the correct transducer assignment

(transducer finder). The transducer finder LED is controlled by the fetal monitor. Click on the numerics to identify the corresponding US transducer. The LED also lights up when the mother is paged with the Call Patient SmartKey. The LED shortly lights up to indicate that the transducer successfully opened a radio communication with the base station and that it is ready to use. The LED lights up green when the transducer is fully charged and docked at the base station. The LED lights up yellow when the transducer is charging and docked at the base station. The LED lights up red when the transducer is out of battery and has to be recharged. The LED lights up cyan to indicate a technical problem that needs your attention. Check your fetal monitor for a related INOP. 52 CL Transducer Battery 3 Basic Operation Battery replacement is recommended after 500 charge/discharge cycles *2) or if the battery is older than 4 years whatever is reached first. If the battery of a cableless transducer has aged and an exchange of the battery is highly recommended, a prompt message is displayed at the fetal monitor for ca. 60 seconds. The prompt is repeated whenever the Tele Info window is opened until the battery is replaced. Depending on the transducer type the following messages are displayed:

cl US battery has aged. Replacement strongly recommended cl Toco battery has aged. Replacement strongly recommended cl ECG/IUP batt has aged. Replacement strongly recommended If you are getting this message contact your service personnel so they can replace the CL transducer's battery. The date of manufacture and number of charge/discharge cycles can be inquired on the connected fetal monitor. For battery cycle and battery life specification of the CL pods (NBP and SpO2) please refer to the Service Guide of the Cableless Measurements. Charge Cycle The CL transducer batteries are designed for frequent recharging. A complete charging cycle is only reached and counted, when all recharging periods equal a 100% charge (900 mAh equal 8 hours continued operation). Audio Signal CL Transducers The Avalon CL transducers have two audio signals:

If a tone sequence is played, the transducer was triggered by the fetal monitor to page the patient wearing it, or to locate a not docked transducer. An INOP tone indicates that the transducer has detected a technical problem (INOP). Check your fetal monitor for a related INOP message. 53 3 Basic Operation CL Pods The two CL Pods provide measurement values for SpO2 and NBP on the built-in display, and communicate them to other system components using a wireless short range radio (SRR) interface. They are controlled with SRR from the Avalon CL base station and the connected fetal monitor. The maternal measurement pods are easily assigned by docking them at the Avalon CL base station. CL NBP Pod CL SpO2 Pod The SpO2 Pod and the NBP Pod have an LCD display and three keys for basic operation e.g. to assign the device to a patient:

Integrated LCD display 1 2 Hard keys 3 Measurement identifier For further operational details read the IntelliVue Cableless Measurements Instruction for Use. 54 Battery Status LED for CL Pods The CL Pods do not have their own battery status LED. On the Avalon CL base station the battery status LED for the CL Pods is located directly under the docking slot. 1 Battery status LED for CL Pods 3 Basic Operation The battery status LED shows five different states:

Status Green Yellow Yellow blinking Cyan Meaning The docked CL Pod is fully charged. The docked CL Pod is charging. The communication is established with the docked CL Pod. Indicates that the docked CL Pod or the charging slot has a technical problem that needs your attention. Check your fetal monitor for a related INOP message. The battery status LED is off, when no CL Pod is docked. Off Audio Signal The Avalon CL base station has audio signals to let you know when a transducer's battery has to be recharged, or if the base station cannot set up radio communication with a CL transducer or a CL Pod. Only active CL transducers and CL Pods emit an audio signal. If the base station issues a descending tone sequence, the attempt to set up radio communication to a CL transducer or a CL Pod has failed. If an interval tone is played, the battery of one or more the CL transducers or CL Pods need to be recharged. Operating and Navigating Your monitor has a touchscreen. Everything you need to operate the monitor, except the on and off switch, is contained on its screen. Most screen elements are interactive. Screen elements include measurement numerics, screen keys, information fields, status indicators, alarms fields, and menus. Operator Position The typical operator's position is in front of the monitor. 55 3 Basic Operation FM40/50 If an optional external touch display is connected to the monitor, you can operate the monitor using the external touch display. 1 Monitor Information line 2 Measurement area 3 Key area Screen Elements Monitor Information Line 1 LAN connection status indicator only. RS232 system connection is not indicated. The train icon indicates if the fetal monitor is connected to OB TraceVue/IntelliSpace Perinatal, via a LAN cable or not. Patient identification 2 3 Date and time 4 Bed label (when connected to a Philips OB TraceVue/IntelliSpace Perinatal system) Fetal heart sound volume adjust/

indicator 5 6 Alarm volume adjust/indicator 7 INOP and alarm status area - shows active alarm messages 56 Measurement Area 3 Basic Operation 1 Antenna symbol (indicates a cableless measurement from a connected Avalon CL or Avalon CTS system). Fetal trace recorder - status indicator 2 Configurable alarm limits 3 NST test 4 Audio source symbol 5 Measurement numeric 6 Alarms off symbol 7 8 Avalon CL or Avalon CTS system - status indicator 9 Battery status indicator 10 Status line - shows status and prompt messages 11 Signal quality indicator: good, acceptable, poor 12 Fetal heart rate measurement label 13 Measurement unit (configurable) 14 Cross-Channel Verification symbol (see Cross-Channel Verification (CCV) on page 149) 15 NST timer, if configured (default is Off) 57 3 Basic Operation Screen Details Icon 58 Description The antenna symbol indicates a cableless measurement

(Avalon CL or Avalon CTS). Indicates a short range radio measurement (IntelliVue CL Pods). Signal quality indicator:

1 Good 2 Acceptable 3 Poor Fetal trace recorder - status indicator Fetal recorder is on Fetal recorder is off (when Paper Save Mode is off) Fetal recorder is off (when Paper Save Mode is on) There is a user-solvable recorder error (paper out, paper jam, wrong paper scale set) Fetal recorder is defective: call service Avalon CL or Avalon CTS system - status indicator: An interface cable is connected to the monitor, a base station is connected, powered on, and at least one cableless transducer has been taken from the base station and is active. Any connected wired transducers are disabled. An interface cable is connected to the monitor, the base station is connected, powered on, and cableless transducers are ready to use, but no cableless transducers are currently active (all are still docked at the base station). An interface cable is connected to the monitor, but the base station is not connected to the interface cable, or it is disconnected from AC mains, or is in Standby mode. 3 Basic Operation Description The CL transducer is moved away from the base station approaching the limit of the area of reach. The US sound is replaced by an artificial QRS sound (like DECG). The DECG and MECG waves are no longer displayed. Icon Key Area 1 SmartKeys - these can vary according to your monitor's configuration 2 Main Screen -

which closes all open menus and windows and returns to main screen Scroll to display more SmartKeys Silence - key which acknowledges all active alarms by switching off audible alarm indicators 3 4 Keys The monitor has three different types of keys. Permanent Keys A permanent key is a graphical key that remains permanently on the screen, giving you fast access to functions. Key Function Acknowledges all active alarms by switching off audible alarm indicators. Name Silence Main Screen Closes all open menus and windows and returns to the main screen. 59 3 Basic Operation SmartKeys SmartKeys are configurable graphical keys, located at the bottom of the main screen. They give you fast access to functions. The selection of SmartKeys available on your monitor depends on your monitor configuration, and on the options purchased. SmartKey Name Main Setup Pause Alarms Start Recordng Record ECG Wave Function Enters main setup menu Pauses alarm indicators. Pause duration depends on monitor configuration. If the pause duration is infinite, this key is labeled Alarms Off Select again to immediately re-enable alarm indicators Turns the trace recorder on Starts printing the MECG, DECG or both waves, when both are available Patient Demogr. Enters the patient identification menu to admit/discharge QuickAdmit Quick admits the patient for monitoring Toco Baseline Resets Toco baseline Zero IUP Start/ Stop Start NBP Repeat Time Zeros IUP measurement Starts/stops manual noninvasive blood pressure measurement Starts auto series Stops current automatic measurement within series Starts manual noninvasive blood pressure measurement Starts auto series Sets the time interval between two noninvasive blood pressure measurements Sound Vol. Up Increases the fetal heart rate volume Monitor Standby Enters the Standby mode, suspends monitoring. All numerics and waves disappear from the display. All settings and patient data information are retained 60 SmartKey Name Recorder Start/ Stop Function Turns the trace recorder on or off 3 Basic Operation Paper Advance Advances the paper automatically to the next fold Stop Recordng Turns the trace recorder off Stored Data Rec Prints trace data from the monitor's memory Enter Notes Enters notes Timer Enters NST timer window Set Marker Marks an event Stop All Stop NBP NBP Modes Defaults Stops all noninvasive blood pressure measurements Stops manual noninvasive blood pressure measurement Stops current automatic measurement within series Access NBP mode selection and setup, with direct start/

stop function Loads User Default Sound Vol. Down Decreases the Fetal Heart Rate volume NST Report Call Patient Initiates an NST trace interpretation and obtains a Non-

stress test (NST) report Pages the patient. Only enabled if at least one CL transducer is currently active Tele Info Calls up the Tele Info window Enter Temp Allows the manual input of the patient's temperature 61 3 Basic Operation Pop-Up Keys Pop-up keys are context-sensitive graphical keys that appear automatically on the monitor screen when required. E.g. the Confirm pop-up key appears when you need to confirm a change. Using the Touchscreen Select screen elements by pressing them directly on the monitor's screen. Disabling Touchscreen Operation 1 2 To temporarily disable the touchscreen operation of the monitor, press and hold the Main Screen permanent key for about three seconds. A red padlock will blink on the Main Screen permanent key. Press and hold the Main Screen permanent key again for about three seconds to re-enable the touchscreen operation. Operating Modes Select the Main Setup menu. Select Operating Modes and select a mode. When you switch on the monitor, it starts up in Monitoring Mode. To change to a different mode:

1 2 Your monitor has four operating modes. Some are passcode protected. Mode Description Password Protected Monitoring Mode Demo Mode The Monitoring Mode is the normal operating mode to monitor patients. You can change elements such as alarm limits. When you discharge the patient, these elements return to their default values. You cannot select or change grayed out items. These items are for your information only. To change these items, switch to the Configuration Mode. The Demo Mode is used for demonstration and training purposes. Do not change into Demo Mode during monitoring. When transducers are connected to the monitor and the recorder is on, a demo trace is recorded. But the demo trace is not transmitted to an information and surveillance system such as OB TraceVue/IntelliSpace Perinatal. no yes 62 3 Basic Operation Mode Description Configuration Mode Service Mode The Configuration Mode is for personnel trained in configuration tasks. You can change and store the default values and patient profiles permanently in the Configuration Mode. These tasks are described in the Configuration Guide. During installation, the fetal monitor is configured for use in your environment. This configuration defines the default settings you work with when you switch on the fetal monitor. The Service Mode is for trained and authorized service personnel only. Password Protected yes yes A field displayed at the fetal monitor screen indicates if the monitor is in Demonstration Mode, Configuration Mode, or Service Mode. To change to a different mode, select this field. Automatic Screen Layouts Your monitor's preconfigured screen layouts define how measurement information is arranged on the screen. The monitor automatically applies the correct screen layout for the measurements you are monitoring. No user action is required. Connecting or disconnecting transducers, or switching the noninvasive blood pressure measurement on or off, results in an automatic adjustment of the screen layout. When a measurement is off, its numerics are removed from the monitor's screen. The monitor stops acquiring data and generating alarms for this measurement. If you disconnect a transducer while it is performing a measurement, the monitor issues a disconnect INOP (and in the case of SpO2, replaces the measurement numeric with a question mark). Settings This section describes the various settings available on the monitor. Active Settings What the monitor displays, and the way it operates, is controlled by its settings. They determine screen content, layout, high and low alarm limits and so forth. The "active settings" are the current settings the monitor uses, including any adjustments made by the last user. Active settings are not permanent, but are retained after a loss of mains power. There are also two preconfigured default settings:

User Default Factory Default 63 3 Basic Operation User Default The User Default is a complete configuration stored in the monitor's long-term memory. You can store the active settings, modified to your preference, in the User Default (in Configuration Mode). In monitoring mode, you can load the User Default settings to return to your preferred settings:

1 Select the Defaults SmartKey 2 Select Confirm in the dialog box to load the User Default. Factory Default The Factory Default is a complete configuration pre-defined at the factory. You cannot modify it. In Configuration Mode, you can load the Factory Default as the active settings. CAUTION This resets all settings to factory defined values, but be aware that some values will differ from those with which the fetal monitor was originally shipped from the factory (recorder speed and paper scale type will need to be corrected, for instance). After loading the Factory Default, check the settings and, if necessary, change them to the settings you normally use. You can use the Factory Default as the basis for producing your User Default. See the Service Guide for details. Global Settings General monitor configuration settings are stored in the Global Settings. These include settings for line frequency, QRS type, and whether the monitor is automatically reset to the User Default after a power interruption of more than one minute. You can change the Global Settings in Configuration Mode. Changing Measurement Settings Each measurement has a setup menu in which you can adjust all of its settings. You can enter a setup menu:

1 with the measurement numeric - select the measurement numeric on the screen to enter its setup menu. For example, to enter the Setup FHR1 menu, select the FHR1 (fetal heart rate 1) numeric. 2 with the Main Setup SmartKey - if you want to setup a measurement when the measurement is switched off, use the Main Setup SmartKey and select Measurements. Then select the measurement name from the pop-up list. With this SmartKey you can access any setup menu in the monitor. This guide always describes the entry method using the measurement's setup menu. You can use the method you prefer. 64 3 Basic Operation Switching the Noninvasive Blood Pressure Measurement On and Off The noninvasive blood pressure measurement is the only measurement that you can manually switch on and off. To do this:

1 Enter the noninvasive blood pressure measurement's setup menu. 2 Select NBP to toggle between on and off. The screen display indicates the active setting. Changing Monitor Settings To change monitor settings such as brightness, or touch tone volume:

1 Enter the Main Setup menu. 2 Select the setting you want to change, or select User Interface to enter a sub menu where you can change user interface settings. Adjusting the Screen Brightness 1 Enter the Main Setup menu. 2 3 4 Select User Interface. Select Brightness. Select the appropriate setting for the screen brightness. 10 is the brightest, 1 is the least bright. Optimum is suitable for most situations. Adjusting Touch Tone Volume The touch tone is the tone you hear when you select any field on the monitor screen. To adjust the touch tone volume:

1 Enter the Main Setup menu. 2 3 Select User Interface. Select Touch ToneVolume, then select the appropriate setting for the touch tone volume: 10 is the loudest and 1 is the quietest. Selecting zero switches the touch tone volume off. Setting the Date and Time The current date and time is displayed in its own element in the information section of the monitor screen. 1 Select the date and time screen element from the monitor's information line to enter the Date, Time menu. Select, in turn, the Year, Month, Day, Hour (in 24 hour format) and Minute, as necessary. Select Store Date, Time to change the date and time. 2 3 65 3 Basic Operation WARNING Do not change the date and time setting, if the fetal monitor is connected to a Philips OB TraceVue/

IntelliSpace Perinatal system via a LAN -setup. The monitor uses the OB TraceVue/IntelliSpace Perinatal system date and time, including daylight saving time changes. As long as the fetal monitor is connected to the OB TraceVue/IntelliSpace Perinatal system via the LAN-setup (locomotive icon displayed on the monitor's screen), the option to change the date and time settings at the fetal monitor are disabled, this is not valid for RS232 connections, or the connection to other systems. When disconnected from AC power, the monitor retains the date and time setting for at least two months. If the monitor is off longer than two month, and the operating system detects that the date and time settings are invalid, the monitor initiates a "cold" start and sets the date to 1 Jan 1997 and the time to 00:00. Checking Your Monitor Revision 1 2 Select Main Setup, Revisions to open the Monitor Revision menu. From the Monitor Revision menu, select the monitor component for which you need revision information. Preparing to Monitor Confirm fetal life before you begin fetal monitoring. Familiarize yourself with the basic operation principles before you start to monitor. CAUTION Check the fetal monitors housing for damage before you start to monitor as part of your safety precautions. After you switch on the monitor:

1 Check that you have the correct patient cables and transducers plugged in for the measurement you want to monitor. If you use an Avalon CL or Avalon CTS system, check if the cableless transducers are ready and charged (apparent by either a lit up green or yellow LED indicator). 2 3 Admit your patient to the monitor (see Admitting a Patient on page 135). 4 Check that the alarm limits, alarm and fetal heart rate volumes, patient category, and so forth are appropriate for your patient. Change the settings if necessary. 5 Refer to the appropriate measurement section for details of how to perform the measurements you require. Start recording. 6 66 Switching On: FM20/FM30 3 Basic Operation FM20/30 1 Connect the monitor to AC mains and switch the monitor on. The green power-on LED lights up. The monitor performs a self-test as it starts up. Selftest: OK, the serial number, and revisions for the software and firmware are printed on the fetal trace paper (if recorder Auto Start is configured to On). The monitor display comes on. There is a start-up tone from the loudspeaker. FM20/30 Battery Option If this option has been chosen, the green power-on LED on both the external power supply and the battery LED indicator will light up. Switching On: FM40/FM50 FM40/50 1 Connect the monitor to AC mains. 2 The green LED lights up. Press the On/Standby switch. The monitor performs a self-test as it starts up. Selftest: OK, the serial number, and revisions for the software and firmware are printed on the fetal trace paper (if recorder Auto Start is configured to On). The monitor display comes on. There is a start-up tone from the loudspeaker. Adjusting the Display Angle (FM20/FM30) FM20/30 You can tilt the display on the FM20 and FM30 to one of five different positions, or you can fold it completely down. The tilt/fold mechanism works on a one-way ratchet system. You hear a click as each of the five positions is reached. The screen can be folded back down only after tilting the display forwards as far as it will go. To tilt the display from the folded position:

1 Unlock the display by releasing the catch. 67 3 Basic Operation 2 Lift the display forward. You will hear a click as the first position engages. If you want to tilt the display further, lift the display further forward until you reach the desired angle. 3 To fold the display, pull the display forwards as far as it will go 4 Then push the display all the way back until it clicks shut. If your monitor is wall-mounted, the display should be folded flat. 68 3 Basic Operation Fastening Belts and Transducers You can use more than one belt if, for example, you are monitoring uterine activity and FHR simultaneously. There are two basic ways to fasten belts and transducers:

Velcro belts together with the butterfly belt clip. Belts with button fixings. What You Need Toco MP or CL Toco+ MP transducer Ultrasound transducer Ultrasound gel Transducer belt (and optional butterfly belt clip, if applicable) Using Belts with Button Fixings 1 2 3 Place the transducer belt across the bed, so that the fixing button will face away from the mother when it is fastened. Lie the patient on the bed and arrange the belt around her until it is tight but still comfortable. Fasten the belt by pushing the fixing button through the overlapping section of the belt. Ensure that the fixing button and the loose ends of the belt are at the patient's side. 69 3 Basic Operation 4 When you have positioned a transducer satisfactorily, you can attach it to the belt by pushing the belt button on the transducer through one of the holes in the belt. 5 Alternatively, attach the butterfly belt clip to the transducer belt button and use this to attach the transducer to the belt. The clip allows you to slide the transducer for easy repositioning. 70 Using CL Transducers with a Belt Clip The Avalon CL transducers have their own belt clip. They can be optional ordered in a kit of 10

(989803184851). 1 Avalon CL belt clip 3 Basic Operation Using Belt with Velcro Fixings Insert one end of the belt between the belt guides on one side of the butterfly belt clip, and secure with the velcro fixing. Insert the other end of the belt between the belt guides on the other side of the butterfly belt clip, adjust for the correct tension, then secure with the velcro fixing. 1 Velcro fixing 2 Belt guides 3 Velcro fixing WARNING When connecting devices for acquiring measurements, always position cables and NBP tubing carefully to avoid entanglement or potential strangulation. 71 3 Basic Operation Repositioning Transducers A patient possibly wears transducers for long periods without interruption. In rare cases, skin irritations may occur if a transducer is attached to one location for a longer period. To ensure there are no adverse effects on the patient's skin, inspect the transducer application site at least every three hours. If the skin quality changes, move the transducer to another site. The ultrasound transducer is often repositioned to follow the fetal heart as part of the normal monitoring process, but this is not so for the Toco transducer. Therefore, remember to check its application site (between contractions) at least every three hours. To reduce the risk of skin irritations, do not allow a cleaning or disinfecting agent to remain on the transducer. Follow all instructions that accompany the specific cleaning and disinfecting agents you are using. Remove agent residues with a cloth dampened in water before applying a transducer to a patient. See Care and Cleaning on page 245 for further information, and a list of approved agents. Connecting a Transducer to the Monitor SpO2 socket 1 2 Noninvasive blood pressure socket 3 Fetal sensor sockets You can plug a fetal transducer, an ECG/IUP patient module, an Avalon CL or Avalon CTS Cableless Fetal Transducer System interface cable (red connector), or an external event marker into any of the four fetal sensor sockets marked by the fetal icon, or "Fetal Sensors" (depending on geography). For measuring maternal SpO2, connect the sensor to the socket marked with the SpO2 icon or "SpO2" (depending on geography). For maternal non-invasive blood pressure, connect the cuff to the socket marked with the NBP icon or "NBP" (depending on geography). 72 3 Basic Operation For the FM20 and FM30, you can connect an Avalon CL Cableless Fetal Transducer system interface cable (red connector) to one of the fetal sensor sockets at the left side of the monitor. For the FM40 and FM50, you can connect an Avalon CL or Avalon CTS Cableless Fetal Transducer System interface cable (black connector) to one of the two dedicated black sockets marked "Tele" at the rear of the monitor, as an alternative to using one of the fetal sensor sockets (red connector) at the front. 1 Interface cable to Avalon CL and Avalon CTS Cableless Fetal Transducer System. 2 Connect the black connector to one of the two black sockets (marked

"Tele") on the rear of the monitor. What You See on the Monitor When you connect a transducer or sensor, the measurement numeric appears on the screen. for FM20/FM30 for FM40/FM50 Fetal heart rate measurements are labeled in the order in which you plug in the transducers for those measurements. It does not matter which fetal sensor socket you use, as the monitor allocates a channel automatically. For instance, when monitoring triplets, the first transducer you connect is automatically allocated a channel, and the measurement is labeled FHR1, the second FHR2, and the third FHR3. See also chapters Monitoring Twin FHRs on page 171 and Monitoring Triple FHRs on page 179. When you touch a measurement numeric on the screen, the setup menu for that measurement opens. The fetal sensor socket to which the transducer for this measurement is connected is identified by the transducer position indicator in the blue setup menu header. 73 3 Basic Operation The blue finder LED on a wired fetal transducer lights up when you touch the measurement on the screen, allowing you to identify the corresponding transducer. 1 Finder LED The white finder LED on a cableless fetal transducer lights up when you touch the measurement on the screen, allowing you to identify the corresponding transducer. 1 Finder LED cableless transducer The recorder prints an annotation showing the date, time, paper speed, and monitoring mode. It repeats this every 10 minutes. Start Recording Checking/Setting Paper Scale You can check the paper Scale Type (US for USA, or Internat'l for other geographies) in the Fetal Recorder menu. In Monitoring Mode, you can see these settings (grayed out), but you cannot change them. They can be changed in Configuration Mode, see the Configuration Guide. 74 3 Basic Operation Paper Guide FM40/FM50 FM40/50 The recorder in the FM40 and FM50 features a transparent paper guide which:

facilitates correct alignment of the paper, both during loading and while the recorder is running. See Loading Paper FM40/FM50 on page 84. incorporates a tear-off edge, which not only allows you to tear off the trace paper where you like

(not necessarily at a fold), but also helps to avoid paper misalignment while doing so (see Tearing Off the Paper on page 80). is removable (see Removing the Paper Guide: FM40/FM50 on page 250). Switching the Recorder On and Off In addition to the normal recording of real-time traces, you will sometimes see a trace recovery printout from the monitor's internal backup memory at high speed when the recorder is started. For details, see Recovering Traces on Paper on page 241. For an explanation of the various symbols that can appear on the trace recording, see Recorder Specifications on page 284. To switch the recorder on, select in Main Setup the menu item Fetal Recorder, or press one of the SmartKeys: Start/ Stop or Start Recordng. The "recorder on" status indicator is displayed in the bottom right-hand corner of the screen when you switch on the recorder. The paper advances quickly for 2 cm and then returns to the set speed. Whenever the recorder is switched on, a trace header is printed vertically on the trace paper, containing the following:

Selftest: OK: confirmation that the monitor's self-test completed successfully, and that it is ready to use. the software revision and firmware revision the serial number the time the date patient name and medical record number (if entered) 75 3 Basic Operation the Recorder Speed 1 Fetal heart rate label 2 Uterine activity label the time the date trace identification symbols the Recorder Speed The current monitoring modes (if any transducers are connected to the monitor) are printed. Whenever a transducer's mode is changed, the following are printed:

The monitor prints the time, date, Recorder Speed, and monitoring modes in the trace header when first switched on, in a periodic time stamp every ten minutes after, and if the monitoring modes change. The time stamp begins with the symbol shown below. The data is reprinted in the header if the 76 time and date are locally adjusted, or if an OB system is connected that readjusts the time and date automatically. 3 Basic Operation 1 Time stamp printed every ten minutes The trace records maternal parameters also. When measuring noninvasive blood pressure, the annotation is made at the end of the measurement. If the noninvasive blood pressure measurement repetition time is short, the noninvasive blood pressure numeric may not always be printed. The recording of notes (see Entering Notes on page 88) or time/date information may be interrupted by connecting, or unplugging a transducer, or by a change in measurement-related setting

(for example, artifact suppression, Toco sensitivity, or alarm settings). A new patient admission or a change to the paper scale setting stops all annotations, and prompts a new vertical trace header to be printed. To switch off the recorder:

1 Either select Start/Stop from the Fetal Recorder menu. 2 Or press one of the SmartKeys (depending on configuration): fetal recorder Start/ Stop or Stop Recordng. If your recorder is configured with Confirmed Stop on (a Configuration Mode setting), you will need to confirm that you want to stop the recorder, before it will stop. When the recorder is off, the "recorder off" status indicator is displayed in the bottom right-hand corner of the screen: When the Paper Save Mode is set to Off the paper icon shows an x mark, and when Paper Save Mode is On the icon shows a paper trace icon. 77 3 Basic Operation Recording Elements The trace paper of the recorder has much information printed on it. Here is an exemplary trace with the most common print outs and their meaning. Each trace header contains the last name and first name, the patient ID, patient date of birth, the current date and time, patient's bed label, and the gestational age of the pregnancy. Recorder Speed FMP - Fetal Movement Profile 1 Name, patient ID, date of birth, current date and time 2 3 Gestational age and patient bed label 4 5 Other measurement for the patient such as temperature, arterial oxygen saturation, and pulse. 6 Entered notes such as patient repositioned, or MD notified, or others 7 Time stamp 8 Trace separation 9 Recorder Speed 10 Maternal ECG 11 Direct ECG 12 Coincidence of heart rate detected 13 HR with Cross Bell 14 Alarm Limits 15 DFHR2 (second fetal heart rate from DECG) 16 FHR1 (first fetal heart rate) 78 3 Basic Operation Choosing Paper Speed You can choose a Recorder Speed of 1, 2, or 3 centimeters per minute (cm/min). The default setting is 3 cm/min. The ACOG technical bulletin on FHR monitoring states that "accurate pattern recognition is difficult if not impossible at 1 cm/min and that 1 cm/min is only recommended for more economic screening. When FHR abnormalities arise, the faster paper speeds will enhance FHR pattern recognition". Additionally, because a change in Recorder Speed results in a change in the appearance of an FHR trace, you are advised to ensure ALL monitors in your institution are set to the same speed. To set the Recorder Speed (in Configuration Mode) see the Configuration Guide. Advancing the Paper You can advance the paper automatically to the next fold by pressing the Paper Advance SmartKey at any time except during a stored data recording. This is also possible using the Fetal Recorder menu. Marking an Event You can record significant events on the trace paper (for example, when pain medication is administered or when the mother changes position). The mother can use the remote event marker to mark events herself. You connect the remote event marker to any free fetal sensor socket. To mark an event on the trace paper you can:

1 Either select the Set Marker SmartKey. 2 Or press the button on the remote event marker. The remote event marker is connected to the monitor via any fetal transducer socket. A small arrow is printed on the heart rate scale on the trace paper. 79 3 Basic Operation This reflects exactly when the marker button was first pressed; keeping the button pressed has no influence on the annotation. Tearing Off the Paper CAUTION Never pull on the paper to advance it, as this can cause misalignment of the paper. Always tear off the paper along the perforation. FM40/FM50 The recorder's paper guide incorporates a tear-off edge, allowing you to tear off the trace paper cleanly where you like (not necessarily at a fold). When not using the paper guide, always tear off the paper along the perforation. To tear off the trace paper after monitoring using the paper guide:

1 If the recorder is running (the "recorder on" status indicator is displayed), turn off the recorder by selecting the fetal recorder Start/ Stop SmartKey or the Stop Recordng SmartKey. 80 2 Tear off the paper as shown in the picture. To ensure a clean tear, always tear in an upwards motion, as indicated by the arrows. You can start tearing from the left or right (right-handed user shown). You may want to use both hands to guarantee that the paper is not misaligned during the tear off. 3 Basic Operation 3 If you wish to tear off the paper at a fold, select the Paper Advance SmartKey, wait for the paper to stop, then tear it off. FM20/FM30 The FM20/FM30 does not have a paper guide. The procedure is the same as described for the FM40/

FM50 with the exception that you should advance the paper to a perforation. If you wish to tear off the paper at a perforation, select the Paper Advance SmartKey, wait for the paper to stop, then tear it off. Paper-Out Indication Each pack of paper has 150 pages. The monitor issues a paper-out warning in the status line at the bottom of the screen, when there are five pages to go. If you switch on the recorder or press the paper advance key when there are fewer than five pages remaining, it may take two pages before the alarm is activated. Load a new pack in time. If the recorder runs out of paper, an audible paper-out alarm is sounded, if so configured. See Loading Paper FM40/FM50 on page 84and Loading Paper FM20/FM30 on page 82 to learn how to reload paper. Fetal traces continue to be recorded into the monitor's backup memory, and can be retrieved and printed completely if new paper is loaded within one hour, when the Bridge Paperout setting is enabled in Configuration Mode. See Recovering Traces on Paper on page 241 for further information. 81 3 Basic Operation Loading Paper FM20/FM30 CAUTION Using recorder paper that is not approved by Philips can result in accelerated paper fading and can damage the thermal line printhead. This type of damage is not covered by warranty. FM20/FM30 To load a pack of paper:

1 If the recorder is on, press the recorder Start/ Stop SmartKey or the Stop Recordng SmartKey to turn it off before loading a new pack of paper. 1 2 Press the paper table release to unlock the paper drawer and then pull the table forward to open it fully. Lift out any remaining paper from the tray. 3 Prepare to place the new pack of paper in the tray with the bottom side down. The bottom side is indicated by the word STOP printed on the final page of the new pack. 82 4 Unfold the top page of the pack and position the uterine activity scale on the right. 3 Basic Operation 5 Slide the pack into the tray. 83 3 Basic Operation 6 Push the paper drawer back until it "clicks" closed. 7 Press the recorder Start/ Stop SmartKey or the Start Recordng SmartKey to switch on the recorder. Annotations of trace information are printed on the trace paper (see Switching the Recorder On and Off on page 75 for details). Loading Paper FM40/FM50 CAUTION Using recorder paper that is not approved by Philips can result in accelerated paper fading and can damage the thermal line printhead. This type of damage is not covered by warranty. FM40/FM50 To load a pack of paper:

1 If the recorder is on, press the Start/ Stop Rec SmartKey or the Stop Recordng SmartKey to turn it off before loading a new pack of paper. 84 2 Press the paper eject button to open the paper drawer. 3 Basic Operation 3 4 Lift out any remaining paper from the tray. Press and hold the paper eject button to partially eject the paper, thus making it easier to remove. 5 Hinge the transparent paper guide forward. It is held in the closed position by a small protrusion on each side of the holder. 85 3 Basic Operation 6 A - Protrusion holds paper guide in closed position. 7 Prepare to place the new pack of paper in the tray with the bottom side down. The bottom side is indicated by the word STOP printed on the final page of the new pack. 8 Unfold the top page of the pack and position the uterine activity scale on the right. 9 Slide the pack into the tray. 86 10 Feed the paper evenly through the paper guide. Do not close the paper guide yet. 3 Basic Operation 11 Close the paper drawer. 12 Now close the paper guide. 87 3 Basic Operation 13 Press the recorder Start/ Stop SmartKey or the Start Recordng SmartKey to switch on the recorder. Annotations of trace information are printed on the trace paper (see Switching the Recorder On and Off on page 75 for details). Entering Notes Your monitor has a set of 15 factory pre-configured notes (see below). The maximum length of one single note is 30 characters. It is possible to edit the notes in Configuration mode (see the Configuration Guide). To enter a note:

1 Press the Enter Notes SmartKey to open the Enter Note menu. 2 3 Scroll if necessary, then select the note you wish to enter. A confirmation dialog box opens:

Select Confirm to enter the note. The note is then shown in the status line of the display, and is annotated on the fetal trace if the fetal recorder is on. 88 3 Basic Operation 4 By default, notes are printed lengthwise in the direction of the trace, in the space between the FHR grid and the uterine activity grid. If you prefer, you can configure the recorder to print across the trace. 5 You can change this in Configuration Mode by changing the Notes Recording setting in the Fetal Recorder menu from Along (default) to Across (notes print width wise across the trace). Tocolytic Given Patient Repositioned Vaginal Examination The following are the pre-configured notes from which to choose:

1 2 3 MD Notified 4 Sitting 5 On Back 6 Left Lateral 7 Ambulating 8 9 Membranes Ruptured 10 Amniotomy 11 Amniotic Fluid Clear 12 Amniotic Fluid Not Clear 13 Oxytocin 14 Urinary Catheter 15 Micro Blood Analysis Up to two notes can be printed directly, and the monitor can temporarily store up to a further two notes, and these are printed after the first two have been recorded. Any further notes are discarded. For example, if you enter six notes in quick succession, the first two notes you entered are recorded right away, the next two are stored in memory and then printed when the first two have been recorded, and the last two are discarded. If the printing of two notes happens to coincide with the regular recording of the time stamp that takes place once every ten minutes, the time stamp is delayed until the notes have finished printing. Signal Quality During monitoring, if the fetal heart rate signal quality fluctuates, and becomes poor, it does not necessarily mean that the transducer needs repositioning. The fluctuation may be caused by fetal movement. Allow time for the signal to stabilize before deciding whether to reposition the transducer

(ultrasound), or apply a new electrode (ECG). For the best trace quality, the signal quality indicator should be full, indicating good signal quality, even though it may be possible to make traces at a lower signal quality level. 89 3 Basic Operation Cableless Monitoring Basics of Cableless Systems The fetal monitors FM20/FM30 and FM40/FM50 are compatible with the Avalon CL and Avalon CTS Cableless Fetal Transducer system. Regard the following points for cableless monitoring:

You can connect one Avalon CL with a red connector to a FM20/FM30 or a FM40/FM50 (fetal socket). You can connect up to two Avalon CLs with a black connector to a FM40/FM50 (Tele socket). You can connect one Avalon CTS system to a FM20/FM30 or FM40/FM50 at a time (either fetal or Tele socket). You cannot connect Avalon CTS and an Avalon CL at the same time to the same fetal monitor. Monitoring multiple pregnancy using cableless transducers is supported by the Avalon CL system only. Using a mixture of wired and cableless fetal transducers is not supported. You can use either wired or cableless fetal transducers. If you cannot get sufficient signal quality using Avalon CTS transducers, switch to wired transducers. Avalon CL Transducer System Avalon CTS Transducer System Assigning Cableless Transducers The cableless transducers of the Avalon CL are assigned by simply docking them at the base station connected to the patients fetal monitor. See the Avalon CTS Instruction for Use for the assignment of the cableless transducers of this system. 90 3 Basic Operation Activating Cableless Transducers The CL transducers of the Avalon CL are activated by picking them up from the base station. If the CL transducer is activated, an antenna symbol is displayed on the fetal monitor screen next to the numeric of the measurement. See the Avalon CTS Instruction for Use for the activation of the cableless transducers of this system. Unassigning Cableless Transducers The CL transducers of the Avalon CL are unassigned by manually removing them in the corresponding setup menu from the group of assigned cableless devices, or by unassigning them directly in the Tele Info window. See the Avalon CTS Instruction for Use for the unassignment of the cableless transducers of this system. Deactivating Cableless Transducers The CL transducers of the Avalon CL are deactivated by redocking them at a base station. To deactivate all cableless transducers at once press the Standby button of the Avalon CL base station. See the Avalon CTS Instruction for Use for the deactivation of the cableless transducers of this system. Configuration of Cableless Systems For the Avalon CL and Avalon CTS Cableless Fetal Transducer system and the corresponding channels have to be configured for the radio communication to work and not to interfere with any other telemetry devices. The configuration of a connected Avalon CL system is done in Configuration Mode or Service Mode of the fetal monitor. Service Mode functions can be used to identify channel assignment conflicts in the hospital environment. The configuration should be carried out by authorized and qualified service personnel, either by the hospital's biomedical department, or by Philips Support. Setup OBR A.00.00 WMTS 4 15 min Revisions Frequency Band Channel Scan Duration Start Scan Stop Scan Start RSSI Trace Stop RSSI Trace For a detailed description of the configuration see the Avalon CL Service Guide and the Fetal Monitor Configuration Guide. For details regarding the configuration of a connected Avalon CTS system see the Avalon CTS Service Guide. 91 3 Basic Operation Tele Info Window The Tele Info window of the fetal monitors allows you to manage the Avalon CL system. Below is an exemplary view of the Tele Info window. Your window may differ depending on the status of the connected system. To open the Tele Info window you can:

1 Configure a Tele Info SmartKey to open the window, 2 3 click on the TELE icon on the main screen, or select the Main Setup and then Tele Info. Transducer icon assigned with the parameter label 1 2 Cableless module icon and equipment ID 3 Base station icon with docking indication (the white slot indicates a charging transducer) 4 Key Remove 5 Key Find 6 Key Battery Report 7 Tele icon 8 Remaining battery time 9 Out of battery icon 10 Indication of signal quality 92 Indicator 3 Basic Operation Telemetry When the monitor recognizes a connected Avalon CL or Avalon CTS interface cable (red or black connector), it confirms the recognition with the following status indicators displayed in the lower right-hand corner of the screen:

Avalon CTS Avalon CTS interface cable is connected to the monitor, but the Avalon CTS base station is not connected to the interface cable, or it is disconnected from AC mains, or is in Standby mode. Avalon CTS interface cable is connected to the monitor, Avalon CTS base station is connected, powered on, and cableless transducers are ready to use, but no cableless transducers are currently active (all are still docked at the base station). Avalon CTS interface cable is connected to the monitor, Avalon CTS base station is connected, powered on, and at least one cableless transducer is active and assigned. Not applicable for Avalon CTS. Avalon CL A base station is connected to the monitor, but the base station is in Standby mode. A base station is connected to the monitor but no cableless transducers and no cableless Pods are currently active. All are still docked at the base station, or the base station holds no transducers. A base station is connected to the monitor, it is on, and minimum one cableless transducer or cableless Pod is active and assigned. The CL transducer is moved away from the base station approaching the end of range (at least 70 m). The US sound is replaced by an artificial QRS sound (like DECG). The DECG and MECG waves are no longer displayed. NOTE A cableless transducer is considered still active, even if it has an INOP condition (e.g. cl US Disconnect), until it is either deactivated by docking it at the base station, or until it is manually removed from the Tele Info window. CL transducers have priority over wired transducers. If an Avalon CL or Avalon CTS base station is connected to the fetal monitor, and both wired and cableless transducers are connected to the monitor, the wired transducers are disabled whenever one cableless transducer is active. If an CL Pod is activated it does not automatically deactivate all wired transducers, just the one with the corresponding measurement. To switch back to using wired transducers, redock the cableless transducers at the base station, or switch the base station to Standby mode, and continue monitoring with the wired transducers. If you cannot get sufficient ultrasound signal quality using the Avalon CTS base station, try repositioning the transducers, or switch to wired transducers. Using a Avalon CL base station you should get a better signal by reducing the distance between CL transducer and base station. When using an Avalon CL or Avalon CTS you should be aware that FMP is not recommended when the mother is likely to move, and you should disable Fetal Movement Profile (FMP) on the fetal monitor (Fetal Movement Off) if the mother is walking. Maternal movements are likely to create artifact in the FMP output. See also Switching FMP On and Off on page 161, the sections Cableless Monitoring - Important Considerations on page 156 and Fetal Movement Profile on page 160. 93 3 Basic Operation With the Avalon CL Transducer system you can now monitor twins and triplets with CL transducers. The Avalon CTS System does not have this option. About RF Signal Quality Signal transmission can be disturbed if:

the patient is out of range of the receiving area. there is interference from another, possibly stronger, RF signal (a broadcasting station, for instance). the patient is near material that absorbs electromagnetic waves (for example, metal-reinforced concrete, elevator doors) or the base station antenna is in an enclosed metal rack. Pop-up Keys Pop-Up Key Remove Find Battery Report Function Selecting the Remove key deactivates and unassigns the selected active transducer or cableless Pod and removes it from the list. This key is disabled if no active device is selected. Selecting the Find key pages the selected active CL transducer or CL Pod. This key is disabled if no active device is selected. Selecting the Battery Report key prints a combined battery report on the built in recorder. The report contains at least the following information for each CL transducer or CL Pod currently in the list:

Cableless device identification (like in the Tele Info window list) Number of cycles This key is only available and enabled in Service mode. Battery identification (e.g. part no.) Battery serial number Battery manufacturing date Battery capacity: remaining/when fully charged/battery temperature Prompts The fetal monitor issues prompt messages to certain user interactions. For example if the CL SpO2 Pod is picked up from the base station to activate it, the monitor displays the prompt message cl SpO Added and the equipment lable of the Pod. CL Transducer Assignment The cableless transducers of the Avalon CL are assigned by simply docking them at the base station connected to the patients fetal monitor. Since twins and triplets can be monitored with the Avalon CL base station, it can be delivered with up to seven CL transducers: one CL Toco+ MP, three CL US, and three CL ECG/IUP transducers. Only up to four CL transducer can be assigned at one time to the Avalon CL base station. Four assigned CL transducers enable monitoring combinations such as 1 CL Toco+ MP transducer + 3 CL US transducers for monitoring triplets externally, or 1 CL Toco+ MP transducer + 2 CL US transducer +

1 CL ECG/IUP transducer for monitoring twins. 94 3 Basic Operation Three CL transducers can be docked and charged at the Avalon CL base station at the time. If a fourth transducer should be assigned to the Avalon CL base station:

1 Remove first the three already docked CL transducers from the base station and place them on the patient. 2 Then dock the remaining fourth transducer at the base station and wait until the LED of the fourth transducer signals that it has communication with the base station. Place the fourth CL transducer on the patient and check on the fetal monitor in the Tele Info window if the base station and the monitor have communication with all four transducers, and if their numerics are displayed on the screen of the fetal monitor. 3 Select Remove from the open setup menu. CL Transducer Unassignment The cableless transducer are not unassigned by simply removing them from the base station. To unassign a cableless transducer, there are two methods:

1 Open the setup menu of the measurement e.g. FHR1 by pressing the numeric on the screen. 2 3 A confirmation window opens with the prompt Please Confirm and Device will be removed. 4 or 1 Open the Tele Info window. 2 Press the pop-up key Confirm. A prompt states then clDev has been removed. Select the symbol of the cableless transducer you want to unassign, and select Remove from the pop-up menu. 3 A confirmation window opens with the prompt Please Confirm and Device will be removed. 4 Press the pop-up key Confirm. A prompt states then clDev has been removed. NOTE When a cableless transducer is unassigned, all the measurements from this transducer are no longer monitored; e.g. if you unassign a CL Toco+ MP, the Toco measurement, SpO2, and MECG are possibly no longer monitored. CL Pods Assignment Select Remove from the open setup menu. The cableless Pods of the Avalon CL are assigned by simply docking them at the base station connected to the patients fetal monitor. CL Pods Unassignment To unassign a cableless Pods, there are four methods:

1 Open the setup menu of the measurement e.g. SpO by pressing the numeric on the screen. 2 3 A confirmation window opens with the prompt Please Confirm and Device will be removed. 4 or 1 Open the Tele Info window. 2 Press the pop-up key Confirm. A prompt states then clDev has been removed. Select the symbol of the cableless Pod you want to unassign, and select Remove from the pop-up menu. 95 3 Basic Operation Press the pop-up key Confirm. A prompt states then clDev has been removed. 3 A confirmation window opens with the prompt Please Confirm and Device will be removed. 4 or Unassign the cableless Pods via it's user interface. See the Cableless Measurement Instruction for Use. or Dock the cableless Pod at another base station or charger and therefore assigning it to the new device. Paging Patients To page a patient currently not near the fetal monitor and base station select the SmartKey Call Patient at the fetal monitor. The base station will then select the cableless transducer with the best signal quality to emit the tone sequence to notify the patient. Underwater Monitoring Only the cableless transducers of the Avalon CL and Avalon CTS systems can be used to monitor under water. You can use them to monitor patients in a bathtub or shower. This does not apply to the maternal cableless SpO2 and NBP Pods, do not immerse the CL Pods into water. Cableless transmission distances are shorter when monitoring under water. A metal bathtub is likely to further reduce the operating range. WARNING Never immerse the base station in liquid. You must protect it against water sprays or splashes. Place the base station where there is no chance of contact with, or falling into water or other liquids. CAUTION Avoid the use of pulsating water jets in the bath or shower while monitoring, as these can be misinterpreted as an incorrect (or totally artificial) heart rate. Toco Baseline drift: The accuracy specified for baseline drift cannot be guaranteed for underwater usage. When using transducers under warm water the temperature increase causes a significant baseline change due to internal pressure increase. The depth under water at which the Toco transducer is used also has an effect on the Toco baseline, as the water pressure increases with depth. After immersion, allow one to two minutes for the pressure to stabilize, then adjust the Toco baseline (between contractions), and check it frequently. When using the transducers underwater, the radio transmission range is reduced, and signal loss may occur. Water-proof belts like M1562B are recommended for the cableless transducers when monitoring in water. 96 3 Switching the Monitor to Standby To switch the monitor to Standby:

Either 1 Select the Monitor Standby SmartKey. Or 1 Enter the Main Setup menu using the SmartKey. 2 3 Select Monitor Standby. Pressing any key or selecting any field on the screen will resume monitoring. Note If a Avalon CL base station is connected to your FM 20/30 monitor, do not turn off the monitor if you need to recharge the batteries of the CL transducers. They can only be recharged if the FM20/30 monitor is on. If an Avalon CL base station is connected to an FM40/50, the batteries of the CL transducers can be recharged while the monitor is in Standby mode. After Monitoring 1 Discharge the patient. 2 Remove the transducer from the patient and, using a soft tissue, remove any gel from it. Then clean the transducer. 3 Dock CL transducers to their base station so they can recharge. 4 Tear off the paper at the fold. To avoid misalignment of the recorder mechanism, NEVER pull on the paper to advance it, or try to tear it other than at a fold (unless using the paper guide with the FM40/FM50). Switch off the monitor. 5 97 3 Basic Operation Disconnecting from Power FM20/30 To disconnect the monitor from AC power, switch the monitor off using the On/Off switch located on the right side of the device, or unplug the power cord from the AC mains socket. FM40/FM50 and FM20/

FM30 with Battery Option The On/Standby button does not disconnect the monitor from the AC power source. To disconnect, unplug the power cord from the AC mains socket. Note that if the power cord is unplugged from the AC mains socket before the monitor is put into Standby, a beeper is activated. The beeper warns you if the monitor is accidentally disconnected from AC mains. Power On/Power Off Behavior The general rules determining the behavior of the fetal monitors when connected to, or disconnected from power are as follows:

A fetal monitor that was switched on prior to a temporary power loss, switches on again when power is restored. A fetal monitor that was switched off prior to a temporary power loss, remains off when power is restored. When AC mains power is lost, a battery powered monitor (FM20/30) continues to run without interruption on battery power. Monitoring After a Power Failure A fetal monitor that was switched on prior to a temporary power loss switches on again when power is restored. A fetal monitor that was switched off prior to a temporary power loss remains off when power is restored. If the fetal monitor is without power for less than one minute, monitoring will resume with all active settings unchanged. If the fetal monitor is without power for more than one minute, the behavior depends on your configuration. If Automat. Default is set to Yes, the default profile will be loaded when power is restored. If Automat. Default is set to No, all active settings are retained, if power is restored within 48 hours. The Automat. Default setting is made in Configuration Mode. 98 Troubleshooting Problem Light or no trace. Possible Causes Wrong paper. Dirty printhead. FM20/30 only: Paper misaligned due to drawer not being correctly shut. Bad paper feed or wrong paper. INOP messages always indicate equipment problems. End of paper noted when pack not finished. Check Paper INOP is displayed. FetRec Equip Malf INOP is displayed. Paper End INOP is displayed. Wrong Paper Scale INOP is displayed. 3 Basic Operation Solutions Use recommended paper. Clean printhead. See Cleaning the Print Head on page 255. Shut the drawer fully, pushing evenly with both hands. Check paper feed and use recommended paper. See Patient Alarms and INOPs on page 121. 99 3 Basic Operation 100 4FM20/30 Battery Option 4 FM20/30 Battery Option You can switch between battery-powered and mains-powered (AC) operation without interrupting monitoring. The monitor is connected to the AC mains power via the external power supply. NOTE The battery option is not available for the FM40/FM50. External Power Supply M8023A The external power supply M8023A (option #E25) allows you to operate the fetal monitor from an AC (alternating current) power source of 100 V to 240 V ( 10%) and 50/60 Hz ( 5%). If this option is used, then the M8023A (option #E25) power supply is included for FM20/30. 1 AC power cord. Connect to AC mains socket. 2 Measurement Link (MSL) cable. Supplies power to the monitor for operation and for battery charging. Power-on LED. The green light is on when the external power supply is connected to AC mains. 3 101 4 FM20/30 Battery Option WARNING Always use the supplied power cord with the earthed mains plug to connect the external power supply M8023A (option #E25) to an earthed AC mains socket. Never adapt the mains plug from the power supply to fit an unearthed AC mains socket. Do not use AC mains extension cords or multiple portable socket-outlets. If a multiple portable socket-outlet without an approved isolation transformer is used, the interruption of its protective earthing may result in enclosure leakage currents equal to the sum of the individual earth leakage currents, so exceeding allowable limits. Do not connect any devices that are not supported as part of a system. Any non-medical device placed and operated in the patients vicinity must be powered via an approved isolation transformer that ensures mechanical fixing of the power cords and covering of any unused power outlets. Using Batteries The Lithium Ion batteries used in your monitor store a large amount of energy in a small package. This allows reliable battery-operated monitoring but also requires care in use and handling of the batteries. Follow the instructions in this chapter and see the Service Guide for further details. Battery Power Indicators The battery LED and battery status information on the Main Screen, in combination with INOP messages and prompts, help you keep track of the battery power status. The indicators always show the remaining capacity in relation to the battery's actual maximum capacity, which may lessen as the battery ages. You can see the actual capacity in the Battery Status window. Battery LED The possible battery LED status on the right side of the monitor is described in the table below. 102 Battery LED Colors Green Yellow Red, flashing If the monitor is connected to mains power, this means Battery power is > 90%

Battery charging (battery power

< 90%) Red, flashes intermittently Battery or charger malfunction 4 FM20/30 Battery Option If the monitor is running on battery power, this means Less than 10 minutes power remaining Battery malfunction Battery Status on the Main Screen Battery status information is permanently displayed on all screens. It shows the status of the battery, with the battery power remaining, with an estimate of the monitoring time this represents. Battery power gauge: This shows the remaining battery power. It is divided into sections, each representing 20% of the total power. If three sections are filled, as in this example, this indicates that 60% battery power remains. If no data is available from the battery, a question mark is shown in the gauge. Monitoring Time Available: Below the battery power gauge a time is displayed. This is the estimated monitoring time available with the current battery power. Note that this time fluctuates depending on the system load (the display brightness, the recorder configuration, and how many measurements you carry out). Battery malfunction symbols: Normal battery function is indicated by the battery power gauge, together with the remaining operating time, on the main screen. You are informed of problems or changes in the status of the battery by the battery status/malfunction indicator. This consists of a blank battery gauge containing a "!" symbol. If the symbol is red, this indicates a critical situation. You can check the specific cause of the problem by looking at the symbol(s) displayed in the Battery Status window. Battery Status Indicator Battery Malfunction Indicator Alternates with the battery gauge on the main screen. Check in the Battery Status window to see which status symbol is displayed to identify the cause. The red exclamation mark flashes. Critical battery situation or malfunction. Check in the Battery Status window to see which malfunction indicator is displayed, or refer to the INOP, to identify the cause. 103 4 FM20/30 Battery Option Battery Status Window 1 To access the Battery Status window and its associated pop-up keys, select the battery status information on the screen, or select Main Setup, Battery. Capacity, remaining tells you how much power is left in the battery. Capacity, fullCharge tells you how much power the battery can hold when fully charged. TimeToEmpty tells you approximately how long you can continue to use the monitor without an AC connection. The time span fluctuates depending on the system load (the display brightness and how many measurements you carry out), and the remaining capacity of the battery. TimeToFull is shown in place of TimeToEmpty if the monitor is connected to a power supply, and tells you how much time is left until the battery is charged to 90%. If >10 hrs is shown here, the battery may not charge completely when the monitor is in use. Battery status/malfunction symbols: If a problem is detected with the battery, an INOP may be issued, and the following symbols are displayed in the Battery Status window, where they may be accompanied by a status message providing more details. Symbols indicating critical situations are colored red. Battery Status Symbols Battery Malfunction Symbols Battery is empty

(Red) incompatible battery Battery not charging as the temperature is above or below the specified range Battery requires maintenance

(Red) battery malfunction

(Red) battery has no power left Charging stopped to protect the battery

(Red) battery temperature too high

(Red) battery is missing, insert battery 104 4 Checking Battery Charge To check the charge status of a battery, refer to the battery power gauge on the screen, or open the Battery Status window. When Battery Lifetime is Expired When the battery is aged, either after 3 years from manufacturing date or after 500 charge/discharge cycles, it is recommended to replace the battery. To remind you of this, a message will appear in the Battery Status window. This message will only be displayed at the appropriate time when the date and time on the monitor is correct. Optimizing Battery Performance The performance of rechargeable batteries may deteriorate over time. Battery maintenance as recommended here can help to slow down this process. Display Brightness Setting 1 In the Main Setup menu, select User Interface, Brightness, then Optimum. This selects a level of brightness suitable for most monitoring locations that uses less battery power than brighter settings. 2 Ensure that the current level of brightness is suitable for your monitoring location. Charging the Battery To charge the battery, 1 Connect the monitor to the external power supply (M8023A). 2 Charge the battery until it is full, the battery LED is green, and the battery power gauge is filled. During high load of the monitor (usage of multiple measurements) the battery may not charge. To remedy this:

Internal temperature conditions can also cause the battery to not charge. This is necessary to protect the battery from damage and does not indicate a malfunction. Keep the monitor at room temperature and move it away from heat sources or out of direct sunlight. The battery will resume charging when the temperature is within range again. The battery will charge more quickly if the monitor is switched off. reduce the load by removing measurements, reduce the screen brightness or stop the recorder. 105 4 FM20/30 Battery Option Conditioning the Battery You must condition the battery when the "battery requires maintenance" symbol shows on the screen. Do not interrupt the charge or discharge cycle during conditioning. CAUTION Condition the battery with a monitor not currently in use. The monitor switches off automatically when there is no battery power left. To condition the battery, 1 Charge the battery until it is completely full. Open the Battery Status window and check that the Batt fully charged message is displayed. 2 Disconnect the monitor from mains power, and let the monitor run until there is no battery power left and the monitor switches itself off. 3 Reconnect the monitor to mains power and charge the battery until it is full for use or charge to 50% for storage. Storing the Battery The battery should not remain inside the monitor if it is not used for a longer period of time. Batteries should be charged to a maximum of 50% for storage. For battery removal or exchange, contact your service personnel. NOTE The battery will discharge over time in a monitor that is not connected to AC via the external power supply (M8023A). The reported values for "remaining capacity" and "runtime" will become less accurate when the battery is stored in this way for a longer period of time (that is, several weeks). 106 Battery Safety Information 4 FM20/30 Battery Option WARNING Use only Philips batteries part number M4605A. Use of a different battery may present a risk of fire or explosion. Do not open batteries, or dispose of them in fire, or cause them to short circuit. They may ignite, explode, leak or heat up, causing personal injury. If battery leakage should occur, avoid contact with skin. Refer to qualified and authorized service personnel. Dispose of used batteries promptly and in an environmentally-responsible manner. Do not dispose of the battery in normal waste containers. Consult your hospital administrator to find out about local arrangements. Do not expose batteries to liquids. Do not crush, drop or puncture batteries - mechanical abuse can lead to internal damage and internal short circuits which may not be visible externally. If a battery has been dropped or banged against a hard surface, whether damage is visible externally or not:

Keep batteries out of the reach of children. discontinue use dispose of the battery in accordance with the disposal instructions above. CAUTION Do not disassemble, heat above 100C (212F) or incinerate the batteries, to avoid the risk of fire and burns. Keep batteries out of the reach of children and in their original package until you are ready to use them. If battery leakage should occur, use caution in removing the battery. Avoid contact with skin. Refer to qualified and authorized service personnel. Do not install or use pre-damaged batteries. 107 4 FM20/30 Battery Option 108 5Alarms 5 Alarms The alarm information here applies to all measurements. Measurement-specific alarm information is contained in the sections on individual measurements. The fetal monitor has two different types of alarm: patient alarms and INOPs. Patient Alarms Red and yellow alarms are patient alarms. A red alarm indicates high priority, such as a potentially life threatening situation (for example, SpO2 below the desaturation alarm limit). A yellow alarm indicates a lower priority alarm (for example, a fetal heart rate alarm limit violation). INOPs INOPs are technical alarms. They indicate that the monitor cannot measure and therefore not detect critical conditions reliably. If an INOP interrupts monitoring and alarm detection (for example, MECG Leads Off), the monitor places a question mark in place of the measurement numeric and sounds an audible tone. INOPs without this tone indicate that there may be a problem with the reliability of the data, but that monitoring is not interrupted. Most INOPs are light blue, however there are a small number of INOPs which are always yellow or red to indicate a severity corresponding to red and yellow alarms. The following INOPs can also be configured as red or yellow INOPs to provide a severity indication:

MECG Leads Off

<SpO Label> No Pulse Alarm Delays There is a delay between a physiological event at the measurement site and the corresponding alarm indication at the monitor. This delay has two components:

The general measurement delay time is the time between the occurrence of the Tele Disconnected Battery Empty / Replace Battery physiological event and when this event is represented by the displayed numerical values. This delay depends on the algorithmic processing and, for certain measurements (SpO2, EEG and BIS), on the configured averaging time. The longer the averaging time is configured, the longer it takes until the numerical values reflect the physiological event. The time between the displayed numerical values exceeding an alarm limit and the alarm indication on the monitor. This delay is the sum of the alarm delay configured for the specific measurement plus the system alarm delay. The system alarm delay is the processing time the system needs for any alarm on the monitor to be indicated after the measurement has triggered the alarm. See the performance specifications in Specifications and Standards Compliance on page 269 for the system alarm delay specification. Multiple Alarms If more than one alarm is active, the alarm messages are shown in the alarm status area in succession. An arrow symbol next to the alarm message informs you that more than one message is active. The monitor sounds an audible indicator for the highest priority alarm. If more than one alarm condition is active in the same measurement, the monitor announces the most severe. 109 5 Alarms WARNING Alarm systems of the monitor and those of the connected OB system are independent and not synchronized. Alarm Mode You can configure the alarm mode for your fetal monitor. There are two possible modes:

All: alarms and INOPs are enabled, with all audible and visual indicators active. INOP only: only INOPs are enabled, with audible and visual indication active. This is the default alarm mode. WARNING In INOP only mode, no fetal/maternal patient alarms are enabled or indicated. The alarm status area for yellow and red alarms shows the INOP only indication in conjunction with the "Alarms Off" symbol. No alarm limits or alarm off icons are displayed. No fetal/maternal patient alarm settings are available in the setup menus. Nurse Call Systems If configured to do so, red, yellow and light blue alarms are indicated on a nurse call system which is connected to the optional nurse call relay. Visual Alarm Indicators Alarm message: An alarm message appears in the alarm status area on the second line at the top of the screen indicating the source of the alarm. If more than one measurement is in an alarm condition, the message changes every two seconds, and has an arrow at the side. The background color of the alarm message matches the alarm priority: red for red alarms, yellow for yellow alarms, and light blue for INOPs. The asterisk symbols (*) beside the alarm message match the alarm priority: *** for red alarms, ** for yellow alarms. INOPs are displayed without asterisks. Depending on how your monitor is configured, it may display alarm limit violation messages:

in text form, for example ** FHR1 Low or in numeric form, for example **FHR1 94<110, where the second number shows the currently set alarm limit, and the first number shows the value at which that alarm limit was violated by the widest margin. Flashing numeric: The numeric of the measurement in alarm flashes. Bright alarm limits: If the alarm was triggered by an alarm limit violation, the corresponding alarm limit on the monitor screen is shown more brightly. 110 5 Alarms Audible Alarm Indicators The audible alarm indicators configured for your fetal monitor depend on which alarm standard applies in your hospital. Audible alarm indicator patterns are repeated until you acknowledge the alarm by switching it off or pausing it, or until the alarm condition ceases (if audible alarm indication is set to non-latching). WARNING Do not rely exclusively on the audible alarm system for fetal monitoring. Adjustment of alarm volume to a low level or off during monitoring may result in a dangerous situation. Remember that the most reliable method of fetal monitoring combines close personal surveillance with correct operation of monitoring equipment. Alarm Tone Configuration The audible alarm indicators of your monitor are configurable. In the monitor's Configuration Mode, you can:

increase the alarm volume of unacknowledged alarms at regular intervals change the interval between alarm sounds (ISO/IEC Standard alarms only) change the base volume of the red and yellow alarm tones and the INOP tones change the alarm sound to suit the different alarm standards valid in different countries. Standard Philips Alarms Red alarms: a high pitched sound is repeated once a second. Two-star yellow alarms and yellow INOPs: a lower pitched sound is repeated every two seconds. One-star yellow alarms (short yellow alarms): the audible indicator is the same as for yellow alarms, but of shorter duration. Standard INOPs: an INOP tone is repeated every two seconds. ISO/IEC Standard 9703-2 Audible Alarms Red alarms and red INOPs: a high pitched tone is repeated five times, followed by a configurable pause. Two-star yellow alarms and yellow INOPs: a lower pitched tone is repeated three times, followed by a configurable pause. One-star yellow alarms (short yellow alarms): the audible indicator is the same as for yellow alarms, but of shorter duration. Standard INOPs: a lower pitched tone is repeated twice, followed by a pause. 111 5 Alarms Changing the Alarm Tone Volume The alarm volume symbol at the top right of the monitor screen gives you an indication of the current volume. To change the volume:

1 Select the volume symbol. 2 The volume scale pops up. Alarm Volume 3 Select the required volume from the volume scale. When the alarm volume is set to zero (Off), the alarm volume symbol shows this symbol:

If you switch the alarm volume off, you will not get any audible indication of alarm conditions. Minimum Volume for Severe Yellow or Red INOPs Severe yellow or red INOPs require action to ensure the well-being of the patient. Therefore the minimum volume for the INOP tone is set to at least alarm volume 8, irrespective of the current alarm volume setting. The INOP tone will sound even if the monitor alarm volume is set to zero. The severe INOPs for which this applies are:

INOP Battery Empty Factory Default cyan INOP tone severe (fetal monitor with battery option) hard (CL Pods) soft (CL transducers) hard severe severe hard ECG Leads Off NBP Cuff Overpress Cuff Not Deflated

!! <SpO Label> No Pulse cyan cyan cyan cyan 112 5 Alarms Power Loss Tone When power is lost - no power is available from the AC power source or from the battery - a beeper will sound. The tone can be silenced by pressing the On/Standby button. FM20/30 with Battery Option, FM40/50 Acknowledging Alarms To acknowledge all active alarms and INOPs, select the Silence key This switches off the audible alarm indicators. A check mark beside the alarm message indicates that the alarm has been acknowledged. If the condition that triggered the alarm is still present after the alarm has been acknowledged, the alarm message stays on the screen with a check mark symbol beside it. If the alarm condition is no longer present, all alarm indicators stop and the alarm is reset. Switching off the alarms for the measurement in alarm, or switching off the measurement itself, also stops alarm indication. Acknowledging Disconnect INOPs Acknowledging an INOP that results from a disconnected transducer switches off the associated measurement. Alarm Reminder If Alarm Reminder is configured on for your monitor, you will get an audible reminder of alarm conditions that remain active after you have acknowledged the alarm. This reminder may take the form of a repetition of the alarm tone for a limited time, or an unlimited repetition of the alarm tone (this is the same as a new alarm). Alarm Reminder is available only for yellow and red INOPs and not for standard light blue INOPs. In Configuration Mode, you can set the interval between silencing the alarm and sounding the reminder tone to one, two, or three minutes. 113 5 Alarms Pausing or Switching Off Alarms Select Main Setup, Alarms, Alarm Settings. If you want to temporarily prevent alarms from sounding, for example while you are moving a patient, you can pause alarms. Depending on your fetal monitor configuration, alarms are paused for one, two, or three minutes, or infinitely. To view the alarm pause setting chosen for your unit:

1 2 Check the Alarms Off setting. This setting can be changed in Configuration Mode. There are some settings made in Configuration Mode that can affect the availability of the pause alarms functionality. The Pause Alarms / Alarms Off permanent key can be removed from the screen to avoid unintentional switching off of alarms. In this case you can only pause alarms or switch alarms off permanently in the Alarms menu, under Main Setup. The Pause Alarms / Alarms Off permanent key and the corresponding hardkey can be configured to pause or switch off red and yellow alarms, yellow alarms only, or not to function at all. If they are configured not to function, you cannot pause alarms or switch alarms off permanently at all. When the alarms off priority is set to Yellow Only, the Pause Alarms / Alarms Off key becomes the Pause Yellow / Yellow Al. Off. To Pause All Alarms If you have configured alarms to be paused for one, two, or three minutes, the SmartKey is labeled Pause Alarms. Select the Pause Alarms SmartKey to pause all alarms. Or 1 2 3 Select Main Setup. Select Alarms. Select Pause Alarms. To Switch All Alarms Off You can switch alarms off permanently if your monitor is configured to allow infinite alarms pause, and the SmartKey is labeled Alarms Off. Select the Alarms Off SmartKey. Or 1 2 Select Main Setup. Select Alarms. 114 3 Select Alarms Off. To Switch Individual Measurement Alarms On or Off This applies to alarm mode All. 5 Alarms Select the measurement numeric to enter its setup menu. Select Alarms to toggle between On and Off. 1 2 The alarms off symbol is shown beside the measurement numeric. While Alarms are Paused or Off When red alarms are paused or off:

The red Alarms Paused lamp on the monitor front panel is lit. In the alarm field, the monitor displays the message Al. Paused x:yy or Alarms Off, together with the alarms paused symbol or the alarms off symbol. When yellow alarms are paused or off:

The yellow Alarms Paused lamp on the monitor front panel is lit. In the alarm field, the monitor displays the message YellowPaused x:yy or Yellow Alarms Off, together with the alarms paused symbol or the alarms off symbol. For red and yellow alarms:

Alarms Paused Alarms Off INOP messages are shown but no INOP tones are sounded. No alarms are sounded and no alarm messages are shown. The following INOPs are the only exceptions:

NBP Cuff Overpress, Batt Empty and Batt Malfunction (these INOPs are issued even if alarms are paused or off). These INOPs switch the alarms on, and the INOP tones are sounded, even if alarms are paused or off. You need to remove the INOP condition first before you can switch the alarm tones off again. Restarting Paused Alarms To manually switch on alarm indication again after a pause, select the SmartKey Pause Alarms (or Alarms Off) again. Alarm indication starts again automatically after the pause period expires. If the monitor is configured to stay paused infinitely, you must select Alarms Off again to restart alarm indication. 115 5 Alarms Extending the Alarm Pause Time If your monitor has the function extended alarm pause enabled, you can extend the alarm pause time. Use this to prevent alarms being indicated, for example, while you are washing a patient or carrying out a procedure. Only extend the alarm pause time when you are sure that clinical personnel are available to monitor the patient's condition closely. To extend the alarm pause time to five or 10 minutes, 1 2 Select one of the alarm fields. This calls up the Alarm Messages window. Select either the pop-up key PauseAl. 5 min or the pop-up key PauseAl. 10 min. Each time you select one of these pop-up keys, the Alarm Pause Time is reset to five (or 10) minutes. Alarm Limits The alarm limits you set determine the conditions that trigger yellow and red limit alarms. WARNING Be aware that the monitors in your care area may each have different alarm settings, to suit different scenarios. Always check that the alarm settings are appropriate before you start monitoring. Viewing Individual Alarm Limits (Alarm Mode "All" Only) Alarm Limits Audio source symbol You can usually see the alarm limits set for each measurement next to the measurement numeric on the main screen. If your monitor is not configured to show the alarm limits next to the numeric, you can see them in the appropriate measurement setup menu. Select the measurement numeric to enter the menu and check the limits. Changing Alarm Limits To change individual measurement alarm limits using the measurement's setup menu:

1 In the measurement's setup menu, select the alarm limit you want to change. This calls up a list of available values for the alarm limit. Select a value from the list to adjust the alarm limit. 2 116 5 Reviewing Alarms To review the currently active alarms and INOPs, select any of the alarm status areas on the fetal monitor screen. The Alarm Messages window pops up. All alarms and INOPs are erased from the monitor's alarm history when you discharge a patient, or if you enter Demonstration Mode. Alarm Messages Window The Alarm Messages window shows all the currently active alarms and INOPs in chronological order, beginning at the top with the most recent. INOPs are shown on the left hand side, and alarms are shown on the right hand side. Any active red alarms are shown first, followed by yellow alarms. Acknowledged alarms or INOPs are shown with the check mark symbol. The Alarm Messages window pop-up keys appear when the window is opened. Selecting the Review Alarms pop-up key opens the Review Alarms window. Review Alarms Window 1 Alarms On 2 SpO No Pulse 3 Alarms Silenced 4 5

** FHR1 High

** SpO Low The Review Alarms window contains a list of up to 300 of the most recent alarms and INOPs with date and time information. If configured to do so, each alarm is shown with the alarm limit active when the alarm was triggered and the maximum value measured beyond this limit. The Review Alarms window also shows any changes made to the Alarms On/Off or Silence status. Only the main alarms On/Off transitions are logged in the alarm history, and On/Off alarm transitions for individual measurements are not logged. The information in the Review Alarms window is deleted when a patient is discharged. The Review Alarms window pop-up keys appear when the window is opened. Selecting the Active Alarms pop-up key opens the Alarm Messages window. 117 5 Alarms Latching Alarms The alarm latching setting for your monitor defines how the alarm indicators behave when you do not acknowledge them. When alarms are set to non-latching, their indicators end when the alarm condition ends. Switching alarm latching on means that visual and/or audible alarm indications are still displayed or announced by the monitor after the alarm condition ends. The indication lasts until you acknowledge the alarm. Viewing the Alarm Latching Settings In the monitor's Main Setup menu, select Alarms. Select Alarm Settings, and see the Visual Latching and Audible Latching settings. To see the alarm latching setting for your monitor:

1 2 This setting can be changed in Configuration Mode. You should be aware of the settings chosen for your unit. There are three possible choices each for visual and audible latching: Red, Red & Yellow, and Off. The audible latching configuration can never be configured to a higher level than that configured for the visual latching. In other words, the audible latching setting is always the same level, or lower, than the visual latching setting. For example, if visual latching is configured to Red Only, then audible latching can only be set to Red or Off. The following table shows the possible combinations for latching settings:

Possible Combinations for Alarm Latching Settings Visual Latching Setting Red & Yellow Red & Yellow Red & Yellow Red Red Off Audible Latching Setting Red & Yellow Red Off Red Off Off 118 Alarm Latching Behavior Alarm Condition Acknowledgment Presence Red and Yellow Measurement Alarms Non-latching alarms Visual and audible Alarm has not been acknowledged Alarm condition still present Alarm condition no longer present Alarm tone on Alarm message All audible and visual alarm indicators automatically stop latching Alarm tone on Alarm message Flashing numerics Alarm tone on Alarm message Flashing numerics Alarm has been acknowledged Alarm condition still present Alarm condition no longer present Alarm tone off. Alarm message. Audible alarm reminder (if configured) Audible and visual alarm indicators automatically stop Alarm tone off Alarm message Flashing numerics Audible alarm reminder (if configured) Audible and visual alarm indicators automatically stop All INOPs except the "unplugged" INOPs are non-latching. Testing Alarms 5 Alarms Visual latching, audible non-latching Alarm tone on Alarm message Flashing numerics Alarm message Flashing numerics Audible alarm indicators automatically stop Alarm tone off Alarm message Flashing numerics Audible alarm reminder (if configured) Audible and visual alarm indicators automatically stop Set the alarm limits. In general, to test the functioning of visible and audible alarms, do the following:

1 Enable the alarm. 2 3 Measure or simulate the parameter that is out of range, or signal loss. 4 Verify that the visible and audible alarms are working. As an example, to test the FHR alarms:

1 Connect the US transducer to a fetal sensor socket. 2 Enable the FHR alarming (see Turning Alarms On or Off on page 185). Set the high alarm limit and delay to 150 bpm and 60 seconds respectively, and the low alarm limit and delay to 110 bpm and 60 seconds respectively (see Changing Alarm Limits on page 185). 1 Generate a fetal heart rate of approximately 180 bpm (3 beats per second) for more than one minute. 2 Verify the functioning of the visible and audible alarm. 119 5 Alarms Alarm Behavior at Power On If the monitor is switched off for longer than one minute and then switched on again, or after a loss of power lasting longer than one minute, the monitor can be configured to restore either the alarm settings from the monitor's User Defaults, or the most recently used alarm settings. When a patient is discharged, the User Defaults of the monitor are always restored independent of the setting. After any of these situations, you should check that the alarm settings are appropriate for your patient. If power is lost for less than one minute, the alarm settings prior to the power loss are restored. If AlarmsOffAtStart is enabled in Configuration Mode alarms will be initially paused or off the next time the monitor is switched on (depending on the configuration setting for Alarms Off). Even if it is enabled, this setting only takes effect if the power down time is more than one minute, and the Global Setting Automat Default is set to Yes. In order for alarms to be paused or switched off initially:

the monitor must be switched off for more than one minute, and the main alarms were switched off or paused before the monitor was switched off. 120 6Patient Alarms and INOPs 6 Patient Alarms and INOPs This chapter lists alarms and technical alarms (INOPs) for the fetal monitors irrespective of their priority. Alarm Messages Fetal alarms are identified by either "FHR" or "DFHR". All other alarms without these identifiers refer to maternal parameters. Alarm Message

*** Brady (Pulse)

***Brady xxx < yyy

*** Desat

*** Desat xx < yy

** DFHR1 High

** DFHR2 High

** DFHR3 High

**DFHR1 xxx>yyy

**DFHR2 xxx>yyy

**DFHR3 xxx>yyy

** DFHR1 Low

** DFHR2 Low

** DFHR3 Low

**DFHR1 xxx<yyy

**DFHR2 xxx<yyy

**DFHR3 xxx<yyy

*** Extreme Brady

***Brady xxx < yyy From SpO2 SpO2 FHR (DECG) FHR (DECG) MECG Condition The heart rate from the Pulse signal has fallen below the bradycardia limit. xxx denotes the lowest measured value; yyy is the bradycardia limit. The SpO2 value has fallen below the desaturation alarm limit. xx denotes the lowest measured value, and yy is the desaturation limit. The fetal heart rate obtained from DECG has risen above the high alarm limit. xxx denotes the highest measured value, and yyy is the high alarm limit. The fetal heart rate obtained from DECG has fallen below the low alarm limit. xxx denotes the lowest measured value, and yyy is the low alarm limit. The maternal heart rate obtained from the maternal ECG has fallen below the extreme bradycardia limit. xxx denotes the lowest measured value, and yyy is the extreme bradycardia limit. Indication Numeric flashes and alarm limit is highlighted, red alarm message, alarm tone. Numeric flashes, red alarm message, alarm tone. Numeric flashes and high limit is highlighted, yellow alarm message, alarm tone. Numeric flashes and low limit is highlighted, yellow alarm message, alarm tone. Numeric flashes, red alarm message, alarm tone. 121 6 Patient Alarms and INOPs Alarm Message

*** Extreme Tachy

***Tachy xxx > yyy From MECG Condition The maternal heart rate obtained from the maternal ECG has risen above the extreme tachycardia limit. xxx denotes the highest measured value, and yy is the extreme tachycardia limit. Indication Numeric flashes, red alarm message, alarm tone.

** FHR1 High

** FHR2 High

** FHR3 High

**FHR1 xxx>yyy

**FHR2 xxx>yyy

**FHR3 xxx>yyy

** FHR1 Low

** FHR2 Low

** FHR3 Low

**FHR1 xxx<yyy

**FHR2 xxx<yyy

**FHR3 xxx<yyy

** HR High

**HR xxx>yyy

** HR Low

**HR xxx<yyy

** NBPs High

** NBPd High

** NBPm High

** NBPs Low

** NBPd Low

** NBPm Low

** Pulse High

** Pulse Low 122 FHR (ultrasound) The fetal heart rate obtained from ultrasound has risen above the high alarm limit. xxx denotes the highest measured value, and yyy is the high alarm limit. Numeric flashes and high limit is highlighted, yellow alarm message, alarm tone. FHR (ultrasound) The fetal heart rate obtained from ultrasound has fallen below the low alarm limit. xxx denotes the lowest measured value, and yyy is the low alarm limit. Numeric flashes and low limit is highlighted, yellow alarm message, alarm tone. MECG MECG Noninvasive blood pressure Noninvasive blood pressure SpO2 SpO2 The maternal heart rate obtained from the maternal ECG has risen above the high alarm limit. xxx denotes the highest measured value, and yyy is the high alarm limit. The maternal heart rate obtained from the maternal ECG has fallen below the low alarm limit. xxx denotes the lowest measured value, and yyy is the low alarm limit. The measured noninvasive blood pressure value is above the high alarm limit.s, d, or m after the label s indicates whether the systolic, diastolic or mean pressure has crossed the limit. The measured noninvasive blood pressure value is below the low alarm limit.s, d, or m after the label s indicates whether the systolic, diastolic or mean pressure has crossed the limit. The pulse rate has exceeded the high alarm limit. The pulse rate has dropped below the low alarm limit. Numeric flashes and high limit is highlighted, yellow alarm message, alarm tone. Numeric flashes and low limit is highlighted, yellow alarm message, alarm tone. Numeric flashes and high limit is highlighted, yellow alarm message, alarm tone. Numeric flashes and low limit is highlighted, yellow alarm message, alarm tone. Numeric flashes and high limit is highlighted, yellow alarm message, alarm tone. Numeric flashes and low limit is highlighted, yellow alarm message, alarm tone. Alarm Message

** SpO High

** SpO Low

*** Tachy (Pulse)

***Tachy/P xxx>yyy From SpO2 SpO2 SpO2

** <iTemp Label> High iTemp

** <iTemp Label> Low iTemp 6 Patient Alarms and INOPs Condition The arterial oxygen saturation has exceeded the high alarm limit. The arterial oxygen saturation has fallen below the low alarm limit. The heart rate from the Pulse signal has exceeded the tachycardia limit. xxx denotes the highest measured value, and yyy is the tachycardia limit. The temperature value has exceeded the high alarm limit. The temperature value has dropped below the alarm limit. Indication Numeric flashes and high limit is highlighted, yellow alarm message, alarm tone. Numeric flashes and low limit is highlighted, yellow alarm message, alarm tone. Numeric flashes, alarm limit is highlighted, red alarm message, alarm tone. Numeric flashes and high limit is high-lighted, yellow alarm lamp, alarm tone Numeric flashes and high limit is high-lighted, yellow alarm lamp, alarm tone 123 6 Patient Alarms and INOPs Technical Alarm Messages (INOPs) Monitor INOPs INOP Message Bus Master Malfunc Indication Monitor: INOP tone What to do There is a problem with the monitor's hardware. Contact your service personnel. The Bus Master board or firmware is incompatible and cannot be used with this monitor software revision. Contact your service personnel. If this INOP appears, check the monitor and patient settings before you resume monitoring. If the settings are unexpected, there may be a problem with the monitor software. Contact your service personnel. A potential internal problem with the monitor has been detected. Contact your service personnel Perform a visual and functional check of the keyboard. Contact your service personnel. Perform a visual and functional check of the mouse input device. Contact your service personnel. OBR (OB Radio) channel configuration is invalid or settings are not present. Check channel configuration and hardware option. If this INOP appears, check the monitor and patient settings before you resume monitoring. If the settings are unexpected, there may be a problem with the monitor software. Contact your service personnel. If this INOP appears, the monitor can be used normally, except for the Trace Interpretation feature. Contact your service personnel. Perform a visual and functional check of the touch input device. Contact your service personnel. One or more fetal/maternal heart rates/pulse rates persistently coincide with each other (see Cross-Channel Verification (CCV) on page 149). The INOP tone has a configurable delay. The default setting is an instant INOP tone. There is a problem with I2C Bus communication in the monitor. Contact your service personnel. There is a problem with the communication to the network. Central monitoring is currently not possible (no patient alarms or information). Check the connection. Contact your service personnel. The end of the paper pack is detected. Insert a new pack of paper. Bus Master Incomp Monitor: INOP tone Check Flex Texts Monitor: INOP tone Check Monitor Func Monitor: INOP tone Check Keyboard Monitor: INOP tone Check Mouse Monitor: INOP tone Check OBR Config Monitor: INOP tone Check Settings Monitor: INOP tone Check TI Config Monitor: INOP tone Check Touch Input Monitor: Display only Coincidence Monitor: INOP tone Internal.Comm.Malf Monitor: INOP tone No Central Monit. Monitor: INOP tone Paper End Monitor: INOP tone 124 INOP Message Settings Malfunct Indication Monitor: INOP tone Speaker Malfunct Monitor: INOP tone SRR Incompatible Monitor: INOP tone SRR Malfunction Monitor: INOP tone SRR Invalid Chan Monitor: INOP tone SRR Interference Monitor: INOP tone Tele Malfunction Monitor: INOP tone Tele Unsupported Monitor: INOP tone TimeExpired:NST Unsupported LAN Monitor: INOP tone

(Message and tone only if Setup NST Timer, Notification is set to Alarm. Monitor: INOP tone User I/F Malfunct Monitor: INOP tone 6 Patient Alarms and INOPs What to do The monitor cannot use the predefined settings for monitoring. Contact your service personnel. Contact your service personnel to check the speaker and the connection to the speaker. The connected SRR (Short Range Radio) board or FW cannot be used with this base station SW revision. Contact your service personnel. Malfunction in the SRR (Short Range Radio) module(s). If the INOP persists, contact your service personnel. The channel configuration of the Short Range Radio is invalid. Check channel and channel mask configuration. The short range radio connection has interference from another device. Try using another channel. Malfunction of the connected base station. If the INOP persists contact your service personnel. The base station is not supported by the monitor. Check software revisions. The time has expired for the NST timer. Clearing the timer clears the INOP. There is a problem with the communication to the network and central monitoring is currently not possible. Check the connection. If the INOP persists, switch off the monitor and contact your service personnel. Perform a visual and functional check of all the monitor input devices. Contact your service personnel. 125 6 Patient Alarms and INOPs FM20/FM30 Battery INOPs INOP Message Batt Empty Indication Monitor: INOP tone Battery: battery LED flashes during this INOP, alarms cannot be paused or switched off Batt Incompat Monitor: INOP tone Batt Low Monitor: INOP tone Batt Malfunction Batt Missing Charger Malfunct Check Batt Temp Monitor: INOP tone Battery: battery LED flashes during this INOP, alarms cannot be paused or switched off unless the monitor is connected to mains power. Monitor: INOP tone Monitor: INOP tone Battery: battery LED may flash Monitor: INOP tone Recorder INOPs INOP Message Check Paper Indication Monitor: display only Recorder: Print-out FetRec Equip Malf Monitor: INOP tone FetRec Chk Config Monitor: INOP tone Printhead Overheat Monitor: INOP tone What to do The estimated remaining battery-powered operating time is less than 10 minutes. Connect the monitor to AC immediately. If the condition persists and the monitor is not connected to mains power, this INOP is re-issued two minutes after you acknowledge it. The battery cannot be used with this monitor. Replace it with the correct battery. The estimated battery-powered operating time remaining is less than 20 minutes. The monitor cannot determine the battery status. If the INOP persists, replace the faulty battery. If the condition persists and the monitor is not connected to mains power, this INOP is reissued two minutes after you acknowledge it. No battery found in FM20/30. Contact your service personnel. There is a problem with the battery charger in the monitor. Connect the monitor to mains power and contact your service personnel. The temperature of the battery is too high. Check that the monitor is not exposed to heat. What to do Check that there is no paper jam, that the print drawer is properly shut, that the paper is loaded with the grid facing upwards, and that the correct Philips paper is being used. There is a problem with the fetal recorder hardware. Contact your service personnel. Recorder Speed and/or Scale Type settings are set to

"Unknown" and need to be set to the correct values in Configuration Mode before the recorder can be operated. The printhead is too hot. The recorder stops, the recorder Start/ Stop key is disabled, and remains so until the printhead cools down sufficiently. Wait for the printhead to cool down, then press the recorder Start/

Stop key or the Silence key to clear the INOP. 126 6 Patient Alarms and INOPs What to do The grid scale of the paper in the monitor does not match the grid scale configured in the monitor. Make sure that you use the correct paper and scale for your institution:

pre-printed: 30-240 in US and Canada, 50-210 in other geographies. INOP Message Wrong Paper Scale Indication Monitor: INOP tone Recorder: Print-out Wired Transducer INOPs FHR (Ultrasound) Indication Monitor: INOP tone What to do There is a problem with the FHR hardware. Contact your service personnel. Monitor: INOP tone INOP tone if Alarm Mode is set to ALL. No tone if Alarm Mode is set to INOP only. Monitor: INOP tone The input signal quality is not sufficient to process the measurement. Adjust the position of the transducer to obtain a better signal. Reconnect the FHR transducer to the monitor. Check all connections are sound. INOP Message FHR1 Equip Malf FHR2 Equip Malf FHR3 Equip Malf FHR1 Signal Loss FHR2 Signal Loss FHR3 Signal Loss FHR1 Unplugged FHR2 Unplugged FHR3 Unplugged IUP INOP Message IUP Equip Malf Indication Monitor: INOP tone IUP Unplugged Monitor: INOP tone Toco INOP Message Toco Equip Malf Indication Monitor: INOP tone Toco Unplugged Monitor: INOP tone Pulse(Toco) Malf Monitor: INOP tone Toco MP Maternal Pulse Measurement What to do There is a problem with the IUP hardware. Contact your service personnel. Reconnect the IUP transducer to the monitor. Check all connections are sound. What to do There is a problem with the Toco hardware. Contact your service personnel. Reconnect the Toco transducer to the monitor. Check all connections are sound. There is a problem with the Toco MP transducer hardware. Contact your service personnel. 127 6 Patient Alarms and INOPs Cableless Transducer INOPs INOP Message cl US Disconnect cl Toco Disconnect cl ECG/IUP Disconn cl US Malfunction cl Toco Malf cl ECG/IUP Malf Indication Monitor: INOP tone CL transducer: tone and cyan LED Monitor: INOP tone Numeric is replaced by a -?-

CL transducer: tone and cyan LED Monitor: Display only CL transducer: LED flashes red What to do The cableless transducer has lost the connection to the monitor for more than 5 sec. Malfunction of the transducer The remaining monitoring time with this transducer is below 30 minutes. Charge battery. Monitor: Display only CL transducer: LED flashes red The remaining monitoring time with this transducer is below 15 minutes. Charge battery. Monitor: INOP tone CL transducer: tone and cyan LED Monitor: INOP tone CL transducer: tone and cyan LED Malfunction of the battery system (charger circuit or battery) detected (e.g. persistent communication error, over-voltage, over-current, battery incompatible). Contact your service personnel. The temperature of the transducer or its battery is critically high. If the transducer is docked on the base station, charging is interrupted. Check that device is not covered and do not expose device to heat sources. Do not place the base station in a sunny window in a room without active air conditioning. The environment temperature to charge a transducer battery should not exceed 40 C. If the INOP persists, remove device from patient and contact your service personnel. cl US Batt Low cl Toco Batt Low cl ECG/IUP BattLow cl US Batt Empty

!!cl US Batt Empty

!!!cl US BattEmpty cl Toco Batt Empty

!!clToco BattEmpty

!!!clTocoBattEmpty cl ECG/IUP Empty

!!cl ECG/IUP Empty

!!!clECG/IUP Empty cl US Batt Malf cl Toco Batt Malf clECG/IUP BattMalf cl US Check Temp cl Toco Chk Temp clECG/IUP Chk Temp 128 DECG and MECG INOPs Indication INOP Message Monitor: INOP tone DFHR1 Equip Malf DFHR2 Equip Malf DFHR3 Equip Malf DFHR1 Leads Off DFHR2 Leads Off DFHR3 Leads Off Monitor: INOP tone Numeric is replaced by a -?-

DFHR1 Signal Loss DFHR2 Signal Loss DFHR3 Signal Loss DFHR1 Unplugged DFHR2 Unplugged DFHR3 Unplugged MECG Equip Malf MECG Leads Off MECG Unplugged NBP INOPs INOP Message Cuff Not Deflated Monitor: INOP tone Numeric is replaced by a -?-

INOP tone if Alarm us set to ALL. no tone if Alarm Mode is set to INOP only. Monitor: INOP tone Numeric is replaced by a -?-

Monitor: INOP tone Monitor: INOP tone Numeric is replaced by a -?-

Monitor: INOP tone Numeric is replaced by a -?-

Indication Monitor: INOP tone (severe yellow/red INOP tone) Numeric is replaced by a -?-

During this INOP, alarms cannot be paused or switched off. 6 Patient Alarms and INOPs What to do There is a problem with the DECG hardware. Contact your service personnel. One or more DECG lead is not attached. Make sure that all required leads are attached, and no electrodes have been displaced. Check all connections are sound, and that the legplate attachment electrode is properly attached. If the INOP persists, try using another adapter cable, or legplate attachment electrode. If the INOP persists, contact your service personnel. The input signal quality is not sufficient to process the measurement. Reapply the fetal scalp electrode. Reconnect the DECG transducer to the monitor. Check all connections are sound. There is a problem with the MECG hardware. Contact your service personnel. One or more MECG lead is not attached. Ensure that all required leads are attached, and no electrodes have been displaced. Check all connections are sound. If the INOP persists, try using another adapter cable. If the INOP still persists, contact your service personnel. Reconnect the MECG transducer to the monitor. Check all connections are sound. What to do Remove the cuff from the patient. Make sure that the tubing is not kinked or twisted. Try restarting the measurement. You can silence the INOP, but the INOP message remains visible until the next measurement is started or the Stop All SmartKey is selected. 129 6 Patient Alarms and INOPs INOP Message NBP Cuff Overpress Indication Monitor: INOP tone (severe yellow/red INOP tone) Numeric is replaced by a -?-

During this INOP, alarms cannot be paused or switched off. NBP Equip Malf Monitor: INOP tone Numeric is replaced by a -?-

NBP Interrupted Monitor: INOP tone Numeric is replaced by a -?-

NBP Measure Failed Monitor: INOP tone Numeric is replaced by a -?-

What to do The cuff pressure exceeds the overpressure safety limits. Remove the cuff from the patient. Ensure that the tubing is not kinked or twisted and that the correct patient category is selected. Try restarting the measurement. You can silence this INOP, but the INOP message remains visible until the next measurement is started or the Stop All SmartKey is selected. Remove the cuff from the patient. The noninvasive blood pressure hardware is faulty. Contact your service personnel. You can silence this INOP, but the INOP message remains visible until the next measurement is started or the Stop All SmartKey is selected. Check the tubing and cuff for leakages or kinks. Check that you are using the correct cuff size and placement, and that the correct patient category is selected. Try restarting the measurement. If the INOP occurs repeatedly, contact your service personnel. You can silence this INOP, but the INOP message remains visible until the next measurement is started or the Stop All SmartKey is selected. This INOP arises when the measurement needed longer than the maximum time for inflation, deflation or the total measurement. Check that you are using the correct cuff size and placement, and that the correct patient category is selected. Try restarting the measurement. You can silence this INOP, but the INOP message remains visible until the next measurement is started or the Stop All SmartKey is selected. Check the condition and suitability of the patient for noninvasive blood pressure monitoring. Use another cuff to continue measuring. 130 CL NBP Pod INOPs INOP Message cl NBP Disconnect cl NBP No Cradle cl NBP Remove cl NBP Batt Empty

!!cl NBP BattEmpty

!!!cl NBP BatEmpty cl NBP Batt Incomp cl NBP Batt Low cl NBP Batt Malf cl NBP Batt Temp cl NBP Check Batt cl NBP Serv Batt Indication Monitor: INOP tone CL NBP Pod: INOP tone and display message Monitor: INOP tone CL NBP Pod: display message Monitor: INOP tone CL NBP Pod: display message Monitor: INOP tone CL NBP Pod: display message Monitor: INOP tone CL NBP Pod: display message Monitor: INOP tone CL NBP POD: display message Monitor: INOP tone CL NBP Pod: display message Monitor: INOP tone CL NBP Pod: display message Monitor: INOP tone CL NBP Pod: display message Monitor: INOP tone CL NBP Pod: display message 6 What to do The CL NBP Pod has lost the SRR connection to the monitor. The CL NBP Pod is not in the cradle. You can silence this INOP, but the INOP message remains visible until the CL NBP Pod is inserted into the cradle and the next measurement is started or the Stop All SmartKey is selected. The temperature of the battery in the CL NBP Pod is too high. Remove the Cableless Measurement Device from the patient and contact service personnel. The remaining battery time of the CL NBP Pod is below 30 minutes. Charge the battery. The battery in use with the CL NBP Pod is incompatible. Replace it with one approved for use with the CL NBP Pod. The remaining battery time of the CL NBP Pod is below 2 hours. There is a malfunction in the CL NBP Pod's battery system. Contact your service personnel. The temperature of the battery in the CL NBP Pod is critically high. Check that the Pod is not covered or exposed to a heat source. If the INOP persists, remove the Pod from the patient and contact your service personnel. The battery in the CL NBP Pod is nearing the end of its useful life. Only 50 charge/discharge cycles remain. Contact your service personnel to replace the battery. The battery in the CL NBP Pod has reached the end of its useful life. It can no longer be charged. Contact your service personnel to replace the battery. 131 6 Patient Alarms and INOPs SpO2 INOPs INOP Message SpO Equip Malf SpO Erratic SpO Extd.Update SpOInterference SpO Low Perf SpO NoisySignal SpO No Pulse SpO No Sensor SpO Poor Signal SpO Pulse?

SpO Searching SpO Sensor Malf SpO Sensor Off Indication Monitor: INOP tone Monitor: INOP tone Numeric is replaced by a -?-

Monitor: display only Numeric is replaced by a -?-

Monitor: INOP tone Numeric is replaced by a -?-

Monitor: display only Numeric is replaced by a -?-

Monitor: INOP tone Numeric is replaced by a -?-

Monitor: INOP tone Numeric is replaced by a -?-

Monitor: INOP tone Numeric is replaced by a -?-

Monitor: display only Numeric is replaced by a -?-

Monitor: INOP tone Numeric is replaced by a -?-

Monitor: display only Numeric unavailable Monitor: INOP tone Numeric unavailable Monitor: INOP tone Numeric unavailable SpO Unkn.Sensor Monitor: display only Numeric is replaced by a -?-

132 What to do There is a problem with the SpO2 hardware. Contact your service personnel. Check the sensor placement. Try another adapter cable and sensor. If the INOP persists, contact your service personnel. The update period of displayed values is extended due to a noninvasive blood pressure measurement on the same limb or an excessively noisy signal. There is too much interference, caused by a high level of ambient light and/or electrical interference. Cover the sensor to minimize ambient light. If the INOP persists, ensure that the sensor cable is not damaged or positioned too close to power cables. Accuracy may be compromised due to very low perfusion. Stimulate circulation at sensor site. If INOP persists, change the measurement site. Excessive patient movement or electrical interference is causing irregular pulse patterns. Try to reduce patient movement or to relieve the cable strain on the sensor. Check the perfusion at measurement site. If necessary, stimulate circulation or change measurement site. If the INOP is due to noninvasive blood pressure measurement on the same limb, wait until the measurement is finished. Ensure the SpO2 sensor is connected. If the INOP persists, try another adapter cable and sensor. If you silence this INOP, the measurement will be switched off. The signal condition of the SpO2 measurement is poor and measurement accuracy may be compromised. The detectable pulsations of the SpO2 signal are outside the specified pulse rate range. SpO2 is analyzing the patient signal to derive Pulse, and SpO2 values. Please wait until the search analysis is complete. The SpO2 sensor or adapter cable is faulty. Try another adapter cable and sensor. If the INOP persists, contact your service personnel. The SpO2 sensor is not properly applied to the patient. Apply the sensor following the instructions supplied by the manufacturer. The connected sensor or adapter cable is not supported by the SpO2 measurement. Use only specified sensors and cables. 6 Patient Alarms and INOPs INOP Message SpO Upgrade Indication Monitor: display only Numeric unavailable What to do The SpO2 measurement is currently in UPGRADE mode. Monitoring is not possible in this mode. CL SpO2 Pod INOPs INOP Message cl SpO Batt Empty

!!cl SpO BatEmpty

!!!cl SpO BtEmpty cl SpO Batt Incmp cl SpO Batt Low cl SpO Batt Malf cl SpO Batt Temp cl SpO Check Batt cl SpO Serv Batt cl SpO Disconnect cl SpO No Cradle cl SpO Remove Indication Monitor: INOP tone CL SpO2 Pod: display message Monitor: INOP tone CL SpO2 Pod: display message Monitor: INOP tone CL SpO2 Pod: display message Monitor: INOP tone CL SpO2 Pod: display message Monitor: INOP tone CL SpO2 Pod: display message Monitor: INOP tone CL SpO2 Pod: display message Monitor: INOP tone CL SpO2 Pod: display message Monitor: INOP tone CL SpO2 Pod: INOP tone and display message Monitor: INOP tone CL SpO2 Pod: display message Monitor: INOP tone CL SpO2 Pod: display message What to do The remaining battery time of the CL SpO2 Pod is below 30 minutes. Charge the battery. The battery in use with the CL SpO2 Pod is incompatible. Replace it with one approved for use with the CL SpO2 Pod. The remaining battery time of the CL SpO2 Pod is below 2 hours. There is a malfunction in the CL SpO2 Pod's battery system. Contact your service personnel. The temperature of the battery in the CL SpO2 Pod is critically high. Check that the Pod is not covered or exposed to a heat source. If the INOP persists, remove the Pod from the patient and contact your service personnel. The battery in the CL SpO2 Pod is nearing the end of its useful life. Only 50 charge/discharge cycles remain. Contact your service personnel to replace the battery. The battery in the CL SpO2 Pod has reached the end of its useful life. It can no longer be charged. Contact your service personnel to replace the battery. The CL SpO2 Pod has lost the SRR connection to the monitor. The CL SpO2 Pod is not in its cradle. The temperature of the battery in the SpO2 Pod is too high. Remove the SpO2 Pod from the patient and contact service personnel. 133 6 Patient Alarms and INOPs Tympanic Temperature INOPs INOP Message

<iTemp Label>

Malfunction Indication Monitor: INOP tone Numeric is replaced by a -?-

<iTemp Label>

Incompat.

<iTemp Label> Meas Failed Monitor: INOP tone Numeric is replaced by a -?-

Monitor: INOP tone Numeric is replaced by a -?-

<iTemp Lbl> NO DEVICE Monitor: INOP tone Numeric unavailable Monitor: INOP tone Numeric is replaced by a -?-

<iTemp Label>

Overrange What to do The thermometer or the interface board are defective. Check module on another monitor. Connect another module to this monitor and replace the interface board. If the problem persists, contact your service personnel. The iTemp device firmware is not supported by the monitor software. Ambient temperature is out of range. If ambient temperature is within valid range, check the thermometer. Try to end the stand-by mode by picking up a new probe cover. If the problem persists, replace thermometer and contact your service personnel. The thermometer is not connected to the monitor. Temperature measurement is out of range. If temperature of measurement is within valid range, check with another thermometer. 134 7 7Admitting and Discharging The fetal monitor can store basic patient demographic information used to identify patients. Admit/Discharge on the Monitor This section describes how you admit and discharge patients when using the monitor as a stand-alone device (that is, when not used with an obstetrical information and surveillance system such as OB TraceVue/IntelliSpace Perinatal). Admitting a Patient The fetal monitor displays physiological data as soon as a patient is connected. This lets you monitor a patient who is not yet admitted. It is however important to admit patients properly so that you can identify your patient on recordings. Use the Patient Demographics window and its associated pop-up keys to admit and discharge patients. To admit a patient, 1 Select the patient name field or select the Patient Demogr. SmartKey to open the Patient Demographics window. 2 Clear any previous patient data by selecting Dischrge Patient and then Confirm. If you do not discharge the previous patient, you will not be able to distinguish data from the previous and current patients, for example, on the recording. Select Admit Patient. 3 4 Enter the patient information: select each field and use the on-screen keyboard. If a conventional keyboard is connected to the monitor you can use this to enter patient information:

MRN: Enter the patient's medical record number (MRN), for example 12345678. Depending Last Name: Enter the patient's last name (family name), for example Doe. First Name: Enter the patient's first name, for example Jane. on your configuration this field may be labeled differently e.g. "Record ID", "Lifetime Id",

"Account Number", "Serial Number", or "SSN". Gestational Age: Enter the gestational age of the pregnancy. Enter one numeric for the week

(0-50) and one numeric for the day (0-6). Date of Birth: Enter the patient's date of birth. 135 7 Admitting and Discharging 5 Select Confirm. The patient status changes to admitted. If the recorder is running, the recorder stops and immediately restarts to annotate the new patient data. Quick Admitting a Patient Use Quick Admit to quickly admit a patient using only a limited set of demographic data. 1 2 Enter the required data (ID fields or last name depending on configuration) with the keyboard or a Select the Quick Admit SmartKey. barcode scanner. Select Enter. In the confirmation window, select Confirm to stop monitoring for the previous patient or free up the fetal monitor (if confirmation is configured). If the monitor is connected to an Information Center and only the ID field is entered, the patient name may be set to - - - at the Information Center, depending on the configuration. 3 4 5 Complete the rest of the demographic details as soon as possible to fully identify the patient on the network, on the monitor, and on printed reports. To complete the details, open the Patient Demographics window and complete all required fields. Editing Patient Information To edit the patient information after a patient has been admitted, select the patient name field on the main screen of the fetal monitor to open the Patient Demographics window, and enter the required changes. Discharging a Patient You should always perform a discharge even if your previous patient was not admitted. A discharge:

clears the information in the Patient Demographics window. resets all monitor settings to the settings defined in the User Default. advances the paper automatically if the recorder is running. stops the fetal recorder. When a patient is discharged from the monitor, all patient demographic data is deleted (trace data is not affected). Depending on your configuration, monitoring for a patient may end automatically when the fetal monitor has been powered off or in standby mode for a set time. To discharge a patient, 1 Select the patient name field to display the Patient Demographics window and associated pop-up keys. Select the pop-up key for Dischrge Patient. Select Confirm to discharge the patient. 2 3 CAUTION In order to ensure that the settings are reset to user defaults for a new patient, always discharge the previous patient from the fetal monitor. 136 7 Admitting and Discharging NOTE In order to ensure a continuous record, it is recommended to discharge the patient at the monitor before performing a new patient admission in OB TraceVue/IntelliSpace Perinatal. New Patient Check after a specified power-off period after a specified standby period The fetal monitor can be configured to ask you in certain situations:

whether a new patient is now being monitored. The pop-up window is entitled Is this a New Patient?

The monitor offers a Yes key to discharge the previous patient and begin monitoring a new patient, and a No key to continue monitoring with the current patient data and settings. The time periods for the two conditions can be configured independently. OB TraceVue/IntelliSpace Perinatal When the monitor is connected to an OB TraceVue/IntelliSpace Perinatal system over a LAN connection, the OB TraceVue/IntelliSpace Perinatal system acts as the "master" over patient demographic data. All patient and location-related data that is visible on the monitor is set, overwritten or updated by the OB TraceVue/IntelliSpace Perinatal system. See the OB TraceVue/IntelliSpace Perinatal Instructions for Use for details. Transferring a Patient When you are transferring a patient from one bed to another, both the monitor from which you are transferring her and the monitor to which you are transferring her must be switched on and connected to the OB TraceVue/IntelliSpace Perinatal network during the patient transfer. OB TraceVue/IntelliSpace Perinatal via RS232 In contrast to a LAN connection, when the monitor is connected to an OB TraceVue/IntelliSpace Perinatal system over an RS232 connection, the OB TraceVue/IntelliSpace Perinatal system has no control over the monitor's patient admission and discharge functions. Depending on how OB TraceVue/IntelliSpace Perinatal is configured, either the Last Name, First Name and the bed label, or just the bed label alone, are taken from the OB TraceVue/IntelliSpace Perinatal system. See the OB TraceVue/IntelliSpace Perinatal Instructions for Use for details. 137 7 Admitting and Discharging 138 8 8Non-Stress Test Timer The non-stress test (NST) timer shows the elapsed time for the non-stress test. The timer counts up to the time you set for the NST. Setting NST Autostart/Autostop You can set the recorder so that it starts automatically (NST Autostart) when the NST timer is started, and stops automatically (NST Autostop) when the NST is complete (when the set run time has elapsed). As default, NST Autostart is On, and NST Autostop is Off. Viewing the NST Timer You can configure the timer notification symbol, (the NST label), a progress bar and the elapsed time to be displayed in the top left-hand corner of the screen. By default, the NST timer is not displayed on the screen. Alternatively, you can view the timer in the Timers window. To open the Timers window:

Either a. Press the Timer SmartKey. Or b. Access the NST pop-up keys (see Accessing the NST Setup Pop-up Keys on page 140), and press the Timers key. 139 8 Non-Stress Test Timer Timer Expiry Notification When the timer expires, the color changes from blue to green, you hear a single tone, and a message appears in the status line on the main screen. The volume of the tone can be set in Configuration Mode. Accessing the NST Setup Pop-up Keys You control and set up the NST timer (for example, start, stop, or clear the timer, and set the run time) using a selection of pop-up keys that you access via any one of three possible routes:

Via the Timer SmartKey (Route 1). Via the Main Setup SmartKey (Route 2). Via the NST menu entry in the menu that pops-up when you touch the top left-hand corner of the screen (Route 3). Via the Timer SmartKey (Route 1) Press the Timer SmartKey. The Timers window opens, and the pop-up keys for controlling/

setting up the NST timer appear (see Pop-up Keys for NST Timer Setup on page 141). Via the Main Setup SmartKey (Route 2) 1 Enter the Main Setup menu using the SmartKey. 2 Select NST to enter the Setup NST menu. At the same time, the pop-up keys for setting up the NST timer appear (see Pop-up Keys for NST Timer Setup on page 141). Via the NST Field (Route 3) Select the NST field displayed in the top left-hand corner of the screen (when so configured). The pop-up keys for controlling/setting up the NST timer appear (see Pop-up Keys for NST Timer Setup on page 141). 140 Pop-up Keys for NST Timer Setup Pop-Up Keys Start Stop Selecting this pop-up key lets you.... Start the timer. Stop the timer, allowing either restarting after a pause

(Start) or clearing (Clear key). Enter the Setup NST menu. From here you can set the run time. Setup NST Timer Return to the Timers window. Run Time 8 Non-Stress Test Timer Comments This pop-up key is not available with Route 2, as the Setup NST menu is already open. This pop-up key is not available with Route 1, as the Timers window is already open. The run time can be set from 10 to 60 minutes. To set the run time, you first need to enter the Setup NST menu:

1 To enter the Setup NST menu:

Either Enter the Main Setup menu using the SmartKey. Then select NST. Or Access the NST pop-up keys (see Accessing the NST Setup Pop-up Keys on page 140), and press the Setup NST key. Select Run Time. 2 141 8 Non-Stress Test Timer 142 9Non-Stress Test Report 9 Non-Stress Test Report It is generally accepted that a non stress test (NST) allows you to assess fetal well-being. The monitor's NST report process uses fetal ultrasound (but not DECG) heart rate traces and the Maternal Toco trace, generating a printed report when criteria are met and it is an indication of the fetal well-being. The American term Non Stress Test (NST) is used for antepartum testing. The interpretation algorithm and rule set are equivalent to those implemented in OB TraceVue Revision G.xx or IntelliSpace Perinatal H.xx and higher, and are based on the 2008 NICHD guidelines. An NST report is a diagnostic aid, but it does not replace the clinicians judgment. The interpretation and the appropriate clinical response remain with the clinician. A fetus normally produces characteristic heart rate patterns. Average baseline variability and acceleration of the FHR in response to fetal movement are considered reassuring signs. This test does not take into account any form of external fetal stimulation. For every active ultrasound fetal heart rate measurement, one NST report can reside in the monitors memory. The reports are cleared when you discharge a patient and when you start a new NST report. When the NST Report option is available and the "NST Report" feature is "on", the NST status for all available ultrasound fetal heart rate measurements are displayed on the screen. The minimum displayed information is:

NST identification (by FHR number: 1, 2, 3) Current NST status (by color: inverse for "not started yet", white for "running", yellow for

"stopped", green for "finished") Setting Up an NST Report To setup NST Report functionality:

1 Enter the Main Setup menu and select the NST Report or 2 3 4 Select from:

Select the NST Report SmartKey. Press the "Setup" pop-up key. Set your configuration options. NST Analysis. Choose from On or Off. This switches the report feature on or off. This is linked to the NST timer. Both must be set to On for the NST report to function. Report Recording. Choose from:

Manual - press the Record Report pop up key to trigger a manual request. After Recorder Stop - report is recorded as soon as recorder becomes idle. Immediately - If a realtime recording is running, the monitor pauses it. The recording is continued after the report has been recorded. Average short term variability (STV) value is documented in [bpm] and [ms] if STV is configured as part of the NST Report. This parameter is not considered as reassuring criteria. 143 9 Non-Stress Test Report NST Report Status Window The NST Report window displays a detailed overview of the current NST status for any available ultrasound fetal heart rate measurement. You can see:

NST Status - whether it is ready, ongoing, or the time and date at which it was stopped, or at which it finished. Baseline - the average baseline value. Short Term Variability - the current short term variability (STV) value. FHR Availability - current statistical FHR availability value. Sinusoidal - the current status of sinusoidal rhythm detection. Elapsed time - the time that has elapsed since the NST began. Accelerations - the number of FHR accelerations detected so far. Variability - the average variability value. Decelerations - the number of FHR decelerations detected so far. For criteria not yet met, a white arrow symbol marks the overall status on the top line, and also appear against every criterion not yet met. A yellow symbol indicates detection of severe or prolonged decelerations. The pop-up keys let you perform the following actions:

FHR1, FHR2, FHR3 - switch to the window showing the current NST status for the fetal heart rate. Record Report - print the NST Report on paper. Record Trace - record the trace episode that belongs to the current report. Depending on device usage, the trace recording might be incomplete. Setup - open the Setup NST Report window. 144 Example NST Report Field Report Title, with FHR label and date Product Information Patient Information Start time, end time, Elapsed time, configured Run time Overall one-line NST result summary Title Result Accelerations Result: Contractions Result: Baseline and Variability Statistics: FHR availability Result: Decelerations Field Content NST Report for FHR1 on 12 Oct. 2009 Product DE53102345 G.01.70, OB A.04.24, Toco DE52401090, FHR1 DE00002345 A.05.26 Rogers, Alice Age: 27 Gestational Age: Week 34, Day 5 Time: 11:34 - 12:06 Elapsed time:32 minutes Run time: 20 minutes NST Criteria*: not met Trace Interpretation Summary Accelerations: 2 at: 11:59 12:02 Contractions: 3 at: 11:57 12:00 12:04 Baseline: 125 bpm (Range: 118 bpm - 129 bpm) Variability: 23 bpm (Range: 20 bpm - 24 bpm) Short Term Var.: 0.9 bpm (3.8 msec) FHR available: 95%

Decelerations: 1 at: 11:58 severe prolonged 9 145 9 Non-Stress Test Report Field Result:

Sinusoidal Rhythm detected Result: Decelerations before Reporting Period Field Content Sinusoidal: No Events before Reporting Period:

Decelerations: 1 at: 11:38 severe prolonged Guideline / Criteria Information valid FHR for 90% of reporting period baseline heart rate between 120 and 160 bpm at least 2 accelerations in 10 min not more than 1 decelerations This field is enabled if there were decelerations between the start of NST and the start of the reporting period.

(*) Interpretation Criteria based on guideline "NICHD 2008, v01"

User-defined criteria for CTG tracing:

moderate baseline variability (5 - 25 bpm) Additional Criteria:

no severe or prolonged decelerations no sinusoidal pattern in reporting period short term var. greater than 5.0 msec NST Criteria The patient is monitored for a user-definable period of time (10 - 60 minutes in steps of 5 minutes). The test is considered reassuring when the following criteria are met:

The fetal heart rate is valid at least 90% (this is configurable) of the specified time span. The FHR features a user-defined minimum number of accelerations. The FHR features a user-defined maximum number of tolerated decelerations, and does not include severe or prolonged decelerations, which are never tolerated. The average baseline fetal heart rate lies within the user-defined limits for low heart rate and high heart rate over the whole time span. The FHR exhibits a moderate variability (user-defined) for the specified time span. 146 9 Non-Stress Test Report An NST Report is generated when the reassuring criteria are met the first time in the current monitoring phase. When performing NST with twins or triplets, a separate NST Report is generated for each fetus. In the printed report, the average short term variability (STV) value is shown in bpm and ms. This is not part of the reassurance criteria. After the reassurance criteria have been met, the clinician can print the NST Report and then turn the fetal monitor off, or may continue fetal monitoring and print the report at any time. Non-Reassuring Report If the reassurance criteria are not met when the test has run for 90 minutes, or if you stop anytime during the 90 minute period, then the test is stopped, and a report is generated stating the reassurance criteria have not been met. Non-Reactive NST Test If a non-reactive test occurs and you then use acoustic stimulation, you must exercise caution in interpreting the resulting traces, as artificial stimulation is not taken into account when calculating test results. 147 9 Non-Stress Test Report 148 10 Cross-Channel Verification (CCV) 10Cross-Channel Verification

(CCV) Misidentification of Heart Rates FHR detection by the monitor may not always indicate that the fetus is alive. Confirm fetal life before monitoring, and continue to confirm that the fetus is the signal source for the recorded fetal heart rate

(see Confirm Fetal Life Before Using the Monitor on page 10). To reduce the possibility of mistaking the maternal HR or pulse for FHR, or FHR1 for FHR2 or FHR3, it is recommended that you monitor both maternal HR/pulse and the heart rates of all fetuses

(see Monitoring FHR and FMP Using Ultrasound on page 155, Monitoring Twin FHRs on page 171, Monitoring Triple FHRs on page 179, and Monitoring Maternal Heart / Pulse Rate on page 223). Here are some examples where the MHR can be misidentified as the FHR, or one FHR for another FHR (twins/triplets). When using an ultrasound transducer:

It is possible to pick up maternal signal sources, such as the maternal heart, aorta, or other large vessels. Especially if the recorded MHR, and any other artifact is over 100 bpm. It is possible to pick up the same fetal heart rate simultaneously with multiple transducers NOTE When an ultrasound transducer is connected to the monitor, but not applied to the patient, the measurement may generate unexpected intermittent FHR readings. When Fetal Movement Profile (FMP) is enabled:

The FMP annotations on a fetal trace alone may not always indicate that the fetus is alive. For example, FMP annotations in the absence of fetal life may be a result of:

Movement of the deceased fetus during or following maternal movement. Movement of the deceased fetus during or following manual palpation of fetal position

(especially if the pressure applied is too forceful). Movement of the ultrasound transducer. When using a scalp electrode (DECG):

Electrical impulses from the maternal heart can sometimes be transmitted to the fetal monitor through a recently deceased fetus via the spiral scalp electrode, appearing to be a fetal signal source. 149 10 Cross-Channel Verification (CCV) Cross-Channel Verification Functionality The cross-channel verification functionality (CCV) of the fetal monitors compares all monitored heart rates (maternal and fetal), and indicates automatically whether any two channels are picking up the same signal, or monitoring similar values. If the fetal monitor detects that any channels have the same or similar values the Coincidence INOP is issued with an INOP tone that can have a configurable delay. In addition yellow questions marks appear next to the numerics on the touch screen that have the same or similar values. On the recording trace there is also a question mark printed out from the point where recorded traces continuously overlap. Visual Aids for CCV Detection Coincidence INOP appears on the touch screen of the fetal monitor. Question mark next to the numerics that show the same or similar values appears on the touch screen of the fetal monitor. Question mark printed out on the recorder trace from the point where two measured values coincide. Overview of Cross-Channel Comparisons Measurements from Transducers Measurement FHR US DFHR (DECG) Maternal pulse Maternal pulse Maternal heart rate Transducer From Ultrasound or CL Ultrasound transducer From a fetal scalp electrode From Toco MP, or CL Toco+ MP transducer From SpO2 or CL SpO2 Pod From MECG electrodes Measurement Comparison Done by the Fetal Monitor for Cross-Channel Verification FHR1 (US) FHR2 (US) FHR3 (US) DFHR (DECG) FHR1 (US) FHR2 (US) FHR3 (US) 150 10 FHR1 (US) FHR2 (US) FHR3 (US) DFHR (DECG) DFHR (DECG) Maternal Pulse

(Toco MP) Maternal Pulse

(SpO2) Maternal HR

(MECG) 151 10 Coincidence Examples Coincidence of Maternal Pulse and FHR When the maternal pulse and FHR are being monitored, and the measured values are very similar or the same, the coincidence question mark is displayed on the monitors screen above both of the corresponding numerics (in this case maternal pulse and FHR). Often the signal loss or coincidence happens because the fetal or maternal movement displaced the ultrasound transducer, and a repositioning of the transducer is necessary. Coincidence INOP 1 2 Coincidence question mark by FHR1 3 Coincidence question mark by pulse from Toco MP 152 10 Cross-Channel Verification (CCV) The coincidence question mark is also printed on the trace paper next to the corresponding FHR and maternal pulse. 1 2 Printed coincidence question mark on trace FHR1 and pulse traces Coincidence of Twins/Triplets FHRs When both FHR1 and FHR2 are being monitored, and the measured values are very similar or the same, the coincidence question mark is displayed on the monitors screen above both of the corresponding numerics (in this case FHR1 and FHR2). Coincidence INOP 1 2 Coincidence question mark by FHR1 3 Coincidence question mark by FHR2 153 10 Cross-Channel Verification (CCV) The coincidence question mark is also printed on the trace paper next to the corresponding FHR1 and FHR2. 1 2 Printed coincidence question mark on trace FHR1 and FHR2 traces Recommended Actions for INOP Coincidence 1 Confirm fetal life by palpation of fetal movement or auscultation of fetal heart sounds using a fetoscope, stethoscope, or Pinard stethoscope. 2 Manual determination of the maternal pulse and comparison with the fetal heart rate sound signals from the loudspeaker. 3 Reposition the transducer, or ensure that the fetal scalp electrode is placed correctly, until you receive a clear signal and the monitor is no longer issuing the Coincidence INOP. In case of difficulties deriving a stable maternal pulse reading using the Toco MP or CL Toco+ MP transducer, use SpO2 or the CL SpO2 Pod instead. In case of similar problems with the pulse measurement from SpO2, use MECG instead. Reasons to switch the method for deriving a maternal pulse or heart rate include: motion artifacts, arrhythmia, and individual differences in pulse signal quality on the abdominal skin (via Toco MP). If you cannot hear the fetal heart sounds, and you cannot confirm fetal movement by palpation, confirm fetal life using obstetric ultrasonography. 4 5 154 11 Monitoring FHR and FMP Using Ultrasound 11Monitoring FHR and FMP Using Ultrasound To monitor a single FHR externally, you use an ultrasound transducer attached to a belt around the mother's abdomen. The ultrasound transducer directs a low-energy ultrasound beam towards the fetal heart and detects the reflected signal. Your monitor can also detect fetal movements and print the fetal movement profile (FMP) on the trace. Monitoring using ultrasound is recommended from the 25th week of gestation for non-stress testing or routine fetal monitoring. WARNING Performing ultrasound imaging or Doppler flow measurements together with ultrasound fetal monitoring may cause false FHR readings, and the trace recording may deteriorate. Technical Description Fetal monitors use the ultrasound Doppler method for externally monitoring the fetal heart rate. Using the Doppler method, the transducer (in transmitter mode) sends sound waves into the body which are then reflected by different tissues. These reflections (Doppler echoes) are picked up by the transducer

(in listening mode). These Doppler echoes are amplified and sent to the monitors speaker through which the fetal heart signal can be heard. In parallel the Doppler echoes are processed through an auto correlation algorithm to determine the fetal heart rate (FHR). The FHR is displayed on the monitors numeric display and on the recorded trace. Properly representing the fetal heart rate using a device that derives heartbeats from motion is a formidable task and the limitations of the technology will be discussed shortly. Basic fetal cardiac physiology may contribute to difficulties in obtaining a reliable ultrasound signal. A heart rate pattern of a fetus is capable of extraordinary variation, ranging from a stable pattern with minimal variation while the fetus is asleep to robust accelerations of 40-60 bpm above baseline rate over a few seconds, or exaggerated variability when the fetus is active. Decelerations of the rate 60-80 bpm below baseline may develop even more abruptly than the accelerations. The Beat-to-Beat arrhythmias of the FHR may further exaggerate how much the the FHR variability at the bottom of the variable decelerations, or in the presence of fetal breathing movements, which also tend to lower the fetal heart rate. The recognition of these normal variations in fetal heart rate patterns will greatly assist in the separation of genuine fetal information from the artifact. Limitations of the Technology All tissues moving towards or away from the transducer generate Doppler echoes. Therefore, the resulting signal that is provided to the monitors speaker, and for further fetal heart signal processing, can contain components of the beating fetal heart wall or valves, fetal movements, fetal breathing or hiccup, maternal movements such as breathing or position changes, and pulsating maternal arteries. The fetal heart signal processing uses an auto correlation algorithm to obtain periodic events such as heart beats. If the signal is erratic such as from a fetal arrhythmia, the ultrasound device may have 155 11 Monitoring FHR and FMP Using Ultrasound trouble tracking the abrupt changes, and may misrepresent the true FHR pattern. Signals such as those from moving fetal limbs are usually very strong, thereby masking the fetal heart signal. During prolonged movements where the fetal heart signal is masked, the FHR appears blank on the numeric display and as a gap on the recorded trace. Fetal position changes, maternal position changes, or uterine contractions can move the fetal heart partly or fully out of the ultrasound beam resulting in signal loss, or even picking up Doppler echoes from pulsating maternal arteries. In these cases a maternal heart rate or sometimes even a rate resulting from the mixture of fetal and maternal signals may be displayed on the monitors numeric display and on the recorded trace. In contrast to the timely well-defined R-peak of an ECG signal obtained with a fetal scalp electrode, the ultrasound Doppler signal from a fetal heart consists of multiple components from atria (diastole), ventricles (systole), valves, and pulsating arteries. These components vary depending on fetal and transducer position and angle, and are further modulated by factors such as fetal or maternal breathing. These effects may produce what is called artifact. Optimal transducer positioning therefore is key to minimizing these effects and thereby minimizing artifact. Misidentification of MHR as FHR FHR detection by the monitor may not always indicate that the fetus is alive. Confirm fetal life before monitoring, and continue to confirm that the fetus is the signal source for the recorded heart rate (see Confirm Fetal Life Before Using the Monitor on page 10 and Cross-Channel Verification (CCV) on page 149). What You Need Toco MP or CL Toco+ MP transducer Ultrasound transducer Ultrasound gel Transducer belt (and optional butterfly belt clip, if applicable) Cableless Monitoring - Important Considerations When using an Avalon CL or Avalon CTS Fetal Transducer system with your monitor, note the following:

Refer to Telemetry on page 93 for general rules regarding the use of cableless transducers from an Avalon CL or Avalon CTS Cableless Fetal Transducer system. When using a cableless ultrasound transducer from an Avalon CL or Avalon CTS system to measure the fetal heart rate, note that you cannot use any other ultrasound transducer (whether cableless or wired) at the same time. CAUTION Never use ultrasound transducers connected to more than one fetal monitor on the same patient. When using an Avalon CL or Avalon CTS you should be aware that FMP is not recommended when the mother is likely to move, and you should disable Fetal Movement Profile (FMP) on the fetal monitor (Fetal Movement Off) if the mother is walking. See also Fetal Movement Profile on page 160. 156 11 Monitoring FHR and FMP Using Ultrasound With the Avalon CL Transducer System you can now monitor twins and triplets with cableless transducers. The Avalon CTS System does not have this option. The wireless symbol appears next to the measurement label, indicating that the measurement is being made by a cableless transducer. FHR1 1 2 Toco parameter WARNING Ensure that the conductive parts of the fetal scalp electrode and the maternal leg plate electrode do not contact other conductive parts, including earth. Indication of the heart-rate may be adversely affected by the operation of cardiac pacemaker pulses or by cardiac arrhythmias. During ambulant FHR monitoring, the chance of losing the signal or detecting the maternal heart rate is higher than during stationary monitoring. The frequency of the patient's walk may be detected, and mistaken for a FHR signal. Check the mothers pulse periodically during monitoring and compare this with the FHR signal. Beware of mistaking a doubled maternal heart rate for FHR. If a fetus is dead, there is a risk that the maternal heart rate is monitored and misinterpreted as the fetal heart rate. Therefore, the simultaneous monitoring of maternal heart rate (preferably, the maternal ECG) and the fetal heart rate is encouraged. Do not interpret maternal movements as fetal movements. Artifacts: FMP artifacts are generated during fetal heart rate searching by changing the transducer position, therefore Philips fetal monitors enable the FMP only after detecting a valid heart rate signal for several seconds. FMP is not recommended when the mother is likely to move, and you should disable Fetal Movement Profile (FMP) at the fetal monitor (Fetal Movement Off) if the mother is walking. Gaps in maternal heart rate detection can occur:

if the transducer is not correctly positioned. due to the pulsation of uterine blood vessels. if the fetus moves. 157 11 Monitoring FHR and FMP Using Ultrasound Preparing to Monitor Prepare for ultrasound monitoring using the list below. The standard procedures in use in your facility determine the sequence of actions. 1 Determine fetal position. 2 3 4 Connect the transducer to a free socket. The signal quality indicator for the heart rate initially Fasten the belt around the patient. Switch on the monitor and the recorder. displays an invalid signal. 5 Apply a thin layer of ultrasound gel to the underside of the transducer. CAUTION Using ultrasound gel not approved by Philips may reduce signal quality and may damage the transducer. This type of damage is not covered by warranty. 1 Place the transducer on the abdomen, if possible over the fetal back or below the level of the umbilicus in a full-term pregnancy of cephalic presentation, or above the level of the umbilicus in a full-term pregnancy of breech presentation. Work the transducer in a circular motion to ensure the gel layer makes good contact. 2 When the sensor is connected correctly and you receive a good signal, the signal quality indicator should be filled out. If an inadequate signal is produced, the signal quality indicator will indicate a poor signal, and no numeric will appear on the screen. 3 Adjust the audio volume of the monitor's loudspeaker to a clearly audible level, while moving the transducer over the abdomen. When you have a good signal, secure the transducer in position below the belt. WARNING Periodically compare the mother's pulse with the signal coming from the monitor's loudspeaker to ensure that you are monitoring fetal heart rate. Do not mistake a doubled or elevated MHR for FHR. The ultrasound transducer may warm slightly (less than 1C/1.8F above ambient temperature) when applied to the patient,. When not applied, the transducer can reach a maximum temperature of 44C/

112.2F at an air temperature of 40C/104F. Selecting Fetal Heart Sound You can listen to the fetal heart sound from one ultrasound transducer at a time. When the fetal heart sound is selected for an FHR channel, you see the audio source symbol next to the FHR numeric label for that channel. 158 11 Monitoring FHR and FMP Using Ultrasound FHR1 1 2 Audio source symbol To select the audio source for an FHR channel:

1 Enter the Setup FHR1 menu for the channel you want to hear (FHR1 used as an example). 2 Press Select Audio. It may take a few seconds for the audio source symbol to appear. Changing the Fetal Heart Sound Volume The FHR volume symbol at the top right of the Fetal Heart Sound Volume window gives you an indication of the current volume. To change the volume:

1 Select the volume symbol. The volume scale pops up. 2 Select the required volume from the volume scale. 1 Fetal Heart Sound Volume 159 11 Monitoring FHR and FMP Using Ultrasound Fetal Movement Profile The Fetal Movement Profile (FMP) parameter detects fetal movements via an ultrasound transducer connected to the monitor. Only the fetus monitored on the FHR1 channel is monitored for FMP. Once you have enabled FMP (see Switching FMP On and Off on page 161), it is triggered automatically whenever:

You connect an ultrasound transducer. A patient is discharged. When FMP is enabled, the ultrasound transducer detects most fetal body movements. Eye movements are not detected and movement of the feet and hands may not be detected. Positioning or repositioning of the transducer is recorded as fetal movement. Maternal movement, excessive fetal breathing, or fetal hiccups may also be recorded as fetal movement (also in case of fetal demise or during the second stage of labor). You can mark these artifacts on the trace paper using either the remote event marker, or the event marker key as described in Marking an Event on page 79. FMP should be interpreted with care, or disabled when the patient is ambulating or during 2nd stage of labor. Ignore these movements when you interpret the FMP. When monitoring twins or triplets, only the fetus monitored on the FHR1 channel is monitored for movement, but be aware that movements recorded for FHR1 may also be caused by movement of the second or third fetus. The fetal movement profile (FMP) appears as "activity blocks" (see A below) along the top of the Toco Scale, the length of each block showing the duration of the activity. FMP Statistics FMP statistics are printed every ten minutes. 1 FMP enabled 160 11 Monitoring FHR and FMP Using Ultrasound 2 A B C FMP started here Indication of current fetal movement. The FMP statistics are presented as two percentage figures:

The first figure shows the percentage of detected fetal movements in the previous ten minutes. The second figure shows the percentage of detected fetal movements since the start of recording. To mark the start of the FMP statistic, FMP is printed on the paper with an arrow. The FMP detection activates after about half a minute of steady heart rate signals (signal indicator half-

full, or full) to minimize transducer positioning artifact. You will notice this deliberate delay:

When a new patient is admitted. A patient discharge restarts the FMP statistics from zero. When you connect an ultrasound transducer. Switching FMP On and Off You can switch FMP on and off from any FHR channel. For example, to set it from the FHR1 channel:

1 Enter the Setup FHR1 menu. 2 3 Return to the main screen. Select Fetal Movement to toggle between On and Off. 161 11 Monitoring FHR and FMP Using Ultrasound Troubleshooting Problem Erratic trace Erratic display Possible Causes Fetal arrhythmia Obese patient Transducer position not optimal Belt loose Too much gel Very active fetus Insufficient gel Signal quality indicator is continuously poor Transducer position not optimal FHR less than 50 bpm (and the FHR is audible) Questionable FHR Recording MHR by mistake Recording periodic signals when the transducer is not applied to the patient Recorded FHR appears to be suspiciously higher, or suspiciously lower, than real FHR. In very rare cases, half- or double-counting of the FHR can occur. Solutions Consider monitoring FHR using DECG after the rupture of membranes. Reposition transducer until signal quality indicator shows a good signal (at least half-full). Tighten belt Remove excess

Use enough gel to ensure the transducer makes good contact with the mother's skin. Reposition transducer until signal quality indicator shows a good signal (at least half-full). If membranes are ruptured, using a fetal scalp electrode (FM30 and FM50 only) allows measurement of FHR down to 30 bpm. Reposition transducer. Confirm fetal life. Disconnect all NON-USED ultrasound transducers, as continuous, regular mechanical, or electromagnetic influences can result in an artificial trace. If you have reason to question the validity of the recorded FHR, always verify FHR by independent means (by auscultation, for example). Measure maternal pulse by independent means. FHR not recorded FHR is less than 50 bpm or over 240 bpm If membranes are ruptured, using a fetal scalp electrode (FM30 and FM50 only) allows measurement of FHR down to 30 bpm. If FHR is outside of the specified range, verify FHR by independent means. See Patient Alarms and INOPs on page 121. FHR1 Equip Malf or FHR2 Equip Malf or FHR3 Equip Malf INOP displayed. FHR1 Signal Loss or FHR2 Signal Loss or FHR3 Signal Loss INOP displayed. FHR1 Unplugged or FHR2 Unplugged or FHR3 Unplugged INOP displayed. If you suspect the transducer is malfunctioning Test the transducer. 162 11 Monitoring FHR and FMP Using Ultrasound Additional Information Artifact in Fetal Heart Rate Measurement How to detect it and reduce its occurrence using the Avalon Fetal Monitor The ultrasound derived FHR measurement technique in Avalon fetal monitors, like all other ultrasound fetal monitors FHR measurement techniques, has limitations that can lead to misrepresentation of the fetal heart rate pattern and potential misinterpretation of the fetal condition. An incorrect interpretation of the trace may lead to either unnecessary interventions, or to failure to detect fetal distress and the need for intervention. Thus, the on-going evaluation of the recorded trace requires regular confirmation that the trace represents the true FHR. Specific situations requiring such confirmation include the following:

After starting a measurement or changing a transducer After maternal position changes, for example during pushing with contractions When the tracing shows abrupt changes in baseline rate, variability, or pattern (decelerations to accelerations) especially in the second stage of labor When the baseline maternal heart rate is within about 15 bpm of the FHR When the user is unable to determine a baseline rate and variability occurs between consecutive contractions There are several ways to verify the source and/or accuracy of the recorded fetal heart rate pattern. These include:

Verification of the FHR with:

An obstetric stethoscope, Ultrasound imaging, or A fetal scalp electrode Verification of the maternal heart rate:

Using pulse oximetry - for a maternal heart rate pattern displayed simultaneously with the FHR

(Cross-Channel Verification (CCV) feature), Using Maternal ECG - for a maternal heart rate pattern displayed simultaneously with the FHR

(CCV feature), or Manual determination of the maternal pulse Whenever possible measure the maternal pulse rate to make use of the monitors Cross-Channel Verification (CCV) feature, especially during the second stage of labor, or when the maternal pulse is elevated over 100 bpm. The Philips Avalon fetal monitor provides a Toco MP or CL Toco+ MP transducer for maternal pulse detection and the creation of a maternal heart rate pattern plotted on the same recorder as the FHR pattern. In case of difficulties deriving a stable maternal pulse reading using the Toco MP or CL Toco+ MP transducer, use SpO2 or MECG instead. When either of these parameters is utilized, the monitor will automatically and continuously perform a CCV of the maternal heart rate pattern against the FHR pattern displayed on the monitor. If the patterns and rates are similar, the CCV provides an alarm that both rates are probably from the same source (i.e., they both represent the maternal heart rate pattern and the fetus is not being monitored). Repositioning the ultrasound transducer will usually correct this, but it may be necessary to apply a fetal scalp electrode. Advising the mother to temporarily cease pushing during contractions may help to more rapidly resolve any uncertainty in this situation. 163 11 Monitoring FHR and FMP Using Ultrasound Doubling: The auto correlation algorithm can display a doubled fetal or maternal heart rate if the duration of diastole and systole are similar to each other, and if the heart rate is below 120 bpm. Doubling, usually brief, is accompanied by an abrupt switch of the trace to double the baseline value. Halving: With fetal tachycardia (above 180 bpm) and some interference from breathing or maternal arteries the auto correlation algorithm may only recognize every second beat resulting in a halved rate for a limited time. If the actual FHR is above the maximum limit of the monitor (240 bpm), the algorithm will also half-count. Halving is accompanied by an abrupt switch of the trace to exactly half the prior baseline value. This switch may simulate a FHR deceleration and be referred to by clinicians as a false deceleration. Switching to maternal heart rate (also referred to as "Maternal Insertion"): The fetal heart can move partly or fully out of the ultrasound beam and the auto correlation algorithm may then pick up and display the maternal heart rate. Depending on the signal mix in the ultrasound signal, switching to the maternal heart rate may mimic several conditions with the potential for erroneous interpretation and response as follows:

The switch to the maternal heart rate may simulate a FHR deceleration (i.e., a decrease of the fetal heart rate, and be referred to by clinicians as a false deceleration). The maternal heart rate may simulate a normal fetal heart rate pattern (i.e., it may mask a FHR deceleration or fetal demise). Especially during pushing with contractions in the second stage of labor, the maternal heart rate may increase to the point where it may equal or exceed the fetal rate. Here the maternal trace may mimic a normal fetal trace while the fetus may be having decelerations or fetal demise has occurred. This change from fetal to maternal heart rate pattern may not be at all obvious unless CCV is used and represents the most dangerous pitfall of all the artifacts because fetal distress may go unrecognized. The maternal heart rate may simulate a FHR acceleration, which is an increase of the fetal heart rate. During expulsive efforts, the maternal heart rate normally accelerates and may be at or above the normal FHR range. The FHR may display gradual appearing decelerations. Generally, the false decelerations described above are abrupt. Rarely, combinations of noisy/erratic signal associated with changes in maternal and/or fetal rate or movement will produce more gradual appearing false decelerations but these are usually short-lived with an abrupt return to an obviously stable FHR baseline. Noisy/Erratic signals: With mixed or weak signals the tracing may reveal very brief episodes of erratic recorded traces. These represent the auto correlation algorithm finding brief sequences of apparent and persistent heartbeats amidst a mixed or weak signal. These erratic recorded traces are commonplace, especially in association with fetal or maternal movement. During prolonged periods of such noisy/erratic signals, the fetus is not being adequately monitored. Drop out: With mixed or weak signals there may be no heart rate tracing at all. These episodes reflect that if the algorithm does not find an apparent and persistent heartbeat amidst a mixed or weak signal, it will not print a heart rate on the tracing. Brief episodes of drop out are commonplace, especially in association with fetal or maternal movement. During prolonged periods of drop out, the fetus is not being adequately monitored. 164 11 Monitoring FHR and FMP Using Ultrasound Multiple Fetuses With multiple fetuses, the potential to experience these artifacts is increased. Positioning of the transducer is even more critical. Ultrasound scanning should be used to help with positioning of individual transducers. See also Monitoring Twin FHRs on page 171 and Monitoring Triple FHRs on page 179. Obtaining a Good Heart Signal To successfully position the ultrasound transducer, first determine the fetal position using palpation. Position the transducer over the strongest audible fetal heart sound from the monitors speaker and wait at least six seconds after each transducer adjustment to verify a good signal quality displayed on the Signal Quality Indicator and a consistent FHR numeric display. Having determined the position that provides a strong fetal signal, fix the transducer on the abdomen with the belt. If the quality of the signal or the appearance of the heart rate trace from the ultrasound transducer is questionable, the transducer should be repositioned as described above. Alternatively, the use of an ultrasound scanner will greatly facilitate the determination of the optimal site for the ultrasound heart rate transducer. Factors during the second stage of labor that may influence the quality of the FHR tracing obtained with ultrasound include:

Uterine contractions Changing contour of the maternal abdomen Maternal body movement - positioning Maternal expulsive efforts - pushing Maternal tachycardia/accelerations with contractions Delayed return of the fetal heart rate from a deceleration Descent of the fetus in the birth canal Rotation of the fetus in the birth canal In some cases during the second stage of labor, a good and reliable ultrasound FHR signal may not be obtainable, and the use of a fetal scalp electrode must be considered (fetal ECG). Fetal decelerations, Fetal tachycardia Heart Rate Sound The heart rate sound emitted by the device is a representation of movement that, in most cases, permits accurate auscultation of the FHR corresponding to the FHR displayed on the monitor and rate pattern depicted on the trace recording. On occasion, the user may hear a FHR that differs from the FHR display and the recorded trace. This may occur in situations where the fetal heart moves partly out of the transducer ultrasound beam. In these cases, the user may hear the FHR emitted from the monitors speaker, even though another periodic signal (usually the maternal heart rate) has become stronger. The auto correlation algorithm will display the stronger maternal heart rate, despite the persistence of a weaker fetal signal. These occurrences are usually very brief and, if persistent, can be addressed by repositioning the transducer. 165 11 Monitoring FHR and FMP Using Ultrasound Signal Quality Indicator Avalon compared with its predecessor, the Series 50 Signal quality indicator on Avalon fetal monitors:

Instead of a traffic light-like design (red yellow green) used on the Series 50, the signal quality on the Avalon fetal monitor is indicated by a triangle on the touch screen that is displayed in one of three ways:

Avalon fetal monitor signal quality indicator display:

1 Completely filled triangle, indicating good signal quality

(good/full). 2 Half-filled triangle, indicating limited signal quality. This condition may indicate a weak or ambiguous signal. If this status persists, reposition the transducer (acceptable/

medium). 3 Empty triangle, indicating insufficient signal quality. No FHR is displayed on the monitors numeric display or the recorded trace. If this status persists, reposition the transducer (poor/no signal). Examples of Artifacts When monitoring the maternal ECG, a beat-to-beat maternal heart rate trace is printed alongside the FHR recorded trace. When monitoring the maternal SpO2 derived pulse rate, a filtered and averaged heart rate trace is printed. Following are recorded trace examples of complaints received regarding inaccurate output from the Avalon monitors. Scaling is 3 cm/min and 30 bpm/cm. Double-Counting Baseline Rate Baseline Variability Accelerations Decelerations 120 Moderate Present Not apparent 166 11 Monitoring FHR and FMP Using Ultrasound Excessive, coupling, hypertonus Double-Counting Reassuring tracing. The excessive uterine activity should prompt discontinuation of any oxytocic agent. The true fetal rate can be confirmed by auscultation or by fetal scalp electrode. Double-Counting Contractions Artifact Comment Remediation Half-Counting Baseline Rate Baseline Variability Accelerations Decelerations Contractions Artifact Comment Remediation 120 Moderate Present Not apparent Minimal Half-counting, noise, drop out Reassuring tracing. The half-count at 4-5 minutes into the tracing may simulate a fetal deceleration, but the abruptness and the lack of any compensatory changes when the normal rate returns suggests that this is half-counting. Insertion of the maternal heart rate (see below) may produce a similar pattern. Note also very brief episodes of half-

counting, maternal insertion, and signal drop out. Auscultation or the application of a direct scalp electrode, if feasible, will reveal the true fetal heart rate. Maternal-Switching (Maternal Insertion) 167 11 Monitoring FHR and FMP Using Ultrasound Maternal-Switching (Maternal Insertion) Baseline Rate 170 - Tachycardia Baseline Variability Moderate Accelerations Unable to determine Decelerations Absent Contractions Absent Artifact Maternal insertion, noise Comment The fetus has an elevated baseline rate of about 170 bpm with minimal to moderate variability. The ability to assess fetal status is limited because about half of the tracing displays the maternal heart rate. The application of a maternal transducer (ECG or pulse oximeter) will likely resolve any possible confusion with the tracing. Repositioning the transducer may produce a more reliable tracing. Consideration must also be given to applying a fetal scalp electrode. Remediation Noisy/Erratic Signal and Dropout Baseline Rate Baseline Variability Accelerations Decelerations Contractions Artifact Comment Remediation 140 Moderate Present Absent Minimal Noisy signal, drop-out Reassuring tracing. Note that there is episodic drop out of the signal with discontinuity of the fetal tracing. Either improving the position of the transducer or the application of a fetal scalp electrode will reduce the amount of artifact in the tracing. Selection of Literature References on Artifacts ___________________________________________________________ Fetal Monitoring, A Multidisciplinary Approach, Seventh edition Susan M. Tucker, Lisa A. Miller, David A. Miller Mosby Inc. 2009, ISBN 978-0-323-08352-2 ___________________________________________________________ 168 11 Signal ambiguity resulting in unexpected outcome with external fetal heart rate monitoring By Duncan R. Neilson Jr, MD; Roger K. Freeman, MD; Shelora Mangan, RNC, MSN, CNS American Journal of Obstetrics & Gynecology, June 2008:

___________________________________________________________ Antepartal and Intrapartal Fetal Monitoring, 3rd Edition (2007) By Michelle L. Murray, PhD, RNC Springer Publishing Company, ISBN 0-8261-3262-6 Page 2, Table 2: Limitations of Continuous EFM Item 15: The US may detect maternal aortic wall movement and the MHR will be printed. A failure to recognize the lack of a FHR may delay appropriate management. Page 38, Solving Equipment Problems, Table 3: The Ultrasound Transducer ___________________________________________________________ JOGC (Journal of Obstetrics and Gynaecology Canada) Volume 29, Number 9, September 2007 Chapter 2: Intrapartum Surveillance Page S35: Methods of Electronic Fetal Monitoring Among its disadvantages are the need for readjustment with maternal or fetal movements and the following: the transducer may record the maternal pulse, it may be difficult to obtain a clear tracing in obese women or those with polyhydramnios, artifact may be recorded, and there may be doubling or halving of the fetal heart rate when it is outside of the normal range. ___________________________________________________________ Maternal of Fetal Heart Rate? Avoiding Intrapartum Misidentification by Michelle L. Murray JOGNN Clinical Issues, April 2003, 33, 93-104; 2004. DOI: 10.1177/0884217503261161 Figure 9 "The recording is of the MHR with occasional doubling."

___________________________________________________________ Maternal Heart Rate Pattern A Confounding Factor In Intrapartum Fetal Surveillance Schifrin BS, Harwell R, Hamilton-Rubinstein T, Visser G:

Prenat Neonat Med 2001; 6:75-82. ___________________________________________________________ Fetal Monitoring in Practice, 2nd Edition 1998 169 11 Monitoring FHR and FMP Using Ultrasound By Donald Gibb, S. Arulkumaran Butterworth-Heinemann, ISBN 0-7506-3432-2 Page 65, False or erroneous baseline because of double counting of low baseline FHR Page 66, Bradycardia: fetal or maternal ___________________________________________________________ Role of Maternal Artifact in Fetal Heart Rate Pattern Interpretation Klapholz, Henry M, MD; Schifrin, Barry S. MD; Myrick, Richard RS Obstetrics & Gynecology, September 1974, Volume 44, Issue 3 ___________________________________________________________ Testing Ultrasound Transducers If any of the following tests fail, repeat the test using another transducer. If the second transducer passes the tests, confirming that the first transducer is defective, contact your service personnel. If the second transducer also fails the tests, contact your service personnel. To test an ultrasound transducer:

1 Switch on the monitor and the recorder. 2 Connect the transducer to the fetal 3 4 monitor. Select the fetal heart sound for this channel. Increase the loudspeaker volume to an audible level. 5 Holding the transducer in one hand, move your other hand repeatedly towards and then away from the surface. 6 Check that a noise is heard from the loudspeaker. You can test all ultrasound transducers, including the cableless ones as described above. 170 12Monitoring Twin FHRs 12 Monitoring Twin FHRs The FHRs of twins are externally monitored using two ultrasound transducers. The Avalon CL Transducer system provides the option to monitor twins with cableless transducers. The Avalon CTS system does not have this option. FM30/50 Twin FHRs are monitored throughout labor and delivery. After rupture of the membranes, you can monitor one twin externally using ultrasound, and the other internally using DECG. Refer to the appropriate preceding chapters for contraindications, and more information about the available measurement methods. FHR detection by the monitor does not always indicate that the fetuses are alive. Confirm fetal life before monitoring, and continue to confirm that the fetuses are the signal source for the recorded fetal heart rates. See Confirm Fetal Life Before Using the Monitor on page 10 and Cross-Channel Verification (CCV) on page 149. Important Considerations When monitoring:

Ensure that you are recording two different fetal heart rates. The cross-channel verification feature alerts you if the two heart rates coincide (if both transducers are recording the same FHR). If this happens, check the trace and if necessary, reposition an ultrasound transducer to detect the second FHR correctly. Fetal heart rate measurements are labeled in the order in which you plug in the transducers for those measurements. It does not matter which fetal sensor socket you use, as the monitor allocates a channel automatically. For instance, the first transducer you connect is automatically allocated a channel, and the measurement is labeled FHR1, the second is labeled FHR2, and so on. If you need to disconnect the transducers measuring the FHR temporarily, with the intention to continue monitoring after the temporary break (for example, if the mother needs to go to the bathroom), it is important that you reconnect the transducers in the same order as you originally connected them to make sure the measurement labels remain consistent. Upon discharge of the patient all connected transducers are reset from left to right. Example: Only one transducer is still connected to the monitor, it was labeled FHR2 while monitoring the previous discharged patient; it is now reset to FHR1. The transducer Finder LED lets you identify at a glance which transducer is monitoring which heart rate channel. The fetal sensor socket to which a transducer is connected is identified by the transducer position indicator in the blue setup menu header:

FM20/FM30 FM40/FM50 171 12 Monitoring Twin FHRs The trace recorded for FHR1 is thicker (darker) than that recorded for FHR2. This ensures that the two heart rates are easily distinguishable. The thickness of the recorded trace can be changed in Configuration Mode. Remember that only one fetal heartbeat can be heard from the loudspeaker at any time. The audio source symbol shows you which fetus you are listening to. To hear the other fetal heartbeat, select the fetal heart rate sound for this channel (see Selecting Fetal Heart Sound on page 158). Monitor maternal pulse, especially during later stages of labor, to avoid mistaking maternal heart rate for FHR. Make sure you are recording the best possible signals by referring to the signal quality indicators and repositioning the transducers if necessary. For the Avalon CL transducer system see Cableless Monitoring - Important Considerations on page 156. Monitoring Twins Externally To monitor twin FHRs externally you need two ultrasound transducers. Follow the procedures described in Monitoring FHR and FMP Using Ultrasound on page 155. The transducer Finder LED lets you identify at a glance which transducer is monitoring which FHR channel, and lights when you select the FHR numeric field on the screen. Example of the screen showing ultrasound monitoring of twin FHRs:

172 FHR 1 1 2 Toco parameter 3 FHR 2 12 Monitoring Twin FHRs Monitoring Twins Internally FM30/50 Monitor one twin using the procedures described in Monitoring FHR and FMP Using Ultrasound on page 155. Monitor the second twin using the procedures described in Monitoring FHR Using DECG on page 195. Example of a screen showing twin monitoring using a combination of US and DECG (the fetal heart rate monitored via DECG is labeled "DFHR1"/"DFHR2"/"DFHR3" on the screen):

1 DFHR 1 2 Toco parameter 3 FHR 2 Separating FHR Traces To help you to interpret traces with similar baselines, you can separate the baselines by an offset of 20 bpm by switching trace separation on. For details of the offset, see Separation Order Type on page 174. Switching Trace Separation On and Off Connect transducers to the monitor to measure FHR. Depending on the measurement method, you need either two ultrasound transducers or:

FM30/50 One ultrasound and one Toco+ transducer, or one CL ECG/IUP transducer (to monitor DECG). 1 Enter the Main Setup menu by pressing the Main Setup. 2 3 4 Exit the Main Setup menu. Select Fetal Recorder. Select Trace Separation to toggle between On and Off. 173 12 Monitoring Twin FHRs Separation Order Type In Configuration Mode, you can choose between two different ways, Standard and Classic, for dealing with the trace offsets on the recording (the order in which they are separated) when Trace Separation is On. Standard: the FHR2 trace is shifted up by 20 bpm (it is recorded 20 bpm higher than it really is). No offset is ever applied to the FHR1 trace - it stays where it is. (In case of a third FHR, this is shifted down by 20 bpm.) Classic: the FHR1 trace is shifted up by 20 bpm when there is more than one FHR measurement. No offset is ever applied to the FHR2 trace - it stays where it is. (In case of a third FHR, this is shifted down by 20 bpm.) When Trace Separation is On When trace separation is turned on, the recorder prints a dotted line labeled with the two FHRs at the top, and +20 at the bottom. Examples of the two methods (Standard, Classic) for determining the trace separation order are provided here.

"Standard" Separation Order To make differentiating the traces easier, the trace from the ultrasound transducer connected to the FHR2 channel is separated from that of FHR1 by 20 bpm. In other words, the trace for FHR2 is recorded 20 bpm higher than it really is. The trace for FHR1 is never shifted. The recorder prints a dotted line labeled +20 across the FHR scale, to identify the trace for FHR2. The FHR trace is labeled +20 every 5 cm:

The label for FHR2 is annotated with a black filled +20:

The following trace shows trace separation switched on. 174 12 Monitoring Twin FHRs Only the FHR2 trace is offset. The numerical FHR value displayed on the monitor remains unchanged. Subtract 20 from the recorded trace for FHR2 to obtain the true FHR2 value. For example, if the recorded trace shows 160, then the true FHR is 140.

"Classic" Separation Order To make differentiating the traces easier, the trace from the ultrasound transducer connected to the FHR1 channel is separated from that of FHR2 by 20 bpm. In other words, the trace for FHR1 is recorded 20 bpm higher than it really is. The trace for FHR2 is never shifted. The recorder prints a dotted line labeled+20 across the FHR scale, to identify the trace for FHR1. The FHR trace is labeled +20 every 5 cm:

The label for FHR1 is annotated with a black filled +20:

The following trace shows trace separation switched on. Only the FHR1 trace is offset. The numerical FHR value displayed on the monitor remains unchanged. Subtract 20 from the recorded trace for FHR1 to obtain the true FHR1 value. For example, if the recorded trace shows 160, then the true FHR is 140. 175 12 Monitoring Twin FHRs When Trace Separation is Off To indicate that trace separation is switched off, a dotted line labeled +0 prints across the FHR scale. 1 Standard trace separation switched off here 2 Classic trace separation switched off here 176 12 Troubleshooting Common problems that may occur when monitoring FHR using ultrasound are listed in Monitoring FHR and FMP Using Ultrasound on page 155. See also Monitoring FHR Using DECG on page 195 for common problems you might encounter when monitoring FHR directly. The following problem may occur when monitoring twins. Problem The question mark is printed repeatedly, and appears on the screen and the INOP Coincidence is issued. Possible Cause Both transducers are recording the same FHR, or one fetal transducer is recording the MHR. Solution Reposition an ultrasound transducer. See Recommended Actions for INOP Coincidence on page 154. For more information, see Additional Information on page 163. 177 12 Monitoring Twin FHRs 178 13 Monitoring Triple FHRs 13Monitoring Triple FHRs If your monitor is equipped with the triplets option, it carries the label. You can monitor triple FHRs externally using three ultrasound transducers. With the Avalon CL Transducer system you can now monitor triplets with cableless transducers. The Avalon CTS system does not have this option. Refer to the appropriate preceding chapters for contraindications, and more information about the available measurement methods. FHR detection by the monitor may not always indicate that the fetuses are alive. Confirm fetal life before monitoring, and continue to confirm that the fetuses are the signal source for the recorded fetal heart rates. See Confirm Fetal Life Before Using the Monitor on page 10 and Cross-Channel Verification (CCV) on page 149. Important Considerations The procedures and any contraindications that apply for twins monitoring also apply for monitoring triplets. In addition, when monitoring triplets: Be aware that monitoring three FHRs is inherently more difficult than monitoring single or twin FHRs. The nature of the application increases the likelihood that a fetal heart rate is monitored by more than one transducer. Ensure that you are recording three different fetal heart rates. Pay particular attention to any coincidence of heart rates detected by the monitor's cross-channel verification feature. Fetal heart rate measurements are labeled in the order in which you plug in the transducers for those measurements. It does not matter which fetal sensor socket you use, as the monitor allocates a channel automatically. For instance, the first transducer you connect is automatically allocated a channel, and the measurement is labeled FHR1, the second is labeled FHR2, and the third FHR3. If you need to disconnect the transducers measuring the FHR temporarily, with the intention to continue monitoring after the temporary break (for example, if the mother needs to go to the bathroom), it is important that you reconnect the transducers in the same order as you originally connected them to make sure the measurement labels remain consistent. Upon discharge of the patient all connected transducers are reset from left to right. Example: Only one transducer is still connected to the monitor, it was labeled FHR2 while monitoring the previous discharged patient; it is now reset to FHR1. The transducer Finder LED lets you identify at a glance which transducer is monitoring which heart rate channel. 179 13 Monitoring Triple FHRs The fetal sensor socket to which a transducer is connected, is identified by the transducer position indicator in the blue setup menu header:

FM20/FM30 FM40/FM50 The trace recorded for the FHR3 is thicker (darker) than that recorded for FHR1, which is thicker than that for FHR2. This ensures that the three heart rates are easily distinguishable. The thickness of the recorded trace can be changed in Configuration Mode. Remember that only one fetal heartbeat can be heard from the loudspeaker at any time. The audio source symbol shows you which fetus you are listening to. To hear the other fetal heartbeat, select the fetal heart rate sound for this channel (see Selecting Fetal Heart Sound on page 158). Monitor maternal pulse to avoid mistaking maternal heart rate for FHR. Ensure you are recording the best possible signals by referring to the signal quality indicators and repositioning the transducers if necessary. For the Avalon CL transducer system see Cableless Monitoring - Important Considerations on page 156. Monitoring Triplets To monitor triple FHRs you need three ultrasound transducers. Follow the procedures described in Monitoring FHR and FMP Using Ultrasound on page 155 and in Monitoring Twin FHRs on page 171. The transducer Finder LED lets you identify at a glance which transducer is monitoring which heart rate channel. Separating FHR Traces To help you to interpret traces with similar baselines, you can separate the baselines by an offset of 20 bpm by switching trace separation on. For details of the offset, see Separation Order Type on page 174.

"Standard" Separation Order To make differentiating the traces easier, the trace for FHR2 is offset by +20 bpm, and the trace for FHR3 is offset by -20 bpm. In other words, the trace for FHR2 is recorded 20 bpm higher than it really is, while the trace for FHR3 is recorded 20 bpm lower than it really is. The trace for FHR1 is never shifted. The recorder prints a dotted line labeled +20 across the FHR scale, to identify the trace for FHR2. 180 13 Monitoring Triple FHRs The recorder prints a dotted line labeled -20 across the FHR scale, to identify the trace for FHR3. The FHR trace is labeled every 5 cm. The label for FHR2 is annotated with +20 and the FHR3 label is annotated with -

20. The following trace shows triplets with Trace Separation on, and using Standard separation order. The traces for FHR2 and FHR3 are offset. The numerical FHR values displayed on the monitor remain unchanged. Subtract 20 from the recorded trace for FHR2 to obtain the true FHR2. For example, if the recorded trace shows 160, then the true FHR is 140. Similarly, add 20 to the recorded trace for FHR3 to obtain the true FHR3.

"Classic" Separation Order To make differentiating the traces easier, the trace for FHR1 is offset by +20 bpm, and the trace for FHR3 is offset by -20 bpm. In other words, the trace for FHR1 is recorded 20 bpm higher than it really is, while the trace for FHR3 is recorded 20 bpm lower than it really is. The trace for FHR2 is never shifted. The recorder prints a dotted line labeled +20 across the FHR scale, to identify the trace for FHR1. The recorder prints a dotted line labeled -20 across the FHR scale, to identify the trace for FHR3. 181 13 Monitoring Triple FHRs The FHR trace is labeled every 5 cm. The label for FHR1 is annotated with +20 and the FHR3 label is annotated with -

20. The following trace shows triplets with Trace Separation on, and using Classic separation order. The traces for FHR1 and FHR3 are offset. The numerical FHR values displayed on the monitor remain unchanged. Subtract 20 from the recorded trace for FHR1 to obtain the true FHR1. For example, if the recorded trace shows 160, then the true FHR is 140. Similarly, add 20 to the recorded trace for FHR3 to obtain the true FHR3. Switching Trace Separation On and Off 1 Connect three ultrasound transducers to the monitor to measure FHR. 2 See Switching Trace Separation On and Off on page 173 for details of how to switch trace separation on or off. When Trace Separation is On When trace separation is turned on, the recorder prints a dotted line labeled with the three FHRs at the top, and 20 at the bottom. Examples of the two methods (Standard, Classic) for determining the trace separation order are provided here. 182 13 When Trace Separation is Off To indicate that trace separation is switched off, a dotted line labeled +0 prints across the FHR scale. 1 Standard trace separation switched off here 183 13 Monitoring Triple FHRs 2 Classic trace separation switched off here Troubleshooting Common problems that may occur when monitoring FHR using ultrasound are listed in Monitoring FHR and FMP Using Ultrasound on page 155. The following problem may occur when monitoring triplets. Problem The question mark is printed repeatedly, and appears on the screen and the INOP Coincidence is issued. Possible Cause More than one transducer is recording the same FHR, or a fetal transducer records the same heart rate as the MHR. Solution Reposition one or more ultrasound transducer, as appropriate. See Recommended Actions for INOP Coincidence on page 154 For more information, see Additional Information on page 163. 184 14 14Fetal Heart Rate Alarms Fetal heart rate (FHR) alarms can give both audible and visual warning of a non-reassuring fetal condition. Your monitor must be configured to alarm mode All to enable the FHR alarms (see Alarms on page 109). Changing Alarm Settings Turning FHR alarms on or off. When you do any of the following actions for any FHR measurement channel, this applies for all active FHR measurements, both ultrasound and DECG:

Changing alarm limits. Changing alarm delays. Changing signal loss delay. The monitor retains these settings, even when switched off. The alarm limits are printed on the trace every few pages if alarms are on. Turning Alarms On or Off 1 Connect either an ultrasound or a DECG transducer to a free socket on the monitor. 2 Enter the Setup menu for a connected FHR measurement. 3 Select Alarms to toggle between On and Off. Changing Alarm Limits 1 Connect either an ultrasound or a DECG transducer to a free socket on the monitor. 2 Enter the Setup menu for a connected FHR measurement. 3 To change the high alarm limit, select High Limit and select the alarm limit from the pop-up list. 4 To change the low alarm limit, select Low Limit and select the alarm limit from the pop-up list. Changing Alarm Delays You can change the alarm delays if the Alarm Mode is set to All. 1 Connect either an ultrasound or a DECG transducer to a free socket on the monitor. 2 Enter the Setup menu for a connected FHR measurement. 185 14 Fetal Heart Rate Alarms 3 To change the high alarm limit delay time, select High Delay and select the delay time (in seconds) from the pop-up list. 4 To change the low alarm limit delay time in seconds, select Low Delay and select the delay time (in seconds) from the pop-up list. Changing Signal Loss Delay The signal loss delay is the configurable delay before a Signal Loss INOP is issued. You can change the delay:

1 Connect either an ultrasound or a DECG transducer to a free socket on the monitor. 2 Enter the Setup menu for a connected FHR measurement. 3 Select SignalLoss Delay and select the signal loss INOP delay time (in seconds) from the pop-up list. 186 15 Monitoring Uterine Activity Externally 15Monitoring Uterine Activity Externally You can measure uterine activity externally using a Toco transducer. You can also use a Toco+, Toco MP, or a CL Toco+ MP transducer for the same purpose, although they also have more (ECG/

IUP and Pulse) capabilities. The external Toco transducer measures the frequency, duration and relative strength of contractions, but not their absolute intensity. Amplitude and sensitivity depend on various factors such as the position of the transducer, the belt tension and the size of the patient. What You Need Toco, Toco MP, or Toco+ transducer CL Toco+ MP transducers (additionally capable of providing the maternal pulse measurement) CL ECG/IUP transducer 187 15 Monitoring Uterine Activity Externally Abdominal Belt (disposable shown) External Toco Monitoring Fasten the abdominal transducer belt around the patient. Prepare for Toco monitoring using the list below. The standard procedures in use in your facility determine the sequence of actions. 1 2 Connect the Toco transducer to a free socket on the monitor. The Toco baseline is automatically reset. The Toco display shows 20. "Toco", indicating external uterine measurement, is printed on the trace at intervals. 3 Place the transducer on the patient's fundus to ensure the optimum recording of uterine activity. 4 Reset the Toco baseline as necessary (see Resetting the Toco Baseline on page 188), but not during a contraction. The following example trace shows two contractions. Resetting the Toco Baseline 1 2 Press the Toco Baseline SmartKey. This resets the Toco baseline to 20 on the display and trace. If the Toco value is negative for more that five seconds, the Toco baseline is automatically reset to 0 units. Toco Sensitivity If the Toco sensitivity is too high, and the Toco trace exceeds the paper scale, you can reduce the Toco sensitivity to 50%. The default setting is 100%. To change the Toco sensitivity:

1 Enter the Setup Toco menu. 2 Select Gain to toggle between 100% and 50%. 188 15 Solutions The belt must be tight enough to ensure good contact between the patient's skin and the entire surface of the transducer without causing discomfort. Ensure you are using the correct belt. Adjust it as necessary. Check if the belt is correctly fastened and adjust it as necessary. Reposition the transducer and reset the Toco baseline if necessary. Check if belt is not too loose. Toco baseline Check if the belt is too tightly fastened. Select 50% Toco sensitivity. See Patient Alarms and INOPs on page 121. See Patient Alarms and INOPs on page 121. Test the Transducer (see Testing Toco Transducers on page 189 below). Troubleshooting External Toco Monitoring Problem Quality of the trace deteriorates or the Toco baseline varies Possible Causes The belt is incorrectly fastened and is too slack or too tight, or the belt has lost its elasticity. Fetal movement Physical transmission of pressure from the uterus to the sensor is much higher than the average value. Toco sensitivity is too high

(above 100 units) Toco trace is exceeding the paper scale Toco Equip Malf is displayed. Toco Unplugged is displayed. If you suspect the signal from the transducer. Testing Toco Transducers Maternal respiration superimposed on trace Maternal movement/change of position Following maternal movement, reset If any of the following tests fail, repeat the test using another transducer. If the second transducer passes the tests, confirming that the first transducer is defective, contact your service personnel. 189 15 Monitoring Uterine Activity Externally If the second transducer also fails the tests, contact your service personnel. To test a Toco transducer:

1 Switch on the monitor and the recorder. 2 Connect the transducer to the fetal monitor. 3 Gently apply pressure to the pick-

up button. 4 Check if after a few seconds the values on the display and paper show this change in pressure. You can test all Toco transducers, including the cableless ones, as described above. 190 16 Monitoring Uterine Activity Internally 16Monitoring Uterine Activity Internally FM30/50 You can monitor intrauterine pressure (IUP) using an intrauterine catheter together with a patient module, Toco+, or the CL ECG/IUP transducer, after rupture of the membranes and the cervix is sufficiently dilated. What You Need Illustration 1 shows the complete connection chain from the IUP catheter to the fetal monitor using the patient module:

1 Disposable Koala IUP Catheter (M1333A) 2 Reusable Koala IUP Adapter Cable (9898 031 43931) 3 Patient Module (M2738A) 191 16 Monitoring Uterine Activity Internally Illustration 2 shows the complete connection chain from the IUP catheter to the fetal monitor using the Toco+ transducer:

1 Disposable Koala IUP Catheter (M1333A) 2 Reusable Koala IUP Adapter Cable (9898 031 43931) 3 Toco+ transducer (M2735A) Illustration 3 shows the complete connection chain from the IUP catheter to the fetal monitor using the CL ECG/IUP transducer:

1 Disposable Koala IUP Catheter (M1333A) 2 Reusable Koala IUP Adapter Cable (9898 031 43931) 3 CL ECG/IUP transducer (866077) 4 Avalon CL base station (866074) 192 16 Internal (IUP) Monitoring Read the instructions that accompany the intrauterine catheter and the adapter cable before you start monitoring. Zero the monitor when instructed. WARNING Do not catheterize if placenta previa is diagnosed, or if uterine bleeding from an undetermined source is present. Prepare for IUP monitoring using the list below. The standard procedures in use in your facility determine the sequence of actions. 1 2 Catheterize after membrane rupture. Insert the catheter according to its accompanying Perform a complete clinical evaluation. instructions. 3 Connect the catheter to the socket on the patient module. 4 Connect the patient module to a free socket on the monitor. The monitor is automatically zeroed. The IUP display shows 0. "IUP", indicating internal measurement, is printed at intervals on the trace. 5 Zero the monitor (see Zeroing the Monitor on page 193). 6 If you suspect the catheter is not responding appropriately, flush as directed in the catheter's Instructions for Use. A pressure spike appears on the trace if you flush after connecting the transducer to the monitor. Zeroing the Monitor Zero the monitor by selecting the Zero IUP SmartKey, or selecting Zero IUP in the Setup IUP menu. This resets the display and trace to 0. If you do not zero the monitor properly, the pressure trace may exceed the paper scaling. Selecting the IUP Unit You can select between mmHg (default) and kPa for the IUP unit. 1 Enter the Setup IUP menu. 2 Press Unit to toggle between mmHg and kPa. 193 16 Monitoring Uterine Activity Internally Troubleshooting Internal (IUP) Monitoring Problem No change in pressure during contraction. Only pressure peaks can be seen (baseline not visible). Trace is a straight line. Trace is superimposed with noise. IUP Equip Malf INOP is displayed. IUP Unplugged INOP is displayed. Possible Causes Dry environment or possible extra-

ovular placement of sensor tip. Zero adjustment is incorrect. Solutions Refer to catheter Instructions for Use. Zero the system. Transducer is defective. Remove and touch the catheter. If the trace does not show up and down movements, use a new transducer. Catheter blocked. Refer to catheter Instructions for Use. End of catheter is in the uterine wall. Refer to catheter Instructions for Use. See Patient Alarms and INOPs on page 121. 194 17Monitoring FHR Using DECG 17 Monitoring FHR Using DECG FM30/50 This chapter describes how to monitor a single fetal heart rate via direct ECG (DECG), using a spiral fetal scalp electrode in the intrapartum period. Read and adhere to the instructions that accompany the fetal scalp electrode, the DECG adapter cable, and the attachment electrode. Pay attention to all the contraindications, warnings, and for the DECG adapter cable, the cleaning and disinfection procedures. Before starting to monitor, first define the fetal position, and ensure that it is suitable for DECG monitoring. Misidentification of MHR as FHR Confirm fetal life before monitoring, and continue to confirm that the fetus is the signal source for the FHR during monitoring. Here are two examples where the MHR can be misidentified as the FHR when using a fetal scalp electrode:

Electrical impulses from the maternal heart can sometimes be transmitted to the fetal monitor through a recently deceased fetus via the spiral scalp electrode, appearing to be a fetal signal source. The recorded MHR, and any artifact, can be misinterpreted as a FHR especially when it is over 100 bpm. To reduce the possibility of mistaking the MHR for FHR, monitor both maternal and fetal heart rates

(see Monitoring Maternal Heart / Pulse Rate on page 223). The monitor's cross-channel verification

(CCV) facility can help by automatically detecting when the same heart rate is being recorded by different transducers. See Confirm Fetal Life Before Using the Monitor on page 10 and Cross-

Channel Verification (CCV) on page 149. If the Coincidence INOP is issued at the fetal monitor if you are measuring FHR with DECG:

1 Confirm that the scalp electrode is placed correctly. 2 Confirm fetal life by palpation of fetal movement or auscultation of fetal heart sounds using a fetoscope, stethoscope, or Pinard stethoscope. If you cannot hear the fetal heart sounds, and you cannot confirm fetal movement by palpation, confirm fetal life using obstetric ultrasonography. In case of difficulties deriving a stable maternal pulse reading using the Toco MP or CL Toco+ MP transducer, use SpO2 instead. In case of similar problems with the pulse measurement from SpO2, use MECG instead. Reasons to switch the method for deriving a maternal pulse or heart rate include: motion artifacts, arrhythmia, and individual differences in pulse signal quality on the abdominal skin (via Toco+ MP). 3 4 195 17 Monitoring FHR Using DECG What You Need You can measure fetal DECG using the equipment combinations shown in the following illustrations. WARNING Never attempt to connect the fetal scalp electrode to anything other than the correct DECG adapter cable. Illustration 1 shows the complete connection chain from the fetal scalp electrode to the fetal monitor using the Toco+ transducer. Fetal Scalp Electrode, single spiral (9898 031 37631) Fetal Scalp Electrode, double spiral, Europe only, not for USA (9898 031 37641) 1 2 3 DECG Adapter Cable (9898 031 37651) with Pre-gelled Attachment Electrode (9898 031 39771) 4 Toco+ transducer (M2735A) 196 Illustration 2 shows the equivalent chain using the CL Toco+ MP or CL ECG/IUP transducer. 17 Monitoring FHR Using DECG Fetal Scalp Electrode, single spiral (9898 031 37631) Fetal Scalp Electrode, double spiral, Europe only, not for USA (9898 031 37641) 1 2 3 DECG Adapter Cable (9898 031 37651) with Pre-gelled Attachment Electrode (9898 031 39771) 4 CL Toco+ MP or CL ECG/IUP transducer (866077) 5 Avalon CL base station (866074) 197 17 Monitoring FHR Using DECG Illustration 3 shows the equivalent chain using the patient module. Fetal Scalp Electrode, single spiral, (9898 031 37631) Fetal Scalp Electrode, double spiral, Europe only, not for USA (9898 031 37641) 1 2 3 DECG Adapter Cable (9898 031 37651) with Pre-gelled Attachment Electrode (9898 031 39771) Patient Module (M2738A) 4 Making Connections WARNING Follow the instructions supplied with each of the monitoring accessories you are using. Prepare for DECG monitoring using the list below. The standard procedures in use in your facility determine the sequence of actions. 1 2 Depending on the equipment you are using, ensure that the Toco+ transducer, CL Toco+ MP, the If changing monitoring mode from US to DECG, first disconnect the US transducer. CL ECG/IUP transducer, or the patient module is connected to the fetal monitor. 3 Attach the fetal scalp electrode to the fetus, following the instructions supplied with the fetal scalp electrode. 5 4 Attach a pre-gelled attachment electrode to the DECG adapter cable, following the instructions supplied with the DECG adapter cable. Fix the attachment electrode to the mother's thigh, following the instructions supplied with the attachment electrode. Depending on the equipment you are using, connect the red connector plug on the DECG adapter cable to the red connector on the Toco+ transducer, CL Toco+ MP, the CL ECG/IUP transducer, or the patient module. 6 Connect the fetal scalp electrode to the DECG adapter cable. 198 17 Monitoring FHR Using DECG You are now ready to begin monitoring DECG. WARNING The fetal/maternal monitor is not a diagnostic ECG device. In particular, the display of fetal/maternal ECG is intended only for evaluating signal quality for fetal/maternal heart rate as derived from the ECG waveform. When in doubt, it can be used to identify sources of compromised signal quality, such as noise or muscle artifacts. It can subsequently be used to verify the result of measures taken to resolve them (e.g. checking ECG cable connections or adapting the fetal ArtifactSuppress configuration). The safety and effectiveness of the displayed fetal/maternal ECG waveform (i.e. P, QRS and T segments) for evaluation of fetal/maternal cardiac status during labor have not been evaluated. Monitoring DECG To simultaneously measure DECG and MECG, you need the CL ECG/IUP transducer or the patient module for DECG, and a Toco+, CL Toco+ MP, or CL ECG/IUP transducer for MECG (see Monitoring Maternal Heart / Pulse Rate on page 223). Alternatively, you can monitor the maternal pulse rate via pulse oximetry (see Pulse Rate from SpO2 on page 230). You can also monitor maternal pulse with the Toco MP or CL Toco+ MP transducer. In any case where you would use a Toco+ or Toco MP transducer, you can also monitor with a CL Toco+ MP transducer. 1 2 The heart rate monitored via DECG is labeled DFHR1 / DFHR2 / DFHR3 on the screen. If Switch on the recorder. configured, the DECG wave is displayed automatically on the screen, labeled DECG and fetal. If MECG is being monitored, both waves are displayed, with the DECG wave above the MECG wave. The MECG wave is labeled MECG and maternal. 199 17 Monitoring FHR Using DECG 3 Check the artifact suppression setting and change it if necessary (see Suppressing Artifacts on page 201). 1 Measurement label (FHR1) 2 Measurement label (Toco) 3 Measurement label (DFHR2) 4 Measurement label (FHR3) 5 Measurement label (SpO2) 6 Measurement label (HR) 7 8 MECG wave with maternal label 9 DECG wave with fetal label 10 Measurement label (Temp) maternal temperature 11 Measurement label NBP 1mV scale bar NOTE The 1mV scale bar for the DECG and MECG wave is not displayed on the screen if you monitor DECG or MECG with an Avalon CTS system. The Avalon CTS system does not provide a scaled ECG. 200 17 WARNING Periodically compare the mother's pulse with the signal coming from the monitor's loudspeaker to ensure that you are monitoring fetal heart rate. If the MHR coincides with the FHR, do not misinterpret the MHR as the FHR (see also Confirm Fetal Life Before Using the Monitor on page 10 and Cross-Channel Verification (CCV) on page 149. Suppressing Artifacts When the monitor's artifact suppression is on, instantaneous heart rate changes of 28 bpm or more, however caused, are not recorded. Fetal arrhythmia will also be suppressed. If you suspect fetal arrhythmia, switch artifact suppression off. When artifact suppression is off, all recorded fetal heartbeats within the specified range are shown. The default setting is On (artifacts are suppressed). To change the setting:

1 Enter the Setup DFHR1 menu. 2 Select ArtifactSuppress to toggle between artifact suppression On (artifacts are suppressed) and Off (no artifact suppression, use this setting if you suspect fetal arrhythmia). When artifact suppression is off, Artifact Suppression Off is annotated on the trace recording. Printing the Waveform You can print the DECG wave onto the trace paper. Refer to Printing the ECG Waveform on page 233. 201 Solutions See Patient Alarms and INOPs on page 121. Reconnect the fetal scalp electrode If the wave is configured to be displayed on the monitor, you can observe if the ECG signal is clear, or if it shows interruptions and noise Check all connections Disconnect and reconnect the connector several times Check all connections Disconnect and reconnect the connector several times If problem persists, use a new fetal scalp electrode Check for fetal demise Use a new fetal scalp electrode if necessary Use a new fetal scalp electrode if necessary See Patient Alarms and INOPs on page 121. See Patient Alarms and INOPs on page 121. 17 Monitoring FHR Using DECG Troubleshooting Problem DFHR1 Equip Malf DFHR2 Equip Malf DFHR3 Equip Malf DFHR1 Leads Off DFHR2 Leads Off DFHR3 Leads Off Numeric is displayed with a -?-;

INOP tone See also Patient Alarms and INOPs on page 121. Erratic trace Erratic display Possible Cause Malfunctioning equipment Fetal scalp electrode detached at connector Poor or no contact between leg attachment electrode and mother No contact between the DECG adapter cable and the leg attachment electrode No contact between the fetal scalp electrode connector and the DECG adapter cable No ECG signal Poor contact between the reference electrode and the mother Fetal arrhythmia No signal Signal quality indicator continuously shows a poor signal DFHR1 Signal Loss DFHR2 Signal Loss DFHR3 Signal Loss DFHR1 Unplugged DFHR2 Unplugged DFHR3 Unplugged Testing DECG Mode No connection See the monitor's Service Guide. 202 18 Monitoring Noninvasive Blood Pressure 18Monitoring Noninvasive Blood Pressure This fetal monitor uses the oscillometric method for the noninvasive blood pressure measurement. In adult mode the blood pressure measurements determined with this device comply with the American National Standard for Electronic or Automated Sphygmomanometers (ANSI/AAMI SP10-1992) in relation to mean error and standard deviation, when compared to intra-arterial or auscultatory measurements (depending on the configuration) in a representative sample population. For the auscultatory reference, the fifth Korotkoff sound was used to determine the diastolic pressure. A physician must determine the clinical significance of the measurement information. Introducing the Oscillometric Noninvasive Blood Pressure Measurement Oscillometric devices measure the amplitude of pressure changes in the occluding cuff as the cuff deflates from above systolic pressure. The amplitude suddenly increases as the pulse breaks through the occlusion in the artery. As the cuff pressure decreases further, the pulsations increase in amplitude, reach a maximum (which approximates to the mean pressure), and then diminish. Studies show that, especially in critical cases (arrhythmia, vasoconstriction, hypertension, shock), oscillometric devices are more accurate and consistent than devices using other noninvasive measuring techniques. WARNING Intravenous infusion: Do not use the NBP cuff on a limb with an intravenous infusion or arterial catheter in place. This could cause tissue damage around the catheter when the infusion is slowed or blocked during cuff inflation. Skin Damage: Do not measure NBP in cases of sickle-cell disease or any condition where skin damage has occurred or is expected. Unattended measurement: Use clinical judgment to decide whether to perform frequent unattended blood pressure measurements in cases of severe blood clotting disorders, because of the risk of hematoma in the limb fitted with the cuff. Measurement Limitations Measurements are impossible with heart rate extremes of less than 40 bpm or greater than 300 bpm, or if the patient is on a heart-lung machine. The measurement may be inaccurate or impossible:

with excessive and continuous patient movement such as during contractions with cardiac arrhythmias if a regular arterial pressure pulse is hard to detect 203 18 Monitoring Noninvasive Blood Pressure with rapid blood pressure changes with severe shock or hypothermia that reduces blood flow to the peripheries with obesity, where a thick layer of fat surrounding a limb dampens the oscillations coming from the artery on an edematous extremity. Measurement Methods There are three measurement methods:

Manual - measurement on demand. Results are displayed for up to one hour. Auto - continually repeated measurements (between one and 120 minute adjustable interval). You can make a manual measurement between two measurements in Auto Mode. Sequence- up to four measurement cycles which will run consecutively, with number of measurements and interval between them configurable for each cycle. Reference Method The measurement reference method can be Auscultatory (manual cuff) or Invasive (intra-arterial). For further information, see the Application Note supplied on the monitor documentation DVD. To check the current setting, select Main Setup, Measurements, NBP, and check whether the Reference setting is set to Auscultatory or Invasive. This setting can be changed in Configuration Mode. Preparing to Measure Noninvasive Blood Pressure If possible, avoid taking measurements during contractions because the measurement may be unreliable and may cause additional stress for the patient. 1 Connect the cuff to the air tubing. 2 Plug the air tubing into the red NBP connector. Avoid compression or restriction of pressure tubes. Air must pass unrestricted through the tubing. 3 Make sure that you are using a Philips-approved correct sized cuff and that the bladder inside the cover is not folded or twisted. A wrong cuff size, and a folded or twisted bladder, can cause inaccurate measurements. The width of the cuff should be in the range from 37% to 47% of the limb circumference. The inflatable part of the cuff should be long enough to encircle at least 80% of the limb. 4 Apply the cuff to a limb at the same level as the heart. If it is not, you must use the measurement correction formula to correct the measurement. The marking on the cuff must match the artery location. Do not wrap the cuff too tightly around the limb. It may cause discoloration, and ischemia of the extremities. Inspect the application site regularly to ensure skin quality and inspect the extremity of the cuffed limb for normal color, warmth and sensitivity. If the skin quality changes, or if the extremity circulation is being affected, move the cuff to another site or stop the blood pressure measurements immediately. Check more frequently when making automatic or stat measurements. 204 18 Monitoring Noninvasive Blood Pressure Correcting the Measurement if Limb is not at Heart Level To correct the measurement if the limb is not at heart level, to the displayed value Add 0.75 mmHg (0.10 kPa) for each centimeter higher or Add 1.9 mmHg (0.25 kPa) for each inch higher. Deduct 1.9 mmHg (0.25 kPa) for each inch Deduct 0.75 mmHg (0.10 kPa) for each centimeter lower or lower. Understanding the Numerics 1 Alarm source 2 Measurement Mode 3 Timestamp/Timer 4 Mean pressure 5 Diastolic 6 Systolic 7 Alarm limits Depending on the numeric size, not all elements may be visible. Your monitor may be configured to display only the systolic and diastolic values. If configured to do so, the pulse from NBP will display with the NBP numeric. Aging Numerics The measured NBP value, together with the corresponding pulse rate if this is switched on, will be displayed for one hour. After that the values are regarded as invalid and are no longer displayed. During this time, measurement values may be grayed out or disappear from the screen after a set time, if configured to do so. This avoids older numerics being misinterpreted as current data. The time can be set in Configuration Mode. In Auto Mode the measurement values may disappear more quickly (to be replaced by new measurement values), if the repeat time is set to less than one hour. NBP and SpO2 numerics from intermittent measurements can be configured to be grayed out or to disappear from the screen after a set time. This avoids older numerics being misinterpreted as current data. The time can be set individually for SpO2 and NBP in Configuration Mode. Alarm Sources If you have parallel alarm sources, the sources are displayed instead of the alarm limits. 205 18 Monitoring Noninvasive Blood Pressure NBP Measurement Timestamp Depending on your configuration, the time shown beside the NBP numeric can be:

the time of the most recent NBP measurement, also known as the "timestamp", or the time until the next measurement in an automatic series, displayed with a graphic representation of the remaining time, as shown here. The NBP timestamp will normally show the completion time of the NBP measurement. NBP Measurement Start Time In Auto or Sequence mode the monitor is configured to synchronize the measurements in a measurement series to an "easy-to-document" time. For example, if you start the first measurement at 08:23, and the Repeat Time is set to 10 min, the monitor automatically performs the next measurement at 8:30, then 8:40 and so on, unless it has been configured to NotSynchron.. During Measurements The cuff pressure is displayed instead of the units and the repeat time. An early systolic value gives you a preliminary indication of the systolic blood pressure during measurement. Starting and Stopping Measurements Use the Setup menu or the SmartKeys to start and stop measurements. Action to be performed Start/Stop manual measurement Start Auto series Stop current automatic measurement Start manual measurement Start Auto series Setup menu

Start/Stop Stop manual measurement Stop current automatic measurement

Stop automatic, or manual measurement AND series Stop All NBP 206 SmartKeys Start/ Stop Start Stop Stop All 18 Monitoring Noninvasive Blood Pressure Enabling Automatic Mode and Setting Repetition Time In the Setup NBP menu, select Mode. 1 2 Toggle between Auto and Manual, if necessary, to pick the measurement method. 3 If making an automatic measurement, select Repeat Time or press the Repeat Time SmartKey and set the time interval between two measurements. NOTE Be aware that a combination of a recorder speed of less than 3 cm/min and a repetition time of less than five minutes can result in not all noninvasive blood pressure measurements being recorded on the fetal trace. For example, if the recorder speed is set to 1 cm/min and the repetition time is set to two minutes, due to the low speed setting, the recorder will only be able to record every other noninvasive blood pressure measurement. This affects only the local fetal trace recording, and all measurements are displayed as normal on the monitor's screen. Enabling Sequence Mode and Setting Up The Sequence 1 2 3 In the Setup NBP menu, select Mode and select Sequence from the pop-up menu. Select Setup Sequence to open the Setup Sequence window. Up to four measurement cycles can be setup which will run consecutively. For each cycle you can set the number of measurements and the interval between them. If you want to run less than four cycles in a sequence, you can set the number of measurements for one or more cycles to Off. Select each sequence in turn, and select the number of measurements and the time interval between the measurements. 4 To have measurements continue after the sequence, set the number of measurements for your last cycle to Continuous and this cycle will run indefinitely. CAUTION Be aware that, if none of the cycles are set to Continuous, NBP monitoring will end after the last measurement of the cycle. When the NBP measurement mode is set to Sequence, the repetition time for Auto Mode cannot be changed. 207 18 Monitoring Noninvasive Blood Pressure Choosing the Alarm Source You can monitor for alarm conditions in systolic, diastolic, and mean pressure, either singly or in parallel. Only one alarm is given, with the priority of mean, systolic, diastolic. Menu option Sys. Dia. Mean Sys & Dia Dia & Mean Sys & Mean Sys&Dia&Mean Pressure value monitored systolic diastolic mean systolic and diastolic in parallel diastolic and mean in parallel systolic and mean in parallel all three pressures in parallel If mean is not selected as alarm source (Sys., Dia., or Sys & Dia selected), but the fetal monitor can only derive a mean value, mean alarms will nevertheless be announced using the most recent mean alarm limits. Check that the mean alarm limits are appropriate for the patient, even when not using mean as the alarm source. When no value can be derived an NBP Measure Failed INOP will be displayed. Assisting Venous Puncture In the Setup NBP menu select VeniPuncture. Puncture vein and draw blood sample. You can use the cuff to cause sub-diastolic pressure. The cuff deflates automatically after a set time if you do not deflate it. 1 2 3 Reselect VeniPuncture to deflate the cuff. During measurement, the display shows the inflation pressure of the cuff and the remaining time in venous puncture mode. 1 Cuff pressure 2 Venous puncture measurement mode 3 Time left in venous puncture mode Calibrating NBP NBP is not user-calibrated. NBP pressure transducers must be verified at least once every two years by a qualified service professional, and calibrated, if necessary. See the Service Guide for details. 208 Troubleshooting Problem Cuff will not inflate High or low values measured (against clinical expectations) Possible Causes Monitor is in Service or Configuration Mode Technical defect Cuff tubing not connected Contraction occurring Patient talking before or during measurement Incorrect cuff size or cuff not at heart level Noninvasive blood pressure reference method set incorrectly Displays zeros for systolic and diastolic values. Measurement automatically repeats Severe vasoconstriction at cuff site Erratic blood pressure fluctuations due to arrhythmias or rapid-acting drugs or contractions Excessive patient movement or convulsions NBP Cuff Overpress INOP is displayed NBP Equip Malf INOP is displayed NBP Interrupted INOP is displayed NBP Measure Failed 18 Solutions Call service Connect cuff tubing Wait until contraction has finished Allow patient to rest quietly, then try again after three to five minutes Check cuff size, level, and position Check the reference method configured

(auscultation or intra-arterial) and correct if necessary in Configuration Mode Move cuff to another limb, check for shock, or verify blood pressure using another method Try again, if unsuccessful, verify blood pressure using another method Wait until contraction has finished. Restrain movement or verify blood pressure using another method See Patient Alarms and INOPs on page 121. 209 18 Monitoring Noninvasive Blood Pressure 210 19 Monitoring Maternal Temperature 19Monitoring Maternal Temperature Measuring Tympanic Temperature The tympanic thermometer measures the patient's temperature in the ear using infrared technology. The result of this measurement can be automatically adjusted to correspond to a different body reference site. The result is displayed on the screen of the thermometer and transmitted to the monitor. The thermometer is used with single-use probe covers for infection control during measurement. WARNING Do not use in the presence of flammable anesthetics, such as a flammable anesthetic mixture with air, oxygen or nitrous oxide. Base station 1 2 Thermometer Place the thermometer into its base station, when it is not in use. The base station allows flexible mounting of the thermometer at the point of care. The base station is connected to the monitor's MIB/RS232 interface (optional) via a cable. It has storage space for up to 32 probe covers. 211 19 Monitoring Maternal Temperature Thermometer Display and Controls The tympanic thermometer has a liquid crystal display. The display shows the patient's temperature in numerics and guides you with symbols through the measurement process. 1 Eject key 2 Change unit key: Celsius / Fahrenheit 3 4 Start measurement key Pulse timer key Functional Keys Description of Use Press the eject key to eject the probe cover. The eject key symbol is shown on the display when a measurement has been taken and transmitted. Press the change unit key after a measurement to switch between C and F. Press the start measurement key when you are ready to take a patient's temperature. The pulse timer key can be used to time vital signs you take manually. Press and hold the pulse timer key to enter timer mode. Press the pulse timer key again to start the timer. The thermometer will issue a one beep at 15 seconds, two beeps at 30 seconds, three beeps at 45 seconds, and four beeps at 60 seconds. 212 19 Monitoring Maternal Temperature Status Screens The thermometer performs an internal test at every start-up to verify that the system components are functioning properly. It measures the ambient temperature. During start-up and measurement, the thermometer screens communicate the current status. Images Description Ambient Temperature above specified range Ambient Temperature below specified range System errors System error 12 - there is a problem with the settings. Contact your service personnel to have them check the settings and reset them, if necessary. If the display shows any other system error, then reset the thermometer by picking up a probe cover. If the system error does not clear, contact your service personnel. Making a Temperature Measurement WARNING Inaccurate measurement results can be caused by:

incorrect application of the thermometer. anatomical variations in the ear. build up of earwax in the ear. excessive patient movement during the measurement. absent, defective or soiled probe covers. probe covers other than the specified probe covers. 1 Ensure that the base station is connected via the appropriate cable to the connector on the monitor. 2 Remove the thermometer from the base station. The thermometer is latched to the base station to avoid an accidental fall when the base station is moved. To pick up the thermometer from the base station move it slightly up and then lift it from the base station to release the latch. Press the eject key on the thermometer to discard any probe that may have been left on the thermometer from a previous use. 3 213 19 Monitoring Maternal Temperature 4 5 6 Pick up a new probe from the probe container on the base station. Inspect the probe cover to make sure it is fully seated (no space between cover and tip base) and there are no holes, tears, or wrinkles in the plastic film. Place the thermometer with the probe in the ear canal, sealing the opening with the probe tip. For consistent results, ensure that the probe shaft is aligned with the ear canal. Press and release the start-up key gently. 7 8 Wait until you hear the three beeps. 9 Remove the probe from the ear. The temperature values are displayed both on the thermometer itself and on the connected monitor. 10 Check that the correct temperature label for the measurement site is displayed: iTrect, iToral, iTcore, or iTtymp 11 Press the eject key to eject the probe cover into a suitable waste receptacle. 12 Return the thermometer to the base station. The thermometer switches to stand-by mode after 30 seconds when not used. Possible INOPs Images Description Patient temperature above measurement range. Patient temperature below measurement range. 214 19 WARNING Never apply the probe to the patient when the probe is not connected to the unit. Always use a single-use probe cover to limit patient cross-contamination. Measurement errors or inaccurate readings may result when probe covers other than the specified probe covers are used (see Tympanic Temperature Accessories on page 267) Insert the probe slowly and carefully to avoid damage to the ear canal and the tympanic membrane. Inspect the probe for damage, holes, tears, or sharp edges to avoid injuring the skin. Always ensure that the used probe cover is removed before attaching a new probe cover. CAUTION Do not immerse the probe in fluids, or drop fluids on the probe. Do not use a probe cover that has been dropped or is damaged. Do not autoclave. To prevent damage to the unit, probe and accessories, refer to the cleaning procedures in the Cleaning and Disinfecting on page 246 chapter. Body Reference Sites and Monitor Labels The tympanic thermometer measures the patient's temperature in the ear. The thermometer can be configured to adjust the result of the measurement to correspond to a different body reference site. The measurement label displayed on the monitor corresponds to the body reference site that is configured. The following body reference sites are available:

Body Reference Site Ear temperature (no adjustment) Oral temperature Core temperature Rectal temperature Label on Monitor iTtymp iToral iTcore iTrect The body reference site can be selected in the Biomed mode of the tympanic thermometer. See the Service Guide for more information. The measured maternal temperature is only transmitted to a connected OB TraceVue/IntelliSpace Perinatal, when the tympanic thermometer is configured to the iTtymp body reference site, and the iTtymp label is displayed on the fetal monitor screen and printed out on the trace paper. 215 19 Monitoring Maternal Temperature Entering Temperature Manually A temperature measurement can be entered manually. 1 Press the SmartKey Enter Temp. 2 A numeric pad opens. 3 Enter the temperature values. 4 The aging time (time the entered value is valid) can be configured in the Configuration Mode. Press the Enter key. 216 20 Monitoring SpO2 20Monitoring SpO2 FM30/40/50 The pulse oximetry measurement (SpO2) is intended for use with maternal patients. Philips pulse oximetry uses a motion-tolerant signal processing algorithm, based on Fourier Artifact Suppression Technology (FAST). It provides two measurements:

Oxygen saturation of arterial blood (SpO2) - percentage of oxygenated hemoglobin in relation to the sum of oxyhemoglobin and deoxyhemoglobin (functional arterial oxygen saturation). Pulse rate - detected arterial pulsations per minute. This is derived from the SpO2 value, and is one of four sources of the maternal heart/pulse rate used for cross-channel verification (see Monitoring Maternal Heart / Pulse Rate on page 223 and Cross-Channel Verification (CCV) on page 149). Selecting an SpO2 Sensor See Accessories and Supplies on page 257 for a list of sensors, and the patient population and application sites for which they are appropriate. Familiarize yourself with the Instructions for Use supplied with your sensor before using it. CAUTION Do not use OxiCliq disposable sensors in a high humidity environment, or in the presence of fluids, which may contaminate sensor and electrical connections causing unreliable or intermittent measurements. Do not use disposable sensors when there is a known allergic reaction to the adhesive. Applying the Sensor Follow the SpO2 sensor's Instructions for Use, adhering to all warnings and cautions. 1 2 Remove colored nail polish from the application site. 3 Apply the sensor to the patient. The application site should match the sensor size so that the sensor can neither fall off, nor apply excessive pressure. 4 Check that the light emitter and the photodetector are directly opposite each other. All light from the emitter must pass through the patient's tissue. 217 20 Monitoring SpO2 WARNING Proper Sensor Fit: If a sensor is too loose, it might compromise the optical alignment or fall off. If it is too tight, for example because the application site is too large or becomes too large due to edema, excessive pressure may be applied. This can result in venous congestion distal from the application site, leading to interstitial edema, hypoxemia and tissue malnutrition. Skin irritations or lacerations may occur as a result of the sensor being attached to one location for too long. To avoid skin irritations and lacerations, periodically inspect the sensor application site and change the application site regularly. Venous Pulsation: Do not apply sensor too tightly as this results in venous pulsation which may severely obstruct circulation and lead to inaccurate measurements. Ambient Temperature: At elevated ambient temperatures be careful with measurement sites that are not well perfused, because this can cause severe burns after prolonged application. All listed sensors operate without risk of exceeding 41C on the skin if the initial skin temperature does not exceed 35C. Extremities to Avoid: Avoid placing the sensor on extremities with an arterial catheter, an NBP cuff or an intravascular venous infusion line. Connecting SpO2 Cables Connect the sensor cable to the color-coded socket on the monitor. If you are using a disposable sensor, plug the sensor into the adapter cable and connect this to the monitor. Connect reusable sensors directly to the monitor. CAUTION Extension cables: Do not use more than one extension cable (M1941A). Do not use an extension cable with Philips reusable sensors or adapter cables with part numbers ending in -L (indicates "long"

cable version). Electrical Interference: Position the sensor cable and connector away from power cables, to avoid electrical interference. Measuring SpO2 During measurement, ensure that the application site:

has a pulsatile flow, ideally with a signal quality indicator of at least medium. has not changed in its thickness (for example, due to edema), causing an improper fit of the sensor. 218 20 Monitoring SpO2 WARNING For fully conscious maternal patients, who have a normal function of perfusion and sensory perception at the measurement site:

To ensure skin quality and correct optical alignment of the sensor, inspect the application site when the measurement results are suspicious or when the patient complains about pressure at the application site, but at least every 24 hours. Correct the sensor alignment if necessary. Move the sensor to another site, if the skin quality changes. For all other patients:

Inspect the application site every two to three hours to ensure skin quality and correct optical alignment. Correct the sensor alignment if necessary. If the skin quality changes, move the sensor to another site. Change the application site at least every four hours. Injected dyes such as methylene blue, or intravascular dyshemoglobins such as methemoglobin and carboxyhemoglobin may lead to inaccurate measurements. Inaccurate measurements may result when the application site for the sensor is deeply pigmented or deeply colored, for example, with nail polish, artificial nails, dye or pigmented cream. Interference can be caused by:

High levels of ambient light (including IR warmers) or strobe lights or flashing lights (such as fire alarm lamps). (Hint: cover application site with opaque material). Another SpO2 sensor in close proximity (e.g. when more than one SpO2 measurement is performed on the same patient). Always cover both sensors with opaque material to reduce cross-interference. Electromagnetic interference, especially at perfusion indicator values below 1.0 or signal quality indicator below medium. Excessive patient movement and vibration. SpO2 Signal Quality Indicator (Fast SpO2 only) The SpO2 numeric is displayed together with a signal quality indicator (if configured and enough space is available) which gives an indication of the reliability of the displayed values. The level to which the triangle is filled shows the quality of the signal; the indicator below shows a medium signal quality, the signal quality is at a maximum when the triangle is completely filled. 219 20 Monitoring SpO2 Assessing a Suspicious SpO2 Reading Traditionally, pulse rate from SpO2 was compared with heart rate from ECG to confirm the validity of the SpO2 reading. With newer algorithms, such as FAST-SpO2, this is no longer a valid criteria because the correct calculation of SpO2 is not directly linked to the correct detection of each pulse. When pulse rate is very low, or strong arrhythmia is present, the SpO2 pulse rate may differ from the heart rate calculated from ECG but this does not indicate an inaccurate SpO2 value. WARNING With pulse oximetry, sensor movement, ambient light (especially strobe lights or flashing lights) or electromagnetic interference can give unexpected intermittent readings when the sensor is not attached. Especially bandage-type sensor designs are sensitive to minimal sensor movement that might occur when the sensor is dangling. Understanding SpO2 Alarms This refers to SpO2 specific alarms. See the Alarms on page 109 chapter for general alarm information. SpO2 offers high and low limit alarms, and a high priority desat alarm. You cannot set the low alarm limit below the desat alarm limit. CAUTION If you measure SpO2 on a limb that has an inflated noninvasive blood pressure cuff, a non-pulsatile SpO2 INOP can occur. If the fetal monitor is configured to suppress this alarm there may be a delay of up to 60 seconds in indicating a critical status, such as sudden pulse loss or hypoxia. Alarm Delays There is a delay between a physiological event at the measurement site and the corresponding alarm at the monitor. This delay has two components:

The general system delay time is the time between the occurrence of the physiological event and when this event is represented by the displayed numerical values. This delay depends on the algorithmic processing and the averaging time. The time between the displayed numerical values crossing an alarm limit and the alarm indication on the monitor. This delay is the combination of the configured alarm delay time plus the general system alarm signal delay time. Adjusting the SpO2 Alarm Limits In the Setup SpO menu:

Select High Limit then choose the upper alarm limit. Select Low Limit then choose the lower alarm limit. 220 20 Adjusting the Desat Limit Alarm The Desat alarm is a high priority (red) alarm notifying you of potentially life threatening drops in oxygen saturation. 1 2 Adjust the limit. In the Setup SpO menu, select Desat Limit. Adjusting the Pulse Alarm Limits See Adjusting the Heart Rate / Pulse Alarm Limits on page 230. Setting Up Tone Modulation If tone modulation is on, the QRS tone pitch lowers when the SpO2 level drops. Remember, the QRS tone is derived from either heart rate (from MECG) or pulse (from built-in SpO2) depending on which is currently displayed (see Priority for Maternal Heart / Pulse Rate on page 223). NOTE Pulse from CL SpO2 and Toco MP does not provide a QRS tone. Setting the QRS Volume In the Setup SpO menu, select QRS Volume and set the appropriate QRS tone volume. 221 20 Monitoring SpO2 222 21 Monitoring Maternal Heart / Pulse Rate 21Monitoring Maternal Heart /

Pulse Rate SpO2 (pulse rate) You can monitor the maternal heart/pulse rate using one of four sources:

Maternal pulse from Toco MP or CL Toco+ MP transducer (pulse rate) Maternal heart rate (MHR) via MECG electrodes NBP (pulse rate) Maternal heart / pulse rates derived from Toco MP or CL Toco+ MP, SpO2 and MECG are continuous measurements, and are compared against the FHR for cross-channel verification. Average pulse rate derived from noninvasive blood pressure is an intermittent measurement, and is therefore not used for cross-channel verification. Priority for Maternal Heart / Pulse Rate Priority Maternal Heart / Pulse Rate Source Alarming Used for CCV 1 2 3 4 5 6 HR from MECG measurement Pulse from SpO2 measurement Pulse from CL SpO2 Pod measurement Pulse from Toco MP measurement cableless or cabled Pulse from CL NBP Pod measurement Pulse from NBP measurement Yes Yes Yes No No No Yes Yes Yes Yes No No Provides QRS Tone Yes Yes No No No No Only one Maternal Heart Rate / Pulse Rate numeric will be displayed and recorded at a time (see priority table). If higher-priority measurements are connected but temporarily not providing valid numerics, lower-priority numerics may be displayed and recorded instead. Misidentification of MHR for FHR To reduce the possibility of mistaking the MHR for FHR, it is recommended that you monitor both maternal and fetal heart rates (see Confirm Fetal Life Before Using the Monitor on page 10 and Cross-Channel Verification (CCV) on page 149). 223 21 Monitoring Maternal Heart / Pulse Rate MHR from MECG Electrodes You can measure MHR using the equipment combinations shown in the following illustrations. Illustration 1 shows the complete connection chain from the foam electrodes applied to the patient to the fetal monitor using the patient module. Patient Module (M2738A) 1 2 MECG Adapter Cable (M1363A) 3 Pre-gelled Foam Electrodes (40493A/B/C/D/E) Illustration 2 shows the equivalent chain using the Toco+ transducer. Toco+ Transducer (M2735A) 1 2 MECG Adapter Cable (M1363A) 3 Pre-gelled Foam Electrodes (40493A/B/C/D/E) 224 21 Monitoring Maternal Heart / Pulse Rate Illustration 3 shows the equivalent chain using a CL Toco+ MP transducer or a CL ECG/IUP transducer. 1 Avalon CL base station (866074) 2 CL Toco+ MP or CL ECG/IUP transducer (866075 or 866077) 3 MECG Adapter Cable (M1363A) 4 Pre-gelled Foam Electrodes (40493A/B/C/D/E) To simultaneously measure DECG and MECG, you can use a Toco+, a CL Toco+ MP, or a CL ECG/IUP transducer for MECG. For measuring DECG you need a CL ECG/IUP transducer or a patient module (see also Monitoring FHR Using DECG on page 195). 225 21 Monitoring Maternal Heart / Pulse Rate Applying Electrodes To derive the MHR (when you do not want to view the MECG waveform), you can place the electrodes just below the outer end of the clavicle near each shoulder. 1 MECG Electrodes Making Connections WARNING Follow the instructions supplied with each of the monitoring accessories you are using. Prepare for monitoring MHR using the list below. The standard procedures in use in your facility determine the sequence of actions. 1 Depending on the equipment you are using, ensure that either the Patient Module or the Toco+

transducer is connected to the fetal monitor. If you are using cableless monitoring use the CL ECG/IUP or the CL Toco+ MP transducer. 2 Connect a pre-gelled foam electrode to each of the two leads on the MECG adapter cable. 3 Apply the foam electrodes to the patient, following the instructions supplied with the foam electrodes. 4 Depending on the equipment you are using, connect the pink connector plug on the MECG adapter cable to the pink connector on either the Patient Module or the Toco+ transducer. If you are using cableless monitoring connect the MECG Adapter cable to the connectors of the CL ECG/

IUP or the CL Toco+ MP transducer. You are now ready to monitor MHR. Monitoring MHR Switch on the recorder. 1 2 The maternal heart rate is labeled HR on the screen. 226 Monitoring MECG Wave 21 Monitoring Maternal Heart / Pulse Rate WARNING The fetal/maternal monitor is not a diagnostic ECG device. In particular, the display of fetal/maternal ECG is intended only for evaluating signal quality for fetal/maternal heart rate as derived from the ECG waveform. When in doubt, it can be used to identify sources of compromised signal quality, such as noise or muscle artifacts. It can subsequently be used to verify the result of measures taken to resolve them

(e.g., checking ECG cable connections or adapting the fetal ArtifactSuppress configuration). The safety and effectiveness of the displayed fetal/maternal ECG waveform (i.e., P, QRS and T segments) for evaluation of fetal/maternal cardiac status during labor have not been evaluated. FM30/50 When measuring MECG with the Avalon FM30 or FM50, the MECG waveform, along with the heart rate numeric, is displayed on the screen when using a Toco+, CL Toco+ MP transducer, a patient module, or a CL ECG/IUP transducer. WARNING The fetal/maternal monitor is NOT intended for use during defibrillation, electro-surgery, or MRI. Remove all transducers, sensors, and accessories before performing electro-surgery, defibrillation, or MRI, otherwise harm to the patient or the user can result. Applying Electrodes To obtain a satisfactory maternal ECG waveform you must use the RA to LL (lead II) position of the standard 5-lead ECG. 1 2 Place the RA electrode

(A) directly below the clavicle and near the right shoulder. Place the LL electrode

(B) on the left lower abdomen. 227 21 Monitoring Maternal Heart / Pulse Rate Viewing the Waveform on the Screen 1 Measurement label (FHR1) 2 Measurement label (Toco) 3 Measurement label (DFHR3) 4 Measurement label (FHR1) 5 Measurement label (SpO2) 6 Measurement label (HR) 7 8 MECG wave with maternal label 9 DECG wave with fetal label 10 Measurement label (Temp) maternal temperature 11 Measurement label NBP 1mV scale bar NOTE The 1mV scale bar for the DECG and MECG wave is not displayed on the screen if you monitor DECG or MECG with an Avalon CTS system. The Avalon CTS system does not provide a scaled ECG. For the FM30/50, the MECG wave is displayed automatically on the screen, labeled MECG. If DECG is also being monitored (FM30/50), and the DECG Wave is configured to On, both waves are displayed, with the DECG Wave above the MECG wave. The DECG Wave is labeled DECG. 228 Troubleshooting Problem MECG Leads Off displayed. Numeric is displayed with a -?- for 10 seconds;

INOP tone See also Patient Alarms and INOPs on page 121 Possible Causes One or more MECG leads is not attached. Bad electrical contact Electrodes defective The ultrasound transducer is measuring maternal pulse. 21 Solutions Make sure that all required leads are attached If the wave is configured to be displayed on the monitor, you can observe if the ECG signal is clear, or if it shows interruptions and noise Check positioning of the electrode, ensuring that none are displaced Check electrodes and replace if necessary Reposition the ultrasound transducer. See Recommended Actions for INOP Coincidence on page 154 prints repeatedly MECG Equip Malf displayed MECG Unplugged Equipment malfunctions See Patient Alarms and INOPs on page 121. Equipment not connected Printing the Waveform You can print the MECG wave onto the trace paper. Refer to Printing the ECG Waveform on page 233. Pulse Rate from Toco MP The maternal pulse is taken from the Toco MP or CL Toco+ MP transducer when SpO2 or MECG measurements are not used or have signal loss. When the pulse rate is very low, or strong arrhythmia is present, the pulse rate measured by the Toco MP or CL Toco+ MP transducer may differ from the heart rate calculated from MECG. If the mother is moving about, or began pressing during the second stage of labor, this can cause longer gaps in the recording of the maternal pulse signal. In this case use the SpO2 or MECG measurement to derive the maternal heart rate. 229 21 Monitoring Maternal Heart / Pulse Rate WARNING No alarm is possible when Toco MP or CL Toco+ MP transducer is the source of the pulse rate. No QRS tone is audible when Toco MP or CL Toco+ MP transducer is the source of the pulse rate. The Toco MP or CL Toco+ MP transducer signal is significantly less reliable if the patient is up and moving about, or is pushing during the second stage of labor. NOTE In rare cases it is possible to pick up a fetal signal source. When a Toco MP or CL Toco+ MP transducer is connected to the monitor but not applied to the patient, the measurement may generate unexpected intermittent pulse readings. Pulse Rate from SpO2 If you are not monitoring MHR via MECG electrodes, but you are monitoring SpO2, the maternal pulse rate is derived from the SpO2 measurement. The pulse numeric is labeled Pulse on the screen. WARNING No QRS tone is audible when the CL SpO2 Pod is the source of the pulse rate. Adjusting the Heart Rate / Pulse Alarm Limits In the Setup SpO menu, select Pulse (SpO). This opens the Setup Pulse (SpO) menu. To adjust the pulse alarm limits for SpO2:

1 2 Ensure Pulse (SpO) is On. Select Pulse (SpO) to toggle between On and Off. 3 Set the pulse alarm limit:

Select High Limit then choose the upper alarm limit for tachycardia from the pop-up list. Select Low Limit then choose the lower alarm limit for bradycardia from the pop-up list. In the Setup MECG menu, select MECG/Pulse Alarms. This opens the Setup Pulse (MECG) menu. To adjust the pulse alarm limits for MECG:

1 2 Ensure Pulse MECG is On. Select Pulse MECG to toggle between On and Off. 3 Set the pulse alarm limit. Select High Limit then choose the upper alarm limit for tachycardia from the pop-up list. Select Low Limit then choose the lower alarm limit for bradycardia from the pop-up list. 230 21 Monitoring Maternal Heart / Pulse Rate Average Pulse Rate from Noninvasive Blood Pressure WARNING No alarm is possible when noninvasive blood pressure is the source of the pulse rate. When you are measuring noninvasive blood pressure, the monitor can also calculate the average pulse rate. This occurs in either manual or automatic mode, when neither MECG, SpO2 nor pulse from Toco MP or CL Toco+ MP transducer are measured. The value is displayed on the screen, and printed on the trace. It is not the actual pulse value, but an average pulse rate, taken during the most recent noninvasive blood pressure measurement. The value is updated after each successive measurement. If you need a continuous measurement, you should monitor using MECG, SpO2 or pulse from Toco MP or CL Toco+ MP transducer. Testing MECG Mode See the monitor's Service Guide. 231 21 Monitoring Maternal Heart / Pulse Rate 232 22Printing the ECG Waveform 22 Printing the ECG Waveform FM30/50 You can print the ECG wave onto the trace paper. If you are monitoring both DECG and MECG, both waves will be printed. The start of the wave recording is annotated above the wave with MECG for Maternal ECG, with DECG for Direct fetal ECG, and with 25 mm/sec below the wave. WARNING The fetal/maternal monitor is not a diagnostic ECG device. In particular, the display of fetal/maternal ECG is intended only for evaluating signal quality for fetal/maternal heart rate as derived from the ECG waveform. When in doubt, it can be used to identify sources of compromised signal quality, such as noise or muscle artifacts. It can subsequently be used to verify the result of measures taken to resolve them

(e.g., checking ECG cable connections or adapting the fetal ArtifactSuppress configuration). The safety and effectiveness of the displayed fetal/maternal ECG waveform (i.e., P, QRS and T segments) for evaluation of fetal/maternal cardiac status during labor have not been evaluated. The ECG waveform is printed along the bottom of the heart rate grid, and the three different possibilities look like this:

DECG waveform on its own 1 DECG 2 Paper speed 233 22 Printing the ECG Waveform MECG waveform on its own 1 MECG 2 Paper speed DECG and MECG waveforms 1 DECG 2 Paper speed When the recorder is on, there are two choices for printing the ECG wave:

Separate: This recording mode gives you a six-second ECG strip on the fetal trace paper in fast printout mode. The real-time fetal trace recording is temporarily interrupted while the ECG strip 234 22 prints. A new trace header is printed out to mark where the MECG print-out starts and another FHR header mark signals when the fetal trace resumes. The following trace shows the MECG waveform:

FHR1 trace interrupted 1 2 MECG header 3 Paper speed 4 FHR1 trace resume Overlap: This recording mode gives you a delayed six-second snapshot of the maternal and/or direct fetal ECG for documentation on the fetal strip, but without interrupting the fetal trace. It takes 5 minutes to print this six-second snapshot at a recorder speed of 3 cm/min. It is documented as if it was recorded at 25 mm/s. 235 22 Printing the ECG Waveform The following trace shows both the DECG and MECG waveforms:

FHR1 and FHR2 1 2 DECG header 3 MECG header 4 Paper speed To make your choice:

1 Enter the Main Setup menu. Select Fetal Recorder to enter the Fetal Recorder menu. Select ECG Wave to toggle between Separate and Overlap. 2 3 To print the ECG wave(s):

Either Select the Record ECG Wave SmartKey. Or 1 Enter the Main Setup menu by selecting the SmartKey. 2 3 Select Fetal Recorder to enter the Fetal Recorder menu. Select Record ECG Wave. 236 Or 1 2 Select the ECG Wave. Select Record ECG Wave in the ECG wave menu. 22 237 22 Printing the ECG Waveform 238 23 Paper Save Mode for Maternal Measurements 23Paper Save Mode for Maternal Measurements Your monitor's recorder features a Paper Save Mode, where maternal vital signs are recorded using less paper than during a normal trace recording. When Paper Save Mode is enabled, and if the recorder is stopped, it will start automatically to print data from maternal measurements as they occur, and then stop again to save paper. You enable Paper Save Mode in Configuration Mode (default is off). A header is printed first before the measurements are recorded. A new header is also printed when there is a date change at midnight. Each NBP measurement is recorded. The time when the measurement ended is recorded. Each Temperature measurement is recorded. The time when the measurement ended is recorded. Other maternal parameters (SpO2, maternal heart rate or Pulse) are recorded every five minutes. The rules described in the section Priority for Maternal Heart / Pulse Rate on page 223 apply. Paper Save Mode recording stops if there are no valid maternal measurements for more than one hour, and a message will notify you that there are no active parameters. Paper Save Mode recording will restart automatically when another valid measurement is made. Event One of the maternal measurements (see above) is valid again. The recorder is turned on and off again or a report has been recorded

(e.g. NST Report). The Paper Advance function is used. The Paper Save Mode setting is set off and on again. ADT information has changed (e.g. because patient information has been completed or updated). The monitor is restarted (e.g. by switching it off and on again). The date has changed (e.g. at midnight). Paper Save Mode Reactivation yes yes yes yes no yes no 239 23 Paper Save Mode for Maternal Measurements 240 24 24Recovering Data The monitor stores trace data, including annotations, in its internal backup memory. This allows the monitor to recover trace data that would otherwise be lost under certain circumstances. This trace recovery data can be automatically retrieved and printed in the event of the paper running out, or automatically transmitted to an OB TraceVue/IntelliSpace Perinatal system (LAN connection only), allowing continuity of data. The fetal trace printed from the trace recovery data contains all data from the real-time trace, with the exception of the maternal heart rate, the pulse numeric and the MECG wave. Note that the data in the memory is cleared when a software upgrade is performed. CAUTION Only use Philips paper. Using paper other than Philips paper may result in the failure to recover traces. Recovering Traces on Paper The monitor is able to recover traces by printing them out at a high speed from the monitor's backup memory. If the monitor runs out of paper, or if the paper drawer is open, the exact time when this happens is annotated in the backup memory. If the Bridge Paperout setting is set to On (default), when new paper is loaded and the recorder is started, a trace recovery printout of the data recovered from the backup memory is automatically printed out at high speed (up to 20 mm/s), starting from the time noted in the backup memory. This ensures that no data is lost. A minimum of one hour of trace recovery data can be printed out from the backup memory. When the trace recovery printout has finished, the recorder automatically switches back to continue recording the current trace at the normal speed. Note the following:

If you press the fetal recorder Start/ Stop SmartKey during a trace recovery printout, the recording stops and the next recording following a recorder restart will be a normal, real-time trace. After switching the monitor off and then back on again, or following a power failure, the time of the last Check Paper INOP or paper-out detection is lost, and therefore any trace recovery data in the backup memory is no longer available to print. The next recording made following a restart of the recorder is a normal, real-time trace. 241 24 Recovering Data The change back to a real-time recording from a trace recovery printout prompts the recording to restart. A new vertical trace header annotation consisting of the time, date and paper speed is printed, letting you see where the trace recovery printout ends, and where the real-time trace continues. There can be a gap of up to 30 seconds between the trace recovery printout and the beginning of the real-time trace. Recovering Traces on an OB TraceVue/IntelliSpace Perinatal System The trace recovery data stored in the monitor's backup memory can also be uploaded at high speed to an OB TraceVue/IntelliSpace Perinatal system connected over the LAN interface (OB TraceVue Revision E.00.00 or later, and IntelliSpace Perinatal H.0 or later). When the OB TraceVue/IntelliSpace Perinatal system reconnects to the fetal monitor and detects that there is trace recovery data in the monitor's backup memory that has not yet been transmitted to the system, this data is transferred at high speed to the system. No user action is required. The exact length of the recovered trace will vary depending on the amount of trace information, but will cover at least one hour of trace data, regardless of how many parameters are being measured. To recover traces on an OB TraceVue/IntelliSpace Perinatal system, the following applies:

The trace data in the monitor's internal memory must relate to a specific patient in the OB TraceVue/IntelliSpace Perinatal system. In other words, there were no discharge events made on the monitor that would change the patient context. The patient must have an open episode. No data will be uploaded if the patient is not admitted to OB TraceVue/IntelliSpace Perinatal. For this reason, it is not possible to use the monitor to collect patient data offline for later transmission to OB TraceVue/IntelliSpace Perinatal. Current online trace data is held back until the fast upload is complete. Recording Stored Data If the recorder is not running, you can choose to print trace data from the monitor's memory at any time. You can see a list of all stored traces, showing patient identification and trace period, in the Stored Data Recording window, from which you can choose one entry at a time. CAUTION Ensure that you admit each patient by name, including other patient identification information, and discharge the patient when you have finished monitoring, so that you can identify which trace period

(entry in the patient list) refers to which patient. Trace storage can be triggered by:

Discharging a patient Entering Standby Entering Service Mode Powering on the monitor 242 24 Recovering Data Traces are not available for periods the monitor was switched off, in Service mode, in Standby, or if the trace period was shorter than one minute. To delete all stored trace periods press the Erase All key. The speed of the printout depends on the configured recorder speed and on the amount of trace data available. The fetal trace printed from the trace data contains all data from the real-time trace, with the exception of the maternal heart rate, the pulse numeric and the ECG wave. Information for scale type, trace separation and recorder speed are not stored in the trace memory, but is applied when the stored recording starts. While the stored recording is printing, all functions are disabled, except that for stopping the recorder. To start a stored data recording:

Either 1 Select the Stored Data Rec SmartKey. Or 1 Enter the Main Setup menu using the SmartKey. 2 3 4 5 Select Fetal Recorder to open the Fetal Recorder menu. Select Stored Data Rec to open the Stored Data Recording window. Select an entry for a patient. Select All to print all stored trace data for the selected entry, or select one of the choices on the other pop-up keys to print only a specified portion of the entry (for example, Last 15 min for the last 15 minutes of trace data). To delete all stored trace periods:

Either 1 Select the Stored Data Rec SmartKey. Or 1 Enter the Main Setup menu using the SmartKey. Select Fetal Recorder to open the Fetal Recorder menu. Select Stored Data Rec to open the Stored Data Recording window. Select the Erase All key to delete all stored trace periods listed. Select the Confirm key. 2 3 4 5 The current patients entry is at the top of the list. The oldest entry at the bottom of the list has no start time specified, as part of the data originally stored may have been over-written by the current patients data. The first part of the data, including the information for the start time, is no longer accessible. 243 24 Recovering Data It may be that you only see one entry (the current patients data) in the Stored Data Recording window if that patient was monitored for a period long enough to erase any earlier entries. If you make a stored data recording for an old entry (that is, not for the current patient), the recorder performs a fast trace printout of the stored data, advances the paper to the next paper fold, then stops. If you make a stored data recording for the current patient, the recorder performs a fast trace printout of the stored data, and then reverts automatically to recording the real-time trace. 244 25 25Care and Cleaning Use only the Philips-approved substances and methods listed in this chapter to clean or disinfect your equipment. Warranty does not cover damage caused by using unapproved substances or methods. Philips makes no claims regarding the efficacy of the listed chemicals or methods as a means for controlling infection. Consult your hospitals Infection Control Officer or Epidemiologist. For comprehensive details on cleaning agents and their efficacy refer to Guideline for Disinfection and Sterilization in Healthcare Facilities issued by the U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control, Atlanta, Georgia, 2008. See also any local policies that apply within your hospital, and country. General Points The transducers and patient modules are sensitive instruments. Handle them with care. Keep your monitor, transducers, patient modules, cables and accessories free of dust and dirt. After cleaning and disinfection, check the equipment carefully. Do not use if you see signs of deterioration or damage. If you need to return any equipment to Philips, always decontaminate it first before sending it back in appropriate packaging. Observe the following general precautions:

Always follow carefully and retain the instructions that accompany the specific cleaning and disinfecting substances you are using. Always dilute according to the manufacturer's instructions or use lowest possible concentration. Do not allow liquid to enter the case. Do not immerse the monitor in liquid. Protect it against water sprays or splashes. Do not pour liquid onto the system. Never use abrasive material (such as steel wool or silver polish). Never use bleach. 245 25 Care and Cleaning WARNING Do not operate the monitor if it is wet. If you spill liquid on the monitor, contact your service personnel or Philips service engineer. Do not perform underwater monitoring (for example, in a bath or shower) using wired transducers. Place the monitor where there is no chance of contact with, or falling into water or other liquid. Do not dry equipment using heating devices such as heaters, ovens (including microwave ovens), hair dryers and heating lamps. Do not put equipment or accessories in autoclave (for sterilization). Cleaning and Disinfecting Clean and disinfect the Avalon FM20, FM30, FM40 and FM50 fetal monitors and the transducers M2734A, M2734B, M2735A, M2736A, and M2738A (including ECG adapter cables) and the Avalon CL base station and the cableless transducers after each use. Clean equipment before disinfecting. For other accessories, see Cleaning and Disinfecting Monitoring Accessories on page 247. Clean with a lint-free cloth, moistened with warm water (40C/104F maximum) and soap, a diluted non-caustic detergent, tenside, or phosphate based cleaning agent (see Recommended Disinfectants on page 247). Do not use strong solvents such as acetone or trichloroethylene. After cleaning, disinfect using only the approved disinfecting agents listed. CAUTION Solutions: Do not mix disinfecting solutions (such as bleach and ammonia) as hazardous gasses may result. Skin contact: To reduce the risk of skin irritations, do not allow a cleaning or disinfecting agent to leave residues on any of the equipment surfaces - wipe it off with a cloth dampened with water, after allowing the appropriate time for the agent to work, or before applying to a patient. Hospital policy: Disinfect the product as determined by your hospital's policy, to avoid long term damage to the product. Local requirements: Observe local laws governing the use of disinfecting agents. Touch display: To clean and disinfect the touch-enabled display, disable the touch operation by switching off the monitor during the cleaning procedure, or by selecting and holding the Main Screen key until the padlock symbol appears on it, indicating that touch operation is disabled. Select and hold again to re-enable touch operation. Take extra care when cleaning the screen of the monitor because it is more sensitive to rough cleaning methods than the housing. Do not permit any liquid to enter the monitor case and avoid pouring it on the monitor while cleaning. Do not allow water or cleaning solution to enter the measurement connectors. Wipe around and not over connector sockets, or those of the Toco+, CL Toco transducer, ECG and IUP Patient Modules, CL ECG/IUP transducer and adapter cables. Wash soiled reusable belts with soap and water. Water temperature must not exceed 60C/140F. 246 25 Care and Cleaning Recommended Disinfectants We recommend that you use one of the following disinfectants:

Product Name Isopropanol Bacillol AF Bacillol25 Meliseptol Accel TB RTU Oxivir Tb Cleaner Disinfectant Oxivir Tb Wipes Carpe DiemTM/MC Tb Ready-to-Use General Virucide, Bactericide, Tuberculocide, Fungicide, Sanitizer Carpe DiemTM/MC Tb Wipes Super Sani-Cloth Germicidal Disposable Wipes SANI-CLOTH PLUS Germicidal Disposable Wipes SANI-CLOTH HB Germicidal Germicidal Disposable Wipes Product Type liquid liquid, spray liquid spray liquid spray wipes spray wipes wipes wipes wipes Ingredients Isopropanol 80%

100 g concentrate contains:

Propan-1-ol 45.0 g; Propan-2-ol 25.0 g; Ethanol 4.7 g. Ethanol 100 mg/g Propan-2-ol (= 2-Propanol) 90 mg/g; Propan-1-ol (= 1-

Propanol) 60 mg/g 50% 1-Propanol 0.5% accelerated hydrogen peroxide 0.5% accelerated hydrogen peroxide 0.5% accelerated hydrogen peroxide 0.5% accelerated hydrogen peroxide 0.5% accelerated hydrogen peroxide isopropanol 55%

quaternary ammonium chlorides 0.5%

isopropanol 15%

quaternary ammonium chlorides 0.25%

isopropanol < 0.15%

quaternary ammonium chlorides 0.14%

Cleaning and Disinfecting Monitoring Accessories To clean, disinfect and sterilize reusable transducers, sensors, cables, leads, and so forth, refer to the instructions delivered with the accessory. Do not allow a cleaning or disinfecting agent to leave residues on any of the equipment surfaces. Wipe residues off, after allowing the appropriate time to for the agent to work, with a cloth. 247 25 Care and Cleaning Cleaning and Disinfecting the Tympanic Temperature Accessories Probe and Thermometer Body 1 Wipe the thermometer body clean with a damp cloth. The water temperature should not exceed 55C (130F). Do not soak, rinse, or submerge the thermometer under water. You may add a mild detergent to the water. 2 Clean the probe tip with a lint free swab. If the probe tip is soiled, clean it with a dampened swab. 3 After you have removed all foreign matter, clean the thermometer lens at the end of the probe tip with a lint free swab or lens wipe. The thermometer lens must be free from fingerprints and/or smudges for proper operation. 4 Thoroughly dry all surfaces before using the equipment. CAUTION Do not use cleaners and disinfectants such as Spray-Nine*, Phisohex*, Hibiclens*, or Vesta-

Syde* as they may result in damage to the thermometer case. Occasional use of a 10:1 water and hypochlorite mixture or a damp isopropyl alcohol wipe or Cidex* or ManuKlenz* or VIROX* or CaviWipes* cleansing agents is acceptable, however, prolonged or repeated use of these chemicals may result in damage to the thermometer case and display area. Use of a cloth or sponge is recommended for cleaning. Never use an abrasive pad or an abrasive cleaner on the thermometer. The thermometer is non-sterile. Do not use ethylene oxide gas, heat, autoclave, or any other harsh method to sterilize this thermometer. Sterilizing Sterilization is not recommended for this monitor, related products, accessories or supplies unless otherwise indicated in the Instructions for Use that accompany the accessories and supplies. WARNING Do not put device and accessories in autoclave (for sterilization). 248 26Maintenance 26 Maintenance WARNING Schedule: Failure on the part of the responsible individual hospital or institution employing the use of this equipment to implement a satisfactory maintenance schedule may cause undue equipment failure and possible health hazards. In case of problems: If you discover a problem with any of the equipment, contact your service personnel, Philips, or your authorized supplier. Electric shock hazard: Do not open the monitor housing. Refer all servicing to qualified service personnel. Inspecting the Equipment and Accessories You should perform a visual inspection before each use, and in accordance with your hospital's policy. With the monitor switched off:

1 Examine unit exteriors for cleanliness and general physical condition. Make sure that the housings are not cracked or broken, that everything is present, that there are no spilled liquids that may have entered the housing, and that there are no signs of abuse. Inspect all accessories (transducers, sensors and cables, and so forth). Do not use a damaged accessory. 2 3 Avoid frequent drops of the transducers. 4 Switch the monitor on and make sure the display is bright enough. If the brightness is not adequate, contact your service personnel or your supplier. Batteries Preventive Maintenance For the FM20/30 with a battery option refer to Using Batteries on page 102. Inspecting the Cables and Cords 1 Examine all system cables, the power plug and cord for damage. Make sure that the prongs of the 2 plug do not move in the casing. If damaged, replace it with an appropriate power cord. Inspect the cables, leads and their strain reliefs for general condition. Make sure there are no breaks in the insulation. Make sure that the connectors are properly engaged at each end to prevent rotation or other strain. 3 Carry out performance assurance checks as described in the monitor's Service Guide. 249 26 Maintenance Maintenance Task and Test Schedule The following tasks are for Philips-qualified service professionals. All maintenance tasks and performance tests are documented in detail in the service documentation supplied on the monitor's documentation DVD. Ensure that these tasks are carried out as indicated by the monitor's maintenance schedule, or as specified by local laws, whichever comes sooner. Contact a Philips-qualified service professionals if your monitor needs a safety or performance test. Clean and disinfect equipment to decontaminate it before testing or maintaining it. Maintenance and Test Schedule Visual Inspection Clean and disinfect the equipment Safety checks according to IEC 60601-1, and where applicable, to national standards Frequency Before each use. After each use. At least once every two years, or as specified by local laws. After any repairs where the power supply has been replaced (by an authorized service professional). If the monitor has been dropped, it must be repaired/

checked by an authorized service agent. At least once every two years, or if you suspect the measurement values are incorrect. At least once every two years, or as specified by local laws. At each paper pack change, or every 500 m of paper run. Performance assurance for all measurements Noninvasive blood pressure calibration Clean the thermal printhead Recorder Maintenance Removing the Paper Guide: FM40/FM50 FM40/50 The paper guide is removable, and you can use the recorder without it. When not using the paper guide, ALWAYS tear off the paper along the perforation to avoid possible paper misalignment (see Tearing Off the Paper on page 80). 250 To remove the paper guide:

26 Maintenance 1 Press the paper eject button to open the paper drawer. 2 Hinge the transparent paper guide forward. 251 26 Maintenance A Protrusion holds paper guide in closed position. 3 Release the paper guide from one side of the holder. 252 26 4 Then remove the paper guide. Refitting is a reversal of the removal procedure. 253 26 Maintenance Storing Recorder Paper Recorder paper is not intended for long-term archival storage. Another medium should be considered if this is required. Dyes contained in thermal papers tend to react with solvents and other chemical compounds that are being used in adhesives. If these compounds come into contact with the thermal print, the print may be destroyed over time. You can take the following precautionary measures to help avoid this effect:

Do not store the paper at temperatures over 40C (104F). Do not store the paper where the relative humidity exceeds 60%. Avoid intensive light (UV light), as this may cause the paper to turn gray or the thermal print to Store the paper in a cool, dry and dark place. fade. Avoid storing the thermal paper in combination with the following conditions:

Papers that contain organic solvents. This includes papers with tributyl and/or dibutyl phosphates, for example recycled paper. Carbon paper and carbonless copy paper. Products containing polyvinyl chlorides or other vinyl chlorides for example (but not exclusively) document holders, envelopes, letter files, divider sheets. Detergents and solvents, such as alcohol, ketone, ester and others, including cleaning and disinfecting agents. Products containing solvent-based adhesives such as (but not exclusively) laminating film, transparent film or labels sensitive to pressure. To ensure long lasting legibility and durability of thermal printouts, store your documents separately in an air-conditioned place and use:

Using such protective envelopes cannot prevent the fading effect caused by other, external agents. only plasticizer-free envelopes or divider sheets for protection. laminating films and systems with water-based adhesives. 254 Cleaning the Print Head To clean the recorder's thermal print-head:

26 Maintenance Switch off the monitor. 1 2 Open the paper drawer, and remove the paper if necessary, to gain access to the thermal print head. FM20/30 FM40/50 3 Gently clean the thermal print head with a cotton swab or soft cloth soaked in isopropyl alcohol. 255 26 Maintenance Disposing of the Monitor WARNING To avoid contaminating or infecting personnel, the environment or other equipment, make sure you disinfect and decontaminate the monitor appropriately before disposing of it in accordance with your country's laws for equipment containing electrical and electronic parts. For disposal of parts and accessories such as thermometers, where not otherwise specified, follow local regulations regarding disposal of hospital waste. You can disassemble the monitor and the transducers as described in the Installation and Service Manual. You will find detailed disposal information on the following web page: http://

www.healthcare.philips.com/main/about/Sustainability/Recycling/pm.wpd Do not dispose of waste electrical and electronic equipment as unsorted municipal waste. Collect it separately, so that it can be safely and properly reused, treated, recycled, or recovered. The Recycling Passports located there contain information on the material content of the equipment, including potentially dangerous materials which must be removed before recycling (for example, batteries and parts containing mercury or magnesium). 256 27Accessories and Supplies 27 Accessories and Supplies All accessories listed for the fetal monitor may not be available in all geographies. You can order parts, accessories and supplies from Philips supplies at www.healthcare.philips.com or consult your local Philips representative for details. All accessories and supplies listed here are reusable, unless indicated otherwise. WARNING Reuse: Disposable accessories and supplies intended for single use, or single patient use only, and are indicated as such on their packaging. Never reuse disposable accessories and supplies, such as transducers, sensors, electrodes and so forth that are intended for single use, or single patient use only. Approved accessories: Use only Philips-approved accessories. Packaging: Do not use a sterilized accessory if its packaging is damaged. Protection against electric shocks: The transducers and accessories listed in this chapter are not defibrillator proof. Electro-Surgery, Defibrillation and MRI: The fetal/maternal monitors are not intended for use during defibrillation, electro-surgery, or MRI. Remove all transducers, sensors, and accessories before performing electro-surgery, defibrillation, or MRI, otherwise harm can result. Information on Latex All Philips transducers and accessories are latex-free, unless indicated otherwise in the following tables. 257 27 Accessories and Supplies Avalon CL Base Station CL Base Station Avalon CL Base Station can either be ordered with the option K30

(red connector) or K40 (black connector) Part Number 866074 Transducers Transducer Avalon Toco Transducer Avalon Toco+ Transducer for Toco, DECG, MECG or IUP monitoring Avalon Toco MP Transducer for Toco and Maternal Pulse Avalon Ultrasound Transducer Avalon Ultrasound Transducer USA ECG/IUP Patient Module (for DECG, MECG or IUP) Avalon CL Toco+ MP Transducer for use with the Avalon CL base station Avalon CL Ultrasound Transducer for use with the Avalon CL base station Avalon CL ECG/IUP Transducer for use with the Avalon CL base station Connector Caps for Avalon CL Cableless Smart Transducers (kit of 10) for use with the Avalon CL Toco+ MP transducer Belt Clip for Avalon CL Cableless Smart Transducers (kit of 10) CL SpO2 Pod for use with the Avalon CL base station CL NBP Pod for use with the Avalon CL base station Remote Event Marker Fetal Accessories Accessory Belt

(reusable, gray, water resistant) Description 32 mm wide, 15 m roll 60 mm wide, 5 belts 60 mm wide, 15 m roll 50 mm wide, 5 belts 258 Part Number M2734A M2735A M2734B M2736A M2736AA M2738A 866075 866076 866077 989803184841 989803184851 865215 865216 989803143411 Part Number M4601A1 M4602A M4603A M1562B 27 Accessories and Supplies Accessory Belt

(reusable, brown, contains latex) Belt

(disposable, yellow, water resistant) Ultrasound gel Belt buttons (kit of 10) Butterfly belt clip (kit of 6) Avalon CL Connector Caps Avalon CL Belt Clip Description 32 mm wide, 15 m roll 50 mm wide, 5 belts 60 mm wide, 5 belts 60 mm wide, 15 m roll 60 mm wide, pack of 100 12 Bottles 5 liter refill (with dispenser) for 40483A Shelf life: 24 months max. Connector Caps for Avalon CL Cableless Smart Transducers (kit of 10) Belt Clip for Avalon CL Cableless Smart Transducers (kit of 10) Avalon CL Battery Replacement Kit Cable Management Kit Belt Clips for Avalon Smart Transducers (kit of 6) DECG Accessories:

New Philips DECG Solution

(NOT compatible with QwikConnect Plus Solution accessories) DECG reusable legplate adapter cable (with flushing port) DECG leg attachment electrode for DECG legplate adapter cable DECG fetal scalp electrode: single spiral, worldwide availability DECG fetal scalp electrode: double spiral, Europe only. Not for USA Disposable Koala IUP catheter Reusable Koala IUP adapter cable Part Number 1500-06281 M1562A 1500-0642 1500-0643 M2208A 40483A 40483B M1569A 989803143401 989803184841 989803184851 989803184861 989803148841 989803143401 989803137651 989803139771 989803137631 989803137641 M1333A 989803143931 259 27 Accessories and Supplies DECG Accessories: Component Compatibility Use the following pictorial guide to check component compatibility for DECG accessories. CAUTION Do not mix accessories from the New Philips DECG Solution (marked 1) with those from the QwikConnect Plus Solution (marked 2). MECG Accessories Accessory MECG reusable adapter cable Foam ECG electrodes, snap-fit, for MECG Adapter Cable (disposable) Part Number M1363A 40493D/E Noninvasive Blood Pressure Accessories The following accessories are approved for use with the fetal monitor:

260 Adult Multi-Patient Comfort Cuffs and Disposable Cuffs Maternal Patient Category Limb Circumference Bladder Reusable cuff Part No. Width Tubing Disposable cuff Part No. M1879A M1878A M1877A M1876A 42.0 - 54.0 cm 34.0 - 43.0 cm 27.0 - 35.0 cm 20.5 - 28.0 cm Adult (Thigh) Large Adult Adult Small Adult Cuff kit of 4 adult sizes 20.0 cm 16.0 cm 13.0 cm 10.5 cm Adult EasyCare Reusable Cuffs Maternal Patient Category (color) Limb Circumference 45.0 - 56.5 cm 45.0 - 56.5 cm 35.5 - 46.0 cm 35.5 - 46.0 cm 35.5 - 46.0 cm 35.5 - 46.0 cm 27.5 - 36.5 cm 27.5 - 36.5 cm 27.5 - 36.5 cm 27.5 - 36.5 cm 20.5 - 28.5 cm 20.5 - 28.5 cm Adult Thigh (grey) Adult Thigh (grey) pack of 5 cuffs Large Adult X-Long (burgundy) Large Adult X-Long (burgundy) pack of 5 cuffs Large Adult (burgundy) Large Adult (burgundy) pack of 5 cuffs Adult X-Long (navy blue) Adult X-Long (navy blue) pack of 5 cuffs Adult (navy blue) Adult (navy blue) pack of 5 cuffs Small Adult (royal blue) Small Adult (royal blue) pack of 5 cuffs Cuff kits containing one small adult, one adult, one large adult and one thigh cuff. Cuff kits containing one small adult, one adult, one adult X-long, one large adult, one large adult X-long and one thigh cuff Bladder Width 21.0 cm 21.0 cm 17.0 cm 17.0 cm 17.0 cm 17.0 cm 13.5 cm 13.5 cm 13.5 cm 13.5 cm 10.6 cm 10.6 cm 27 Accessories and Supplies M1598B (1.5 m) or M1599B (3.0 m) M1576A M1575A M1574A M1573A M1578A Part No. Tubing M1598B (1.5 m) or M1599B (3.0 m) M4559B M4559B5 M4558B M4558B5 M4557B M4557B5 M4556B M4556B5 M4555B M4555B5 M4554B M4554B5 864288 864291 261 27 Accessories and Supplies Adult Single Patient Soft Cuffs Maternal Patient Category Limb Circumference Adult (Thigh) Large Adult X-Long Large Adult Adult X-Long Adult Small Adult 45.0 - 56.5 cm 35.5 - 46.0 cm 35.5 - 46.0 cm 27.5 - 36.5 cm 27.5 - 36.5 cm 20.5 - 28.5 cm Bladder Width 20.4 cm 16.4 cm 16.4 cm 13.1 cm 13.1 cm 10.4 cm Part No. M4579B M4578B M4577B M4576B M4575B M4574B Tubing M1598B (1.5 m) or M1599B (3.0 m) IntelliVue CL NBP Pod Accessories Description Bladder Width Contents Product No. 1 cuff 1 cuff 1 cuff 20 cuffs 20 cuffs 20 cuffs 989803163171 989803163191 989803163211 989803163181 989803163201 989803163221 20 cradles 989803163251 1 extension air hose 989803163131 1 Battery 1 disassembly tool 1 front housing 50 pouches 4 boxes of 50 pouches 50 pouches 4 boxes of 50 pouches 989803163261 989803137831 989803140371 989803101971

(9300-0768-050) 989803101981

(9300-0768-200) 10.5 cm 13.0 cm 16.0 cm 10.5 cm 13.0 cm 16.0 cm

Limb Circumference Range 21 - 27 cm 21 - 27 cm Mobile CL Reusable Small Adult Cuff Mobile CL Reusable Adult Cuff 26.0 - 34.5 cm 33.5 - 45.0 cm Mobile CL Reusable Large Adult Cuff Mobile CL Single-Patient Small Adult Cuff Mobile CL Single-Patient Adult Cuff Mobile CL Single-Patient Large Adult Cuff Mobile CL NBP Cradle Kit Mobile CL Extension Air Hose, 1.0 m Mobile CL NBP Battery Kit 26.0 - 34.5 cm 33.5 - 45.0 cm

Telemetry Pouch with window -

Telemetry Pouch with window -

White Telemetry Pouch with Snaps; box of 50 White Telemetry Pouch with Snaps; 4 boxes of 50

262 SpO2 Accessories 27 Accessories and Supplies Some Nellcor sensors contain natural rubber latex which may cause allergic reactions. See the Instructions for Use supplied with the sensors for more information. M1901B, M1903B and M1904B are not available in USA from Philips. Purchase Nellcor OxiCliq sensors and adapter cables directly from Tyco Healthcare. Some sensors may not be available in all countries. Do not use more than one extension cable with any sensors or adapter cables. Do not use an extension cable with Philips reusable sensors or adapter cables with part numbers ending in -L (indicates "Long"

version). All listed sensors operate without risk of exceeding 41C on the skin if ambient temperature is below 37C. Make sure that you use only the accessories that are specified for use with this device, otherwise patient injury can result. Philips SpO2 Accessories Description Philips reusable sensors Adult sensor (2.0 m cable), for patients over 50 kg. Any finger, except thumb. M1191A with longer cable (3.0 m) Small adult, pediatric sensor (1.5 m cable) for patients between 15 kg and 50 kg. Any finger except thumb. Use only on adult patients with FM30/40/50. Ear sensor (1.5 m cable) for patients more than 40 kg. Use only on adult patients with FM30/40/50. Adult clip sensor (3 m cable) for patients over 40 kg. Any finger except thumb. Adult clip sensor (2 m cable) for patients over 40 kg. Any finger except thumb. Adult sensor (0.45 m), for patients over 50 kg. Any finger except thumb. Small adult, pediatric sensor (0.45 m cable) for patients between 15 kg and 50 kg. Any finger except thumb. Use only on adult patients with FM30/40/50. Adult clip sensor (0.9 m cable) for patients over 40 kg. Any finger except thumb. Comments Product Number No adapter cable required. Requires M1943A (1.0 m) or M1943AL (3.0 m) adapter cable. M1191B M1191BL M1192A M1194A M1196A M1196S M1191T M1192T M1196T 263 27 Accessories and Supplies Description Special Edition (SE) Adult sensor (3 m cable), for patients over 50 kg. Any finger except thumb. Special Edition (SE) Small adult, pediatric sensor (1.5 m cable) for patients between 15 kg and 50 kg. Any finger except thumb. Use only on adult patients with FM30/40/50. Special Edition (SE) Ear sensor (1.5 m cable) for patients more than 40 kg. Philips disposable sensors. Not available in the USA. Identical to OxiMax MAX-A Identical to OxiMax MAX-P Identical to OxiMax MAX-N Philips disposable sensors. Available worldwide. Adult/Pediatric finger sensor (0.45 m cable) Use only on adult patients with FM30/40/50. Adult/Infant/Neonatal (0.9 m cable) for patients

> 40 kg. Any finger except thumb. Use only on adult patients with FM30/40/50. Adult/Infant/Neonatal (0.9 m cable) for patients

> 40 kg. Any finger except thumb. Adhesive-free Use only on adult patients with FM30/40/50. Comments No adapter cable required. SE sensors work with FM30/40/50, as well as with OxiMax-compatible SpO2 versions of other Philips monitors. Requires M1943A (1.0 m) or M1943AL (3.0 m) adapter cable Requires M1943A (1.0 m) or M1943AL (3.0 m) adapter cable Product Number M1191ANL M1192AN M1194AN M1904B M1903B M1901B M1131A M1133A M1134A 264 27 Accessories and Supplies Nellcor SpO2 Accessories Product Number Description NELLCOR disposable sensors (must be ordered from Nellcor) OxiMax MAX-A OxiMax MAX-AL OxiMax MAX-A with long cable OxiMax MAX-P Adult finger sensor (patient size > 30 kg) Pediatric foot/hand sensor (patient size 10-50 kg) Use only on adult patients with FM30/40/50. OxiMax MAX-N Adult finger or neonatal foot/hand sensor

(patient size > 40 kg or < 3 kg) Use only on adult patients with FM30/40/50. Oxisensor II D-25 Adult sensor (patient size > 30 kg) Oxisensor II D-20 Pediatric sensor (patient size 10-50 kg) Use only on adult patients with FM30/40/50. Oxisensor II N-25 Neonatal/Adult sensor (patient size < 3 kg or > 40 kg) Use only on OxiCliq A OxiCliq P OxiCliq N adult patients with FM30/40/50. See OxiMax MAX-A See OxiMax MAX-P Use only on adult patients with FM30/40/50. See OxiMax MAX-N Use only on adult patients with FM30/40/50 Masimo SpO2 Accessories Product Number Description MASIMO LNOP reusable sensors (No adapter cable required) LNOP DC-I LNOP DC-IP Adult Finger Sensor (> 30 kg) Pediatric Finger Sensor (10 - 50 kg) Use only on adult patients with FM30/40/50 Multi-Site Sensor (> 1kg) Use only on adult patients with FM30/40/50 Ear Sensor (> 30 kg) Use only on adult patients with FM30/40/50 MASIMO LNCS reusable sensors (No adapter cable required) LNCS DC-I LNCS DC-IP LNOP TC-I LNOP YI Adult Finger Sensor (> 30 kg) Pediatric Finger Sensor (10 - 50 kg) Use only on adult patients with FM30/40/50 Ear Sensor (> 30 kg) Use only on adult patients with FM30/40/50 LNCS TC-I MASIMO LNOP disposable adhesive sensors LNOP Adt Adult Sensor (> 30 kg) Comments Requires M1943A (1.0 m) or M1943AL (3.0 m) adapter cable. Requires M1943A (1.0 m) or M1943AL (3.0 m) adapter cable. Requires M1943A (1.0 m) or M1943AL (3.0 m) adapter cable together with OC3 adapter cable. Philips Part Number 989803140321 989803140331 n/a 989803140341 989803148281 989803148291 989803148301 989803140231 265 27 Accessories and Supplies Product Number Description LNOP Adtx LNOP Pdt LNOP Pdtx LNOP Neo-L LNCS Neo-L Adult Sensor (> 30 kg) Pediatric Sensor (10 - 50 kg) Use only on adult patients with FM30/40/50 Pediatric Sensor (10 - 50 kg) Use only on adult patients with FM30/40/50 Neonatal Sensor (< 3kg) or Adult adhesive Sensor (> 40 kg) Use only on adult patients with FM30/40/50 Adult Sensor (> 30 kg) Pediatric Finger Sensor (10 - 50 kg) Use only on adult patients with FM30/40/50 Neonatal Foot Sensor (<3 kg) or Adult Finger Sensor (>40 kg) Use only on adult patients with FM30/40/50 MASIMO LNCS disposable adhesive sensors (No adapter cable required) LNCS Adtx LNCS Pdtx Philips Part Number n/a 989803140261 n/a 989803140291 989803148231 989803148241 989803148271 IntelliVue CL SpO2 Pod Accessories All listed sensors operate without risk of exceeding 41C on the skin, if the initial skin temperature does not exceed 35C. Ensure that you use only the accessories that are specified for use with this device, otherwise patient injury can result. Description Mobile CL 20 single patient SpO2 Sensors and Cradles for use on adult patients >10 kg Mobile CL 20 single patient SpO2 Sensors for use on adult patients > 10 kg Mobile CL reusable SpO2 sensor and Cradles for use on adult patients > 15 kg Contents 20 Single-Patient Mobile CL DSpO2-1A Sensors 20 Single-Patient Wristbands 20 Single-Patient Cradles pre-assembled 20 Single-Patient Mobile CL DSpO2-1A Sensors 989803165921 Product No. 989803165941 1 Reusable Mobile CL RSpO2-1A Sensor 20 Single-Patient Cradles with pre-attached Wristbands Mobile CL 20 SpO2 Cradles (single patient) 20 Single-Patient Cradles with pre-attached 9898031659311 989803165951 989803165961 989803168861 Mobile CL 50 SpO2 Wristbands (single patient) Mobile CL SpO2 Battery Kit Wristbands 50 Single-Patient Wristbands 1 Battery 1 disassembly tool 1 front housing 1 May not be available in all geographies 266 Extension / Adapter Cables Comments Description For use with Philips reusable sensors and adapter cables. Extension cable (2 m) Adapter cable (1.1 m cable) Adapter cable for Philips/Nellcor disposable sensors. Adapter cable (3 m cable) Adapter Cable for OxiCliq sensors LNOP MP12 Available from Nellcor. LNOP MP Series Patient Cable (3.6 m) Adapter Cable for Masimo LNOP sensors 27 Product No. M1941A M1943A M1943AL OC 3 M1020-61102 LNC MP10 LNCS MP Series Patient Cable (3.0 m) Adapter Cable for Masimo LNCS sensors 989803148221 Tympanic Temperature Accessories Description Temperature probe Disposable probe cover with CE marking (22 boxes @ 96) Disposable probe cover (22 boxes @ 96) Part No. 989803180831 989803179611 989803179381 Recorder Paper Supplied in cases of 40 packs. Each pack has 150 numbered pages. Single use. Use the paper specified here. Geography FHR Scale Grid Color USA/Canada and Asia Europe/Japan 30 - 240 50 - 210 Red/Orange Green Japan Japan 50 - 210 50 - 210 Green Green*

Scale Units mmHg mmHg and kPa mmHg mmHg Highlighted 3 cm Lines?

Yes No Yes Yes Product No. M1910A M1911A M1913A M1913J

* Bradycardia and tachycardia alarm ranges are shaded. 267 27 Accessories and Supplies Batteries Description Smart Battery 10.8 V, 6000 mAh, Lithium Ion Avalon CL Cableless Smart transducer Battery Replacement Kit Comment For Avalon FM20 or Avalon FM30 with battery option #E25 Consists of one Philips Lithium Ion Battery

(Part No. 453564107871), a tool to open and close the cableless transducer for battery replacement and two replacement O-ring seals. Product No. M4605A 989803184861 268 28 Specifications and Standards Compliance 28Specifications and Standards Compliance The monitors are intended to monitor a mother and her fetus(es), which from an electrical safety point of view, are one person. Environmental Specifications The monitor may not meet the given performance specifications if stored and used outside the specified temperature and humidity ranges. Avalon CL Base station 866074 Temperature Range Humidity Range Altitude Range Operating Storage/Transportation Operating Storage/Transportation Operating Storage/Transportation 0C to 45C (32F to113F)

-20C to 60C (-4F to 140F)

<95% relative humidity @ 45C/113F

<90% relative humidity @ 60C/140F

-500 to 3000 m/-1640 to 9840 ft.

-500 to 13100 m/-1640 to 43000 ft. Monitor (M2702A/M2703A); Interface Cable for Avalon CTS (M2731-60001 and M2732-60001) Temperature Range Operating Humidity Range Altitude Range Storage/Transportation Operating Storage/Transportation Operating Storage/Transportation Without battery option: 0C to 45C (32F to 113F) With battery option/charging: 0C to 35C (32F to 95F) With battery option/fully charged: 0C to 40C (32F to 104F)

-20C to 60C (-4F to 140F)

<95% relative humidity @ 40C/104F

<90% relative humidity @ 60C/140F

-500 to 3000 m/-1640 to 9840 ft.

-500 to 13100 m/-1640 to 43000 ft. Transducers (M2734A/M2734B/M2735A/M2736A/M2738A) Temperature Range Humidity Range Operating Storage/Transportation Operating Storage/Transportation 0C to 40C (32F to 104F)

-20C to 60C (-4F to 140F)

<95% relative humidity @ 40C/104F

<90% relative humidity @ 60C/140F 269 28 Specifications and Standards Compliance Transducers (M2734A/M2734B/M2735A/M2736A/M2738A) Altitude Range Operating Storage/Transportation

-500 to 3000 m/-1640 to 9840 ft.

-500 to 13100 m/-1640 to 43000 ft. Avalon CL Transducers (866075/866076/866077) Temperature Range Humidity Range Altitude Range Operating Charging Storage/Transportation Operating Storage/Transportation Operating Storage/Transportation 0C to 40C (32F to 104F) 0C to 35C (32F to 95F)

-20C to 60C (-4F to 140F)

<95% relative humidity @ 40C/104F

<90% relative humidity @ 60C/140F

-500 to 3000 m/-1640 to 9840 ft.

-500 to 13100 m/-1640 to 43000 ft. SpO2 Sensors Operating Temperature Range 0C to 37C (32F to 98.6F) WARNING Explosion Hazard: Do not use in the presence of flammable anesthetics, such as a flammable anesthetic mixture with air, oxygen, nitrous oxide, or in oxygen rich environment. Use of the devices in such an environment may present an explosion hazard. 270 28 Specifications and Standards Compliance Physical Specifications Avalon CL Base Station Dimension and Weight Size mm/(in):

width x height x depth Weight When connected to M2702A/

M2703A/M2704A/M2705A Class II equipment using a red connector at the fetal sockets. External (powered by fetal monitor) Continuous operation Connector color Electrical Class Electrical Power Source Mode of Operation Interface cable connector type Interface cable length Ingress Protection 349 x 74 x 183 mm

(349 mm-5% max. width 350 mm)

(13.7 x 2.9 x 7.2 in 13.7 in -5% max. width 13.8 in) 0.985 kg /2.2 lbs When connected to M2704A/M2705A Class I equipment using a black connector in the telemetry socket. Red for FM20/30 left side or FM40/50 front fetal connector socket Black for FM40/50 rear telemetry connector socket 1,5 m /4.11 ft IP31 Monitor Physical Specifications Power Supply Voltages Supply Frequency Range Power Consumption

(current) Dimensions and Weight Size (without options) mm/

(in):

width x height x depth Weight Degree of Protection Against Electrical Shock Electrical Class Electrical Power Source Mode of Operation Water Ingress Protection Code M2702A/M2703A 100 VAC to 240 VAC 10%

50 Hz/60 Hz 0.7 - 0.4 A (M2702A/

M2703A) 1.3 - 0.7 A

(M8023A#E25) 286 x 133 x 335 1%

(11.3 x 5.2 x 13.2 in 1%)

< 5.1 kg/11.2 lbs Type CF Class II equipment External (AC) without battery option #E25 Internal (LiIo battery) if with battery option

#E25 Continuous operation M2704A/M2705A 1.3 - 0.7 A 420 x 172 x 370 5%

(16.5 x 6.8 x 14.6 in 5%)

< 9.0 kg/19.8 lbs Class I equipment External (AC)

IP X1 (provided recorder drawer is shut) 271 28 Specifications and Standards Compliance Monitor Physical Specifications Global Speed Startup Time Time taken from switching on the monitor to seeing the first parameter labels M2704A/M2705A M2702A/M2703A 6.25 mm/sec, 12.5 mm/sec, 25 mm/sec, 50 mm/sec

< 30 seconds Transducers (M2734A/M2734B/M2735A/M2736A/M2738A) Shock Resistance Water Ingress Protection Code Dimensions and Weight M2734A&B/35/36A M2738A M2734A&B/35/36A M2738A Degree of Protection Against Electrical Shock Transducer Identification Withstands a 1 m drop to concrete surface with possible cosmetic damage only IP 68 (immersion up to 1 m water depth for 5 hours) IP 67 (immersion up to 0.5 m water depth for 30 minutes) Size (diameter) 83 mm/3.27 in Weight (without cable) < 220 g/7.8 oz. Maximum size mm/

(in): width x height x depth Cable length Weight Type CF Optical Signal Element (Finder LED). Not M2738A 2.5 m

< 150 g/5.3 oz. 50 x 28 x 135 (2.0 x 1.1 x 5.3 in) Avalon CL Transducers (866075/866076/866077) Shock Resistance Water Ingress Protection Code Dimensions and Weight Avalon Cableless Toco+ MP Transducer 866075 Withstands a 1.5 m drop to concrete surface with possible cosmetic damage only. IP 68 (immersion up to 1 m water depth for 5 hours) Size (diameter/height) Avalon Cableless US Transducer 866076 Avalon Cableless ECG/IUP Transducer 866077 Weight Size (diameter/height) Weight Size (diameter/height) 75.5 mm/ 36.6 mm 2.9 / 1.4 in 123 g 10%/4.3 oz 10%

75.5 mm/ 36.6 mm 2.9 / 1.4 in 131 g 10%/4.6 oz 10%

75.5 mm/ 36.6 mm 2.9 / 1.4 in 121 g 10%/4.2 oz 10%

Weight Type CF Optical Signal Element (Finder LED). Degree of Protection Against Electrical Shock Transducer Identification 272 28 Specifications and Standards Compliance Interface Cable for Avalon CTS (M2731-60001 and M2732-60001) Shock Resistance Water Ingress Protection Code Dimensions and Weight Withstands a 1m drop to concrete surface with possible cosmetic damage only IP X1 Maximum size mm/(in):

width x height x depth Cable length Weight 2.5 m

< 200 g/7.0 oz. 55 x 28 x 50 (2.2 x 1.1 x 2.0 in) M8023A (Option #E25) External Power Supply Weight and Dimensions Maximum Weight Size (W x H x D) 700 g 10% (1.5 lb 10%) 207 x 70 x 113 mm / 8.1 x 2.8 x 4.4 in Interface Specifications Network MIB/RS232 Standard Connector Isolation Standard Connectors Mode USB Interface RS232 (Standard) RS232 (Independent display interface option) Basic Nurse Call Relay 100-Base-TX (IEEE 802.3 Clause 25) RJ45 (8 pin) Basic insulation (reference voltage: 250 V; test voltage: 1500 V) IEEE 1073-3.2-2000 RJ45 (8 pin) Software-controllable BCC (RxD/TxD cross over) or DCC (RxD/TxD straight through 5 V 5 %, 100 mA (max.) Basic insulation (reference voltage: 250 V; test voltage: 1500 V) USB 2.0 full-speed (embedded host) USB series "Standard A" receptacle Low power port 4.4V min; max. load for all ports together 500 mA none RJ45 (8-pin) none Basic insulation (reference voltage: 250 V; test voltage: 1500 V) RJ45 (8-pin) none none Power Isolation Standard Connectors Power Isolation Connectors Power Insulation Connectors Power Isolation Connectors Modular Jack 6P6C, active open and closed contact Contact Isolation Delay

<=100 mA, <=24 V DC Basic insulation (reference voltage: 250 V; test voltage: 1500 V)

<[Configured Latency +0.5] sec 273 28 Specifications and Standards Compliance Interface Specifications Flexible Nurse Call Relay1 Connectors Contact Isolation Delay 20 pin MDR (Mini D-Ribbon), active open and closed contacts

<=100 mA, <=24 V DC Basic insulation (reference voltage: 250 V; test voltage: 1500 V)

<[Configured Latency +0.5] sec 1 The power loss indication functionality of the Nurse Call Relay board is not supported with fetal monitors. Internal SRR interface IEEE 802.15.4 2.4 GHz ISM (2.400 - 2.483 GHz) DSSS (O -QPSK) max. 0 dBm (1 mW) ca. 5 m without any physical obstructions as walls and doors 608 - 614 MHz

<20 mW (Base Station)

<1 mW (CL transducers) min. 70 m 433.05 -434.79 MHz

<10 mW (Base Station)

<1 mW (CL transducers) min. 70 m 920.6 - 923.4 MHZ

<20 mW (Base Station)

<10 mW (CL transducers) min. 70 m Avalon CL Radio Interface Specifications Short Range Radio Interface Type Technology Frequency Band Modulation Technique Effective radiated power Range Frequency Band Effective radiated power Range Frequency Band Effective radiated power Range Frequency Band Effective radiated power Range OBR (WMTS) OBR (ISM) OBR (T108) 274 28 Specifications and Standards Compliance Basic monitoring configuration: >2 hours

(Display Brightness: 70%, Recorder: "On" at 3cm/min, NBP: Auto Mode at 15min, 2 US Transducers, 1 Toco+

with MECG, 1 Patient Module with DECG) When monitor is off: approx. 6 hours When monitor is in use: more than 10 hours (depending on monitor configuration). With a new and fully charged battery min. 8 hours From a "low battery" indication to a "fully charged" indication min. 3 hours Performance Specifications Battery Specifications Performance Specifications Avalon FM20/30 Battery Option #E25 Operating Time

(with new, fully charged battery) Charge Time Performance Specification Avalon CL Transducer Battery Operating time Charge time Fetal / Maternal Specifications Performance Specifications Ultrasound Measurement Method Measurement Range Resolution Jitter @ 200 bpm Display Update Rate US Intensity (M2736A/AA) US Display Printer Ultrasound Pulse Doppler 50 to 240 bpm 1 bpm 1/4 bpm 3 bpm 1 / second P = (7.4 0.4) mW p_ = (40.4 4.3) kPa Isata = (2.38 0.59) mW/cm2 Average output power Peak-negative acoustic pressure Output beam intensity (Iob)

(= spatial average - temporal average intensity) Spatial-peak temporal average intensity Effective radiating area @ -12 dB Thermal index (TI) and mechanical index (MI) are always below 1.0. Ispta = (15.0 3.2) mW/cm2

(3.11 0.74) cm2 275 28 Specifications and Standards Compliance Performance Specifications US Intensity CL (866076) Signal Quality Indication Beat-to -Beat (max.) for Ultrasound US Frequency US Signal range US Burst FMP Signal Range @ 33 Hz Performance Specifications Toco Measurement Method Sensitivity Resolution Display Printer Measurement Range Signal Range Maximum Offset Range Baseline Setting Update Rate Auto Offset Correction Auto Zero Adjust Display Printer Performance Specifications Maternal Pulse from Toco Emitted Light Energy 276 P = (12.4 0.4) mW p_ = (49.1 5.2) kPa Isata = (2.77 0.56) mW/cm2 Average output power Peak-negative acoustic pressure Output beam intensity (Iob)

(= spatial average - temporal average intensity) Ispta = (21.1 5.1) mW/cm2 Spatial-peak temporal average intensity A-12dB = (4.47 0.89) cm2 Effective radiating area @ -12 dB Thermal index (TI) and mechanical index (MI) are always below 1.0. Poor Quality Acceptable Quality Good Quality empty half-full full 28bmp 1 MHz 100 Hz 3.5 Vpp to 350 Vpp @ 200 Hz 3.0 kHz 100 s 200 Vpp to 40 Vpp Repetition Rate Duration Strain Gauge Sensor Element 1 unit = 2.5 g 1 unit 1/4 unit 400 units 0 to 127 units

-300 units 20 units 1 / second

~4 / seconds 3 seconds after connecting the transducer, the Toco value is set to 20 units Toco value is set to zero following a negative measurement value for 5 seconds 15 mW Performance Specifications Wavelength Range Range Resolution Display Update Rate Accuracy Update Rate Performance Specifications IUP Measurement Method Measurement Range Signal Range Resolution Display Printer Sensitivity Offset Compensation Accuracy (not including sensor accuracy) Update Rate Display Printer Auto Offset Correction DECG MECG Display Recorder Performance Specifications ECG Performance Specifications Type Measurement Range Resolution Wave Speed Accuracy Beat-to -Beat (max.) Differential Input Impedance 28 Specifications and Standards Compliance 780 to 1100 nm 40 to 240 bpm 1 bpm 1 / s 2% or 1 bpm, whichever is greater every 4 seconds Passive Resistive Strain Gauge Elements

-100 to +300 mmHg

-99 to 127 mmHg or -13.2 to 16.9 kPa 1 mmHg 1/4 mmHg 5 V/V/mmHg

+100 to -200 mmHg 0.5% per 100 mmHg 1 / second

~4 / seconds 3 seconds after connecting the transducer, the IUP value is set to 0 mmHg Single Lead ECG (derived from Fetal Scalp Electrode) Single Lead ECG (derived from RA and LA electrodes) 30 to 240 bpm 1 bpm (display update rate 1/s) 1/4 bpm 6.25 mm/sec, 12.5 mm/sec, 25 mm/sec, 50 mm/sec 1 bpm or 1%, whichever is greater

(non-averaging) MECG: 28 bpm DECG: 28 bpm (with Artifact Suppression On)

> 15M 277 28 Specifications and Standards Compliance Performance Specifications Electrode Offset Potential Tolerance Filter Bandwidth INOP Auxiliary Current (Leads Off Detection) DECG Input Signal Range MECG Dielectric Strength Defibrillator Protection ESU Protection Pace pulse detection 400 mV 0.8 to 80 Hz

< 100 A 20 Vpp to 6 mVpp 150 Vpp to 6 mVpp 1500 Vrms None None None WARNING The fetal/maternal monitor is not a diagnostic ECG device. In particular, the display of fetal/maternal ECG is intended only for evaluating signal quality for fetal/maternal heart rate as derived from the ECG waveform. When in doubt, it can be used to identify sources of compromised signal quality, such as noise or muscle artifacts. It can subsequently be used to verify the result of measures taken to resolve them

(e.g., checking ECG cable connections or adapting the fetal ArtifactSuppress configuration). The safety and effectiveness of the displayed fetal/maternal ECG waveform (i.e., P, QRS and T segments) for evaluation of fetal/maternal cardiac status during labor have not been evaluated. Fetal Heart Rate (Ultrasound/DECG) Alarm Specifications FHR Alarm Limits Range Bradycardia

(low limit) Tachycardia

(high limit) Bradycardia

(low limit) Delay Tachycardia

(high limit) Delay Signal Loss Delay FHR Alarm Delay Range 278 60 to 200 bpm adjustable in 10 bpm steps Default: 110 bpm 70 to 210 bpm adjustable in 10 bpm steps Default: 170 bpm 10 to 300 seconds in steps of 10s Default: 240s 10 to 300 seconds in steps of 10s Default: 300s 10 to 30 seconds in steps of 10s 28 Specifications and Standards Compliance MECG Alarm Specifications Range MECG Alarm Limits Tachycardia Bradycardia High Range: 31 to 240 Default: 120 bpm Low Range: 30 to 235 Default: 50 bpm Difference to high limit: 0 to 50 bpm Default: 20 bpm Clamping at: 150 to 240 bpm Default: 200 bpm Difference to low limit: 0 to 50 bpm Default: 20 bpm Clamping at: 30 to 100 bpm Default: 40 bpm Adjustment 1 bpm steps (30 to 40 bpm) 5 bpm steps (40 to 240 bpm) 5 bpm steps 5 bpm steps 5 bpm steps 5 bpm steps Maternal ECG Supplemental Information as required by IEC 60601-2-27 Heart Rate Averaging Method Display Update Rate Response Time of Heart Rate Meter to Change in Heart Rate The maternal heart rate is computed by averaging the 12 most recent RR intervals. If each of 3 consecutive RR intervals is greater than 1200 ms (i.e. rate less than 50 bpm), then the 4 most recent RR intervals are averaged to compute the HR. 2 s HR change from 80 to 120 bpm: 10 sec. HR change from 80 to 40 bpm: 14 sec. Noninvasive Blood Pressure Complies with IEC 80601-2-30:2010/EN 80601-2-30:2010. Performance Specifications Measurement Systolic Ranges Diastolic Mean Accuracy Pulse Rate Measurement Time Range Accuracy

(average over noninvasive blood pressure measurement cycle) 30 to 270 mmHg (4 to 36 kPa) 10 to 245 mmHg (1.5 to 32 kPa) 20 to 255 mmHg (2.5 to 34 kPa) Max. Std. Deviation:8 mmHg (1.1 kPa) Max. Mean Error: 5 mmHg (0.7 kPa) 40 to 300 bpm 40 to 100 bpm: 5 bpm 101 to 200 bpm: 5% of reading 201 to 300 bpm: 10% of reading Typical at HR > 60bpm Auto/manual: 30 seconds (adult) Maximum time: 180 seconds (adult) 279 28 Specifications and Standards Compliance Performance Specifications Cuff Inflation Time Initial Cuff Inflation Pressure Auto Mode Repetition Times Venipuncture Mode Inflation Inflation Pressure Automatic deflation after Typical for normal adult cuff: Less than 10 seconds 165 15 mmHg 1, 2, 2.5, 3, 5, 10, 15, 20, 30, 45, 60 or 120 minutes 20 to 120 mmHg (3 to 16 kPa) 170 seconds Measurement Validation: In adult mode, the blood pressure measurements determined with this device comply with the American National Standard for Electronic or Automated Sphygmomanometers (ANSI/AAMI SP10:2002/A1:2003) in relation to mean error and standard deviation, when compared to intra-arterial or auscultatory measurements (depending on the configuration) in a representative population. For the auscultatory reference the 5th Korotkoff sound was used to determine the diastolic pressure. Alarm Specifications Systolic Diastolic Mean Range Adult: 30 to 270 mmHg (4 to 36 kPa) Adult: 10 to 245 mmHg (1.5 to 32 kPa) Adult: 20 to 255 mmHg (2.5 to 34 kPa) Overpressure Settings

> 300 mmHg (40 kPa) > 2 sec Adjustment not user adjustable SpO2 Adjustment 10 to 30 mmHg: 2 mmHg (0.5 kPa)

> 30 mmHg: 5 mmHg (1 kPa) Complies with EN/ISO 80601-2-61 2011 (except alarm system; alarm system complies with IEC 60601-1-8:2006). Measurement Validation: The SpO2 accuracy has been validated in human studies against arterial blood sample reference measured with a CO-oximeter. Pulse oximeter measurements are statistically distributed, only about two-thirds of the measurements can be expected to fall within the specified accuracy compared to CO-oximeter measurements. 280 28 Specifications and Standards Compliance Display Update Period: Typical: 2 seconds, Maximum: 30 seconds. Max. with noninvasive blood pressure INOP suppression on: 60 seconds. Range Accuracy SpO2 Performance Specifications SpO2 The specified accuracy is the root-mean-square

(RMS) difference between the measured values and the reference values Pulse Sensors Resolution Range Accuracy Resolution Wavelength range Emitted Light Energy 0 to 100%

Philips Reusable Sensors:

M1191A/B, M1191AL/BL, M1191ANL, M1192A, M1192AN =

2% (70% to 100%) M1191T, M1192T, M1194A, M1194AN, M1196A, M1196T = 3%

(70% to 100%) Philips Disposable Sensors with M1943A(L):

M1131A, M1901B, M1903B, M1904B = 3% (70% to 100%) M1133A, M1134A = 2% (70% to 100%) NellcorPB Sensors with M1943A(L):

MAX-A, MAX-AL, MAX-P, MAX-N, D-25, D-20, N-25, OxiCliq A, P, N = 3% (70% to 100%) Masimo Reusable Sensors with LNOP MP12 or LNC MP10:

LNOP DC-I, LNOP DC-IP, LNOP YI, LNCS DC-I, LNCS DC-IP:

2% (70% to 100%) LNOP TC-I, LNCS TC-I: 3.5% (70% to 100%) Masimo Disposable Sensors with LNOP MP12 or LNC MP10:

LNOP Adt, LNOP Adtx, LNOP Pdt, LNOP Pdtx, LNCS Adtx, LNCS Pdtx: 2% (70% to 100%) LNOP Neo-L, LNCS Neo-L: 3% (70% to 100%) 1%

30 to 300 bpm 2% or 1 bpm, whichever is greater 1 bpm 500 to 1000 nm. Information about the wavelength range can be especially useful to clinicians (for instance, when photodynamic therapy is performed). 15mW Pulse Oximeter Calibration Range 70% - 100%

SpO2 Alarm Specifications Range SpO2 Desat Pulse 50 to 100%

50 to Low alarm limit 30 to 300 bpm Adjustment 1% steps 1% steps 1 bpm steps (30 to 40 bpm) 5 bpm steps (40 to 300 bpm) Delay

(0, 1, 2, 3,... 30) +

4 seconds max. 14 seconds 281 28 Specifications and Standards Compliance SpO2 Alarm Specifications Range Tachycardia Bradycardia Adjustment 5 bpm steps Difference to high limit 0 to 50 bpm 5 bpm steps Clamping at 150 to 300 bpm Difference to low limit 0 to 50 bpm 5 bpm steps Clamping at 30 to 100 bpm 5 bpm steps Delay max. 14 seconds max. 14 seconds Tympanic Temperature Complies with:

EN 12470-5 (Clinical thermometers - Part 5:2003: Performance of infra-red thermometers) ASTM E1965-98 (Infrared Thermometers for Intermittent Determination of Patient Temperature) with minor exceptions as noted below. Performance Specifications 0.1 C or 0.1 F less than 2 seconds Performance Specifications Temperature Resolution Response Time Temperature Calibrated Accuracy Specifications (out of the Factory) Ambient Temperature 25C (77F) 16C to 33C (60.8 to 91.4F) Temperature Calibrated Accuracy Specifications (after recalibration using Genius 2 Checker/Calibrator) Ambient Temperature 16C to 33C (60.8 to 91.4F) 16C to 33C (60.8 to 91.4F) Target Temperature 37.7C to 38.9C (98.4F to 102F) 0.1C (0.2F) 33C to 42C (91.4F to 107.6F) 0.2C (0.4F) Target Temperature 36C to 39C (96.8F to 102.2F) Accuracy 0.2C (0.4F) 0.3C (0.5F) Accuracy Less than 36C or greater then 39C

(Less than 96.8F or greater than 102.2F) ASTM laboratory requirement for IR thermometers in the display range 37C to 39C (98F to 102F) is 0.2C

(0.4F), whereas for mercury-in-glass and electronic thermometers, the requirement per ASTM standards E667-86 and E1112-86 is 0.1C (0.2F). Clinical accuracy characteristics and procedures are available from Covidien llc on request. To verify the accuracy, use a certified black body as specified in EN 12470-5:2003, Annex C, or use a Genius 2 Checker/Calibrator - available from Covidien llc under part number 303097. Clinical repeatability: meets section A.5 of EN 12470-5:2003 (E) per Covidien llc technical report. Data is available from Covidien llc on request. 282 28 Specifications and Standards Compliance Displayed Temperature Measurement Range Range C Mode Ear 33.0 to 42.0 33.6 to 42.0 Oral (ear + 0.6. C) 34.0 to 42.0 Core (ear + 1.04 C) Rectal (ear + 1.16 C) 34.2 to 42.0 Caution: ASTM E1965-98 specifies 34.4C to 42.2C (94F to 108F) Range F 91.4 to 107.6 92.5 to 107.6 93.2 to 107.6 93.6 to 107.6 Range C 16 to 33 Ambient Temperature Range Mode Operating 10 to 95% RH, non-

condensing Storage up to 95% RH, non-

condensing Caution: EN12470-5 specifies 16.0C to 35.0 C (60.8 F to 95 F), 10 to 95% RH, non-condensing ASTM E1965-98 specifies 16.0C to 40.0 C (60.8 F to 104 F), up to 95% RH, non-condensing Storing the thermometer outside the specified temperature/humidity range might adversely affect measurement accuracy. Check the calibration after storage in uncertain conditions. Range F 60.8 to 91.4

-25 to 55.0

-13 to 131 Tympanic Temperature Alarm Specifications Range Adjustment 33.0C to 42.0 C (91 F to 108 F) 0.5 C steps (33 C to 35 C) 0.1 C steps (35 C to 42 C) 1.0 F steps (91 F to 95 F) 0.2 F steps (95 F to 108 F) Physical Specifications Thermometer Dimensions Cable length Weight (including cable) Base Station Dimensions Weight (excluding cable) 190 mm x 43 mm x 55 mm (3 mm) 60 5 cm (spiral cable relaxed) 250 15 cm (spiral cable extended) 180 10 g 205 mm x 65 mm x 75 mm (3 mm) 400g 10 mm 283 28 Specifications and Standards Compliance Recorder Specifications Built-in Thermal Array Fetal Trace Recorder Mechanism Paper & Printing Thermal Array Recorder Type Standard Speeds (real-time traces) Fast Print Speed (stored traces) Accuracy @ 3 cm/min, 2 cm/min, 1 cm/min Usable Print Width Resolution Time Delay to see trace on paper Trace Separation Offset for FHR

(Ultrasound and DECG) ECG Wave Print Speed

(not real-time) Paper Advance Sensing 5 mm/page 128 mm 8 dots/mm (200 dpi)

<30s @ 1 cm/min Twin Triplet Standard Classic Standard Classic Standard Z-fold paper 3 cm/min, 2 cm/min, 1cm/min Max. 20 mm/s Print speed is variable and depends on the print load Emulated 25 mm/s Print speed is variable and depends on the print load 20 mm/s Optical Reflex Sensor for black page marks FHR2 +20 bpm FHR1 +20 bpm FHR2 +20 bpm FHR3 -20 bpm FHR1 +20 bpm FHR3 -20 bpm Recorder Symbols Symbol Description Parameter is capable of alarming and alarms were enabled at the time of printing the annotation. Low / high limit are printed surrounding the symbol. Parameter is capable of alarming but alarms were disabled at the time of printing the annotation.

(Note: There is no alarm related annotation at all if a parameter does not have alarming capability.) Alarm is on (printed next to measurement label) Upper and lower alarm limit (printed next to measurement label) 284 28 Specifications and Standards Compliance Recorder Symbols Symbol Description FMP detection is on Beginning of the date/time annotation Warning (INOP) Measurement from a cableless transducer (printed next to measurement label) Measurement from a cableless maternal measurement Pod (SpO2 or NBP) Pulse from SpO2 Pulse from Toco MP Pulse from NBP Trace separation +20 bpm (in label) Trace separation -20 bpm (in label) Trace separation Off (in trace) Trace separation +20 bpm (in trace) Trace separation -20 bpm (in trace) Trace separation +20 bpm and -20 bpm (in trace) 285 28 Specifications and Standards Compliance Recorder Symbols Symbol Description Coincidence of heart rates is detected Marker Special wave, with different speed and scale (for example, fast printout of MECG wave on FM30) Compatible External Displays: FM40/FM50 Only External displays can be connected with a maximum cable run of 10 m. Compatible Display Specifications Resolution*

Refresh frequency Useful screen Pixel size External XGA Display

(M8031B) 1024 x 768 60 Hz or 75 Hz Depends on size of display External SXGA Display (M8033C) 1280 x 1024 pixel 60 Hz

* The video output of the Avalon FM40/FM50 has VGA resolution. Manufacturer's Information You can write to Philips at this address:

Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard-Str. 2 71034 Boeblingen Germany Visit our website for local contact information at: www.healthcare.philips.com Copyright 2013. Koninklijke Philips N.V. All Rights Reserved. Trademark Acknowledgment OxisensorTM II, Oxi-CliqTM, and OxiMaxTM are trademarks of Tyco Healthcare Group LP, Nellcor Puritan Bennett Division. 286 28 Specifications and Standards Compliance Regulatory and Standards Compliance The monitor is in conformity with the requirements of the European Medical Devices Directive 93/

42/EEC and bears the CE marking:

The monitor is classified into Class IIb to Annex IX rule 10. Safety and Performance The monitor complies with the following major international safety and performance standards:

IEC 60601-1:2005+A1:2012 / EN 60601-1:2006+AC:2010 IEC 60601-1-6:2010 / EN 60601-1-6:2010 IEC 60601-1-8:2006 / EN 60601-1-8:2007+AC:2010 IEC 60601-2-27:2011+AC:2012 / EN 60601-2-27:2006+AC:2006 IEC 80601-2-30:2009+C1:2010 / EN 80601-2-30:2010 IEC 60601-2-37:2007 / EN 60601-2-37:2008 IEC 60601-2-49:2011 / EN 60601-2-49:2001 ISO 80601-2-61:2011 / EN 80601-2-61:2011 ANSI/AAMI ES60601-1+C1:2009+A2:2010 CAN/CSA C22.2#60601-1-08+TC2:2011 AS/NZS 3200.1.0-1998 The possibility of hazards arising from hardware and software errors was minimized in compliance with ISO 14971:2012, IEC 60601-1:2005+A1:2012 / EN 60601-1:2006+AC:2010. Alarm sounds are compliant with Standard ISO/IEC 9703-2 and IEC 60601-1-8:2006 / EN 60601-1-

8:2007+AC:2010. JIS T 1303 2005 287 28 Specifications and Standards Compliance Safety Tests Fetal Monitor All the safety tests and procedures required after an installation or an exchange of system components are described in your monitor's Service Guide. These safety tests are derived from international standards but may not be sufficient to meet local requirements. WARNING Do not use additional AC mains extension cords or multiple portable socket-outlets. If a multiple portable socket-outlet is used, the resulting system must be compliant with IEC/EN 60601-1 A1:

2012. Do not connect any devices that are not supported as part of a system. Do not use a device in the patient vicinity if it does not comply with IEC/EN 60601-1-1. The whole installation, including devices outside of the patient vicinity, must comply with IEC/EN 60601-1 A1: 2012. Any non-medical device, including a PC running an OB TraceVue/IntelliSpace Perinatal system, placed and operated in the patient's vicinity must be powered via a separating transformer (compliant with IEC/EN 60601-1 A1: 2012) that ensures mechanical fixing of the power cords and covering of any unused power outlets. Do not use USB devices with own power supplies unless an appropriate separation device is used

(either between USB interface and device or between device and power). During the installation the fetal monitor is configured for your environment. This configuration defines your custom default settings you work with when you switch on your fetal monitor. See the Fetal Monitor's Service Guide and the Configuration Guide for details on how to configure your fetal monitor. Electromagnetic Compatibility (EMC) The device and its accessories, listed in the accessories section, comply with the following EMC standards:

EN 60601-1-2+AC:2010 (IEC 60601-1-2:2007) Take special precautions regarding electromagnetic compatibility (EMC) when using medical electrical equipment. You must operate your monitoring equipment according to the EMC information provided in this book. Before using the device, assess the electromagnetic compatibility of the device with surrounding equipment. This ISM device complies with Canadian ICES-003:2012. Cet appareil ISM est conforme la norme NMB-003 du Canada. CAUTION FM20/FM30 only: Although this is an electrical Class II device, it has a protective earth conductor which is needed for EMC purposes. Always use the supplied power cord with the three-prong plug to connect the monitor to AC mains. Never adapt the three-prong plug from the power supply to fit a two-slot outlet. 288 28 Specifications and Standards Compliance CAUTION The use of accessories, transducers and cables other than those specified may result in increased electromagnetic emissions or decreased electromagnetic immunity of the device. WARNING Do not use cordless/mobile phones or any other portable RF communication system within the patient vicinity, or within a 1.0 m radius of any part of the fetal monitoring system. WARNING For paced patients: The radiated SRR power of the CL SpO2 and CL NBP Maternal Cableless Measurement Devices, and other sources of radio-frequency energy, when used in very close proximity of a pacemaker, might be sufficient to interfere with pacemaker performance. Due to shielding effects of the body, internal pacemakers are somewhat less vulnerable than external pacemakers. However, caution should be exercised when monitoring paced patients. In order to minimize the possibility of interference, avoid positioning and wearing the Cableless Measurement Devices in very close proximity to a pacemaker. Consult the pacemaker manufacturer for information on the RF susceptibility of their products EMC Testing CAUTION Fetal parameters, especially ultrasound and ECG, are sensitive measurements involving small signals, and the monitoring equipment contains very sensitive high gain front-end amplifiers. Immunity levels for radiated RF electromagnetic fields and conducted disturbances induced by RF fields are subject to technological limitations. To ensure that external electromagnetic fields do not cause erroneous measurements, it is recommended to avoid the use of electrically radiating equipment in close proximity to these measurements. 289 28 Specifications and Standards Compliance Reducing Electromagnetic Interference CAUTION The device should not be used adjacent to, or stacked with, other equipment unless otherwise specified. The product and associated accessories can be susceptible to interference from continuous, repetitive, power line bursts, and other RF energy sources, even if the other equipment is compliant with EN 60601-1-2 emission requirements. Examples of other sources of RF interference are other medical electrical devices, cellular products, information technology equipment, and radio/television transmissions. When electromagnetic interference (EMI) is encountered, for example, if you can hear spurious noises on the fetal monitor's loudspeaker, attempt to locate the source. Assess the following:

Is the interference due to misplaced or poorly applied transducers? If so, re-apply transducers correctly according to directions in this book or in the Instructions for Use accompanying the accessory. Is the interference intermittent or constant?

Does the interference occur only in certain locations?

Does the interference occur only when in close proximity to certain medical electrical equipment?

Once the source is located, there are a number of things that can be done to mitigate the problem:

1 Eliminating the source. Turn off or move possible sources of EMI to reduce their strength. 2 Attenuating the coupling. If the coupling path is through the patient leads, the interference may be reduced by moving and/or rearranging the leads. If the coupling is through the power cord, connecting the system to a different circuit may help. 3 Adding external attenuators. If EMI becomes an unusually difficult problem, external devices such as an isolation transformer or a transient suppressor may be of help. Your service provider can be of help in determining the need for external devices. Where it has been established that electromagnetic interference is affecting physiological parameter measurement values, a physician, or a suitably qualified person authorized by a physician, should determine if it will negatively impact patient diagnosis or treatment. System Characteristics The phenomena discussed above are not unique to this system but are characteristic of fetal patient monitoring equipment in use today. This performance is due to very sensitive high gain front end amplifiers required to process the small physiological signals from the patient. Among the various monitoring systems already in clinical use, interference from electromagnetic sources is rarely a problem. 290 28 Specifications and Standards Compliance Electromagnetic Emissions and Immunity The EMC standards state that manufacturers of patient-coupled equipment must specify immunity levels for their systems. See Tables 1 to 4 for this detailed immunity information. See Table 5 for recommended minimum separation distances between portable and mobile communications equipment and the product. Immunity is defined in the standard as the ability of a system to perform without degradation in the presence of an electromagnetic disturbance. Caution should be exercised in comparing immunity levels between different devices. The criteria used for degradation are not always specified by the standard and can therefore vary with the manufacturer. In the table below, the term "device" refers to the Avalon FM20/30/40/50 fetal monitor together with its accessories. The table gives details of the electromagnetic emissions, and how these are classified, for the device, and the electromagnetic environments in which the device is specified to technically function. Table 1 - Guidance and Manufacturer's Declaration: Electromagnetic Emissions Emissions Test Radiofrequency (RF) emissions Compliance Group 1 Avoiding Electromagnetic Interference The device uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. Harmonic emissions IEC 61000-3-2 Class A Voltage fluctuations and flicker IEC 61000-3-3 complies RF emissions CISPR 11 Class B For the Avalon FM20/30 fetal monitor with all accessories except the IUP/ECG patient module M2738A. Class A RF emissions CISPR 11 For the Avalon FM40/FM50 with all accessories. For the Avalon FM20/30 fetal monitor whenever used with the IUP/ECG patient module M2738A. For the Avalon CTS Interface Cable (M2731-

60001/M2732-60001) whenever used with the Avalon CTS Cableless Fetal Transducer System. For the Avalon CL Base Station with cableless transducers whenever used with the fetal monitors. The device is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage supply network that supplies buildings used for domestic purposes 1. The device is suitable for use in all establishments other than domestic establishments and those directly connected to the public low-voltage supply network that supplies buildings used for domestic purposes. 1 Note that the device is not intended for home use. Electromagnetic Immunity The monitor is suitable for use in the specified electromagnetic environment. The user must ensure that it is used in the appropriate environment as described below. 291 28 Specifications and Standards Compliance Table 2 - Guidance and Manufacturer's Declaration: Electromagnetic Immunity Immunity Test Compliance Level Electrostatic discharge (ESD) IEC 61000-4-2 Electrical fast transient/burst IEC 61000-4-4 Surge IEC 61000-4-5 Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 IEC 60601-1-2 Test Level 6 kV contact 8kV air 2 kV for power supply lines 1 kV for input/

output lines 1 kV differential mode 2 kV common mode

<5% UT (> 95% dip in UT) for 0.5 cycles 40% UT (60% dip in UT) for 5 cycles 70% UT

(30% dip in UT) for 25 cycles

< 5% UT

(> 95% dip in UT) for 5 sec 3 A/m 6 kV contact 8kV air 2 kV for power supply lines 1 kV for input/output lines 1 kV differential mode 2 kV common mode Electromagnetic Environment Guidance Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Mains power quality should be that of a typical commercial and/or hospital environment Mains power quality should be that of a typical commercial and/or hospital environment

<5% UT (> 95% dip in UT) for 0.5 cycles 40% UT (60% dip in UT) for 5 cycles 70% UT (30% dip in UT) for 25 cycles Mains power quality should be that of a typical commercial and/or hospital environment. If the user of the device requires continued operation during power mains interruptions, it is recommended that the device is powered from an uninterruptible power supply.

< 5%UT (> 95% dip in UT) for 5 sec Power frequency

(50/60 Hz) magnetic field IEC 61000-4-8 Key: UT is the AC mains voltage prior to application of the test level. 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial and/or hospital environment 292 28 Specifications and Standards Compliance Radio Compliance Notice Avalon CL with WMTS Operation of this equipment requires the prior coordination with a frequency coordinator designated by the FCC for the Wireless Medical Telemetry Service. This device complies with Part 15 of the FCC Rules and RSS-210 of Industry Canada. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Any changes or modifications to this equipment not expressly approved by Philips Medical Systems may cause harmful radio frequency interference and void your authority to operate this equipment. Installation of this telemetry device is permitted in hospitals and health care facilities only. This device shall not be operated in mobile vehicles (including ambulances and other vehicles associated with health care facilities). The installer/user of this device shall ensure that it is at least 80 km from the Dominion Radio Astrophysical Observatory (DRAO) near Penticton, British Columbia. The coordinates of DRAO are: latitude N 49E 19' 15", longitude W 119 37 12. For medical telemetry systems not meeting this 80 km separation (e.g. the Okanagan Valley, British Columbia) the installer/

user must coordinate with, and obtain the written concurrence of, the Director of DRAO before the equipment can be installed or operated. The Director of DRAO may be contacted at 250-497-2300

(telephone) or 250-497-2355 (fax). (Alternatively, the Manager, Regulatory Standards, Industry Canada, may be contacted.) Le prsent appareil est conforme aux CNR d'Industrie Canada applicables aux appareils radio exempts de licence. L'exploitation est autorise aux deux conditions suivantes: (1) l'appareil ne doit pas produire de brouillage, et (2) l'utilisateur de l'appareil doit accepter tout brouillage radiolectrique subi, mme si le brouillage est susceptible d'en compromettre le fonctionnement. L'utilisation de cet appareil de tlmesure est permise seulement dans les hpitaux et tablissements de soins de sant. Cet appareil ne doit pas tre mis en marche dans des vhicules (y compris les ambulances et autres vhicules associs aux tablissements de sant). La personne qui installe/utilise cet appareil doit sassurer quil se trouve au moins 80 km de lObservatoire fdral de radioastrophysique (OFR) de Penticton en Colombie-Britannique. Les coordonnes de lOFR sont :

latitude N 49 19 15, longitude O 119 37 12 . La personne qui installe/utilise un systme de tlmesure mdicale ne pouvant respecter cette distance de 80 km (p. ex. dans la valle de lOkanagan

(Colombie-Britannique), doit se concerter avec le directeur de lOFR et obtenir de sa part une autorisation crite avant que lquipement ne puisse tre install ou mis en marche. Le directeur de l OFR peut tre contact au 250-497-2300 (tl.) ou au 250-497-2355 (tlcopieur). (Le Directeur des Norm es rglementaires dIndustrie Canada peut galement tre contact). Avalon CL with T108 Japanese Radio Law and Japanese Telecommunications Business Law Compliance. This device should not be modified (otherwise the granted designation number will become invalid). 293 28 Specifications and Standards Compliance Finding Recommended Separation Distances In the following table, P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer, and d is the recommended separation distance in meters (m). Portable and mobile RF communications equipment should be used no closer to any part of the device, including cables, than the recommended separation distance calculated from the equation appropriate for the frequency of the transmitter. Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range. Interference may occur in the vicinity of equipment marked with this symbol:

Table 3 - Guidance and Manufacturer's Declaration: Electromagnetic Immunity Conducted RF Immunity Test EN/IEC 61000-4-6 IEC 60601-1-2 Test Level over 150 kHz to 80 MHz Compliance Level Electromagnetic Environment Guidance:

Recommended Separation Distance (d)

(in Meters, at Frequency Range Tested) for Ultrasound and ECG Measurements d = 1, 2P 3.0 VRMS 3.0 VRMS Key: d = Recommended separation distance in meters (m) P = maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer V1 = Tested compliance level (in Volts) for the Conducted RF Immunity test IEC 61000-4-6 The device meets the compliance level of 3.0 VRMS according to IEC 60601-1-2 over the specified test frequency range. Over the frequency range 150 kHz to 80 MHz, the recommended separation distance in meters (d) is found by the following equation:

For a compliance level of 3.0 VRMS: d = 1, 2P Table 4 - Guidance and Manufacturer's Declaration: Electromagnetic Immunity Radiated RF Immunity Test EN/IEC 61000-4-3 IEC 60601-1-2 Test Level over 80 MHz to 2.5 GHz Compliance Level 3.0 V/m 3.0 V/m 294 Electromagnetic Environment Guidance:

Recommended Separation Distance (d)

(in Meters, at Frequency Range Tested) for Ultrasound and ECG Measurements Over 80 MHz to 800 MHz:d = 1, 2P Over 800 MHz to 2.5 GHz:d = 2, 3P 28 Specifications and Standards Compliance Table 4 - Guidance and Manufacturer's Declaration: Electromagnetic Immunity Radiated RF Immunity Test EN/IEC 61000-4-3 IEC 60601-1-2 Test Level over 80 MHz to 2.5 GHz Compliance Level Electromagnetic Environment Guidance:

Recommended Separation Distance (d)

(in Meters, at Frequency Range Tested) for Ultrasound and ECG Measurements Key: d = Recommended separation distance in meters (m) P = maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer E1 = Tested compliance level (in Volts/meter) for the Radiated RF Immunity test IEC 61000-4-3 The device meets the compliance level of 3.0 VRMS according to IEC 60601-1-2 over the specified test frequency range. Over the frequency range 80 kHz to 800 MHz, the recommended separation distance in meters (d) is found by the following equation:

For a compliance level of 3.0 VRMS: d = 1, 2P Over the frequency range 800 kHz to 2.5 GHz, the recommended separation distance in meters (d) is found by the following equation:

For a compliance level of 3.0 VRMS: d = 2, 3P Field strengths from fixed transmitters, such as base stations or radio (cellular, cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the device is used exceeds the applicable RF compliance level above, it should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the device. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. If you require further information or assistance, please contact Philips Support. 295 28 Specifications and Standards Compliance Recommended Separation Distances from Other RF Equipment The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment and the device as recommended below, according to the maximum output power of the communications equipment. Table 5 - Separation Distance (d) in Meters According to Frequency of Transmitter at IEC 60601-1-2 Test Compliance Level Rated Maximum Output Power (P) of Transmitter

(in Watts) 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz 0.01 W 0.1 W 1 W 10 W 100 W 0.1 m 0.4 m 1.2 m 3.8 m 12.0 m 0.1 m 0.4 m 1.2 m 3.8 m 12.0 m 0.23 m 0.7 m 2.3 m 7.3 m 23.0 m Radio Frequency Radiation Exposure Information The radiated output power of the device is far below the FCC radio frequency exposure limits. Nevertheless, the device shall be used in such a manner that the potential for human contact during normal operation is minimized. Environment Before operation, make sure that the fetal monitor is free from condensation. This can form when equipment is moved from one building to another, and is exposed to moisture and differences in temperature. Use the monitor in an environment which is reasonably free from vibration, dust, corrosive or explosive gasses, extremes of temperature, humidity, and so forth. It operates within specifications at ambient temperatures between 0 and +45C (32F to 113F). Ambient temperatures that exceed these limits can affect the accuracy of the system, and can damage the components and circuits. Ambient temperature ranges for storage are -20C to +60C (-4F to 140F) for the monitor, and -

40C to +60C (-40F to 140F) for transducers. The transducers are watertight to a depth of 1.0 m for at least five hours (rated IP 68). WARNING Leakage currents: If several items of equipment used to monitor a patient are interconnected, the resulting leakage current may exceed allowable limits. ECG electrodes: NEVER allow ECG electrodes to contact other electrical conductive parts, including earth. 296 Monitoring After a Loss of Power 28 Specifications and Standards Compliance If the monitor is without power for less than one minute, monitoring will resume with all active settings unchanged. If the monitor is without power for more than one minute, the behavior depends on your configuration. If Automat. Default is set to Yes, the User Defaults will be loaded when power is restored. If Automat. Default is set to No, all active settings are retained, if power is restored within 48 hours. The Automat. Default setting is made in Configuration mode. When power is lost - no power is available from the AC power source or from the battery - a beeper will sound. The tone can be silenced by pressing the On/Standby switch. FM20/30 with Battery Option, FM40/50 ESU, MRI and Defibrillation WARNING The fetal/maternal monitors are NOT intended for use during defibrillation, electro-surgery, or MRI. Remove all transducers, sensors, and accessories before performing electro-surgery, defibrillation, or MRI, otherwise harm to the patient or the user can result. Cardiac Pacemakers and Electrical Stimulators WARNING The fetal/maternal monitors are not intended for use for ECG measurements on patients connected to external electrical stimulator or with cardiac pacemakers. Fast Transients/Bursts The equipment will return to the previous operating mode within 10 seconds without loss of any stored data. 297 28 Specifications and Standards Compliance Symbols on the System This caution/warning symbol indicates that you should consult the Instructions for Use (this document), and particularly any warning messages. This symbol indicates that you should consult the Instructions for Use (this document). Power-On/Off Switch -

FM20/FM30 without Battery Option Power-On/StandBy Switch -

FM40/FM50 and FM20/30 with Battery Option Power-On LED Electrical Class II equipment, in which the protection against electric shock relies on double or reinforced insulation

(FM20/FM30). Video Fetal Sensor Socket symbol. IP 67 Connection direction indicator FM20/FM30 with battery option Mouse connection indicator

(optional) Keyboard connection indicator

(optional) Serial/MIB connector

(optional) USB interface

(optional) Analog interface indicator for connection to any analog video display (VGA resolution) FM40/FM50 Ingress Protection code according to IEC 60529. The IUP/ECG patient module

(M2738A) is rated IP 67

(protection against dust, access to hazardous parts, and the effects of continuous immersion in water to a depth of 0.5 meter for 30 minutes). 298 28 Ingress Protection code according to IEC 60529. All transducers (excluding M2738A) are rated IP 68

(protection against dust, access to hazardous parts, and the effects of continuous immersion in water to a depth of 1.0 meter for five hours). Ingress Protection code according to IEC 60529. The monitors and interface cable for the Avalon CTS

(M2731-60001/

M2732-60001) are rated IP X1 (protection against water dripping vertically only). Type CF equipment, not defibrillation proof. Indicates location of service number Indicates location of serial number SpO2 Socket symbol. IP 68 Noninvasive Blood Pressure Socket symbol. IP X1 Symbol indicating the monitor has the triplets option. Symbol indicating the monitor is capable of intrapartum monitoring. Button to open paper drawer/

paper eject. (FM40/FM50). Protective earth terminal

(FM40/FM50). Indicates location of catalog number Equipotential grounding point

(FM40/FM50). Indicates location of the date of manufacture and/or name and address of manufacturer 299 28 Specifications and Standards Compliance Socket for connecting Avalon CTS interface cable M2732-60001 or Avalon CL interface cable (with black connector, FM40/FM50) Symbol indication for non-

ionizing radiation. China ROHS GOST-R mark FCC ID Federal Communications Commission: FCC ID xxxx CMIIT ID Japanese Radio marking: Radio mark + "PMS Japan" (in Japanese) + Prod. No. + [R]-

symbol + ID

"Taiwan Radio Label" (NCC Logo) + ID Industrial, Scientific, & Medical radio frequency band (Avalon CL frequency band used e.g. in the EU) Association Of Radio Industries And Businesses T108 (Avalon CL frequency band used e.g. in Japan) IC-ID (Industry Canada ID) One IC-ID labeling for each built in radio: OBR, SRR 300 Identifies the year and month of manufacture. Symbol indicating separate collection for waste electrical and electronic equipment. CSA US mark R&TTE Compliance Association: "Class 2 Device" Mark Chinese Radio marking:

CMIIT ID (China Ministry of Industry and Information Technology) Korea radio mark: KC logo, KCC ID number, and Conformity assessment information Wireless Medical Telemetry Service (Avalon CL frequency band used e.g. in North America) CE marking accompanied by the VDE NB number 0366 Taiwan Radio Label (NCC Logo) + ID 29Default Settings Appendix 29 Default Settings Appendix This appendix documents the most important default settings of your fetal monitor and the Avalon CL Base Station with the cableless transducers as they are delivered from the factory. For a comprehensive list and explanation of default settings see the Configuration Guide supplied with your fetal monitor. The monitor's default settings can be permanently changed in Configuration Mode. Alarm and Measurement Default Settings Alarm Defaults Settings Choice Alarm Setting INOP only, All Alarm Mode 0..10 Alarm Volume 1 min, 2 min, 3 min, Infinite Alarms Off Standard/Enhanced Alarm Text Red&Yellow/Red/Off Visual Latching Red Only/Off Audible Latching Traditional/ISO Alarm Sounds 0..10 Alarm Low Default INOP only 5 3 min Standard Off Off Traditional 4 Fetal / Maternal Defaults Settings FHR (Ultrasound/DECG) Toco IUP Maternal Heart Rate HR Measurement Alarms On/Off Default Default Color for FHR Numeric Default color for Toco numeric Default IUP Scale Unit Default color for IUP numeric Default Color for MECG Numeric On Orange Green mmHg Green Red 301 29 Default Settings Appendix immediately Coincidence Default Settings Coincidence Default Settings Coincidence Tone NBP Default Settings Factory Default Settings Mode Repeat Time Alarms from Low Limit High Limit VP Pressure Done Tone Veni Puncture Start Time NBP Alarms Color Reference CL NBP Default Settings NBP Setting Mode Repeat Time NBP VP Pressure Reference Unit Done Tone Start Time Aging Time Color Manual 15 min Sys. 90 / 50 (60) 160 / 90 (110) mmHg Off 60 mmHg Synchronized On On Red Auscultatory Factory Defaults Auto 10 min On 60 mmHg Auscultatory mmHg Off Synchronized 10 min Red 302 SpO2 Default Settings SpO2 Factory Default Settings Desat Limit Low Limit Low Limit High Limit Desat Delay Low Alarm Delay High Alarm Delay NBP Alarm Suppr. Alarms Color 80 90 100 20 seconds 10 seconds 10 seconds 10 seconds On On Cyan Pulse Default Settings Pulse (SpO) High Limit Low Limit Bradycardia: Difference to Low Limit Bradycardia: Clamp Tachycardia: Difference to High Limit Tachycardia: Clamp On 120 bpm 50 bpm 20 bpm 40 bpm 20 bpm 200 bpm CL SpO2 Default Settings SpO2 Settings Repeat Time Signal Quality NBP Alarm Suppr. Color 29 Default Settings Appendix Factory Defaults 15 min On On 303 29 Default Settings Appendix Tympanic Temperature Default Settings pTemp Settings Adult Factory defaults H10/H20/H40 H30 (deviations from H10/H20/H40) Adult 36C (96.8F) 39C (102.2F) C On Green Low Limit High Limit Unit Alarms Color Manually Entered Values Default Settings Manual Entered Values Label Unit Color Interval Msmt Default Settings Temp C white 1h off Choice 1, 2, or 3 cm/min US, Internat'l Thin, Medium, Thick, Extra Thick Thick Default 3 cm/min US Recorder Default Settings Setting Recorder Speed Scale Type Trace Style FHR1 Trace Style FHR2 Trace Style FHR3 Trace Style Toco Trace Style HR Wave Style ECG ECG Wave printing choice Notes Recording Auto Start Confirmed Stop Bridge Paperout Paper Save Mode NST Autostart NST Autostop Trace Separation Separation Order Separate, Overlap Along, Across Off, On Standard, Classic 304 Medium Extra Thick Thick Thin Thin Separate Along Off Off On Off On Off Off Standard 29 Default Settings Appendix Setting Intensity Cal. Offset Choice 4 (medium) 5 Default n/a n/a 305 29 Default Settings Appendix 306 A accessories 267, 268, 270, 271, 272, 273, 277 cl NBP pod accessories 272 cl SpO2 pod accessories 276 fetal accessories 268 fetal recorder accessories 277 latex information 267 MECG accessories 270 noninvasive blood pressure accessories 270, 271, 272 adult cuffs 272 multi-patient comfort cuff kits 271 reusable cuffs 271 single-hose disposable cuffs 272 SpO2 accessories 273 Philips sensors (disposable) 273 Philips sensors (reusable) 273 transducer accessories 268 ACOG technical bulletin 80 actions after monitoring 98 active alarms 109 adjusting brightness 66 adjusting display 68 adjusting screen brightness 66 admitting a patient 137, 138 editing information 138 aging numerics 213 alarms 109, 110, 111, 113, 114, 115, 116, 117, 118, 120, 121, 123, 191, 216, 230, 285, 289, 290, 311 acknowledging alarms 114 active alarms 109 alarm behavior at on/off 121 alarm latching 119 alarm limit delay 285 alarm reminder 114 alarm standards 111 audible alarm indicators 111 yellow alarms 109 artifact suppression 208 artifact suppression and fetal arrhythmia 208 explanation of artifact suppression 208 switching on and off artifact suppression 208 automatic noninvasive blood pressure repeat time 215 B baseline measurement 177, 184, 194 Battery Option 101 using batteries 101 belt actions 70, 72 belt fastening 70 belt fixing button 70 C Cableless Monitoring 91 Avalon CL 40 configuration cableless system 92 important considerations 159 LED indication 53 TELE window 93 Telemetry 94 Underwater monitoring 97 calibration 216, 260 calibrating noninvasive blood pressure 260 cautions 9 changing FHR alarm delays 191 changing FHR alarm limits 191 cleaning monitor actions 255, 256, 257, 265 cleaning method 256 cleaning monitoring accessories 257 general cleaning requirements 255 infection control 255 printhead cleaning 265 configuration mode 63 configuring alarm tone 111 confirming fetal life 10, 158, 175, 183 connecting power 12 cross-channel verification 10, 175, 183, 234 CCV and triplets 183 CCV and twins 175 D data recovery 251 date from OB TraceVue 66 date setting 66 DECG 205, 209, 285 DECG INOPs 209 DECG specifications 285 DECG testing 209 DECG troubleshooting 209 default alarm settings 311 default IUP settings 285 default settings 285 FHR default settings 285 1Index IUP default settings 285 MECG default settings 285 Toco default settings 285 user defaults 65 defibrillation precautions 238, 267, 307 demo mode 63 disabling touchscreen 63 discharging a patient 138 disinfecting 255, 256, 257 infection control 255 recommended substances 257 display 68, 213, 285 adjusting display 68 display noninvasive blood pressure 213 fetal display specifications 285 disposal of electronic waste 266 disposal of monitor 266 dyshemoglobins 228 intravascular dyshemoglobins 228 E early systolic blood pressure 213 ECG 205, 235, 285 ECG specifications 285 electrical safety tests 298 electrical surgery precautions. See ESU 228, 238, 267, 307 electrodes 237 applying electrodes 237 EMC 298 electromagnetic compatibility 298 electromagnetic emissions 301 electromagnetic interference 300 how to reduce electromagnetic interference 300 EMC and compliant accessories 298 EMC precautions 298 EMC standards 298 entering notes 61 ESU precautions 238, 267, 307 event marker remote 80 extension cable for SpO2 228 external monitoring 157, 176, 184, 194 external monitoring - Toco 194 external monitoring - triplets 184 external monitoring - twins 176 external monitoring - ultrasound 157 317 F factory defaults 289, 290, 294 noninvasive blood pressure factory defaults 289 recorder factory defaults 294 SpO2 factory defaults 290 FAST 227 Fourier Artifact Suppression Technology 227 fetal accessories 268 fetal arrhythmia 208 fetal demise 10 fetal display specifications 285 IUP - fetal display specifications 285 Toco - fetal display specifications 285 US - fetal display specifications 285 fetal heart rate alerting. See FHR 191 fetal heart rate. See FHR 157 fetal movement 163 fetal movement profile. See FMP 157 FHR 10, 158, 165, 175, 177, 183, 184, 191, 192, 234, 285 alerting 191 cross-channel verification 234 misidentification 10 trace separation 177, 184 FHR alarms 285 finder LED 45, 73, 175, 183 finding monitor revision 67 flexible nurse call 30, 42, 44 FMP 163, 164 FMP and twins 163 FMP statistics 163 functional arterial oxygen saturation 227 G global settings 65 H high priority alarms 109 I infection control 255 infection and sterilizing 255 INOPs 109, 114 CCV INOP 33 coincidence tone 30 disconnect INOPs 114 INOP alarms 109 INOPs indicators 109 silencing INOPs 114 interference 298, 300 how to reduce interference 300 interference from RF equipment 298 318 internal monitoring 177, 199, 201 intrauterine pressure. See IUP 197 intravascular dyshemoglobins 228 intravascular dyshemoglobins effects on

(SpO2) 228 ISO/IEC standard 9703-2 111 IUP 197, 199, 285 IUP specifications 285 L latching alarms 118, 119 latching alarm behavior 119 M mains power (AC) 12, 99 connecting to mains power 12 disconnecting from mains power 99 maintenance 259, 260 maintenance schedule 259, 260 visual inspection 259 maternal ECG 208, 238, 240 electrode position 238 printing waveform 208, 240 viewing waveforms 238 maternal heart rate 233, 234, 235 maternal heart rate and cross-channel verification 234 maternal heart rate and priorities 233 maternal heart rate from MECG 235 sources of maternal heart rate 233 maternal puls from Toco 32 Maternal Temperature 30 measurement settings 65 changing measurement settings 65 entering setup menu 65 measurements 64, 65, 285 setting up measurements 65 switching on and off measurements 64 MECG 208, 235, 237, 238, 240, 242, 243, 270, 285 accessories 270 alarm limits 285 connection illustration 235 default settings 285 electrodes 237 specifications 285 waveform printing 208, 240 MECG alarm limits 285 methemoglobin (SpO2) 228 MHR 158, 233, 235, 237 MHR from MECG 235 MHR priorities 233 MHR sources 233 monitor settings 10, 40, 66, 68, 98, 251 changing monitor settings 66 major parts and keys 40 power on/off behavior 99 Standby 98 switching on 68 monitoring mode 63 monitoring triplets and FHR 183 monitoring twins and FHR 175 MR imaging and the SpO2 transducer 228 MRI precautions 238, 267, 307 N NBP. See noninvasive blood pressure 211 NIBP. See noninvasive blood pressure 211 Noninvasive Blood Pressure (NBP) 211, 212, 213, 214, 215, 216, 217, 242, 260, 270, 271, 272, 289 calibration interval 260 comfort cuff kits 271 factory defaults 289 how the measurement works 211 measurement 212, 214 limitations 212 methods 212 starting 214 stopping 214 NBP accessories 270 NBP adult cuffs 272 NBP automatic mode 215 NBP numerics 213 NBP pediatric cuffs 272 NBP performance specifications 289 NBP reusable cuffs 271 NBP single-hose disposable cuffs 272 NBP site inspection 212 NBP troubleshooting 217 NBP venous puncture 216 preparing to measure NBP 212 non-medical devices 298 non-medical devices in patient vicinity 298 Non-Stress Test timer. See NST timer 143 NST Report NST analysis 32 Trace Interpretation 145, 148 NST timer 141, 142, 143 O OB TraceVue 38, 39, 252 connection to OB TraceVue 38, 39 LAN connection 252 operating modes 63 configuration mode 63 demo mode 63 monitoring mode 63 service mode 63 operating temperatures 306 oscillometric measurement method 211 P Paging Patient 97 paper 80, 81, 82, 83, 85, 264, 277 default paper speed 80 loading paper 83, 85 paper out INOP 82 paper speed 80 changing 80 default 80 defaults 80 setting 80 paper, when to reload 82 recorder paper 277 removing paper 83, 85 storing paper 264 tearing off a trace 81 Paper Advance key 61 Paper-Out indication 82 passcode protection 63 patient alarms 123 Patient Demographics window 137 patient module 205, 235 paused alarms 115, 116 restarting paused alarms 116 pausing alarms 115 performance specifications 285, 289, 290 noninvasive blood pressure specifications 289 SpO2 specifications 290 physiological alarms 109 pop-up keys 95 power 12, 99 connecting power 12 disconnecting from 99 power connection 12 power failure 99 pulse 242 pulse from noninvasive blood pressure 242 pulse rate 233 R recorder 76, 100, 264, 265, 277, 294 factory defaults 294 paper storage 264 printhead cleaning 265 recorder paper 277 recorder specifications 294 recorder speed 33 recorder troubleshooting 100 Recorder Elements 79 recording stored data 61 recovering traces 251 trace recovery printout 251 recycling 266 red alarms 109 regulatory compliance 297 remote event marker 80 restarting paused alarms 116 reviewing alarms 118 reviewing alarms window 118 S safety 260, 297 maintenance interval 260 safety standards 297 screen layouts 64 selftest 68, 76, 120 sensor 227 disposable SpO2 sensors 227 selecting SpO2 sensors 227 separating FHR traces 177, 184 separating triplet traces 184 separating twin traces 177 service mode 63 settings 64, 65, 66 active settings 64 changing settings 66 global settings 65 monitor settings 66 user default settings 65 signal loss delay 192 signal quality 90, 230 signal quality during monitoring 90 signal quality of SpO2 230 silencing alarms 114 specifications 279, 281, 285, 294 built-in recorder specifications 294 DECG specifications 285 ECG specifications 285 environmental specifications 279 monitor 279 SpO2 sensors 279 transducers 279 IUP specifications 285 measurement specifications 285 MECG specifications 285 performance specifications 285 Toco specifications 285 transducer specifications 281 US specifications 285 SpO2 227, 228, 230, 273, 290 accessories 273 alarm specifications 290 connecting the cables 228 disposable sensors 227 factory defaults 290 FAST technology 227 performance specifications 290 Philips sensors (disposable) 273 Philips sensors (reusable) 273 signal quality 230 SpO2 alarms 230, 290 standards 297, 298 EMC standards 298 safety standards 297 standards compliance 297 Standby 61 sterilizing 255, 258 infection control 255 storage temperatures 306 stored data recording 61 suppressing artifacts 208 suspended alarm 116 suspicious SpO2 reading 230 switching on and off 164 switching on and off alarms 116 switching on monitor 68 switching on recorder 76 symbols on the system 308 T technical alarm messages. See INOPs 126 temperatures 306 operating temperatures 306 storage temperatures 306 testing 120, 209, 242, 298 DECG testing 209 MECG testing 242 safety testing 298 testing alarms 120 time 66 setting time 66 time from OB TraceVue 66 Toco 193, 194, 195, 205, 237, 285 default Toco settings 285 testing a Toco transducer 195 Toco baseline 194 Toco display specifications 285 Toco monitoring 193 Toco sensitivity 195 Toco specifications 285 Toco MP transducer 193, 233 Toco+ transducer 193 touch tone volume 66 touchscreen operation 56, 63 trace actions 81, 251, 252 separation on/off 33 tearing off traces 81 trace recovery on OB TraceVue 252 trace recovery on paper 251 transducer 45, 70, 73, 173, 175, 183, 193, 195, 319 voltage setting 12 volume 66, 113 alarm volume 113 IUP, zeroing 199 touch tone volume 66 warnings 9 281 connecting transducer to monitor 73 fixing transducer to belt 70 repositioning transducers 73 Toco transducer 193 Toco+ transducer 193 transducer belt clip 70 transducer specifications 281 transducer testing 173, 195 Toco 195 ultrasound 173 triplets 183, 184, 185, 188 cross-channel verification 183 external monitoring 184 importance of monitoring MHR 183 monitoring triplets 183 offsetting baselines 184 troubleshooting 100, 165, 181, 188, 195, 199, 209, 217, 240 DECG 209 FHR 165 IUP 199 MECG 240 troubleshooting FHR 165 twins 163, 175, 176, 177, 178, 179, 181 cross-channel verification 175 external monitoring 176 importance of monitoring MHR 175 invasive monitoring 177 monitoring FHR 175 monitoring twins 175 offsetting baselines 177 twins and FMP 163 U ultrasound 157, 160, 173, 285 applying gel 160 testing a transducer 173 ultrasound display specifications 285 ultrasound monitoring 157 ultrasound specifications 285 understanding screens 64 USB 30 using the adapter cable 205 uterine activity 193, 194, 195, 197, 199, 205, 237 external monitoring 193 internal monitoring 197 monitoring uterine activity 194, 197, 199, 205, 237 troubleshooting uterine activity 195, 199 V velcro belt 72 venous puncture 216 visual alarm indicators 110 320 Part Number xxxxxxxxxxx Printed in Germany 06/13

*453564405521*

 

 

In stru ctio ns fo r Use Avalon Fetal Monitor FM20/30, FM40/50, Avalon CL Rel ease L .3 with Software R e visi o n L .3x .x x Patient Monitori ng 2 1 Introduction Who this Book is For Confirm Fetal Life Before Using the Monitor Introducing the Avalon Family of Fetal Monitors 2 What's New What's New in Release L.3 What's New in Release J.3 3 Basic Operation Supported Measurements Avalon FM20 and FM30 Avalon FM40 and FM50 Getting to Know Your Avalon FM20/FM30 Getting to Know Your Avalon FM40/FM50 Connecting the Monitor to AC Mains Wired Transducers Operating and Navigating Operating Modes Automatic Screen Layouts Using the XDS Remote Display Settings Preparing to Monitor After Monitoring Switching the Monitor to the Standby Screen Disconnecting from Power Power On/Power Off Behavior Monitoring After a Power Failure Troubleshooting 4 Cableless Monitoring Avalon CL Transducer System Basics of Cableless Systems Twins and Triplets Support Configuration of Cableless Systems Getting to Know Your Avalon CL Cableless Transducers CL Pods Contents 11 11 12 13 25 25 27 31 31 32 33 34 36 38 38 39 44 45 45 45 48 70 71 71 71 71 72 73 73 74 74 75 75 81 86 3 Calling Patients Preparing to Monitor Cablelessly Battery Lifetime Management Patient Transport Within the Hospital Underwater Monitoring 5 FM20/30 Battery Option External Power Supply M8023A Using Batteries Optimizing Battery Performance Storing the Battery Cableless Monitoring with FM20/30 Battery Option Patient Transport Within the Hospital 6 Alarms Alarm Mode Nurse Call Systems Visual Alarm Indicators Audible Alarm Indicators Acknowledging Alarms Acknowledging Disconnect INOPs Alarm Reminder Pausing or Switching Off Alarms Alarm Limits Reviewing Alarms Latching Alarms Testing Alarms Alarm Behavior at Power On 7 Patient Alarms and INOPs Alarm Messages Technical Alarm Messages (INOPs) 8 Admitting and Discharging Admit/Discharge on the Monitor New Patient Check OB TraceVue/IntelliSpace Perinatal 9 Non-Stress Test Timer Setting NST Autostart/Autostop Viewing the NST Timer Timer Expiry Notification 4 96 96 103 104 105 107 107 108 110 112 112 113 115 116 116 116 117 119 119 119 119 121 122 123 124 125 127 127 130 145 145 147 147 149 149 149 149 Accessing the NST Setup Pop-up Keys 10 Non-Stress Test Report Setting Up an NST Report Criteria Not Met Nonreactive NST Test Printing an NST Report NST According to NICHD Trace Interpretation NST According to Dawes/Redman Trace Interpretation 11 Cross-Channel Verification (CCV) Misidentification of Heart Rates Cross-Channel Verification Functionality Overview of Cross-Channel Comparisons Coincidence Examples Recommended Actions for Coincidence INOP 12 Monitoring FHR and FMP Using Ultrasound Technical Description Limitations of the Technology Misidentification of Maternal HR as FHR What You Need Cableless Monitoring - Important Considerations Preparing to Monitor Selecting Fetal Heart Sound Changing the Fetal Heart Sound Volume Fetal Movement Profile Troubleshooting Additional Information 13 Monitoring Twin FHRs Important Considerations Monitoring Twins Externally Monitoring Twins Internally Separating FHR Traces Troubleshooting 14 Monitoring Triple FHRs Important Considerations Monitoring Triplets Separating FHR Traces Standard Separation Order 149 151 152 152 152 152 152 157 163 163 164 164 165 167 169 169 170 170 170 171 172 172 173 173 175 176 185 185 186 186 187 190 191 191 192 192 192 5 Classic Separation Order Switching Trace Separation On and Off When Trace Separation is On When Trace Separation is Off Troubleshooting 15 Fetal Heart Rate Alarms Changing Alarm Settings Changing Signal Loss Delay 16 Monitoring FHR Using DECG Misidentification of Maternal HR as FHR What You Need Making Connections Monitoring DECG Suppressing Artifacts Troubleshooting Testing DECG Mode 17 Monitoring Uterine Activity Externally What You Need External Toco Monitoring Toco Sensitivity Troubleshooting 18 Monitoring Uterine Activity Internally What You Need Internal (IUP) Monitoring Troubleshooting 19 Monitoring aFHR, aHR, and aToco Fetal Heart Rate aFHR Uterine Activity aToco What You Need At the Monitor Troubleshooting 20 Monitoring Maternal Heart / Pulse Rate Priority for Maternal Heart / Pulse Rate Misidentification of Maternal HR for FHR Maternal HR from MECG Electrodes 6 193 194 194 194 196 197 197 198 199 199 200 202 203 204 204 205 207 207 208 208 209 211 211 213 214 215 215 216 217 217 218 219 219 219 220 Monitoring MECG Wave Pulse Rate from Toco+ MP Pulse Rate from SpO2 Adjusting the Heart Rate / Pulse Alarm Limits Average Pulse Rate from Noninvasive Blood Pressure Testing MECG Mode 21 Printing the ECG Waveform 22 Monitoring Noninvasive Blood Pressure Introducing the Oscillometric Noninvasive Blood Pressure Measurement Preparing to Measure Noninvasive Blood Pressure Starting and Stopping Measurements Enabling Automatic Mode and Setting Repetition Time Enabling Sequence Mode and Setting Up the Sequence Choosing the Alarm Source Assisting Venous Puncture Calibrating NBP Troubleshooting 23 Monitoring SpO2 Selecting an SpO2 Sensor Applying the Sensor Connecting SpO2 Cables Measuring SpO2 SpO2 Signal Quality Indicator Assessing a Suspicious SpO2 Reading Understanding SpO2 Alarms Setting Up Tone Modulation Setting the QRS Volume 24 Monitoring Maternal Temperature Measuring Tympanic Temperature Entering Temperature Manually 25 Paper Save Mode for Maternal Measurements 26 Recovering Data Recovering Traces on Paper Recovering Traces on an OB TraceVue/IntelliSpace Perinatal System Manually Recording Stored Data 222 224 225 225 225 225 227 231 231 232 234 235 235 235 236 236 236 239 239 239 240 241 241 242 242 243 243 245 245 250 251 253 253 254 254 7 27 Care and Cleaning General Points Cleaning and Disinfecting the Monitor Cleaning and Disinfecting Fetal Monitoring Accessories Cleaning and Disinfecting the Tympanic Temperature Accessories Sterilizing 28 Maintenance Inspecting the Equipment and Accessories Inspecting the Cables and Cords Maintenance Task and Test Schedule Recorder Maintenance Cleaning the Print Head Returning Equipment for Repair Disposing of the Monitor 29 Accessories and Supplies Information on Latex Avalon CL Base Station Transducers Fetal Accessories Noninvasive Blood Pressure Accessories SpO2 Accessories Tympanic Temperature Accessories Recorder Paper Batteries 30 Specifications and Standards Compliance Environmental Specifications Physical Specifications Interface Specifications Performance Specifications Recorder Specifications External Displays: FM40/FM50 Only Manufacturer's Information Trademark Acknowledgment Regulatory and Standards Compliance Environment Monitoring After a Loss of Power ESU, MRI, and Defibrillation Symbols 8 257 257 258 261 264 265 267 267 267 268 268 272 273 273 275 275 275 276 277 278 280 285 285 285 287 287 291 294 297 310 310 311 311 312 317 318 318 318 31 Default Settings Appendix Alarm and Measurement Default Settings Recorder Default Settings Index 323 323 327 329 9 10 1 1Introduction Who this Book is For This book is for trained healthcare professionals using the Avalon FM20, FM30, FM40, and FM50 fetal/

maternal monitors, and the Avalon CL Transducer System. It describes how to set up and use the monitor and transducers. Familiarize yourself with all instructions including warnings and cautions before starting to monitor patients. Read and keep the Instructions for Use that come with any accessories, as these contain important information about application, care, and cleaning that is not repeated in this book. If you have received this Instruction for Use because your fetal monitor has been upgraded to a newer software version L.3, be aware that the standards compliance information contained in the Instructions for Use for L.3 does not apply to your fetal monitor. Refer to your original Instructions for Use for standards compliance information. You should be:

Trained in the use of fetal heart rate (FHR) monitors. Trained in the interpretation of FHR traces. Familiar with using medical devices and with standard fetal monitoring procedures. For information on how to configure and service the monitor, see the Configuration Guide and the Service Guides, or contact your authorized service provider. Your monitor may not have all of the features and options described in this guide. The exact appearance of the monitor may differ slightly from that shown in the illustrations. This guide may contain descriptions of functionality and features that are not implemented in the equipment currently shipped to Japan and/or of products that are not currently sold in Japan due to limitations and restrictions under the applicable local laws and regulations in Japan. Please contact your local sales representative and/or Philips Customer Support for details. In this guide:

A warning alerts you to a potential serious outcome, adverse event, or safety hazard. Failure to observe a warning may result in death or serious injury to the user or patient. Always use clinical judgment to decide whether the benefit of using the device/the measurement in a specific situation outweighs the risk. A caution alerts you to where special care is necessary for the safe and effective use of the product. Failure to observe a caution may result in:

minor or moderate personal injury, damage to the product or other property, possibly in a remote risk of more serious injury. A contraindication describes a situation, such as patient population, medical reason, or clinical condition, in which a device may not be used because the risk of use clearly outweighs any possible benefit. 11 1 Introduction Monitor refers to the entire fetal/maternal monitor. Display refers to the physical display unit. Screen refers to everything you see on the monitor's display, such as measurements, alarms, patient data, and so forth. NOTE Any serious incident that has occurred in relation to this device should be reported to Philips and the competent authority of the member state in which the user and/or patient is established. In this context, member state refers to European Economic Area (EEA) countries including Switzerland and Turkey. FM30 Whenever a monitors identifier appears to the left of a heading or paragraph, it means that the information applies to that monitor only. Where the information applies to all models, no distinction is made. Avalon CL Avalon CTS Whenever one of these identifiers appear to the left of a heading or paragraph, it means that the information applies to that cableless transducer system. Where the information applies to both systems, no distinction is made. For installation instructions and technical description, see the corresponding Service Guide of the fetal monitors. Confirm Fetal Life Before Using the Monitor Fetal monitoring technology available today is not always able to differentiate a fetal heart rate (FHR) signal source from a maternal heart rate (HR) source in all situations. Therefore, you should confirm fetal life by independent means before starting to use the fetal monitor, for example, by palpation of fetal movement or auscultation of fetal heart sounds using a fetoscope, stethoscope, or Pinard stethoscope. If you cannot hear the fetal heart sounds, and you cannot confirm fetal movement by palpation, confirm fetal life using obstetric ultrasonography. Continue to confirm that the fetus is the signal source for the FHR during monitoring. Be aware that:

a maternal HR trace can exhibit features that are very similar to those of an FHR trace, even including accelerations and decelerations. Do not rely solely on trace pattern features to identify a fetal source. Fetal Movement Profile (FMP) annotations on a fetal trace alone may not always indicate that the fetus is alive. The body of a deceased fetus can move and cause the monitor to annotate fetal body movements. Here are some examples where the maternal HR can be misidentified as the FHR. When using an ultrasound transducer:

It is possible to pick up maternal signal sources, such as the aorta or other large vessels. Misidentification may occur when the maternal HR is higher than normal (especially when it is over 100 bpm). When using a fetal scalp electrode:

Electrical impulses from the maternal heart can sometimes be transmitted to the fetal monitor through a recently deceased fetus via the spiral scalp electrode cable, appearing to be a fetal signal source. The recorded maternal HR (and any artifact) can be misinterpreted as an FHR (especially when it is over 100 bpm). When Fetal Movement Profile (FMP) is enabled:

FMP annotations in the absence of fetal life may be a result of:

Movement of the deceased fetus during or following maternal movement. Movement of the deceased fetus during or following manual palpation of fetal movement (especially if the pressure applied is too forceful). Movement of the ultrasound transducer. 12 1 Introduction The ultrasound transducer detecting a maternal movement source, such as the mother coughing. See also Monitoring FHR and FMP Using Ultrasound on page 169 and Monitoring FHR Using DECG on page 199. To reduce the possibility of mistaking the maternal HR for an FHR, it is recommended that you monitor both maternal and fetal heart rates. The monitor's cross-channel verification (CCV) feature can help by automatically detecting when a maternal HR coincides with an FHR. For further details, see Cross-Channel Verification (CCV) on page 163. Introducing the Avalon Family of Fetal Monitors The Avalon family of fetal monitors consists of the Avalon FM20, FM30, FM40, and FM50. While the FM20/FM30 and the FM40/FM50 have different form factors, the method of operation is very similar for all monitors. The Avalon fetal monitors also share transducers, accessories, software, and are compatible with the Avalon CL, and Avalon CTS Fetal Transducer Systems. Intended Use The Philips Avalon FM20 (M2702A), FM30 (M2703A), FM40 (M2704A), and FM50 (M2705A) fetal/

maternal monitors are intended for:

noninvasive monitoring of fetal heart rates and movements. noninvasive monitoring of maternal heart rates, maternal pulse rates, uterine activity, maternal noninvasive blood pressure, maternal oxygen saturation, and maternal temperature. invasive monitoring of direct fetal heart rate, intrauterine pressure, and for displaying and recording of fetal and maternal electrocardiogram (ECG) (FM30 and FM50 only). displaying, storing, and recording patient data and parameter values, and for generating alarms from fetal and maternal parameters. transmitting patient data and parameter values to a patient information and surveillance system. use by trained healthcare professionals. use in antepartum testing areas, in labor and delivery rooms, and during postpartum recovery in the hospital environment. They are not intended for use in intensive care units or operating rooms. monitoring in a bath or shower (Avalon CL cableless transducers Toco+ MP, Ultrasound, and ECG/

IUP only). transport situations in healthcare facilities, for healthcare facilities outside hospitals, such as doctors offices, and for use in private households (FM20 and FM30 only). WARNING Check the mother's pulse periodically during monitoring and compare this with the FHR signal. Beware of mistaking a doubled maternal heart rate for FHR. Always confirm fetal life before using the monitor. If a fetus is dead, there is a risk that the maternal heart rate is monitored and misinterpreted as the fetal heart rate. The simultaneous monitoring of maternal heart rate (preferably, the maternal ECG) and the fetal rate is encouraged. Whenever possible make use of the cross-channel verification (CCV) feature. See Cross-Channel Verification (CCV) on page 163 13 1 Introduction WARNING The fetal/maternal monitors are not intended for:

use during defibrillation, electro-surgery, or magnetic resonance imaging (MRI). Electrocardiography (ECG) measurements on patients connected to electrical stimulator or with cardiac pacemakers. use of the invasive measurements IUP and fetal DECG, use of the patient module (M2738A) and use of the Avalon CL system in domestic establishments, and those connected directly to the public low-

voltage supply network that supplies buildings used for domestic purposes. measuring the maternal temperature using the tympanic thermometer (866149) in private households. WARNING No modification of the fetal monitors, transducers, and the Avalon CL base station is allowed. CAUTION U.S. federal law restricts this device to sale by, or on the order of, a physician. All users must read the Instructions for Use before working with the fetal monitor. Disregarding the contents of the Instructions for Use is considered abnormal use. Indications for Use Avalon Fetal/Maternal Monitor FM20 Indicated for use by trained health care professionals whenever there is a need for monitoring the physiological parameters uterine activity, heart rate, oxygen saturation, noninvasive blood pressure, pulse rate, and temperature of pregnant women, and the fetal heart rates of single fetuses, twins, and triplets in labor and delivery rooms, in antepartum testing areas, in private households and during transports in healthcare facilities. Avalon Fetal/Maternal Monitor FM30 Indicated for use by trained health care professionals whenever there is a need for monitoring the physiological parameters uterine activity, heart rate, electrocardiography (ECG), oxygen saturation, noninvasive blood pressure, and pulse rate, and temperature of pregnant women, and the fetal heart rates of single fetuses, twins, and triplets in labor and delivery rooms, in antepartum testing areas, in private households and during transports in healthcare facilities. Avalon Fetal/Maternal Monitor FM40 Indicated for use by trained health care professionals whenever there is a need for monitoring the physiological parameters uterine activity, heart rate, oxygen saturation, noninvasive blood pressure, and pulse rate, and temperature of pregnant women, and the fetal heart rates of single fetuses, twins, and triplets in labor and delivery rooms and in antepartum testing areas. Avalon Fetal/Maternal Monitor FM50 Indicated for use by trained health care professionals whenever there is a need for monitoring the physiological parameters uterine activity, heart rate, electrocardiography (ECG), oxygen saturation, noninvasive blood pressure, and pulse rate, and temperature of pregnant women, and the fetal heart rates of single fetuses, twins, and triplets in labor and delivery rooms and in antepartum testing areas. 14 1 Introduction Contraindications A contraindication describes a situation, such as patient population, medical reason, or clinical condition, in which a device may not be used because the risk of use clearly outweighs any possible benefit. The fetal/maternal monitors are not intended for electrocardiography (ECG) measurements on patients connected to electrical stimulator or with cardiac pacemakers. Do not use the Avalon CL Wide Range Pod with patients for whom a momentary loss of vital sign monitoring is not acceptable. Do not use the CL Fetal & Maternal Pod and electrode patch for monitoring if the patient carries multiple fetuses. The Non-Stress Test Report (NST Report) functionality is not intended for intrapartum use. IUP Catheter: Do not catheterize if placenta previa is diagnosed, or if uterine bleeding from an undetermined source is present. Safety Information In this guide:

A warning alerts you to a potential serious outcome, adverse event or safety hazard. Failure to observe a warning may result in death or serious injury to the user or patient. A caution alerts you to where special care is necessary for the safe and effective use of the product. Failure to observe a caution may result in minor or moderate personal injury or damage to the product or other property, and possibly in a remote risk of more serious injury. A contraindication describes a situation, such as patient population, medical reason, or clinical condition, in which a device may not be used because the risk of use clearly outweighs any possible benefit. Electrical Hazards WARNING Electrical shock hazard: Do not open the monitor housing. Refer all servicing to qualified service personnel. Always use the supplied power cord with the earthed mains plug to connect to an earthed AC mains socket. Never adapt the mains plug from the fetal monitor to fit an unearthed AC mains socket. Do not use AC mains extension cords or multiple portable socket-outlets. FM20/FM30 only: The protective earth conductor is required for EMC purposes. It has no protective function against electric shock. Double and/or reinforced insulation protects this device against electric shock. Do not connect any devices that are not supported as part of a system. Any non-medical device placed and operated in the patients vicinity must be powered with an approved isolation transformer that ensures mechanical fixing of the power cords, and covering of any unused power outlets. 15 1 Introduction The fetal/maternal monitor is NOT intended for use during defibrillation, electro-surgery, or MRI. Remove all transducers, sensors, and accessories before performing electro-surgery, defibrillation, or MRI, otherwise harm to the patient or the user can result. Do not touch the charging contacts for the cableless transducers at the Avalon CL base station while you are touching the patient. Leakage currents: If several items of equipment used to monitor a patient are interconnected, the resulting leakage current may exceed allowable limits. Radio Frequency Interference WARNING Short range radio connections are subject to interruption due to interference from other radio sources in the vicinity, including microwaves, bluetooth devices, WLAN devices (802.11b,g,n), and cordless phones. Depending on the strength and duration of the interference, the interruption may occur for an extended period. A loss of connection, due to moving out-of-range, interference, or for other reasons, is indicated with a No Host Monitoring INOP (here the host is the fetal monitor) on the IntelliVue CL NBP or CL SpO2 Pods, or a No Host Monitoring, or cl NBP Disconnect, or cl SpO Disconnect INOP at the fetal monitor. Correct channel configuration is important, refer to the Service Guides and the Configuration Guide for details. To avoid magnetic interference affecting the mode of the pacemaker, ensure that the Avalon CL base station does not come into close contact with implanted pacemakers. This equipment generates, uses, and radiates radio-frequency energy, and if it is not installed and used in accordance with its accompanying documentation, may cause interference to radio communications. Operation of this equipment in a residential area may cause interference, in which case the users must take whatever measures may be required to correct the interference. Do not use cordless/mobile phones or any other portable RF communication system within the patient vicinity, or within a 1.0 m radius of any part of the fetal monitoring system. For paced patients: The radiated SRR power of the CL SpO2, CL NBP Pods, CL F&M Pod, and the CL Wide Range Pod, and other sources of radio-frequency energy, when used in very close proximity of a pacemaker, might be sufficient to interfere with pacemaker performance. Due to shielding effects of the body, internal pacemakers are somewhat less vulnerable than external pacemakers. However, caution should be exercised when monitoring paced patients. In order to minimize the possibility of interference, avoid positioning and wearing the Cableless Measurement Devices in very close proximity to a pacemaker. Consult the pacemaker manufacturer for information on the RF susceptibility of their products. 16 1 Introduction WARNING The Avalon CL Wide Range Pod uses a WLAN connection to extend the operating range of CL transducers and CL Pods. The Avalon CL Wide Range Pod sends real-time patient data to the fetal monitor. The fetal monitor displays real-time patient data, provides alarms, data storage, and clinical decision support applications. The data is also transmitted to a connected obstetrical surveillance system. Using a WLAN connection may lead to network drop-outs resulting in the data loss of monitored vital signs. Do not use the Avalon CL Wide Range Pod with patients for whom a momentary loss of vital sign monitoring is not acceptable. In case of frequent or prolonged network drop-outs (indicated by Disconnect INOPs at the fetal monitor and at the CL transducers or CL Pods):

revert to the use of CL devices without the CL Wide Range Pod, restrict the patient to a reduced range around the Avalon CL base station, and inform your service personnel. Use Environment WARNING Explosion Hazard:

Do not use in the presence of flammable anesthetics, such as a flammable anesthetic mixture with air, oxygen, nitrous oxide, or in oxygen rich environment. Use of the devices in such an environment may present an explosion hazard. Use only Philips batteries part number M4605A with the FM20 or FM30 with battery option. Use of a different battery may present a risk of fire or explosion. Environmental Specifications:

The performance specifications for the monitors, measurements, and accessories apply only for use within the temperature, humidity, and altitude ranges specified in Environmental Specifications on page 287. Liquid Ingress:

Do not operate the monitor if it is wet. If you spill liquid on the monitor, contact your service personnel, or Philips service engineer. Never immerse the fetal monitor or the CL base station in liquid. You must protect them against water sprays or splashes. Place the fetal monitor and the CL base station where there is no chance of contact with, or falling into water or other liquids. Do not perform underwater monitoring (for example, in a bath or shower) using wired transducers. The CL Fetal & Maternal Pod is not intended for underwater monitoring. The contacts between the CL Fetal & Maternal Pod and the electrode patch have to be kept dry at all times. The CL Fetal &

Maternal Pod mounted on the electrode patch, can be worn underneath a shower, as long as the CL Fetal & Maternal Pod stays mounted. Radio transmissions in the shower may be compromised. Heat Exposure:

Do not dry equipment using heating devices such as heaters, ovens (including microwave ovens), hair dryers, and heating lamps. Do not put equipment or accessories in autoclave (for sterilization). Positioning Equipment:

The device should not be used adjacent to, or stacked with, other equipment unless otherwise specified. 17 1 Introduction Prohibited Environments:

The monitors and their transducers, Pods, and accessories are not intended for use in an MRI environment or in an oxygen-enriched environment (for example, hyperbaric chambers).

,Alarms WARNING Do not rely exclusively on the audible alarm system for fetal monitoring. Adjustment of alarm volume to a low level or off during monitoring may result in a dangerous situation. Remember that the most reliable method of fetal monitoring combines close personal surveillance with correct operation of monitoring equipment. Alarm systems of the monitor and those of any connected obstetrical information and surveillance system are interdependent and not synchronized. Therefore audible alarms should not be relied upon for remote monitoring. In INOP only mode, no fetal/maternal patient alarms are enabled or indicated. Accessories WARNING Philips' approval: Use only Philips-approved accessories. Using non-Philips-approved accessories may compromise device functionality and system performance, and cause a potential hazard. Reuse: Never reuse disposable transducers, sensors, accessories, and so forth, that are intended for single use, or single patient use only. Reuse may compromise device functionality and system performance, and cause a potential hazard. Electromagnetic compatibility: The use of accessories, transducers, and cables other than those specified may result in increased electromagnetic emissions or decreased electromagnetic immunity of the device. Damage: Do not use a damaged sensor or one with exposed electrical contacts. Cables and tubing: When connecting devices for acquiring measurements, always position cables and NBP tubing carefully to avoid entanglement or potential strangulation. 18 Security Information Protecting Personal Information 1 Introduction Protecting personal health information is a primary component of a security strategy. Each facility using the monitors must provide the protective means necessary to safeguard personal information consistent with country laws and regulations, and consistent with the facilitys policies for managing this information. Protection can only be realized if you implement a comprehensive, multi-layered strategy (including policies, processes, and technologies) to protect information and systems from external and internal threats. As per its intended use, the patient monitor operates in the patient vicinity and contains personal and sensitive patient data. This also includes the trace print-outs at the monitor. The monitor also includes controls to allow you to adapt the monitor to the patient's care model. To ensure the patient's safety and protect their personal health information, you need a security concept that includes:

Physical security access measures - access to the monitor must be limited to authorized users. It is essential that you consider physical security measures to ensure that unauthorized users cannot gain access. Operational security measures - for example, ensuring that patients are discharged after monitoring in order to remove their data from the monitor. Procedural security measures - for example, assigning only staff with a specific role the right to use the monitors. In addition, any security concept must consider the requirements of local country laws and regulations. Always consider data security aspects of the network topology and configuration when connecting patient monitors to shared networks. Your medical facility is responsible for the security of the network, where sensitive patient data from the monitor may be transferred. When a monitor is returned for repair, disposed of, or removed from your medical facility for other reasons, always ensure that all patient data is removed from the monitor by ending monitoring for the last patient

(see Discharging a Patient on page 146). Also select Erase All in the Stored Data Recording menu, to erase all stored data. NOTE Log files generated by the monitors and measurement modules are used for system troubleshooting and do not contain protected health data. About HIPAA Rules If applicable, your facilitys security strategy should include the standards set forth in the Health Insurance Portability and Accountability Act of 1996 (HIPAA), introduced by the United States Department of Health and Human Services. You should consider both the security and the privacy rules and the HITECH Act when designing policies and procedures. For more information, please visit:

http://www.hhs.gov/ocr/privacy/

About the EU Directives If applicable, your facilitys security strategy should include the practices set forth in the Directive on the protection of individuals with regard to the processing of personal data and on the free movement of such data (Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016). In addition, your facility should also take into account any additional, more stringent standards put forward by any individual EU countries; that is, Germany, France, and so on. 19 1 Introduction Philips Product Security Policy Statement Additional security and privacy information can be found on the Philips product security web site at:

http://www.usa.philips.com/healthcare/about/customer-support/product-security Manufacturer Disclosure Statement for Medical Device Security MDS2 You can view the Manufacturer Disclosure Statements for Medical Device Security (MDS2) for specific devices at:

http://www.usa.philips.com/healthcare/about/customer-support/product-security Cyber Security Requirements and Controls The Avalon fetal monitors cannot be connected to portable media such as USB drives or CDs. Cyber security threats therefore result mainly from network connectivity and may impact safe and secure operation of your network or any devices attached to this network. As part of your security concept, you are responsible for establishing controls to protect your network and any networked devices, including the Avalon fetal monitors, against such cyber security threats. Network Cyber Security Measures Only connect the Avalon fetal monitors to networks that are explicitly intended for that purpose. The fetal monitor is intended to be used for monitoring of, and to generate alarms for, multiple physiological signals of patients. If you connect the fetal monitor to a network, it is therefore highly recommended that you deploy measures for protecting the network against cyber security threats. This includes the deployment of firewalls to limit remote access and antivirus protection of standard computer systems. Network Security Requirements for Connectivity to Philips Systems You must follow the network configuration instructions of the specific Philips system product. The IntelliVue Network Specification provides detailed network configuration requirements associated with the safe and secure operation of Avalon devices within your hospital network for the purpose of patient monitoring. The IntelliVue Network Specification ensures the configuration and operation of a logical isolated network (LAN or VLAN) for Avalon devices by the configuration of network infrastructure devices (switches, routers, etc.). The document also defines the interconnection of the isolated network with other hospital networks using firewalls as well as the use of antivirus software for computer platforms based on standard operating systems. Compliance to the IntelliVue Network Specifications is verified by Philips in cooperation with the customer prior to go-live. Network Security Requirements for Connectivity to other Systems To ensure safe and secure operation of networked data collection applications involving Avalon fetal monitors, you must implement network traffic isolation by using dedicated physical or logical networks

(isolated VLANs). Network traffic separation can be achieved by configuration of network infrastructure devices (switches, routers and firewalls) as outlined in the IntelliVue Network Specification. Only devices required by the specific system application should share this dedicated network. To prevent malware from affecting network performance or device operation, always ensure that all networked devices with standard operating systems have virus protection installed and kept up to date. For managing risks in clinical network deployments, Philips recommends that you apply a formal process such as the IEC 80001 series of standards to address safety, effectiveness, and data and system security. 20 1 Introduction Security Software Updates All software for the Avalon fetal monitors is completely built and integrated by Philips. There are no separate user-updatable software components from other manufacturers. Philips authorized software updates for the Avalon fetal monitors, including any potential cyber security updates, are communicated via the Field Change Order Process which is a component of the Philips Quality System. Field Change Orders are published and available on InCenter at:

http://incenter.medical.philips.com/. The procedure on how to install software updates is described within this Field Change Order. If you have questions about InCenter access, please contact your local sales representative or service personnel. Overview of System Components New Generation Avalon Transducers The new generation of Avalon transducers has the same functionality and usability aspects as the previous Avalon transducers, but they have the look and feel of the cableless transducers. Availability of the new generation Avalon transducers for all countries and territories depends on the local Regulatory market clearance. The Avalon CL system consists of the Avalon CL base station, the Avalon CL transducers, the Avalon CL Fetal & Maternal Pod, the CL Wide Range Pod, and the IntelliVue CL Pods. The IntelliVue CL Pods are only used for maternal measurements within the Avalon CL solution. The following tables provide an overview of all the devices. Wired Monitoring Avalon monitors FM20/FM30 FM40/FM50 M2702A and M2703A M2704A and M2705A 21 1 Introduction Wired transducers US transducer Toco+ MP transducer 867246 ECG/IUP transducer 867245 Toco+ transducer 867247 Toco MP transducer 867249 Cableless Monitoring 867248 Avalon monitors FM20/FM30 FM40/FM50 Avalon CL base station base station M2702A and M2703A M2704A and M2705A 22 866074 Cableless transducers CL US transducer CL Toco+ MP transducer 1 Introduction 866076 CL ECG/IUP transducer 866075 Avalon CL Pods CL Fetal & Maternal Pod CL Wide Range Pod 866077 866488 IntelliVue CL NBP Pod IntelliVue CL SpO2 Pod 866487 865216 865215 23 1 Introduction Previous Generation Transducers The previous generation of transducers has been discontinued in some countries and these transducers do no longer carry the CE mark. However, they are still supported and compatible with the fetal monitors. Wired Transducers Avalon Toco Transducer Avalon Toco MP Transducer for Toco and Maternal Pulse Avalon Toco+ Transducer for Toco, DECG, MECG or IUP monitoring Part Number M2734A M2734B M2735A Avalon US Transducer M2736A/M2736AA ECG/IUP Patient Module (for DECG, MECG or IUP) M2738A 24 2 2What's New This section lists the most important new features and improvements to the fetal monitors and their user interface introduced with Release L.3 and J.3. You may not have all of these features, depending on the fetal monitor configuration purchased. What's New in Release L.3 Avalon CL Fetal & Maternal Pod The Avalon CL Fetal & Maternal Pod is an extension of the Avalon CL solution. The Avalon CL Fetal & Maternal Pod is used together with a single use patch with five abdominal electrodes. Prior to use, the Avalon CL Fetal & Maternal Pod is charged and assigned at the Avalon CL base station. The Avalon CL Fetal & Maternal Pod is used for women who are at >36 completed weeks, in labor, with singleton pregnancies, using surface electrodes on the maternal abdomen. This solution provides especially benefits to patients with high body mass index (BMI), although it can be used for all patients. The Avalon CL Fetal & Maternal Pod includes the following features:

The Avalon CL Fetal & Maternal Pod measures fetal heart rate (aFHR), maternal heart rate (aHR), and uterine activity (aToco) from electrical signals. The cl F&M Electrode Status window at the monitor gives an overview of the current electrode contact status, when the CL Fetal & Maternal Pod is placed on the electrode patch and the electrodes are applied to the patient's abdominal skin. The window can be opened by selecting the new SmartKey cl F&M Status, or selecting the corresponding function in the main setup menu. The Avalon CL Fetal & Maternal Pod and the CL Wide Range Pod are assigned at the CL base station in the same easy way as the IntelliVue CL Pods. The functions Find and Call Patient also work with the Avalon CL Fetal & Maternal Pod, CL Wide Range Pod, the CL NBP Pod, and the CL SpO2 Pod. See Avalon CL Fetal & Maternal Pod on page 25, CL Fetal & Maternal Patch on page 88, Applying the CL Fetal & Maternal Patch and Pod on page 97, and CL Pod Assignment on page 95. NOTE The Avalon CL Fetal & Maternal Pod and Patch are not available for U.S., other FDA regulated territories, and Canada. Avalon CL Wide Range Pod The Avalon CL Wide Range Pod is an extension of the Avalon CL solution. The Avalon CL Wide Range Pod extends the signal range of the cableless measurements. It transmits the cableless measurement signals via the hospital WLAN/WiFi to the fetal monitors. Wearing the CL Wide Range Pod, the patient can walk freely within the hospital's WLAN/WiFi range during monitoring. Prior to use, the Avalon CL Wide Range Pod is charged and assigned at the Avalon CL base station. A new WLAN symbol is printed on the trace to indicate the use of an assigned and active Avalon CL Wide Range Pod. 25 2 What's New During monitoring with an active Avalon CL Wide Range Pod, the sound from the fetal heart rate is replaced by an artificial QRS sound (when the patient is monitored with a CL US transducer or CL F&M Pod). See CL Wide Range Pod on page 88. New Generation Avalon Transducers The new generation of Avalon transducers has the same functionality and usability aspects as the previous Avalon transducers, but they have the look and feel of the cableless transducers. Availability of the new generation Avalon transducers for all countries and territories depends on the local Regulatory market clearance. Toco + MP Transducer (867245) The new wired Toco+ MP transducer requires the Avalon Fetal Monitor software L.3x.xx. NST Trace Interpretation according to Dawes/Redman The NST trace interpretation according to Dawes/Redman is a method to assist the assessment of the fetal well-being. The algorithm based on the Dawes/Redman criteria for normality uses the parameters fetal heart rate, gestational age, fetal movement, accelerations and decelerations, and long term variability and short term variability to generate a report. Not available for U.S. and FDA regulated territories. Support of XDS Remote Display The fetal monitor software supports the IntelliVue XDS Remote Display functionality only in combination with IntelliSpace Perinatal revision K or higher. From IntelliSpace Perinatal, you can access all screen-

operable functions of the LAN connected fetal monitor. These functions include for example, starting and stopping physiological measurements, changing measurement modes, changing alarm limits, and silencing alarms. New Alarm Behavior of CL Battery Empty INOP The CL <xxx> Battery Empty INOP issued by the CL devices and the fetal monitor has a new alarm behavior:

At the fetal monitor, it is issued now with a cyan INOP alarm and tone. At CL devices (CL transducers and CL Pods), it is issued now with a tone corresponding to a yellow alarm. See Patient Alarms and INOPs on page 127. New Alarm Mode Default The new default configuration for the Alarm Mode is All. See the Avalon Fetal Monitor Configuration Guide for information on how to change the Alarm Mode setting. Using CL Pods with FM20/30 #E25 The CL Pods can now also be used with a battery operated FM20 or FM30 (option #E25). All CL Pods can be assigned and activated. The CL F&M Pod can also be charged. See Using Batteries on page 108. Entering Notes - Type a Note In the menu Enter Note, it is now possible to enter a note manually, instead of selecting one of the pre-configured notes. To enter a note, select the new menu item Type a note. A window with a touch keypad opens. The typed note can be up to 30 characters long. See Typing Notes on page 70. 26 2 What's New What's New in Release J.3 Avalon CL Transducer System The Avalon CL Transducer System provides cableless monitoring with the Avalon FM20/FM30 and FM40/FM50 with the same functionality and performance as the wired measurement devices (e.g. twin and triplets monitoring). The Avalon CL Transducer System has a straight-forward handling and operating concept. The CL transducers are assigned by simply docking them at the CL base station, no further configuration is necessary. The Avalon CL Transducer System includes the following features:

Cableless monitoring of twins and triplets (see Monitoring Twin FHRs on page 185 and Monitoring Triple FHRs on page 191) Cableless maternal measurement Pods CL SpO2 and CL NBP (see IntelliVue CL Pods on page 89) Maternal pulse from a CL Toco+ MP (Smart Pulse) transducer (see Monitoring Maternal Heart /

Pulse Rate on page 219) A cableless ECG/IUP transducer measuring IUP or fetal/maternal ECG (see Monitoring MECG Wave on page 222 and Monitoring FHR Using DECG on page 199) Watertight cableless transducers that can be used to monitor in water (see Underwater Monitoring on page 105) Patient call that pages an ambulating mother with an audible signal emitted by the worn CL transducers

(see Calling Patients on page 96) Out-of-range audible signal emitted by the worn CL transducers to inform an ambulating mother that she has reached the limit of the active signal area-of-reach (see Standard Radio Range of CL Transducers on page 84) A transducer finder LED on all CL transducers to help identify the assigned transducer (see Cableless Transducer LED Indication on page 82) Support For Use of Maternal Cableless Measurement Devices The IntelliVue CL measurement Pods are patient-worn, battery-powered measurement devices for SpO2 and NBP. The devices provide measurement values on the built-in display and communicate them to the fetal monitor using the wireless short range radio (SRR) interface of the Avalon CL base station (see IntelliVue CL Pods on page 89). Maternal Temperature Measurement To measure maternal temperature, the new optional tympanic thermometer (866149) is available for the Avalon fetal monitors (see Monitoring Maternal Temperature on page 245). The measurement data is:

documented and printed out at the local recorder, and transmitted to the obstetrical information and surveillance system. displayed as a numeric on the screen. Manually Entered Maternal Temperature Measurements Manually measured temperatures can be entered at the fetal monitor. They are displayed as a numeric on screen, and are printed out on the recorder trace (see Monitoring Maternal Temperature on page 245). SpO2 Recordings and Transmissions SpO2 annotation on local recorder You can now configure the interval for printing the SpO2 numeric values on the recorder trace. With the new configuration setting Record on Trace, you can set the interval to 1 or 5 minutes. 27 2 What's New SpO2 transmission to an obstetrical information and surveillance system You can now configure the interval for transmitting the SpO2 numeric values to an obstetrical information and surveillance system. With the new configuration setting Send to OB Sys, you can set the interval to 1 or 5 minutes. New Design for the User Interface The user interface for the fetal monitors has been redesigned to bring the presented information into the foreground, letting the structural elements such as keys and frames retreat into the background. Additionally special regard was given to making the look and feel similar to that of standard software products (see Operating and Navigating on page 39). New SmartKeys The Start ECG SmartKey and menu item is renamed to Record ECG. With the Call Patient SmartKey, you can now page patients who are ambulating wearing Avalon CL transducers. With the Tele Info SmartKey, you can call up the Tele Info window on the fetal monitor display. In the Tele Info window, you can control and view the status of the cableless transducers from the connected Avalon CL base station. With the Enter Temp SmartKey, a pop-up window opens showing a numeric pad for entering manually measured maternal temperature values. With the NBP Modes SmartKey, you can access the NBP Mode selection and setup, and can directly start and stop a measurement. With the QuickAdmit SmartKey, you can quick admit a patient to the monitor. All new SmartKeys are optional, and have to be configured in Configuration Mode for use (see SmartKeys on page 42). Coincidence INOP Tone When the cross-channel verification detects that the signal of the maternal heart rate coincides with the fetal heart rate, the Coincidence INOP is now issued with a tone at the fetal monitor. The Coincidence INOP tone has a configurable delay (see Cross-Channel Verification (CCV) on page 163). Increased Internal Back-up Memory The internal back-up memory is now able to store traces and data from at least the last 3.5 hours with the software revision J.3, and minimum 7 hours with the new mainboard hardware revision A 00.18 (see Manually Recording Stored Data on page 254 and Recovering Data on page 253). Dual System Interface Support If the fetal monitor is connected via a LAN connection to OB TraceVue/IntelliSpace Perinatal, the RS232 interface can be used independently to connect e.g. an EMR system on read-only basis. The system connected to the RS232 interface in this case cannot alter any data (such as ADT data, or the date and time setting), or interfere with functions of the monitor, but is able to read output data. The obstetrical information and surveillance system connected via LAN has priority. USB Interface An optional USB interface allows the use of bar code readers and input devices such as a keyboard, or mouse (see Getting to Know Your Avalon FM20/FM30/Bottom on page 35 and Getting to Know Your Avalon FM40/FM50/Rear on page 36). 28 2 What's New Flexible Nurse Call Interface An optional Flexible Nurse Call interface allows the connection of a nurse call device to the fetal monitors

(see Getting to Know Your Avalon FM20/FM30/Bottom on page 35 and Getting to Know Your Avalon FM40/FM50/Rear on page 36). DHCP Support The DHCP support offers an alternative to BOOTP. DHCP (Dynamic Host Configuration Protocol) enables the fetal monitors to request an IP address (internet protocol address) from the connected network

(OB TraceVue/IntelliSpace Perinatal) automatically. Data Export Support You can now export measurement values from the monitor to other devices via the LAN interface, or with the optional MIB RS232 interface (see Getting to Know Your Avalon FM20/FM30/Bottom on page 35 and Getting to Know Your Avalon FM40/FM50/Rear on page 36). Compatibility with third-

party obstetrical information and surveillance systems has not been verified. Users should ensure that all required functionality is verified with any third-party system prior to clinical use. NBP Configurable Measurement Sequence Up to four measurement cycles can be set up which will run consecutively. For each cycle, you can set the number of measurements and the interval between them. By setting the last cycle to run continuously, you can have regular measurements continue after the sequence has run (see Enabling Sequence Mode and Setting Up the Sequence on page 235). Alarms Enhancements In addition to the standard cyan INOPs, some INOPs can now be configured as red or yellow INOPs to provide a severity indication (ECG Leads Off, Cuff Overpress, Cuff NotDeflated, Battery Empty, No Pulse)

(see Alarms on page 115). Alarm Reminder In Configuration Mode, you can set now an Alarm Reminder. The Alarm Reminder emits an audible reminder of alarm conditions that remain active after the alarm is acknowledged. This reminder may take the form of a repetition of the alarm tone for a limited time, or an unlimited repetition of the alarm tone

(this is the same as a new alarm). The interval between silencing the alarm and sounding the reminder tone can be set to one, two, or three minutes (see Alarm Reminder on page 119). Auto Free In Configuration Mode, you can now set an Auto Free setting which discharges a patient automatically when the fetal monitor has been powered off, or is in Standby mode for a set time. Only the demographic patient data is deleted, the trace data is not affected. 29 2 What's New 30 3 3Basic Operation This chapter gives you an overview of the monitor and its functions. It tells you how to perform tasks that are common to all measurements (such as entering data, switching on a measurement, changing some monitor settings, and setting up the recorder). The alarms section gives an overview of alarms. The remaining sections tell you how to perform individual measurements, and how to care for and maintain the equipment. Supported Measurements Different measurements for the same physiological parameter may have a different appearance on the trace, due to: variability (HR), averaging, delay, amplitude, or artifacts. Before interpreting the trace, regard the fetal monitor setup and transducers used. The following Fetal measurements are supported:

Measurements Fetal Heart Rate (FHR) via US

(including Twins) Triple FHR via US FM20 Standard Optional dFHR via Direct ECG (DECG)

aFHR via CL F&M Pod Toco aToco via CL F&M Pod Optional Standard Optional Intrauterine Pressure (IUP)

FM30 Standard Optional Standard Optional Standard Optional Standard FM40 Standard Optional

Optional Standard Optional

FM50 Standard Optional Standard Optional Standard Optional Standard 31 3 Basic Operation The following Maternal measurements are supported:

Measurements Maternal Heart Rate (HR) via Maternal ECG Electrodes FM20 Standard Maternal ECG (MECG wave)

Optional Standard Optional aHR via CL F&M Pod Maternal Pulse from Toco Noninvasive Blood Pressure with Pulse Rate Pulse Oximetry (Maternal SpO2) with Pulse Rate Maternal Temperature FM30 Standard Standard Optional Standard Optional FM40 Standard

Optional Standard Optional FM50 Standard Standard Optional Standard Optional Optional Optional Optional Optional Optional Optional Optional Optional Avalon FM20 and FM30 This section outlines the capabilities of your monitor. Avalon FM20 The Avalon FM20 fetal/maternal monitor provides a solution for external fetal monitoring applications, and optional noninvasive maternal vital signs. You can monitor fetal heart rates (FHRs) externally using ultrasound, uterine activity and maternal pulse using an external Toco transducer, and the maternal heart rate (HR) with maternal ECG electrodes, and optionally, noninvasive blood pressure and maternal oxygen saturation (SpO2). Measurements are displayed on a 6.5 inch color display as numerics. The display is a touchscreen, and you operate the monitor using this touchscreen interface. The integrated recorder documents fetal and maternal measurements as well as the user-defined annotations. You can connect the monitor to an OB TraceVue/IntelliSpace Perinatal system via the RS232 connection, or over a LAN connection (with OB TraceVue Revision E.00.00 and later, or IntelliSpace Perinatal Revision H.0 and later). 32 3 Basic Operation Avalon FM30 The Avalon FM30 fetal/maternal monitor offers a solution for both external and internal fetal monitoring applications, and optional noninvasive maternal vital signs. The Avalon FM30 shares all the features and capabilities of the Avalon FM20. In addition, you can monitor one FHR internally with a direct fetal electrocardiogram (DECG), uterine activity internally using an intrauterine pressure (IUP) catheter together with a Toco+ transducer or patient module. The Avalon FM30 carries the IP label, indicating that it is capable of intrapartum monitoring. FM20/30 with Battery Option #E25 Only The battery option for the FM20/30 provides support for the in-transport monitoring of all measurements when disconnected from a power supply. Existing data storage is automatically uploaded to OB TraceVue or IntelliSpace Perinatal after reconnecting it to the system. Trace printing during transport is also possible. Avalon FM40 and FM50 This section outlines the capabilities of your monitor. Avalon FM40 The Avalon FM40 fetal/maternal monitor provides a solution for external fetal monitoring applications, and noninvasive maternal vital signs. You can monitor fetal heart rates (FHRs) externally using ultrasound, uterine activity using an external Toco transducer, and the maternal heart rate (HR) via maternal ECG electrodes, and noninvasive blood pressure and maternal oxygen saturation (SpO2). Measurements are displayed on a 6.5 inch color display as numerics. The display is a touchscreen, and you operate the monitor using this touchscreen interface. The integrated recorder documents fetal and maternal measurements as well as the user-defined annotations. You can connect the monitor to an OB TraceVue/IntelliSpace Perinatal system with the RS232 connection, or over a LAN connection (with OB TraceVue Revision E.00.00 and later, or IntelliSpace Perinatal Revision H.0 and later). 33 3 Basic Operation Avalon FM50 The Avalon FM50 fetal/maternal monitor offers a solution for both external and internal fetal monitoring applications, and noninvasive maternal vital signs. The Avalon FM50 shares all the features and capabilities of the Avalon FM40. In addition, you can monitor one FHR internally with a direct fetal electrocardiogram (DECG), and uterine activity internally using an intrauterine pressure (IUP) catheter together with a Toco+ transducer or patient module. The Avalon FM50 carries the IP label, indicating that it is capable of intrapartum monitoring. Getting to Know Your Avalon FM20/FM30 Overview 1 2 3 4 Touchscreen display (tilt and fold) Power LED Paper drawer Paper drawer release 5 Connectors 1 On/Off switch 2 Power connector 1 On/Standby button with power LED 2 MSL connector for external power supply Right Side with Battery Option 34 Left Side 3 Basic Operation 1 SpO2 socket (optional) 2 Noninvasive Blood Pressure socket

(optional) 3 Fetal sensor sockets Each of the fetal sensor sockets accepts any fetal transducer, one Avalon CL or one Avalon CTS Cableless Fetal Transducer System base station, or an event marker. Bottom There are five optional interfaces available for the Avalon FM20/30 monitor:

LAN/RS232 system interface Dual PS/2 interface Dual MIB/RS232 interface Flexible Nurse Call interface USB ports interface You can use two of the five optional interfaces at the same time. 1 LAN/RS232 system interface 2 Dual PS/2 system interface Optional Interfaces Description Flexible nurse call interface card Quad. USB ports Dual MIB/RS232 35 3 Basic Operation Rear 1 Display release 2 Carrying handle 3 Built-in stand Getting to Know Your Avalon FM40/FM50 Front 1 2 3 4 Touchscreen color display Transparent paper guide with tear-off edge Paper eject button Power LED 5 On/Standby button 6 Recorder paper table 7 Fetal sensor sockets 8 Noninvasive blood pressure socket

(optional) 9 SpO2 socket (optional) Connect any fetal sensor or patient module at the fetal sensor sockets, including an Avalon CL or an Avalon CTS via interface cable (with red connector). 36 Rear 3 Basic Operation 1 Reserved for future use: protective earth intended for use in system installations 2 Equipotential grounding point 3 4 5 Power cord connector Loudspeaker Slot 01 for optional LAN/RS232 system interface (for connection to an obstetrical information and surveillance system) 6 Slot 03 reserved for future use 7 Video output (VGA) 8 9 Telemetry interface Slot 02 for optional interfaces: Either dual PS/2 system interface (A) for mouse and keyboard connection Or MIB interface (B) for external touchscreen connection, or the optional interfaces for the flexible nurse call or USB ports Two Avalon CL base stations, or one Avalon CTS can be also connected to the Telemetry interface sockets using the interface cable (with black connector). Additional Optional Interfaces Optional Interfaces Description Flexible nurse call interface card Quad. USB ports Dual MIB/RS232 interface 37 3 Basic Operation Connecting the Monitor to AC Mains WARNING Always use the supplied power cord with the earthed mains plug to connect to an earthed AC mains socket. Never adapt the mains plug from the fetal monitor to fit an unearthed AC mains socket. Check that the line frequency is correctly configured in the Global Settings menu. FM20/FM30 only: The protective earth conductor is required for EMC purposes. It has no protective function against electric shock. Double and/or reinforced insulation protects this device against electric shock. Do not use AC mains extension cords or multiple portable socket-outlets. Always ensure that the monitor is positioned so that the AC mains plug is easily accessible, to allow disconnection of the monitor from the AC mains. Wired Transducers 1 2 Belt button Label of transducer type 3 Connector - for connecting ECG/IUP adapter cables for the Toco+ transducer (867249), Toco+ MP transducer

(867245), and the ECG/IUP transducer (867247) 4 Transducer finder LED - lights up to help identify the assigned transducer 5 Cable - connects to any of the four fetal sensor sockets on the monitor 38 3 Basic Operation Operating and Navigating Your monitor has a touchscreen. Everything you need to operate the monitor, except the on and off switch, is contained on its screen. Most screen elements are interactive. Screen elements include measurement numerics, screen keys, information fields, status indicators, alarms fields, and menus. It is possible to view and operate the screen of a LAN connected fetal monitor with the IntelliSpace Perinatal K.00.1x or higher using the IntelliVue XDS Solution. Operator Position The typical operator's position is in front of the monitor. FM40/50 If an optional external touch display is connected to the monitor, you can operate the monitor using the external touch display. 1 Monitor information line 2 Measurement area 3 Key area CAUTION The screen contains sensitive personal data. For information how to protect personal information, see Protecting Personal Information on page 19. 39 3 Basic Operation Screen Elements Monitor Information Line 1 LAN connection status indicator only. RS232 system connection is not indicated. The locomotive icon indicates if the fetal monitor is connected to OB TraceVue/IntelliSpace Perinatal, via a LAN cable or not. 2 Patient identification 3 Date and time 4 5 Bed label (when connected to a Philips OB TraceVue/IntelliSpace Perinatal system) Fetal heart sound volume adjust/indicator 6 Alarm volume adjust/indicator 7 INOP and alarm status area - shows active alarm messages Measurement Area 1 Antenna symbol (indicates a cableless measurement from a connected Avalon CL or Avalon CTS system) 2 Configurable alarm limits 3 NST test 4 Audio source symbol 5 Measurement numeric 6 Alarms off symbol 7 Fetal trace recorder - status indicator 8 Avalon CL or Avalon CTS system - status indicator 9 Battery status indicator 40 3 Basic Operation 10 Status line - shows status and prompt messages 11 Signal quality indicator: good, acceptable, poor 12 Fetal heart rate measurement label 13 Measurement unit (configurable) 14 Coincidence symbol (see Cross-Channel Verification (CCV) on page 163) 15 NST timer, if configured (default is Off) Screen Details Icon Description The antenna symbol indicates a cableless measurement (Avalon CL or Avalon CTS). Indicates a short range radio measurement (CL Pods). Signal quality indicator:

1 Good 2 Acceptable 3 Poor Fetal trace recorder - status indicator Fetal recorder is on Fetal recorder is off (when Paper Save Mode is off) Fetal recorder is off (when Paper Save Mode is on) There is a user-solvable recorder error (paper out, paper jam, wrong paper scale set) Fetal recorder is defective: call service When an Avalon CL or Avalon CTS system is connected to the monitor, a CL symbol is shown. It changes with the states of the connected cableless device see Cableless Status Indication on page 91. 41 3 Basic Operation Key Area 1 SmartKeys - these can vary according to your monitor's configuration 2 Main Screen - closes all open menus and windows and returns to main screen 3 Scroll to display more SmartKeys 4 Silence - acknowledges all active alarms by switching off audible alarm indicators Keys The monitor has three different types of keys. Permanent Keys A permanent key is a graphical key that remains permanently on the screen, giving you fast access to functions. Key Name Silence Main Screen Function Acknowledges all active alarms by switching off audible alarm indicators. Closes all open menus and windows and returns to the main screen. SmartKeys SmartKeys are configurable graphical keys, located at the bottom of the main screen. They give you fast access to functions. The selection of SmartKeys available on your monitor depends on your monitor configuration, and on the options purchased. SmartKey Name Function FRStart/Stop Turns the trace recorder on or off Start Rec Stop Rec Turns the trace recorder on Turns the trace recorder off Paper Advance Advances the paper automatically to the next fold Set Marker Enter Notes Record ECG Stored Rec NST Report Marks an event Enters notes Starts printing the MECG, DECG, or both waves, when both are available Prints trace data from the monitor's memory Initiates an NST trace interpretation and obtains a Non-stress test (NST) report 42 3 Basic Operation SmartKey Name Function Sound Vol. Up Increases the fetal heart rate volume Sound Vol. Down Decreases the fetal heart rate volume Toco/IUP Bsl Tele Info Call Patient Resets Toco baseline Calls up the Tele Info window Pages the patient. Only enabled, if at least one CL transducer or CL Pod is active cl F&M Status Calls up the cl F&M Electrode Status window Pause Alarms Defaults Main Setup Strt/Stp NBP Start NBP Stop NBP Stop All NBP Repeat NBP NBP Modes Enter Temp Zero IUP Timer Standby Pauses alarm indicators. Pause duration depends on monitor configuration. If the pause duration is infinite, this key is labeled Alarms Off Select again to immediately re-enable alarm indicators Loads User Default Enters main setup menu Starts/stops manual noninvasive blood pressure measurement Starts auto series Stops current automatic measurement within series Starts manual noninvasive blood pressure measurement Starts auto series Stops manual noninvasive blood pressure measurement Stops current automatic measurement within series Stops all noninvasive blood pressure measurements Sets the time interval between two noninvasive blood pressure measurements Access NBP mode selection and setup, with direct start/stop function Allows the manual input of the patient's temperature Resets the display and trace to 0. If you do not zero the IUP measurement properly, the pressure trace may exceed the paper scaling. Enters NST timer window Switches to Standby screen, suspends monitoring. All numerics and waves disappear from the display. All settings and patient data information are retained Patient Demogr. Enters the patient identification menu to admit/discharge QuickAdmit Blank Key Quick admits the patient for monitoring Blank key, can be used as divider between a group of keys Pop-Up Keys Pop-up keys are context-sensitive graphical keys that appear automatically on the monitor screen when required. For example, the Confirm pop-up key appears when you need to confirm a change. 43 3 Basic Operation Using the Touchscreen Select screen elements by pressing them directly on the monitor's screen. Disabling Touchscreen Operation 1 2 To temporarily disable the touchscreen operation of the monitor, press and hold the Main Screen permanent key for about three seconds. A red padlock will blink on the Main Screen permanent key. Press and hold the Main Screen permanent key again for about three seconds to re-enable the touchscreen operation. Operating Modes When you switch on the monitor, it starts up in Monitoring Mode. To change to a different mode:

1 2 Select the Main Setup menu. Select Operating Modes and select a mode. Your monitor has four operating modes. Some are passcode protected. Mode Description Monitoring Mode Demo Mode Configuration Mode The Monitoring Mode is the normal operating mode to monitor patients. You can change elements such as alarm limits. When you discharge the patient, these elements return to their default values. You cannot select or change grayed out items. These items are for your information only. To change these items, switch to the Configuration Mode. The Demo Mode is used for demonstration and training purposes. Do not change into Demo Mode during monitoring. When transducers are connected to the monitor and the recorder is on, a demo trace is recorded. But the demo trace is not transmitted when the fetal monitor is connected via RS232 to an information and surveillance system such as OB TraceVue/IntelliSpace Perinatal. The Configuration Mode is for personnel trained in configuration tasks. You can change and store the default values and patient profiles permanently in the Configuration Mode. These tasks are described in the Configuration Guide. During installation, the fetal monitor is configured for use in your environment. This configuration defines the default settings you work with when you switch on the fetal monitor. Password Protected no yes yes yes Service Mode The Service Mode is for trained and authorized service personnel only. A field displayed at the fetal monitor screen indicates if the monitor is in Demonstration Mode, Configuration Mode, or Service Mode. To change to a different mode, select this field. 44 3 Basic Operation Automatic Screen Layouts Your monitor's preconfigured screen layouts define how measurement information is arranged on the screen. The monitor automatically applies the correct screen layout for the measurements you are monitoring. No user action is required. Connecting or disconnecting transducers, or activating or deactivating a cableless measurement, results in an automatic adjustment of the screen layout. When a measurement is off, its numerics are removed from the monitor's screen. The monitor stops acquiring data and generating alarms for this measurement. If you disconnect a transducer while it is performing a measurement, the monitor issues a disconnect INOP (and in the case of SpO2, replaces the measurement numeric with a question mark). Using the XDS Remote Display Using the IntelliVue XDS Solution it is possible to view and operate the screen of a connected fetal monitor in the IntelliSpace Perinatal application. XDS must be installed on the same PC as the IntelliSpace Perinatal application. XDS must be connected to the same Local Area Network (LAN) as the monitor. Depending on the configuration you can view or operate the monitor from the external display. Use the remote display to access the following functions at the connected fetal monitor:

Change measurement and alarm limits Start and stop physiological measurements Start and stop the recorder Check the status of the Avalon CL transducers and Pods Page the patient (in combination with CL transducers and CL Pods) Change the operation mode of the fetal monitor Configure the fetal monitor Switch the fetal monitor to Standby mode For more details, including limitations and restrictions, refer to the IntelliSpace Perinatal Instruction for Use and the IntelliVue XDS Software Instructions for Use. Settings This section describes the various settings available on the monitor. Active Settings What the monitor displays, and the way it operates, is controlled by its settings. They determine sound volume settings, recorder settings, high and low alarm limits and so forth. The active settings are the current settings the monitor uses, including any adjustments made by the last user. Active settings are not permanent, but are retained after a loss of mains power. There are also two preconfigured default settings:

User Default Factory Default User Default The User Defaults are a complete configuration stored in the monitor's long-term memory. You can store the active settings, modified to your preference, in the User Defaults (in Configuration Mode). 45 3 Basic Operation In Monitoring Mode, you can load the User Defaults settings to return to your preferred settings:

1 Select the Defaults SmartKey. 2 Select Confirm in the dialog box to load the User Defaults. Factory Default The Factory Defaults is a complete configuration predefined at the factory. You cannot modify it. In Configuration Mode, you can load the Factory Defaults as the active settings. CAUTION This resets all settings to factory defined values, but be aware that some values will differ from those with which the fetal monitor was originally shipped from the factory (recorder speed and paper scale type will need to be corrected, for instance). After loading the Factory Defaults, check the settings, and if necessary, change them to the settings you normally use. You can use the Factory Defaults as the basis for producing your User Defaults. See the Configuration Guide for details. Global Settings General monitor configuration settings are stored in the Global Settings. These include settings for line frequency, QRS type, and whether the monitor is automatically reset to the User Defaults after a power interruption of more than one minute. You can change the Global Settings in Configuration Mode. Changing Measurement Settings Each measurement has a setup menu in which you can adjust all of its settings. You can enter a setup menu:

1 with the measurement numeric - select the measurement numeric on the screen to enter its setup menu. For example, to enter the Setup FHR1 menu, select the FHR1 (fetal heart rate 1) numeric. 2 with the Main Setup SmartKey - if you want to set up a measurement when the measurement is switched off, use the Main Setup SmartKey and select Measurements. Then select the measurement name from the pop-up list. With this SmartKey you can access any setup menu in the monitor. This guide always describes the entry method using the measurement's setup menu. You can use the method you prefer. Changing Monitor Settings To change monitor settings such as brightness, or touch tone volume:

1 2 Enter the Main Setup menu. Select the setting you want to change, or select User Interface to enter a sub menu where you can change user interface settings. 46 3 Basic Operation Adjusting the Screen Brightness 1 2 3 4 Enter the Main Setup menu. Select User Interface. Select Brightness. Select the appropriate setting for the screen brightness. 10 is the brightest, 1 is the least bright. Optimum is suitable for most situations. Adjusting Audio Volume Here you can adjust the audio volume for Alarm Volume, QRS Volume, and Timer Volume. To adjust an audio volume:

1 2 3 Enter the Main Setup menu. Select User Interface. Select Audio Volumes, then select one of the volume types, and select an audio level. 10 is the loudest and 1 is the quietest. Selecting zero switches the volume off. Setting the Date and Time The current date and time is displayed in its own element in the information line of the monitor screen. 1 2 3 Select the date and time screen element from the monitor's information line to enter the Date, Time menu. Select, in turn, the Year, Month, Day, Hour (in 24 hour format), and Minute, as necessary. Select Store Date, Time to change the date and time. WARNING Do not change the date and time setting, if the fetal monitor is connected to a Philips OB TraceVue/

IntelliSpace Perinatal system. The monitor uses the OB TraceVue/IntelliSpace Perinatal system date and time, including daylight saving time changes. As long as the fetal monitor is connected to the OB TraceVue/IntelliSpace Perinatal system via the LAN-setup (locomotive symbol displayed on the monitor's screen), the option to change the date and time settings at the fetal monitor are disabled, this is not valid for RS232 connections, or the connection to other systems. When disconnected from AC power, the monitor retains the date and time setting for at least 48 hours

(typical: >72 hours). If the monitor is off longer than that, and the operating system detects that the date and time settings are invalid, the monitor initiates a cold start and sets the date to 1 Jan 1997 and the time to 00:00. Checking Your Monitor Revision 1 2 Select Main Setup, Revisions to open the Monitor Revision menu. From the Monitor Revision menu, select the monitor component for which you need revision information. 47 3 Basic Operation Preparing to Monitor Confirm fetal life before you begin fetal monitoring. Familiarize yourself with the basic operation principles before you start to monitor. CAUTION Check the fetal monitors housing for damage before you start to monitor as part of your safety precautions. After you switch on the monitor:

1 2 Check that you have the correct patient cables and transducers plugged in for the measurement you want to monitor. If you use an Avalon CL or Avalon CTS system, check if the cableless transducers are ready and charged (apparent by either a lit up green or yellow LED indicator). 3 Admit your patient to the monitor (see Admitting a Patient on page 145). 4 Check that the alarm limits, alarm and fetal heart rate volumes, patient category, and so forth, are appropriate for your patient. Change the settings if necessary. 5 Refer to the appropriate measurement section for details of how to perform the measurements you require. 6 Start recording. There is no special emergency access for the Avalon Fetal monitors. For all clinical use cases according the Intended Use, the monitors are taken into operation by connecting them to AC mains and by switching them on. Switching On: FM20/FM30 1 Connect the monitor to AC mains and switch the monitor on. The green power-on LED lights up. The monitor performs a self-test as it starts up. Self-test: OK, the serial number, and revisions for the software and firmware are printed on the fetal trace paper (if recorder Auto Start is configured to On). The monitor display comes on. There is a start-up tone from the loudspeaker. Battery Option If this option has been chosen, the green power-on LED on both the external power supply and the battery LED indicator will light up. 48 3 Basic Operation Switching On: FM40/FM50 1 Connect the monitor to AC mains. The green LED lights up. 2 Press the On/Standby switch. The monitor performs a self-test as it starts up. Self-test: OK, the serial number, and revisions for the software and firmware are printed on the fetal trace paper (if recorder Auto Start is configured to On). The monitor display comes on. There is a start-up tone from the loudspeaker. Adjusting the Display Angle (FM20/FM30) You can tilt the display on the FM20 and FM30 to one of five different positions, or you can fold it completely down. The tilt/fold mechanism works on a one-way ratchet system. You hear a click as each of the five positions is reached. The screen can be folded back down only after tilting the display forwards as far as it will go. To tilt the display from the folded position:

1 Unlock the display by releasing the catch. 2 Lift the display forward. You will hear a click as the first position engages. If you want to tilt the display further, lift the display further forward until you reach the desired angle. 49 3 Basic Operation 3 To fold the display, pull the display forwards as far as it will go. 4 Then push the display all the way back until it clicks shut. If your monitor is wall-mounted, the display should be folded flat. Fastening Belts and Transducers You can use more than one belt if, for example, you are monitoring uterine activity and FHR simultaneously. There are two basic ways to fasten belts and transducers:

Belts with button fixings. Velcro belts together with the butterfly belt clip. What You Need Ultrasound transducer Toco+ MP or CL Toco+ MP transducer Ultrasound gel Transducer belt (and optional butterfly belt clip, if applicable) 50 3 Basic Operation Using Belts with Button Fixings 1 2 3 Place the transducer belt across the bed, so that the fixing button will face away from the mother when it is fastened. Lie the patient on the bed and arrange the belt around her until it is tight but still comfortable. Fasten the belt by pushing the fixing button through the overlapping section of the belt. Ensure that the fixing button and the loose ends of the belt are at the patient's side. 4 When you have positioned a transducer satisfactorily, you can attach it to the belt by pushing the belt button on the transducer through one of the holes in the belt. 51 3 Basic Operation 5 Alternatively, attach the butterfly belt clip to the transducer belt button and use this to attach the transducer to the belt. The clip allows you to slide the transducer for easy repositioning. Using Belt with Velcro Fixings Insert one end of the belt between the belt guides on one side of the butterfly belt clip, and secure with the velcro fixing. Insert the other end of the belt between the belt guides on the other side of the butterfly belt clip, adjust for the correct tension, then secure with the velcro fixing. 1 Velcro fixing 2 Belt guides 3 Velcro fixing WARNING When connecting devices for acquiring measurements, always position cables and NBP tubing carefully to avoid entanglement or potential strangulation. 52 Repositioning Transducers 3 Basic Operation A patient possibly wears transducers for long periods without interruption. In rare cases, skin irritations may occur if a transducer is attached to one location for a longer period. To ensure there are no adverse effects on the patient's skin, inspect the transducer application site at least every three hours. If the skin quality changes, move the transducer to another site. NOTE At elevated ambient temperatures, the housing temperature of all fetal transducers (M2734A/B, M2735A, M2736A/AA, M2738A, 867245, 867246, 867247, 867248, 867249) may exceed 41C on the skin. Especially after prolonged application on the same application site, consider inspection of the transducer application site. The ultrasound transducer is often repositioned to follow the fetal heart as part of the normal monitoring process, but this is not so for the Toco transducer. Therefore, remember to check its application site

(between contractions) at least every three hours. To reduce the risk of skin irritations, do not allow a cleaning or disinfecting agent to remain on the transducer. Follow all instructions that accompany the specific cleaning and disinfecting agents you are using. Remove agent residues with a cloth dampened in water before applying a transducer to a patient. See Care and Cleaning on page 257 for further information, and a list of approved agents. Connecting a Transducer to the Monitor 1 SpO2 socket 2 Noninvasive blood pressure socket 3 Fetal sensor sockets You can plug a fetal transducer, an ECG/IUP patient module, an Avalon CL or Avalon CTS Cableless Fetal Transducer System interface cable (red connector), or an external event marker into any of the four fetal sensor sockets marked by the fetal symbol, or Fetal Sensors

(depending on geography). For measuring maternal SpO2, connect the sensor to the socket marked with the SpO2 symbol or SpO2 (depending on geography). For maternal noninvasive blood pressure, connect the cuff to the socket marked with the NBP symbol or NBP (depending on geography). For the FM20 and FM30, you can connect an Avalon CL or Avalon CTS Cableless Fetal Transducer system interface cable (red connector) to one of the fetal sensor sockets at the left side of the monitor. 53 3 Basic Operation For the FM40 and FM50, you can connect an Avalon CL or Avalon CTS Cableless Fetal Transducer System interface cable (black connector) to one of the two dedicated black sockets marked Tele at the rear of the monitor, as an alternative to using one of the fetal sensor sockets (red connector) at the front. 1 Interface cable to Avalon CL and Avalon CTS Cableless Fetal Transducer System. 2 Connect the black connector to one of the two black sockets (marked Tele) on the rear of the monitor. What You See on the Monitor When you connect a transducer or sensor, the measurement numeric appears on the screen. FM20/FM30 FM40/FM50 Fetal heart rate measurements are labeled in the order in which you plug in the transducers for those measurements. It does not matter which fetal sensor socket you use, as the monitor allocates a channel automatically. For instance, when monitoring triplets, the first transducer you connect is automatically allocated a channel, and the measurement is labeled FHR1, the second FHR2, and the third FHR3. See also chapters Monitoring Twin FHRs on page 185 and Monitoring Triple FHRs on page 191. When you touch a measurement numeric on the screen, the setup menu for that measurement opens. The fetal sensor socket to which the transducer for this measurement is connected is identified by the transducer position indicator in the setup menu header. 54 3 Basic Operation The blue finder LED on a wired fetal transducer lights up when you touch the measurement on the screen, allowing you to identify the corresponding transducer. 1 finder LED The white finder LED on a cableless fetal transducer lights up when you touch the measurement on the screen, allowing you to identify the corresponding transducer. 1 finder LED cableless transducer The recorder prints an annotation showing the date, time, recorder speed, and Monitoring Mode. It repeats this every 10 minutes. Start Recording Checking/Setting Paper Scale You can check the paper Scale Type (US for U.S., or Internat'l for other geographies) in the Fetal Recorder menu. In Monitoring Mode, you can see these settings (grayed out), but you cannot change them. They can be changed in Configuration Mode, see the Configuration Guide. NOTE Check if the scale type of the paper and the settings in the fetal monitor match. 55 3 Basic Operation Paper Guide FM40/FM50 The recorder in the FM40 and FM50 features a transparent paper guide which:

facilitates correct alignment of the paper, both during loading and while the recorder is running. See Loading Paper FM40/FM50 on page 65. incorporates a tear-off edge, which not only allows you to tear off the trace paper where you like (not necessarily at a fold), but also helps to avoid paper misalignment while doing so (see Tearing Off the Paper on page 62). is removable (see Removing the Paper Guide: FM40/FM50 on page 268). Switching the Recorder On and Off In addition to the normal recording of real-time traces, you will sometimes see a trace recovery printout from the monitor's internal backup memory at high speed when the recorder is started. For details, see Recovering Traces on Paper on page 253. For an explanation of the various symbols that can appear on the trace recording, see Recorder Specifications on page 310. To switch the recorder on, select in Main Setup the menu item Fetal Recorder, or press one of the SmartKeys: Start/ Stop or Start Recordng. The recorder on status indicator is displayed in the bottom right-hand corner of the screen when you switch on the recorder. The paper advances quickly for 2 cm and then returns to the set speed. Whenever the recorder is switched on, a trace header is printed vertically on the trace paper, containing the following:

Self-test: OK: confirmation that the monitor's self-test completed successfully, and that it is ready to use the software revision and firmware revision the serial number the time the date patient first name, last name, lifetime ID (with the configured label), encounter ID (with the configured label), date of birth, gestational age, and patient bed label the recorder speed 56 3 Basic Operation 1 Fetal heart rate label 2 Uterine activity label The current parameter setup information (if any transducers are connected to the monitor) are printed. Whenever a transducer's mode is changed, the following are printed:

the time the date trace identification symbols the recorder speed The monitor prints the time, date, recorder speed, and current parameter setup information in the trace header when first switched on, in a periodic time stamp every ten minutes after, and if the monitoring modes change. The time stamp begins with the symbol shown below. The data is reprinted in the header if the time and date are locally adjusted, or if an obstetrical information and surveillance system is connected that readjusts the time and date automatically. 1 The time stamp is printed every ten minutes and every time the measurement parameter setup is changed. 57 3 Basic Operation The trace records maternal parameters also. When measuring noninvasive blood pressure, the annotation is made at the end of the measurement. If the noninvasive blood pressure measurement repetition time is short, the noninvasive blood pressure numeric may not always be printed. The recording of notes (see Entering Notes on page 69) or time/date information may be interrupted by connecting, or unplugging a transducer, or by a change in measurement-related setting (for example, artifact suppression, Toco sensitivity, or alarm settings). A new patient admission or a change to the paper scale setting stops all annotations, and prompts a new vertical trace header to be printed. To switch off the recorder:

1 Either select Start/Stop from the Fetal Recorder menu. 2 Or press one of the SmartKeys (depending on configuration): fetal recorder Start/ Stop or Stop Recordng. If your recorder is configured with Confirmed Stop on (a Configuration Mode setting), you will need to confirm that you want to stop the recorder, before it will stop. When the recorder is off, the recorder off status indicator is displayed in the bottom right-hand corner of the screen: When the Paper Save Mode is set to Off the paper symbol shows an x mark, and when Paper Save Mode is On the icon shows a paper trace icon. 58 3 Basic Operation Recording Elements A variety of information can appear on the recorder trace. Here is a sample trace with some of the most common elements and their meaning. Each trace header contains the last name and first name, the patient ID, patient date of birth, the current date and time, patient's bed label, and the gestational age of the pregnancy. Trace example obtained from wired transducers 1 Last name, first name, lifetime ID (with the configured label), encounter ID (with the configured label), date of birth 2 Current date and time 3 Recorder speed 4 Gestational age and patient bed label 5 FMP - Fetal Movement Profile 6 Other measurements for the patient such as temperature, arterial oxygen saturation, and pulse 7 Entered notes such as patient repositioned, or MD notified, or others 8 9 Time stamp Trace separation 10 Recorder speed 11 Maternal ECG 12 Direct ECG 13 Coincidence of heart rate detected 14 HR with Alarms Off symbol 15 dFHR2 (second fetal heart rate from DECG) 16 Alarm Limits 17 FHR1 (first fetal heart rate) 59 3 Basic Operation Trace example obtained from the Avalon CL Fetal & Maternal Pod and Patch and CL Wide Range Pod If the CL Wide Range Pod transfers the data of a CL Pod or a CL transducer via WLAN to the fetal monitor, it is indicated by an additional WLAN symbol next to the parameter label. 1 2 Fetal and maternal heart rate from the Avalon CL Fetal & Maternal Pod and Patch transferred over the CL Wide Range Pod. aToco measurement from the Avalon CL Fetal & Maternal Pod and Patch transferred over the CL Wide Range Pod. For a complete list of recording symbols, see Recorder Symbols on page 321. CAUTION The trace contains sensitive personal data. For information how to protect personal information, see Protecting Personal Information on page 19. Choosing Recorder Speed You can choose a recorder speed of 1, 2, or 3 centimeters per minute (cm/min). The default setting is 3 cm/min. The ACOG technical bulletin on FHR monitoring states that accurate pattern recognition is difficult if not impossible at 1 cm/min and that 1 cm/min is only recommended for more economic screening. When FHR abnormalities arise, the faster recorder speeds will enhance FHR pattern recognition. Additionally, because a change in recorder speed results in a change in the appearance of an FHR trace, you are advised to ensure ALL monitors in your institution are set to the same speed. To set the recorder speed (in Configuration Mode), see the Configuration Guide. 60 Advancing the Paper You can advance the paper automatically to the next fold by pressing the Paper Advance SmartKey at any time except during a stored data recording. This is also possible using the Fetal Recorder menu. 3 Basic Operation Marking an Event You can record significant events on the trace paper (for example, when pain medication is administered or when the mother changes position). The mother can use the remote event marker to mark events herself. You connect the remote event marker to any free fetal sensor socket. To mark an event on the trace paper, you can:

1 Either select the Set Marker SmartKey. 2 Or press the button on the optional remote event marker (989803143411). The remote event marker is connected to the monitor via any fetal transducer socket. A small arrow is printed on the heart rate scale on the trace paper. This reflects exactly when the marker button was first pressed; keeping the button pressed has no influence on the annotation. 61 3 Basic Operation Tearing Off the Paper CAUTION Never pull on the paper to advance it, as this can cause misalignment of the paper. Always tear off the paper along the perforation. FM40/FM50 The recorder's paper guide incorporates a tear-off edge, allowing you to tear off the trace paper cleanly where you like (not necessarily at a fold). When you are not using the paper guide, always tear off the paper along the perforation. To tear off the trace paper after monitoring using the paper guide:

1 2 If the recorder is running (the recorder on status indicator is displayed), turn off the recorder by selecting the fetal recorder Start/ Stop SmartKey or the Stop Recordng SmartKey. Tear off the paper as shown in the picture. To ensure a clean tear, always tear in an upwards motion, as indicated by the arrows. You can start tearing from the left or right, (right-handed user shown). You may want to use both hands to guarantee that the paper is not misaligned during the tear off. 3 If you wish to tear off the paper at a fold, select the Paper Advance SmartKey, wait for the paper to stop, then tear it off. FM20/FM30 The FM20/FM30 does not have a paper guide. The procedure is the same as described for the FM40/

FM50 with the exception that you should advance the paper to a perforation. If you wish to tear off the paper at a perforation, select the Paper Advance SmartKey, wait for the paper to stop, then tear it off. 62 3 Basic Operation Paper-Out Indication Each pack of paper has 150 pages. The monitor issues a paper-out warning in the status line at the bottom of the screen, when there are five pages to go. If you switch on the recorder or press the Paper Advance key when there are fewer than five pages remaining, it may take two pages before the alarm is activated. Load a new pack in time. If the recorder runs out of paper, an audible paper-out alarm is sounded, if so configured. See Loading Paper FM40/FM50 on page 65, and Loading Paper FM20/FM30 on page 63 to learn how to reload paper. Fetal traces continue to be recorded into the monitor's backup memory, and can be retrieved and printed completely if new paper is loaded within one hour, when the Bridge Paperout setting is enabled in Configuration Mode. See Recovering Traces on Paper on page 253 for further information. Loading Paper FM20/FM30 CAUTION Using recorder paper that is not approved by Philips can result in accelerated paper fading and can damage the thermal line printhead. This type of damage is not covered by warranty. FM20/FM30 To load a pack of paper:

1 If the recorder is on, press the recorder Start/ Stop SmartKey or the Stop Recordng SmartKey to turn it off before loading a new pack of paper. 2 3 Press the paper table release to unlock the paper drawer and then pull the table forward to open it fully. Lift out any remaining paper from the tray. 63 3 Basic Operation 4 Prepare to place the new pack of paper in the tray with the bottom side down. The bottom side is indicated by the word STOP printed on the final page of the new pack. 5 Unfold the top page of the pack and position the uterine activity scale on the right. 6 Slide the pack into the tray. 64 7 Push the paper drawer back until it clicks closed. 3 Basic Operation 8 Press the recorder Start/ Stop SmartKey or the Start Recordng SmartKey to switch on the recorder. Annotations of trace information are printed on the trace paper (see Switching the Recorder On and Off on page 56 for details). Loading Paper FM40/FM50 CAUTION Using recorder paper that is not approved by Philips can result in accelerated paper fading and can damage the thermal line printhead. This type of damage is not covered by warranty. FM40/FM50 To load a pack of paper:

1 If the recorder is on, press the Start/ Stop Rec SmartKey or the Stop Recordng SmartKey to turn it off before loading a new pack of paper. 2 Press the paper eject button to open the paper drawer. 3 Lift out any remaining paper from the tray. 65 3 Basic Operation 4 Press and hold the paper eject button to partially eject the paper, thus making it easier to remove. 5 Hinge the transparent paper guide forward. It is held in the closed position by a small protrusion on each side of the holder. A - Protrusion holds paper guide in closed position. 6 Prepare to place the new pack of paper in the tray with the bottom side down. The bottom side is indicated by the word STOP printed on the final page of the new pack. 7 Unfold the top page of the pack and position the uterine activity scale on the right. 66 8 Slide the pack into the tray. 3 Basic Operation 9 Feed the paper evenly through the paper guide. Do not close the paper guide yet. 67 3 Basic Operation 10 Close the paper drawer. 11 Now close the paper guide. 12 Press the recorder Start/ Stop SmartKey or the Start Recordng SmartKey to switch on the recorder. Annotations of trace information are printed on the trace paper (see Switching the Recorder On and Off on page 56 for details). 68 3 Basic Operation Entering Notes Your monitor has a set of 15 factory pre-configured notes (see below). It is possible to edit these notes in Configuration Mode (see the Configuration Guide). The maximum length of one single note is 30 characters. To enter a note:

1 2 3 4 Select the Enter Notes SmartKey to open the Enter Note menu. Scroll if necessary, then select the note you wish to enter. A confirmation dialog box opens:

Select Confirm to enter the note. The note is then shown in the status line of the display, and is annotated on the fetal trace if the fetal recorder is on. By default, notes are printed lengthwise in the direction of the trace, in the space between the FHR grid and the uterine activity grid. If you prefer, you can configure the recorder to print across the trace. You can change this in Configuration Mode. The following are the pre-configured notes from which to choose:

1 2 Patient Repositioned Vaginal Examination 3 MD Notified 4 Sitting 5 On Back 6 Left Lateral 7 Ambulating 8 Tocolytic Given 9 Membranes Ruptured 10 Amniotomy 11 Amniotic Fluid Clear 12 Amniotic Fluid Not Clear 13 Oxytocin 14 Urinary Catheter 15 Micro Blood Analysis Up to two notes can be printed directly, and the monitor can temporarily store up to a further two notes, and these are printed after the first two have been printed. Any further notes are discarded. For example, if you enter six notes in quick succession, the first two notes you entered are printed right away, the next two are stored in memory and then printed when the first two have been printed, and the last two are discarded. If the printing of two notes happens to coincide with the regular printing of the time stamp that takes place once every ten minutes, the time stamp is delayed until the notes have finished printing. 69 3 Basic Operation Typing Notes Other than the pre-configured notes selectable in the Enter Note menu, a note can be typed in manually. To type a note:

1 2 3 Select the Enter Notes SmartKey to open the Enter Note menu. Select Type a note and a window with a touch keypad opens. Type the note and select Enter. The typed note can be up to 30 characters long. The note is shown in the status line of the display, and is annotated on the fetal trace if the fetal recorder is on. NOTE The typed note remains in the window until it is deleted by using the backspace/clear key of the keyboard. Signal Quality During monitoring, if the fetal heart rate signal quality fluctuates, and becomes poor, it does not necessarily mean that the transducer needs repositioning. The fluctuation may be caused by fetal movement. Allow time for the signal to stabilize before deciding whether to reposition the transducer (ultrasound), or apply a new electrode (ECG). For the best trace quality, the signal quality indicator should be full, indicating good signal quality, even though it may be possible to make traces at a lower signal quality level. After Monitoring Wired and cableless transducers 1 Discharge the patient. 2 Remove the transducer from the patient and, using a soft tissue, remove any gel from it. Then clean the transducers. 3 Dock CL transducers to the base station so they can recharge. 4 Tear off the paper at the fold. To avoid misalignment of the recorder mechanism, NEVER pull on the paper to advance it, or try to tear it other than at a fold (unless using the paper guide with the FM40/

FM50). 5 Switch off the monitor. NOTE If an Avalon CL base station is connected to your FM20/30 monitor, do not turn off the monitor if you need to recharge the batteries of the CL transducers. They can only be recharged if the FM20/30 monitor is on. If an Avalon CL base station is connected to an FM40/50 at the Telemetry ports in the rear, the batteries of the CL transducers can be recharged while the monitor is not switched on. If you disconnect a base station from a fetal monitor when the CL transducers are not fully charged, the base station starts beeping. If you want to still disconnect it, confirm your choice by pressing the Standby key of the base station, and the beeping stops. 70 3 Basic Operation Switching the Monitor to the Standby Screen To switch the monitor to the Standby screen:

Either 1 Select the Monitor Standby SmartKey. Or 1 2 3 Enter the Main Setup menu using the SmartKey. Select Monitor Standby. Pressing any key or selecting any field on the screen will resume monitoring. Disconnecting from Power FM20/30 To disconnect the monitor from AC power, switch the monitor off using the On/Off switch located on the right side of the device, or unplug the power cord from the AC mains socket. FM20/FM30 with Battery Option and FM40/FM50 The On/Standby button does not disconnect the monitor from the AC power source. To disconnect, unplug the power cord from the AC mains socket. Note that if the power cord is unplugged from the AC mains socket before the monitor is put into Standby, a beeper is activated. The beeper warns you if the monitor is accidentally disconnected from AC mains. External Power Supply for the Avalon CL Base Station To disconnect, unplug the power supply from the AC mains socket. Note that if the power supply is unplugged from the AC mains socket before all CL devices are fully charged, a beep is issued. To confirm the disconnection from power, and to silence the beep, press the On/Standby button of the CL base station. Power On/Power Off Behavior The general rules determining the behavior of the fetal monitors when connected to, or disconnected from power are as follows:

A fetal monitor that was switched on prior to a temporary power loss, switches on again when power is restored. A fetal monitor that was switched off prior to a temporary power loss, remains off when power is restored. When AC mains power is lost, a battery powered monitor (FM20/30) continues to run without interruption on battery power. Monitoring After a Power Failure A fetal monitor that was switched on prior to a temporary power loss, switches on again when power is restored. A fetal monitor that was switched off prior to a temporary power loss, remains off when power is restored. If the fetal monitor is without power for less than one minute, monitoring will resume with all active settings unchanged. 71 3 Basic Operation If the fetal monitor is without power for more than one minute, the behavior depends on your configuration. If Automat. Default is set to Yes, the default profile will be loaded when power is restored. If Automat. Default is set to No, all active settings are retained, if power is restored within 48 hours. The Automat. Default setting is made in Configuration Mode. Troubleshooting Problem Light or no trace End of paper noted when pack not finished Check Paper INOP is displayed FetRec Equip Malf INOP is displayed Paper End INOP is displayed Wrong Paper Scale INOP is displayed Possible Causes Wrong paper Dirty printhead Solutions Use recommended paper Clean printhead, see Cleaning the Print Head on page 272 FM20/30 only: Paper misaligned due to drawer not being correctly shut Shut the drawer fully, pushing evenly with both hands Bad paper feed or wrong paper Check paper feed and use recommended paper INOP messages always indicate equipment problems See Patient Alarms and INOPs on page 127 72 4 4Cableless Monitoring Avalon CL Transducer System The Avalon CL Fetal Transducer System lets you monitor the patient continuously with cableless transducers during the antepartum period, labor, and delivery. You can monitor the fetal heart rate (FHR):

Noninvasively, using the CL Ultrasound transducers Noninvasively, using the CL F&M Pod Invasively, using the CL ECG/IUP transducer or CL Toco+ MP transducer with a fetal scalp electrode You can monitor the uterine activity:

Noninvasively, using the CL Toco+ MP transducer Noninvasively, using the CL F&M Pod Invasively, using the CL ECG/IUP transducer or CL Toco+ MP with an IUP catheter NOTE The Avalon CL Fetal & Maternal Pod and Patch are not available for the U.S., other FDA regulated territories, and Canada. The fetal and maternal parameters are measured and transmitted via radio frequency from the CL transducers and CL Pods to the CL base station, eliminating the need for patient cables. With the Avalon CL Transducer System, you can monitor a single fetus, twins, and triplets. The Avalon fetal monitor (FM20-FM50) connected to the CL base station displays and records the parameters. All the CL transducers and the CL F&M Pod are watertight. The IntelliVue CL Pods should not be immersed in water. You can continuously monitor patients in a bath or shower using the CL Toco+ MP and the CL Ultrasound transducers, the CL F&M Pod should not be used during a bath. 73 4 Cableless Monitoring Basics of Cableless Systems Avalon CL Transducer System Avalon CTS Transducer System Assigning Cableless Devices The cableless devices of the Avalon CL are assigned by simply docking them at the base station connected to the patients fetal monitor. See the Avalon CTS Instructions for Use for the assignment of the CTS transducers. Activating Cableless Devices The CL devices of the Avalon CL are activated by picking them up from the base station. If the CL devices are activated, a corresponding symbol is displayed on the fetal monitor screen next to the numeric of the measurement. See the Avalon CTS Instructions for Use for the activation of the CTS transducers. Deactivating Cableless Devices The CL devices of the Avalon CL are deactivated by redocking them at a base station. To deactivate all cableless devices at once, press the Standby key of the Avalon CL base station. See the Avalon CTS Instructions for Use for the deactivation of the CTS transducers. Unassigning Cableless Devices The CL devices of the Avalon CL are unassigned by manually removing them in the corresponding setup menu from the group of assigned cableless devices, or by unassigning them directly in the Tele Info window. See the Avalon CTS Instructions for Use for the unassignment of the CTS transducers. Twins and Triplets Support Twins and Triplets Singletons only Avalon CL Transducer System and CL transducers Avalon CTS System Avalon CL Transducer System with CL Fetal & Maternal Pod 74 4 Cableless Monitoring Configuration of Cableless Systems You have to configure the radio channels of the Avalon CL and Avalon CTS transducer system for communication to work, and not to interfere with any other telemetry devices. The configuration of a connected Avalon CL system is done in Configuration Mode or Service Mode of the fetal monitor. Service Mode functions can be used to identify channel assignment conflicts in the hospital environment. The configuration should be carried out by authorized and qualified service personnel, either by the hospital's biomedical department, or by Philips Support. For a detailed description of the configuration see the Avalon CL Service Guide and the Fetal Monitor Configuration Guide. For details regarding the configuration of a connected Avalon CTS system see the Avalon CTS Service Guide. Fetal Movement Profile When using an Avalon CL or Avalon CTS you should be aware that monitoring FMP is not recommended when the mother is likely to move, and you should disable Fetal Movement Profile (FMP) on the fetal monitor (Fetal Movement Off) if the mother is walking. Maternal movements are likely to create artifact in the FMP output. See also Switching FMP On and Off on page 175, the sections Cableless Monitoring -

Important Considerations on page 171, and Fetal Movement Profile on page 173. Getting to Know Your Avalon CL Front 1 Transducer docking slots 2 On/Standby button with LED 3 Device label 4 LED for optional cableless Pods 5 Docking slot for cableless Pods WARNING To avoid magnetic interference affecting the mode of the pacemaker, ensure that the Avalon CL base station does not come into close contact with implanted pacemakers. This equipment generates, uses, and radiates radio-frequency energy, and if it is not installed and used in accordance with its accompanying documentation, may cause interference to radio communications. Operation of this equipment in a residential area may cause interference, in which case you must take whatever measures may be required to correct the interference. 75 4 Cableless Monitoring Docking Slots for Cableless Transducers The Avalon CL base station has three docking slots to hold the CL transducers. The transducers are charged while docked. The base station has a built-in radio interface with an integrated antenna to communicate with the transducers. On/Standby Button Pressing the On/Standby button switches the Avalon CL base station between the two modes On and Standby. 1 On/Standby button If you switch the base station to On, the LED button lights up green. The base station is ready for use. When the transducers are picked up from their docking slot, the base station sets up the radio communication to the CL transducer automatically. Wired transducers connected to the fetal monitor are disabled, and the antenna symbol for the CL transducer is displayed on the screen of the fetal monitor. NOTE The wired event marker is supported when cableless transducers are active. If you switch the base station to Standby, the LED button turns off. The base station is now in Standby mode. No radio communication occurs, any existing radio communication is stopped. If the LED of the On/Standby button turns red, it indicates a technical problem has occurred that needs your attention. Check your monitor for a possible related INOP message. Docking Slot for Cableless Measurement Pods The Avalon CL base station has one docking slot to hold a CL F&M Pod or an IntelliVue CL Pod. The CL Pod is charged while docked. The LED under the docking slot indicates the battery status of the CL Pod. The base station has a built-in short range radio interface with an integrated antenna to communicate with the CL Pod. 76 4 Cableless Monitoring 1 Docking slot for CL Pods WARNING Short range radio connections are subject to interruption due to interference from other radio sources in the vicinity, including microwaves, bluetooth devices, WLAN devices (802.11b,g,n), and cordless phones. Depending on the strength and duration of the interference, the interruption may occur for an extended period. A loss of connection, due to moving out-of-range, interference, or for other reasons, is indicated with a No Host Monitoring INOP (here the host is the fetal monitor) on the NBP or SpO2 Pods, or a cl NBP Disconnect or cl SpO Disconnect INOP at the fetal monitor. Correct channel configuration is important, see the Configuration Guide for details. Audio Signal CL Base Station The Avalon CL base station has two audio signals:

If the base station issues a descending tone sequence, the attempt to set up radio communication to a CL transducer or CL Pod has failed. The base station issues a permanent beeping tone if it is disconnected from a fetal monitor, or if the FM20 or FM30 monitor is switched off, and the base station has transducers or a Pod currently docked that need to be recharged. Alarming is only available at the Avalon Fetal Monitor, not at the Cableless Measurement Devices, see the Instructions of Use for the IntelliVue Cableless Measurements. Rear and Bottom 1 Name plate 77 4 Cableless Monitoring 1 Manufacturer label 2 Cable reel Connection Options The fetal monitors FM20/FM30 and FM40/FM50 are compatible with the Avalon CL and Avalon CTS Transducer Systems. Regard the following points for cableless monitoring:

You can connect one Avalon CL base station with a red connector to an FM20/FM30 or an FM40/

FM50 (fetal socket), or one Avalon CL base station with a black connector to an FM40/FM50

(telemetry socket). 78 You can connect two Avalon CL base stations with black connectors to an FM40/FM50 (telemetry sockets) 4 Cableless Monitoring You cannot connect two Avalon CL base stations to an FM40/FM50, if one Avalon CL base station has a red connector, and the other Avalon CL base station has a black connector. 79 4 Cableless Monitoring You cannot connect an Avalon CTS and an Avalon CL at the same time to the same fetal monitor. Monitoring a multiple pregnancy using cableless transducers is supported by the Avalon CL system only. Using a mixture of wired and cableless fetal transducers is not supported. You can use either wired or cableless fetal transducers. NOTE The wired event marker is supported when cableless transducers are active. Connecting Two CL Base Stations to an FM40/50 Monitor Two base stations can be connected to an FM40/50 fetal monitor at the rear black telemetry ports. At both base stations CL transducers and CL Pods can be assigned, activated, and redocked for charging. The base stations work as one extended system together. Pressing the Standby key of either base station, puts both base stations in Standby mode. The Tele Info window shows both base stations in operation. 80 4 Cableless Monitoring External Power Supply (Option K60) In combination with the optional external AC power supply an Avalon CL base station serves only as a charging station for Avalon CL transducers and IntelliVue CL Pods, and all radio communications are disabled. The On/Standby button of the base station lights up white in this operation mode. The charging indication of the LEDs of the docked CL transducers and the IntelliVue CL Pods remain the same as described in the sections Cableless Transducer LED Indication on page 82 and Battery Status LED for CL Pods on page 90. When a transducer is picked up from the base station after charging, it needs to be activated for monitoring by docking it on a CL base station connected to the patient's fetal monitor. Cableless Transducers The cableless Avalon CL transducers have a built-in radio interface with an on-board, integrated antenna. The fetal monitor connected to the Avalon CL base station can control the transducer using radio communication. The CL transducer transmits measured values, alarms, and status information to the fetal monitor. The CL transducers are assigned by simply docking them at the Avalon CL base station. If they are picked up from their docking slot at the base station, they are automatically activated. CAUTION To ensure the correct assignment of CL transducers to the fetal monitor in use, always dock them at the base station connected to that fetal monitor before use. This is particularly important when you add an additional CL transducer that was previously docked at another base station. NOTE Avoid dropping the transducers. 1 Transducer finder LED - lights up on the transducer providing the measurement source. 2 CL Toco+ MP transducers (capable of providing the maternal pulse measurement) 3 Belt button 81 4 Cableless Monitoring CL Ultrasound transducer CL ECG/IUP transducer Connector Cap for the CL Toco+ MP Transducer The CL Toco+ MP transducer is delivered with a connector cap covering the MECG/DECG/IUP connector. The connector cap is designed to cover the connector, not to protect it from water. (The connector itself is water-proof and may be immersed in water). Cableless Transducer LED Indication The cableless transducers have a multi-color LED that indicates the status of the transducer with specific colors. This LED remains visible when the transducer is correctly attached to the transducer belt (Philips standard belt). 82 4 Cableless Monitoring 1 LED LED Status Meaning White The LED lights up to identify the transducer among other transducers, and to easily verify the correct transducer assignment (transducer finder). The transducer finder LED is controlled by the fetal monitor. Press the numerics to identify the corresponding transducer. The LED also lights up when the mother is paged with the Call Patient SmartKey. White one short blink The LED shortly lights up to indicate that the transducer successfully opened a radio communication with the base station and that it is ready to use. Green Yellow Red Cyan The LED lights up green when the transducer is fully charged and docked at the base station. The LED lights up yellow when the transducer is charging and docked at the base station. The LED flashes red when the transducer is out of battery and has to be recharged. When a docked transducer performs an update, the LED will blink fast red for about 1 minute. In this case, do not remove the transducer until the LED lights up green or yellow again. The LED lights up cyan to indicate a technical problem that needs your attention. Check your fetal monitor for a related INOP. 83 4 Cableless Monitoring Audio Signal CL Transducers The Avalon CL transducers have three audio signals:

If an ascending tone sequence is played three times, the transducer was triggered by the fetal monitor to page the patient wearing it, or to locate a not docked transducer. If the CL transducer's battery is empty, the transducer issues three beeps in intervals. An INOP tone indicates that the transducer has detected a technical problem (INOP). Check your fetal monitor for a related INOP message. Standard Radio Range of CL Transducers The CL transducers have an operating range around the base station of at least 100 m/300 ft in the line of sight. Obstructions such as walls, metal doors, elevators, and other environment structures can lead to signal loss. The CL symbol indicator and the Tele Info window on the monitor's display (see Screen Elements on page 40 and Tele Info Window on page 90) provide information on the status of the signal strength. When a patient is approaching the end of range, the US sound is replaced by an artificial QRS sound (like DECG), and the DECG and MECG waves are no longer displayed on the monitor. Out of Range If the patient walks out-of-range, the CL transducer LED lights up cyan and every 16 seconds a two-tone audio signal is emitted. At the monitor the INOP e.g. cl US Disconnect is issued. Inform the patient to return to the CL base station, when a CL transducer starts beeping. Radiated Transmission Power The Avalon CL transducers provide all the benefits and flexibility of cableless operation, but do so with an effective radiated transmission power significantly less than that of a typical remote controlled childs toy or mobile phone. Extended Range Radio Using the optional CL Wide Range Pod extends the radio range of the CL transducers and the CL Pods to the local WLAN infrastructure. If the CL Wide Range Pod is active, the US sound is replaced by an artificial QRS sound (like DECG), and the DECG and MECG waves are no longer displayed on the fetal monitor. Numerics, alarms, and traces are shown at the fetal monitor as usual. See also CL Wide Range Pod on page 88. 84 4 Cableless Monitoring WARNING The Avalon CL Wide Range Pod uses a WLAN connection to extend the operating range of CL transducers and CL Pods. The Avalon CL Wide Range Pod sends real-time patient data to the fetal monitor. The fetal monitor displays real-time patient data, provides alarms, data storage, and clinical decision support applications. The data is also transmitted to a connected obstetrical surveillance system. Using a WLAN connection may lead to network drop-outs resulting in the data loss of monitored vital signs. Do not use the Avalon CL Wide Range Pod with patients for whom a momentary loss of vital sign monitoring is not acceptable. In case of frequent or prolonged network drop-outs (indicated by Disconnect INOPs at the fetal monitor and at the CL transducers or CL Pods):

revert to the use of CL devices without the CL Wide Range Pod, restrict the patient to a reduced range around the Avalon CL base station, and inform your service personnel. Using CL Transducers with a Belt Clip The Avalon CL transducers can also be used with an optional belt clip to be ordered separately

(989803184851). 1 Avalon CL belt clip 85 4 Cableless Monitoring CL Pods CL Fetal & Maternal Pod The CL F&M Pod transmits measurement values for FHR, Toco, and maternal HR to the Avalon CL base station and the connected fetal monitor using short range radio (SRR). The CL F&M Pod is assigned by docking it at the Avalon CL base station. Before monitoring, the CL F&M Pod is mounted on a single-use electrode patch, the CL Fetal & Maternal Patch, and held in place by integrated magnets. When the CL F&M Pod is active, the wired transducers connected to the fetal monitor are disabled, except the wired event marker is still supported. CL F&M Pod CL F&M patch WARNING The CL Fetal & Maternal Pod has been validated with a gestational age of >36 completed weeks with patients in labor. The Avalon CL Fetal & Maternal Pod is used for women who are in labor, with singleton pregnancies, using surface electrodes on the maternal abdomen. If the measurement signals are not good or in any way suspicious, use other means of monitoring (CL transducers or wired transducers). NOTE The Avalon CL Fetal & Maternal Pod and Patch are not available for the U.S., other FDA regulated territories, and Canada. 86 CL Fetal & Maternal Pod LED Indication The CL F&M Pod has a multi-color LED that indicates the status of the CL F&M Pod with specific colors. 1 LED 4 Cableless Monitoring LED Status Meaning White The LED lights up to identify the CL Pod, and to easily verify the correct assignment (finder). The finder LED is controlled by the fetal monitor. Select the numerics to identify the corresponding CL Pod. The LED also lights up when the mother is paged with the Call Patient SmartKey. White, one short blink The LED briefly lights up to indicate that the CL Pod successfully opened a radio communication with the base station and that it is ready to use. Green Yellow Red Cyan The LED lights up green when the CL Pod is fully charged and docked at the base station. The LED lights up yellow when the CL Pod is charging and docked at the base station. The LED flashes red when the CL Pod's battery is empty, and has to be recharged. The LED lights up cyan to indicate a technical problem that needs your attention. Check your fetal monitor for a related INOP. 87 4 Cableless Monitoring Audio Signal CL Fetal & Maternal Pod The Avalon CL F&M Pod has three audio signals:

If an ascending tone sequence is played three times, the CL F&M Pod was triggered by the fetal monitor to page the patient wearing it, or to locate a not docked CL F&M Pod. If three beeps are issued at intervals, the CL F&M Pod's battery is empty. An INOP tone indicates that the CL F&M Pod has detected a technical problem (INOP). Check your fetal monitor for a related INOP message. CL Fetal & Maternal Patch The single-use disposable adhesive electrode patch holds the CL F&M Pod at the intended application site on the abdomen of the patient. The electrode patch has five adhesive electrodes. The CL F&M Pod is held in place during monitoring with magnetic contacts, and a connector. The electrode patch and the CL F&M Pod can only be used together and within the Avalon Cableless Transducer System solution for monitoring. CAUTION The electrode patch is single-patient use only, do not reuse the electrode patch on another patient to avoid possible cross-infection. CL Wide Range Pod The Avalon CL Wide Range Pod is a battery-powered auxiliary network device that converts the SRR and OB radio technology of Avalon CL transducers and the CL Pods into WLAN technology. This allows data from the measurement devices to be transmitted to a fetal monitor while the patient is ambulating. The Avalon CL Wide Range Pod is a mobile device which can be worn by the patient or by an attending caregiver. The display on the CL Wide Range Pod shows only technical data that may be useful for troubleshooting system problems. The Avalon CL Wide Range Pod is assigned by docking it at the Avalon CL base station. See also Understanding the Display on page 101. 88 4 Cableless Monitoring CL Wide Range Pod Working with IntelliSpace Perinatal When the fetal monitor is connected via LAN to IntelliSpace Perinatal K.00.1x or higher, the CL Wide Range Pod's current WLAN connection status and location is displayed with an icon in the Patient Panel of the application. IntelliVue CL Pods The two IntelliVue CL Pods provide measurement values for SpO2 and NBP on the built-in display, and communicate them to the fetal monitor using short range radio (SRR). They are controlled with SRR from the Avalon CL base station and the connected fetal monitor. The maternal measurement pods are assigned by docking them at the Avalon CL base station. CL NBP Pod CL SpO2 Pod The CL SpO2 Pod and the CL NBP Pod have a display and three keys for basic operation e.g. to assign the device to a patient:

1 Integrated display 2 Hardkeys 3 Measurement identifier For further details, see the IntelliVue Cableless Measurements Instructions for Use. 89 4 Cableless Monitoring Battery Status LED for CL Pods The CL Pods do not have their own battery status LED, but a small battery gauge on their display. On the Avalon CL base station, the battery status LED for the CL Pods is located directly under the docking slot. 1 Battery status LED for CL Pods The battery status LED shows five different states:

Status Green Yellow Meaning The docked CL Pod is fully charged. The docked CL Pod is charging. Yellow blinking The communication is established with the docked CL Pod. Cyan Off Indicates that the docked CL Pod or the charging slot has a technical problem that needs your attention. Check your fetal monitor for a related INOP message. The battery status LED is off, when no CL Pod is docked. Audio and Visual Signals CL Pods The CL Pods have audio and visual signals:

If a CL Pod's battery is empty, the CL Pod issues three beeps at intervals. If an ascending tone sequence is played three times and the backlight of the display lights up, the CL Pods were triggered by the fetal monitor to page the patient wearing them, or to locate a not docked CL Pod. Telemetry Tele Info Window The Tele Info window of the fetal monitors allows you to manage the Avalon CL or CTS system. Below is an exemplary view of the Tele Info window. Your window may differ depending on the status of the connected system. To open the Tele Info window, you can:

1 Configure a Tele Info SmartKey to open the window, select the CL symbol on the main screen, or select the Main Setup and then Tele Info. 2 3 90 4 Cableless Monitoring 1 CL transducer symbol assigned with the parameter labels 2 Cableless measurement symbol and equipment ID 3 Base station symbol with docking indication (the white slot indicates a charging transducer) 4 Key Remove 5 Key Find 6 Key Battery Report (in Service Mode) 7 CL symbol 8 Remaining battery time 9 Out of battery symbol 10 Indication of radio signal quality Cableless Status Indication When the monitor recognizes a connected Avalon CL or Avalon CTS interface cable (red or black connector), it confirms the recognition with the following status indicators displayed in the lower right-hand corner of the screen:

Avalon CL Indicator Description A base station is connected to the monitor, but the base station is in Standby mode. A base station is connected to the monitor, but the base station is in Standby mode. The CL Wide Range Pod is activated and trying to connect to the monitor. A base station is connected to the monitor, but the base station is in Standby mode. The CL Wide Range Pod is activated and connected to the monitor. 91 4 Cableless Monitoring Indicator Description A base station is connected to the monitor but no cableless transducers and no cableless Pods are currently active. All are still docked at the base station, or the base station holds no transducers. A base station is connected to the monitor but no cableless transducers and no cableless Pods (except the CL Wide Range Pod) are currently active. All are still docked at the base station, or the base station holds no transducers. The CL Wide Range Pod is activated and trying to connect to the monitor. A base station is connected to the monitor but no cableless transducers and no cableless Pods (except the CL Wide Range Pod) are currently active. All are still docked at the base station, or the base station holds no transducers. The CL Wide Range Pod is activated and connected to the monitor. A base station is connected to the monitor, it is on, and minimum one assigned cableless transducer or cableless Pod is active. A base station is connected to the monitor, it is on, and minimum one assigned cableless transducer or cableless Pod is active. The CL Wide Range Pod is activated and trying to connect to the monitor. A base station is connected to the monitor, it is on, and minimum one assigned cableless transducer or cableless Pod is active. The CL Wide Range Pod is activated and connected to the monitor. A CL transducer has moved away from the base station and is approaching the limit of the area of reach (min. 100 m/300 ft in line of sight). The US sound is replaced by an artificial QRS sound (like DECG). The DECG and MECG waves are no longer displayed. A CL transducer has moved away from the base station and is approaching the limit of the area of reach (min. 100 m/300 ft in line of sight). The CL Wide Range Pod is activated and trying to connect to the monitor. NOTE A CL transducer is considered still active, even if it has an INOP condition (e.g. cl US Disconnect), until it is either deactivated by docking it at the base station, or until it is manually removed from the Tele Info window. Avalon CTS Indicator Description Avalon CTS interface cable is connected to the monitor, but the Avalon CTS base station is not connected to the interface cable, or it is disconnected from AC mains, or is in Standby mode. 92 4 Cableless Monitoring Indicator Description Avalon CTS interface cable is connected to the monitor, Avalon CTS base station is connected, powered on, and cableless transducers are ready to use, but no cableless transducers are currently active (all are still docked at the base station). Avalon CTS interface cable is connected to the monitor, Avalon CTS base station is connected, powered on, and at least one cableless transducer is active and assigned. Pop-up Keys Pop-Up key Function Remove Find Messages Selecting the Remove key deactivates and unassigns the selected active transducer or CL Pod and removes it from the list. This key is disabled if no active device is selected. Selecting the Find key pages the selected active CL transducer or CL Pod. This key is disabled if no active device is selected, or if the selected device is currently out of range. The fetal monitor issues messages to certain user interactions. For example, if the CL SpO2 Pod is picked up from the base station to activate it, the monitor displays the message cl SpO Added and the equipment label of the CL Pod. Use Priority When Combining Cableless and Wired Measurements CL Transducers versus wired transducers CL transducers have priority over wired transducers. If an Avalon CL or Avalon CTS base station is connected to the fetal monitor, and both wired and CL transducers are connected to the monitor, all the wired transducers are disabled whenever one CL transducer is active. A wired connected event marker remains active. To switch back to using wired transducers, switch the base station to Standby mode, or redock all CL transducers at the base station, and continue monitoring with the wired transducers. CL NBP and CL SpO2 versus fetal monitor built-in NBP and SpO2 measurements CL NBP and CL SpO2 have priority over the built-in NBP and SpO2 measurements. If a CL NBP or CL SpO2 Pod is activated, the corresponding built-in measurement of the fetal monitor is deactivated. To switch back to the built-in measurements, switch the base station to Standby mode, or redock the CL Pods at the base station. CL F&M Pod versus wired transducers The CL F&M Pod has priority over wired transducers. If a CL F&M Pod is active, all the wired transducers are disabled. To switch back to using wired transducers, switch the base station to Standby mode, or redock the CL F&M Pod at the base station. 93 4 Cableless Monitoring About RF Signal Quality If you cannot get sufficient ultrasound signal quality using the Avalon CTS base station, try repositioning the transducers, or switch to wired transducers. Using an Avalon CL base station you should get a better signal by reducing the distance between the CL transducer and the base station. Signal transmission can be disturbed if:

the patient is out of range of the receiving area. there is interference from another, possibly stronger, RF signal (a broadcasting station, for instance). the patient is near material that absorbs electromagnetic waves (for example, metal-reinforced concrete, elevator doors) or the base station is in an enclosed metal rack. CL Transducer Assignment The CL transducers are assigned by simply docking them at the Avalon CL base station connected to the patients fetal monitor. Since twins and triplets can be monitored with the Avalon CL base station, it can be delivered with up to six CL transducers: one CL Toco+ MP, three CL US, and two CL ECG/IUP transducers. Up to four CL transducer can be assigned at one time to the Avalon CL base station. Four assigned CL transducers enable monitoring combinations such as 1 CL Toco+ MP transducer + 3 CL US transducers for monitoring triplets externally, or 1 CL Toco+ MP transducer + 2 CL US transducer + 1 CL ECG/IUP transducer for monitoring twins. Three CL transducers can be docked and charged at the Avalon CL base station at a time. If a fourth transducer should be assigned to the Avalon CL base station:

1 2 3 Remove first the three docked CL transducers from the base station and place them on the patient. Then dock the remaining fourth transducer at the base station and wait until the LED of the fourth transducer signals that it has communication with the base station. Place the fourth CL transducer on the patient and check on the fetal monitor in the Tele Info window if the base station and the monitor have communication with all four transducers, and if their numerics are displayed on the screen of the fetal monitor. CL Transducer Unassignment The cableless transducer needs to be unassigned:

before being used with another base station on another patient to allow cleaning before docking it back onto the base station (e.g. to replace it with a fully charged transducer of the same type) There are three methods to do this:

1 Open the setup menu of the measurement e.g. FHR1 by selecting the numeric on the screen. 2 Select Remove from the open setup menu. 3 A confirmation window opens with the prompt Please Confirm and Device will be removed. 4 Select the Confirm pop-up key. A message confirms cl US has been removed. or 1 Open the Tele Info window. 2 Select the symbol of the cableless transducer you want to unassign, and select Remove from the pop-up menu. 3 A confirmation window opens with the prompt Please Confirm and Device will be removed. 4 Select Confirm the pop-up key. A message confirms cl US has been removed. 94 4 Cableless Monitoring or 1 2 Redock the CL transducer at the base station. Switch the base station to stand-by. 3 Remove the CL transducer; it is now unassigned. NOTE When a CL transducer is unassigned, all the measurements from this transducer are no longer monitored. For example, if you unassign a CL Toco+ MP transducer, the Toco measurement, maternal Pulse, and, if in use, the MECG/DECG/IUP measurement are no longer monitored. CL Pod Assignment The CL Pods are assigned by simply docking them at the Avalon CL base station connected to the patients fetal monitor. CL Pod Unassignment The CL Pods have to be unassigned:

before assigning them to another base station or to another patient to allow cleaning, before docking them back onto the base station There are three methods to do this:

1 Open the setup menu of the measurement e.g. by selecting the numeric on the screen (not available for the CL Wide Range Pod). 2 Select Remove from the open setup menu. 3 A confirmation window opens with the prompt Confirm and Device will be removed. 4 Select the Confirm pop-up key. A message confirms <cl Measurement> has been removed. or 1 Open the Tele Info window. 2 Select the symbol of the CL Pod, and select Remove from the pop-up menu. 3 A confirmation window opens with the prompt Confirm and Device will be removed. 4 Select the Confirm pop-up key. A message confirms <cl Measurement> has been removed. or 1 2 Redock the CL Pod at the base station. Switch the base station to Standby. 3 Remove the CL Pod; it is now unassigned. To unassign a IntelliVue CL Pod using its user interface, see the Cableless Measurement Instructions for Use. NOTE If you unassign a CL Pod, all the measurements from it are no longer monitored, or are monitored by a connected lesser prioritized sensor. Replacing a CL Pod with an empty battery To replace CL Pod with an empty battery, assign and activate a new CL Pod of the same type at the CL base station. The CL Pod with the empty battery is unassigned automatically from the CL base station, and replaced by the newly activated CL Pod. 95 4 Cableless Monitoring Calling Patients To call a patient currently not near the fetal monitor and base station, select the SmartKey Call Patient at the fetal monitor. The base station will then select one transducer, or one of the CL Pods, if one is assigned and active, to emit the tone sequence to notify the patient. Inform the ambulating patient, if the cableless device is issuing any beeping sounds, to return to the room with the fetal monitor. Preparing to Monitor Cablelessly When monitoring cablelessly with the FM20/30/40/50 monitors, most of the same procedures apply as described in Preparing to Monitor on page 48. Additions and deviations applying to cableless devices and existing procedures are described here. WARNING The Avalon CL Wide Range Pod uses a WLAN connection to extend the operating range of CL transducers and CL Pods. The Avalon CL Wide Range Pod sends real-time patient data to the fetal monitor. The fetal monitor displays real-time patient data, provides alarms, data storage, and clinical decision support applications. The data is also transmitted to a connected obstetrical surveillance system. Using a WLAN connection may lead to network drop-outs resulting in the data loss of monitored vital signs. Do not use the Avalon CL Wide Range Pod with patients for whom a momentary loss of vital sign monitoring is not acceptable. In case of frequent or prolonged network drop-outs (indicated by Disconnect INOPs at the fetal monitor and at the CL transducers or CL Pods):

revert to the use of CL devices without the CL Wide Range Pod, restrict the patient to a reduced range around the Avalon CL base station, and inform your service personnel. CL Transducers 1 2 To monitor cablelessly with the CL transducers, assign them at the base station as described in CL Transducer Assignment on page 94. Place the CL transducers and the belt on the patient as described in Fastening Belts and Transducers on page 50. 3 Check the measurements on the monitor, and if necessary, move the CL transducers until you have a good signal for all measurements. IntelliVue CL Pods 1 2 To monitor cablelessly with the IntelliVue CL Pods, assign them at the base station as described in CL Pod Assignment on page 95. Put the CL Pods in their cradles and place them on the patient as described in the IntelliVue Cableless Measurements Instructions for Use. 96 Applying the CL Fetal & Maternal Patch and Pod 4 Cableless Monitoring WARNING Do not use the CL Fetal & Maternal Pod and electrode patch for monitoring if:

The skin on the abdomen of the patient has established erythema, lesions, infection, inflammation, or any kind of injuries at the applications site The patient has a history of skin irritation, allergies, or hypersensitivity to adhesives The patient carries multiple fetuses The gestational age is less than 36 completed weeks. The measurement method is also only validated with patients in labor. CAUTION During handling, avoid close contact of the CL Fetal & Maternal Pod or the electrode patch to an implanted pacemaker or defibrillator. NOTE The Avalon CL Fetal & Maternal Pod and Patch are not available for the U.S., other FDA regulated territories, and Canada. At the Mother's Side 1 Have a new single-use electrode patch ready, and make sure that the pouch is still intact. Check the expiration date that is printed on the pouch. 2 Clean the application area on the abdomen of the patient. Use mild soap to wash any cream, oil, or gel from the abdomen. Make sure to thoroughly wipe the area dry afterwards, ideally using paper towels. 3 4 Take the electrode patch from its pouch. Study the electrode patch Instructions for Use showing the correct placement of the electrode patch on the abdomen of the patient. 5 Remove the cover from the adhesive area under the central area of the patch. (Do not remove the cover from any of the five surrounding electrodes yet). 6 Verify the correct orientation of the patch. The Philips/Monica printed top electrode must point to the patients chest. 7 Place the central adhesive area of the patch over the patients umbilicus as shown in the patch Instructions for Use. Then press it down. For patients with a displaced umbilicus:

Where the umbilicus has been displaced downwards, position the center of the patch along the midline, where it intersects the horizontal line passing over the iliac crests. Alternatively, estimate the mid-point between the fundus and symphysis pubis. For very obese patients or patients with a large panniculus:

An alternative strategy is to position the patch along the midline such that the edge of the top electrode is placed 10-12 cm (4-5 in) below the fundus. 8 Lift up one of the four electrodes. Identify the small area of the skin where you will place the center of the electrode. 97 4 Cableless Monitoring 9 Use one piece of abrasive ECG skin preparation paper to prepare the patient's skin. Make three horizontal and three vertical strokes with the skin preparation paper. Focus the strokes on the small area of the skin where the conductive center of the electrode will be placed. Make deliberate but gentle strokes, lifting the finger after each stroke. CAUTION Do not use too much pressure with the abrasive skin preparation paper to avoid skin injury. incorrect correct 10 Remove the protective cover from the electrode. Place the electrode on the prepared skin. Press it down firmly, but avoid pressing the central gel area of electrode. CAUTION Avoid placing electrodes over: umbilicus, piercings, scars, thick stretch marks, open skin, moles, and very dark linea nigra if possible. 11 Repeat the steps for the skin preparation and electrode placement for the other three electrodes. 12 For the last remaining electrode attached to the long flexible cable, identify the small area of skin to prepare, so that the center of this reference electrode will be positioned on the midline, approximately 6 cm (2.4 in) above the rim of the symphysis pubis. For patients with a displaced umbilicus, very obese patients, or patients with a large panniculus:

Place the electrode on top of the panniculus approximating to the point 6 cm (2.4 in) vertically from the symphysis pubis. If during monitoring the aFHR signal quality is poor, reposition the electrode lower down on the abdomen to maximize the FHR signal, and consider placing the electrode under the panniculus just below the turn. 13 Prepare the skin like for the first four electrodes. 14 Remove the protective cover from the electrode. Then place the electrode on the prepared skin and press it down firmly, but avoid pressing the central gel area of electrode. 15 Assign a CL F&M Pod at the base station as described in CL Pod Assignment on page 95. 16 Place the CL F&M Pod on the electrode patch. 17 After you have placed the CL F&M Pod on the patch, allow the measurement some time to get to stable parameter value readings and leave the patient 10 to 15 minutes in bed before ambulating. 98 4 Cableless Monitoring 1 2 CL F&M Pod and electrode patch centered on the umbilicus Placement of electrode 6 cm

(2.4 in) above the rim of the symphysis pubis At the Monitor After you have placed the CL F&M Pod on the electrode patch, the cl F&M Electrode Status window opens at the monitor. In the cl F&M Electrode Status window, the electrodes and their skin contact status are shown. The skin contact status indicates, whether the skin preparation at each electrode site was successful. 1 2 cl F&M Electrode Status Skip Check, Start Measurement There are three methods to reopen a closed cl F&M Electrode Status window. Select:

The clF&M Status SmartKey (configurable) cl F&M Status in the setup menu of one of the CL F&M parameters (for example, Setup aFHR1) cl F&M Status from the Main Setup menu 99 4 Cableless Monitoring Electrode Status Description What to Do The skin contact status is good. When a good skin contact status is indicated for all five electrodes, the cl F&M Electrode Status window closes, and the measurement starts automatically. The skin contact is limited. Further skin preparation may be required:

1 Carefully remove the electrode from the skin. 2 Dry the skin. 3 Repeat the skin preparation procedure. 4 If the contact status cannot be improved, you can choose to skip the electrode status check by selecting the Skip Check, Start Measurement button in the cl F&M Electrode Status window. Measurement accuracy should not be affected, but fetal heart rate detection may be less sensitive. The skin contact is insufficient. The electrode is not applied to the skin, or further skin preparation is required:

1 Carefully remove the electrode from the skin. 2 Dry the skin. 3 Repeat the skin preparation procedure. 4 It is not recommended to skip the electrode status check, if bad skin contact quality is persistently indicated for one or more electrodes. This status may be shown temporarily, or in case of a patch malfunction, combined with an INOP message. Electrode status is unknown. NOTE If you have to repeat the skin preparation, or fix a loose electrode, ensure that enough wet gel remains in the conductive middle of the electrode during the reapplication of the electrode. Add additional fixation (any type of medical grade tape) to the pad in case the adhesive is compromised. Allow the skin some minutes to absorb the gel before repeating the skin preparation. If you cannot get a good measurement signal quality, use an alternative monitoring method. The electrode patch can remain applied for up to 48 hours. Remove the electrode patch, if there are signs of skin irritation. If you have to replace an electrode patch:

Gently remove the electrode patch from the abdomen of the patient. Wipe the abdomen dry thoroughly. Apply a new patch over exactly the same location. In this case, no further skin preparation is required. Monitoring with the CL F&M Pod and electrode patch can continue when the patient takes a shower. However, ensure that the CL F&M Pod remains on the electrode patch all the time, to keep the contacts of the electrode patch dry. The achievable maximum wireless operating range may be compromised when monitoring under a shower. The CL Fetal & Maternal Pod is not intended for underwater monitoring, for example in a bathtub. 100 4 Cableless Monitoring WARNING Do not reuse a patch on another patient due to the risk of cross contamination. After Monitoring 1 After monitoring is done, remove the CL F&M Pod from the electrode patch. 2 Clean and disinfect the CL F&M Pod, see Care and Cleaning on page 257. 3 Dock the CL F&M Pod back at the base station. 4 Gently remove the electrode patch and the electrodes from the abdomen of the patient. 5 Dispose of the electrode patch. 6 Remove the residuals of the adhesive from the patient's skin. Working with the CL Wide Range Pod The CL Wide Range Pod extends the signal range for the cableless measurement devices worn by the ambulating patient. Understanding the Display When the CL WRP Pod is active, the display shows the following screen elements:

Equipment label Network and WLAN connectivity status Channel configured Number of connected CL Pods Alarm status Battery status When the CL WRP is inactive, the display only shows:

Equipment label Time Network and WLAN connectivity status Battery status When the CL WRP Pod is charging on the CL base station, the display only shows:

Equipment label Network and WLAN connectivity status Battery status 101 4 Cableless Monitoring 1 Number of connected CL Pods 2 Channel configured 3 Network status and connectivity 4 Equipment label 5 Alarm status 6 Battery status 7 Hardkeys Assigning and Activating the CL WRP Pod Assign the CL Wide Range Pod at the base station as described in CL Pod Assignment on page 95. To activate a CL WRP Pod, place it on the CL base station. When a CL WRP Pod is not activated, the backlight of the display is automatically switched off and the low-activity screen is displayed. The CL WRP has three hardkeys. The three hardkeys have an additional function when a key is pressed for a couple of seconds:

Opens the network menu. Opens the SmartKeys menu. Returns to the Main Screen. Pressing the hardkey while on the Main Screen, locks the hardkeys and a lock symbol appears on the screen above the battery symbol. Press it again to unlock the keys and the lock symbol disappears. As soon as the CL WRP Pod is picked up from the CL base station, it connects itself over WLAN and LAN with the fetal monitor. With the connection established, the CL WRP Pod takes over from the base station, and sends the signals from the cableless devices to the monitor. While the CL WRP Pod is active, cableless devices can still be assigned or unassigned at the base station dynamically to the patient. It does not matter in which sequence the cableless devices or the CL WRP Pod are activated. At the fetal monitor The connection status of the CL WRP Pod is shown on the monitor, see Cableless Status Indication on page 91. The telemetry icon indicates that the CL WRP Pod is active and connected to the fetal monitor. The Tele Info shows the active CL WRP Pod. 102 4 Cableless Monitoring Redocking the CL WRP Pod at the CL base station hands the signal transfer from the CL WRP Pod back to the CL base station. Handing the CL WRP Pod to the Patient Hand the CL Wide Range Pod to the patient to carry with her, or optionally wearing it using the Mobile CL Transmitter Cradle (989803168881) or Telemetry Pouch with window (989803137831). The CL Wide Range Pod should be worn with its rear side facing the body. CL Wide Range Pod carried in hand, or CL Wide Range Pod worn with the belt clip (supporting loop and belt clip part of the optional Mobile CL Transmitter Cradle). Battery Lifetime Management The lifetime of a Lithium Ion battery depends on the frequency and duration of use. CL Transducers Battery replacement is recommended after 500 charge-discharge cycles, or if the battery is older than 4 years whatever is reached first. If the battery of a cableless transducer has aged and an exchange of the battery is highly recommended, a prompt message is displayed at the fetal monitor for ca. 60 seconds. The prompt is repeated whenever the Tele Info window is opened until the battery is replaced. The CL transducer battery allows for 10 hours of continuous operation. Depending on the transducer type the following messages are displayed:

cl US battery has aged. Replacement strongly recommended cl Toco battery has aged. Replacement strongly recommended cl ECG/IUP batt has aged. Replacement strongly recommended If you are getting this message, contact your service personnel so they can replace the CL transducer's battery. CL F&M Pod Pod replacement is recommended after 500 charge-discharge cycles, or if the battery is older than 4 years whatever is reached first. If the battery of a CL F&M Pod has aged and an exchange of the Pod is highly recommended, a prompt message is displayed at the fetal monitor for ca. 60 seconds. The prompt is repeated whenever the Tele Info window is opened. The CL F&M battery allows for 16 hours of continuous operation. 103 4 Cableless Monitoring The following message is displayed:

cl F&M battery has aged. Replacement strongly recommended If you are getting this message, contact your service personnel so they can replace the CL F&M Pod. CL Wide Range Pod Battery replacement is recommended after 500 charge-discharge cycles, or if the battery is older than 4 years whatever is reached first. If the battery of a CL Wide Range Pod has aged and an exchange of the battery is highly recommended, a prompt message is displayed at the fetal monitor for ca. 60 seconds. The prompt is repeated whenever the Tele Info window is opened until the battery is replaced. The CL Wide Range Pod battery allows for 4 hours of continuous operation The following message is displayed:

cl WRP battery has aged. Replacement strongly recommended CL NBP and CL SpO2 Pods For battery charge-discharge cycles specification of the IntelliVue CL Pods (NBP and SpO2), refer to the Service Guide of the Cableless Measurements. Charge Cycle The age of a lithium ion battery begins at the date of manufacture. The lithium batteries are designed for frequent recharging. A complete charging cycle is only reached and counted, when all recharging periods equal a 100% charge. The date of manufacture and number of charge-discharge cycles can be printed out in a battery report. Patient Transport Within the Hospital During transport, the patient wearing the CL transducers can be transferred from one fetal monitor to another fetal monitor. 1 To stop monitoring, discharge the patient at the fetal monitor. Do not switch the CL base station to Standby. Note: If you switch the CL base station to Standby after the discharge, the CL transducers only hold the assignment to the CL base station for 1 minute. 2 Disconnect the CL base station from the fetal monitor. 3 The CL transducers hold the assignment to the CL base station for 30 minutes. Transport the patient wearing the CL transducers with the disconnected CL base station to another fetal monitor. 4 Connect the CL base station to the other fetal monitor. The fetal monitors need to have the same software revisions, and the correct time and date settings. 5 Manually admit the patient to the fetal monitor, unless the patient is transferred to the new fetal monitor with the OB TraceVue/IntelliSpace Perinatal system. 6 Resume monitoring. Once the base station and the transducer are connected and assigned to the new monitor, the previous monitor can be switched off or to Standby. 104 Underwater Monitoring 4 Cableless Monitoring Only the battery-operated CL transducers of the Avalon CL and Avalon CTS systems can be used to monitor under water. You can use them to monitor patients in a bathtub or shower. This does not apply to the IntelliVue CL SpO2, CL NBP, and the CL Wide Range Pod, do not immerse the CL Pods into water. The CL F&M Pod can be worn within the shower, if the Pod is securely placed on the electrode patch, so that the contacts cannot get wet. Radio transmission range of the CL F&M Pod may be reduced under a shower. Cableless transmission distances are shorter when monitoring under water. A metal bathtub is likely to further reduce the operating range. WARNING Never immerse the base station in liquid. You must protect it against water sprays or splashes. Place the base station where there is no chance of contact with water, or falling into water or other liquids. CAUTION Avoid the use of pulsating water jets in the bath or shower while monitoring, as these can be misinterpreted as an incorrect (or totally artificial) heart rate. Toco Baseline drift: When using transducers under warm water, the temperature increase causes a significant baseline change due to internal pressure increase. The depth under water at which the Toco transducer is used also has an effect on the Toco baseline, as the water pressure increases with depth. After immersion, allow one to two minutes for the pressure to stabilize, then adjust the Toco baseline (between contractions), and check it frequently. When using the transducers underwater, the radio transmission range is reduced, and signal loss may occur. Water-proof belts like M1562B are recommended for the cableless transducers when monitoring in water. 105 4 Cableless Monitoring 106 5 5FM20/30 Battery Option You can switch between battery-powered and mains-powered (AC) operation without interrupting monitoring. The monitor is connected to the AC mains power via the external power supply. NOTE The battery option is not available for the FM40/FM50. External Power Supply M8023A The external power supply M8023A (option #E25) allows you to operate the fetal monitor from an AC

(alternating current) power source of 100 V to 240 V (10%) and 50/60 Hz (5%). If this option is used, then the M8023A (option #E25) power supply is included for FM20/30. 1 AC power cord, connected to AC mains socket 2 Measurement Link (MSL) cable, supplies the power to the monitor for operation and for battery charging 3 Power-on LED, the green light is on when the external power supply is connected to the AC mains 107 5 FM20/30 Battery Option WARNING Always use the supplied power cord with the earthed mains plug to connect the external power supply M8023A (option #E25) to an earthed AC mains socket. Never adapt the mains plug from the power supply to fit an unearthed AC mains socket. Do not use AC mains extension cords or multiple portable socket-outlets. If a multiple portable socket-

outlet without an approved isolation transformer is used, the interruption of its protective earthing may result in enclosure leakage currents equal to the sum of the individual earth leakage currents, so exceeding allowable limits. Do not connect any devices that are not supported as part of a system. Any non-medical device placed and operated in the patients vicinity must be powered with an approved isolation transformer that ensures mechanical fixing of the power cords and covering of any unused power outlets. Using Batteries The Lithium Ion batteries used in your monitor store a large amount of energy in a small package. This allows reliable battery-operated monitoring, but also requires care in use and handling of the batteries. Follow the instructions in this chapter and see the Service Guide for further details. Battery Power Indicators The battery LED and battery status information on the main screen, in combination with INOP messages and prompts, help you keep track of the battery power status. The indicators always show the remaining capacity in relation to the battery's actual maximum capacity, which may lessen as the battery ages. You can see the actual capacity in the Battery Status window. Battery LED The possible battery LED status on the right side of the monitor is described in the table below. 1 Battery LED 108 5 FM20/30 Battery Option Battery LED Colors If the monitor is connected to mains power, this means If the monitor is running on battery power, this means Green Yellow Red, flashing Battery power is >90%

Battery charging (battery power

<90%) Less than 10 minutes power remaining Red, flashes intermittently Battery or charger malfunction Battery malfunction Battery Status on the Main Screen Battery status information is permanently displayed on all screens. It shows the status of the battery, with the battery power remaining, with an estimate of the monitoring time this represents. Battery power gauge: This shows the remaining battery power. It is divided into sections, each representing 20% of the total power. If three sections are filled, as in this example, this indicates that 60%

battery power remains. If no data is available from the battery, a question mark is shown in the gauge. Monitoring Time Available: Below the battery power gauge a time is displayed. This is the estimated monitoring time available with the current battery power. Note that this time fluctuates depending on the system load (the display brightness, the recorder configuration, and how many measurements you carry out). Battery malfunction symbols: Normal battery function is indicated by the battery power gauge, together with the remaining operating time, on the main screen. You are informed of problems or changes in the status of the battery by the battery status/malfunction indicator. This consists of a blank battery gauge containing a "!" symbol. If the symbol is red, this indicates a critical situation. You can check the specific cause of the problem by looking at the symbol(s) displayed in the Battery Status window. Battery Status Indicator Battery Malfunction Indicator Alternates with the battery gauge on the main screen. Check in the Battery Status window to see which status symbol is displayed to identify the cause. The red exclamation mark flashes. Critical battery situation or malfunction. Check in the Battery Status window to see which malfunction indicator is displayed, or refer to the INOP, to identify the cause. 109 5 FM20/30 Battery Option Battery Status Window 1 To access the Battery Status window and its associated pop-up keys, select the battery status information on the screen, or select Main Setup, Battery. Capacity, remaining tells you how much power is left in the battery. Capacity, fullCharge tells you how much power the battery can hold when fully charged. TimeToEmpty tells you approximately how long you can continue to use the monitor without an AC connection. The time span fluctuates depending on the system load (the display brightness and how many measurements you carry out), and the remaining capacity of the battery. TimeToFull is shown in place of TimeToEmpty if the monitor is connected to a power supply, and tells you how much time is left until the battery is charged to 90%. If >10 hr is shown here, the battery may not charge completely when the monitor is in use. Battery status/malfunction symbols: If a problem is detected with the battery, an INOP may be issued, and the following symbols are displayed in the Battery Status window, where they may be accompanied by a status message providing more details. Symbols indicating critical situations are colored red. Battery Status Symbols Battery Malfunction Symbols Battery is empty

(Red) incompatible battery Battery not charging as the temperature is above or below the specified range

(Red) battery malfunction Battery requires maintenance

(Red) battery has no power left Charging stopped to protect the battery

(Red) battery temperature too high

(Red) battery is missing, insert battery Checking Battery Charge To check the charge status of a battery, refer to the battery power gauge on the screen, or open the Battery Status window. When Battery Lifetime is Expired When the battery is aged, either after 3 years from manufacturing date or after 500 charge-discharge cycles, it is recommended to replace the battery. To remind you of this, a message will appear in the Battery Status window. This message will only be displayed at the appropriate time when the date and time on the monitor is correct. Optimizing Battery Performance The performance of rechargeable batteries may deteriorate over time. Battery maintenance as recommended here can help to slow down this process. 110 5 FM20/30 Battery Option Display Brightness Setting 1 In the Main Setup menu, select User Interface, Brightness, then Optimum. This selects a level of brightness suitable for most monitoring locations that uses less battery power than brighter settings. 2 Ensure that the current level of brightness is suitable for your monitoring location. Charging the Battery To charge the battery:

1 Connect the monitor to the external power supply (M8023A). 2 Charge the battery until it is full, the battery LED is green, and the battery power gauge is filled. During high load of the monitor (usage of multiple measurements) the battery may not charge. To remedy this:

reduce the load by removing measurements reduce the screen brightness or stop the recorder Internal temperature conditions can also cause the battery to not charge. This is necessary to protect the battery from damage and does not indicate a malfunction. Keep the monitor at room temperature and move it away from heat sources or out of direct sunlight. The battery will resume charging when the temperature is within range again. The battery will charge more quickly if the monitor is switched off. Conditioning the Battery You must condition the battery when the battery requires maintenance symbol shows on the screen. Do not interrupt the charge or discharge cycle during conditioning. CAUTION Condition the battery with a monitor not currently in use. The monitor switches off automatically when there is no battery power left. To condition the battery:

1 Charge the battery until it is completely full. Open the Battery Status window and check that the Batt fully charged message is displayed. 2 Disconnect the monitor from mains power, and let the monitor run until there is no battery power left and the monitor switches itself off. 3 Reconnect the monitor to mains power and charge the battery until it is full for use or charge to 50%

for storage. Battery Safety Information WARNING Use only Philips batteries part number M4605A. Use of a different battery may present a risk of fire or explosion. Do not open batteries, or dispose of them in fire, or cause them to short circuit. They may ignite, explode, leak, or heat up, causing personal injury. If battery leakage should occur, avoid contact with skin. Refer to qualified and authorized service personnel. Dispose of used batteries promptly and in an environmentally responsible manner. Do not dispose of the battery in normal waste containers. Consult your hospital administrator to find out about local arrangements. Do not expose batteries to liquids. 111 5 FM20/30 Battery Option Do not crush, drop, or puncture batteries - mechanical abuse can lead to internal damage and internal short circuits which may not be visible externally. If a battery has been dropped or banged against a hard surface, whether damage is visible externally or not:

discontinue use dispose of the battery in accordance with the disposal instructions above. Keep batteries out of the reach of children. CAUTION Do not disassemble, heat above 100C (212F) or incinerate the batteries, to avoid the risk of fire and burns. Keep batteries out of the reach of children and in their original package until you are ready to use them. If battery leakage should occur, use caution in removing the battery. Avoid contact with skin. Refer to qualified and authorized service personnel. Do not install or use pre-damaged batteries. Storing the Battery WARNING Remove the battery from the monitor when it is not used for a longer period of time, to avoid potential damage caused by battery leakage. Batteries should be charged to a maximum of 50% for storage. The battery will discharge over time if it is stored inside the monitor without AC power connection. The reported values for remaining capacity and runtime will become less accurate when the battery is stored in this way for a longer period of time (that is, several weeks). Cableless Monitoring with FM20/30 Battery Option The CL Pods can be used with the FM20/30 with battery option #E25. The CL Pods can be assigned and activated, but will not be charged. The only exception to this is the CL F&M Pod, which can also be charged. The charging time of the CL transducers can take up to 6 hours if they are charged from an FM20/30 with battery option. If you charge the CL transducers at an FM20/30 with battery option, be sure to remove all wired transducers from the fetal monitor. Leaving them connected to the fetal monitor can cause the CL transducers not to charge at all. 112 5 FM20/30 Battery Option Patient Transport Within the Hospital The FM20 and FM30 fetal monitor with battery option offer the possibility of continuous monitoring of a patient, while she is transported within the hospital. 1 Unplug the MSL connector at the fetal monitor. Or, in case an external power supply is mounted on a rollstand, unplug it from the AC Mains. The fetal monitor is now operating on battery power. 2 Move the patient with the fetal monitor (on a cart) to the new location. 3 Reconnect the MSL connector at the fetal monitor or the external power supply to the AC Mains. 113 5 FM20/30 Battery Option 114 6Alarms 6 The alarm information here applies to all measurements. Measurement-specific alarm information is contained in the sections on individual measurements. The fetal monitor has two different types of alarm: patient alarms and INOPs. Patient Alarms Patient alarms are red and yellow alarms. A red alarm indicates high priority, such as a potentially life threatening situation (for example, SpO2 below the desaturation alarm limit). A yellow alarm indicates a lower priority alarm (for example, a fetal heart rate alarm limit violation). INOPs INOPs are technical alarms. They indicate that the monitor cannot measure and therefore not detect critical conditions reliably. If an INOP interrupts monitoring and alarm detection (for example, MECG Leads Off), the monitor places a question mark in place of the measurement numeric and sounds an audible tone. INOPs without this tone indicate that there may be a problem with the reliability of the data, but that monitoring is not interrupted. INOPs are cyan by default. The following INOPs can also be configured as red or yellow INOPs to provide a severity indication:

ECG Leads Off Battery Empty (FM20/30, CL devices) Cuff Overpress Cuff NotDeflated No Pulse Alarm Delays There is a delay between a physiological event at the measurement site and the corresponding alarm indication at the monitor. This delay has two components:

The general measurement delay time is the time between the occurrence of the physiological event and when this event is represented by the displayed numerical values. This delay depends on the algorithmic processing and on the measurement dependent averaging time. The time between the displayed numerical values exceeding an alarm limit and the alarm indication on the monitor. This delay is the sum of the alarm delay configured for the specific measurement plus the system alarm delay. The system alarm delay is the processing time the system needs for any alarm on the monitor to be indicated after the measurement has triggered the alarm. See the performance specifications in Specifications and Standards Compliance on page 287 for the system alarm delay specification. 115 6 Alarms Multiple Alarms If more than one alarm is active, the alarm messages are shown in the alarm status area in succession. An arrow symbol next to the alarm message informs you that more than one message is active. The monitor sounds an audible indicator for the highest priority alarm. If more than one alarm condition is active in the same measurement, the monitor announces the most severe alarm condition first. WARNING Alarm systems of the monitor and those of any connected obstetrical information and surveillance system are interdependent and not synchronized. Therefore audible alarms should not be relied upon for remote monitoring. Alarming is only available at the Avalon fetal monitor, not at the Cableless Measurement Devices, see the Instructions for Use for the IntelliVue Cableless Measurements. If configured so, SpO No Pulse will only be displayed in yellow or red (instead of cyan), when no other Pulse source is valid and is displayed instead of the Pulse from SpO2. Alarm Mode You can configure the alarm mode for your fetal monitor. There are two possible modes:

All: alarms and INOPs are enabled, with all audible and visual indicators active. INOP only: only INOPs are enabled, with audible and visual indication active. WARNING In INOP only mode, no fetal/maternal patient alarms are enabled or indicated. The alarm status area for yellow and red alarms shows the INOP only indication in conjunction with the Alarms Off symbol. No individual measurement alarm limits or alarm off symbols are displayed. No fetal/maternal patient alarm settings are available in the setup menus. Nurse Call Systems If configured to do so, red, yellow, and cyan alarms are indicated on a nurse call system which is connected to the optional nurse call relay. Visual Alarm Indicators Alarm message: An alarm message appears in the alarm status area on the second line at the top of the screen indicating the source of the alarm. If more than one measurement is in an alarm condition, the message changes every two seconds, and has an arrow at the side. The background color of the alarm message matches the alarm priority: red for red alarms and red INOPs, yellow for yellow alarms and yellow INOPs, and cyan for INOPs. The asterisk symbols (*) beside the alarm message match the alarm priority:

*** for red alarms, and ** for yellow alarms. INOPs are displayed without asterisks, but a red INOP has !!!

three exclamation marks, and a yellow INOP has !! two exclamation marks before it. Depending on how your monitor is configured, it may display alarm limit violation messages:

in text form, for example ** FHR1 Low or in numeric form, for example ** FHR1 94<110, where the second number shows the currently set alarm limit, and the first number shows the value at which that alarm limit was violated by the widest margin. 116 6 Alarms Flashing numeric: The numeric of the measurement in alarm flashes. Bright alarm limits: If the alarm was triggered by an alarm limit violation, the corresponding alarm limit on the monitor screen is shown more brightly. Audible Alarm Indicators The audible alarm indicators configured for your fetal monitor depend on which alarm standard applies in your hospital. Audible alarm indicator patterns are repeated until you acknowledge the alarm by switching it off or pausing it, or until the alarm condition ceases (if audible alarm indication is set to non-latching). WARNING Do not rely exclusively on the audible alarm system for fetal monitoring. Adjustment of alarm volume to a low level or off during monitoring may result in a dangerous situation. Remember that the most reliable method of fetal monitoring combines close personal surveillance with correct operation of monitoring equipment. Alarm Tone Configuration The audible alarm indicators of your monitor are configurable. In the monitor's Configuration Mode, you can:

increase the alarm volume of unacknowledged alarms at regular intervals change the interval between alarm sounds (ISO/IEC Standard alarms only) change the base volume of the red and yellow alarm tones and the INOP tones change the alarm sound to suit the different alarm standards valid in different countries Standard Philips Alarms Red alarms and red INOPs: a high pitched sound is repeated once a second. Two-star yellow alarms and yellow INOPs: a lower pitched sound is repeated every two seconds. One-star yellow alarms (short yellow alarms): the audible indicator is the same as for yellow alarms, but of shorter duration. Standard INOPs: an INOP tone is repeated every two seconds. ISO/IEC Standard Audible Alarms Red alarms and red INOPs: a high pitched tone is repeated five times, followed by a configurable pause. Two-star yellow alarms and yellow INOPs: a lower pitched tone is repeated three times, followed by a configurable pause. One-star yellow alarms (short yellow alarms): the audible indicator is the same as for yellow alarms, but of shorter duration. Standard INOPs: a lower pitched tone is repeated twice, followed by a pause. Changing the Alarm Tone Volume The alarm volume symbol at the top right of the monitor screen gives you an indication of the current volume. To change the volume:

1 Select the volume symbol. 117 6 Alarms 2 The volume scale pops up. 1 Alarm Volume 3 Select the required volume from the volume scale. When the alarm volume is set to zero (Off), the alarm volume symbol shows this symbol:

If you switch the alarm volume off, you will not get any audible indication of alarm conditions. Minimum Volume for Severe Yellow or Red INOPs Severe yellow or red INOPs require action to ensure the well-being of the patient. Therefore the minimum volume for the INOP tone is set to at least alarm volume 8, irrespective of the current alarm volume setting. The INOP tone will sound even if the monitor alarm volume is set to zero. The severe INOPs for which this applies are:

INOP Battery Empty Battery Empty Cuff Overpress Cuff NotDeflated Factory Default INOP tone cyan cyan cyan cyan severe (fetal monitor with battery option) severe (CL transducers and Pods) severe severe Power Loss Tone FM20/30 with Battery Option, FM40/50 When power is lost - no power is available from the AC power source or from the battery - a beeper will sound. The tone can be silenced by pressing the On/Standby button. 118 Acknowledging Alarms To acknowledge all active alarms and INOPs, select the Silence key. This switches off the audible alarm indicators. 6 Alarms A checkmark beside the alarm message indicates that the alarm has been acknowledged. If the condition that triggered the alarm is still present after the alarm has been acknowledged, the alarm message stays on the screen with a checkmark symbol beside it. If the alarm condition is no longer present, all alarm indicators stop and the alarm is reset. Switching off the alarms for the measurement in alarm, or switching off the measurement itself, also stops alarm indication. Acknowledging Disconnect INOPs Acknowledging an INOP that results from a disconnected transducer, switches off the associated measurement. Alarm Reminder If Alarm Reminder is configured on for your monitor, you will get an audible reminder of alarm conditions that remain active after you have acknowledged the alarm. This reminder may take the form of a repetition of the alarm tone for a limited time, or an unlimited repetition of the alarm tone (this is the same as a new alarm). Alarm Reminder is available only for yellow and red alarms and INOPs and not for standard cyan INOPs. In Configuration Mode, you can set the interval between silencing the alarm and sounding the reminder tone to one, two, or three minutes. Pausing or Switching Off Alarms If you want to temporarily prevent alarms from sounding, for example while you are moving a patient, you can pause alarms. Depending on your fetal monitor configuration, alarms are paused for one, two, or three minutes, or infinitely. To view the alarm pause setting chosen for your unit:

1 Select Main Setup, Alarms, Alarm Settings. 2 Check the Alarms Off setting. This setting can be changed in Configuration Mode. There are some settings made in Configuration Mode that can affect the availability of the pause alarms functionality. The Pause Alarms/Alarms Off SmartKey can be removed from the screen to avoid unintentional switching off of alarms. In this case you can only pause alarms or switch alarms off permanently in the Alarms menu, under Main Setup. The Pause Alarms/Alarms Off SmartKey can be configured to pause or switch off red and yellow alarms, yellow alarms only, or not to function at all. If it is configured not to function, you cannot pause alarms or switch alarms off permanently at all. When the alarms off priority is set to Yellow Only, the Pause Alarms/Alarms Off key becomes the Pause Yellow/Yellow Al. Off. 119 6 Alarms To Pause All Alarms If you have configured alarms to be paused for one, two, or three minutes, the SmartKey is labeled Pause Alarms. Select the Pause Alarms SmartKey to pause all alarms. Or 1 2 3 Select Main Setup. Select Alarms. Select Pause Alarms. To Switch All Alarms Off You can switch alarms off permanently if your monitor is configured to allow infinite alarms pause, and the SmartKey is labeled Alarms Off. Select the Alarms Off SmartKey. Or 1 2 3 Select Main Setup. Select Alarms. Select Alarms Off. While Alarms are Paused or Off When red alarms are paused or off:

In the alarm field, the monitor displays the message Al. Paused x:yy or Alarms Off, together with the alarms paused symbol or the alarms off symbol. When yellow alarms are paused or off:

In the alarm field, the monitor displays the message YellowPaused x:yy or Yellow Alarms Off, together with the alarms paused symbol or the alarms off symbol. For red and yellow alarms:

Alarms Paused Alarms Off No alarms are sounded and no alarm messages are shown. INOP messages are shown but no INOP tones are sounded. The only exceptions are the INOPs Cuff NotDeflated, Cuff Overpress, and Battery Empty from the FM20/

30 monitor with battery option. These INOPs switch all alarms back on again, so that an INOP tone can be sounded. You must remove the INOP condition first, before you can switch off or pause the alarms again. 120 6 Alarms Restarting Paused Alarms To manually switch on alarm indication again after a pause, select the SmartKey Pause Alarms (or Alarms Off) again. Alarm indication starts again automatically after the pause period expires. If the monitor is configured to stay paused infinitely, you must select Alarms Off again to restart alarm indication. Extending the Alarm Pause Time If your monitor has the function extended alarm pause enabled, you can extend the alarm pause time. Use this to prevent alarms being indicated, for example, while you are washing a patient or carrying out a procedure. Only extend the alarm pause time when you are sure that clinical personnel are available to monitor the patient's condition closely. To extend the alarm pause time to five or 10 minutes:

1 2 Select one of the alarm fields. This calls up the Alarm Messages window. Select either the pop-up key PauseAl. 5 min or the pop-up key PauseAl. 10 min. Each time you select one of these pop-up keys, the Alarm Pause Time is reset to five or 10 minutes. To Switch Individual Measurement Alarms On or Off This applies to Alarm Mode All. 1 2 Select the measurement numeric to enter its setup menu. Select Alarms to switch between On and Off. The alarms off symbol is shown beside the measurement numeric. Alarm Limits The alarm limits you set determine the conditions that trigger yellow and red limit alarms. WARNING Be aware that the monitors in your care area may each have different alarm settings, to suit different scenarios. Always check that the alarm settings are appropriate before you start monitoring. Viewing Individual Alarm Limits (Alarm Mode "All" Only) 1 Alarm Limits 121 6 Alarms You can usually see the alarm limits set for each measurement next to the measurement numeric on the main screen. If your monitor is not configured to show the alarm limits next to the numeric, you can see them in the related measurement setup menu. Select the measurement numeric to enter the menu and check the limits. Changing Alarm Limits To change individual measurement alarm limits using the measurement's setup menu:

1 2 In the measurement's setup menu, select the alarm limit you want to change. This calls up a list of available values for the alarm limit. Select a value from the list to adjust the alarm limit. CAUTION Set the alarm limits to a meaningful value for the individual patient. Setting the alarm limits to a too high or too low value may render the alarm function useless. Extreme Alarm Limits for Heart Rate and Maternal Pulse The extreme rate alarms, Extreme Tachy and Extreme Brady, generated by the active alarm source, either HR or Pulse, are set in Configuration Mode by adding a set value (the value) to the high and low alarm limits. 1 2 Extreme Brady Limit Low Limit 3 High Limit 4 Extreme Tachy Limit 5 6 Extreme Brady Extreme Tachy You need to know which value has been configured for your monitor. Changing the high and low alarm limits automatically changes the extreme alarm limits within the allowed range. To see the extreme rate alarms set for your monitor, in the Setup ECG menu, see the menu items ExtrTachy and ExtrBrady. Reviewing Alarms To review the currently active alarms and INOPs, select any of the alarm status areas on the fetal monitor screen. The Alarm Messages window pops up. All alarms and INOPs are erased from the monitor's alarm history when you discharge a patient, or if you leave the Demonstration Mode. Alarm Messages Window The Alarm Messages window shows all the currently active alarms and INOPs in chronological order, beginning at the top with the most recent. INOPs are shown on the left hand side, and alarms are shown on the right hand side. Any active red alarms are shown first, followed by yellow alarms. Acknowledged alarms or INOPs are shown with the checkmark symbol. The Alarm Messages window pop-up keys appear when the window is opened. Selecting the Review Alarms pop-up key opens the Review Alarms window. 122 Review Alarms Window 6 Alarms 1 2 3 4 5 Alarms On SpO No Pulse Alarms Silenced

** FHR1 High

** SpO Low The Review Alarms window contains a list of up to 300 of the most recent alarms and INOPs with date and time information. If configured to do so, each alarm is shown with the alarm limit active when the alarm was triggered and the maximum value measured beyond this limit. The Review Alarms window also shows any changes made to the Alarms On/Off or Alarms Silenced status. Only the main alarms On/Off transitions are logged in the alarm history, and On/Off alarm transitions for individual measurements are not logged. The information in the Review Alarms window is deleted when a patient is discharged. The Review Alarms window pop-up keys appear when the window is opened. Selecting the Active Alarms pop-up key opens the Alarm Messages window. Latching Alarms The alarm latching setting for your monitor defines how the alarm indicators behave when you do not acknowledge them. When alarms are set to non-latching, their indicators end when the alarm condition ends. Switching alarm latching on means that visual and/or audible alarm indications are still displayed or announced by the monitor after the alarm condition ends. The indication lasts until you acknowledge the alarm. Viewing the Alarm Latching Settings To see the alarm latching setting for your monitor:

1 2 In the monitor's Main Setup menu, select Alarms. Select Alarm Settings, and see the Visual Latching and Audible Latching settings. This setting can be changed in Configuration Mode. You should be aware of the settings chosen for your unit. There are three possible choices each for visual and audible latching: Red & Yellow, Red Only, and Off. The audible latching configuration can never be configured to a higher level than that configured for the visual latching. In other words, the audible latching setting is always the same level, or lower, than the visual latching setting. For example, if visual latching is configured to Red Only, then audible latching can only be set to Red Only or Off. The following table shows the possible combinations for latching settings:

Possible Combinations for Alarm Latching Settings Visual Latching Setting Audible Latching Setting Red & Yellow Red & Yellow Red & Yellow Red Only Red Only Off Red & Yellow Red Only Off Red Only Off Off 123 6 Alarms Alarm Latching Behavior Alarm Condition Red and Yellow Measurement Alarms Acknowledgment Presence Non-latching alarms Visual and audible Alarm has not been acknowledged Alarm condition still present Alarm tone on Alarm message Flashing numerics Alarm condition no longer present All audible and visual alarm indicators automatically stop latching Alarm tone on Alarm message Flashing numerics Alarm tone on Alarm message Flashing numerics Visual latching, audible non-latching Alarm tone on Alarm message Flashing numerics Audible alarm indicators automatically stop Alarm message Flashing numerics Alarm has been acknowledged Alarm condition still present Alarm tone off Audible alarm reminder

(if configured) Alarm message Flashing numerics Alarm tone off Audible alarm reminder

(if configured) Alarm message Flashing numerics Alarm tone off Audible alarm reminder

(if configured) Alarm message Flashing numerics Alarm condition no longer present Audible and visual alarm indicators automatically stop Audible and visual alarm indicators automatically stop Audible and visual alarm indicators automatically stop All INOPs except the unplugged INOPs are non-latching. Testing Alarms When you switch the fetal monitor on, a self test is started. You should hear a single tone. This indicates that the audible alarm indicators are functioning correctly. For further testing of individual measurement alarms, perform the measurement on yourself (for example SpO2 or NBP) or use a simulator. Adjust alarm limits and check that appropriate alarm behavior is observed. To test the functioning of visible and audible alarms, do the following:

1 2 Enable the alarm (Alarm Mode needs to be set to All, see the Configuration Guide). Set the alarm limits. 3 Measure or simulate the parameter that is out of range, or signal loss. 4 Verify that the visible and audible alarms are working. As an example, to test the FHR alarms:

1 Connect the US transducer to a fetal sensor socket. 2 Enable the FHR alarming (see Turning Alarms On or Off on page 197). 3 Set the high alarm limit and delay to 150 bpm and 60 seconds respectively, and the low alarm limit and delay to 110 bpm and 60 seconds respectively (see Changing Alarm Limits on page 197). 4 Generate a fetal heart rate of approximately 180 bpm (3 beats per second) for more than one minute. 5 Verify the functioning of the visible and audible alarms. 124 6 Alarms Alarm Behavior at Power On If the monitor is switched off for longer than one minute and then switched on again, or after a loss of power lasting longer than one minute, the monitor can be configured to restore either the alarm settings from the monitor's User Defaults, or the most recently used alarm settings. When a patient is discharged, the User Defaults of the monitor are always restored independent of the setting. After any of these situations, ensure that the alarm settings are appropriate for your patient. If power is lost for less than one minute, the alarm settings prior to the power loss are restored. If AlarmsOffAtStart is enabled in Configuration Mode alarms will be initially paused or off the next time the monitor is switched on, depending on a set of related configuration settings, see the Configuration Guide. 125 6 Alarms 126 7 7Patient Alarms and INOPs This chapter lists alarms and technical alarms (INOPs) for the fetal monitors irrespective of their priority. Alarm Messages Fetal alarms are identified by either FHR, dFHR, or aFHR. All other alarms without these identifiers refer to maternal parameters. Alarm messages can be configured with the Enhanced setting to give more information. These messages are shown additionally in the table below, with xxx for the measured value and yyy for the alarm limit concerned. Alarm Message From Condition Indication

** aFHR1 High

** aFHR2 High

** aFHR3 High

** aFHR1 xxx>yyy

** aFHR2 xxx>yyy

** aFHR3 xxx>yyy

** aFHR1 Low

** aFHR2 Low

** aFHR3 Low

** aFHR1 xxx<yyy

** aFHR2 xxx<yyy

** aFHR3 xxx<yyy

**aHR High

** HR xxx>yyy FHR

(CL F&M Pod) The fetal heart rate obtained from the CL F&M Pod has risen above the high alarm limit. Numeric flashes and high limit is highlighted, yellow alarm message, alarm tone. xxx denotes the highest measured value, and yyy is the high alarm limit. FHR

(CL F&M Pod) The fetal heart rate obtained from the CL F&M Pod has fallen below the low alarm limit. Numeric flashes and low limit is highlighted, yellow alarm message, alarm tone. xxx denotes the lowest measured value, and yyy is the low alarm limit. HR

(CL F&M Pod) The maternal heart rate obtained from the CL F&M Pod has risen above the high alarm limit. Numeric flashes and high limit is highlighted, yellow alarm message, alarm tone. xxx denotes the highest measured value, and yyy is the high alarm limit.

**aHR Low

** HR xxx<yyy HR

(CL F&M Pod) The maternal heart rate obtained from the CL F&M Pod has fallen below the low alarm limit. Numeric flashes and low limit is highlighted, yellow alarm message, alarm tone. xxx denotes the lowest measured value, and yyy is the low alarm limit.

*** Brady (Pulse) SpO2

*** Brady/P xxx<yyy The heart rate from the Pulse signal has fallen below the bradycardia limit. Numeric flashes, red alarm message, alarm tone. xxx denotes the lowest measured value; yyy is the bradycardia limit. 127 7 Patient Alarms and INOPs Alarm Message

*** Desat

*** Desat xx < yy From SpO2 Condition Indication The SpO2 value has fallen below the desaturation alarm limit. xx denotes the lowest measured value, and yy is the desaturation limit. Numeric flashes, red alarm message, alarm tone.

** dFHR1 High

** dFHR2 High

** dFHR3 High

** dFHR1 xxx>yyy

** dFHR2 xxx>yyy

** dFHR3 xxx>yyy

** dFHR1 Low

** dFHR2 Low

** dFHR3 Low

** dFHR1 xxx<yyy

** dFHR2 xxx<yyy

** dFHR3 xxx<yyy FHR (DECG) The fetal heart rate obtained from DECG has risen above the high alarm limit. xxx denotes the highest measured value, and yyy is the high alarm limit. Numeric flashes and high limit is highlighted, yellow alarm message, alarm tone. FHR (DECG) The fetal heart rate obtained from DECG has fallen below the low alarm limit. xxx denotes the lowest measured value, and yyy is the low alarm limit. Numeric flashes and low limit is highlighted, yellow alarm message, alarm tone.

*** Extreme Brady MECG

*** xBrady xxx<yyy

*** Extreme Tachy MECG

*** xTachy xxx>yyy The maternal heart rate obtained from the maternal ECG has fallen below the extreme bradycardia limit. xxx denotes the lowest measured value, and yyy is the extreme bradycardia limit. The maternal heart rate obtained from the maternal ECG has risen above the extreme tachycardia limit. xxx denotes the highest measured value, and yyy is the extreme tachycardia limit. Numeric flashes, red alarm message, alarm tone. Numeric flashes, red alarm message, alarm tone.

** FHR1 High

** FHR2 High

** FHR3 High

** FHR1 xxx>yyy

** FHR2 xxx>yyy

** FHR3 xxx>yyy

** FHR1 Low

** FHR2 Low

** FHR3 Low

** FHR1 xxx<yyy

** FHR2 xxx<yyy

** FHR3 xxx<yyy

** HR High

** HR xxx>yyy FHR

(ultrasound) The fetal heart rate obtained from ultrasound has risen above the high alarm limit. xxx denotes the highest measured value, and yyy is the high alarm limit. Numeric flashes and high limit is highlighted, yellow alarm message, alarm tone. FHR

(ultrasound) The fetal heart rate obtained from ultrasound has fallen below the low alarm limit. xxx denotes the lowest measured value, and yyy is the low alarm limit. Numeric flashes and low limit is highlighted, yellow alarm message, alarm tone. MECG The maternal heart rate obtained from the maternal ECG has risen above the high alarm limit. Numeric flashes and high limit is highlighted, yellow alarm message, alarm tone. xxx denotes the highest measured value, and yyy is the high alarm limit. 128 7 Patient Alarms and INOPs Alarm Message

** HR Low

** HR xxx<yyy From MECG Condition Indication The maternal heart rate obtained from the maternal ECG has fallen below the low alarm limit. Numeric flashes and low limit is highlighted, yellow alarm message, alarm tone.

** <iTemp Label> High iTemp

** <iTemp Label> Low iTemp

** NBPs High

** NBPd High

** NBPm High Noninvasive blood pressure

** NBPs Low

** NBPd Low

** NBPm Low Noninvasive blood pressure

** Pulse High

** Pulse Low

** SpO High

** SpO Low

*** Tachy (Pulse)

*** Tachy/P xxx>yyy SpO2 SpO2 SpO2 SpO2 SpO2 xxx denotes the lowest measured value, and yyy is the low alarm limit. The temperature value has exceeded the high alarm limit. Numeric flashes and high limit is highlighted, alarm tone. The temperature value has dropped below the alarm limit. Numeric flashes and low limit is highlighted, alarm tone. The measured noninvasive blood pressure value is above the high alarm limits s, d, or m after the label indicates whether the systolic, diastolic, or mean pressure has crossed the limit. The measured noninvasive blood pressure value is below the low alarm limits s, d, or m after the label indicates whether the systolic, diastolic, or mean pressure has crossed the limit. The pulse rate has exceeded the high alarm limit. The pulse rate has dropped below the low alarm limit. The arterial oxygen saturation has exceeded the high alarm limit. The arterial oxygen saturation has fallen below the low alarm limit. Numeric flashes and high limit is highlighted, yellow alarm message, alarm tone. Numeric flashes and low limit is highlighted, yellow alarm message, alarm tone. Numeric flashes and high limit is highlighted, yellow alarm message, alarm tone. Numeric flashes and low limit is highlighted, yellow alarm message, alarm tone. Numeric flashes and high limit is highlighted, yellow alarm message, alarm tone. Numeric flashes and low limit is highlighted, yellow alarm message, alarm tone. The heart rate from the Pulse signal has exceeded the tachycardia limit. Numeric flashes, red alarm message, alarm tone. xxx denotes the highest measured value, and yyy is the tachycardia limit. 129 7 Patient Alarms and INOPs Technical Alarm Messages (INOPs) Measurement INOPs FHR INOPs: aFHR, dFHR, FHR INOP Message Indication What to do aFHR1 Signal Loss aFHR2 Signal Loss aFHR3 Signal Loss dFHR1 Equip Malf dFHR2 Equip Malf dFHR3 Equip Malf dFHR1 Leads Off

!! dFHR1 Leads Off

!!! dFHR1 Leads Off dFHR2 Leads Off

!! dFHR2 Leads Off

!!! dFHR2 Leads Off dFHR3 Leads Off

!! dFHR3 Leads Off

!!! dFHR3 Leads Off dFHR1 Signal Loss dFHR2 Signal Loss dFHR3 Signal Loss FHR1 Equip Malf FHR2 Equip Malf FHR3 Equip Malf FHR1 Signal Loss FHR2 Signal Loss FHR3 Signal Loss Monitor: INOP tone Numeric is replaced by a -?-

INOP tone if Alarm Mode is set to All. No tone if Alarm Mode is set to INOP only. CL F&M Pod: No LED indication, no INOP tone Monitor: INOP tone Monitor: INOP tone

(configurable cyan, yellow, red) Numeric is replaced by a -?-

Monitor: INOP tone Numeric is replaced by a -?-

INOP tone if Alarm Mode is set to All. No tone if Alarm Mode is set to INOP only. Monitor: INOP tone Monitor: INOP tone Numeric is replaced by a -?-

INOP tone if Alarm Mode is set to All. No tone if Alarm Mode is set to INOP only. The input signal quality is not sufficient to process the measurement. Reapply the electrodes of the electrode patch. There is a problem with the DECG hardware. Contact your service personnel. One or more DECG lead is not attached. Make sure that all required leads are attached, and no electrodes have been displaced. Check all connections are sound, and that the leg plate attachment electrode is properly attached. If the INOP persists, try using another adapter cable, or leg plate attachment electrode. If the INOP persists, contact your service personnel. The input signal quality is not sufficient to process the measurement. Reapply the fetal scalp electrode. There is a problem with the FHR hardware. Contact your service personnel. The input signal quality is not sufficient to process the measurement. Adjust the position of the transducer to obtain a better signal. 130 7 Patient Alarms and INOPs Maternal HR and Pulse INOPs: aHR, HR, Pulse INOP Message Indication What to do MECG Equip Malf Monitor: INOP tone MECG Leads Off

!! MECG Leads Off

!!! MECG Leads Off Monitor: INOP tone

(configurable cyan, yellow, red) Numeric is replaced by a -?-

There is a problem with the MECG hardware. Contact your service personnel. One or more MECG leads are not attached. Ensure that all required leads are attached, and no electrodes have been displaced. Check if all connections are sound. If the INOP persists, try using another adapter cable. If the INOP still persists, contact your service personnel. Toco and IUP INOPs INOP Message Indication What to do IUP Equip Malf Monitor: INOP tone Monitor: INOP tone Toco MP Maternal Pulse Measurement Monitor: INOP tone Pulse(Toco) Malf Toco Equip Malf NBP INOPs There is a problem with the IUP hardware. Contact your service personnel. There is a problem with the Toco MP transducer hardware. Contact your service personnel. There is a problem with the Toco hardware. Contact your service personnel. INOP Message Indication What to do Cuff Not Deflated

!! Cuff Not Deflat

!!! Cuff Not Deflat Monitor: INOP tone

(configurable cyan, yellow, red) Numeric is replaced by a -?-

During this INOP, alarms cannot be paused or switched off. Remove the cuff from the patient. Make sure that the tubing is not kinked or twisted. Try restarting the measurement. You can silence the INOP, but the INOP message remains visible until the next measurement is started, or the Stop All SmartKey is selected. NBP Check Cuff Monitor: INOP tone Numeric is replaced by a -?-

Check if cuff is connected to the CL NBP Pod or the NBP connector at the fetal monitor and the cuff is applied to the patient; check tubing and cuff for leakage. Try restarting the measurement. If the INOP occurs repeatedly, contact your service personnel. You can silence this INOP, but the INOP message remains visible until the next measurement is started or the Stop All SmartKey is selected. This INOP is issued, when the maximum time for inflation is exceeded, or when there is a significant change in inflation time between two successive measurements in auto and sequence mode. 131 7 Patient Alarms and INOPs INOP Message Indication What to do NBP Cuff Overpress

!! Cuff Overpress

!!! Cuff Overpress Monitor: INOP tone

(configurable cyan, yellow, red) Numeric is replaced by a -?-

During this INOP, alarms cannot be paused or switched off. NBP Equip Malf Monitor: INOP tone Numeric is replaced by a -?-

NBP Interrupted Monitor: INOP tone Numeric is replaced by a -?-

NBP Measure Failed Monitor: INOP tone Numeric is replaced by a -?-

NBP Neo Patient?

(only with CL NBP Pod) Monitor: INOP tone Numeric is replaced by -?-

CL NBP Pod: Display message The cuff pressure exceeds the overpressure safety limits. Remove the cuff from the patient. Ensure that the tubing is not kinked or twisted, and that the correct patient category is selected. Try restarting the measurement. You can silence this INOP, but the INOP message remains visible until the next measurement is started, or the Stop All SmartKey is selected. Remove the cuff from the patient. The noninvasive blood pressure hardware is faulty. Contact your service personnel. You can silence this INOP, but the INOP message remains visible until the next measurement is started, or the Stop All SmartKey is selected. Check the tubing and cuff for leakages or kinks. Check that you are using the correct cuff size and placement, and that the correct patient category is selected. Try restarting the measurement. If the INOP occurs repeatedly, contact your service personnel. You can silence this INOP, but the INOP message remains visible until the next measurement is started, or the Stop All SmartKey is selected. This INOP arises when the measurement needed longer than the maximum time allowed for inflation, deflation, or the total measurement. Check that you are using the correct cuff size and placement, and that the correct patient category is selected. Try restarting the measurement. You can silence this INOP, but the INOP message remains visible until the next measurement is started, or the Stop All SmartKey is selected. Check the condition and suitability of the patient for noninvasive blood pressure monitoring. Use another cuff to continue measuring. The CL NBP Pod has detected a neonatal cuff. Replace the neonatal cuff by an adult cuff or if an adult cuff is used check the tube for kinks. If the INOP persists, contact your service personnel. SpO2 INOPs INOP Message Indication What to do SpO Equip Malf Monitor: INOP tone Monitor: INOP tone Numeric is replaced by a -?-

Monitor: No INOP tone Numeric is replaced by a -?-

SpO Erratic SpO Extd.Update 132 There is a problem with the SpO2 hardware. Contact your service personnel. Check the sensor placement. Try another adapter cable and sensor. If the INOP persists, contact your service personnel. The update period of displayed values is extended due to a noninvasive blood pressure measurement on the same limb, or an excessively noisy signal. 7 Patient Alarms and INOPs INOP Message Indication What to do SpO Interference Monitor: INOP tone Numeric is replaced by a -?-

SpO Low Perf Monitor: No INOP tone Numeric is displayed with a -?-

SpO No Pulse

!! <SpO Label> No Pulse

!!! <SpO Label> No Pulse Monitor: INOP tone

(configurable cyan, yellow, red) Numeric is replaced by a -?-

SpO No Sensor Monitor: INOP tone Numeric is replaced by a -?-

SpO NoisySignal Monitor: INOP tone Numeric is replaced by a -?-

SpO Poor Signal Monitor: No INOP tone SpO Pulse?

SpO Searching SpO Sensor Malf SpO Sensor Off Numeric is displayed with a -?-

Monitor: INOP tone Numeric is replaced by a -?-

Monitor: No INOP tone Numeric unavailable Monitor: INOP tone Numeric unavailable Monitor: INOP tone Numeric unavailable SpO Unkn.Sensor Monitor: INOP tone Numeric is replaced by a -?-

There is too much interference caused by a high level of ambient light, and/or electrical interference. Cover the sensor to minimize ambient light. If the INOP persists, ensure that the sensor cable is not damaged, or positioned too close to power cables. Accuracy may be compromised due to very low perfusion. Stimulate circulation at sensor site. If INOP persists, change the measurement site. Check the perfusion at measurement site. If necessary, stimulate circulation or change measurement site. If the INOP is due to noninvasive blood pressure measurement on the same limb, wait until the measurement is finished. Ensure the SpO2 sensor is connected. If the INOP persists, try another adapter cable and sensor. If you silence this INOP, the measurement will be switched off. Excessive patient movement or electrical interference is causing irregular pulse patterns. Try to reduce patient movement, or to relieve the cable strain on the sensor. The signal condition of the SpO2 measurement is poor and measurement accuracy may be compromised. The detectable pulsations of the SpO2 signal are outside the specified pulse rate range. SpO2 is analyzing the patient signal to derive Pulse, and SpO2 values. Please wait until the search analysis is complete. The SpO2 sensor or adapter cable is faulty. Try another adapter cable and sensor. If the INOP persists, contact your service personnel. The SpO2 sensor is not properly applied to the patient. Apply the sensor following the instructions supplied by the manufacturer. The connected sensor or adapter cable is not supported by the SpO2 measurement. Use only specified sensors and cables. SpO Upgrade Monitor: No INOP tone Numeric unavailable The SpO2 measurement is currently in upgrade mode. Monitoring is not possible in this mode. 133 7 Patient Alarms and INOPs Tympanic Temperature INOPs INOP Message Indication What to do

<iTemp Label> CalRequired Monitor: INOP tone

<iTemp Label> Malfunction Monitor: INOP tone Numeric is replaced by a -?-

<iTemp Label> Meas Failed Monitor: INOP tone Numeric is replaced by a -?-

<iTemp Label> Overrange Monitor: INOP tone Numeric is replaced by a -?-

The thermometer requires calibration. Contact your service personnel. The thermometer or the interface board is defective. Check the thermometer on another monitor - if the same INOP occurs, replace the thermometer. If not, connect another thermometer to this monitor. If the problem persists, the interface board has a problem. Contact your service personnel. The ambient temperature is out of range. If the ambient temperature is within the valid range, check the thermometer. Try picking up a new probe cover. If the problem persists replace the thermometer and contact your service personnel. The measured temperature is out of range. If the temperature is within the valid range, check with another thermometer. Measurement Applications INOPs INOP Message Indication What to do The fetal heart rate(s) and maternal heart rate/pulse persistently coincide with another. (see Cross-Channel Verification (CCV) on page 163). The INOP tone has a configurable delay. The default setting is an instant INOP tone. The time has expired for the NST timer. Clearing the timer clears the INOP. Coincidence

!! Coincidence Monitor: Yellow with INOP tone.

(If the initial temporary reduction of severity is configured: Cyan without INOP tone).

(See Coincidence Tone in Alarm Settings menu) Monitor: INOP tone

(Message and tone only if Setup NST Timer, Notification is set to Alarm in Configuration Mode). NST:TimeElapsed 134 7 Patient Alarms and INOPs Device INOPs Monitor INOPs INOP Message Indication What to do 2nd Tele Incompat Monitor: INOP tone Bus Master Incomp Monitor: INOP tone Bus Master Malfunc Monitor: INOP tone Check Flex Texts Monitor: INOP tone Check Keyboard Monitor: INOP tone Check Monitor Func Monitor: INOP tone Check Monitor Temp Monitor: INOP tone Check Mouse Monitor: INOP tone Check OBR Config Monitor: INOP tone Check Settings Monitor: INOP tone Check TI Config Monitor: INOP tone Check Touchscreen Monitor: No INOP tone Internal.Comm.Malf Monitor: INOP tone OBR Interference Monitor: INOP tone Rem. Display Malf. Monitor: INOP tone Settings Malfunct Monitor: INOP tone One of the connected base stations is not supported by the monitor. Check software revisions. The Bus Master board or firmware is incompatible and cannot be used with this monitor software revision. Contact your service personnel. There is a problem with the monitor's hardware. Contact your service personnel. If this INOP appears, check the monitor and patient settings before you resume monitoring. If the settings are unexpected, there may be a problem with the monitor software. Contact your service personnel. Perform a visual and functional check of the keyboard. Contact your service personnel. A potential internal problem with the monitor has been detected. Contact your service personnel. The temperature inside the monitor is too high. Check that the monitor ventilation is not obstructed. If the situation continues, contact your service personnel. Perform a visual and functional check of the mouse input device. Contact your service personnel. OBR (OB Radio) channel configuration is invalid or settings are not present. Check channel configuration and hardware option. If this INOP appears, check the monitor and patient settings before you resume monitoring. If the settings are unexpected, there may be a problem with the monitor software. Contact your service personnel. If this INOP appears, the monitor can be used normally, except for the Trace Interpretation feature. Contact your service personnel. Perform a visual and functional check of the touch input device. Contact your service personnel. There is a problem with I2C Bus communication in the monitor. Contact your service personnel. OBR (OB Radio) communication is disturbed by other devices (not necessarily other wireless measurements). Contact service personnel. One of the Remote Display's input devices is not working correctly. Perform a visual and functional check. If the INOP persists contact your service personnel. The monitor cannot use the predefined settings for monitoring. Contact your service personnel. 135 7 Patient Alarms and INOPs INOP Message Indication What to do Speaker Malfunct Monitor: INOP tone SRR Incompatible Monitor: INOP tone SRR Malfunction Monitor: INOP tone Tele Incompatible Monitor: INOP tone Tele Malfunction Monitor: INOP tone Tele Unplugged Monitor: INOP tone Unsupported LAN Monitor: INOP tone User I/F Malfunct Monitor: INOP tone FM20/FM30 Battery INOPs Contact your service personnel to check the speaker and the connection to the speaker. The connected SRR (Short Range Radio) board or firmware cannot be used with this base station's software revision. Contact your service personnel. Malfunction in the SRR (Short Range Radio) module(s). If the INOP persists, contact your service personnel. The base station is not supported by the monitor. Check software revisions. Malfunction of the connected base station. If the INOP persists contact your service personnel. The base station has been disconnected from the monitor, while one or more CL devices were active. This INOP is only issued, if the setting Sensor Disconnct is No Auto Off, or the Alarm Mode is set to All. There is a problem with the communication to the network and central monitoring is currently not possible. Check the connection. If the INOP persists, switch off the monitor and contact your service personnel. Perform a visual and functional check of all the monitor input devices. Contact your service personnel. INOP Message Indication What to do Batt Empty

!! Batt Empty

!!! Batt Empty Monitor: INOP tone

(configurable cyan, yellow, red) Battery LED at the monitor flashes. During this INOP, alarms cannot be paused or switched off. The estimated remaining battery-powered operating time is less than 10 minutes. Connect the monitor to AC immediately. If the condition persists and the monitor is not connected to mains power, this INOP is re-issued two minutes after you acknowledge it. Batt Incompat Monitor: INOP tone Batt Low Monitor: INOP tone Batt Malfunction Monitor: INOP tone Battery LED at the monitor flashes. During this INOP, alarms cannot be paused or switched off unless the monitor is connected to mains power. The battery cannot be used with this monitor. Replace it with the correct battery. The estimated battery-powered operating time remaining is less than 20 minutes. The monitor cannot determine the battery status. If the INOP persists, replace the faulty battery. If the condition persists and the monitor is not connected to mains power, this INOP is reissued two minutes after you acknowledge it. Batt Missing Monitor: INOP tone No battery found in FM20/30. Contact your service personnel. 136 7 Patient Alarms and INOPs INOP Message Indication What to do Charger Malfunct Monitor: INOP tone Battery LED at the monitor may flash. Check Batt Temp Monitor: INOP tone There is a problem with the battery charger in the monitor. Connect the monitor to mains power and contact your service personnel. The temperature of the battery is too high. Check that the monitor is not exposed to heat. Recorder INOPs INOP Message Indication What to do Check Paper Monitor: No INOP tone Recorder: printout FetRec Chk Config Monitor: INOP tone FetRec Equip Malf Monitor: INOP tone Paper End Monitor: INOP tone Printhead Overheat Monitor: INOP tone Wrong Paper Scale Monitor: INOP tone Recorder: printout Check that there is no paper jam, that the print drawer is properly shut, that the paper is loaded with the grid facing upwards, and that the correct Philips paper is being used. Recorder Speed and/or Scale Type settings are set to Unknown and need to be set to the correct values in Configuration Mode before the recorder can be operated. There is a problem with the fetal recorder hardware. Contact your service personnel. The end of the paper pack is detected. Insert a new pack of paper. The printhead is too hot. The recorder stops, the recorder Start/ Stop key is disabled, and remains so until the printhead cools down sufficiently. Wait for the printhead to cool down, then press the recorder Start/ Stop key or the Silence key to clear the INOP. The grid scale of the paper in the monitor does not match the grid scale configured in the monitor. Make sure that you use the correct paper and scale for your institution: pre-

printed: 30-240 in US and Canada, 50-210 in other geographies. Wired Transducer INOPs INOP Message Indication What to do dFHR1 Unplugged dFHR2 Unplugged dFHR3 Unplugged FHR1 Unplugged FHR2 Unplugged FHR3 Unplugged Monitor: INOP tone Numeric is replaced by a -?-

Reconnect the DECG transducer to the monitor. Check if all connections are sound. Monitor: INOP tone Reconnect the FHR transducer to the monitor. Check if all connections are sound. IUP Unplugged Monitor: INOP tone Reconnect the IUP transducer to the monitor. Check if all connections are sound. 137 7 Patient Alarms and INOPs INOP Message Indication What to do MECG Unplugged Monitor: INOP tone Numeric is replaced by a -?-

Toco Unplugged Monitor: INOP tone Reconnect the MECG transducer to the monitor. Check if all connections are sound. Reconnect the Toco transducer to the monitor. Check if all connections are sound. Cableless Transducer INOPs INOP Message Indication What to do Monitor: INOP tone

(configurable cyan, yellow, red) CL transducer: LED flashes red, yellow INOP tone The remaining monitoring time with this transducer is below 15 minutes. Charge battery. cl US Batt Empty

!! cl US Batt Empty

!!! cl US BattEmpty cl Toco Batt Empty

!! clToco BattEmpty

!!! clTocoBattEmpty cl ECG/IUP Empty

!! cl ECG/IUP Empty

!!! clECG/IUP Empty cl US Batt Low cl Toco Batt Low cl ECG/IUP BattLow cl US Batt Malf cl Toco Batt Malf clECG/IUP BattMalf Monitor: No INOP tone CL transducer: LED flashes red, no INOP tone Monitor: INOP tone CL transducer: Cyan LED, INOP tone cl US Check Temp cl Toco Chk Temp clECG/IUP Chk Temp Monitor: INOP tone CL transducer: Cyan LED, INOP tone cl US Disconnect cl Toco Disconnect cl ECG/IUP Disconn cl US Malfunction cl Toco Malf cl ECG/IUP Malf Monitor: INOP tone CL transducer: Cyan LED, INOP tone Monitor: INOP tone Numeric is replaced by a -?-

CL transducer: Cyan LED, INOP tone 138 The remaining monitoring time with this transducer is below 30 minutes. Charge battery. Malfunction of the battery system (charger circuit or battery) detected (e.g. persistent communication error, overvoltage, overcurrent, battery incompatible). Contact your service personnel. The temperature of the transducer or its battery is critically high. If the transducer is docked on the base station, charging is interrupted. Check that the transducer is not covered and do not expose it to a heat source. Do not place the base station in a sunny window in a room without active air conditioning. The environment temperature to charge a transducer battery should not exceed 40C/104F. If the INOP persists, remove the transducer from patient and contact your service personnel. The cableless transducer has lost the connection to the monitor. Malfunction of the transducer. Contact your service personnel. CL Fetal & Maternal Pod INOPs The INOP indication describes the system behavior when the Pod is connected to the monitor. INOP Message Indication What to do 7 Patient Alarms and INOPs Monitor: INOP tone

(configurable cyan, yellow, red) The remaining monitoring time with the CL F&M Pod is below 15 minutes. Charge the battery. cl F&M Batt Empty

!! cl F&M BattEmpty

!!! cl F&M BatEmpty cl F&M Batt Low CL F&M Pod: LED flashes red, yellow INOP tone Monitor: No INOP tone CL F&M Pod: LED flashes red, no INOP tone cl F&M Batt Malf Monitor: INOP tone CL F&M Pod: Cyan LED, no INOP tone cl F&M Batt Temp Monitor: INOP tone CL F&M Pod: Cyan LED, no INOP tone The remaining monitoring time with the CL F&M Pod is below 30 minutes. Charge the battery. Malfunction of the battery system (charger circuit or battery) detected (for example: persistent communication error, overvoltage, overcurrent, battery incompatible). Contact your service personnel. The temperature of the CL F&M Pod or its battery is critically high (in charging mode) or critically low

(independent of battery mode). If the Pod is docked on the base station, charging is interrupted. Check that device is not covered. Do not expose device to heat sources. If INOP persists, remove the CL F&M Pod from patient. Contact your service personnel. cl F&M Chk Electr. Monitor: INOP tone; without tone, if no CL F&M Pod parameter shows -?-

Not all electrodes have sufficient skin contact: Prepare the skin at the application site further with the abrasive pad. CL F&M Pod: No LED indication, no INOP tone One or more leads between the measurement Pod and the electrode(s) is broken: Replace the electrode patch. cl F&M ChkSettings Monitor: INOP tone CL F&M Pod: Cyan LED, no INOP tone cl F&M Disconnect Monitor: INOP tone CL F&M Pod: Cyan LED, INOP tone cl F&M License Req Monitor: INOP tone CL F&M Pod: No LED indication, no INOP tone cl F&M Malfunction Monitor: INOP tone CL F&M Pod: No LED indication, no INOP tone Contact problem between the CL F&M Pod and the electrode patch: Reconnect the CL F&M Pod. This INOP can only occur in Monitoring Mode after the initial electrode impedance check has occurred. The CL F&M Pod settings are incompatible or corrupted. Check the settings. Contact your service personnel. The CL F&M Pod has lost the connection to the monitor. Call the patient back to the monitor. If the CL F&M Pod has still no connection, remove it from the monitor, and reassign it. If it still does not have a connection, contact your service personnel. There is no valid license registered. Contact your service personnel. The CL F&M Pod malfunctions. Contact your service personnel. 139 7 Patient Alarms and INOPs INOP Message Indication What to do cl F&M Patch Disc cl F&M Patch Malf cl F&M Remove Monitor: INOP tone CL F&M Pod: No LED indication, no INOP tone Monitor: INOP tone CL F&M Pod: No LED indication, no INOP tone Monitor: INOP tone CL F&M Pod: Cyan LED, no INOP tone The CL F&M Pod has been disconnected from the electrode patch during Monitoring Mode. Reconnect the CL F&M Pod. The connected electrode patch cannot be identified. Either the electrode patch is malfunctioning, or the connection between the CL F&M Pod and the patch is defective. The battery temperature is too high (above 60C/140F). Remove the CL F&M Pod immediately from the patient. Contact your service personnel. CL Wide Range Pod INOPs The INOP indication describes the system behavior when the Pod is connected to the monitor. INOP Message Indication What to do cl WRP Batt Empty

!! cl WRP BattEmpty

!!! cl WRP BatEmpty Monitor: INOP tone

(configurable cyan, yellow, red) The remaining monitoring time with the CL Wide Range Pod is below 15 minutes. Charge the battery. CL Wide Range Pod: Display and yellow INOP tone cl WRP Batt Low Monitor: No INOP tone CL Wide Range Pod: Display only cl WRP Batt Malf Monitor: INOP tone CL Wide Range Pod: Display only cl WRP Batt Temp Monitor: INOP tone CL Wide Range Pod: Display only cl WRP Chk Chrg IF Monitor: INOP tone CL Wide Range Pod: Display only cl WRP ChkSettings Monitor: INOP tone CL Wide Range Pod: Display only cl WRP Disconnect Monitor: INOP tone CL Wide Range Pod: No message, no tone The remaining monitoring time with the CL Wide Range Pod is below 30 minutes. Charge the battery. Malfunction of the battery system (charger circuit or battery) detected (for example: persistent communication error, overvoltage, overcurrent, battery incompatible). Contact your service personnel. The temperature of the CL Wide Range Pod or its battery is critically high (in charging mode) or critically low

(independent of battery mode). If the Pod is docked on the base station, charging is interrupted. Check that device is not covered. Do not expose device to heat sources. If INOP persists, remove the CL Wide Range Pod from patient. Contact your service personnel. Overvoltage or undervoltage detected at the charger interface. Clean contacts of charger interface at Cableless Measurement Device and charging station. If the INOP persists, contact your service personnel. The CL Wide Range Pod settings are incompatible or corrupted. Check the settings. Contact your service personnel. The CL Wide Range Pod has lost the WLAN/LAN connection for more than 10 seconds to the monitor. 140 7 Patient Alarms and INOPs INOP Message Indication What to do cl WRP License Req Monitor: INOP tone CL Wide Range Pod: Display only cl WRP Malfunction Monitor: INOP tone CL Wide Range Pod: No message, no tone Monitor: INOP tone CL Wide Range Pod: Display only cl WRP Remove CL NBP Pod INOPs There is no valid license registered. Contact your service personnel. The CL Wide Range Pod is malfunctioning. Contact your service personnel. The battery temperature is too high (above 60C/140F). Remove the CL Wide Range Pod immediately from the patient. Contact your service personnel. The INOP indication describes the system behavior when the Pod is connected to the monitor. The INOP message on the CL device differs from the text on the monitor. For further information see IntelliVue CL Device Instruction for Use. INOP Message Indication What to do cl NBP Batt Empty

!! cl NBP BattEmpty

!!! cl NBP BatEmpty Monitor: INOP tone

(configurable cyan, yellow, red) The remaining battery time of the CL NBP Pod is below 30 minutes. Charge the battery. CL NBP Pod: Display, yellow INOP tone cl NBP Batt Low Monitor: INOP tone CL NBP Pod: Display only cl NBP Batt Malf Monitor: INOP tone CL NBP Pod: Display only cl NBP Batt Temp Monitor: INOP tone CL NBP Pod: Display only cl NBP Check Batt Monitor: INOP tone CL NBP Pod: Display only cl NBP Chk Chrg IF Monitor: INOP tone CL NBP Pod: Display only The remaining battery time of the CL NBP Pod is below 2 hours. There is a malfunction in the CL NBP Pod's battery system. Contact your service personnel. The temperature of the battery in the CL NBP Pod is critically high (in charging mode) or critically low

(independent of battery mode). Check that the Pod is not covered or exposed to a heat source. If the INOP persists, remove the Pod from the patient, and contact your service personnel. The battery in the CL NBP Pod is nearing the end of its useful life. Only 50 charge-discharge cycles remain. Contact your service personnel to replace the battery. Overvoltage or undervoltage detected at the charger interface. Clean contacts of charger interface at Cableless Measurement Device and charging station. If the INOP persists, contact your service personnel. 141 7 Patient Alarms and INOPs INOP Message Indication What to do cl NBP ChkSettings Monitor: INOP tone CL NBP Pod: Display only cl NBP Disconnect Monitor: INOP tone CL NBP Pod: Display message No host monitoring, INOP tone If this INOP appears and an INOP tone sounds, check the Cableless Measurement Device and patient settings before you resume making measurements. If the settings are unexpected, there may be a problem with the Cableless Measurement Device software. Contact your service personnel. If this INOP is acknowledged at the Cableless Measurement Device, it is cleared. If it is silenced remotely, only the tone is cleared. The CL NBP Pod has lost the SRR connection to the monitor. cl NBP License Req Monitor: INOP tone CL NBP Pod: Display only The CL NBP Pod requires a valid software license for operating. Contact your service personnel. cl NBP No Cradle Monitor: INOP tone CL NBP Pod: Display only cl NBP Remove Monitor: INOP tone CL NBP Pod: Display only cl NBP Serv Batt Monitor: INOP tone CL NBP Pod: Display only The CL NBP Pod is not in the cradle. You can silence this INOP, but the INOP message remains visible until the CL NBP Pod is inserted into the cradle, and the next measurement is started, or the Stop All SmartKey is selected. The temperature of the battery in the CL NBP Pod is too high. Remove the Cableless Measurement Device from the patient and contact service personnel. The battery in the CL NBP Pod has reached the end of its useful life. It can no longer be charged. Contact your service personnel to replace the battery. CL SpO2 Pod INOPs The INOP indication describes the system behavior when the Pod is connected to the monitor. The INOP message on the CL device differs from the text on the monitor. For further information see IntelliVue CL Device Instruction for Use. INOP Message Indication What to do cl SpO Batt Empty

!! cl SpO BatEmpty

!!! cl SpO BtEmpty Monitor: INOP tone

(configurable cyan, yellow, red) The remaining battery time of the CL SpO2 Pod is below 30 minutes. Charge the battery. CL SpO2 Pod: Display, yellow INOP tone cl SpO Batt Low Monitor: INOP tone cl SpO Batt Malf CL SpO2 Pod: Display only Monitor: INOP tone CL SpO2 Pod: Display only The remaining battery time of the CL SpO2 Pod is below 2 hours. There is a malfunction in the CL SpO2 Pod's battery system. Contact your service personnel. 142 7 Patient Alarms and INOPs INOP Message Indication What to do cl SpO Batt Temp Monitor: INOP tone CL SpO2 Pod: Display only cl SpO Check Batt Monitor: INOP tone CL SpO2 Pod: Display only cl SpO Chk ChrgIF Monitor: INOP tone CL SpO2 Pod: Display only cl SpO Chk Sett Monitor: INOP tone CL SpO2 Pod: Display only cl SpO Disconnect cl SpO Remove Monitor: INOP tone CL SpO2 Pod: Display message No host monitoring, INOP tone Monitor: INOP tone CL SpO2 Pod: Display only cl SpO Serv Batt Monitor: INOP tone CL SpO2 Pod: Display only clSpO License Req Monitor: INOP tone CL SpO2 Pod: Display only The temperature of the battery in the CL SpO2 Pod is critically high (in charging mode) or critically low

(independent of battery mode). Check that the Pod is not covered or exposed to a heat source. If the INOP persists, remove the CL Pod from the patient, and contact your service personnel. The battery in the CL SpO2 Pod is nearing the end of its useful life. Only 50 charge-discharge cycles remain. Contact your service personnel to replace the battery. Overvoltage or undervoltage detected at the charger interface. Clean contacts of charger interface at Cableless Measurement Device and charging station. If the INOP persists, contact your service personnel. If this INOP appears and an INOP tone sounds, check the Cableless Measurement Device and patient settings before you resume making measurements. If the settings are unexpected, there may be a problem with the Cableless Measurement Device software. Contact your service personnel. If this INOP is acknowledged at the Cableless Measurement Device, it is cleared. If it is silenced remotely, only the tone is cleared. The CL SpO2 Pod has lost the SRR connection to the monitor. The temperature of the battery in the CL SpO2 Pod is too high. Remove the CL SpO2 Pod from the patient and contact service personnel. The battery in the CL SpO2 Pod has reached the end of its useful life. It can no longer be charged. Contact your service personnel to replace the battery. The CL SpO2 Pod requires a valid software license for operating. Contact your service personnel. 143 7 Patient Alarms and INOPs 144 8 8Admitting and Discharging The fetal monitor can store basic patient demographic information used to identify patients. Admit/Discharge on the Monitor This section describes how you admit and discharge patients when using the monitor as a stand-alone device (that is, when not used with an obstetrical information and surveillance system such as OB TraceVue/IntelliSpace Perinatal). Admitting a Patient The fetal monitor displays physiological data as soon as a patient is connected. This lets you monitor a patient who is not yet admitted. It is however important to admit patients properly so that you can identify your patient on recordings. Use the Patient Demographics window and its associated pop-up keys to admit and discharge patients. To admit a patient:

1 Select the patient name field or select the Patient Demogr. SmartKey to open the Patient Demographics window. 2 Clear any previous patient data by selecting Dischrge Patient and then Confirm. If you do not discharge the previous patient, you will not be able to distinguish data from the previous and current patients on the recording. 3 Select Admit Patient. 4 Enter the patient information: select each field and use the on-screen keyboard. If a conventional keyboard is connected to the monitor, you can use this to enter patient information:

Last Name: Enter the patient's last name (family name), for example Doe. First Name: Enter the patient's first name, for example Jane. MRN: Enter the patient's medical record number (MRN), for example 12345678. Depending on your configuration this field may be labeled differently e.g. Record ID, Lifetime ID, Account Number, Serial Number, or SSN. Gestational Age: Enter the gestational age of the pregnancy. Enter one numeric for the week (0-50) and one numeric for the day (0-6). Date of Birth: Enter the patient's date of birth. 5 Select Confirm. The patient status changes to admitted. If the recorder is running, the recorder stops and immediately restarts to annotate the new patient data. 145 8 Admitting and Discharging Quick Admitting a Patient Use Quick Admit to quickly admit a patient using only a limited set of demographic data. 1 Select the Quick Admit SmartKey. 2 Enter the required data (ID fields or last name depending on configuration) with the keyboard or a barcode scanner. 3 4 Select Enter. In the confirmation window, select Confirm to stop monitoring for the previous patient. Complete the rest of the demographic details as soon as possible to fully identify the patient on the network, on the monitor, and on printed reports. To complete the details, open the Patient Demographics window and complete all required fields. Editing Patient Information To edit the patient information after a patient has been admitted, select the patient name field on the main screen of the fetal monitor to open the Patient Demographics window, and enter the required changes. Discharging a Patient You should always perform a discharge even if your previous patient was not admitted. A discharge:

clears the information in the Patient Demographics window. resets all monitor settings to the settings defined in the User Defaults. advances the paper automatically if the recorder is running. stops the fetal recorder. When a patient is discharged from the monitor, all patient demographic data is deleted (trace data is not affected). Depending on your configuration, monitoring for a patient may end automatically when the fetal monitor has been powered off, or is in Standby mode for a set time. To discharge a patient:

1 2 3 Select the patient name field to display the Patient Demographics window and associated pop-up keys. Select the pop-up key for Dischrge Patient. Select Confirm to discharge the patient. CAUTION In order to ensure that the settings are reset to User Defaults for a new patient, always discharge the previous patient from the fetal monitor. NOTE In order to ensure a continuous record, it is recommended to discharge the patient at the monitor before performing a new patient admission in OB TraceVue/IntelliSpace Perinatal. 146 8 Admitting and Discharging New Patient Check The fetal monitor can be configured to ask you in certain situations:

after a specified power-off period after a specified Standby period whether a new patient is now being monitored. The pop-up window is entitled Is this a New Patient?. The monitor offers a Yes key, to discharge the previous patient and begin monitoring a new patient, and a No key, to continue monitoring with the current patient data and settings. The time periods for the two conditions can be configured independently. OB TraceVue/IntelliSpace Perinatal When the monitor is connected over a LAN connection to an OB TraceVue/IntelliSpace Perinatal system, the patient demographic data is controlled by the OB TraceVue/IntelliSpace Perinatal system. All patient and location-related data visible on the monitor is set, overwritten, or updated by the OB TraceVue/

IntelliSpace Perinatal system. In the Patient Demographics window, a padlock symbol before the patient identification fields indicates the locked state. The locked state prevents the reuse of the monitor for another patient, until the current patient is discharged, and the monitor is freed through the OB TraceVue/

IntelliSpace Perinatal system. Locked fields remain locked when system connectivity is lost, until the monitor is freed by discharging the patient. See the OB TraceVue/IntelliSpace Perinatal Instructions for Use for details. Transferring a Patient When you are transferring a patient from one bed to another, both the monitor from which you are transferring her and the monitor to which you are transferring her must be switched on and connected to the OB TraceVue/IntelliSpace Perinatal network during the patient transfer. OB TraceVue/IntelliSpace Perinatal via RS232 In contrast to a LAN connection, when the monitor is connected to an OB TraceVue/IntelliSpace Perinatal system over an RS232 connection, the OB TraceVue/IntelliSpace Perinatal system does not have full control over the monitor's patient admission and discharge functions. Depending on how OB TraceVue/IntelliSpace Perinatal is configured, either the Last Name, First Name, and the bed label, or just the bed label alone, are taken from the OB TraceVue/IntelliSpace Perinatal system. See the OB TraceVue/IntelliSpace Perinatal Instructions for Use for details. 147 8 Admitting and Discharging 148 9 9Non-Stress Test Timer The non-stress test (NST) timer shows the elapsed time for the non-stress test. The timer counts up to the time you set for the NST. Setting NST Autostart/Autostop You can set the recorder so that it starts automatically (NST Autostart) when the NST timer is started, and stops automatically (NST Autostop) when the NST is complete (when the set run time has elapsed). As default, NST Autostart is On, and NST Autostop is Off. Viewing the NST Timer You can configure the timer notification symbol, (the NST label), a progress bar and the elapsed time to be displayed in the top left-hand corner of the screen. By default, the NST timer is not displayed on the screen. Alternatively, you can view the timer in the Timers window. To open the Timers window:

Either Or Press the Timer SmartKey. Access the NST pop-up keys (see Accessing the NST Setup Pop-up Keys on page 149), and press the Timers key. Timer Expiry Notification When the timer expires, the color changes from blue to green, you hear a single tone, and a message appears in the status line on the main screen. The volume of the tone can be set in Configuration Mode. Accessing the NST Setup Pop-up Keys You control and set up the NST timer (for example, start, stop, or clear the timer, and set the run time) using a selection of pop-up keys that you access via any one of three possible routes:

Via the Timer SmartKey (Route 1) Via the Main Setup SmartKey (Route 2) Via the NST display area at the top left-hand corner of the screen (Route 3). When you touch the NST display area, the NST pop-up keys become available at the bottom of the screen. 149 9 Non-Stress Test Timer Via the Timer SmartKey (Route 1) Press the Timer SmartKey. The Timers window opens, and the pop-up keys for controlling/setting up the NST timer appear (see Pop-up Keys for NST Timer Setup on page 150). Via the Main Setup SmartKey (Route 2) 1 2 Enter the Main Setup menu using the SmartKey. Select NST to enter the Setup NST menu. At the same time, the pop-up keys for setting up the NST timer appear (see Pop-up Keys for NST Timer Setup on page 150). Via the NST Display Area (Route 3) Select the NST display area at the top left-hand corner of the screen (when so configured). The pop-up keys for controlling/setting up the NST timer become available at the bottom of the screen (see Pop-up Keys for NST Timer Setup on page 150). Pop-up Keys for NST Timer Setup Pop-Up Keys Selecting this pop-up key lets you:

Comments Start Stop Setup NST Start the timer. Stop the timer, allowing either restarting after a pause (Start) or clearing (Clear key). Enter the Setup NST menu. From here you can set the run time. Timer Return to the Timers window. This pop-up key is not available with Route 2, as the Setup NST menu is already open. This pop-up key is not available with Route 1, as the Timers window is already open. Run Time The run time can be set from 10 to 60 minutes. See the Configuration Guide for details how to set the run time. 150 10Non-Stress Test Report 10 A Non-Stress Test (NST) allows you to assess fetal well-being. The monitor's NST report functionality is intended for antepartum testing. It interprets the fetal heart rate trace (FHR from ultrasound, but not dFHR or aFHR) and the maternal Toco trace to generate a printed report of criteria met or not met. The interpretation algorithm and rule sets are equivalent to those implemented in OB TraceVue Revision G.xx or IntelliSpace Perinatal Revision H.xx and higher. An NST report is a diagnostic aid, but it does not replace the clinicians judgment. The interpretation and the appropriate clinical response remain with the clinician. A fetus normally produces characteristic heart rate patterns. Average baseline variability and acceleration of the FHR in response to fetal movement are considered normal. This test does not take into account any form of external fetal stimulation. For every active ultrasound fetal heart rate measurement, one NST report can reside in the monitors memory. The reports are cleared when you discharge a patient and when you start a new NST trace interpretation. When the NST Report option is available and the NST Report feature is on, the NST status for all available ultrasound fetal heart rate measurements are displayed on the screen. The minimum displayed information is:

NST identification (by FHR number: 1, 2, 3) Current NST status NST Status Transitions Inverse for Ready to white for Ongoing White for Ongoing to green for Finished at *

White for Ongoing to yellow for Stopped at *

*For date and time see the NST Status window or the printed report. Depending on the report configuration, Non-Stress Tests can be calculated:

Based on NICHD Guideline for trace interpretation The NST test using the NICHD algorithm has configurable parameters. It has a maximum run time of 90 minutes and no interdependent criteria. The interpretation algorithm and rule set are based on the 2008 NICHD guidelines. Based on Dawes/Redman Guideline for trace interpretation The trace interpretation according to Dawes/Redman 2002 is not available for U.S. and other FDA regulated territories. It has preconfigured parameters (range and limit), a maximum run time of 60 minutes, and interdependent input criteria. 151 10 Non-Stress Test Report Terminology FHR variability/FHR variation NST according to the NICHD guideline uses the term variability. NST according to the Dawes/Redman trace interpretation uses the term FHR variation. Setting Up an NST Report To set up NST Report functionality:

1 Enter the Main Setup menu and select the NST Report. 2 Or select the NST Report SmartKey. 3 Press the Setup pop-up key. Set your configuration options. 4 Select from:

NST Analysis- choose from On or Off. This switches the report feature on or off. This is linked to the NST timer. Both must be set to On for the NST report to function. Report Recording choose from:

Manual - press the Record Report pop-up key to trigger a manual request. After Recorder Stop - report is recorded as soon as recorder becomes idle. Immediately - if a realtime recording is running, the monitor pauses it. The recording is continued after the report has been recorded. Criteria Not Met If the criteria are not met when the test has finished, or if you stop anytime during the test period, a report is generated stating the criteria have not been met. Nonreactive NST Test If a nonreactive test occurs, and you then use acoustic stimulation, you must exercise caution in interpreting the resulting traces, as artificial stimulation is not taken into account when calculating test results. Printing an NST Report When an NST test is finished or has been stopped, an NST report is printed depending on the Report Recording configuration. NST According to NICHD Trace Interpretation NST Criteria NICHD The patient is monitored for a user-definable period of time (10-60 minutes in steps of 5 minutes). The test is considered reassuring when the following criteria are met:

The fetal heart rate is valid at least 90% (this is configurable) of the specified time span. The FHR features a user-defined minimum number of accelerations. The FHR features a user-defined maximum number of tolerated decelerations, and must not include severe or prolonged decelerations, which are never tolerated. There are no severe, prolonged, late, or variable decelerations. Does not include severe or prolonged decelerations, which are never tolerated. 152 10 Non-Stress Test Report The average baseline fetal heart rate lies within the user-defined limits for low heart rate and high heart rate over the whole time span. The FHR exhibits a moderate variability (user-defined) for the specified time span. An NST Report is generated when the reassuring criteria are met the first time in the current monitoring phase. When performing NST with twins or triplets, a separate NST Report is generated for each fetus. After the reassurance criteria have been met, the clinician can print the NST Report and then turn the fetal monitor off, or may continue fetal monitoring and print the report at any time. Reporting Parameters NICHD Long Term Variability Variability is generally understood to be fluctuations in the baseline FHR that are irregular in amplitude and frequency. The NICHD definitions classify variability as absent, minimal, moderate, and marked, based on the amplitude of the complexes related to baseline FHR variability. Classification Absent FHR variability Minimal FHR variability Moderate FHR variability Marked FHR variability Sinusoidal Pattern Condition amplitude range undetectable (02 bpm) amplitude range > undetectable and 5 bpm 6-25 bpm amplitude range >25 bpm A sinusoidal pattern is a smooth, sine wave-like pattern of regular frequency and amplitude. The calculation to determine if the FHR trace exposes a sinusoidal pattern is done every 1 minute covering a time window of about 8.5 minutes. Wave-like patterns with less than 12 cycles per minute go into the calculation. However, the segment is only considered as being sinusoidal, when a cycle frequency of 3-5/min is detected. Accelerations An FHR acceleration is generally understood to be a visually apparent abrupt increase in the FHR from the baseline (from onset to peak less than 30 seconds). The detection of accelerations depends on the calculated gestational age. If the gestational age is not available, the system uses the limits for >32 weeks gestation. Accelerations Criterion Amplitude Duration Gestational age <32 weeks Gestational age 32 weeks 10 bpm 15 bpm 10 seconds, <10 minutes 15 seconds, <10 minutes The onset of acceleration to peak must be <30 seconds. Decelerations An FHR deceleration is generally understood to be a gradual or abrupt decrease in the FHR from the baseline. Decelerations are classified as late, early, variable, and prolonged. Decelerations Types Criterion Type Late Early Variable Prolonged Other Duration 15 seconds 15 seconds 15 seconds

>2 minutes,

<10 minutes 15 seconds 153 10 Non-Stress Test Report Decelerations Types Associated contractions Yes Yes n/a n/a n/a Amplitude 15 bpm 15 bpm 15 bpm 15 bpm 15 bpm No No Yes

>10 seconds 10 seconds n/a n/a n/a n/a n/a Steep fall (onset to nadir

<30 seconds) Time from acme of contraction to nadir of deceleration Deceleration Severity Classification Criterion Amplitude Duration Severe

>60 bpm

>60 seconds Moderate Mild

>30 bpm, 60 bpm 30 bpm

>30 seconds, 60 seconds 30 seconds Average short term variability (STV) value is documented in [bpm] and [ms] if STV is configured as part of the NST Report. This parameter is not a criterion of the NICHD guideline. NST Report Status Window NICHD The NST Report window displays a detailed overview of the current NST status for any available ultrasound fetal heart rate measurement. You can see:

NST Status - whether it is ready, ongoing, or the time and date at which it was stopped, or at which it was finished. Elapsed Time - the time that has elapsed since the NST began. Accelerations - the number of FHR accelerations detected so far. Baseline - the average baseline value. Variability - the average variability value. Short Term Var. - the current short term variability (STV) value (only displayed if it is configured). Decelerations - the number of FHR decelerations detected so far. FHR Available - current statistical FHR availability value. Sinusoidal - the current status of sinusoidal rhythm detection. For criteria not yet met, a white arrow symbol marks the overall status on the top line, and also appears next to every criterion not yet met. A yellow symbol indicates detection of severe or prolonged decelerations. The pop-up keys let you perform the following actions:

FHR1, FHR2, FHR3 - switch to the window showing the current NST status for the fetal heart rate. Record Report - print the NST Report on paper. Record Trace - record the trace episode that belongs to the current report. Depending on device usage, the trace recording might be incomplete. Setup - open the Setup NST Report window. 154 Example NST Report According to NICHD 10 Non-Stress Test Report Field Field Content Report Title, with FHR label and date NST Report for FHR1 on 12 Oct. 2017 Product Information Product DE53102345 G.01.70, OB A.04.24, Toco DE52401090, FHR1 DE00002345 A.05.26 Patient Information Rogers, Alice Start time, end time, Elapsed time, configured runtime Overall one-line NST result summary Title Result Accelerations Result: Contractions Date of Birth: 30.5.1991 Age: 26 Gestational Age: Week 34, Day 5 Time: 11:34 12:06 Elapsed time: 32 min Run time: 20 min NST Criteria*: not met Trace Interpretation Summary Accelerations: 2 at: 11:59 12:02 Contractions: 3 at: 11:57 12:00 12:04 Result: Baseline and Variability Baseline: 125 bpm (Range: 118-129 bpm) Variability: 23 bpm Short Term Variability 0.9 bpm (3.8 msec) Statistics: FHR availability FHR available: 95%

Result: Decelerations Decelerations: 1 at: 11:58 severe prolonged Sinusoidal: No Result:

Sinusoidal Rhythm detected 155 10 Non-Stress Test Report Field Field Content Result: Decelerations before Reporting Period Events before Reporting Period:

Decelerations: 1 at: 11:38 severe prolonged This field is enabled if there were decelerations between the start of NST and the start of the reporting period. Guideline/Criteria Information (*) Interpretation criteria based on guideline NICHD 2008, v<xx>

User-defined criteria for CTG tracing:

valid FHR for 90% of reporting period baseline heart rate between 120 bpm and 160 bpm at least 2 accelerations in 10 min not more than 1 decelerations moderate baseline variability (6-25 bpm) Additional criteria:

no severe or prolonged decelerations no sinusoidal pattern in reporting period 156 10 Non-Stress Test Report NST According to Dawes/Redman Trace Interpretation NOTE Not available for USA and other FDA regulated territories. WARNING The Non-Stress Test Report (NST Report) functionality according to Dawes & Redman has not been validated for use for patients with a gestational age of less than 26 weeks. NST Criteria According to Dawes/Redman A trace is considered normal whenever the following criteria are met within the time range of 10-60 minutes:

The recording must contain at least one episode of high variation. The short-term variation (STV) must be greater than 3.0 ms. If STV is greater than 3.0 ms but less than 4.5 ms, the long-term variation (LTV) averaged across all episodes of high variation must be greater than the third percentile for the gestational age (GA). There must be no evidence of a high-frequency sinusoidal rhythm. There must be either:

at least one acceleration, or a fetal movement rate of 20 per hour, and an LTV averaged across all episodes of high variation that is greater than the 10th percentile for the GA. There must be at least one fetal movement or three accelerations. Concerning decelerations:

If the recording time is less than 30 minutes, there must be no decelerations of more than 20 lost beats. If the recording time is more than 30 minutes, there must be no more than one deceleration of 21-100 lost beats. Independent of recording time, there must be no decelerations at all of more than 100 lost beats. If the recording time is less than 30 minutes, the basal heart rate must be in the range 116-160 bpm. The LTV must be within three standard deviations (SDs) of its estimated value. Alternatively, if it is not, all the following must apply:

the STV must be larger than 5.0 ms, there must be an episode of high variation with 0.5 fetal movements per minute, the basal heart rate must be 120 bpm, the signal loss must be smaller than 30%. The final epoch of the recording:

must not be part of a deceleration if the recording time is less than 60 minutes, can include a deceleration at 60 minutes, but this must not be larger than 20 lost beats. If the recording time is less than 60 minutes, there must be no suspected artifacts at the end of the recording. NOTE STV is the short-term variation parameter used in the guideline based on the Dawes/Redman criteria*

157 10 Non-Stress Test Report LTV is the long-term variation parameter used in the guideline based on the Dawes/Redman criteria*

Fetal movements are maternally perceived fetal movements. To acquire these movements, a remote event marker (989803143411) is required, and the patient or a clinician is required to press the marker button whenever fetal movements are perceived. Lost beats in association with decelerations are the number of fetal heart beats missing due to the reduced FHR during the deceleration compared to the baseline. Example: If the baseline is 140 bpm, and there is a deceleration with a duration of 1 minute, and a decreased FHR of 100 bpm on average, the number of lost beats would be 140-100 = 40 beats. The NST analysis according to Dawes/Redman requires the entering of the gestational age. The Non-

Stress Test Report (NST Report) functionality according to Dawes & Redman is not intended for use for patients with a gestational age of less than 26 weeks.

*James Pardey, Mary Moulden, Christopher Redman: A computer system for the numerical analysis of Non-Stress Tests, American journal of obstetrics and gynecology, vol 186 nr 5, 2002. Reporting Parameters Dawes/Redman Long Term Variation Variation is generally understood to be fluctuations in the baseline FHR that are irregular in amplitude and frequency. The Dawes/Redman criteria classify the variation as low or high FHR variation. For each minute of the trace the maximum excursions of the FHR above and below the baseline are calculated. The sum of these two values is the minute range. The average of consecutive minute ranges is the mean range and is used to measure the long term variation. Classification Condition Low FHR variation High FHR variation Sinusoidal Pattern When the minute range in at least 5 of 6 consecutive 1-minute intervals is less than, or equal to, a threshold defined by a pulse interval of 30 ms. When the minute range in at least 5 of 6 consecutive 1-minute intervals is greater than, or equal to, a threshold defined by a pulse interval of 32 ms, and the mean minute range over the entire episode is above the first centile in the distribution of mean minutes ranges for episodes of high variation in healthy fetuses at that gestational age. A sinusoidal pattern is a smooth, sine wave-like pattern of regular frequency and amplitude. The calculation to determine if the FHR trace exposes a sinusoidal pattern is done every 1 minute covering a time window of about 20 minutes. When a cycle frequency of 2-5/min is detected, the segment is considered as being sinusoidal. Short Term Variation Short term variation (STV) is averaged in milliseconds based on the averaged epochs of 3.75 seconds (1/

16 minute). The short term variation is calculated by discarding the minutes containing all or part of the decelerations and calculating the difference between the average pulse interval values for adjacent epochs. These pulse interval differences are then averaged over each minute, and the 1-minute averages are in turn averaged over the entire NST to give the short term variation in milliseconds. Accelerations An FHR acceleration is generally understood to be an increase in FHR above the baseline that lasts for longer than 15 seconds and has a maximum excursion above the baseline of greater than 10 beats per minute. 158 10 Non-Stress Test Report Accelerations Criterion Amplitude Duration Decelerations Definition

>10 bpm

>15 seconds, <10 minutes A deceleration is defined as a decrease in FHR below the baseline that lasts for longer than 30 seconds and has a maximum excursion below the baseline of greater that 10 beats per minute. The size of a deceleration is measured by its area in lost beats. This measurement provides an estimate of the number of fetal heart beats that would have occurred, if there was no deceleration. Decelerations Criterion Amplitude Duration Definition

>10 bpm

>20 bpm

>60 seconds, <10 minutes

>30 seconds, <10 minutes The deceleration types are not defined in the Dawes/Redman guidelines, but are additional classifications of IntelliSpace Perinatal. Decelerations Types Criterion Type Late Early Variable Prolonged Other Duration 15 seconds 15 seconds 15 seconds

>2 minutes,

<10 minutes 15 seconds Associated contractions Yes Yes n/a n/a n/a Amplitude 15 bpm 15 bpm 15 bpm 15 bpm 15 bpm No No Yes

>10 seconds 10 seconds n/a n/a n/a n/a n/a Steep fall (onset to nadir

<30 seconds) Time from acme of contraction to nadir of deceleration Lost Beats Lost beats are the number of fetal heartbeats missing caused by a deceleration compared to the normal baseline. Example: When an FHR drops from 120 bpm to 100 bpm for 1 minute, the number of lost beats would be (120 bpm-100 bpm) * 1 minute = 20 beats. NST Report Status Window Dawes/Redman The NST Report window displays a detailed overview of the current NST status for any available ultrasound fetal heart rate measurement. You can see:

NST Status - whether it is ready, ongoing, or the time and date at which it was stopped, or at which it was finished. Elapsed Time - the time that has elapsed since the NST began. 159 10 Non-Stress Test Report Signal Loss - the current percentage of fetal heart rate signal loss. Baseline - the current average baseline value. Accelerations > 10 bpm - the number of FHR accelerations detected so far greater than 10 beats per minute. Accelerations > 15 bpm - the number of FHR accelerations detected so far greater than 15 beats per minute. Decelerations > 20 lost beats - the number of FHR decelerations detected so far, greater than 20 lost beats (the number of fetal heartbeats missing caused by a deceleration compared to the normal baseline). Contractions - the number of contractions detected so far. Short Term Var. - the current short term variation (STV) value. Long Term Var. - the current long term variation (LTV) value. High Variation - When the minute range in at least 5 of 6 consecutive 1 minute intervals is greater than, or equal to, a threshold defined by a pulse interval of 32 ms, and the mean minute range over the entire episode is above the first centile in the distribution of mean minutes ranges for episodes of high variation in healthy fetuses at that gestational age. Low Variation - When the minute range in at least 5 of 6 consecutive 1 minute intervals is less than, or equal to, a threshold defined by a pulse interval of 30 ms. Sinusoidal - the current status of sinusoidal rhythm detection. Fetal Movements - the number of times fetal movement was detected and indicated by pressing the remote event marker button. For criteria not yet met, a white arrow symbol marks the overall status on the top line, and also appears next to every criterion not yet met. A yellow symbol indicates that criteria are not met for example, if a sinusoidal pattern or a deceleration with more than 100 lost beats were detected. The pop-up keys let you perform the following actions:

Record Report - print the NST Report on paper. Record Trace - record the trace episode that belongs to the current report. Depending on device usage, the trace recording might be incomplete. NST Details - opens a detail window with detailed descriptions of the criteria. FHR1, FHR2, FHR3 - switch to the window showing the current NST status for the fetal heart rate. Setup - open the Setup NST Report window. 160 Example NST Report According to Dawes/Redman 10 Non-Stress Test Report Field Field Content Report Title, with FHR label and date NST Report for FHR1 on 3 Dec. 2017 Product Information Product M2705A DE74200202 L.33.04 BsMstr A.11.12, Toco DE24800233 B.00.39, FHR1 DE32200649 B.00.39 Patient Information Rogers, Alice Time Elapsed time Date of Birth: 30.05.1991 Age: 26 Gestational Age: Week 34, Day 5 Time: 11:34 12:06 Elapsed time: 32 min Overall one-line NST result summary: NST Criteria*: not met If the short term variation is <4.5 ms, the long term variation must be higher. The short term variation must be >3.0 ms. Title Signal Loss Result: Baseline Trace Interpretation Summary Signal Loss: 15%

Baseline: 125 bpm (Range: 118-129 bpm) Result: Accelerations > 10 bpm Accelerations: 3 Result: Accelerations >15 bpm Accelerations: 1 Result: Decelerations >100 lost beats Decelerations: 1 at 11:46 Result: Short Term Variation Short Term Var.: 5 msec Result: High Variation Result: Low Variation Result:

Sinusoidal Rhythm detected High Variation: 0 min Low Variation: 0 min Sinusoidal: No Result: Fetal Movements Fetal Movements: 0/hr Maternally perceived fetal movements are indicated using the remote event marker Result: Accelerations Accelerations: 3 at 11:59 12:02 12:05 Result: Decelerations at 4:15 Decelerations at 4:15 Result: Contractions

>100 lost beats Contractions: 3 at: 11:57 12:00 12:04 Guideline/Criteria Information

(*) Interpretation criteria based on guideline Dawes/

Redman 2002 v<xx>

161 10 Non-Stress Test Report 162 11 11Cross-Channel Verification (CCV) The cross-channel verification helps to reduce the possibility of misidentification of the maternal heart rate for the fetal heart rate. It does this by comparing the measured fetal heart rate to the maternal heart rate. If there are multiple fetal rates, they are also compared with each other and the maternal heart rate. Misidentification of Heart Rates FHR detection by the monitor may not always indicate that the fetus is alive. Confirm fetal life before monitoring, and continue to confirm that the fetus is the signal source for the recorded fetal heart rate (see Confirm Fetal Life Before Using the Monitor on page 12). To reduce the possibility of mistaking the maternal HR or pulse for FHR, or FHR1 for FHR2 or FHR3, it is recommended that you monitor both maternal HR/pulse and the heart rates of all fetuses (see Monitoring FHR and FMP Using Ultrasound on page 169, Monitoring Twin FHRs on page 185, Monitoring Triple FHRs on page 191, and Monitoring Maternal Heart / Pulse Rate on page 219). Here are some examples where the maternal HR can be misidentified as the FHR, or one FHR for another FHR (twins/triplets). When using an ultrasound transducer:

It is possible to pick up maternal signal sources, such as the maternal heart, aorta, or other large vessels. Especially if the recorded maternal HR, and any other artifact is over 100 bpm. It is possible to pick up the same fetal heart rate simultaneously with multiple transducers. NOTE When an ultrasound transducer is connected to the monitor, but not applied to the patient, the measurement may generate unexpected intermittent FHR readings. When Fetal Movement Profile (FMP) is enabled:

The FMP annotations on a fetal trace alone may not always indicate that the fetus is alive. For example, FMP annotations in the absence of fetal life may be a result of:

Movement of the deceased fetus during or following maternal movement. Movement of the deceased fetus during or following manual palpation of fetal position (especially if the pressure applied is too forceful). Movement of the ultrasound transducer. When using a scalp electrode (DECG):

Electrical impulses from the maternal heart can be transmitted to the fetal monitor through a recently deceased fetus via the spiral scalp electrode, appearing to be a fetal signal source. 163 11 Cross-Channel Verification (CCV) Cross-Channel Verification Functionality The cross-channel verification functionality (CCV) of the fetal monitors compares all monitored heart rates

(maternal and fetal), and indicates automatically whether any two channels are picking up the same signal, or monitoring similar values. If the fetal monitor detects that any channels have the same or similar values, the Coincidence INOP is issued with an INOP tone that can have a configurable delay. In addition, yellow question marks appear next to the numerics on the touchscreen that have the same or similar values. On the recording trace there is also a question mark from the point where recorded traces continuously overlap. Visual Aids for CCV Detection Coincidence INOP appears on the screen of the fetal monitor. Question mark appears on the screen of the fetal monitor next to the numerics that show the same or similar values. Question mark recorded on the trace from the point where two measured values coincide. Overview of Cross-Channel Comparisons Measurements from Transducers Measurement FHR (US) dFHR (DECG) aFHR (abdom. ECG) Pulse (Toco) Pulse (SpO2) HR (MECG) Transducer From Ultrasound or CL Ultrasound transducer From a fetal scalp electrode From the CL Fetal & Maternal Pod From Toco+ MP, or CL Toco+ MP transducer From SpO2 or CL SpO2 Pod From MECG electrodes aHR (abdom. ECG) From the CL Fetal & Maternal Pod Measurement Comparison Done by the Fetal Monitor for Cross-Channel Verification FHR1 (US) FHR2 (US) FHR3 (US) dFHR (DECG)*

aFHR* (ECG) FHR1 (US) FHR2 (US) FHR3 (US) dFHR (DECG)*

aFHR (abdom. ECG) 164 11 Cross-Channel Verification (CCV) FHR1 (US) FHR2 (US) FHR3 (US) dFHR (DECG)*

aFHR* (ECG) Pulse (Toco) Pulse (SpO2) HR (MECG) aHR (abdom. ECG)

* dFHR and aFHR always replace one of the fetal channels (1,2, or 3) and cannot be compared to the channel it replaces. If you monitor for example twins with two ultrasound transducers, you see the numerics FHR1 and FHR2 at the monitor. If you decide to replace the ultrasound transducer for FHR2 with a fetal scalp electrode, the dFHR numeric is then shown as dFHR2. Coincidence Examples Coincidence of Maternal Pulse and FHR When the maternal pulse and FHR are being monitored, and the measured values are very similar or the same, the coincidence question mark is displayed on the monitors screen above both of the corresponding numerics (in this case maternal pulse and FHR). Often the signal loss or coincidence happens because the fetal or maternal movement displaced the ultrasound transducer, and a repositioning of the transducer is necessary. 1 Coincidence INOP 2 Coincidence question mark above FHR1 3 Coincidence question mark above pulse from Toco+ MP Pulse Delay SpO2 pulse rate traces have an averaging calculation of approximately 10 seconds and an overall delay of approximately 12 seconds (depending on recorder speed). This differs from a non-averaged beat-to-beat MECG heart rate trace or an ultrasound heart rate trace calculation (having switched to the maternal HR) 165 11 Cross-Channel Verification (CCV) with no significant delay. Note that Maternal Pulse from Toco has an averaging of 4 seconds and an overall delay of between 6 and 8 seconds. The coincidence question mark is also printed on the trace paper next to the corresponding FHR and maternal pulse. 1 2 Printed coincidence question mark on trace Fetal heart rate trace from Ultrasound 3 Maternal pulse trace from SpO2 Coincidence of Twins/Triplets FHRs When both FHR1 and FHR2 are being monitored, and the measured values are very similar or the same, the coincidence question mark is displayed on the monitors screen above both of the corresponding numerics

(in this case FHR1 and FHR2). 1 Coincidence INOP 2 Coincidence question mark above FHR1 3 Coincidence question mark above FHR2 166 11 Cross-Channel Verification (CCV) The coincidence question mark is also printed on the trace paper next to FHR1 and FHR2. 1 2 Printed coincidence question mark on trace FHR1 and FHR2 traces Recommended Actions for Coincidence INOP 1 Confirm fetal life by palpation of fetal movement or auscultation of fetal heart sounds using a fetoscope, stethoscope, or Pinard stethoscope. 2 Manual determination of the maternal pulse and comparison with the fetal heart rate sound signals from the loudspeaker. 3 Reposition the transducer, or ensure that the fetal scalp electrode is placed correctly, until you receive a clear signal and the monitor is no longer issuing the Coincidence INOP. In case of difficulties deriving a stable maternal pulse reading using the Toco+ MP or CL Toco+ MP transducer, use SpO2 or the CL SpO2 Pod instead. In case of similar problems with the pulse measurement from SpO2, use MECG instead. Reasons to switch the method for deriving a maternal pulse or heart rate include: motion artifacts, arrhythmia, and individual differences in pulse signal quality on the abdominal skin (via Toco+ MP). If you cannot hear the fetal heart sounds, and you cannot confirm fetal movement by palpation, confirm fetal life using obstetric ultrasonography. 4 5 167 11 Cross-Channel Verification (CCV) 168 12 12Monitoring FHR and FMP Using Ultrasound To monitor a single FHR externally, you use an ultrasound transducer attached to a belt around the mother's abdomen. The ultrasound transducer directs a low-energy ultrasound beam towards the fetal heart and detects the reflected signal. Your monitor can also detect fetal movements and print the fetal movement profile (FMP) on the trace. Monitoring using ultrasound is recommended from the 25th week of gestation for non-stress testing or routine fetal monitoring. WARNING Performing ultrasound imaging or Doppler flow measurements together with ultrasound fetal monitoring may cause false FHR readings, and the trace recording may deteriorate. Technical Description Fetal monitors use the ultrasound Doppler method for externally monitoring the fetal heart rate. Using the Doppler method, the transducer (in transmitter mode) sends sound waves into the body which are then reflected by different tissues. These reflections (Doppler echoes) are picked up by the transducer (in listening mode). These Doppler echoes are amplified and sent to the monitors speaker through which the fetal heart signal can be heard. In parallel the Doppler echoes are processed through an autocorrelation algorithm to determine the fetal heart rate (FHR). The FHR is displayed on the monitors numeric display and on the recorded trace. Properly representing the fetal heart rate using a device that derives heartbeats from motion is a formidable task and the limitations of the technology will be discussed shortly. Basic fetal cardiac physiology may contribute to difficulties in obtaining a reliable ultrasound signal. A heart rate pattern of a fetus is capable of extraordinary variation, ranging from a stable pattern with minimal variation while the fetus is asleep to robust accelerations of 40-60 bpm above baseline rate over a few seconds, or exaggerated variability when the fetus is active. Decelerations of the rate 60-80 bpm below baseline may develop even more abruptly than the accelerations. Beat-to-beat arrhythmias may further exaggerate the amount of variability and can be seen at the bottom of variable decelerations, or in the presence of fetal breathing movements which also tend to lower the fetal heart rate. The recognition of these normal variations in fetal heart rate patterns will greatly assist in the separation of genuine fetal information from the artifact. 169 12 Monitoring FHR and FMP Using Ultrasound Limitations of the Technology All tissues moving towards or away from the transducer generate Doppler echoes. Therefore, the resulting signal that is provided to the monitors speaker, and for further fetal heart signal processing, can contain components of the beating fetal heart wall or valves, fetal movements, fetal breathing or hiccup, maternal movements such as breathing or position changes, and pulsating maternal arteries. The fetal heart signal processing uses an autocorrelation algorithm to obtain periodic events such as heart beats. If the signal is erratic such as from a fetal arrhythmia, the ultrasound device may have trouble tracking the abrupt changes, and may misrepresent the true FHR pattern. Signals such as those from moving fetal limbs are usually very strong, thereby masking the fetal heart signal. During prolonged movements where the fetal heart signal is masked, the FHR appears blank on the numeric display and as a gap on the recorded trace. Fetal position changes, maternal position changes, or uterine contractions can move the fetal heart partly or fully out of the ultrasound beam resulting in signal loss, or even picking up Doppler echoes from pulsating maternal arteries. In these cases a maternal heart rate or sometimes even a rate resulting from the mixture of fetal and maternal signals may be displayed on the monitors numeric display and on the recorded trace. In contrast to the timely well-defined R-peak of an ECG signal obtained with a fetal scalp electrode, the ultrasound Doppler signal from a fetal heart consists of multiple components from atria (diastole), ventricles (systole), valves, and pulsating arteries. These components vary depending on fetal and transducer position and angle, and are further modulated by factors such as fetal or maternal breathing. These effects may produce what is called artifact. Optimal transducer positioning therefore is key to minimizing these effects and thereby minimizing artifact. Misidentification of Maternal HR as FHR FHR detection by the monitor may not always indicate that the fetus is alive. Confirm fetal life before monitoring, and continue to confirm that the fetus is the signal source for the recorded heart rate (see Confirm Fetal Life Before Using the Monitor on page 12 and Cross-Channel Verification (CCV) on page 163). What You Need Ultrasound transducer Toco+ MP or CL Toco+ MP transducer Ultrasound gel Transducer belt (and optional butterfly belt clip, if applicable) 170 Cableless Monitoring - Important Considerations 12 Monitoring FHR and FMP Using Ultrasound When using an Avalon CL or Avalon CTS Fetal Transducer system with your monitor, note the following:

Refer to Cableless Status Indication on page 91 for general rules regarding the use of cableless transducers from an Avalon CL or Avalon CTS Cableless Fetal Transducer system. CAUTION Never use ultrasound transducers connected to more than one fetal monitor on the same patient. When using an Avalon CL or Avalon CTS you should be aware that FMP is not recommended when the mother is likely to move, and you should disable Fetal Movement Profile (FMP) on the fetal monitor (Fetal MovementOff) if the mother is walking. See also Fetal Movement Profile on page 173. With the Avalon CL Transducer System, you can monitor twins and triplets with cableless transducers. The Avalon CTS System does not have this option. The OBR symbol appears next to the measurement label, indicating that the measurement is being made by a cableless transducer with OB radio. The SRR symbol appears next to the measurement label, indicating that the measurement is being made by a cableless Pod with short range radio. 1 2 FHR1 Toco parameter WARNING During ambulant FHR monitoring, the chance of losing the signal or detecting the maternal heart rate is higher than during stationary monitoring. The frequency of the patient's walk may be detected, and mistaken for an FHR signal. Check the mothers pulse periodically during monitoring and compare this with the FHR signal. Beware of mistaking a doubled maternal heart rate for FHR. If a fetus is dead, there is a risk that the maternal heart rate is monitored and misinterpreted as the fetal heart rate. Therefore, the simultaneous monitoring of maternal heart rate (preferably, the maternal ECG) and the fetal heart rate is encouraged. Periodically compare the mother's pulse with the signal coming from the monitor's loudspeaker to ensure that you are monitoring fetal heart rate. Do not mistake a doubled or elevated maternal HR for FHR. Do not interpret maternal movements as fetal movements. Artifacts: FMP artifacts are generated during fetal heart rate searching by changing the transducer position, therefore the fetal monitors enable the FMP only after detecting a valid heart rate signal for several seconds. FMP is not recommended when the mother is likely to move, and you should disable Fetal Movement Profile (FMP) at the fetal monitor (Fetal MovementOff) if the mother is walking. 171 12 Monitoring FHR and FMP Using Ultrasound Gaps in maternal heart rate detection can occur:

If the transducer is not correctly positioned. Due to the pulsation of uterine blood vessels. If the fetus moves. Preparing to Monitor Prepare for ultrasound monitoring using the list below. The standard procedures in use in your facility determine the sequence of actions. 1 Determine fetal position. 2 3 Fasten the belt around the patient. Switch on the monitor and the recorder. 4 Connect the transducer to a free socket. The signal quality indicator for the heart rate initially displays an invalid signal. 5 Apply a thin layer of ultrasound gel to the underside of the transducer. CAUTION Using ultrasound gel not approved by Philips may reduce signal quality and may damage the transducer. This type of damage is not covered by warranty. 1 Place the transducer on the abdomen, if possible over the fetal back or below the level of the umbilicus in a full-term pregnancy of cephalic presentation, or above the level of the umbilicus in a full-term pregnancy of breech presentation. Work the transducer in a circular motion to ensure the gel layer makes good contact. 2 When the transducer is connected correctly and you receive a good signal, the signal quality indicator should be filled out. If an inadequate signal is produced, the signal quality indicator will indicate a poor signal, and no numeric will appear on the screen. 3 Adjust the audio volume of the monitor's loudspeaker to a clearly audible level, while moving the transducer over the abdomen. When you have a good signal, secure the transducer in position below the belt. The ultrasound transducer may warm slightly (less than 1C/1.8F above ambient temperature) when applied to the patient. When not applied, the transducer can reach a maximum temperature of 44C/

112.2F at an air temperature of 40C/104F. Selecting Fetal Heart Sound You can listen to the fetal heart sound from one ultrasound transducer at a time. When the fetal heart sound is selected for an FHR channel, you see the audio source symbol next to the FHR numeric label for that channel. 172 12 Monitoring FHR and FMP Using Ultrasound 1 FHR1 2 Audio source symbol To select the audio source for an FHR channel:

1 2 Enter the Setup FHR1 menu for the channel you want to hear (FHR1 used as an example). Press Select Audio. It may take a few seconds for the audio source symbol to appear. Changing the Fetal Heart Sound Volume The FHR volume symbol at the top right of the Fetal Heart Sound Volume window gives you an indication of the current volume. To change the volume:

1 2 Select the volume symbol. The volume scale pops up. Select the required volume from the volume scale. 1 Fetal Heart Sound Volume Fetal Movement Profile The Fetal Movement Profile (FMP) parameter detects fetal movements with an ultrasound transducer connected to the monitor. Only the fetus monitored on the FHR1 channel is monitored for FMP. Once you have enabled FMP (see Switching FMP On and Off on page 175), it is triggered automatically whenever:

You connect an ultrasound transducer. A patient is discharged. 173 12 Monitoring FHR and FMP Using Ultrasound When FMP is enabled, the ultrasound transducer detects most fetal body movements. Eye movements are not detected, and movement of the feet and hands may not be detected. Positioning or repositioning of the transducer is recorded as fetal movement. Maternal movement, excessive fetal breathing, or fetal hiccups may also be recorded as fetal movement (also in case of fetal demise or during the second stage of labor). You can mark these artifacts on the trace paper using either the remote event marker, or the event marker key as described in Marking an Event on page 61. FMP should be interpreted with care, or disabled when the patient is ambulating or during the second stage of labor. Ignore these movements when you interpret the FMP. When monitoring twins or triplets, only the fetus monitored on the FHR1 channel is monitored for movement, but be aware that movements recorded for FHR1 may also be caused by movement of the second or third fetus. The fetal movement profile (FMP) appears as activity blocks along the top of the Toco scale, the length of each block showing the duration of the activity. FMP Statistics FMP statistics are printed every ten minutes. 1 2 A B C FMP enabled FMP started here Indication of current fetal movement The FMP statistics are presented as two percentage figures:

The first figure shows the percentage of detected fetal movements in the previous ten minutes. The second figure shows the percentage of detected fetal movements since the start of recording. To mark the start of the FMP statistic, FMP is printed on the paper with an arrow. The FMP detection activates after about half a minute of steady heart rate signals (signal indicator half-full, or full) to minimize transducer positioning artifact. You will notice this deliberate delay:

When a new patient is admitted. A patient discharge restarts the FMP statistics from zero. When you connect an ultrasound transducer. 174 Switching FMP On and Off You can switch FMP on and off from any FHR channel. For example, to set it from the FHR1 channel:

12 Monitoring FHR and FMP Using Ultrasound 1 2 Enter the Setup FHR1 menu. Select Fetal Movement to switch between On and Off. 3 Return to the main screen. Troubleshooting Problem Erratic trace Erratic display Possible Causes Fetal arrhythmia Obese patient Transducer position not optimal Belt loose Too much gel Very active fetus Insufficient gel Signal quality indicator is continuously poor Transducer position not optimal FHR less than 50 bpm (and the FHR is audible) Solutions Consider monitoring FHR using DECG after the rupture of membranes. Reposition transducer until signal quality indicator shows a good signal (at least half-full). Tighten belt Remove excess

Use enough gel to ensure the transducer makes good contact with the mother's skin. Reposition transducer until signal quality indicator shows a good signal (at least half-full). If membranes are ruptured, using a fetal scalp electrode (FM30 and FM50 only) allows measurement of FHR down to 30 bpm. Questionable FHR Recording maternal HR by mistake Reposition transducer Recording periodic signals when the transducer is not applied to the patient Recorded FHR appears to be suspiciously higher, or suspiciously lower, than real FHR. In very rare cases, half- or double-counting of the FHR can occur. FHR not recorded FHR is less than 50 bpm or over 240 bpm Confirm fetal life Disconnect all NON-USED ultrasound transducers, as continuous, regular mechanical, or electromagnetic influences can result in an artificial trace. If you have reason to question the validity of the recorded FHR, always verify FHR by independent means (by auscultation, for example). Measure maternal pulse by independent means. If membranes are ruptured, using a fetal scalp electrode (FM30 and FM50 only) allows measurement of FHR down to 30 bpm. If FHR is outside of the specified range, verify FHR by independent means. FHR1 Equip Malf or FHR2 Equip Malf or FHR3 Equip Malf INOP displayed. See Patient Alarms and INOPs on page 127. FHR1 Signal Loss or FHR2 Signal Loss or FHR3 Signal Loss INOP displayed. FHR1 Unplugged or FHR2 Unplugged or FHR3 Unplugged INOP displayed. If you suspect the transducer is malfunctioning Test the transducer. 175 12 Monitoring FHR and FMP Using Ultrasound Testing Ultrasound Transducers If any of the following tests fail, repeat the test using another transducer. If the second transducer passes the tests, confirming that the first transducer is defective, contact your service personnel. If the second transducer also fails the tests, contact your service personnel. To test an ultrasound transducer:

1 Switch on the monitor and the recorder. 2 Connect the transducer to the fetal monitor. 3 4 Select the fetal heart sound for this channel. Increase the loudspeaker volume to an audible level. 5 Holding the transducer in one hand, move your other hand repeatedly towards and then away from the surface. 6 Check that a noise is heard from the loudspeaker. You can test all ultrasound transducers, including the cableless ones, as described above. Additional Information Artifact in Fetal Heart Rate Measurement How to detect it and reduce its occurrence using the Avalon Fetal Monitor The ultrasound derived FHR measurement technique in Avalon fetal monitors, like all other ultrasound fetal monitors FHR measurement techniques, has limitations that can lead to misrepresentation of the fetal heart rate pattern and potential misinterpretation of the fetal condition. An incorrect interpretation of the trace may lead to either unnecessary interventions, or to failure to detect fetal distress, and the need for intervention. Thus, the on-going evaluation of the recorded trace requires regular confirmation that the trace represents the true FHR. Specific situations requiring such confirmation include the following:

After starting a measurement or changing a transducer After maternal position changes, for example during pushing with contractions When the tracing shows abrupt changes in baseline rate, variability, or pattern (decelerations to accelerations) especially in the second stage of labor When the baseline maternal heart rate is within about 15 bpm of the FHR When you are unable to determine a baseline rate, and variability occurs between consecutive contractions 176 12 Monitoring FHR and FMP Using Ultrasound There are several ways to verify the source and/or accuracy of the recorded fetal heart rate pattern. These include:

Verification of the FHR with:

An obstetric stethoscope Ultrasound imaging A fetal scalp electrode Verification of the maternal heart rate:

Using pulse oximetry - for a maternal heart rate pattern displayed simultaneously with the FHR (Cross-

Channel Verification (CCV) feature) Using Maternal ECG - for a maternal heart rate pattern displayed simultaneously with the FHR (CCV feature) Manual determination of the maternal pulse Whenever possible measure the maternal pulse rate to make use of the monitors Cross-Channel Verification (CCV) feature. The Avalon fetal monitor provides a Toco+ MP or CL Toco+ MP transducer for maternal pulse detection and the creation of a maternal heart rate pattern plotted on the same recorder as the FHR pattern. In case of difficulties deriving a stable maternal pulse reading using the Toco+ MP or CL Toco+ MP transducer, use SpO2 or MECG instead. When either of these parameters is utilized, the monitor will automatically and continuously perform a CCV of the maternal heart rate pattern against the FHR pattern displayed on the monitor. If the patterns and rates are similar, the CCV provides an alarm that both rates are probably from the same source (i.e., they both represent the maternal heart rate pattern and the fetus is not being monitored). Repositioning the ultrasound transducer will usually correct this, but it may be necessary to apply a fetal scalp electrode. Advising the mother to temporarily cease pushing during contractions may help to more rapidly resolve any uncertainty in this situation. Doubling: The autocorrelation algorithm can display a doubled fetal or maternal heart rate if the duration of diastole and systole are similar to each other, and if the heart rate is below 120 bpm. Doubling, usually brief, is accompanied by an abrupt switch of the trace to double the baseline value. Halving: With fetal tachycardia (above 180 bpm) and some interference from breathing or maternal arteries the autocorrelation algorithm may only recognize every second beat resulting in a halved rate for a limited time. If the actual FHR is above the maximum limit of the monitor (240 bpm), the algorithm will also half-count. Halving is accompanied by an abrupt switch of the trace to exactly half the prior baseline value. This switch may simulate an FHR deceleration and be referred to by clinicians as a false deceleration. Switching to maternal heart rate (also referred to as Maternal Insertion): The fetal heart can move partly or fully out of the ultrasound beam and the autocorrelation algorithm may then pick up and display the maternal heart rate. Depending on the signal mix in the ultrasound signal, switching to the maternal heart rate may mimic several conditions with the potential for erroneous interpretation and response as follows:

The switch to the maternal heart rate may simulate an FHR deceleration (i.e., a decrease of the fetal heart rate, and be referred to by clinicians as a false deceleration). The maternal heart rate may simulate a normal fetal heart rate pattern (i.e., it may mask an FHR deceleration or fetal demise). Especially during pushing with contractions in the second stage of labor, the maternal heart rate may increase to the point where it may equal or exceed the fetal rate. Here the maternal trace may mimic a normal fetal trace while the fetus may be having decelerations or fetal demise has occurred. This change from fetal to maternal heart rate pattern may not be at all obvious unless CCV is used and represents the most dangerous pitfall of all the artifacts because fetal distress may go unrecognized. 177 12 Monitoring FHR and FMP Using Ultrasound The maternal heart rate may simulate an FHR acceleration, which is an increase of the fetal heart rate. During expulsive efforts, the maternal heart rate normally accelerates and may be at or above the normal FHR range. The FHR may display gradual appearing decelerations. Generally, the false decelerations described above are abrupt. Rarely, combinations of noisy/erratic signal associated with changes in maternal and/or fetal rate or movement will produce more gradual appearing false decelerations but these are usually short-lived with an abrupt return to an obviously stable FHR baseline. Noisy/Erratic signals: With mixed or weak signals the tracing may reveal very brief episodes of erratic recorded traces. These represent the autocorrelation algorithm finding brief sequences of apparent and persistent heartbeats amidst a mixed or weak signal. These erratic recorded traces are commonplace, especially in association with fetal or maternal movement. During prolonged periods of such noisy/

erratic signals, the fetus is not being adequately monitored. Drop out: With mixed or weak signals there may be no heart rate tracing at all. These episodes reflect that if the algorithm does not find an apparent and persistent heartbeat amidst a mixed or weak signal, it will not print a heart rate on the tracing. Brief episodes of drop out are commonplace, especially in association with fetal or maternal movement. During prolonged periods of drop out, the fetus is not being adequately monitored. Multiple Fetuses With multiple fetuses, the potential to experience these artifacts is increased. Positioning of the transducer is even more critical. Ultrasound scanning should be used to help with positioning of individual transducers. See also Monitoring Twin FHRs on page 185 and Monitoring Triple FHRs on page 191. Obtaining a Good Heart Signal To successfully position the ultrasound transducer, first determine the fetal position using palpation. Position the transducer over the strongest audible fetal heart sound from the monitors speaker and wait at least six seconds after each transducer adjustment to verify a good signal quality displayed on the Signal Quality Indicator and a consistent FHR numeric display. Having determined the position that provides a strong fetal signal, fix the transducer on the abdomen with the belt. 178 12 Monitoring FHR and FMP Using Ultrasound If the quality of the signal or the appearance of the heart rate trace from the ultrasound transducer is questionable, the transducer should be repositioned as described above. Alternatively, the use of an ultrasound scanner will greatly facilitate the determination of the optimal site for the ultrasound heart rate transducer. Factors during the second stage of labor that may influence the quality of the FHR tracing obtained with ultrasound include:

Uterine contractions Changing contour of the maternal abdomen Maternal body movement - positioning Maternal expulsive efforts - pushing Maternal tachycardia/accelerations with contractions Fetal decelerations, Fetal tachycardia Delayed return of the fetal heart rate from a deceleration Descent of the fetus in the birth canal Rotation of the fetus in the birth canal In some cases during the second stage of labor, a good and reliable ultrasound FHR signal may not be obtainable, and the use of a fetal scalp electrode must be considered (fetal ECG). Heart Rate Sound The heart rate sound emitted by the device is a representation of movement that, in most cases, permits accurate auscultation of the FHR corresponding to the FHR displayed on the monitor and rate pattern depicted on the trace recording. On occasion, the user may hear an FHR that differs from the FHR display and the recorded trace. This may occur in situations where the fetal heart moves partly out of the transducer ultrasound beam. In these cases, the user may hear the FHR emitted from the monitors speaker, even though another periodic signal (usually the maternal heart rate) has become stronger. The autocorrelation algorithm will display the stronger maternal heart rate, despite the persistence of a weaker fetal signal. These occurrences are usually very brief and, if persistent, can be addressed by repositioning the transducer. Signal Quality Indicator The signal quality on the Avalon fetal monitor is indicated by a triangle on the touchscreen that is displayed in one of three ways:

1 Completely filled triangle, indicating good signal quality (good/full). 2 Half-filled triangle, indicating limited signal quality. This condition may indicate a weak or ambiguous signal. If this status persists, reposition the transducer

(acceptable/medium). 3 Empty triangle, indicating insufficient signal quality. No FHR is displayed on the monitors numeric display or the recorded trace. If this status persists, reposition the transducer (poor/no signal). 179 12 Monitoring FHR and FMP Using Ultrasound Examples of Artifacts When monitoring the maternal ECG, a beat-to-beat maternal heart rate trace is printed alongside the FHR recorded trace. When monitoring the maternal SpO2 derived pulse rate, a filtered and averaged heart rate trace is printed. Following are recorded trace examples of complaints received regarding inaccurate output from the Avalon monitors. Scaling is 3 cm/min and 30 bpm/cm. Double-Counting Baseline Rate Baseline Variability Accelerations Decelerations Contractions Artifact Comment 120 Moderate Present Not apparent Excessive, coupling, hypertonus Double-Counting Reassuring tracing. The excessive uterine activity should prompt discontinuation of any oxytocic agent. Remediation The true fetal rate can be confirmed by auscultation or by fetal scalp electrode. Half-Counting Baseline Rate Baseline Variability Accelerations Decelerations 120 Moderate Present Not apparent 180 12 Monitoring FHR and FMP Using Ultrasound Half-Counting Contractions Minimal Artifact Comment Half-counting, noise, drop out Reassuring tracing. The half-count at 4-5 minutes into the tracing may simulate a fetal deceleration, but the abruptness and the lack of any compensatory changes when the normal rate returns suggests that this is half-counting. Insertion of the maternal heart rate (see below) may produce a similar pattern. Note also very brief episodes of half-counting, maternal insertion, and signal dropout. Remediation Auscultation or the application of a direct scalp electrode, if feasible, will reveal the true fetal heart rate. Maternal-Switching (Maternal Insertion) Baseline Rate 170 - Tachycardia Baseline Variability Moderate Accelerations Decelerations Contractions Artifact Comment Remediation Unable to determine Absent Absent Maternal insertion, noise The fetus has an elevated baseline rate of about 170 bpm with minimal to moderate variability. The ability to assess fetal status is limited because about half of the tracing displays the maternal heart rate. The application of a maternal transducer (ECG or pulse oximeter) will likely resolve any possible confusion with the tracing. Repositioning the transducer may produce a more reliable tracing. Consideration must also be given to applying a fetal scalp electrode. 181 12 Monitoring FHR and FMP Using Ultrasound Noisy/Erratic Signal and Dropout Baseline Rate 140 Baseline Variability Moderate Accelerations Decelerations Contractions Artifact Comment Remediation Present Absent Minimal Noisy signal, drop-out Reassuring tracing. Note that there is episodic drop out of the signal with discontinuity of the fetal tracing. Either improving the position of the transducer or the application of a fetal scalp electrode will reduce the amount of artifact in the tracing. Selection of Literature References on Artifacts ___________________________________________________________ Mosby's Pocket Guide to Fetal Monitoring: A Multidisciplinary Approach (Nursing Pocket Guides) 8th Edition (May 2016). Lisa A. Miller, David A. Miller, Rebecca L. Cypher Elsevier Ltd, Oxford. 2017, ISBN 978-0-323-40157-9 ___________________________________________________________ Signal ambiguity resulting in unexpected outcome with external fetal heart rate monitoring By Duncan R. Neilson Jr, MD; Roger K. Freeman, MD; Shelora Mangan, RNC, MSN, CNS American Journal of Obstetrics & Gynecology, June 2008 ___________________________________________________________ Antepartal and Intrapartal Fetal Monitoring, 3rd Edition (2007) By Michelle L. Murray, PhD, RNC Springer Publishing Company, ISBN 0-8261-3262-6 Page 2, Table 2: Limitations of Continuous EFM Item 15: The US may detect maternal aortic wall movement and the maternal HR will be printed. A failure to recognize the lack of an FHR may delay appropriate management. Page 38, Solving Equipment Problems, Table 3: The Ultrasound Transducer ___________________________________________________________ 182 12 Monitoring FHR and FMP Using Ultrasound JOGC (Journal of Obstetrics and Gynecology Canada) Volume 29, Number 9, September 2007 Chapter 2: Intrapartum Surveillance Page S35: Methods of Electronic Fetal Monitoring Among its disadvantages are the need for readjustment with maternal or fetal movements and the following: the transducer may record the maternal pulse, it may be difficult to obtain a clear tracing in obese women or those with polyhydramnios, artifact may be recorded, and there may be doubling or halving of the fetal heart rate when it is outside of the normal range. ___________________________________________________________ Maternal or Fetal Heart Rate? Avoiding Intrapartum Misidentification by Michelle L. Murray JOGNN Clinical Issues, April 2003, 33, 93-104; 2004. DOI: 10.1177/0884217503261161 Figure 9 The recording is of the MHR with occasional doubling. ___________________________________________________________ Maternal Heart Rate Pattern A Confounding Factor In Intrapartum Fetal Surveillance Schifrin BS, Harwell R, Hamilton-Rubinstein T, Visser G:

Prenat Neonat Med 2001; 6:75-82 ___________________________________________________________ Fetal Monitoring in Practice, 2nd Edition 1998 By Donald Gibb, S. Arulkumaran Butterworth-Heinemann, ISBN 0-7506-3432-2 Page 65, False or erroneous baseline because of double counting of low baseline FHR Page 66, Bradycardia: fetal or maternal ___________________________________________________________ Role of Maternal Artifact in Fetal Heart Rate Pattern Interpretation Klapholz, Henry M, MD; Schifrin, Barry S. MD; Myrick, Richard RS Obstetrics & Gynecology, September 1974, Volume 44, Issue 3 ___________________________________________________________ 183 12 Monitoring FHR and FMP Using Ultrasound 184 13 13Monitoring Twin FHRs The FHRs of twins are externally monitored using two ultrasound transducers. The Avalon CL Transducer system provides the option to monitor twins with cableless transducers. The Avalon CTS system and the CL F&M Pod do not have this option. FM30/50 Twin FHRs are monitored throughout labor and delivery. After rupture of the membranes, you can monitor one twin externally using ultrasound, and the other internally using DECG. Refer to the appropriate preceding chapters for contraindications, and more information about the available measurement methods. FHR detection by the monitor does not always indicate that the fetuses are alive. Confirm fetal life before monitoring, and continue to confirm that the fetuses are the signal source for the recorded fetal heart rates. See Confirm Fetal Life Before Using the Monitor on page 12 and Cross-Channel Verification (CCV) on page 163. Important Considerations When monitoring:

Ensure that you are recording two different fetal heart rates. The cross-channel verification feature alerts you if the two heart rates coincide (if both transducers are recording the same FHR). If this happens, check the trace and if necessary, reposition an ultrasound transducer to detect the second FHR correctly. Fetal heart rate measurements are labeled in the order in which you plug in the transducers for those measurements. It does not matter which fetal sensor socket you use, as the monitor allocates a channel automatically. For instance, the first transducer you connect is automatically allocated a channel, and the measurement is labeled FHR1, the second is labeled FHR2, and so on. If you need to disconnect the transducers measuring the FHR temporarily, with the intention to continue monitoring after the temporary break (for example, if the mother needs to go to the bathroom), it is important that you reconnect the transducers in the same order as you originally connected them to make sure that the measurement labels remain consistent. Upon discharge of the patient all connected transducers are reset from left to right. Example: Only one transducer is still connected to the monitor, it was labeled FHR2 while monitoring the previous discharged patient; it is now reset to FHR1. The transducer finder LED lets you identify at a glance which transducer is monitoring which heart rate channel. The fetal sensor socket to which a transducer is connected is identified by the transducer position indicator in the setup menu header:

FM20/FM30 FM40/FM50 185 13 Monitoring Twin FHRs The trace recorded for FHR1 is thicker (darker) than that recorded for FHR2. This ensures that the two heart rates are easily distinguishable. The thickness of the recorded trace can be changed in Configuration Mode. Remember that only one fetal heartbeat can be heard from the loudspeaker at a time. The audio source symbol shows you which fetus you are listening to. To hear the other fetal heartbeat, select the fetal heart rate sound for this channel (see Selecting Fetal Heart Sound on page 172). Monitor maternal pulse, especially during later stages of labor, to avoid mistaking maternal heart rate for FHR. Make sure that you are recording the best possible signals by referring to the signal quality indicators and repositioning the transducers if necessary. For the Avalon CL transducer system, see Cableless Monitoring - Important Considerations on page 171. Monitoring Twins Externally To monitor twin FHRs externally, you need two ultrasound transducers. Follow the procedures described in Monitoring FHR and FMP Using Ultrasound on page 169. The transducer finder LED lets you identify at a glance which transducer is monitoring which FHR channel, and lights when you select the FHR numeric field on the screen. Example of the screen showing ultrasound monitoring of twin FHRs:

1 2 3 FHR 1 Toco parameter FHR 2 Monitoring Twins Internally FM30/50 Monitor one twin using the procedures described in Monitoring FHR and FMP Using Ultrasound on page 169. Monitor the second twin using the procedures described in Monitoring FHR Using DECG on page 199. 186 13 Monitoring Twin FHRs Example of a screen showing twin monitoring using a combination of US and DECG (the fetal heart rate monitored via DECG is labeled dFHR1/ dFHR2 / dFHR3 on the screen):

1 2 3 dFHR 1 Toco parameter FHR 2 Separating FHR Traces To help you to interpret traces with similar baselines, you can separate the baselines by an offset of 20 bpm by switching on trace separation. For details of the offset, see Separation Order Type on page 187. Switching Trace Separation On and Off Connect transducers to the monitor to measure FHR. Depending on the measurement method, you need either two ultrasound transducers or, for FM30/FM50, one ultrasound and one Toco+ transducer, or one CL ECG/IUP transducer (to monitor DECG):

1 2 3 Enter the Main Setup menu by pressing the Main Setup. Select Fetal Recorder. Select Trace Separation to switch between On and Off. 4 Exit the Main Setup menu. Separation Order Type In Configuration Mode, you can choose between two methods, Standard and Classic, for dealing with the trace offsets on the recording (the order in which they are separated) when Trace Separation is On. Standard: the FHR2 trace is shifted up by 20 bpm (it is recorded 20 bpm higher than it really is). No offset is ever applied to the FHR1 trace - it stays where it is (a third FHR would be shifted down by 20 bpm). Classic: the FHR1 trace is shifted up by 20 bpm when there is more than one FHR measurement. No offset is ever applied to the FHR2 trace - it stays where it is (a third FHR would be shifted down by 20 bpm). 187 13 Monitoring Twin FHRs When Trace Separation is On When trace separation is turned on, the recorder prints a dotted line labeled with the two FHRs at the top, and +20 at the bottom. Examples of the two methods (Standard, Classic) for determining the trace separation order are provided here. Standard Separation Order To make differentiating the traces easier, the trace from the ultrasound transducer connected to the FHR2 channel is separated from that of FHR1 by 20 bpm. In other words, the trace for FHR2 is recorded 20 bpm higher than it really is. The trace for FHR1 is never shifted. The recorder prints a dotted line labeled +20 across the FHR scale, to identify the trace for FHR2. The FHR trace is labeled +20 every 5 cm:

The label for FHR2 is annotated with a black filled +20:

The following trace shows trace separation switched on. Only the FHR2 trace is offset. The numerical FHR value displayed on the monitor remains unchanged. Subtract 20 from the recorded trace for FHR2 to obtain the true FHR2 value. For example, if the recorded trace shows 160, then the true FHR is 140. Classic Separation Order To make differentiating the traces easier, the trace for FHR1 is offset by +20 bpm when FHR2 is present. The FHR2 trace is never shifted. The recorder prints a dotted line labeled +20 across the FHR scale, to identify the trace for FHR1. The FHR trace is labeled +20 every 5 cm:

188 13 Monitoring Twin FHRs The label for FHR1 is annotated with a black filled +20:

The following trace shows trace separation switched on. Only the FHR1 trace is shifted. The numerical FHR value displayed on the monitor remains unchanged. Subtract 20 from the recorded trace for FHR1 to obtain the true FHR1 value. For example, if the recorded trace shows 160, then the true FHR is 140. When Trace Separation is Off To indicate that trace separation is switched off, a dotted line labeled +0 prints across the FHR scale. 1 Standard trace separation switched off here 189 13 Monitoring Twin FHRs 2 Classic trace separation switched off here Troubleshooting Common problems that may occur when monitoring FHR using ultrasound are listed in Monitoring FHR and FMP Using Ultrasound on page 169. See also Monitoring FHR Using DECG on page 199 for common problems you might encounter when monitoring FHR directly. The following problem may occur when monitoring twins. Problem Possible Cause Solution The question mark is printed repeatedly, and appears on the screen and the INOP Coincidence is issued. Both transducers are recording the same FHR, or one fetal transducer is recording the maternal HR. Reposition an ultrasound transducer. See Recommended Actions for Coincidence INOP on page 167. For more information, see Additional Information on page 176. 190 14 14Monitoring Triple FHRs If your monitor is equipped with the triplets option, it carries the label:

You can monitor triple FHRs externally using three ultrasound transducers. With the Avalon CL Transducer system, you can monitor triplets with cableless transducers. The Avalon CTS system and the CL F&M Pod do not have this option. Refer to the appropriate preceding chapters for contraindications, and more information about the available measurement methods. FHR detection by the monitor may not always indicate that the fetuses are alive. Confirm fetal life before monitoring, and continue to confirm that the fetuses are the signal source for the recorded fetal heart rates. See Confirm Fetal Life Before Using the Monitor on page 12 and Cross-Channel Verification (CCV) on page 163. Important Considerations The procedures and any contraindications that apply for twins monitoring also apply for monitoring triplets. In addition, when monitoring triplets: Be aware that monitoring three FHRs is inherently more difficult than monitoring single or twin FHRs. The nature of the application increases the likelihood that a fetal heart rate is monitored by more than one transducer. Ensure that you are recording three different fetal heart rates. Pay particular attention to any coincidence of heart rates detected by the monitor's cross-channel verification feature. Fetal heart rate measurements are labeled in the order in which you plug in the transducers for those measurements. It does not matter which fetal sensor socket you use, as the monitor allocates a channel automatically. For instance, the first transducer you connect is automatically allocated a channel, and the measurement is labeled FHR1, the second is labeled FHR2, and the third FHR3. If you need to disconnect the transducers measuring the FHR temporarily, with the intention to continue monitoring after the temporary break (for example, if the mother needs to go to the bathroom), it is important that you reconnect the transducers in the same order as you originally connected them to make sure that the measurement labels remain consistent. Upon discharge of the patient all connected transducers are reset from left to right. Example: Only one transducer is still connected to the monitor, it was labeled FHR2 while monitoring the previous discharged patient; it is now reset to FHR1. The transducer finder LED lets you identify at a glance which transducer is monitoring which heart rate channel. The fetal sensor socket to which a transducer is connected, is identified by the transducer position indicator in the setup menu header:

191 14 Monitoring Triple FHRs FM20/FM30 FM40/FM50 The trace recorded for the FHR3 is thicker (darker) than that recorded for FHR1, which is thicker than that for FHR2. This ensures that the three heart rates are easily distinguishable. The thickness of the recorded trace can be changed in Configuration Mode. Remember that only one fetal heartbeat can be heard from the loudspeaker at a time. The audio source symbol shows you which fetus you are listening to. To hear the other fetal heartbeat, select the fetal heart rate sound for this channel (see Selecting Fetal Heart Sound on page 172). Monitor maternal pulse to avoid mistaking maternal heart rate for FHR. Ensure you are recording the best possible signals by referring to the signal quality indicators and repositioning the transducers if necessary. For the Avalon CL transducer system, see Cableless Monitoring - Important Considerations on page 171. Monitoring Triplets To monitor triple FHRs, you need three ultrasound transducers. Follow the procedures described in Monitoring FHR and FMP Using Ultrasound on page 169 and in Monitoring Twin FHRs on page 185. The transducer finder LED lets you identify at a glance which transducer is monitoring which heart rate channel. Separating FHR Traces To help you to interpret traces with similar baselines, you can separate the baselines by an offset of 20 bpm by switching on trace separation. For details of the offset, see Separation Order Type on page 187. Standard Separation Order To make differentiating the traces easier, the trace for FHR2 is offset by +20 bpm, and the trace for FHR3 is offset by -20 bpm. In other words, the trace for FHR2 is recorded 20 bpm higher than it really is, while the trace for FHR3 is recorded 20 bpm lower than it really is. The trace for FHR1 is never shifted. The recorder prints a dotted line labeled +20 across the FHR scale, to identify the trace for FHR2. The recorder prints a dotted line labeled -20 across the FHR scale, to identify the trace for FHR3. The FHR trace is labeled every 5 cm. The label for FHR2 is annotated with +20 and the FHR3 label is annotated with -20. 192 The following trace shows triplets with Trace Separation on, and using Standard separation order. 14 Monitoring Triple FHRs The traces for FHR2 and FHR3 are offset. The numerical FHR values displayed on the monitor remain unchanged. Subtract 20 from the recorded trace for FHR2 to obtain the true FHR2. For example, if the recorded trace shows 160 bpm, then the true FHR is 140 bpm. Similarly, add 20 to the recorded trace for FHR3 to obtain the true FHR3. Classic Separation Order To make differentiating the traces easier, the trace for FHR1 is offset by +20 bpm when other FHR measurements are present, and the trace for FHR3 is offset by -20 bpm. The FHR2 trace is never shifted. In other words, the FHR traces are always sorted in ascending order from top to bottom. The recorder prints a dotted line labeled +20 across the FHR scale, to identify the trace for FHR1. The recorder prints a dotted line labeled -20 across the FHR scale, to identify the trace for FHR3. The FHR trace is labeled every 5 cm. The label for FHR1 is annotated with +20 and the FHR3 label is annotated with -20. 193 14 Monitoring Triple FHRs The following trace shows triplets with Trace Separation on, and using Classic separation order. The traces for FHR1 and FHR3 are shifted. The numerical FHR values displayed on the monitor remain unchanged. Subtract 20 from the recorded trace for FHR1 to obtain the true FHR1. For example, if the recorded trace shows 160 bpm, then the true FHR is 140 bpm. Similarly, add 20 to the recorded trace for FHR3 to obtain the true FHR3. Switching Trace Separation On and Off 1 2 Connect three ultrasound transducers to the monitor to measure FHR. See Switching Trace Separation On and Off on page 187 for details of how to switch trace separation on or off. When Trace Separation is On When trace separation is turned on, the recorder prints a dotted line labeled with the three FHRs at the top, and 20 at the bottom. Examples of the two methods (Standard, Classic) for determining the trace separation order are provided here. When Trace Separation is Off To indicate that trace separation is switched off, a dotted line labeled +0 prints across the FHR scale. 194 14 Monitoring Triple FHRs 1 Standard trace separation switched off here 2 Classic trace separation switched off here 195 14 Monitoring Triple FHRs Troubleshooting Common problems that may occur when monitoring FHR using ultrasound are listed in Monitoring FHR and FMP Using Ultrasound on page 169. The following problem may occur when monitoring triplets. Problem Possible Cause Solution The question mark is printed repeatedly, and appears on the screen and the INOP Coincidence is issued. More than one transducer is recording the same FHR, or a fetal transducer records the same heart rate as the maternal HR. Reposition one or more ultrasound transducer, as appropriate. See Recommended Actions for Coincidence INOP on page 167 For more information, see Additional Information on page 176. 196 15 15Fetal Heart Rate Alarms Fetal heart rate (FHR) alarms can give both audible and visual warning of a non-reassuring fetal condition. Your monitor must be configured to Alarm Mode All to enable the FHR alarms (see Alarms on page 115). Changing Alarm Settings When you do any of the following actions for any FHR measurement channel, this applies for all active FHR measurements, ultrasound, DECG, and aFHR:

Turning FHR alarms on or off Changing alarm limits Changing alarm delays Changing signal loss delay The monitor retains these settings, even when switched off. The alarm limits are printed on the trace every few pages if alarms are on. Turning Alarms On or Off 1 Connect either an ultrasound or a DECG transducer to a free socket on the monitor, or use the CL F&M Pod. 2 Enter the setup menu for a connected FHR measurement. 3 Select Alarms to switch between On and Off. Changing Alarm Limits 1 Connect either an ultrasound or a DECG transducer to a free socket on the monitor, or use the CL F&M Pod. 2 Enter the setup menu for a connected FHR measurement. 3 4 To change the high alarm limit, select High Limit and select the alarm limit from the pop-up list. To change the low alarm limit, select Low Limit and select the alarm limit from the pop-up list. Changing Alarm Delays You can change the alarm delays if the Alarm Mode is set to All. 1 Connect either an ultrasound or a DECG transducer to a free socket on the monitor, or use the CL F&M Pod. 2 Enter the setup menu for a connected FHR measurement. 3 4 To change the high alarm limit delay time, select High Delay and select the delay time (in seconds) from the pop-up list. To change the low alarm limit delay time in seconds, select Low Delay and select the delay time (in seconds) from the pop-up list. 197 15 Fetal Heart Rate Alarms Changing Signal Loss Delay The signal loss delay is the configurable delay before a Signal Loss INOP is issued. You can change the delay:

1 Connect either an ultrasound or a DECG transducer to a free socket on the monitor, or use the CL F&M Pod. 2 Enter the setup menu for a connected FHR measurement. 3 Select SignalLoss Delay and select the signal loss INOP delay time (in seconds) from the pop-up list. 198 16 16Monitoring FHR Using DECG FM30/50 This chapter describes how to monitor a single fetal heart rate via direct ECG (DECG), using a spiral fetal scalp electrode in the intrapartum period. Read and adhere to the instructions that accompany the fetal scalp electrode, the DECG adapter cable, and the attachment electrode. Pay attention to all the contraindications, warnings, and for the DECG adapter cable, the cleaning and disinfection procedures. Before starting to monitor, first define the fetal position, and ensure that it is suitable for DECG monitoring. Misidentification of Maternal HR as FHR Confirm fetal life before monitoring, and continue to confirm that the fetus is the signal source for the FHR during monitoring. Here are two examples where the maternal HR can be misidentified as the FHR when using a fetal scalp electrode:

Electrical impulses from the maternal heart can sometimes be transmitted to the fetal monitor through a recently deceased fetus via the spiral scalp electrode, appearing to be a fetal signal source. The recorded maternal HR, and any artifact, can be misinterpreted as an FHR especially when it is over 100 bpm. To reduce the possibility of mistaking the maternal HR for FHR, monitor both maternal and fetal heart rates (see Monitoring Maternal Heart / Pulse Rate on page 219). The monitor's cross-channel verification

(CCV) facility can help by automatically detecting when the same heart rate is being recorded by different transducers. See Confirm Fetal Life Before Using the Monitor on page 12 and Cross-Channel Verification (CCV) on page 163. If the Coincidence INOP is issued at the fetal monitor if you are measuring FHR with DECG:

1 Confirm that the scalp electrode is placed correctly. 2 Confirm fetal life by palpation of fetal movement or auscultation of fetal heart sounds using a fetoscope, stethoscope, or Pinard stethoscope. 3 If you cannot hear the fetal heart sounds, and you cannot confirm fetal movement by palpation, confirm fetal life using obstetric ultrasonography. 199 16 Monitoring FHR Using DECG 4 In case of difficulties deriving a stable maternal pulse reading using the Toco+ MP or CL Toco+ MP transducer, use SpO2 instead. In case of similar problems with the pulse measurement from SpO2, use MECG instead. Reasons to switch the method for deriving a maternal pulse or heart rate include:

motion artifacts, arrhythmia, and individual differences in pulse signal quality on the abdominal skin

(via Toco+ MP). What You Need You can measure fetal DECG using the equipment combinations shown in the following figures. WARNING Never attempt to connect the fetal scalp electrode to anything other than the correct DECG adapter cable. DECG with ECG/IUP Transducer (cable) The figure below shows the chain using the ECG/IUP transducer. 1 2 Fetal Scalp Electrode, single spiral, (989803137631) Fetal Scalp Electrode, double spiral, Europe only, not for U.S. (989803137641) 3 DECG Adapter Cable (9898 031 37651) with Pre-gelled Attachment Electrode (989803139771) 4 ECG/IUP (867247) 200 16 Monitoring FHR Using DECG DECG with Toco+ or Toco+ MP (cable) The figure below shows the complete connection chain from the fetal scalp electrode to the fetal monitor using the Toco+ MP transducer. 1 2 Fetal Scalp Electrode, single spiral (989803137631) Fetal Scalp Electrode, double spiral, Europe only, not for U.S. (989803137641) 3 DECG Adapter Cable (9898 031 37651) with Pre-gelled Attachment Electrode (989803139771) 4 Toco+ transducer (M2735A), Toco+ transducer (867249), Toco+ MP (867245) DECG with CL Toco+ MP or CL ECG/IUP Transducer (cableless) The figure below shows the equivalent chain using the CL Toco+ MP or CL ECG/IUP transducer. 1 2 Fetal Scalp Electrode, single spiral (989803137631) Fetal Scalp Electrode, double spiral, Europe only, not for U.S. (989803137641) 3 DECG Adapter Cable (9898 031 37651) with Pre-gelled Attachment Electrode (989803139771) 201 16 Monitoring FHR Using DECG 4 CL Toco+ MP (866075) or CL ECG/IUP (866077) transducer 5 Avalon CL base station (866074) Making Connections WARNING Follow the instructions supplied with each of the monitoring accessories you are using. Prepare for DECG monitoring using the list below. The standard procedures in use in your facility determine the sequence of actions. 1 If you change the Monitoring Mode from US to DECG, first disconnect the US transducer. 2 Depending on the equipment you are using, ensure that the transducer, or the patient module is connected to the fetal monitor. 3 Attach the fetal scalp electrode to the fetus, following the instructions supplied with the fetal scalp electrode. 4 Attach a pre-gelled attachment electrode to the DECG adapter cable, following the instructions supplied with the DECG adapter cable. 5 Fix the attachment electrode to the mother's thigh, following the instructions supplied with the attachment electrode. Depending on the equipment you are using, connect the red connector plug on the DECG adapter cable to the red connector on the Toco+ MP or CL Toco+ MP transducer, or the ECG/IUP or CL ECG/IUP transducer, or the patient module. 6 Connect the fetal scalp electrode to the DECG adapter cable. You are now ready to begin monitoring DECG. WARNING The fetal/maternal monitor is not a diagnostic ECG device. In particular, the display of fetal/maternal ECG is intended only for evaluating signal quality for fetal/maternal heart rate as derived from the ECG waveform. When in doubt, it can be used to identify sources of compromised signal quality, such as noise or muscle artifacts. It can subsequently be used to verify the result of measures taken to resolve them (e.g. checking ECG cable connections or adapting the fetal ArtifactSuppress configuration). The safety and effectiveness of the displayed fetal/maternal ECG waveform (i.e. P, QRS, and T segments) for evaluation of fetal/maternal cardiac status during labor have not been evaluated. 202 Monitoring DECG 16 Monitoring FHR Using DECG To simultaneously measure DECG and MECG, you need the ECG/IUP or CL ECG/IUP transducer, or the patient module for DECG, and a Toco+, Toco+ MP, or CL Toco+ MP, or ECG/IUP, CL ECG/IUP transducer for MECG (see Monitoring Maternal Heart / Pulse Rate on page 219). Alternatively, you can monitor the maternal pulse rate via pulse oximetry (see Pulse Rate from SpO2 on page 225). You can also monitor maternal pulse with the Toco+ MP or CL Toco+ MP transducer. In any case, where you would use a Toco+ or Toco MP transducer, you can also monitor with a Toco+ MP or CL Toco+ MP transducer. 1 Switch on the recorder. 2 The heart rate monitored via DECG is labeled dFHR1 / dFHR2 / dFHR3 on the screen. If configured, the DECG wave is displayed automatically on the screen, labeled DECG, and fetal. If MECG is being monitored, both waves are displayed, with the DECG wave above the MECG wave. The MECG wave is labeled MECG and maternal. 3 Check the artifact suppression setting and change it if necessary (see Suppressing Artifacts on page 204). 1 Measurement label (dFHR1) 2 Measurement label (Toco) 3 Measurement label (FHR2) 4 Measurement label (HR) 5 1mV scale bar 6 MECG wave with maternal label 7 DECG wave with fetal label 8 Measurement label (Temp) maternal temperature 9 Measurement label NBP NOTE The 1mV scale bar for the DECG and MECG wave is not displayed on the screen if you monitor DECG or MECG with an Avalon CTS system. The Avalon CTS system does not provide a scaled ECG. 203 16 Monitoring FHR Using DECG WARNING Periodically compare the mother's pulse with the signal coming from the monitor's loudspeaker to ensure that you are monitoring fetal heart rate. If the maternal HR coincides with the FHR, do not misinterpret the maternal HR as the FHR (see also Confirm Fetal Life Before Using the Monitor on page 12 and Cross-

Channel Verification (CCV) on page 163. Suppressing Artifacts When the monitor's artifact suppression is on, instantaneous heart rate changes of 28 bpm or more, however caused, are not recorded. Fetal arrhythmia will also be suppressed. If you suspect fetal arrhythmia, switch artifact suppression off. When artifact suppression is off, all recorded fetal heartbeats within the specified range are shown. The default setting is On (artifacts are suppressed). To change the setting:

1 2 Enter the Setup dFHR1 menu. Select ArtifactSuppress to switch between artifact suppression On (artifacts are suppressed) and Off (no artifact suppression, use this setting if you suspect fetal arrhythmia). When artifact suppression is off, Artifact Suppression Off is annotated on the trace recording. Printing the Waveform You can print the DECG wave onto the trace paper. Refer to Printing the ECG Waveform on page 227. Troubleshooting NOTE In many cases you need to see the DECG wave to check if the signal quality is good enough to derive a valid fetal heart rate. In the dFHR setup menu, switch on the display of the DECG wave. Problem Possible Cause Solutions dFHR1 Equip Malf dFHR2 Equip Malf dFHR3 Equip Malf Malfunctioning equipment See Patient Alarms and INOPs on page 127. 204 Problem Possible Cause Solutions 16 Monitoring FHR Using DECG Fetal scalp electrode detached at connector Reconnect the fetal scalp electrode dFHR1 Leads Off dFHR2 Leads Off dFHR3 Leads Off Numeric is displayed with a -?-;

INOP tone See also Patient Alarms and INOPs on page 127. Poor or no contact between leg attachment electrode and mother Erratic trace Erratic display No contact between the DECG adapter cable and the leg attachment electrode No contact between the fetal scalp electrode connector and the DECG adapter cable If the wave is configured to be displayed on the monitor, you can observe if the ECG signal is clear, or if it shows interruptions and noise Check all connections Disconnect and reconnect the connector several times Check all connections Disconnect and reconnect the connector several times If problem persists, use a new fetal scalp electrode No ECG signal Check for fetal demise Poor contact between the reference electrode and the mother Use a new fetal scalp electrode if necessary Signal quality indicator continuously shows a poor signal Fetal arrhythmia dFHR1 Signal Loss dFHR2 Signal Loss dFHR3 Signal Loss dFHR1 Unplugged dFHR2 Unplugged dFHR3 Unplugged No signal No connection Testing DECG Mode See the monitor's Service Guide. Use a new fetal scalp electrode if necessary See Patient Alarms and INOPs on page 127. See Patient Alarms and INOPs on page 127. 205 16 Monitoring FHR Using DECG 206 17 17Monitoring Uterine Activity Externally You can measure uterine activity externally using a Toco transducer. You can use a Toco+, Toco MP, Toco+ MP, or a CL Toco+ MP transducer for the same purpose, although they also have more (ECG/IUP and Pulse) capabilities. The external Toco transducer allows to monitor the frequency, duration, and relative strength of contractions, but not their absolute intensity. Amplitude and sensitivity depend on various factors such as the position of the transducer, the belt tension, and the size of the patient. What You Need Toco+, Toco MP, or Toco+ MP transducer (Toco MP and Toco+ MP additionally capable of providing the maternal pulse measurement) CL Toco+ MP transducers (additionally capable of providing the maternal pulse measurement) Abdominal belt (disposable shown) 207 17 Monitoring Uterine Activity Externally External Toco Monitoring Prepare for Toco monitoring using the list below. The standard procedures in use in your facility determine the sequence of actions. 1 Fasten the abdominal transducer belt around the patient. 2 Connect the Toco transducer to a free socket on the monitor. The Toco baseline is automatically reset. The Toco display shows 20. Toco, indicating external uterine measurement, is printed on the trace at intervals. 3 Place the transducer on the patient's fundus to ensure the optimum recording of uterine activity. 4 Reset the Toco baseline as necessary (see Resetting the Toco Baseline on page 208), but not during a contraction. The following example trace shows two contractions. Resetting the Toco Baseline 1 2 Press the Toco Baseline SmartKey. This resets the Toco baseline to 20 on the display and trace. If the Toco value is negative for more than five seconds, the Toco baseline is automatically reset to 0 units. Toco Sensitivity If the Toco sensitivity is too high, and the Toco trace exceeds the paper scale, you can reduce the Toco sensitivity to 50%. The default setting is 100%. To change the Toco sensitivity:

1 2 Enter the Setup Toco menu. Select Gain to switch between 100% and 50%. 208 17 Monitoring Uterine Activity Externally Troubleshooting External Toco Monitoring Problem Possible Causes Solutions Quality of the trace deteriorates or the Toco baseline varies The belt is incorrectly fastened and is too slack or too tight, or the belt has lost its elasticity. Fetal movement Maternal respiration superimposed on trace Maternal movement/change of position Physical transmission of pressure from the uterus to the sensor is much higher than the average value. Physical transmission of pressure from the uterus to the sensor is insufficient. Check if the belt is too loose. Select 100% Toco Gain. Toco sensitivity is too high (above 100 units) Toco trace is exceeding the paper scale Toco sensitivity is too low. Contractions are not clearly visible on the trace. Toco Equip Malf is displayed. Toco Unplugged is displayed. If you suspect the signal from the transducer. The belt must be tight enough to ensure good contact between the patient's skin and the entire surface of the transducer without causing discomfort. Ensure you are using the correct belt. Adjust it as necessary. Check if the belt is correctly fastened and adjust it as necessary. Reposition the transducer and reset the Toco baseline if necessary. Check if belt is not too loose. Following maternal movement, reset Toco baseline Check if the belt is too tightly fastened. Select 50% Toco Gain. See Patient Alarms and INOPs on page 127. See Patient Alarms and INOPs on page 127. Test the Transducer (see Testing Toco Transducers on page 210 below). 209 17 Monitoring Uterine Activity Externally Testing Toco Transducers If any of the following tests fail, repeat the test using another transducer. If the second transducer passes the tests, confirming that the first transducer is defective, contact your service personnel. If the second transducer also fails the tests, contact your service personnel. You can test all Toco transducers, including the cableless ones. To test a Toco transducer:

1 Switch on the monitor and the recorder. 2 Connect the transducer to the fetal monitor. 3 Gently apply pressure to the pick-up button. 4 Check if after a few seconds the values on the display and paper show this change in pressure. 210 18 18Monitoring Uterine Activity Internally FM30/50 You can monitor intrauterine pressure (IUP) using an intrauterine catheter together with a patient module, Toco+, Toco+ MP, ECG/IUP, or the CL ECG/IUP or CL Toco+ MP transducer, after rupture of the membranes and the cervix is sufficiently dilated. WARNING IUP Catheter: Do not catheterize if placenta previa is diagnosed, or if uterine bleeding from an undetermined source is present. What You Need IUP with ECG/IUP Transducer (cable) The figure below shows the complete connection chain from the IUP catheter to the fetal monitor using the ECG/IUP transducer:

1 Disposable Koala IUP Catheter (M1333A) 2 Reusable Koala IUP Adapter Cable (9898 031 43931) 3 ECG/IUP transducer (867247) 211 18 Monitoring Uterine Activity Internally IUP with Toco+ MP or Toco+ Transducer (cable) The figure below shows the complete connection chain from the IUP catheter to the fetal monitor using the Toco+ MP transducer:

1 Disposable Koala IUP Catheter (M1333A) 2 Reusable Koala IUP Adapter Cable (9898 031 43931) Toco+ MP (867245) or Toco+ (867249) transducer 3 IUP with CL ECG/IUP, or CL Toco+ MP Transducer (cableless) The figure below shows the complete connection chain from the IUP catheter to the fetal monitor using the CL ECG/IUP transducer:

1 Disposable Koala IUP Catheter (M1333A) 2 Reusable Koala IUP Adapter Cable (9898 031 43931) 3 CL ECG/IUP transducer (866077), or CL Toco+ MP (866075) transducer 4 Avalon CL base station (866074) 212 Internal (IUP) Monitoring 18 Monitoring Uterine Activity Internally Read the instructions that accompany the intrauterine catheter and the adapter cable before you start monitoring. Zero the IUP measurement when instructed. WARNING Do not catheterize if placenta previa is diagnosed, or if uterine bleeding from an undetermined source is present. Prepare for IUP monitoring using the list below. The standard procedures in use in your facility determine the sequence of actions. 1 Perform a complete clinical evaluation. 2 Catheterize after membrane rupture. Insert the catheter according to its accompanying instructions. 3 Connect the catheter to the socket on the patient module. 4 Connect the patient module to a free socket on the monitor. The monitor is automatically zeroed. The IUP display shows 0. IUP, indicating internal measurement is printed at intervals on the trace. 5 Zero the IUP measurement (see Zero The IUP Measurement on page 213). 6 If you suspect the catheter is not responding appropriately, flush as directed in the catheter's Instructions for Use. A pressure spike appears on the trace if you flush after connecting the transducer to the monitor. Zero The IUP Measurement Zero the IUP measurement by selecting the Zero IUP SmartKey, or selecting Zero IUP in the Setup IUP menu. This resets the display and trace to 0. If you do not zero the monitor properly, the pressure trace may exceed the paper scaling. Selecting the IUP Unit You can select between mmHg (default) and kPa for the IUP unit. 1 2 Enter the Setup IUP menu. Press Unit to switch between mmHg and kPa. 213 18 Monitoring Uterine Activity Internally Troubleshooting Internal (IUP) Monitoring Problem Possible Causes Solutions Only pressure peaks can be seen

(baseline not visible). No change in pressure during contraction. Trace is a straight line. Zero adjustment is incorrect. Zero the IUP measurement. Catheter tip not in contact with amniotic fluid or possible extra-ovular placement of the catheter. Refer to catheter Instructions for Use. Connection issue or cable or catheter defective. Unplug/replug catheter Unplug/replug or exchange adapter cable Try new catheter Trace is superimposed with noise. Possible extra-ovular placement of catheter. Refer to catheter Instructions for Use. IUP Equip Malf INOP is displayed. IUP Unplugged INOP is displayed. See Patient Alarms and INOPs on page 127. 214 19 19Monitoring aFHR, aHR, and aToco Introducing the abdominal Avalon CL Fetal & Maternal Pod Measurement The Avalon CL Fetal & Maternal Pod (CL F&M Pod) noninvasively measures fetal heart rate (aFHR), maternal heart rate (aHR), and uterine activity (aToco). The CL F&M Pod is used together with a single-use electrode patch. The electrode patch has five adhesive electrodes. The CL F&M Pod and electrode patch are placed on the maternal abdomen. It picks up the fetal and maternal electrocardiography (ECG) signals, and the uterine electromyography (EMG) signals. The CL F&M Pod separates and processes the signals, and transmits aFHR, aHR, and aToco to the fetal monitor via the CL base station. WARNING Use the CL F&M Pod and electrode patch with singleton pregnancies only. The measurements have been validated with a gestational age of >36 completed weeks. NOTE Fetal ECG and uterine EMG signals are very small. Therefore, skin preparation is required when applying the electrodes. Different measurements for the same physiological parameter may have a different appearance on the trace, due to variability (HR), averaging, delay, amplitude, or artifacts. The beat-to-beat variability of aFHR may appear lower than FHR from ultrasound and lower than dFHR from DECG due to averaging. The accuracy of all FHR parameters is sufficient for diagnosis following commonly agreed guidelines. NOTE The Avalon CL Fetal & Maternal Pod and Patch are not available for U.S., other FDA regulated territories, and Canada. Fetal Heart Rate aFHR It is recommended to verify the presence of the fetal heart beat, for example with a stethoscope, before starting continuous monitoring with the CL F&M Pod. CAUTION If the aFHR signal quality indicator on the fetal monitor screen continuously indicates an insufficient signal quality (empty triangle), although the CL F&M electrode status is green, then an alternative method to monitor should be used. 215 19 Monitoring aFHR, aHR, and aToco Uterine Activity aToco The CL F&M Pod measures the electrical activity of the uterus which is different to the mechanical measurements of a Toco transducer or an IUP catheter. Depending on the measurement method, the shape of a recorded contraction can look different. The uterine EMG signals can be interfered with by the electrical activity of other muscles, for example during maternal or fetal movements or position changes. CAUTION The aToco measurement does not represent the absolute intrauterine pressure. If aToco seems questionable, verify uterine activity by other means (maternal perception, manual palpation, or intrauterine pressure (IUP) measurement). For monitoring the real intrauterine pressure in mmHg or kPa, an IUP catheter is required. CAUTION The duration of the contraction measured by the CL F&M Pod can be shorter than the physical contractions. When you palpate the uterus, there is a delay between the manual detection of contraction, and when it is displayed at the monitor. CAUTION Maternal or fetal movements can cause electrical signals that may result in uterine contraction-like artifacts. Maternal movement Shortly after and during consistent maternal movement is detected:

A question mark is displayed in front of the aToco numeric at the monitor (?aToco). The aToco trace is printed with a lighter intensity for the duration of the maternal movements, indicating that the signal may be compromised and not suitable for trace interpretation. Uterine Activity Measurement Priority When several uterine activity measurements are active, the priority given on the monitor display is:

IUP (Intrauterine pressure from the connection with an IUP catheter) aToco (CL F&M Pod) Toco (CL Toco+ MP transducer, Toco+, or Toco+ MP wired transducer) aToco Sensitivity Monitoring with the CL F&M Pod, the aToco sensitivity can be set to High or Low at any time. The Low sensitivity setting provides an additional suppression of artifacts, for example artifacts coming from maternal and fetal movements. The additional filtering delays the onset of recording the contraction on the trace and shows a reduced amplitude. The default setting is High and recommended for active labor. Setting the aToco Sensitivity 1 2 Select the Setup aToco menu. Select the Sensitivity by toggling between High and Low. 216 19 Monitoring aFHR, aHR, and aToco What You Need For monitoring with the CL F&M Pod, see Avalon CL Fetal & Maternal Pod on page 25 and CL Fetal & Maternal Patch on page 88. For assigning the CL F&M Pod, see CL Pod Assignment on page 95. For applying the electrode patch and the CL F&M Pod, see Applying the CL Fetal & Maternal Patch and Pod on page 97. At the Monitor 1 2 3 Switch on the recorder. The fetal heart rate is labeled aFHR1, aFHR2, or aFHR3 on the screen. The CL F&M Pod monitors only singletons, but if in addition to aFHR a CL US transducer and/or a scalp electrode (DECG) are used to monitor FHR, the aFHR numeric is labeled 1 to 3 depending on the sequence in which the other measurement methods are added. aFHR and aHR have a QRS tone. The volume can be set in the measurement's setup menu, see Selecting Fetal Heart Sound on page 172. 1 Measurement label aFHR 2 Measurement label aToco 3 Measurement label aHR 217 19 Monitoring aFHR, aHR, and aToco Troubleshooting Problem Erratic trace Erratic display Possible Causes Fetal arrhythmia Electrode contact not optimal Obese patient Too much maternal or fetal movement Signal quality indicator is continuously poor Electrode contact not optimal Solutions Consider monitoring FHR with alternative methods. Reposition the electrode and repeat the skin preparation until the CL F&M Status shows that all electrodes have good contact. If a patient is obese, re-position the lower electrode on the midline 1-2 in/3-5 cm below the original placement, or on the underside of the panniculus just below the turn. Ask the patient to sit or lie still until the signal improves. If the signal indication does not improve, consider monitoring with alternative methods. Repeat the skin preparation until the CL F&M Status shows that all electrodes have good contact. Patient in unfavorable position Make the patient more comfortable, if the abdominal Mobile abdomen aFHR not recorded or questionable aFHR is less than 60 bpm or over 240 bpm, fetal demise, fetal arrhythmia, or the baby is born muscles are relaxed it may improve the signal. For example, place a pillow to support the patients back. If the signal indication does not improve, consider monitoring with alternative methods. If the abdomen is mobile, or patient position has changed, use a rolled blanket/towel or pillow to support abdomen to keep the patch centered on the uterus. If the signal indication does not improve, consider monitoring with alternative methods. Verify the FHR by independent means. NOTE For all signal loss, malfunction, or other alerts see Patient Alarms and INOPs on page 127. 218 20 20Monitoring Maternal Heart / Pulse Rate You can monitor the maternal heart/pulse rate using one of five sources:

Maternal heart rate (HR) via MECG electrodes Maternal heart rate (aHR) via CL F&M Pod Maternal pulse rate from Toco MP, Toco+ MP, or CL Toco+ MP transducer (Pulse) Maternal pulse rate from SpO2 (Pulse) Maternal pulse rate from NBP (Pulse) Maternal heart/pulse rates derived from Toco MP, Toco+ MP, or CL Toco+ MP, SpO2, aHR, and MECG are continuous measurements, and are compared against the FHR for cross-channel verification. Average pulse rate derived from noninvasive blood pressure is an intermittent measurement, and is therefore not used for cross-channel verification. Priority for Maternal Heart / Pulse Rate Priority Maternal Heart / Pulse Rate Source Alarming Used for CCV Provides QRS Tone 1 2 3 4 5 6 7 HR from MECG measurement aHR from CL F&M Pod Pulse from CL SpO2 Pod measurement Pulse from SpO2 measurement Pulse from Toco MP measurement cableless or cabled Pulse from CL NBP Pod measurement Pulse from NBP measurement Yes Yes Yes Yes No No No Yes Yes Yes Yes Yes No No Yes Yes No Yes No No No Only one maternal heart rate/pulse rate numeric is displayed and recorded at a time (see priority table). If higher-priority measurements are connected but temporarily not providing valid numerics, lower-priority numerics may be displayed and recorded instead. Misidentification of Maternal HR for FHR To reduce the possibility of mistaking the maternal HR for FHR, it is recommended that you monitor both maternal and fetal heart rates (see Confirm Fetal Life Before Using the Monitor on page 12 and Cross-

Channel Verification (CCV) on page 163). 219 20 Monitoring Maternal Heart / Pulse Rate Maternal HR from MECG Electrodes You can measure maternal HR using the equipment combinations shown in the following figures. MECG with ECG/IUP Transducer (cable) The figure below shows the complete connection chain from the foam electrodes applied to the patient to the fetal monitor using the ECG/IUP transducer. 1 ECG/IUP (867247) 2 MECG Adapter Cable (M1363A) 3 Pre-gelled Foam Electrodes (40493A/B/C/D/E) MECG with Toco+ or Toco+ MP (cable) The figure below shows the equivalent chain using the Toco+ MP transducer. 1 Toco+ (M2735A), Toco+ (867249), or Toco+ MP (867245) transducer 2 MECG Adapter Cable (M1363A) 3 Pre-gelled Foam Electrodes (40493A/B/C/D/E) 220 20 Monitoring Maternal Heart / Pulse Rate MECG with CL Toco+ MP or CL ECG/IUP Transducer (cableless) The figure below shows the equivalent chain using a CL Toco+ MP transducer or a CL ECG/IUP transducer. 1 Avalon CL base station (866074) 2 CL Toco+ MP (866075) or CL ECG/IUP transducer (866077) 3 MECG Adapter Cable (M1363A) 4 Pre-gelled Foam Electrodes (40493A/B/C/D/E) To simultaneously measure DECG and MECG, you need the ECG/IUP or CL ECG/IUP transducer, or the patient module for DECG, and a Toco+, Toco+ MP, or CL Toco+ MP, or ECG/IUP, CL ECG/IUP transducer for MECG. For measuring DECG, you need a Toco+, Toco+ MP, or CL Toco+ MP, or ECG/

IUP, CL ECG/IUP transducer or a patient module (see also Monitoring FHR Using DECG on page 199). Applying Electrodes To derive the maternal HR (when you do not want to view the MECG waveform), you can place the electrodes just below the outer end of the clavicle near each shoulder. 1 MECG Electrodes 221 20 Monitoring Maternal Heart / Pulse Rate Making Connections WARNING Follow the instructions supplied with each of the monitoring accessories you are using. Prepare for monitoring maternal HR using the list below. The standard procedures in use in your facility determine the sequence of actions. 1 Depending on the equipment you are using, ensure that either the Patient Module or the Toco+, Toco+ MP, or ECG/IUP transducer is connected to the fetal monitor. If you are using cableless monitoring, use the CL ECG/IUP or the CL Toco+ MP transducer. 2 Connect a pre-gelled foam electrode to each of the two leads on the MECG adapter cable. 3 Apply the foam electrodes to the patient, following the instructions supplied with the foam electrodes. 4 Depending on the equipment you are using, connect the pink connector plug on the MECG adapter cable to the pink connector on either the Patient Module or the Toco+, Toco+ MP, or ECG/IUP transducer. If you are using cableless monitoring, connect the MECG Adapter cable to the connectors of the CL ECG/IUP or the CL Toco+ MP transducer. You are now ready to monitor maternal HR. Monitoring Maternal HR 1 Switch on the recorder. 2 The maternal heart rate is labeled HR on the screen. Monitoring MECG Wave WARNING The fetal/maternal monitor is not a diagnostic ECG device. In particular, the display of fetal/maternal ECG is intended only for evaluating signal quality for fetal/maternal heart rate as derived from the ECG waveform. When in doubt, it can be used to identify sources of compromised signal quality, such as noise or muscle artifacts. It can subsequently be used to verify the result of measures taken to resolve them (e.g., checking ECG cable connections or adapting the fetal ArtifactSuppress configuration). The safety and effectiveness of the displayed fetal/maternal ECG waveform (i.e., P, QRS, and T segments) for evaluation of fetal/maternal cardiac status during labor have not been evaluated. FM30/50 When measuring MECG with the Avalon FM30 or FM50, the MECG waveform, along with the heart rate numeric, is displayed on the screen when using a Toco+, Toco+ MP, or CL Toco+ MP, or ECG/IUP, CL ECG/IUP transducer, or a patient module. If a maternal ECG wave analysis is required, use a patient monitor. 222 20 Monitoring Maternal Heart / Pulse Rate WARNING The fetal/maternal monitor is NOT intended for use during defibrillation, electro-surgery, or MRI. Remove all transducers, sensors, and accessories before performing electro-surgery, defibrillation, or MRI, otherwise harm to the patient or the user can result. Applying Electrodes To obtain a satisfactory maternal ECG waveform, you must use the RA to LL (lead II) position of the standard 5-lead ECG. Viewing the Waveform on the Screen 1 2 Place one electrode directly below the clavicle and near the right shoulder. Place the other electrode on the left lower abdomen. 1 Measurement label dFHR1 2 Measurement label Toco 3 Measurement label FHR2 4 Measurement label HR 5 1mV scale bar 6 MECG wave with maternal label 7 DECG wave with fetal label 8 Measurement label Temp maternal temperature 9 Measurement label NBP NOTE The 1mV scale bar for the DECG and MECG wave is not displayed on the screen if you monitor DECG or MECG with an Avalon CTS system. The Avalon CTS system does not provide a scaled ECG. For the FM30/50, the MECG wave is displayed automatically on the screen, labeled MECG. If DECG is also being monitored (FM30/50), and the DECG Wave is configured to On, both waves are displayed, with the DECG Wave above the MECG wave. The DECG Wave is labeled DECG. 223 20 Monitoring Maternal Heart / Pulse Rate Troubleshooting Problem Possible Causes Solutions MECG Leads Off displayed. Numeric is displayed with a

-?- for 10 seconds; INOP tone One or more MECG leads is not attached. See also Patient Alarms and INOPs on page 127 Bad electrical contact Electrodes defective The ultrasound transducer is measuring maternal pulse prints repeatedly MECG Equip Malf displayed Equipment malfunctions Equipment not connected MECG Unplugged Printing the Waveform Make sure that all required leads are attached If the wave is configured to be displayed on the monitor, you can observe if the ECG signal is clear, or if it shows interruptions and noise Check positioning of the electrode, ensuring that none are displaced Check electrodes and replace if necessary Reposition the ultrasound transducer. See Recommended Actions for Coincidence INOP on page 167 See Patient Alarms and INOPs on page 127 You can print the MECG wave onto the trace paper. Refer to Printing the ECG Waveform on page 227. Pulse Rate from Toco+ MP The maternal pulse is taken from the Toco+ MP or CL Toco+ MP transducer when SpO2 or MECG measurements are not used or have signal loss. When the pulse rate is very low, or strong arrhythmia is present, the pulse rate measured by the Toco+ MP or CL Toco+ MP transducer may differ from the heart rate calculated from MECG. If the mother is moving about, or began pressing during the second stage of labor, this can cause longer gaps in the recording of the maternal pulse signal. In this case, use the SpO2 or MECG measurement to derive the maternal heart rate. WARNING Physiological alarms (pulse low / pulse high) are not available if the maternal pulse is measured with either Toco+ MP or CL Toco+ MP. No QRS tone is audible when the Toco+ MP or the CL Toco+ MP transducer is the source of the pulse rate. The Toco+ MP or CL Toco+ MP transducer signal is significantly less reliable, if the patient is up and moving about, or is pushing during the second stage of labor. NOTE In rare cases, it is possible to pick up a fetal signal source. When a Toco+ MP or CL Toco+ MP transducer is connected to the monitor, but not applied to the patient, the measurement may generate unexpected intermittent pulse readings. 224 20 Monitoring Maternal Heart / Pulse Rate Pulse Rate from SpO2 If you are not monitoring maternal HR via MECG electrodes, but you are monitoring SpO2, the maternal pulse rate is derived from the SpO2 measurement. The pulse numeric is labeled Pulse on the screen. WARNING No QRS tone is audible when the CL SpO2 Pod is the source of the pulse rate. Adjusting the Heart Rate / Pulse Alarm Limits To adjust the pulse alarm limits for SpO2:

1 In the Setup SpO menu, select Pulse (SpO). This opens the Setup Pulse (SpO) menu. 2 Ensure Pulse (SpO) is On. Select Pulse (SpO) to switch between On and Off. 3 Set the pulse alarm limit:

Select High Limit then choose the upper alarm limit for tachycardia from the pop-up list. Select Low Limit then choose the lower alarm limit for bradycardia from the pop-up list. To adjust the pulse alarm limits for MECG:

1 In the Setup MECG menu, select MECG/Pulse Alarms. This opens the Setup Pulse (MECG) menu. 2 Ensure Pulse MECG is On. Select Pulse MECG to switch between On and Off. 3 Set the pulse alarm limit. Select High Limit then choose the upper alarm limit for tachycardia from the pop-up list. Select Low Limit then choose the lower alarm limit for bradycardia from the pop-up list. Average Pulse Rate from Noninvasive Blood Pressure WARNING Physiological alarms (pulse low / pulse high) are not available if the maternal pulse is measured with NBP. When you are measuring noninvasive blood pressure, the monitor can also calculate the average pulse rate. This occurs in either manual or automatic mode, when neither MECG, SpO2 nor pulse from Toco+ MP or CL Toco+ MP transducer are measured. The value is displayed on the screen, and printed on the trace. It is not the actual pulse value, but an average pulse rate, taken during the most recent noninvasive blood pressure measurement. The value is updated after each successive measurement. If you need a continuous measurement, you should monitor using MECG, SpO2, or pulse from Toco+ MP or CL Toco+ MP transducer. Testing MECG Mode See the monitor's Service Guide. 225 20 Monitoring Maternal Heart / Pulse Rate 226 21 21Printing the ECG Waveform FM30/50 You can print the ECG wave onto the trace paper. If you are monitoring both DECG and MECG, both waves will be printed. The start of the wave recording is annotated above the wave with MECG for Maternal ECG, with DECG for Direct fetal ECG, and with 25 mm/sec below the wave. When only MECG and/or DECG are measured without any real-time recording, the 25 mm/sec recorder speed is printed in the trace header. WARNING 1 The fetal/maternal monitor is not a diagnostic ECG device. In particular, the display of fetal/maternal ECG is intended only for evaluating signal quality for fetal/maternal heart rate as derived from the ECG waveform. When in doubt, it can be used to identify sources of compromised signal quality, such as noise or muscle artifacts. It can subsequently be used to verify the result of measures taken to resolve them (e.g., checking ECG cable connections or adapting the fetal ArtifactSuppress configuration). The safety and effectiveness of the displayed fetal/maternal ECG waveform (i.e., P, QRS, and T segments) for evaluation of fetal/maternal cardiac status during labor have not been evaluated. The ECG waveform is printed along the bottom of the heart rate grid, and the three different possibilities look like this:

DECG waveform on its own 1 DECG 2 Recorder speed 227 21 Printing the ECG Waveform MECG waveform on its own 1 MECG 2 Recorder speed DECG and MECG waveforms 1 DECG 2 MECG 3 Recorder speed When the recorder is on, there are two choices for printing the ECG wave:

Separate: This recording mode gives you a six-second ECG strip on the fetal trace paper in fast printout mode. The real-time fetal trace recording is temporarily interrupted while the ECG strip prints. A new MECG header is printed to mark where the MECG wave starts, and a new trace header and FHR header mark when the fetal trace resumes. 228 The following trace shows the MECG waveform:

21 Printing the ECG Waveform 1 FHR1 trace interrupted 2 MECG header 3 Recorder speed 4 FHR1 trace resume Overlap: This recording mode gives you a delayed six-second snapshot of the maternal and/or direct fetal ECG for documentation on the fetal strip, but without interrupting the fetal trace. It takes 5 minutes to print this six-second snapshot at a recorder speed of 3 cm/min. It is documented as if it was recorded at 25 mm/s. The following trace shows both the DECG and MECG waveforms:

1 FHR1 and FHR2 2 DECG header 3 MECG header 229 21 Printing the ECG Waveform 4 Recorder speed To make your choice:

1 Enter the Main Setup menu. 2 3 Select Fetal Recorder to enter the Fetal Recorder menu. Select ECG Wave to switch between Separate and Overlap. To print the ECG wave(s):

1 Select the Record ECG Wave SmartKey (configurable) and the recording trace is started. Or 1 2 3 Or 1 2 Enter the Main Setup menu by selecting the SmartKey. Select Fetal Recorder to enter the Fetal Recorder menu. Select Record ECG Wave and the recording trace is started. Select the ECG Wave. Select Record ECG Wave in the ECG wave menu and the recording trace is started. 230 22 22Monitoring Noninvasive Blood Pressure The noninvasive blood pressure measurement (NBP) is intended for use with maternal patients. This monitor uses the oscillometric method for measuring NBP. A physician must determine the clinical significance of the NBP information. Introducing the Oscillometric Noninvasive Blood Pressure Measurement Oscillometric devices measure the amplitude of pressure changes in the occluding cuff as the cuff deflates from above systolic pressure. The amplitude suddenly increases as the pulse breaks through the occlusion in the artery. As the cuff pressure decreases further, the pulsations increase in amplitude, reach a maximum

(which approximates to the mean pressure), and then diminish. Studies show that, especially in critical cases (arrhythmia, vasoconstriction, hypertension, shock), oscillometric devices are more accurate and consistent than devices using other noninvasive measuring techniques. WARNING Intravenous infusion: Do not use the NBP cuff on a limb with an intravenous infusion or arterial catheter in place. This could cause tissue damage around the catheter when the infusion is slowed or blocked during cuff inflation. Skin Damage: Do not measure NBP in cases of sickle-cell disease or any condition where skin damage has occurred or is expected. Existing Wounds: Do not apply the cuff over a wound as this can cause further injury. Mastectomy or lymph node clearance: Avoid applying the cuff on the side of the mastectomy or lymph node clearance, as the pressure increases the risk of lymphedema. For patients with a bilateral mastectomy or lymph node clearance, use clinical judgment to decide whether the benefit of the measurement outweighs the risk. Unattended Measurement: Use clinical judgment to decide whether to perform frequent unattended blood pressure measurements. Too frequent measurements can cause blood flow interference potentially resulting in injury to the patient. In cases of severe blood clotting disorders frequent measurements increase the risk of hematoma in the limb fitted with the cuff. Temporary Loss of Function: The pressurization of the cuff can temporarily cause loss of function of monitoring equipment used simultaneously on the same limb. 231 22 Monitoring Noninvasive Blood Pressure Measurement Limitations NBP readings can be affected by the position of the subject, their physiological condition, the measurement site, and physical exercise. Thus a physician must determine the clinical significance of the NBP information. The measurement may be inaccurate or impossible:

with excessive and continuous patient movement such as during contractions if a regular arterial pressure pulse is hard to detect with cardiac arrhythmias with rapid blood pressure changes with severe shock or hypothermia that reduces blood flow to the peripheries with obesity, where a thick layer of fat surrounding a limb dampens the oscillations coming from the artery on an edematous extremity Measurement Methods There are three measurement methods:

Manual - measurement on demand. Results are displayed for up to one hour. Auto - continually repeated measurements (between one and 120 minute adjustable interval). You can make a manual measurement between two measurements in Auto Mode. Sequence - up to four measurement cycles which run consecutively, with a number of measurements and intervals between them configurable for each cycle. Reference Method The measurement reference method can be Auscultatory (manual cuff) or Invasive (intra-arterial). For further information, see the Application Note supplied on the monitor documentation DVD. To check the current setting, select Main Setup, Measurements, NBP, and check whether the Reference setting is set to Auscultatory or Invasive. This setting can be changed in Configuration Mode. Preparing to Measure Noninvasive Blood Pressure If possible, avoid taking measurements during contractions, because the measurement may be unreliable, and may cause additional stress for the patient. 1 2 Connect the cuff to the air tubing. Plug the air tubing into the red NBP connector. Avoid compression or restriction of pressure tubes. Air must pass unrestricted through the tubing. WARNING Kinked or otherwise restricted tubing can lead to a continuous cuff pressure, causing blood flow interference, and potentially resulting in injury to the patient. 3 Make sure that you are using a Philips-approved correct sized cuff, and that the bladder inside the cover is not folded or twisted. A wrong cuff size, and a folded or twisted bladder, can cause inaccurate measurements. The width of the cuff should be in the range from 37% to 47% of the limb circumference. The inflatable part of the cuff should be long enough to encircle at least 80% of the limb. 232 22 Monitoring Noninvasive Blood Pressure 4 Apply the cuff to a limb at the same level as the heart. If it is not, you must use the measurement correction formula to correct the measurement. The marking on the cuff must match the artery location. Do not wrap the cuff too tightly around the limb. It may cause discoloration, and ischemia of the extremities. WARNING Inspect the application site regularly to ensure skin quality and inspect the extremity of the cuffed limb for normal color, warmth, and sensitivity. If the skin quality changes, or if the extremity circulation is being affected, move the cuff to another site, or stop the blood pressure measurements immediately. Check more frequently when making automatic measurements. Correcting the Measurement if Limb is not at Heart Level To correct the measurement if the limb is not at heart level, to the displayed value:

Add 0.75 mmHg (0.10 kPa) for each centimeter higher or Deduct 0.75 mmHg (0.10 kPa) for each centimeter lower or Add 1.9 mmHg (0.25 kPa) for each inch higher. Deduct 1.9 mmHg (0.25 kPa) for each inch lower. Recommendations For Measurements Used in Diagnosis of Hypertension To make a measurement for use in the diagnosis of hypertension, follow the steps below:

1 Ensure the patient is comfortably seated, with their legs uncrossed, feet flat on the floor, and back and arm supported. 2 Ask the patient to relax and not talk before and during the measurement. 3 If possible, wait 5 minutes before making the first measurement. Understanding the Numerics 1 Alarm limits 2 Alarm source 3 Measurement label 4 Pulse from NBP 5 Measurement mode 6 Timestamp/Timer 7 Mean pressure 8 Diastolic 9 Systolic Depending on the numeric size, not all elements may be visible. Your monitor may be configured to display only the systolic and diastolic values. If configured to do so, the pulse from NBP is displayed with the NBP numeric. 233 22 Monitoring Noninvasive Blood Pressure Aging Numerics The measured NBP value, together with the corresponding pulse rate, if this is switched on, are displayed for one hour. After that the values are regarded as invalid and are no longer displayed. During this time, measurement values may be grayed out, or disappear from the screen after a set time, if configured to do so. This avoids older numerics being misinterpreted as current data. The time can be set in Configuration Mode. In Auto Mode, the measurement values may disappear more quickly (to be replaced by new measurement values), if the repeat time is set to less than one hour. Alarm Sources If you have parallel alarm sources, the sources are displayed instead of the alarm limits. NBP Measurement Timestamp Depending on your configuration, the time shown beside the NBP numeric can be:

the time of the most recent NBP measurement, also known as the timestamp, or the time until the next measurement in an automatic series, displayed with a graphic representation of the remaining time, as shown here. The NBP timestamp will normally show the completion time of the NBP measurement. NBP Measurement Start Time In Auto or Sequence mode, the monitor is configured to synchronize the measurements in a measurement series to an easy-to-document time. For example, if you start the first measurement at 08:23, and the Repeat Time is set to 10 min, the monitor automatically performs the next measurement at 8:30, then 8:40, and so on, unless it has been configured to NotSynchron. During Measurements The cuff pressure is displayed instead of the units and the repeat time. An early systolic value gives you a preliminary indication of the systolic blood pressure during measurement. Starting and Stopping Measurements Use the setup menu or the SmartKeys to start and stop measurements. Action to be performed Setup menu SmartKeys Start/Stop manual measurement Start Auto series Stop current automatic measurement Start manual measurement Start Auto series Stop manual measurement Stop current automatic measurement Start/Stop

Stop automatic, or manual measurement AND series Stop All NBP Start/ Stop Start NBP Stop NBP Stop All 234 22 Monitoring Noninvasive Blood Pressure Enabling Automatic Mode and Setting Repetition Time 1 2 3 In the Setup NBP menu, select Mode. Switch between Auto and Manual, if necessary, to pick the measurement method. If making an automatic measurement, select Repeat Time, or press the Repeat Time SmartKey and set the time interval between two measurements. NOTE Be aware that a combination of a recorder speed of less than 3 cm/min and a repetition time of less than five minutes can result in not all noninvasive blood pressure measurements being recorded on the fetal trace. For example, if the recorder speed is set to 1 cm/min and the repetition time is set to two minutes, due to the low speed setting, the recorder will only be able to record every other noninvasive blood pressure measurement. This affects only the local fetal trace recording, and all measurements are displayed as normal on the monitor's screen. Enabling Sequence Mode and Setting Up the Sequence 1 2 3 4 In the Setup NBP menu, select Mode and select Sequence from the pop-up menu. Select Setup Sequence to open the Setup Sequence window. Up to four measurement cycles can be set up which run consecutively. For each cycle, you can set the number of measurements and the intervals between them. If you want to run fewer than four cycles in a sequence, you can set the number of measurements for one or more cycles to Off. Select each sequence in turn, and select the number of measurements and the time interval between the measurements. To have measurements continue after the sequence, set the number of measurements for your last cycle to Continuous and this cycle will run indefinitely. CAUTION Be aware that, if none of the cycles are set to Continuous, NBP monitoring will end after the last measurement of the cycle. When the NBP measurement mode is set to Sequence, the repetition time for Auto Mode cannot be changed. Choosing the Alarm Source You can monitor for alarm conditions in systolic, diastolic, and mean pressure, either singly or in parallel. Only one alarm is given, with the priority of mean, systolic, diastolic. Menu option Pressure value monitored Sys. Dia. Mean Sys & Dia Dia & Mean systolic diastolic mean systolic and diastolic in parallel diastolic and mean in parallel 235 22 Monitoring Noninvasive Blood Pressure Menu option Sys & Mean Sys&Dia&Mean Pressure value monitored systolic and mean in parallel all three pressures in parallel If mean is not selected as alarm source (Sys., Dia., or Sys & Dia selected), but the fetal monitor can only derive a mean value, mean alarms will nevertheless be announced using the most recent mean alarm limits. Check that the mean alarm limits are appropriate for the patient, even when not using mean as the alarm source. When no value can be derived, an NBP Measure Failed INOP is displayed. Assisting Venous Puncture You can use the cuff to cause subdiastolic pressure. The cuff deflates automatically after a set time if you do not deflate it. 1 2 In the Setup NBP menu, select VeniPuncture. Puncture vein and draw blood sample. 3 Reselect VeniPuncture to deflate the cuff. During measurement, the display shows the inflation pressure of the cuff and the remaining time in venous puncture mode. 1 Cuff pressure 2 Venous puncture measurement mode 3 Time left in venous puncture mode Calibrating NBP NBP is not user-calibrated. NBP pressure transducers must be verified at least once every two years by a qualified service professional, and calibrated, if necessary. See the Service Guide for details. Troubleshooting Problem Possible Causes Solutions Cuff will not inflate Monitor is in Service or Configuration Mode High or low values measured

(against clinical expectations) Technical defect Call service Cuff tubing not connected Connect cuff tubing Contraction occurring Wait until contraction has finished Patient talking before or during measurement Allow patient to rest quietly, then try again after three to five minutes Incorrect cuff size or cuff not at heart level Check cuff size, level, and position Noninvasive blood pressure reference method set incorrectly Check the reference method configured

(auscultation or intra-arterial) and correct if necessary in Configuration Mode Measurement limitations have not been taken into account Check the list in Measurement Limitations on page 232 236 Problem Possible Causes Solutions 22 Monitoring Noninvasive Blood Pressure Severe vasoconstriction at cuff site Move cuff to another limb, check for shock, or verify blood pressure using another method Erratic blood pressure fluctuations due to arrhythmias or rapid-acting drugs or contractions Try again, if unsuccessful, verify blood pressure using another method Wait until contraction has finished Excessive patient movement or convulsions Restrain movement or verify blood pressure using another method See Patient Alarms and INOPs on page 127. Displays zeros for systolic and diastolic values. Measurement automatically repeats NBP Cuff Overpress INOP is displayed NBP Equip Malf INOP is displayed NBP Interrupted INOP is displayed NBP Measure Failed 237 22 Monitoring Noninvasive Blood Pressure 238 23 23Monitoring SpO2 FM30/40/50 The pulse oximetry measurement (SpO2) is intended for use with maternal patients. Philips pulse oximetry uses a motion-tolerant signal processing algorithm, based on Fourier Artifact Suppression Technology (FAST). It provides two measurements:

Oxygen saturation of arterial blood (SpO2) - percentage of oxygenated hemoglobin in relation to the sum of oxyhemoglobin and deoxyhemoglobin (functional arterial oxygen saturation). Pulse rate - detected arterial pulsations per minute. This is derived from the SpO2 value, and is one of four sources of the maternal heart/pulse rate used for cross-channel verification (see Monitoring Maternal Heart / Pulse Rate on page 219 and Cross-Channel Verification (CCV) on page 163). Selecting an SpO2 Sensor See Accessories and Supplies on page 275 for a list of sensors, and the patient population and application sites for which they are appropriate. Familiarize yourself with the Instructions for Use supplied with your sensor before using it. CAUTION Do not use OxiCliq disposable sensors in a high humidity environment, or in the presence of fluids, which may contaminate sensor and electrical connections causing unreliable or intermittent measurements. Do not use disposable sensors when there is a known allergic reaction to the adhesive. Applying the Sensor 1 Follow the SpO2 sensor's Instructions for Use, adhering to all warnings and cautions. 2 Remove colored nail polish from the application site. 3 Apply the sensor to the patient. The application site should match the sensor size so that the sensor can neither fall off, nor apply excessive pressure. 4 Check that the light emitter and the photo detector are directly opposite each other. All light from the emitter must pass through the patient's tissue. 239 23 Monitoring SpO2 WARNING Compatibility: Use only the accessories that are specified for use with this fetal monitor, otherwise patient injury can result. Proper Sensor Fit: If a sensor is too loose, it might compromise the optical alignment or fall off. If it is too tight, for example because the application site is too large or becomes too large due to edema, excessive pressure may be applied. This can result in venous congestion distal from the application site, leading to interstitial edema, hypoxemia, and tissue malnutrition. Skin irritations or lacerations may occur as a result of the sensor being attached to one location for too long. To avoid skin irritations and lacerations, periodically inspect the sensor application site and change the application site regularly. Skin irritation, allergies or hypersensitivity: Do not use disposable sensors on patients with history of skin irritation, allergies or hypersensitivity to adhesives. Venous Pulsation: Do not apply sensor too tightly as this results in venous pulsation which may severely obstruct circulation and lead to inaccurate measurements. Ambient Temperature: At elevated ambient temperatures, be careful with measurement sites that are not well perfused, because this can cause severe burns after prolonged application. All listed sensors operate without risk of exceeding 41C on the skin if the initial skin temperature does not exceed 35C. MRI Scanning: Do not use the pulse oximeter or oximetry sensors during magnetic resonance imaging

(MRI) scanning. Induced current could potentially cause burns. The device may affect the MRI image, and the MRI unit may affect the accuracy of the oximetry measurements. Damaged Sensors: Do not use damaged sensors/cables or sensors with exposed optical components. Low Perfusion: With very low perfusion at the monitored site, the performance might be impaired and the SpO2 readings may read lower than arterial oxygen saturation. Conditions Affecting Performance: During hypotension, severe vasoconstriction, severe anemia, or hypothermia of the patient the performance may be impaired. Also in these conditions or when the patient is in cardiac arrest or in shock, it may not be possible to make measurements at all. Extremities to Avoid: Avoid placing the sensor on extremities with an arterial catheter, an NBP cuff, or an intravascular venous infusion line. Connecting SpO2 Cables Connect the sensor cable to the color-coded socket on the monitor. If you are using a disposable sensor, plug the sensor into the adapter cable and connect this to the monitor. Connect reusable sensors directly to the monitor. CAUTION Do not use any extension cable with the long versions (> 2 m) of the Philips reusable sensors (e.g. M1191AL, M1191BL, M1191ANL or M1196A) with the long versions of adapter cables (e.g. M1943AL), and not with the Masimo adapter cables (e.g. LNOP MP12 or LNC MP10). Extension cables: Do not use more than one extension cable (M1941A). Do not use an extension cable with Philips reusable sensors or adapter cables with part numbers ending in -L (indicates long cable version). Electrical Interference: Position the sensor cable and connector away from power cables, to avoid electrical interference. 240 Measuring SpO2 23 Monitoring SpO2 During measurement, ensure that the application site:

has a pulsatile flow, ideally with a signal quality indicator of at least medium. has not changed in its thickness (for example, due to edema), causing an improper fit of the sensor. WARNING For fully conscious maternal patients, who have a normal function of perfusion and sensory perception at the measurement site:

To ensure skin quality and correct optical alignment of the sensor, inspect the application site when the measurement results are suspicious, or when the patient complains about pressure at the application site, but at least every 24 hours. Correct the sensor alignment if necessary. Move the sensor to another site, if the skin quality changes. For all other patients:

Inspect the application site every two to three hours to ensure skin quality and correct optical alignment. Correct the sensor alignment if necessary. If the skin quality changes, move the sensor to another site. Change the application site at least every four hours. Injected dyes such as methylene blue, or intravascular dyshemoglobins such as methemoglobin and carboxyhemoglobin may lead to inaccurate measurements. Inaccurate measurements may result when the application site for the sensor is deeply pigmented or deeply colored, for example, with nail polish, artificial nails, dye, or pigmented cream. Interference can be caused by:

High levels of ambient light (including IR warmers), or strobe lights or flashing lights (such as fire alarm lamps). (Hint: cover application site with opaque material). Another SpO2 sensor in close proximity (e.g. when more than one SpO2 measurement is performed on the same patient). Always cover both sensors with opaque material to reduce cross-

interference. Electromagnetic interference, especially when the signal quality indicator is below medium. Excessive patient movement and vibration. SpO2 Signal Quality Indicator The SpO2 numeric is displayed together with a signal quality indicator (if configured and enough space is available) which gives an indication of the reliability of the displayed values. The level to which the triangle is filled shows the quality of the signal; the indicator below shows a medium signal quality. The signal quality is at a maximum when the triangle is completely filled. 241 23 Monitoring SpO2 Assessing a Suspicious SpO2 Reading Traditionally, pulse rate from SpO2 was compared with heart rate from ECG to confirm the validity of the SpO2 reading. With newer algorithms, such as FAST-SpO2, this is no longer a valid criteria because the correct calculation of SpO2 is not directly linked to the correct detection of each pulse. When the pulse rate is very low, or strong arrhythmia is present, the SpO2 pulse rate may differ from the heart rate calculated from ECG, but this does not indicate an inaccurate SpO2 value. WARNING With pulse oximetry, sensor movement, ambient light (especially strobe lights, or flashing lights), or electromagnetic interference can give unexpected intermittent readings when the sensor is not attached. Especially bandage-type sensor designs are sensitive to minimal sensor movement that might occur when the sensor is dangling. Understanding SpO2 Alarms This refers to SpO2 specific alarms. See the Alarms on page 115 chapter for general alarm information. SpO2 offers high and low limit alarms, and a high priority desat alarm. You cannot set the low alarm limit below the desat alarm limit. CAUTION If you measure SpO2 on a limb that has an inflated noninvasive blood pressure cuff, a non-pulsatile SpO2 INOP can occur. If the fetal monitor is configured to suppress this alarm, there may be a delay of up to 60 seconds in indicating a critical status, such as sudden pulse loss or hypoxia. Alarm Delays There is a delay between a physiological event at the measurement site and the corresponding alarm at the monitor. This delay has two components:

The general system delay time is the time between the occurrence of the physiological event and when this event is represented by the displayed numerical values. This delay depends on the algorithmic processing and the averaging time. The time between the displayed numerical values crossing an alarm limit and the alarm indication on the monitor. This delay is the combination of the configured alarm delay time plus the general system alarm signal delay time. Adjusting the SpO2 Alarm Limits In the Setup SpO menu:

Select High Limit then choose the upper alarm limit. Select Low Limit then choose the lower alarm limit. 242 Adjusting the Desat Limit Alarm The Desat alarm is a high priority (red) alarm notifying you of potentially life threatening drops in oxygen saturation. 23 Monitoring SpO2 1 In the Setup SpO menu, select Desat Limit. 2 Adjust the limit. Adjusting the Pulse Alarm Limits See Adjusting the Heart Rate / Pulse Alarm Limits on page 225. Setting Up Tone Modulation If tone modulation is on, the QRS tone pitch lowers when the SpO2 level drops. Remember, the QRS tone is derived from either heart rate (from MECG or the CL F&M Pod) or pulse (from built-in SpO2) depending on which is currently displayed (see Priority for Maternal Heart / Pulse Rate on page 219). NOTE Pulse from CL SpO2 and Toco MP does not provide a QRS tone. Setting the QRS Volume In the Setup SpO menu, select QRS Volume and set the appropriate QRS tone volume. 243 23 Monitoring SpO2 244 24 24Monitoring Maternal Temperature Measuring Tympanic Temperature The tympanic thermometer (866149) measures the patient's temperature in the ear using infrared technology. The result of this measurement can be automatically adjusted to correspond to a different body reference site. The result is displayed on the screen of the thermometer and transmitted to the monitor. The thermometer is used with single-use probe covers for infection control during measurement. WARNING Do not use in the presence of flammable anesthetics, such as a flammable anesthetic mixture with air, oxygen, or nitrous oxide. 1 2 Base station Thermometer Place the thermometer into its base station, when it is not in use. The base station allows flexible mounting of the thermometer at the point of care. The base station is connected to the monitor's MIB/RS232 interface (optional) with a cable. It has storage space for up to 32 probe covers. 245 24 Monitoring Maternal Temperature Thermometer Display and Controls The tympanic thermometer has a liquid crystal display. The display shows the patient's temperature in numerics and guides you with symbols through the measurement process. 1 Eject key 2 Change unit key: Celsius/Fahrenheit 3 4 Start measurement key Pulse timer key Functional Keys Description of Use Press the eject key to eject the probe cover. The eject key symbol is shown on the display when a measurement has been taken and transmitted. Press the change unit key after a measurement to switch between C and F

(only affects the handheld device and not the monitor numerics). Press the start measurement key when you are ready to take a patient's temperature. The pulse timer key can be used to time vital signs you take manually. The pulse timer only functions after you have taken a temperature measurement. Press and hold the pulse timer key to enter timer mode. Press the pulse timer key again to start the timer. The thermometer will issue a one beep at 15 seconds, two beeps at 30 seconds, three beeps at 45 seconds, and four beeps at 60 seconds. 246 24 Monitoring Maternal Temperature Status Screens The thermometer performs an internal test at every start-up to verify that the system components are functioning properly. It measures the ambient temperature. During start-up and measurement, the thermometer screens communicate the current status. Images Description Ambient temperature above specified range Ambient temperature below specified range System errors System error 12 - there is a problem with the settings. Contact your service personnel to have them check the settings and reset them, if necessary. If the display shows any other system error, then reset the thermometer by picking up a probe cover. If the system error does not clear, contact your service personnel. Making a Temperature Measurement WARNING Inaccurate measurement results can be caused by:

incorrect application of the thermometer anatomical variations in the ear build up of earwax in the ear excessive patient movement during the measurement absent, defective, or soiled probe covers probe covers other than the specified probe covers external environment temperature outside the range of 16C-33C (60.8F-91.4F) 247 24 Monitoring Maternal Temperature 1 Ensure that the base station is connected with the appropriate cable to the connector on the monitor. 2 Remove the thermometer from the base station. The thermometer is latched to the base station to avoid an accidental fall when the base station is moved. To pick up the thermometer from the base station move it slightly up, and then lift it from the base station to release the latch. Press the eject key on the thermometer to discard any probe that may have been left on the thermometer from a previous use. Pick up a new probe cover from the container on the base station. Inspect the probe cover to make sure that it is fully seated (no space between cover and tip base) and that there are no holes, tears, or wrinkles in the plastic film. Place the thermometer with the probe in the ear canal, sealing the opening with the probe tip. For consistent results, ensure that the probe shaft is aligned with the ear canal. Press and release the start-up key gently. 3 4 5 6 7 8 Wait until you hear the three beeps. 9 Remove the probe from the ear. The temperature values are displayed both on the thermometer itself, and on the connected monitor. 10 Check that the correct temperature label for the measurement site is displayed: iTrect, iToral, iTcore, or iTtymp. 11 Press the eject key to eject the probe cover into a suitable waste receptacle. 12 Return the thermometer to the base station. The thermometer switches to stand-by mode after 30 seconds when it is not used. Possible INOPs Images Description Patient temperature above measurement range. Patient temperature below measurement range. 248 24 Monitoring Maternal Temperature WARNING Never apply the probe to the patient when the thermometer is not connected to the base station. Always use a single-use probe cover to limit patient cross-contamination. Measurement errors or inaccurate readings may result when probe covers other than the specified probe covers are used (see Tympanic Temperature Accessories on page 285). Insert the probe slowly and carefully to avoid damage to the ear canal and the tympanic membrane. Inspect the probe cover for damage, holes, tears, or sharp edges to avoid injuring the skin. Always ensure that the used probe cover is removed before attaching a new probe cover. CAUTION Do not immerse the probe in fluids, or drop fluids on the probe. Do not use a probe cover that has been dropped or is damaged. Do not autoclave. To prevent damage to the base station, thermometer and accessories, refer to the cleaning procedures in the Care and Cleaning on page 257 chapter. WARNING If you have dropped the base station or thermometer, or if the unit has been stored below -25C or above 55C, have service personnel test the unit for proper functions, and calibrate the unit before further use. The Value Lifetime (length of time the entered value is shown on the screen) can be configured in Configuration Mode. Body Reference Sites and Monitor Labels The tympanic thermometer measures the patient's temperature in the ear. The thermometer can be configured to adjust the result of the measurement to correspond to a different body reference site. The measurement label displayed on the monitor corresponds to the body reference site that is configured. The following body reference sites are available:

Body Reference Site Ear temperature (no adjustment) Oral temperature Core temperature Rectal temperature Label on Monitor iTtymp iToral iTcore iTrect The body reference site can be selected in the Biomed mode of the tympanic thermometer. Refer to the Service Guide for more information. The measured maternal temperature is only transmitted to a connected OB TraceVue/IntelliSpace Perinatal system, when the tympanic thermometer is configured to the iTtymp body reference site, and the iTtymp label is displayed on the fetal monitor screen, and printed on the trace. 249 24 Monitoring Maternal Temperature Entering Temperature Manually A temperature measurement can be entered manually. 1 Press the SmartKey Enter Temp (configurable) or select the SmartKey Main Setup, then select Measurements, Enter Temp. A numeric pad opens. 2 Enter the temperature values. 3 Select the Enter key. Interval Use the Interval setting to define the time after which a manually entered temperature value becomes invalid

(no value is then displayed). NOTE A manually entered temperature has to be 25C or higher to be transmitted to a connected obstetrical information and surveillance system. As soon as the temperature value is entered, it is printed on the trace and transmitted to a connected obstetrical information and surveillance system. The time stamp of the temperature value on the display shows the time the user has opened the numeric pad and started to enter the temperature value. 250 25 25Paper Save Mode for Maternal Measurements Your monitor's recorder features a Paper Save Mode, where maternal vital signs are recorded using less paper than during a normal trace recording. When Paper Save Mode is enabled, and if the recorder is stopped, it will start automatically to print data from maternal measurements as they occur, and then stops again to save paper. You enable Paper Save Mode in Configuration Mode (default is off). A header is printed first before the measurements are recorded. A new header is also printed when there is a date change at midnight. Each NBP measurement is recorded. The time when the measurement ended is recorded. Each Temperature measurement is recorded. The time when the measurement ended is recorded. Other maternal parameters (SpO2, maternal heart rate, or Pulse) are recorded every five minutes. The rules described in the section Priority for Maternal Heart / Pulse Rate on page 219 apply. Paper Save Mode recording stops if there are no valid maternal measurements for more than one hour, and a message will notify you that there are no active parameters. Paper Save Mode recording will restart automatically when another valid measurement is made. Event Paper Save Mode Reactivation One of the maternal measurements (see above) is valid again. The recorder is turned off and on again or a report has been recorded (e.g. NST Report). The Paper Advance function is used. The Paper Save Mode setting is set off and on again. ADT information has changed (e.g. because patient information has been completed or updated). The monitor is restarted (e.g. by switching it off and on again). The date has changed (e.g. at midnight). yes yes yes yes no yes no 251 25 Paper Save Mode for Maternal Measurements 252 26 26Recovering Data The monitor stores trace data, including annotations, for a minimum of 3.5 hours with the software revision J.3 or higher, and for a minimum of 7 hours with the new mainboard hardware revision A 00.18, in its internal backup memory. This allows the monitor to recover trace data that would otherwise be lost under certain circumstances. In the event of the paper running out, this trace recovery data can be automatically retrieved and printed, or automatically transmitted to an OB TraceVue/IntelliSpace Perinatal system (LAN connection only), allowing continuity of data. The fetal trace printed from the trace recovery data contains all data from the real-time trace. Note that the data in the memory is cleared when a software upgrade is performed. CAUTION Only use Philips paper. Using paper other than Philips paper may result in the failure to recover traces. Recovering Traces on Paper The monitor is able to recover traces by printing them out at a high speed from the monitor's backup memory. If the monitor runs out of paper, or if the paper drawer is open, the exact time when this happens is stored in the backup memory. If the Bridge Paperout setting is set to On (default), when new paper is loaded and the recorder is started, a trace recovery printout of the data recovered from the backup memory is automatically printed out at high speed (up to 20 mm/s), starting from the time noted in the backup memory. This ensures that no data is lost. A minimum of one hour of trace recovery data is available for printing out from the backup memory. When the trace recovery printout has finished, the recorder automatically switches back to continue recording the current trace at the normal speed. Note the following:

If you press the fetal recorder Start/ Stop SmartKey during a trace recovery printout, the recording stops, and the next recording following a recorder restart will be a normal, real-time trace. After switching off the monitor, and then back on again, or following a power failure, the time of the last Check Paper INOP or paper-out detection is lost, and therefore any trace recovery data in the backup memory is no longer available to print. The next recording made following a restart of the recorder is a normal, real-time trace. The change back to a real-time recording from a trace recovery printout prompts the recording to restart. A new vertical trace header annotation consisting of the time, date, and recorder speed is printed, letting you see where the trace recovery printout ends, and where the real-time trace continues. 253 26 Recovering Data There can be a gap of up to 30 seconds between the trace recovery printout, and the beginning of the real-time trace. With every time or date change, a question mark is displayed in front of the timestamp of the stored data recording. Recovering Traces on an OB TraceVue/IntelliSpace Perinatal System The trace recovery data stored in the monitor's backup memory can also be uploaded at high speed to an OB TraceVue/IntelliSpace Perinatal system connected over the LAN interface (OB TraceVue Revision E.00.00 or later, and IntelliSpace Perinatal H.0 or later). When the OB TraceVue/IntelliSpace Perinatal system reconnects to the fetal monitor and detects that there is trace recovery data in the monitor's backup memory that has not yet been transmitted to the system, this data is transferred at high speed to the system. No user action is required. The exact length of the recovered trace will vary depending on the amount of trace information, but it will cover at least 3.5 hours of trace data with the software revision J.3 or higher, and 7 hours with the new mainboard hardware revision A 00.18, depending on the number of active parameters. To recover traces on an OB TraceVue/IntelliSpace Perinatal system, the following applies:

The trace data in the monitor's internal memory must relate to a specific patient in the OB TraceVue/

IntelliSpace Perinatal system. In other words, there were no discharge events made on the monitor that would change the patient context. The patient must have an open episode. No data will be uploaded if the patient is not admitted to OB TraceVue/IntelliSpace Perinatal. For further details see the OB TraceVue/IntelliSpace Perinatal Instructions for Use. Current online trace data is held back until the fast upload is complete. Manually Recording Stored Data If the recorder is not running, you can choose to print trace data from the monitor's memory at any time. You can see a list of all stored traces, showing patient identification and trace period, in the Stored Data Recording window, from which you can choose one of the entries at a time. CAUTION Ensure that you admit each patient by name, including other patient identification information, and discharge the patient when you have finished monitoring, so that you can identify which trace period (entry in the patient list) refers to which patient. Trace storage can be triggered by:

Discharging a patient Powering on the monitor Entering Standby Entering Service Mode Traces are not available for periods the monitor was switched off, in Service Mode, in Standby, or if the trace period was shorter than one minute. The speed of the printout depends on the configured recorder speed and on the amount of trace data available. The fetal trace printed from the trace data contains all data from the real-time trace, with the exception of the maternal heart rate, the pulse numeric, and the ECG wave. 254 26 Recovering Data Information for scale type, trace separation, and recorder speed are not stored in the trace memory, but is applied when the stored recording starts. While the stored recording is printing, all functions are disabled, except that for stopping the recorder. To start a stored data recording:

Either 1 2 Or 1 2 3 4 5 Select the Stored Data Rec SmartKey. Select All to print all stored trace data for the selected entry, or select one of the choices on the other pop-up keys to print only a specified portion of the entry (for example, Last 15 min for the last 15 minutes of trace data). Enter the Main Setup menu using the SmartKey. Select Fetal Recorder to open the Fetal Recorder menu. Select Stored Data Rec to open the Stored Data Recording window. Select an entry for a patient. Select All to print all stored trace data for the selected entry, or select one of the choices on the other pop-up keys to print only a specified portion of the entry (for example, Last 15 min for the last 15 minutes of trace data). To delete all stored trace periods:

Either 1 2 3 Or 1 2 3 4 5 Select the Stored Data Rec SmartKey. Select the Erase All key to delete all stored trace periods listed. Select the Confirm key. Enter the Main Setup menu using the SmartKey. Select Fetal Recorder to open the Fetal Recorder menu. Select Stored Data Rec to open the Stored Data Recording window. Select the Erase All key to delete all stored trace periods listed. Select the Confirm key. The current patients entry is at the top of the list. The oldest entry at the bottom of the list has no start time specified, as part of the data originally stored may have been over-written by the current patients data. It may be that you only see one entry (the current patients data) in the Stored Data Recording window if that patient was monitored for a period long enough to erase any earlier entries. If you make a stored data recording for an old entry (that is, not for the current patient), the recorder performs a fast trace printout of the stored data, advances the paper to the next paper fold, then stops. If you make a stored data recording for the current patient, the recorder performs a fast trace printout of the stored data, and then reverts automatically to recording the real-time trace. 255 26 Recovering Data 256 27 27Care and Cleaning Use only the Philips-approved substances and methods listed in this chapter to clean or disinfect your equipment. Warranty does not cover damage caused by using unapproved substances or methods. Philips makes no claims regarding the efficacy of the listed chemicals, or methods as a means for controlling infection. Consult your hospitals Infection Control Officer or Epidemiologist. For comprehensive details on cleaning agents and their efficacy refer to Guideline for Disinfection and Sterilization in Healthcare Facilities issued by the U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control, Atlanta, Georgia, 2008. See also any local policies that apply within your hospital, and country. General Points The transducers and patient modules are sensitive instruments. Handle them with care. Keep your monitor, transducers, patient modules, cables, and accessories free of dust and dirt. After cleaning and disinfection, check the equipment carefully. Do not use if you see signs of deterioration or damage. If you need to return any equipment to Philips, always decontaminate it first before sending it back in appropriate packaging. Observe the following general precautions:

Always follow carefully and retain the instructions that accompany the specific cleaning and disinfecting substances you are using. Always dilute cleaning agents according to the manufacturer's instructions or use lowest possible concentration. Do not allow liquid to enter the case. Do not immerse the monitor in liquid. Protect it against water sprays or splashes. Do not pour liquid onto the system. Never use abrasive material (such as steel wool or silver polish). Never use bleach. WARNING If you spill liquid on the equipment, battery, or accessories, or they are accidentally immersed in liquid, contact your service personnel or Philips service engineer. Do not operate the equipment before it has been tested and approved for further use. WARNING Do not operate the monitor if it is wet. If you spill liquid on the monitor, contact your service personnel or Philips service engineer. Do not perform underwater monitoring (for example, in a bath or shower) using wired transducers. 257 27 Care and Cleaning Place the monitor where there is no chance of contact with, or falling into water or other liquid. Do not dry equipment using heating devices such as heaters, ovens (including microwave ovens), hair dryers, and heating lamps. Do not put equipment or accessories in autoclave (for sterilization). Cleaning and Disinfecting the Monitor Clean and disinfect the Avalon FM20, FM30, FM40, and FM50 fetal monitors and all wired and cableless transducers (including ECG adapter cables), the Avalon CL base station, and all fetal accessories that are not limited to single use after each use and before initial use. Clean equipment before disinfecting. For other accessories, see Cleaning and Disinfecting Fetal Monitoring Accessories on page 261. Clean with a lint-free cloth, moistened with warm water (40C/104F maximum) and soap, a diluted non-

caustic detergent, tenside, or phosphate-based cleaning agent. Do not use strong solvents such as acetone or trichloroethylene. After cleaning, disinfect using only the approved disinfecting agents listed (see Recommended Disinfectants on page 259). CAUTION Solutions: Do not mix disinfecting solutions (such as bleach and ammonia) as hazardous gases may result. Hospital policy: Disinfect the product as determined by your hospital's policy, to avoid long-term damage to the product. Local requirements: Observe local laws governing the use of disinfecting agents. Touch display: To clean and disinfect the touch-enabled display, disable the touch operation by switching off the monitor during the cleaning procedure, or by selecting and holding the Main Screen key until the padlock symbol appears on it, indicating that touch operation is disabled. Select and hold again to re-enable touch operation. WARNING Skin contact: To reduce the risk of skin irritations, do not allow a cleaning or disinfecting agent to leave residues on any of the equipment surfaces - wipe it off with a cloth dampened with water, after allowing the appropriate time for the agent to work. Follow the safety instructions of the used cleaning or disinfection agent, especially regarding skin contact. Take extra care when cleaning the screen of the monitor, because it is more sensitive to rough cleaning methods than the housing. Do not permit any liquid to enter the monitor case and avoid pouring it on the monitor while cleaning. Do not allow water or cleaning solution to enter the measurement connectors. Wipe around and not over connector sockets, or those of the Toco+, CL Toco+ MP transducer, ECG and IUP Patient Modules, CL ECG/IUP transducer and adapter cables. 258 27 Care and Cleaning Recommended Disinfectants We recommend that you use one of the following disinfectants:

Product Name Isopropanol Bacillol AF Product Type Ingredients liquid liquid, spray Isopropanol 80%

100 g concentrate contains:

Propan-1-ol 45.0 g Propan-2-ol 25.0 g Ethanol 4.7 g Bacillol25 liquid Ethanol 100 mg/g Meliseptol Accel TB RTU Oxivir Tb Cleaner Disinfectant Oxivir Tb Wipes Carpe DiemTM/MC Tb Ready-to-Use General Virucide, Bactericide, Tuberculocide, Fungicide, Sanitizer Carpe DiemTM/MC Tb Wipes Super Sani-Cloth Germicidal Disposable Wipes SANI-CLOTH PLUS Germicidal Disposable Wipes spray liquid spray wipes spray wipes wipes wipes Propan-2-ol (= 2-Propanol) 90 mg/g Propan-1-ol (= 1-Propanol) 60 mg/g 50% 1-Propanol Accelerated hydrogen peroxide 0.5%

Accelerated hydrogen peroxide 0.5%

Accelerated hydrogen peroxide 0.5%

Accelerated hydrogen peroxide 0.5%

Accelerated hydrogen peroxide 0.5%

Isopropanol 55%

quaternary ammonium chlorides 0.5%

Isopropanol 15%

quaternary ammonium chlorides 0.25%

SANI-CLOTH HB Germicidal wipes Isopropanol < 0.15%

Germicidal Disposable Wipes quaternary ammonium chlorides 0.14%

Preparation Before cleaning and disinfecting, secure the following supplies:

non-linting wipes cotton swabs with tapered mini tips the validated cleaner and disinfectant using the concentration recommended by the cleaner and disinfectant manufacturer, see Recommended Disinfectants on page 259. Before cleaning and disinfecting the product:

1 Visually inspect the monitor for any visible damage or deterioration. Check for any tears, cracks, or bent connector pins. 2 Visually inspect the monitor for moderate to severe soiling. 259 27 Care and Cleaning Cleaning the Monitor The cleaning procedure described below has been validated using an enzymatic solution. Before cleaning, visually inspect the monitor for moderate to severe soiling. If the monitor is severely soiled, use swabs to clear soil before cleaning. To clean the monitor:

1 Prepare an enzymatic detergent solution (for example, Prolystica Manual 2X Enzymatic Presoak and Cleaner, Cidezyme or Enzol) per the manufacturers instructions. Using non-linting wipe(s) saturated (but not dripping) with the prepared detergent solution, thoroughly wipe the exterior surfaces of the device for a minimum of one (1) minute and until visibly clean. Pay attention to surfaces such as seams and ridges. NOTE Take extra care when cleaning the screen of the monitor because it is more sensitive to rough cleaning methods than the housing. If the drawer opens when cleaning the ejection button, close the drawer. FM20/30: Use cotton swab(s) with tapered mini tip(s) (Puritan P/N: 826-WC or equivalent) dampened in the prepared detergent solution to swab the difficult to clean surfaces of the on/off switch and handle. Do not permit any liquid to enter the monitor case and do not pour liquid onto the monitor while cleaning. Do not allow water or cleaning solution to enter the measurement connectors. Wipe around, not over, connector sockets. CAUTION To clean and disinfect the touch-enabled display, disable the touch operation by switching off the monitor during the cleaning procedure, or by selecting and holding the Main Screen key until the padlock symbol appears on it, indicating that touch operation is disabled. Select and hold again to re-

enable touch operation 1 2 3 Remove the cleaner residue by wiping the device surfaces a minimum of one (1) time with non-linting wipe(s) saturated (but not dripping) with tap water. Thoroughly dry the device using non-linting wipe(s). Inspect the device in a well-lit area to ensure all surfaces are clean. Disinfecting the Monitor NOTE The disinfection procedure described below has been tested and its efficacy validated using 70%

Isopropanol Alcohol (IPA). Clean equipment before disinfecting. 1 Thoroughly wipe all exterior surfaces of the device using non-linting wipe(s) saturated (but not dripping) with 70% Isopropanol Alcohol (IPA). NOTE Do not permit any liquid to enter the monitor case and do not pour liquid onto the monitor while cleaning. Do not allow water or disinfectant to enter the measurement connectors. Wipe around, not over, connector sockets. 260 27 Care and Cleaning CAUTION To clean and disinfect the touch-enabled display, disable the touch operation by switching off the monitor during the cleaning procedure, or by selecting and holding the Main Screen key until the padlock symbol appears on it, indicating that touch operation is disabled. Select and hold again to re-

enable touch operation 2 Allow all surfaces to remain visibly wet for a minimum of ten (10) minutes. If needed, use additional wipes to ensure the surfaces remain wet for the full duration. 3 Thoroughly dry the device using non-linting wipe(s). Cleaning and Disinfecting Fetal Monitoring Accessories The MECG cable and the Remote Event Marker consist of parts that can be cleaned and disinfected. CAUTION Never submerge the products in any aqueous solution. Never sterilize cables. Preparation Before cleaning and disinfecting, secure the following supplies:

non-linting wipes cotton swabs with tapered mini tips the validated cleaner and disinfectant using the concentration recommended by the cleaner and disinfectant manufacturer, see Recommended Disinfectants on page 259. Before cleaning and disinfecting the product:

1 Visually inspect the MECG cable and the Remote Event Marker for any visible damage or deterioration. Check for any tears, cracks, or bent connector pins. Discard the product if damaged since there is a potential for incorrect readings. 2 Always replace the product when there is any visible damage to the product (such as, exposed wires or breaks). 3 Visually inspect the product for moderate to severe soiling. Products with moderate to severe soiling are not intended to be cleaned or disinfected. If this situation occurs, dispose of the product according to your institutions recommended disposal procedure for hospital waste. Refer to Disposal in the products Instructions for Use for the additional information. Validated Cleaner and Disinfectant Philips has validated the following cleaner and disinfectant which were tested for efficacy and use on the MECG cable and Remote Event Marker. These agents were tested by Philips for both efficacy and prevention of damage to the Philips products being cleaned and disinfected:

Cleaner: Enzymatic detergent composition:

Product Ingredients Alcohol, C9-11, ethoxylated surfactant Glycerin Citric Acid Percent 1-5 1-5 1-5 261 27 Care and Cleaning Product Ingredients N, N-Dimethyloctadecylamine oxide Subtilisins (proteolytic enzymes) Percent 1-2 0.1-1 Disinfectant: 70% Isopropanol Alcohol (Chemical Abstract Service #67-63-0) Refer to the detergent manufacturers label for proper concentration and water temperature requirements. Material Compatibility with Disinfectants The following disinfectants were tested for material compatibility during product development. The disinfectants listed below have not been tested for their efficacy as a means for inactivating and destroying microorganisms on these devices. See Recommended Disinfectants on page 259 Do not use the following disinfectants because they will damage the product Product Name Hexanios G+R Incidin Plus Mikrobac forte Surfanios Citron Virex Tb RTU Cleaning the MECG Cable and the Remote Event Marker Starting Position the connector end of the cable to ensure that no liquid can enter the inside of the connector during cleaning. The term 'saturate' in a step refers to a very wet condition, but not to the point where dripping occurs. If at any time during the procedure the non-linting wipes become visibly soiled, discard soiled wipes and use more clean wipes. Use cotton swabs during the procedure, as needed, to reach seams, grooves, and narrow spaces. Cleaning 1 2 3 Saturate a non-linting wipe with the validated cleaner. Saturate all surfaces of the product with the cleaner. Saturate the surfaces of all accessories. 4 Allow surfaces to remain visibly wet for 3-5 minutes. 5 Dampen another non-linting wipe with cleaner. 6 Wipe the multi-pin connector and cable(s) until they are visibly clean. Be sure to clean all sides of the product. Do not allow liquid to come in contact with the inside of the connector. 7 MECG Adapter Cable only: Wipe the cable connectors. 8 Thoroughly clean all sides of the product. 262 27 Care and Cleaning Rinsing 1 2 Saturate a non-linting wipe with tap water. Start at the multi-pin connector and wipe the connector and cable(s) at least one time. 3 Visually inspect the product and repeat steps 6 and 7, if needed. If any part is not visibly clean, use a cotton swab to clean between the grooves and narrow spaces. 4 Using clean wipes, dry all sides of the product. 5 Proceed with Disinfecting the MECG Cable and the Remote Event Marker on page 263 Disinfecting the MECG Cable and the Remote Event Marker Starting Position the multi-pin connector to ensure that no liquid can enter the inside of the connector or come in contact with the electrical contacts. If at any time during the procedure non-linting wipes become visibly soiled, discard soiled wipes and use clean wipes. Use cotton swabs during the procedure, as needed, to disinfect and rinse seams, grooves, open areas, and narrow spaces. Disinfecting 1 2 Saturate a non-linting wipe with the validated disinfectant. Thoroughly saturate all surfaces of the product. 3 Allow surfaces to stay visibly wet for 10 minutes. Ensure that all seams, grooves, and narrow spaces are saturated. Rinsing and completing final inspection 1 2 Saturate a non-linting wipe with tap water. Start at the multi-pin connector and wipe to the end of the product. 3 Repeat step 2 two more times, using more wipes as needed. 4 Using clean wipes, dry the entire product. 5 Visually inspect the product to ensure all surfaces are clean and dry. Washing Reusable Belts (M4601A, M4602A, M4603A, M1562B) Reusable belts must be washed prior to patient use. Reusable Belts (M4601A, M4602A, M4603A, M1562B) Washing cycles Time per cycle Washing recommendations 30 45 minutes Wash soiled reusable belts with washing detergent and water. Water temperature must not exceed 60C/140F. Tumble dry. 263 27 Care and Cleaning Cleaning and Disinfecting the Tympanic Temperature Accessories Probe and Thermometer Body 1 Wipe the thermometer body clean with a damp cloth. The water temperature should not exceed 55C

(130F). Do not soak, rinse, or submerge the thermometer under water. You may add a mild detergent to the water. 2 Clean the probe tip with a lint free swab. If the probe tip is soiled, clean it with a dampened swab. 3 After you have removed all foreign matter, clean the thermometer lens at the end of the probe tip with a lint free swab or lens wipe. The thermometer lens must be free from fingerprints and/or smudges for proper operation. 4 Thoroughly dry all surfaces before using the equipment. CAUTION Do not use cleaners and disinfectants such as Spray-Nine, Phisohex, Hibiclens, or Vesta-Syde as they may result in damage to the thermometer case. Occasional use of a 10:1 water and hypochlorite mixture or a damp isopropyl alcohol wipe or Cidex or ManuKlenz or VIROX or CaviWipes cleansing agents is acceptable, however, prolonged or repeated use of these chemicals may result in damage to the thermometer case and display area. Use of a cloth or sponge is recommended for cleaning. Never use an abrasive pad or an abrasive cleaner on the thermometer. The thermometer is non-sterile. Do not use ethylene oxide gas, heat, autoclave, or any other harsh method to sterilize this thermometer. Cradle To clean the cradle:

1 Prepare an enzymatic detergent solution (for example, Prolystica Manual 2X Enzymatic Presoak and Cleaner, Cidezyme or Enzol) per the manufacturers instructions. Using non-linting wipe(s) saturated (but not dripping) with the prepared detergent solution, thoroughly wipe the exterior surfaces of the device for a minimum of one (1) minute and until visibly clean. Pay attention to surfaces such as seams and ridges. 2 If any portion of the device is not visibly clean after two (2) minutes using wipes, use cotton swab(s) with tapered mini tip(s) (Puritan P/N: 826-WC or equivalent) dampened in the prepared detergent solution and swab the difficult to clean surfaces. Pay attention to surfaces such as cavities and seams. 3 Remove the cleaner residue by wiping the device surfaces a minimum of one (1) time with non-linting wipe(s) saturated (but not dripping) with tap water. Thoroughly dry the device using non-linting wipe(s). Inspect the device in a well-lit area to ensure all surfaces are clean. 4 5 264 27 Care and Cleaning To disinfect the cradle:

NOTE The disinfection procedure described below has been tested and its efficacy validated using 70%

Isopropanol Alcohol (IPA). Clean equipment before disinfecting. 1 Thoroughly wipe all exterior surfaces of the device using non-linting wipe(s) saturated (but not dripping) with 70% Isopropanol Alcohol (IPA). 2 Allow all surfaces to remain visibly wet for a minimum of ten (10) minutes. If needed, use additional wipes to ensure the surfaces remain wet for the full duration. 3 Thoroughly dry the device using non-linting wipe(s). Sterilizing Sterilization is not allowed for this monitor, related products, accessories, or supplies unless otherwise indicated in the Instructions for Use that accompany the accessories and supplies. WARNING Do not put device and accessories in autoclave (for sterilization). 265 27 Care and Cleaning 266 28 28Maintenance WARNING Schedule: Failure on the part of the responsible individual hospital or institution employing the use of this equipment to implement a satisfactory maintenance schedule may cause undue equipment failure and possible health hazards. In case of problems: If you discover a problem with any of the equipment, contact your service personnel, Philips, or your authorized supplier. Electric shock hazard: Do not open the monitor housing. Refer all servicing to qualified service personnel. Inspecting the Equipment and Accessories You should perform a visual inspection before each use, and in accordance with your hospital's policy. With the monitor switched off:

1 2 3 Examine unit exteriors for cleanliness and general physical condition. Make sure that the housings are not cracked or broken, that everything is present, that there are no spilled liquids that may have entered the housing, and that there are no signs of abuse. Inspect all accessories (transducers, sensors and cables, and so forth). Do not use a damaged accessory. Switch the monitor on, and make sure the display is bright enough. If the brightness is not adequate, contact your service personnel or your supplier. Batteries Preventive Maintenance For the FM20/30 with a battery option, see Using Batteries on page 108. Inspecting the Cables and Cords 1 2 Examine all system cables, the power plug, and cord for damage. Make sure that the prongs of the plug do not move in the casing. If damaged, replace it with an appropriate power cord. Inspect the cables, leads, and their strain reliefs for general condition. Make sure there are no breaks in the insulation. Make sure that the connectors are properly engaged at each end to prevent rotation or other strain. 3 Carry out performance assurance checks as described in the monitor's Service Guide. 267 28 Maintenance Maintenance Task and Test Schedule The following tasks are for Philips-qualified service professionals. All maintenance tasks and performance tests are documented in detail in the service documentation supplied on the monitor's documentation DVD. Ensure that these tasks are carried out as indicated by the monitor's maintenance schedule, or as specified by local laws, whichever comes sooner. Contact a Philips-qualified service professional, if your monitor needs a safety or performance test. Clean and disinfect equipment to decontaminate it before testing or maintaining it. Maintenance and Test Schedule Frequency Visual Inspection Before each use. Clean and disinfect the equipment After each use. Safety checks according to IEC 60601-1, and where applicable, to national standards At least once every two years, or as specified by local laws. After any repairs where the power supply has been replaced

(by an authorized service professional). If the monitor has been dropped, it must be repaired/

checked by an authorized service agent. Performance assurance for all measurements At least once every two years, or if you suspect the measurement values are incorrect. Noninvasive blood pressure calibration At least once every two years, or as specified by local laws. Tympanic Thermometer Calibration Once a year. If the unit is dropped or damaged, or if the unit was stored at less than -25C or above 55C, check it and calibrate it before further use. Clean the thermal printhead At each paper pack change, or every 500 m of paper run. Recorder Maintenance Removing the Paper Guide: FM40/FM50 FM40/50 The paper guide is removable, and you can use the recorder without it. When not using the paper guide, ALWAYS tear off the paper along the perforation to avoid possible paper misalignment (see Tearing Off the Paper on page 62). 268 To remove the paper guide:

1 Press the paper eject button to open the paper drawer. 28 Maintenance 2 Hinge the transparent paper guide forward. 269 28 Maintenance 3 A protrusion (A) holds paper guide in closed position. 4 Release the paper guide from one side of the holder. 270 5 Then remove the paper guide. 28 Maintenance 6 Refitting is a reversal of the removal procedure. Storing Recorder Paper Recorder paper is not intended for long-term archival storage. Another medium should be considered if this is required. Dyes contained in thermal papers tend to react with solvents and other chemical compounds that are being used in adhesives. If these compounds come into contact with the thermal print, the print may be destroyed over time. You can take the following precautionary measures to help avoid this effect:

Store the paper in a cool, dry, and dark place. Do not store the paper at temperatures over 40C (104F). Do not store the paper where the relative humidity exceeds 60%. Avoid intensive light (UV light), as this may cause the paper to turn gray, or the thermal print to fade. 271 28 Maintenance Avoid storing the thermal paper in combination with the following conditions:

Papers that contain organic solvents. This includes papers with tributyl and/or dibutyl phosphates, for example recycled paper. Carbon paper and carbonless copy paper. Products containing polyvinyl chlorides, or other vinyl chlorides for example (but not exclusively) document holders, envelopes, letter files, divider sheets. Detergents and solvents, such as alcohol, ketone, ester, and others, including cleaning and disinfecting agents. Products containing solvent-based adhesives such as (but not exclusively) laminating film, transparent film, or labels sensitive to pressure. To ensure long lasting legibility and durability of thermal printouts, store your documents separately in an air-conditioned place and use:

only plasticizer-free envelopes or divider sheets for protection. laminating films and systems with water-based adhesives. Using such protective envelopes cannot prevent the fading effect caused by other, external agents. Cleaning the Print Head To clean the recorder's thermal print-head:

1 Switch off the monitor. 2 Open the paper drawer, and remove the paper if necessary, to gain access to the thermal print head. 3 Gently clean the thermal print head with a cotton swab, or soft cloth soaked in isopropyl alcohol. FM20/30 272 28 Maintenance FM40/50 NOTE If the print head is heavily coated with dust or dirt, contact your service personnel to clean it. Returning Equipment for Repair Before returning equipment for repair:

disinfect and decontaminate the equipment appropriately. ensure that all patient data has been removed (i.e. that no patient is admitted). Disposing of the Monitor WARNING To avoid contaminating or infecting personnel, the environment, or other equipment, make sure that you disinfect and decontaminate the monitor appropriately before disposing of it in accordance with your country's laws for equipment containing electrical and electronic parts. For disposal of parts and accessories such as thermometers, where not otherwise specified, follow local regulations regarding disposal of hospital waste. You can disassemble the monitor and the transducers as described in the Service Guide. You will find detailed disposal information on the following web page:

http://www.healthcare.philips.com/main/about/Sustainability/Recycling/pm.wpd Do not dispose of waste electrical and electronic equipment as unsorted municipal waste. Collect it separately, so that it can be safely and properly reused, treated, recycled, or recovered. The Recycling Passports located on the Philips' web page contain information on the material content of the equipment, including potentially dangerous materials which must be removed before recycling (for example, batteries and parts containing mercury or magnesium). 273 28 Maintenance 274 29 29Accessories and Supplies All accessories listed for the fetal monitor may not be available in all geographies. To order parts, accessories, and supplies, consult your local Philips representative for details. For customers in the United States, Australia, and Great Britain you can order at www.philips.com/healthcarestore. All accessories and supplies listed here are reusable, unless indicated otherwise. WARNING Reuse: Disposable accessories and supplies intended for single use, or single patient use only, are indicated as such on their packaging. Never reuse disposable accessories and supplies, such as transducers, sensors, electrodes, and so forth, that are intended for single use, or single patient use only. Approved accessories: Use only Philips-approved accessories. Packaging: Do not use a sterilized accessory if its packaging is damaged. Protection against electric shocks: The transducers and accessories listed in this chapter are not defibrillator proof. Electro-Surgery, Defibrillation and MRI: The fetal/maternal monitors are not intended for use during defibrillation, electro-surgery, or MRI. Remove all transducers, sensors, and accessories before performing electro-surgery, defibrillation, or MRI, otherwise harm can result. Information on Latex All Philips transducers and accessories are not manufactured with natural rubber latex, unless indicated otherwise in the following tables. Avalon CL Base Station CL Base Station Part Number Avalon CL Base Station can either be ordered with the option K30 (red connector), or K40

(black connector), or K60 (charging station) 866074 275 29 Accessories and Supplies Transducers New Generation Avalon Transducers The new generation of Avalon transducers provides the same functionality as the previous generation of Avalon transducers. So wherever the previous generation of Avalon transducers were used to measure the fetal and maternal parameters, you can now use the new generation of Avalon transducers in the same way.The old and new generations of Avalon transducers correspond as follows:

Old Generation Avalon Transducers New Generation Avalon Transducers Avalon Toco MP Transducer (M2734B) Toco+ Transducer (M2735A)

Toco MP Transducer (867248) Toco+ Transducer (867249) Toco+ MP Transducer (867245) requires Avalon software revision L.3x.xx Ultrasound Transducer (M2736A/AA) Patient Module ECG/ IUP (M2738A) Ultrasound Transducer (867246) ECG/IUP Transducer (867247) Remote Event Marker (989803143411)

Part Number 866075 866076 866077 866488 866487 865215 865216 CL Transducer and CL Pods Avalon CL Toco+ MP Transducer for use with the Avalon CL base station Avalon CL Ultrasound Transducer for use with the Avalon CL base station Avalon CL ECG/IUP Transducer for use with the Avalon CL base station Avalon CL Fetal & Maternal Pod for use with the Avalon CL base station Avalon CL Wide Range Pod for use with the Avalon CL base station CL SpO2 Pod for use with the Avalon CL base station CL NBP Pod for use with the Avalon CL base station 276 Fetal Accessories Accessory Description Part Number 29 Accessories and Supplies M4601A M4602A M4603A M1562B M2208A 40483A M1569A 989803143401 989803184841 Belt (reusable, gray, water resistant) 32 mm wide, 15 m roll 60 mm wide, 5 belts 60 mm wide, 15 m roll 50 mm wide, 5 belts Belt (disposable, yellow, water resistant) 60 mm wide, pack of 100 Ultrasound gel 12 Bottles Belt buttons (kit of 10) for wired transducers M273xA Belt Clips for wired Smart Transducers (kit of 6) Avalon CL Connector Caps Avalon CL Belt Clip Avalon CL Battery Replacement Kit Cable Management Kit Avalon CL Wide Range Battery Kit Kit of 20 Mobile CL Transmitter Cradles for use with 866487 Avalon CL Wide Range Pod Telemetry Pouch with window (case with 50 pouches) for use with 866487 Avalon CL Wide Range Pod Avalon CL Fetal & Maternal Patch (case with 10 each) ECG Skin Preparation Paper for use with the 989803196341 Avalon CL F&M patch DECG Accessories: Philips DECG Solution

(NOT compatible with QwikConnect Plus Solution accessories) Connector Caps for Avalon CL Cableless Smart Transducers (kit of 10) Belt Clip for Avalon CL Cableless Smart Transducers (kit of 10) 989803184851 989803184861 989803148841 989803196421 989803168881 989803137831 989803196341 M4606A 989803137651 989803139771 10 sheets, with 10 finger-tip sized skin prep pieces per sheet (100 preps per bag) DECG reusable leg plate adapter cable (with flushing port) DECG leg attachment electrode for DECG leg plate adapter cable Disposable Koala IUP catheter Reusable Koala IUP adapter cable DECG fetal scalp electrode: single spiral, worldwide availability 989803137631 DECG fetal scalp electrode:

double spiral, Europe only. Not for USA 989803137641 M1333A (obsolete) 989803143931 277 29 Accessories and Supplies MECG Accessories Accessory MECG reusable adapter cable Foam ECG electrodes, snap-fit, for MECG Adapter Cable (disposable) Noninvasive Blood Pressure Accessories The following accessories are approved for use with the fetal monitor:

Comfort Care 2-piece Reusable Cuffs Part Number M1363A 40493D/E Maternal Patient Category Limb Circumference Part Number Adult (Thigh) Large Adult Large Adult XL Adult Adult XL Small Adult Small Adult XL Cuff kit of 4 adult sizes Cuff kit of 3 adult XL sizes 42.0-54.0 cm 34.0-43.0 cm 34.0-43.0 cm 27.0-35.0 cm 27.0-35.0 cm 20.5-28.0 cm 20.5-28.0 cm The tubing required for all cuffs is M1598B (1.5 m) or M1599B (3.0 m). Adult Multi Care Reusable Cuffs Maternal Patient Category Limb Circumference Adult (Thigh) Large Adult Adult Adult X-Long Small Adult 42.0-54.0 cm 34.0-43.0 cm 27.0-35.0 cm 27.0-35.0 cm 20.5-28.0 cm M1576A M1575A M1575XL M1574A M1574XL M1573A M1573XL M1578A M1579XL Part Number 989803183371 989803183361 989803183341 989803183351 989803183331 The tubing required for all cuffs is M1598B (1.5 m) or M1599B (3.0 m). Easy Care 1-piece Reusable Cuffs Maternal Patient Category (color) Limb Circumference Part Number Adult Thigh (gray) Adult Thigh (gray) pack of 5 cuffs Large Adult X-Long (burgundy) Large Adult X-Long (burgundy) pack of 5 cuffs 45.0-56.5 cm 45.0-56.5 cm 35.5-46.0 cm 35.5-46.0 cm M4559B M4559B5 M4558B M4558B5 278 29 Accessories and Supplies Maternal Patient Category (color) Limb Circumference Part Number Large Adult (burgundy) Large Adult (burgundy) pack of 5 cuffs Adult X-Long (navy blue) Adult X-Long (navy blue) pack of 5 cuffs Adult (navy blue) Adult (navy blue) pack of 5 cuffs Small Adult (royal blue) Small Adult (royal blue) pack of 5 cuffs 35.5-46.0 cm 35.5-46.0 cm 27.5-36.5 cm 27.5-36.5 cm 27.5-36.5 cm 27.5-36.5 cm 20.5-28.5 cm 20.5-28.5 cm Cuff kits containing one small adult, one adult, one large adult and one thigh cuff Cuff kits containing one small adult, one adult, one adult X-long, one large adult, one large adult X-long and one thigh cuff M4557B M4557B5 M4556B M4556B5 M4555B M4555B5 M4554B M4554B5 864288 864291 The tubing required for all cuffs is M1598B (1.5 m) or M1599B (3.0 m). Gentle Care Single Patient Use Cuffs Maternal Patient Category Limb Circumference Part Number Adult (Thigh) Large Adult X-Long Large Adult Adult X-Long Adult Small Adult 45.0-56.5 cm 35.5-46.0 cm 35.5-46.0 cm 27.5-36.5 cm 27.5-36.5 cm 20.5-28.5 cm The tubing required for all cuffs is M1598B (1.5 m) or M1599B (3.0 m). Adult Single Care Cuffs Maternal Patient Category Limb Circumference Large Adult Adult X-Long Adult Small Adult 35.0-45.0 cm 27.5-36.0 cm 27.5-36.0 cm 20.5-28.5 cm The tubing required for all cuffs is M1598B (1.5 m) or M1599B (3.0 m). Adult Value Care Cuffs Maternal Patient Category Limb Circumference Large Adult Adult XL 34.0-43.0 cm 27.0-35.0 cm M4579B M4578B M4577B M4576B M4575B M4574B Part Number 989803182321 989803182311 989803182301 989803182291 Part Number 989803160861 989803160851 279 29 Accessories and Supplies Maternal Patient Category Limb Circumference Adult Small Adult 27.0-35.0 cm 20.5-28.0 cm Part Number 989803160841 989803160831 The tubing required for all cuffs is M1598B (1.5 m) or M1599B (3.0 m). IntelliVue CL NBP Pod Accessories Description Limb Circumference Range Contents Part Number Mobile CL Reusable Small Adult Cuff 21-27 cm Mobile CL Reusable Adult Cuff 26.0-34.5 cm Mobile CL Reusable Large Adult Cuff 33.5-45.0 cm Mobile CL Single-Patient Small Adult Cuff Mobile CL Single-Patient Adult Cuff Mobile CL Single-Patient Large Adult Cuff Mobile CL NBP Cradle Kit Mobile CL Extension Air Hose, 1.0 m Mobile CL NBP Battery Kit Telemetry Pouch with window Telemetry Pouch with window 21-27 cm 26.0-34.5 cm 33.5-45.0 cm

1 cuff 1 cuff 1 cuff 20 cuffs 20 cuffs 20 cuffs 989803163171 989803163191 989803163211 989803163181 989803163201 989803163221 20 cradles 1 extension air hose 989803163251 989803163131 1 Battery 1 disassembly tool 1 front housing 989803163261 50 pouches 989803137831 4 boxes of 50 pouches 989803140371 White Telemetry Pouch with Snaps -

50 pouches White Telemetry Pouch with Snaps -

4 boxes of 50 pouches 989803101971

(9300-0768-050) 989803101981

(9300-0768-200) SpO2 Accessories Some Nellcor sensors contain natural rubber latex which may cause allergic reactions. See the Instructions for Use supplied with the sensors for more information. M1901B, M1903B, and M1904B are not available in U.S. from Philips. Purchase Nellcor OxiCliq sensors and adapter cables directly from Tyco Healthcare. Some sensors may not be available in all countries. Do not use more than one extension cable with any sensors or adapter cables. Do not use an extension cable with Philips reusable sensors or adapter cables with part numbers ending in -L (indicates Long version). All listed sensors operate without risk of exceeding 41C/105.8F on the skin if ambient temperature is below 37C/98.6F. 280 Make sure that you use only the accessories that are specified for use with this device, otherwise patient injury can result. 29 Accessories and Supplies Philips Reusable Sensors Description Adult sensor (2.0 m cable), for patients over 50 kg. Any finger, except thumb. M1191A/B with longer cable (3.0 m) Small adult, pediatric sensor (1.5 m cable) for patients between 15 kg and 50 kg. Any finger except thumb. Use only on adult patients with FM30/40/50. Part Number M1191B M1191AL/BL M1192A Ear sensor (1.5 m cable) for patients more than 40 kg. Use only on adult patients with FM30/

40/50. M1194A Adult clip sensor (3 m cable) for patients over 40 kg. Any finger except thumb. Adult clip sensor (2 m cable) for patients over 40 kg. Any finger except thumb. M1196A M1196S No adapter cable required. Description Adult sensor (0.45 m cable), for patients over 50 kg. Any finger except thumb. Small adult, pediatric sensor (0.45 m cable) for patients between 15 kg and 50 kg. Any finger except thumb. Use only on adult patients with FM30/40/50. Part Number M1191T M1192T Adult clip sensor (0.9 m cable) for patients over 40 kg. Any finger except thumb. M1196T Requires M1943A (1.0 m) or M1943AL (3.0 m) adapter cable. Description Special Edition (SE). Adult sensor (3 m cable), for patients over 50 kg. Any finger except thumb. Part Number M1191ANL Special Edition (SE). Small adult, pediatric sensor (1.5 m cable) for patients between 15 kg and 50 kg. Any finger except thumb. Use only on adult patients with FM30/40/50. M1192AN Special Edition (SE). Ear sensor (1.5 m cable) for patients more than 40 kg. M1194AN No adapter cable required. SE sensors work with FM30/40/50, as well as with OxiMax-compatible SpO2 versions of other Philips monitors. Philips Disposable Sensors Not available in the U.S.:

Description Identical to OxiMax MAX-A Identical to OxiMax MAX-P Identical to OxiMax MAX-N Requires M1943A (1.0 m) or M1943AL (3.0 m) adapter cable Part Number M1904B M1903B M1901B 281 29 Accessories and Supplies Available worldwide:

Description Part Number Adult/Pediatric finger sensor (0.45 m cable). Use only on adult patients with FM30/40/50. M1131A Adult/Pediatric finger sensor (0.9 m cable) for patients >40 kg. Any finger except thumb. Use only on adult patients with FM30/40/50. M1133A Adult/Pediatric finger sensor (0.9 m cable) for patients >40 kg. Any finger except thumb. Adhesive-free, use only on adult patients with FM30/40/50. M1134A Requires M1943A (1.0 m) or M1943AL (3.0 m) adapter cable Nellcor Sensors Nellcor sensors must be ordered from Nellcor/Covidien. OxiMax Sensors Description Adult finger sensor (patient size >30 kg) OxiMax MAX-A with long cable Pediatric foot/hand sensor (patient size 10-50 kg). Use only on adult patients with FM30/40/

50. Part Number OxiMax MAX-A OxiMax MAX-AL OxiMax MAX-P Adult finger or neonatal foot/hand sensor (patient size >40 kg or <3 kg). Use only on adult patients with FM30/40/50. OxiMax MAX-N Require M1943A (1.0 m) or M1943AL (3.0 m) adapter cable. Oxisensor II Sensors Description Adult sensor (patient size >30 kg) Part Number Oxisensor II D-25 Pediatric sensor (patient size 10-50 kg). Use only on adult patients with FM30/40/50. Oxisensor II D-20 Neonatal/Adult sensor (patient size <3 kg or >40 kg). Use only on adult patients with FM30/

40/50. Oxisensor II N-25 Requires M1943A (1.0 m) or M1943AL (3.0 m) adapter cable. OxiCliq Sensors Description See OxiMax MAX-A See OxiMax MAX-P. Use only on adult patients with FM30/40/50. See OxiMax MAX-N. Use only on adult patients with FM30/40/50. Part Number OxiCliq A OxiCliq P OxiCliq N Requires M1943A (1.0 m) or M1943AL (3.0 m) adapter cable together with OC-3 adapter cable. 282 29 Accessories and Supplies Masimo LNOP Reusable Sensors Description Adult Finger Sensor (>30 kg) Pediatric Finger Sensor (10-50 kg). Use only on adult patients with FM30/40/50. Product Number LNOP DC-I LNOP DC-IP Multi-Site Sensor (>1 kg). Use only on adult patients with FM30/40/50. LNOP YI Part Number 989803140321 989803140331 n/a Ear Sensor (>30 kg). Use only on adult patients with FM30/40/50. LNOP TC-I 989803140341 For use with this sensor the adapter cable LNOP MP12 (M1020-61102) is needed. Masimo LNCS Reusable Sensors Description Adult Finger Sensor (>30 kg) Pediatric Finger Sensor (10-50 kg). Use only on adult patients with FM30/40/50. Ear Sensor (>30 kg). Use only on adult patients with FM30/40/50. Product Number LNCS DC-I LNCS DC-IP Part Number 989803148281 989803148291 LNCS TC-I 989803148301 For use with this sensor the adapter cable LNC MP10 (989803148221) is needed. Masimo LNOP Disposable Adhesive Sensors Description Adult Sensor (>30 kg) Adult Sensor (>30 kg) Pediatric Sensor (10-50 kg). Use only on adult patients with FM30/40/50. Product Number LNOP Adt LNOP Adtx LNOP Pdt Pediatric Sensor (10-50 kg). Use only on adult patients with FM30/40/50. LNOP Pdtx Neonatal (<3 kg) or Adult adhesive Sensor (>40 kg). Use only on adult patients with FM30/40/50. LNOP Neo-L Appropriate LNOP/LNCS adapter cable required. Part Number 989803140231 n/a 989803140261 n/a 989803140291 283 29 Accessories and Supplies Masimo LNCS Disposable Adhesive Sensors Description Adult Sensor (>30 kg) Pediatric Finger Sensor (10-50 kg). Use only on adult patients with FM30/40/50. Product Name LNCS Adtx LNCS Pdtx Neonatal Foot Sensor (<3 kg) or Adult Finger Sensor

(>40 kg). Use only on adult patients with FM30/40/50. LNCS Neo-L Appropriate LNOP/LNCS adapter cable required. IntelliVue CL SpO2 Pod Accessories Part Number 989803148231 989803148241 989803148271 All listed sensors operate without risk of exceeding 41C on the skin, if the initial skin temperature does not exceed 35C. Ensure that you use only the accessories that are specified for use with this device, otherwise patient injury can result. Description Contents Mobile CL 20 single patient SpO2 Sensors and Cradles for use on patients >10 kg 20 Single-Patient Mobile CL DSpO2-1A Sensors 20 Single-Patient Wristbands 20 Single-Patient Cradles pre-assembled Part Number 989803165941 Mobile CL 20 single patient SpO2 Sensors for use on patients >10 kg 20 Single-Patient Mobile CL DSpO2-1A Sensors Mobile CL reusable SpO2 sensor and Cradles for use on patients >15 kg 1 Reusable Mobile CL RSpO2-1A Sensor 20 Single-Patient Cradles with pre-attached Wristbands 989803165921 9898031659311 Mobile CL 20 SpO2 Cradles (single patient) Mobile CL 50 SpO2 Wristbands (single patient) Mobile CL SpO2 Battery Kit 20 Single-Patient Cradles with pre-attached Wristbands 989803165951 50 Single-Patient Wristbands 989803165961 1 Battery 1 disassembly tool 1 front housing 1 May not be available in all geographies Extension / Adapter Cables Description Extension cable (2 m) Adapter cable (1.1 m cable) Adapter cable (3 m cable) Comments For use with Philips reusable sensors and adapter cables Adapter cable for Philips/Nellcor disposable sensors Adapter Cable for OxiCliq sensors Available from Nellcor 284 989803168861 Part Number M1941A M1943A M1943AL OC-3 29 Accessories and Supplies Description Masimo MP 12 LNC MP10 Comments LNOP MP Series Patient Cable (3.6 m) Adapter Cable for Masimo LNOP sensors LNCS MP Series Patient Cable (3.0 m) Adapter Cable for Masimo LNCS sensors Part Number M1020-61100 989803148221 Tympanic Temperature Accessories Description Temperature probe Disposable probe cover with CE marking (22 boxes each containing 96 covers) Disposable probe cover (22 boxes each containing 96 covers) Part Number 989803180831 989803179611 989803179381 Recorder Paper Supplied in cases of 40 packs. Each pack has 150 numbered pages. Single use. Use the paper specified here. Geography FHR Scale Grid Color Scale Units Highlighted 3 cm Lines?

Part Number U.S./Canada/Asia Europe Japan Japan 30-240 50-210 50-210 50-210 Red/Orange mmHg Yes Green Green Green*

mmHg and kPa No mmHg mmHg Yes Yes M1910A M1911A M1913A M1913J

*Bradycardia and tachycardia alarm ranges are shaded. Batteries Description Comment Part Number Smart Battery 10.8 V, 6000 mAh, Lithium Ion For Avalon FM20 or Avalon FM30 with M4605A Avalon CL Cableless Smart transducer Battery Replacement Kit battery option #E25 Consists of one Philips Lithium Ion Battery

(Part No. 453564107871), a tool to open and close the cableless transducer for battery replacement and two replacement O-ring seals. 989803184861 Avalon CL Wide Range Battery Kit For Avalon CL Wide Range Pod 989803196421 285 29 Accessories and Supplies 286 30 30Specifications and Standards Compliance The monitors are intended to monitor a mother and her fetus(es), which from an electrical safety point of view, are one person. Environmental Specifications The monitor may not meet the given performance specifications, if stored and used outside the specified temperature and humidity ranges. Avalon CL Base station 866074 with Option K30 and K40 Temperature Range Operating 0C-45C (32F-113F) Storage/Transportation

-20C-60C (-4F-140F) Humidity Range Operating

<95% relative humidity @ 45C (113F) Storage/Transportation

<90% relative humidity @ 60C (140F) Altitude Range Operating

-500-3000 m (-1640-9840 ft) Storage/Transportation

-500-13100 m (-1640-43000 ft) Avalon CL Base station 866074 with Option K60 Temperature Range Operating 0C-40C (32F-104F) Storage/Transportation

-20C-60C (-4F-140F) Humidity Range Operating

<90% relative humidity @ 45C (113F) Storage/Transportation

<90% relative humidity @ 60C (140F) Altitude Range Operating 0-2000 m (0-6562 ft) Storage/Transportation

-500-13100 m (-1640-43000 ft) Monitor (M2702A/M2703A/M2704A/M2705A); Interface Cable for Avalon CTS (M2731-60001 and M2732-60001) Temperature Range Operating Without battery option: 0C-45C (32F-113F) With battery option/charging: 0C-35C (32F-95F) With battery option/fully charged: 0C-40C (32F-

104F) Storage/Transportation

-20C-60C (-4F-140F) Humidity Range Operating

<95% relative humidity @ 40C (104F) Storage/Transportation

<90% relative humidity @ 60C (140F) Altitude Range Operating

-500-3000 m (-1640-9840 ft) Storage/Transportation

-500-13100 m (-1640-43000 ft) 287 30 Specifications and Standards Compliance Previous Generation Transducers (M2734A/M2734B/M2735A/M2736A/M2738A) Temperature Range Operating 0C-40C (32F-104F) Storage/Transportation

-20C-60C (-4F-140F) Humidity Range Operating

<95% relative humidity @ 40C (104F) Storage/Transportation

<90% relative humidity @ 60C (140F) Altitude Range Operating

-500-3000 m (-1640-9840 ft) Storage/Transportation

-500-13100 m (-1640-43000 ft) New Generation Transducers (867245, 867246, 867247, 867248, 867249) Temperature Range Operating 0C-40C (32F-104F) Storage/Transportation

-20C-60C (-4F-140F) Humidity Range Operating

<95% relative humidity @ 40C (104F) Storage/Transportation

<90% relative humidity @ 60C (140F) Altitude Range Operating

-500-3000 m (-1640-9840 ft) Storage/Transportation

-500-13100 m (-1640-43000 ft) NOTE Do not locate the M2738A ECG/IUP Module directly on the patients skin when operated at an environmental temperature above 37C (98.6F). When operated at an environmental temperature of 40C

(104F), the transducers can reach a temperature of 41-43C (106-110F). Remote Event Marker (989803143411) Temperature Range Humidity Range Altitude Range Operating Storage Transportation Operating Storage 0C-55C (32F-131F)

-40C-70C (-40F-158F)

-40C-70C (-40F-158F))

<95% relative humidity @ 40C (104F)

<90% relative humidity @ 65C (149F) Transportation

<90% relative humidity @ 65C (149F) Operating Storage

-500-3000 m (-1640-9840 ft) 1075hPa-700hPa

-500-13100 m (-1640-43000 ft) 1075hPa-160hPa Transportation

-500-13100 m (-1640-43000 ft) 1075hPa-160hPa Avalon CL Transducers (866075/866076/866077) Temperature Range Operating Charging 0C-40C (32F-104F) 0C-35C (32F-95F) Storage/Transportation

-20C-60C (-4F-140F) Humidity Range Operating

<95% relative humidity @ 40C (104F) Storage/Transportation

<90% relative humidity @ 60C (140F) Altitude Range Operating

-500-3000 m (-1640-9840 ft) Storage/Transportation

-500-13100 m (-1640-43000 ft) 288 30 Specifications and Standards Compliance Avalon CL Fetal & Maternal Pod (866488) Temperature Range Operating Charging 10C-40C (50F-104F) 10C-35C (50F-95F) Storage/Transportation

-20C-60C (-4F-140F) Humidity Range Operating

<95% relative humidity @ 40C (104F) Storage/Transportation

<90% relative humidity @ 60C (140F) Altitude Range Operating

-500-3000 m (-1640-9840 ft) Storage/Transportation

-500-13100 m (-1640-43000 ft) Avalon CL Fetal & Maternal Patch (989803196341) Temperature Range Operating 10C-40C (50F-104F) Storage/Transportation 10C-30C (50F-86F) Humidity Range Operating

<95% relative humidity Storage/Transportation

<90% relative humidity Altitude Range Operating

-500-3000 m (-1640-9840 ft) Storage/Transportation

-500-13100 m (-1650-43000 ft) Avalon CL Wide Range Pod (866487) Temperature Range Operating Charging 0C-40C (32F-104F) 0C-35C (32F-95F) Storage/Transportation

-20C-60C (-4F-140F) Humidity Range Operating

<95% relative humidity @ 40C (104F) Storage/Transportation

<90% relative humidity @ 60C (140F) Altitude Range Operating

-500-3000 m (-1640-9840 ft) Storage/Transportation

-500-4600 m (-1640-15092 ft) MECG Adapter Cable (M1363A) Temperature Range Humidity Range Altitude Range SpO2 Sensors Operating Storage Transportation Operating Storage 0C-55C (32F-131F)

-40C-70C (-40F-158F)

-40C-70C (-40F-158F))

<95% relative humidity @ 40C (104F)

<90% relative humidity @ 65C (149F) Transportation

<90% relative humidity @ 65C (149F) Operating Storage

-500-3000 m (-1640-9840 ft) 1075hPa-700hPa

-500-13100 m (-1640-43000 ft) 1075hPa-160hPa Transportation

-500-13100 m (-1640-43000 ft) 1075hPa-160hPa Operating Temperature Range 0C-37C (32F-98.6F) 289 30 Specifications and Standards Compliance Tympanic Temperature Operating Temperature Range 16C-33C (60.8F-91.4F) Fetal Recorder Paper (M1910A, M1911A, M1913A, M1913J) Temperature Range Humidity Range Altitude Range Operating Storage 0C-45C (32F-113F)

-20C-40C (-4F-104F) Transportation

-20C-60C (-40F-140F) Operating Storage

<95% relative humidity @ 40C (104F)

<70% relative humidity @ 40C (104F) Transportation

<90% relative humidity @ 60C (140F) Operating Storage

-500-3000 m (-1640-9840 ft) 1075hPa-700hPa

-500-13100 m (-1640-43000 ft) 1075hPa-160hPa Transportation

-500-13100 m (-1640-43000 ft) 1075hPa-160hPa WARNING Explosion Hazard: Do not use in the presence of flammable anesthetics, such as a flammable anesthetic mixture with air, oxygen, nitrous oxide, or in oxygen rich environment. Use of the devices in such an environment may present an explosion hazard. 290 30 Specifications and Standards Compliance Physical Specifications Fetal Monitors Monitor Physical Specifications M2702A/M2703A M2704A/M2705A Power Supply Voltages 100 VAC-240 VAC 10%

Supply Frequency Range 50 Hz-60 Hz Power Consumption (current) 0.7-0.4 A (M2702A/M2703A) 1.3-0.7 A 1.3-0.7 A (M8023A#E25) Dimensions and Weight Size (without options) mm/

(in):

286 x 134 x 335 mm

(11.3 x 5.3 x 13.2 in) 425 x 174 x 365 mm

(16.6 x 6.9 x 14.4 in) width x height x depth Weight

<5.1 kg (11.2 lbs)

<8.8 kg (19.5 lbs) Degree of Protection Against Electrical Shock Type CF Electrical Class Electrical Power Source Mode of Operation Class II equipment Class I equipment External (AC) External (AC) without battery option #E25 Internal (Lithium Ion battery) if with battery option #E25 Continuous operation Water Ingress Protection Code IP X1 (provided recorder drawer is shut) Global Speed (DECG and MECG wave on the screen) 6.25 mm/sec, 12.5 mm/sec, 25 mm/sec, 50 mm/sec Startup Time Time taken from switching on the monitor to seeing the first parameter labels

<30 seconds Fetal Monitor Sounds Source Description Patient alarms and INOPs See the sections on Patient Alarms and INOPs on page 127, Standard Philips Alarms on page 117, and ISO/IEC Standard Audible Alarms on page 117. Ultrasound Doppler Direct transmission of Doppler echoes to the speaker of the fetal monitor. Pulse from SpO2, MECG, DECG SpO2 NST Timer Status/Prompt tone QRS tone Optional modulation of the QRS tone for changes in the SpO2 level. Tone for Timer expired. Configurable volume tone sounded when status or prompt messages are issued by the fetal monitor. Touch feed back tone Anytime the user touches the display a low beep is issued in response. 291 30 Specifications and Standards Compliance Avalon CL Base Station Avalon CL Base Station Dimension and Weight Size mm/(in) Electrical Class W x H x D Weight 349 x 74 x 183 mm (13.8 x 2.9 x 7.2 in) 1 kg (2.3 lbs) When the base station is connected to the monitors M2702A/M2703A/M2704A/

M2705A it is a Class II equipment. Electrical Power Source External (powered by fetal monitor) Mode of Operation Continuous operation Interface cable connector type Connector color Red for FM20/30 left side or FM40/50 front fetal connector socket Black for FM40/50 rear telemetry connector socket Interface cable length Ingress Protection 1.5 m (4.11 ft) IP 31 External Power Supply (Option K60 for the Avalon CL Base Station) Maximum Weight (with cable) 140 g (4.94 oz) (incl. cable, without country-dependent AC adapter) Size (W x H x D) Charging cable length Supply Voltages 52.0 x 39.5 x 85.0 mm (2.0 x 1.6 x 3.4 in) 1.6 m (5.2 ft) (incl. power supply) 100 VAC-240 VAC Supply Frequency Range 50 Hz/60 Hz Power Consumption (current) Electrical Class Electrical Power Source Mode of Operation 0.4-0.2A Class II AC Mains Continuous Water Ingress Protection Code IP40 Wired Transducers Previous Generation Avalon Transducers (M2734A/M2734B/M2735A/M2736A/M2738A) Withstands a 1 m drop to concrete surface with possible cosmetic damage only M2734A&B/35/36A IP 68 (immersion up to 1 m water depth for 5 hours) M2738A IP 67 (immersion up to 0.5 m water depth for 30 minutes) M2734A&B/35/36A Size (diameter) M2738A Weight (without cable) Maximum size mm/(in):

width x height x depth Cable length Weight 83 mm (3.27 in) 0.2 kg (0.5 lb) 42 x 30 x 123 mm

(1.7 x 1.2 x 4.8 in) 2.5 m 0.2 kg (0.5 lb) Shock Resistance Water Ingress Protection Code Dimensions and Weight 292 30 Specifications and Standards Compliance Previous Generation Avalon Transducers (M2734A/M2734B/M2735A/M2736A/M2738A) Degree of Protection Against Electrical Shock Type CF Transducer Identification Optical Signal Element (Finder LED), not M2738A New Generation Avalon Transducers (867245, 867246, 867247, 867248, 867249) Shock Resistance Withstands a 1.5 m drop to concrete surface with possible cosmetic damage only Water Ingress Protection Code IP 68 (immersion up to 1 m water depth for 5 hours) Dimensions and Weight Size (diameter/height) Degree of protection against electrical shock Cable length Weight Type CF 76 mm/37 mm

(3 in/1.5 in) 2.5 m

<0.2 kg (0.5 lb) Transducer Identification Optical Signal Element (Finder LED) Avalon CL Transducers Avalon CL Transducers (866075/866076/866077) Shock Resistance Withstands a 1.5 m drop to concrete surface with possible cosmetic damage only. Water Ingress Protection Code IP 68 (immersion up to 1 m water depth for 5 hours) Dimensions and Weight Avalon CL Toco+ MP Transducer 866075 Size (diameter/height) 76 mm/37 mm (3 in/1.5 in) Weight 0.2 kg (0.5 lb) Avalon CL US Transducer 866076 Size (diameter/height) 76 mm/37 mm (3 in/1.5 in) Avalon CL ECG/IUP Transducer 866077 Degree of Protection Against Electrical Shock Weight 0.2 kg (0.5 lb) Size (diameter/height) 76 mm/37 mm (3 in/1.5 in) Weight Type CF 0.2 kg (0.5 lb) Transducer Identification Optical Signal Element (Finder LED) Avalon CL Fetal & Maternal Pod Avalon CL Fetal & Maternal Pod (866488) Shock Resistance Withstands a 1.5 m drop to concrete surface with possible cosmetic damage only. Water Ingress Protection Code IP 67 (immersion up to 1 m water depth for 30 minutes) Dimensions and Weight Degree of Protection Against Electrical Shock W x H x D Weight Type CF 63 x 20 x 49 mm

(2.5 x 0.8 x 1.9 in) 0.07 kg (0.15 lb) Pod Identification Optical Signal Element (Finder LED) 293 30 Specifications and Standards Compliance Avalon CL Wide Range Pod Avalon CL Wide Range Pod (866487) Shock Resistance Withstands a 1 m drop to concrete surface with possible cosmetic damage only. Water Ingress Protection Code IP 32 (protection from dripping water) Dimensions and Weight W x H x D Weight 55 x 26.5 x 122 mm

(2.1 x 1 x 4.8 in) 0.14 kg (0.3 lb) Interface Cable Avalon CTS Interface Cable for Avalon CTS (M2731-60001 and M2732-60001) Shock Resistance Withstands a 1 m drop to concrete surface with possible cosmetic damage only Water Ingress Protection Code IP X1 Dimensions and Weight Maximum size mm/(in):

width x height x depth Cable length Weight 55 x 28 x 50 mm (2.2 x 1.1 x 2.0 in) 2.5 m 0.2 kg (0.5 lb) External Power Supply Option E25 M8023A (Option #E25) External Power Supply Weight and Dimensions Maximum Weight Size (W x H x D) 0.6 kg (1.4 lb) 208 x 105 x 135 mm (8.2 x 4.1 x 5.3 in) Interface Specifications Standard Connector Isolation 100-Base-TX (IEEE 802.3 Clause 25) RJ45 (8 pin) Basic isolation (reference voltage: 250 V; test voltage:

1500 V) Fetal Monitors Interface Specifications Network 294 Interface Specifications MIB/RS232 USB Interface RS232 (Standard) RS232 (Independent display interface option) Standard Connectors Mode Power Isolation Standard Connectors Power Isolation Connectors Power Isolation Connectors Power Isolation Flexible Nurse Call Relay1 Connectors Contact Isolation Delay 30 Specifications and Standards Compliance IEEE 1073-3.2-2000 RJ45 (8 pin) Software-controllable BCC (RxD/TxD cross over) or DCC (RxD/TxD straight through) 5 V 5%, 100 mA (max.) Basic isolation (reference voltage: 250 V; test voltage:

1500 V) USB 2.0 full-speed (embedded host) USB series Standard A receptacle Low power port 4.4V min; max. load for all ports together 500 mA none RJ45 (8 pin) none Basic isolation (reference voltage: 250 V; test voltage:

1500 V) RJ45 (8 pin) none none 20 pin MDR (Mini D-Ribbon), active open and closed contacts 100 mA, 24 V DC Basic isolation (reference voltage: 250 V; test voltage:

1500 V)

<[Configured Latency +0.5] sec 1 The power loss indication functionality of the Nurse Call Relay board is not supported with fetal monitors. Avalon CL Radio Avalon CL Radio Interface Specifications Electronic Article Surveillance (EAS) Short Range Radio Interface*

Type Technology Frequency Band EAS tag inside the housing (58 kHz) Internal SRR interface IEEE 802.15.4 2.4 GHz ISM (2.400-2.483 GHz) Modulation Technique DSSS (O-QPSK) Effective radiated power max. 0 dBm (1 mW) Range ca. 5 m without any physical obstructions as walls and doors 295 30 Specifications and Standards Compliance Avalon CL Radio Interface Specifications OBR (WMTS)*

Frequency Band 608-614 MHz OBR (ISM)*

Effective radiated power Range Frequency Band Effective radiated power

<10 mW (base station)

<1 mW (CL transducers) min. 100 m/300 ft (in line of sight) 433.05-434.79 MHz

<10 mW (base station)

<1 mW (CL transducers) OBR (T108)*

Frequency Band 920.6-923.4 MHz Range min. 100 m/300 ft (in line of sight) Effective radiated power

<40 mW (base station)

<10 mW (CL transducers) Range min. 100 m/300 ft (in line of sight)

*Wireless transmissions are encrypted for security. CL Wide Range Pod Radio OBR (OB Radio) OBR (WMTS) Frequency Band Effective radiated power Range 608-614 MHz

<1 mW 5 m/16 ft OBR (ISM) Frequency Band 433.05-434.79 MHz Effective radiated power Range

<1 mW 5 m/16 ft OBR (T108) Frequency Band 920.6-923.4 MHz Effective radiated power Range

<5 mW 5 m/16 ft Short Range Radio Specifications Type Technology Frequency Band Modulation Bandwidth Built-in interface with integrated antenna IEEE 802.15.4 2.4 GHz ISM (2.400-2.483 GHz) MBAN (2.360-2.400 GHz, for US / FCC regulated countries only)1 DSSS (O-QPSK) 5 MHz Effective Radiated Power (ERP) max. 0 dBm (1 mW) WLAN Specifications Type Technology Internal wireless adapter IEEE 802.11a/b/g/n 296 30 Specifications and Standards Compliance WLAN Specifications Frequency Band U.S.: 2.400-2.483 GHz, 5.15-5.35 GHz, 5.725-5.825 GHz Europe: 2.400-2.483 GHz, 5.15-5.35 GHz, 5.47-5.725 GHz Japan: 2.400-2.483 GHz, 5.150-5.250 GHz, 5.25-5.35 GHz, 5.470-5.725 GHz China: 2.400-2.483 GHz, 5.725-5.85 GHz Modulation Technique 802.11b/g DSSS (DBPSK, DQPSK, CCK) OFDM (BPSK, QPSK, 16-QAM, 64-QAM) 802.11a OFDM (BPSK, QPSK, 16-QAM, 64-QAM) Effective Radiated Power (ERP) 2.400-2.483 GHz: max. 18 dBm (63 mW) 5.150-5.725 GHz: max. 19 dBm (79 mW) 5.745-5.825 GHz: max. 14 dBm (25 mW) Performance Specifications Essential Performance This section defines the Essential Performance for FM20/30 and FM40/50 monitors, alone and in combination with the Avalon CL Solution. Under normal and single fault conditions and when operating under non-transient electromagnetic phenomena according to IEC 60601-1-2, either at least the performance listed in the following table is provided or failure to provide this performance is readily identifiable by the user. For example, identifiers are technical alarms, no waveforms and/or numeric values, complete failure of the monitor, readily identifiable distorted signals, and so on. The following are non-

transient electromagnetic phenomena according to IEC 60601-1-2:

Radiated radio frequency (RF) electromagnetic fields Conducted disturbances induced by RF fields Power frequency magnetic fields Voltage dips Proximity electromagnetic fields from RF wireless communication equipment Measurement General Essential Performance No interruption or cessation of current operating mode (e.g. no reboot, display OK). No spontaneous operation of controls (e.g. no activation of touchscreen without user interaction). ECG (fetal and maternal heart rate monitoring): dFHR, HR Measurement of heart rate within 10% or 5 bpm, whichever is greater. Abdominal ECG: aFHR, aHR Alarming on heart rate limit violation within specified delay time. No FHR/HR gaps greater than 30 s, no FHR/HR error >15 bpm for 15 s. No interruption of the transmission mode. Alarming on heart rate limit violation within specified delay time. 297 30 Specifications and Standards Compliance Measurement Essential Performance Maternal Pulse from Toco (MP) Measurement of the maternal pulse rate within the specified accuracy NBP SpO2 limits. MP is susceptible to movement artifact potentially resulting in signal loss. It is not intended for continuous maternal HR monitoring. Limit alarms are not provided. Measurement of noninvasive systolic, diastolic, and mean blood pressure and pulse rate within specified accuracy and error limits. Automatic cycling Alarming on limit violations of systolic, diastolic, and mean blood pressure, and pulse rate. Measurement of oxygen saturation within 4%RMS over the range from 70 to 100% and pulse rate within 10%RMS or 5 bpmRMS whichever is greater. Alarming on oxygen saturation and pulse rate limit violation. Temperature (tympanic) Measurement of temperature within 0.3C. Toco extern Toco intern (IUP) Alarming on temperature limit violation. Measurement of the external Toco 5 units on display and recorder

(with paper adjusted). Measurement of the internal Toco within specified accuracy limits on display and recorder (with paper adjusted). Abdominal uterine EMG: aToco No aToco gaps greater than 30 s, no aToco error larger than 20% of Ultrasound full scale for more than 30 s. No interruption of the transmissions mode. Measurement of the fetal heart rate 5 bpm on display and recorder

(with paper adjusted). Ultrasound energy within safe limits for continuous operation:

p_ < 1 MPa, Iob < 20 mW/cm2, Ispta < 100 mW/cm2. When operating under transient electromagnetic phenomena according to IEC 60601-1-2, either at least the performance listed in the following table is provided or failure to provide this performance is readily identifiable by the user. For example, identifiers are technical alarms, no waveforms and/or numeric values, complete failure of the monitor, readily identifiable distorted signals, and so on. The following are transient electromagnetic phenomena according to IEC 60601-1-2:

Electrostatic Discharge (ESD) Electrical Fast Transients/Bursts Surges Voltage interruptions Measurement Essential Performance All 298 After electrostatic discharge, fast transients/bursts, and surges, the equipment returns to previous operation mode within 30 seconds without operator intervention and without loss of any stored data. After voltage interruptions the equipment returns to previous operating mode without operator intervention and without loss of any stored data. 30 Specifications and Standards Compliance Fetal Monitors Fetal Monitor Performance Specifications Alarm Signal System alarm delay. The system alarm delay is the processing time the system needs for any alarm to be indicated on the fetal monitor, after the measurement has triggered the alarm. less than 4 seconds Pause duration Extended alarm pause Sound pressure range Review Alarms Information Real time Clock Capacity Range Accuracy Hold Time Buffered Memory Hold Time 1, 2, 3 minutes or infinite, depending on the configuration 5 to 10 minutes min. 0 dB(A) max. 45-85 dB(A) all alarms/INOPs, main alarms on/off, alarm silence and time of occurrence 300 items from: January 1, 1997, 00:00 to:

December 31, 2080, 23:59 better than 1 min. per month infinite if powered by AC; otherwise at least 48 hours (typical: >72 hours) infinite if powered by AC without power: at least 8 hours Contents active settings, review alarms, stored trace data Battery Specifications Performance Specifications Avalon FM20/30 Battery Option #E25 Operating Time (with new, fully charged battery) Charge Time Performance Specification Avalon CL Transducer Battery Operating time Charge time Basic monitoring configuration: >2 hours

(Display Brightness: 70%, Recorder: On at 3 cm/min, NBP: Auto Mode at 15 min, 2 US Transducers, 1 Toco+ with MECG, 1 Patient Module with DECG) When monitor is off: approx. 6 hours When monitor is in use: more than 10 hours (depending on monitor configuration) With a new and fully charged battery min. 10 hours From a low battery indication to a fully charged indication <3 hours Charge time with Avalon FM20/30 Battery Option #E25 From a low battery indication to a fully charged indication >6 hours 299 30 Specifications and Standards Compliance Performance Specification Avalon CL F&M Battery Operating time With a new and fully charged battery min. 16 hours Charge time From a low battery indication to a fully charged indication <3 hours Charge time with Avalon FM20/30 Battery Option #E25 From a low battery indication to a fully charged indication >6 hours Performance Specification Avalon CL Wide Range Pod Battery Operating time Charge time Fetal / Maternal Specifications Ultrasound With a new and fully charged battery min. 4 hours From a low battery indication to a fully charged indication <3 hours Complies with IEC 60601-2-37:2007+A1:2015/ EN 60601-2-37:2008 Performance Specifications Ultrasound Measurement Method Measurement Range Resolution Jitter @ 200 bpm US Intensity (867246) US Display Printer Ultrasound Pulse Doppler 50-240 bpm 1 bpm 1/4 bpm 3 bpm Average output power P = (12.4 0.4) mW Peak-negative acoustic pressure Output beam intensity (Iob)

(= spatial average - temporal average intensity) p_ = (49.1 5.2) kPa Isata = (2.77 0.56) mW/cm2 Spatial-peak temporal average intensity Effective radiating area @ -12 dB Ispta = (21.1 5.1) mW/cm2 A-12dB = (4.47 0.89) cm2 Thermal index (TI) and mechanical index (MI) are always below 1.0. US Intensity (M2736A/AA) Average output power P = (7.4 0.4) mW Peak-negative acoustic pressure Output beam intensity (Iob)

(= spatial average - temporal average intensity) p_ = (40.4 4.3) kPa Isata = (2.38 0.59) mW/cm2 Spatial-peak temporal average intensity Effective radiating area @ -12 dB Ispta = (15.0 3.2) mW/cm2

(3.11 0.74) cm2 Thermal index (TI) and mechanical index (MI) are always below 1.0. 300 30 Specifications and Standards Compliance Performance Specifications US Intensity CL (866076) Average output power P = (12.4 0.4) mW Peak-negative acoustic pressure Output beam intensity (Iob)

(= spatial average - temporal average intensity) p_ = (49.1 5.2) kPa Isata = (2.77 0.56) mW/cm2 Spatial-peak temporal average intensity Effective radiating area @ -12 dB Ispta = (21.1 5.1) mW/cm2 A-12dB = (4.47 0.89) cm2 Thermal index (TI) and mechanical index (MI) are always below 1.0. Signal Quality Indication Poor Quality Acceptable Quality Good Quality Beat-to-Beat change (max.) for Ultrasound empty half-full full 28 bpm US Frequency US Signal range US Burst FMP Signal Range @ 33 Hz Toco Performance Specifications Toco Measurement Method Resolution Sensitivity Measurement Range Signal Range Maximum Offset Range Baseline Setting Auto Offset Correction Auto Zero Adjust Performance Specifications Maternal Pulse from Toco Emitted Light Energy Wavelength Range Range Repetition Rate Duration 1 MHz 100 Hz 3.5 Vpp-350 Vpp @ 200 Hz 3.0 kHz 100 s 200 Vpp-40 mVpp Strain Gauge Sensor Element 1/4 unit 1 unit = 2.5 g 400 units 0-127 units

-300 units 20 units 3 seconds after connecting the transducer, the Toco value is set to 20 units Toco value is set to zero following a negative measurement value for 5 seconds 15 mW 780-1100 nm 40-240 bpm 301 30 Specifications and Standards Compliance Performance Specifications Resolution Accuracy Update Rate IUP Performance Specifications IUP Measurement Method Measurement Range Resolution Signal Range Sensitivity Offset Compensation 1 bpm 2% or 1 bpm, whichever is greater every 4 seconds Passive Resistive Strain Gauge Elements

-100-+300 mmHg 1/4 mmHg

-99-127 mmHg or (-13.2-16.9 kPa) 5 V/V/mmHg

+100- -200 mmHg Accuracy (not including sensor accuracy) 0.5% per 100 mmHg Auto Offset Correction 3 seconds after connecting the transducer, the IUP value is set to 0 mmHg ECG Complies with IEC 60601-2-27:2011+AC:2012/ EN 60601-2-27:2014 except clauses listed below:

201.6.2, 201.8.5.5 201.12.1.101 202.6.2.101 Performance Specifications ECG Performance Specifications Type DECG MECG Display Recorder Measurement Range Resolution Wave Speed (Global Speed) Accuracy Beat-to-Beat change (max.) Single Lead ECG (derived from Fetal Scalp Electrode) Single Lead ECG (derived from RA and LA electrodes) 30-240 bpm 1 bpm (display update rate 1 per second) 1/4 bpm 6.25 mm/sec, 12.5 mm/sec, 25 mm/sec, 50 mm/sec 1 bpm or 1%, whichever is greater (non-averaging) MECG: 28 bpm DECG: 28 bpm (with Artifact Suppression On) Differential Input Impedance Electrode Offset Potential Tolerance INOP Auxiliary Current (Leads Off Detection)

>15M 400 mV

<100 A 302 30 Specifications and Standards Compliance Performance Specifications Input Signal Range Dielectric Strength Defibrillator Protection ESU Protection Paced pulse detection WARNING DECG MECG 20 Vpp-6 mVpp 150 Vpp-6 mVpp 1500 Vrms None None None The fetal/maternal monitor is not a diagnostic ECG device. In particular, the display of fetal/maternal ECG is intended only for evaluating signal quality for fetal/maternal heart rate as derived from the ECG waveform. When in doubt, it can be used to identify sources of compromised signal quality, such as noise or muscle artifacts. It can subsequently be used to verify the result of measures taken to resolve them (e.g., checking ECG cable connections or adapting the fetal ArtifactSuppress configuration). The safety and effectiveness of the displayed fetal/maternal ECG waveform (i.e., P, QRS, and T segments) for evaluation of fetal/maternal cardiac status during labor have not been evaluated. Fetal Heart Rate (Ultrasound/DECG) Alarm Specifications FHR Alarm Limits Range Bradycardia (low limit) Tachycardia (high limit) FHR Alarm Delay Range Bradycardia (low limit) Delay 60-200 bpm adjustable in 10 bpm steps Default: 110 bpm 70-210 bpm adjustable in 10 bpm steps Default: 170 bpm 10-300 seconds in steps of 10 seconds + system alarm delay Default: 240 seconds Tachycardia (high limit) Delay 10-300 seconds in steps of Signal Loss Delay 10 seconds + system alarm delay Default: 300 seconds 10-30 seconds in steps of 10 seconds + system alarm delay 303 30 Specifications and Standards Compliance MECG Alarm Specifications Range Adjustment Alarm Delay MECG Alarm Limits High Range: 31-240 bpm Default: 120 bpm Low Range: 30-235 bpm Default: 50 bpm 1 bpm steps (30-40 bpm) 5 bpm steps (40-240 bpm) System alarm delay (see Fetal Monitors on page 299). Extreme Tachycardia Difference to high limit: 0-50 bpm 5 bpm steps Default: 20 bpm Clamping at: 150-240 bpm 5 bpm steps Default: 200 bpm Extreme Bradycardia Difference to low limit: 0-50 bpm 5 bpm steps Default: 20 bpm Clamping at: 30-100 bpm 5 bpm steps Default: 40 bpm Maternal ECG Supplemental Information as required by IEC 60601-2-27 Heart Rate Averaging Method The maternal heart rate is computed by averaging the 12 most recent R-R intervals. If each of three consecutive R-R intervals is greater than 1200 ms (i.e. rate less than 50 bpm), then the four most recent R-R intervals are averaged to compute the HR. Display Update Rate 2 seconds Ventricular tachycardia alarm for waveforms B1 and B2 No heart rate is detected for waveforms B1 and B2, resulting in *** Extreme Brady alarm Tall T-Wave Rejection Capability M2735A 1.2 mV T-Wave amplitude Response Time of Heart Rate meter to Change in Heart Rate M2738A CL Toco+ MP, CL ECG/IUP 867245 867247 867249 1.4 mV T-Wave amplitude 1.2 mV T-Wave amplitude 1.2 mV T-Wave amplitude M2735A, M2738A HR change from 80-120 bpm Average: 12 seconds CL Toco+ MP, CL ECG/IUP 867245 867247 867249 HR change from 80-40 bpm Average: 15 seconds HR change from 80-120 bpm Average: 10 seconds HR change from 80-40 bpm Average: 12 seconds HR change from 80-120 bpm Average: 11 seconds HR change from 80-40 bpm Average: 13 seconds 304 Maternal ECG Supplemental Information as required by IEC 60601-2-27 30 Specifications and Standards Compliance Heart Rate Meter Accuracy and Response to Irregular Rhythm M2735A, M2738A Ventricular bigeminy 40-60 bpm CL Toco+ MP, CL ECG/IUP 867245 867247 867249 Slow alternating ventricular bigeminy 45 bpm Rapid alternating ventricular bigeminy 163 bpm Bidirectional systoles 63-73 bpm Ventricular bigeminy 40-60 bpm Slow alternating ventricular bigeminy 30 bpm Rapid alternating ventricular bigeminy 70-163 bpm Bidirectional systoles 63-73 bpm Ventricular bigeminy 64-97 bpm Slow alternating ventricular bigeminy 93 bpm Rapid alternating ventricular bigeminy 92-138 bpm Bidirectional systoles 57-67 bpm aFHR, aHR, aToco aFHR Measurement Method Measurement Range Resolution Accuracy aHR Measurement Method Measurement Range Resolution Accuracy aToco Measurement Method Measurement Range Signal Range Accuracy Display Printer Display Printer electrocardiography 60-240 bpm 1 bpm 1/4 bpm 1 bpm electrocardiography 40-240 bpm 1 bpm 1/4 bpm 1 bpm uterine electromyography 0-500 V 0-100 units 5%

305 30 Specifications and Standards Compliance Noninvasive Blood Pressure Complies with IEC 80601-2-30:2009 + A1:2013 / EN 80601-2-30:2010 + A12015. Performance Specifications Measurement Ranges Systolic Diastolic Mean Accuracy 1 30-270 mmHg (4-36 kPa) 10-245 mmHg (1.5-32 kPa) 20-255 mmHg (2.5-34 kPa) Max. Std. Deviation: 8 mmHg (1.1 kPa) Max. Mean Error: 5 mmHg (0.7 kPa) Pulse Rate Range 40-300 bpm Accuracy (average over noninvasive blood pressure measurement cycle) 40-100 bpm: 5 bpm 101-200 bpm: 5% of reading 201-300 bpm: 10% of reading Measurement Time Typical at HR >60 bpm Cuff Inflation Time Initial Cuff Inflation Pressure Auto Mode Repetition Times Venipuncture Mode Inflation Inflation Pressure Automatic deflation after Auto/manual: 30 seconds (adult) Maximum time: 180 seconds (adult) Typical for normal adult cuff: Less than 10 seconds 165 15 mmHg 1, 2, 2.5, 3, 5, 10, 15, 20, 30, 45, 60, or 120 minutes 20-120 mmHg (3-16 kPa) 170 seconds

*1: Clinical investigation with the auscultatory reference method The 5th Korotkoff sound (K5) was used to determine the diastolic reference pressures. The approximation MAP = (2*DIA + SYS) / 3 was used to calculate reference MAP (mean arterial pressure) values from the systolic and diastolic reference pressures. Alarm Specifications Range Adjustment Alarm Delay Systolic Diastolic Mean Adult: 30-270 mmHg (4-

36 kPa) 10-30 mmHg: 2 mmHg (0.5 kPa)

>30 mmHg: 5 mmHg (1 kPa) Adult: 10-245 mmHg (1.5-

32 kPa) Adult: 20-255 mmHg (2.5-

34 kPa) System alarm delay (see Fetal Monitors on page 299). Overpressure Settings

> 300 mmHg (40 kPa) > 2 sec Adjustment not user adjustable 306 30 Specifications and Standards Compliance SpO2 Complies with ISO 80601-2-61:2011 / EN ISO 80601-2-61:2011. Measurement Validation: The SpO2 accuracy has been validated in human studies against arterial blood sample reference measured with a CO-oximeter. Pulse oximeter measurements are statistically distributed, only about two-thirds of the measurements can be expected to fall within the specified accuracy compared to CO-oximeter measurements. Display Update Period: Typical: 2 seconds, maximum: 30 seconds. Maximum with noninvasive blood pressure INOP suppression on: 60 seconds. SpO2 Performance Specifications Range Accuracy SpO 2 The specified accuracy is the root-mean-square

(RMS) difference between the measured values and the reference values 0-100%

Philips Reusable Sensors:

M1191A/B, M1191AL/BL, M1191ANL, M1192A, M1192AN = 2%

(70%-100%) M1191T, M1192T, M1194A, M1194AN, M1196A, M1196T = 3%

(70%-100%) Philips Disposable Sensors with M1943A(L):

M1131A, M1901B, M1903B, M1904B = 3% (70%-100%) M1133A, M1134A = 2% (70%-100%) Nellcor Sensors with M1943A(L):

MAX-A, MAX-AL, MAX-P, MAX-N, D-25, D-20, N-25, OxiCliq A, P, N = 3% (70%-100%) Masimo Reusable Sensors with LNOP MP12 or LNC MP10:

LNOP DC-I, LNOP DC-IP, LNOP YI, LNCS DC-I, LNCS DC-IP:

2% (70%-100%) LNOP TC-I, LNCS TC-I: 3.5% (70%-100%) Masimo Disposable Sensors with LNOP MP12 or LNC MP10:

LNOP Adt, LNOP Adtx, LNOP Pdt, LNOP Pdtx, LNCS Adtx, LNCS Pdtx: 2% (70%-100%) LNOP Neo-L, LNCS Neo-L: 3% (70%-100%) Pulse Resolution Range Accuracy Resolution 1%

30-300 bpm 2% or 1 bpm, whichever is greater 1 bpm Sensors Wavelength range 500-1000 nm Information about the wavelength range can be especially useful to clinicians (for instance, when photodynamic therapy is performed). Pulse Oximeter Calibration Range 70%-100%

Emitted Light Energy 15 mW SpO2 Alarm Specifications Range Adjustment Delay SpO 2 Desat 50-100%

50-Low alarm limit 1% steps 1% steps

(0, 1, 2, 3, ... 30) +

4 seconds 307 30 Specifications and Standards Compliance SpO2 Alarm Specifications Range Pulse 30-300 bpm Adjustment Delay 1 bpm steps (30-40 bpm) 5 bpm steps (40-300 bpm) max. 14 seconds Tachycardia Difference to high limit 0-50 bpm 5 bpm steps max. 14 seconds Clamping at 150-300 bpm 5 bpm steps Bradycardia Difference to low limit 0-50 bpm 5 bpm steps max. 14 seconds Clamping at 30-100 bpm 5 bpm steps Tympanic Temperature Complies with:

EN 12470-5 (Clinical thermometers - Part 5:2003: Performance of infra-red thermometers) ASTM E1965-98 (Infrared Thermometers for Intermittent Determination of Patient Temperature) with minor exceptions as noted below. The fetal monitor additionally complies with ISO 80601-2-56:2017 / EN ISO 80601-2-56:2017. Performance Specifications Temperature Resolution Response Time 0.1C or 0.1F less than 2 seconds Temperature Calibrated Accuracy Specifications (out of the Factory) Ambient Temperature Target Temperature Accuracy 25.0C (77.0F) 37.7C-38.9C (98.4F-102.0F) 0.1C (0.2F) 16.0C-33.0C (60.8F-91.4F) 33.0C-42.0C (91.4F-107.6F) 0.2C (0.4F) Temperature Calibrated Accuracy Specifications (after recalibration using Genius 2 Checker/Calibrator) Ambient Temperature Target Temperature Accuracy 16.0C-33.0C (60.8F-91.4F) 36.0C-39.0C (96.8F-102.2F) 0.2C (0.4F) 16.0C-33.0C (60.8F-91.4F)

<36.0C or >39.0C

(<96.8F or >102.2F) 0.3C (0.5F) ASTM laboratory requirement for IR thermometers in the display range 37.0C-39.0C (98.0F-102.0F) is 0.2C

(0.4F), whereas for mercury-in-glass and electronic thermometers, the requirement per ASTM standards E667-86 and E1112-86 is 0.1C (0.2F). Clinical accuracy characteristics and procedures are available from Covidien llc on request. To verify the accuracy, use a certified black body as specified in EN ISO 80601-2-56, Annex C, or use a Genius 2 Checker/Calibrator - available from Covidien llc under part number 303097. Clinical repeatability: meets section A.5 of EN ISO 80601-2-56(E) per Covidien llc technical report. Data is available from Covidien llc on request. Displayed Temperature Measurement Range Mode Ear Oral (ear + 0.6C) 308 Range C 33.0-42.0C 33.6-42.0C Range F 91.4-107.6F 92.5-107.6F 30 Specifications and Standards Compliance Displayed Temperature Measurement Range Mode Core (ear + 1.04C) Rectal (ear + 1.16C) Range C 34.0-42.0C 34.2-42.0C Caution: ASTM E1965-98 specifies 34.4C-42.2C (94F-108F) Ambient Temperature Range Mode Operating 10%-95% RH, non-

condensing Range C 16.0-33.0C Range F 93.2-107.6F 93.6-107.6F Range F 60.8-91.4F Storage up to 95% RH, non-condensing -25.0-55.0C

-13.0-131.0F Caution: EN ISO 80601-2-56 specifies 16.0C-35.0C (60.8F-95.0F), 10%-95% RH, non-condensing ASTM E1965-98 specifies 16.0C-40.0C (60.8F-104.0F), up to 95% RH, non-condensing Storing the thermometer outside the specified temperature/humidity range might adversely affect measurement accuracy. Check the calibration after storage in uncertain conditions. Tympanic Temperature Alarm Specifications Range Adjustment 33.0C-42.0C (91.0F-108.0F) 0.5C steps (33.0C-35.0C) 0.1C steps (35.0C-42.0C) 1.0F steps (91.0F-95.0F) 0.2F steps (95.0F-108.0F) Alarm delay System alarm delay (see Fetal Monitors on page 299). Physical Specifications Thermometer Dimensions Cable length 187 x 44 x 71 mm (7.4 x 1.7 x 2.8 in) spiral cable relaxed: 600 mm (23.6 in) spiral cable extended: 2500 mm (98.4 in) Weight (including cable) 0.2 kg (0.4 lbs) Ingress protection classification IP 21 Base Station Dimensions 205 x 65 x 78 mm (8.2 x 2.5 x 3.1 in) Weight (excluding cable) 0.3 kg (0.7 lbs) 309 30 Specifications and Standards Compliance Recorder Specifications Built-in Thermal Array Fetal Trace Recorder Mechanism Paper & Printing Thermal Array Recorder Type Standard Z-fold paper Standard Speeds (real-time traces) 3 cm/min, 2 cm/min, 1 cm/min Fast Print Speed (stored traces) ECG Wave Print Speed

(not real-time) Paper Advance Sensing Max. 20 mm/s Print speed is variable and depends on the print load Emulated 25 mm/s Print speed is variable and depends on the print load 20 mm/s Optical Reflex Sensor for black page marks Accuracy @ 3 cm/min, 2 cm/min, 1 cm/min 5 mm/page Usable Print Width Resolution 128 mm 8 dots/mm (200 dpi) Time Delay to see trace on paper

<30s @ 1 cm/min Trace Separation Offset for FHR

(Ultrasound and DECG) Twin Standard Classic Triplet Standard FHR2 +20 bpm FHR1 +20 bpm in the presence of FHR2 FHR2 +20 bpm FHR3 -20 bpm Classic FHR1 +20 bpm FHR3 -20 bpm in the presence of FHR2 and/or FHR3 External Displays: FM40/FM50 Only External displays can be connected with a maximum cable run of 10 m. External displays must be approved for medical use (IEC 60601-1). The video output of the Avalon FM40/FM50 has VGA resolution. 310 30 Specifications and Standards Compliance Manufacturer's Information You can write to Philips at this address:

Philips Medizin Systeme Bblingen GmbH Hewlett-Packard-Str. 2 71034 Bblingen Germany Visit our website at: www.healthcare.philips.com Copyright 2020. Koninklijke Philips N.V. All Rights Reserved. Australia Sponsor Philips Electronics Australia Ltd 65 Epping Road North Ryde, NSW Australia 2113 Importer for European Union For all Philips branded products used with the Avalon Fetal Monitors, if not manufactured by Philips Medizin Systeme Bblingen GmbH, the Importer in the European Union is:

Trademark Acknowledgment OxisensorTM II, Oxi-CliqTM, and OxiMaxTM are trademarks of Tyco Healthcare Group LP, Nellcor Puritan Bennett Division. 311 30 Specifications and Standards Compliance Regulatory and Standards Compliance The fetal monitors and their current class IIa/b accessories are in conformity with the requirements of the European Medical Devices Directive 93/42/EEC and bear the CE marking:

The current class I accessories for fetal monitors are in conformity with the requirements of the European Medical Devices Directive 93/42/EEC and bear the CE marking:

The Avalon CL Transducer System is in conformity with the requirements of the European Radio Equipment Directive 2014/53/EU. The Avalon CL base station used in this system is class 1 and the Avalon CL transducers of this system are class 1 under the scope of the RED Directive. To obtain a copy of the original Declaration of Conformity, please contact Philips at the address given in the Manufacturer's Information on page 311 section of this manual. The following products do not meet the requirements of the IEC 60601-1-2:2014 / EN 60601-1-2:2015. They are no longer presumed to comply with the corresponding essential requirements of the Medical Device Directive 93/42/EEC. Therefore shipped after December 31, 2018 they no longer carry the CE marking accordingly. Toco+Transducer (M2735A) Toco MP Transducer (M2734B) Ultrasound Transducer (M2736A/AA) Patient Module (M2738A) Safety and Performance The fetal monitors comply with the following major international safety and performance standards:

IEC 60601-1:2005+A1:2012 / EN 60601-1:2006+A1:2013 IEC 60601-1-6:2010+A1:2013 / EN 60601-1-6:2010+A1:2015 IEC 60601-1-8:2006+A1:2012 / EN 60601-1-8:2007+A1:2013 IEC 60601-2-49:2011 / EN 60601-2-49:2015 ANSI/AAMI ES60601-1:2005+A1:2012+C1:2009/2012+A2:2010/2012 CAN/CSA C22.2#60601-1-14 JIS T 1303 2005 The possibility of hazards arising from hardware and software errors was minimized in compliance with ISO 14971:2007/EN ISO 14971:2012, and IEC 60601-1:2005+A1:2012 / EN 60601-1:2006+A1:2013. Alarm sounds are compliant with standard IEC 60601-1-8:2006+A1:2012 / EN 60601-1-8:2007+A1:2013. Compatibility When your fetal monitor is compliant with IEC 60601-1:1988+A1:1991+A2:1995 / EN 60601-

1:1990+A1:1993+A2:1995 (Edition 2) and related standards, it can still be used with the Avalon CL Transducer System and the software upgrade J.3 or higher, and all measurement accessories that are compliant with IEC 60601-1:2005+A1:2012 / EN 60601-1:2006+A1:2013 (Edition 3) and related standards. When your fetal monitor is compliant with IEC 60601-1:2005+A1:2012 / EN 60601-1:2006+A1:2013

(Edition 3) and related standards, it can still be used with the Avalon CTS Transducer System, and all measurement accessories that are compliant with IEC 60601-1:1988+A1:1991+A2:1995 /

EN 60601-1:1990+A1:1993+A2:1995 (Edition 2) and related standards. 312 Radio The Avalon CL Transducer System complies with the following major international radio standards:

30 Specifications and Standards Compliance ETSI EN 300 220-1:2017 ETSI EN 300 220-2:2017 ETSI EN 300 328:2016 FCC 47 CFR Part 95 FCC 47 CFR Part 2 & 15 IC RSS-210 Issue 8 ARIB STD-T108 ARIB STD-T66 AS/NSZ 4268 Safety Tests Fetal Monitor All the safety tests and procedures required after an installation, or an exchange of system components are described in your monitor's Service Guide. These safety tests are derived from international standards, but may not be sufficient to meet local requirements. WARNING Do not use additional AC mains extension cords or multiple portable socket-outlets. If a multiple portable socket-outlet is used, the resulting system must be compliant with IEC 60601-

1:2005+A1:2012 / EN 60601-1:2006+A1:2013. Do not connect any devices that are not supported as part of a system. Do not use a device in the patient vicinity if it does not comply with IEC 60601-1:2005+A1:2012 /

EN 60601-1:2006+A1:2013. The whole installation, including devices outside of the patient vicinity, must comply with IEC 60601-1:2005+A1:2012 / EN 60601-1:2006+A1:2013. Any non-medical device, including a PC running an OB TraceVue/IntelliSpace Perinatal system, placed and operated in the patient's vicinity must be powered via a separating transformer (compliant with IEC 60601-1:2005+A1:2012 / EN 60601-1:2006+A1:2013) that ensures mechanical fixing of the power cords and covering of any unused power outlets. Do not use USB devices with own power supplies, unless an appropriate separation device is used,

(either between USB interface and device or between device and power). During the installation the fetal monitor is configured for your environment. This configuration defines your custom default settings you work with when you switch on your fetal monitor. See the fetal monitor's Service Guide and the Configuration Guide for details on how to configure your fetal monitor. Electromagnetic Compatibility (EMC) The device and its accessories, except the Avalon Fetal Toco+Transducer (M2735A), Toco MP Transducer (M2734B), Ultrasound Transducer (M2736A/AA), the Patient Module (M2738A), the IntelliVue CL NBP Pod (865216), and the IntelliVue CL SpO2 Pod (865215), listed in the accessories section, comply with the following EMC standards:

IEC 60601-1-2:2014 / EN 60601-1-2:2015 Take special precautions regarding electromagnetic compatibility (EMC) when using medical electrical equipment. You must operate your monitoring equipment according to the EMC information provided in this book. Before using the device, assess the electromagnetic compatibility of the device with surrounding equipment. 313 30 Specifications and Standards Compliance This ISM device complies with Canadian ICES-003:2012. Cet appareil ISM est conforme la norme NMB-

003 du Canada. CAUTION FM20/FM30 only: Although this is an electrical Class II device, it has a protective earth conductor which is needed for EMC purposes. Always use the supplied power cord with the three-prong plug to connect the monitor to AC mains. Never adapt the three-prong plug from the power supply to fit a two-slot outlet. WARNING The use of accessories, transducers, and cables other than those specified, may result in increased electromagnetic emissions, or decreased electromagnetic immunity of the device. WARNING Do not use cordless/mobile phones, or any other portable RF communication system within the patient vicinity, or within a 1.0 m radius of any part of the fetal monitoring system. WARNING For paced patients: The radiated SRR power of the CL SpO2 and CL NBP Maternal Cableless Measurement Devices, and other sources of radio-frequency energy, when used in very close proximity of a pacemaker, might be sufficient to interfere with pacemaker performance. Due to shielding effects of the body, internal pacemakers are somewhat less vulnerable than external pacemakers. However, caution should be exercised when monitoring paced patients. In order to minimize the possibility of interference, avoid positioning and wearing the Cableless Measurement Devices in very close proximity to a pacemaker. Consult the pacemaker manufacturer for information on the RF susceptibility of their products. CAUTION High power radars are allocated as primary users (meaning they have priority) of the bands 5250-5350 MHz and 5650-5850 MHz and these radars could cause interference and/or damage to LE-LAN devices. NOTE Based on their emission characteristics, the Avalon FM40/FM50 and Avalon CL system are suitable for use in hospitals only (CISPR 11 class A). If they are used in a residential environment (for which CISPR 11 class B is usually required), these monitors might not offer adequate protection to radio frequency communication services. You might need to take mitigation measures, such as relocating or reorienting the equipment. 314 30 Specifications and Standards Compliance EMC Testing CAUTION Fetal parameters, especially ultrasound and ECG, are sensitive measurements involving small signals, and the monitoring equipment contains very sensitive high gain front-end amplifiers. Immunity levels for radiated RF electromagnetic fields and conducted disturbances induced by RF fields are subject to technological limitations. To ensure that external electromagnetic fields do not cause erroneous measurements, it is recommended to avoid the use of electrically radiating equipment in close proximity to these measurements. Reducing Electromagnetic Interference WARNING The device should not be used adjacent to, or stacked with, other equipment unless otherwise specified. The product and associated accessories can be susceptible to interference from continuous, repetitive, power line bursts, and other RF energy sources, even if the other equipment is compliant with EN 60601-1-2 emission requirements. Examples of other sources of RF interference are other medical electrical devices, cellular products, information technology equipment, and radio/television transmissions. When electromagnetic interference (EMI) is encountered, for example, if you can hear spurious noises on the fetal monitor's loudspeaker, attempt to locate the source. Assess the following:

Is the interference due to misplaced or poorly applied transducers? If so, re-apply transducers correctly according to directions in this book, or in the Instructions for Use accompanying the accessory. Is the interference intermittent or constant?

Does the interference occur only in certain locations?

Does the interference occur only when in close proximity to certain medical electrical equipment?

Once the source is located, there are a number of things that can be done to mitigate the problem:

1 Eliminating the source. Turn off or move possible sources of EMI to reduce their strength. 2 Attenuating the coupling. If the coupling path is through the patient leads, the interference may be reduced by moving and/or rearranging the leads. If the coupling is through the power cord, connecting the system to a different circuit may help. 3 Adding external attenuators. If EMI becomes an unusually difficult problem, external devices such as an isolation transformer or a transient suppressor may be of help. Your service provider can be of help in determining the need for external devices. Where it has been established that electromagnetic interference is affecting physiological parameter measurement values, a physician, or a suitably qualified person authorized by a physician, should determine if it will negatively impact patient diagnosis or treatment. System Characteristics The phenomena discussed above are not unique to this system, but are characteristic of fetal patient monitoring equipment in use today. This performance is due to very sensitive high gain front end amplifiers required to process the small physiological signals from the patient. Among the various monitoring systems already in clinical use, interference from electromagnetic sources is rarely a problem. 315 30 Specifications and Standards Compliance Radio Compliance Notice CAUTION High power radars are allocated as primary users (meaning they have priority) of the bands 5250-5350 MHz and 5650-5850 MHz and these radars could cause interference and/or damage to LE-LAN devices. Avalon CL with WMTS Operation of this equipment requires the prior coordination with a frequency coordinator designated by the FCC for the Wireless Medical Telemetry Service. This device complies with Part 15 of the FCC Rules and RSS-210 of Industry Canada. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Any changes or modifications to this equipment not expressly approved by Philips Medical Systems may cause harmful radio frequency interference and void your authority to operate this equipment. Radio Information Canada Installation of this telemetry device is permitted in hospitals and health care facilities only. This device shall not be operated in mobile vehicles (including ambulances and other vehicles associated with health care facilities). The installer/user of this device shall ensure that it is at least 80 km from the Dominion Radio Astrophysical Observatory (DRAO) near Penticton, British Columbia. The coordinates of DRAO are:

latitude N 49E 19' 15", longitude W 119 37 12. For medical telemetry systems not meeting this 80 km separation (e.g. the Okanagan Valley, British Columbia) the installer/user must coordinate with, and obtain the written concurrence of, the Director of DRAO before the equipment can be installed or operated. The Director of DRAO may be contacted at 250-497-2300 (telephone) or 250-497-2355 (fax). (Alternatively, the Manager, Regulatory Standards, Industry Canada, may be contacted.) Le prsent appareil est conforme aux CNR d'Industrie Canada applicables aux appareils radio exempts de licence. L'exploitation est autorise aux deux conditions suivantes: (1) l'appareil ne doit pas produire de brouillage, et (2) l'utilisateur de l'appareil doit accepter tout brouillage radiolectrique subi, mme si le brouillage est susceptible d'en compromettre le fonctionnement. L'utilisation de cet appareil de tlmesure est permise seulement dans les hpitaux et tablissements de soins de sant. Cet appareil ne doit pas tre mis en marche dans des vhicules (y compris les ambulances et autres vhicules associs aux tablissements de sant). La personne qui installe/utilise cet appareil doit sassurer quil se trouve au moins 80 km de lObservatoire fdral de radioastrophysique (OFR) de Penticton en Colombie-Britannique. Les coordonnes de lOFR sont: latitude N 49 19 15, longitude O 119 37 12 . La personne qui installe/utilise un systme de tlmesure mdicale ne pouvant respecter cette distance de 80 km (p. ex. dans la valle de lOkanagan (Colombie-Britannique), doit se concerter avec le directeur de lOFR et obtenir de sa part une autorisation crite avant que lquipement ne puisse tre install ou mis en marche. Le directeur de l OFR peut tre contact au 250-497-2300 (tl.) ou au 250-497-2355 (tlcopieur). (Le Directeur des Norm es rglementaires dIndustrie Canada peut galement tre contact). CAUTION High power radars are allocated as primary users (meaning they have priority) of the bands 5250-5350 MHz and 5650-5850 MHz and these radars could cause interference and/or damage to LE-LAN devices. 316 Avalon CL with T108 Japanese Radio Law and Japanese Telecommunications Business Law Compliance. 30 Specifications and Standards Compliance This device should not be modified (otherwise the granted designation number will become invalid). Radio Frequency Radiation Exposure Information The radiated output power of the Avalon CL Transducer System is far below the FCC radio frequency exposure limits. CL Wide Range Pod For body worn operation, this device has been tested and meets FCC RF exposure guidelines when used in the standard configuration with the rear side towards the body, without a gap. Alternatively, it can be used with any accessory that positions the front side of the device a minimum of 10 mm from the body. The accessory itself must not contain any metal parts. Use of other accessories may not ensure compliance with FCC RF exposure guidelines. Nevertheless it is strongly recommended to operate the CL Wide Range Pod with the rear side towards the body to achieve best possible radio performance. Environment Before operation, make sure that the fetal monitor is free from condensation. This can form when equipment is moved from one building to another, and is exposed to moisture and differences in temperature. Use the monitor in an environment which is reasonably free from vibration, dust, corrosive or explosive gases, extremes of temperature, humidity, and so forth. It operates within specifications at ambient temperatures between 0-+45C (32F-113F). Ambient temperatures that exceed these limits can affect the accuracy of the system, and can damage the components and circuits. Ambient temperature ranges for storage are -20C-+60C (-4F-140F) for the monitor, and -40C-+60C

(-40F-140F) for transducers. The transducers are watertight to a depth of 1.0 m for at least five hours (rated IP 68). WARNING Leakage currents: If several items of equipment used to monitor a patient are interconnected, the resulting leakage current may exceed allowable limits. ECG electrodes: NEVER allow ECG electrodes to contact other electrical conductive parts, including earth. Explosion Hazard: Do not use in the presence of flammable anesthetics, such as a flammable anesthetic mixture with air, oxygen, nitrous oxide, or in oxygen rich environment. Use of the devices in such an environment may present an explosion hazard. 317 30 Specifications and Standards Compliance Monitoring After a Loss of Power If the monitor is without power for less than one minute, monitoring will resume with all active settings unchanged. If the monitor is without power for more than one minute, the behavior depends on your configuration. If Automat. Default is set to Yes, the User Defaults will be loaded when power is restored. If Automat. Default is set to No, all active settings are retained, if power is restored within 48 hours. The Automat. Default setting is made in Configuration Mode. When power is lost - no power is available from the AC power source, or from the battery - a beeper will sound. The tone can be silenced by pressing the On/Standby button. FM20/30 with Battery Option, FM40/50 ESU, MRI, and Defibrillation WARNING The fetal/maternal monitors are NOT intended for use during defibrillation, electro-surgery, or MRI. Remove all transducers, sensors, and accessories before performing electro-surgery, defibrillation, or MRI, otherwise harm to the patient or the user can result. Symbols Symbols on the System These symbols can appear on the monitor and its associated equipment and packaging. Symbols This safety symbol indicates that you have to consult the Instructions for Use (this document), and particularly any warning messages. The symbol can be also printed out black and white. This safety symbol indicates that you have to consult the Instructions for Use (this document), and particularly any warning messages. The symbol can be also printed out black and white. This symbol indicates that you have to consult the Instructions for Use (this document). Equipotential grounding point (FM40/

FM50) Type CF equipment, not defibrillation proof Type BF 318 Operating instructions should be considered when operating the device. Indicates that IfU is available in electronic form at www.philips.com/IFU Prescription use only Protective earth terminal (FM40/FM50) Electrical Class II equipment, in which the protection against electric shock relies on double or reinforced insulation (FM20/

FM30) It is unsafe to use the device in MR environments. The symbol can be also printed out black and white. Symbols IP X1 IP 31 IP 67 30 Specifications and Standards Compliance Symbol indication for non-ionizing radiation Temperature limitations Humidity limitations Atmospheric pressure limitations Keep away from rain Indicates the number of pieces in packaging Ingress Protection code according to IEC 60529. The monitors and interface cable for the Avalon CTS (M2731-60001/

M2732-60001) are rated IP X1 (protection against water dripping vertically only) Ingress Protection code according to IEC 60529 (protection against condensation only) Ingress Protection code according to IEC 60529. The IUP/ECG patient module

(M2738A) is rated IP 67 (protection against dust, access to hazardous parts, and the effects of continuous immersion in water to a depth of 0.5 meter for 30 minutes) Power-On/Off Switch - FM20/FM30 without Battery Option Power-On LED Connection direction indicator FM20/

FM30 with battery option IP 21 IP 32 IP 68 Ingress Protection code according to IEC 60529 (protection against ingress of water when the water is dripping vertically) Ingress Protection code according to IEC 60529. The CL Wide Range Pod is rated IP 32 (protection against dripping water when the casing is inclined to 15 degree) Ingress Protection code according to IEC 60529. All transducers (excluding M2738A) are rated IP 68 (protection against dust, access to hazardous parts, and the effects of continuous immersion in water to a depth of 1.0 meter for five hours) Power-On/StandBy button - FM40/FM50 and FM20/30 with Battery Option Button to open paper drawer/paper eject.

(FM40/FM50) Serial/MIB connector (optional) Socket for connecting Avalon CTS interface cable M2732-60001 or Avalon CL interface cable (with black connector, FM40/FM50) Fetal sensor socket USB interface (optional) SpO2 socket Noninvasive Blood Pressure socket The monitor has the triplets option Analog interface indicator for connection to any analog video display (VGA resolution) FM40/FM50 The monitor is capable of intrapartum monitoring 319 30 Specifications and Standards Compliance Symbols Mouse connection indicator (optional) Keyboard connection indicator (optional) Indicates location of the date of manufacture and/or name and address of manufacturer Indicates the environmental specifications for storage Authorized representative in the European Community Indicates the country and date of manufacture, for example DE stands for Germany. Indicates the environmental specifications for transport Indicates location of serial number Indicates location of catalog number Batch code Indicates the model number Indicates the location of the UDI (Unique Device Identification). Identifier symbol with the GTIN (Global Trade Item Number). Medical Device Symbol GS1 Data Matrix Indicates location of service number Separate collection for waste electrical and electronic equipment Use by date Do not reuse Not manufactured with natural rubber latex Not manufactured with di-(ethylhexyl)pthalate CE marking accompanied by the Notified Body number 0123 CSA US and Canadian mark EAC mark China RoHS CE Marking (EU certification mark) General symbol for recovery/recyclable Mercury free Please recycle waste batteries RCM compliance mark Federal Communications Commission: FCC ID xxxx 320 30 Specifications and Standards Compliance Symbols Chinese Radio marking: CMIIT ID (China Ministry of Industry and Information Technology) CAN ICES-1/

NMB-1 This ISM device complies with Canadian ICES-001. Cet appareil ISM est conforme la norme NMB-001 du Canada. Industrial, Scientific, & Medical radio frequency band (Avalon CL frequency band used e.g. in the EU) Wireless Medical Telemetry Service (Avalon CL frequency band used e.g. in North America) Association Of Radio Industries And Businesses T108 (Avalon CL frequency band used e.g. in Japan) IC-ID (Industry Canada ID) One IC-ID labeling for each built in radio:

OBR, SRR Japanese Radio marking: Radio mark + [R]-symbol + ID Taiwan Radio Label (NCC Logo) + ID Korea radio mark: KC logo, KCC ID number, and Conformity assessment information Recorder Symbols Recorder Symbols Parameter is capable of alarming and alarms were enabled at the time of printing the annotation. The low limit is printed before the symbol, and the high limit after it. FMP detection is on Warning (INOP) Measurement from a cableless measurement Pod Pulse from SpO2 Pulse from NBP Parameter is capable of alarming, but alarms were disabled at the time of printing the annotation. (Note: There is no alarm related annotation at all if a parameter does not have alarming capability.) Beginning of the date/time annotation Measurement from a cableless transducer

(printed next to measurement label) Measurement from cableless devices connected via WLAN (CL Wide Range Pod) Pulse from Toco+ MP Trace separation +20 bpm (in label) Trace separation -20 bpm (in label) Trace separation Off (in trace) Trace separation +20 bpm (in trace) Trace separation -20 bpm (in trace) 321 30 Specifications and Standards Compliance Recorder Symbols Trace separation +20 bpm and -20 bpm (in trace) Marker Coincidence of heart rates is detected Special wave, with different speed and scale

(for example, fast printout of MECG wave on FM30) 322 31 31Default Settings Appendix This appendix documents the most important default settings of your fetal monitor and the Avalon CL Base Station with the cableless transducers as they are delivered from the factory. For a comprehensive list and explanation of default settings see the Configuration Guide supplied with your fetal monitor. The monitor's default settings can be permanently changed in Configuration Mode. Alarm and Measurement Default Settings Alarm Defaults Settings Alarm Settings Alarm Mode Alarm Volume Alarms Off Alarm Text Visual Latching Audible Latching Alarm Sounds Alarm Low Fetal / Maternal Defaults Settings (International) Settings FHR, dFHR, aFHR High Limit Low Limit Alarms Sensitivity Toco, aToco IUP HR, aHR Measurement High Limit Low Limit MECG Alarms Default All 5 2 min Standard Red & Yellow Red & Yellow Traditional 4 Default On Orange 160 bpm 110 bpm On Green High mmHg Green Red 120 bpm 50 bpm On 323 31 Default Settings Appendix Fetal / Maternal Defaults Settings (U.S./CAN) Settings FHR, dFHR, aFHR High Limit Low Limit Alarms Sensitivity Toco, aToco IUP HR, aHR Measurement High Limit Low Limit MECG Alarms Default On Red Blue Green 160 bpm 110 bpm On Green (Toco) Yellow (aToco) High mmHg White Red 120 bpm 50 bpm On Coincidence Default Settings Coincidence Default Settings Coincidence Tone immediately NBP Default Settings Factory Default Settings Mode Repeat Time Alarms from NBP Sys/Dia only Low Limit High Limit VP Pressure Done Tone Veni Puncture Start Time 324 Manual 15 min Sys. (International) Sys&Dia&Mean (U.S./CAN) Yes (International) No (U.S./CAN) 90/50 (60) 160/90 (110) 60 mmHg Off n/a Synchronized Factory Default Settings NBP Alarms Color Reference CL NBP Default Settings NBP Settings Sys.High/Sys. Low Dia.High/Dia. Low MeanHigh/Mean Low Alarms Mode Repeat Time NBP Pulse VP Pressure Reference Unit Done Tone Start Time Aging Time AnnouncementTone Automatic Start Accelerated Msmt Color SpO2 Default Settings SpO2 Factory Default Settings Desat Limit Low Limit High Limit Desat Delay Low Alarm Delay High Alarm Delay Average NBP Alarm Suppr. On On Red Auscultatory Factory Defaults 160/90 90/50 110/50 On Auto 10 min On On 60 mmHg Auscultatory mmHg Off Synchronized 10 min Off Off Off Red 80 90 100 20 seconds 10 seconds 10 seconds 10 seconds On 31 Default Settings Appendix 325 31 Default Settings Appendix SpO2 Factory Default Settings Alarms Color Pulse Default Settings Pulse (SpO) High Limit Low Limit ExtrBrady Bradycardia: Difference to Low Limit Brady Clamp ExtrTachy Tachycardia: Difference to High Limit Tachy Clamp CL SpO2 Default Settings SpO2 Settings Mode Repeat Time Alarms Pulse Volume ToneMod. Perfusion Average NBP Alarm Suppr. Aging Time Color Average in Mon. Signal Quality Label On Cyan On 120 bpm 50 bpm 20 bpm 40 bpm 20 bpm 200 bpm Factory Defaults Continuous 15 min On 1 Yes On 10 sec On 10 min Cyan No On SpO SpO2 Alarm Default Settings Factory Defaults DesatLim Low Lim High Lim Desat Delay High Alarm Delay Low Alarm Delay 326 80 90 100 20 sec 10 sec 10 sec Pulse Settings Pulse Alarms High Lim Low Lim Brady Brady Clamp Tachy Tachy Clamp Tympanic Temperature Default Settings pTemp Settings Low Limit High Limit Unit Alarms Color Factory Defaults On On 120 50 20 40 20 200 Factory defaults Adult 36C (96.8F) 39C (102.2F) C On White Manually Entered Values Default Settings Manual Entered Values Label Unit Color Interval Msmnt Recorder Default Settings Setting Recorder Speed Scale Type Trace Style FHR1 Trace Style FHR2 Trace Style FHR3 Trace Style Toco Trace Style HR Wave Style ECG ECG Wave printing choice Default Settings Temp (fixed) C White 1 h Off Default 3 cm/min US Thick Medium Extra Thick Thick Thin Thin Separate 31 Default Settings Appendix 327 31 Default Settings Appendix Setting Notes Recording Change Rec Speed Auto Start Confirmed Stop Bridge Paperout Paper Save Mode NST Autostart NST Autostop Trace Separation Separation Order Intensity Cal. Offset Default Along (International) Across (U.S./CAN) Config Off Off On Off (International) On (U.S./CAN) On Off Off Standard (International) Classic (U.S./CAN) n/a n/a 328 1 Index A reviewing alarms window 123 CL Fetal & Maternal Pod 86 accessories 275, 276, 277, 278, 279, 280, 285 Avalon CL base station 275 cl NBP Pod accessories 280 cl SpO2 Pod accessories 284 fetal accessories 277 electrode patch 277 fetal recorder accessories 285 latex information 275 MECG accessories 278 noninvasive blood pressure accessories 278, 279 adult cuffs 279 multi-patient comfort cuff kits 278 reusable cuffs 278 single-hose disposable cuffs 279 SpO2 accessories 280 Philips sensors (disposable) 280 Philips sensors (reusable) 280 transducer accessories 276 tympanic temperature 285 tympanic temperature accessories 285 ACOG technical bulletin 60 actions after monitoring 70 adjusting display 49 admitting a patient 145, 146 auto free 29 editing information 146 OB TraceVue/IntelliSpace Perinatal 147 quick admit 146 aging numerics 234 alarms 115, 116, 117, 119, 120, 121, 122, 123, 124, 125, 127, 197, 235, 242, 300, 306, 307, 323 acknowledging alarms 119 active alarms 115 alarm behavior at on/off 125 alarm latching 124 alarm limit delay 302 alarm reminder 119 alarm standards 117 audible alarm indicators 117 changing alarm delays 197 high priority alarms 115 latching alarms 123, 124 latching alarm behavior 124 pausing alarms 119 red alarms 115 restarting paused alarms 121 reviewing alarms 122, 123 standard Philips alarms 117 yellow alarms 115 applying the fetal & maternal pod 97 artifact suppression 204 artifact suppression and fetal arrhythmia 204 explanation of artifact suppression 204 switching on and off artifact suppression 204 B baseline measurement 187, 192, 208 battery option 107 using batteries 107 belt actions 50, 51, 52 belt fastening 50, 51 belt fixing button 51 C cableless monitoring 73 Avalon CL 73 applying 97 audio signals CL F&M pod 88 LED indications 87 CL Wide Range Pod 88 cleaning monitor actions 257, 258, 261, 272 cleaning method 258 cleaning monitoring accessories 261 general cleaning requirements 257 infection control 257 printhead cleaning 272 configuration mode 44 configuring alarm tone 117 confirming fetal life 12, 170, 185, 191 cross-channel verification 12, 163, 164, 165, 166, 167, 185 CCV and triplets 166, 191 CCV and twins 166, 185 coincidence examples 165 comparing FHR with maternal HR 164 functionality 164 misidentification of heart rates 163 overview 164 recommended actions 167 audio signals CL base station 77 connection options 78, 80 cableless transducers 81 D assignment 94 audio signal 84 cl belt clip 85 connector cap 82 LED indication 82 radio range 84 cl pods 89 assignment 95 audio signal 90 battery status LED 90 configuration cableless system 75 important considerations 171 LED indication 82 paging patients 96 prompts 93 Tele Info window 90 Telemetry 91, 93, 94 underwater monitoring 105 calibration 236, 268 calibrating noninvasive blood pressure 268 cautions 11 changing FHR alarm delays 197 changing FHR alarm limits 197 CL Fetal & Maternal Patch 88 data recovery 253 date from OB TraceVue/IntelliSpace Perinatal System 47 date setting 47 Dawes/Redman 157, 161 DECG 202, 204, 205, 300 DECG INOPs 204 DECG specifications 300 DECG testing 205 DECG troubleshooting 204 default settings 300 alarm default settings 323 FHR default settings 300 IUP default settings 300 MECG default settings 300 noninvasive blood pressure default settings 306 recorder factory default settings 310 SpO2 factory default settings 307 Toco default settings 300 user defaults 45 defibrillation precautions 222, 275, 318 demo mode 44 device classification 21 329 disabling touchscreen 44 discharging a patient 146 disinfecting 257, 258, 259 infection control 257 recommended substances 259 display 49, 233, 300 adjusting display 49 adjusting screen brightness 47 display noninvasive blood pressure 233 fetal display specifications 300 disposal of electronic waste 273 disposal of monitor 273 dyshemoglobins 241 intravascular dyshemoglobins 241 E early systolic blood pressure 233 ECG 202, 220, 300 ECG specifications 300 electrical safety tests 313 electrical surgery precautions. See ESU 222, 241, 275, 318 electrodes 221 applying electrodes 221 EMC 313 electromagnetic compatibility 313 electromagnetic interference 315 how to reduce electromagnetic interference 315 EMC and compliant accessories 313 EMC precautions 313 EMC standards 313 entering notes 42 ESU precautions 222, 275, 318 extension cable for SpO2 240 external monitoring 169, 186, 192, 208 external monitoring - Toco 208 external monitoring - triplets 192 external monitoring - twins 186 external monitoring - ultrasound 169 F FAST 239 Fourier Artifact Suppression Technology 239 fetal accessories 277 fetal arrhythmia 204 fetal demise 12 fetal display specifications 300 IUP - fetal display specifications 300 Toco - fetal display specifications 300 US - fetal display specifications 300 fetal heart rate alerting. See FHR 197 fetal heart rate. See FHR 169 330 fetal movement 173 fetal movement profile. See FMP 169 FHR 12, 170, 175, 185, 187, 191, 192, 197, 198, 219, 300 aFHR 215 alerting 197 cross-channel verification 219 misidentification 12 trace separation 187, 192 FHR alarms 300 finder LED 38, 53, 185, 191 finding monitor revision 47 flexible nurse call 29, 35, 37 FMP 173, 174, 175 FMP and twins 173 FMP statistics 174 functional arterial oxygen saturation 239 G global settings 46 I infection control 257 infection and sterilizing 257 INOPs 115, 119 CCV INOP coincidence tone 28 disconnect INOPs 119 INOP alarms 115 red or yellow INOPs 28, 29 INOPs indicators 115 silencing INOPs 119 interference 313, 315 how to reduce interference 315 interference from RF equipment 313 internal monitoring 186, 199, 213 intrauterine pressure. See IUP 211 intravascular dyshemoglobins 241 intravascular dyshemoglobins effects on

(SpO2) 241 IUP 211, 213, 300 IUP specifications 300 M mains power (AC) 71 disconnecting from mains power 71 maintenance 267, 268 maintenance schedule 267, 268 visual inspection 267 manual data entry 250 maternal ECG 204, 222, 223, 224 electrode position 223 printing waveform 204, 224 viewing waveforms 222 maternal heart rate 219, 220 maternal heart rate and cross-channel verification 219 maternal heart rate and priorities 219 maternal heart rate from MECG 220 sources of maternal heart rate 219 maternal HR 170, 219, 220, 221 aHR 215 Maternal HR from MECG 220 Maternal HR priorities 219 Maternal HR sources 219 maternal temperature 27 measurement settings 46 changing measurement settings 46 entering setup menu 46 measurements 45, 46, 297 setting up measurements 46 switching on and off measurements 45 MECG 204, 220, 221, 222, 224, 225, 227, 278, 300 accessories 278 alarm limits 302 connection illustration 220 default settings 300 electrodes 221 specifications 300 waveform printing 204, 224 MECG alarm limits 300 methemoglobin (SpO2) 241 monitor settings 12, 34, 46, 48, 49, 71, 253 changing monitor settings 46 major parts and keys 34 power on/off behavior 71 Standby 71 starting monitoring 172 switching on 48, 49 monitoring mode 44 monitoring triplets and FHR 191 monitoring twins and FHR 185 MR imaging and the SpO2 transducer 241 MRI precautions 222, 275, 318 N NBP. See noninvasive blood pressure 231 NIBP. See noninvasive blood pressure 231 Noninvasive Blood Pressure (NBP) 225, 231, 232, 233, 234, 235, 236, 268, 278, 279, 306 automatic noninvasive blood pressure repeat time 235 calibration interval 268 comfort cuff kits 278 factory defaults 306 how the measurement works 231 measurement 232, 234 limitations 232 methods 232 starting 234 stopping 234 NBP accessories 278 NBP adult cuffs 279 NBP automatic mode 235 NBP configurable measurement sequence 29 NBP numerics 233 NBP pediatric cuffs 279 NBP performance specifications 306 NBP reusable cuffs 278 NBP single-hose disposable cuffs 279 NBP site inspection 232 NBP troubleshooting 236 NBP venous puncture 236 preparing to measure NBP 232 non-medical devices 313 non-medical devices in patient vicinity 313 Non-Stress Test timer. See NST timer 150 NST Report NST analysis 151 Trace Interpretation 151, 152 NST timer 149, 150 O OB TraceVue/IntelliSpace Perinatal System 32, 33, 254 connection to OB TraceVue/

IntelliSpace Perinatal System 32, 33 LAN connection 254 operating modes 44 configuration mode 44 demo mode 44 monitoring mode 44 service mode 44 specifications 306 SpO2 specifications 307 Toco 301 ultrasound 300 physiological alarms 115 pop-up keys 93 power 71 disconnecting from 71 external power supply Avalon CL 81 power failure 71 power on/ power off behavior 71 pulse 225 pulse from noninvasive blood pressure 225 pulse rate 219 Q QRS tone pitch 243 R recorder 56, 72, 271, 272, 285, 310 factory defaults 310 paper storage 271 printhead cleaning 272 recorder paper 285 recorder specifications 310 recorder speed 60 recorder troubleshooting 72 recording elements 59 recording stored data 42 recovering traces 253 trace recovery printout 253 recycling 273 regulatory compliance 312 remote event marker 61 operating temperatures 317 oscillometric measurement method 231 S P paging patient 96 Paper Advance key 42 Paper-Out indication 63 passcode protection 44 patient alarms 127 Patient Demographics window 145 patient module 202, 220 paused alarms 119, 121 restarting paused alarms 121 safety 268, 312 maintenance interval 268 safety information 15 safety standards 312 screen layouts 45 selftest 48, 49, 56, 124 sensor 239 disposable SpO2 sensors 239 selecting SpO2 sensors 239 separating FHR traces 187, 192 separating triplet traces 192 separating twin traces 187 performance specifications 297, 306, 307 fetal and maternal specifications 300 service mode 44 settings 45, 46 aFHR, aHR, aToco 305 ECG 302 IUP 302 noninvasive blood pressure active settings 45 changing settings 46 factory default settings 46 global settings 46 monitor settings 46 user default settings 45 short range radio 89, 316, 317 signal loss delay 198 signal quality 70, 242 signal quality during monitoring 70 signal quality of SpO2 242 silencing alarms 119 specifications 291, 297, 300, 310 built-in recorder specifications 310 DECG specifications 300 ECG specifications 300 environmental specifications 287 IUP specifications 300 measurement specifications 297 MECG specifications 300 performance specifications 297, 300 Toco specifications 300 transducer specifications 291 US specifications 300 SpO2 239, 240, 241, 242, 280, 307 accessories 280 alarm specifications 307 connecting the cables 240 disposable sensors 239 factory defaults 307 FAST technology 239 performance specifications 307 Philips sensors (disposable) 280 Philips sensors (reusable) 280 signal quality 242 tone modulation 243 SpO2 alarms 242, 307 standards 312, 313 EMC standards 313 safety standards 312 standards compliance 312 Standby 42 starting monitoring 48 sterilizing 257, 265 infection control 257 storage temperatures 317 stored data recording 42 suppressing artifacts 204 suspended alarm 120 suspicious SpO2 reading 242 switching on and off alarms 121 switching on and off FMP 175 switching on monitor 48, 49 switching on recorder 56 symbols on the system 318 T technical alarm messages. See INOPs 130 331 touch tone volume 47 W warnings 11 X XDS remote display 45 temperatures 317 operating temperatures 317 storage temperatures 317 testing 124, 205, 225, 313 DECG testing 205 MECG testing 225 safety testing 313 testing alarms 124 time 47 setting time 47 time from OB TraceVue/IntelliSpace Perinatal System 47 Toco 202, 207, 208, 210, 222, 300 aToco 215, 216 default Toco settings 300 testing a Toco transducer 210 Toco baseline 208 Toco display specifications 300 Toco monitoring 207 Toco sensitivity 208 Toco specifications 300 Toco MP transducer 207, 219 Toco+ transducer 207 tone modulation (SpO2) 243 touch tone volume 47 touchscreen operation 39, 44 trace actions 62, 253, 254 switching trace separation on/off 187 tearing off traces 62 trace recovery on OB TraceVue/

IntelliSpace Perinatal System 254 trace recovery on paper 253 transducer 38, 51, 53, 176, 185, 191, 207, 210, 291 connecting transducer to monitor 53 fixing transducer to belt 51 repositioning transducers 53 Toco MP transducer 224 Toco transducer 207 Toco+ transducer 207 transducer belt clip 51 transducer specifications 291 transducer testing 176, 210 Toco 210 ultrasound 176 triplets 191, 192, 193, 196 cross-channel verification 191 external monitoring 192 importance of monitoring MHR 191 monitoring triplets 191 offsetting baselines 192 troubleshooting 72, 175, 190, 196, 204, 209, 214, 224, 236 DECG 204 FHR 175 IUP 214 MECG 224 332 twins 173, 185, 186, 187, 188, 190 cross-channel verification 185 external monitoring 186 importance of monitoring maternal HR 185 invasive monitoring 186 monitoring FHR 185 monitoring twins 185 offsetting baselines 187 twins and FMP 173 Tympanic Temperature 245 body reference sites 249 display and controls 246 manual data entry 250 status screens 247 taking temperature 247 tympanic temperature accessories 285 U ultrasound 169, 172, 176, 300 applying gel 172 testing a transducer 176 ultrasound display specifications 300 ultrasound monitoring 169 ultrasound specifications 300 understanding screens 45 USB 28 using paper 60, 62, 63, 65, 271, 285 default recorder speed 60 loading paper 63, 65 paper out INOP 63 paper speed 60 changing 60 default 60 defaults 60 setting 60 paper, when to reload 63 recorder paper 285 removing paper 63, 65 storing paper 271 tearing off a trace 62 using the adapter cable 202 uterine activity 202, 207, 208, 209, 211, 213, 214, 222 external monitoring 207 internal monitoring 211 monitoring uterine activity 202, 208, 211, 213, 222 troubleshooting uterine activity 209, 214 V velcro belt 52 venous puncture 236 visual alarm indicators 116 volume settings 47, 117 alarm volume 117 IUP, zeroing 213 Part Number 453564898421 Published in Germany 10/20

*453564898421*

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Federal Communication Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD 21046 USA Date: 30-November 2023 _ Attestation Statement according to 2.911(d)(5)(i) and 2.911(d)(5)(ii) FCC ID: PQC-OBRTBV1 TO WHOM IT MAY CONCERN:

Hereby we certify that the equipment for which authorization is sought is not covered _ equipment prohibited from receiving an equipment authorization pursuant to section 2.903 of the FCC rules. Further we certify that, as of the date of the filing of the application, Philips Medizin Systeme Bblingen GmbH is not identified on the Covered List as an entity producing covered equipment. Sincerely,

(signature) Philips Medizin Systeme Bblingen GmbH FRN: 0017950635 Hewlett-Packard-Strasse 2 71034 Bblingen, Germany Anna Brouhard 004970314630 Device.registration.boeblingen@philips.com Philips Medizin Systeme Bblingen GmbH Hewlett-Packard-Strasse 2, 71034 Bblingen, Germany, Tel +49(0)7031 463-0, Fax +49(0)7031 463-2202 Geschftsfhrer: Dr. Dieter Haase (Sprecher), Gnter Gegner, Sang Do Kim, Florian Kuhn Registergericht Stuttgart Reg.-Nr. HRB 245187, Sitz der Gesellschaft: Bblingen, www.philips.com/healthcare

 

 

PHILIPS Federal Communication Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD 21046 USA Date: 23-October 2023 Attestation Statement according to 2.911(d)(7) TO WHOM IT MAY CONCERN:

We, Philips Medizin Systeme Bblingen GmbH designate Philips Medical Systems North America Co. to act as U.S. agent for service of process. Philips Medical Systems North America Co. hereby acknowledges the obligation of the U.S. agent for service of process. Further Philips Medizin Systeme Boblingen GmbH accepts to maintain an agent for no less than one year after the grantee has terminated all marketing and importation or the conclusion of any Commission-related proceeding involving the equipment. Anna Brouharck DS hm we ee / H Gignature & company stamp) (Signature & company stamp) Philips Medizin Systeme Bblingen GmbH Philips Medical Systems North America Co. FRN: 0017950635 FRN: 0004980637 Hewlett-Packard-Strasse 2 222 Jacobs Street 71034 Bblingen, Germany 02141 Cambridge, Massachusetts, US Anna Brouhard Delroy Smith 004970314630 1-617-798-0865 Device.registration.boeblingen@philips.com Delroy.smith@philips.com Philips Medizin Systeme Boblingen GmbH Hewlett-Packard-Strasse 2, 71034 Bblingen, Germany, Tel +49(0)7031 463-0, Fax +49(0)7031 463-2202 Geschaftsfiihrer: Dr. Dieter Haase (Sprecher), Ginter Gegner, Sang Do Kim, Florian Kuhn, Registergericht Stutteart Reg.-Nr, HRB 245187, Sitz der Gesellschaft: Boblingen, www.philips.com/healthcare

 

 

Federal Communication Commission Equipment Authorization Devision, Application Processing Branch 7435 Oakland Mills Road Columbia, MD 21048 C2PCPX Letter according to Notification 202109-001 FCC ID: PQC-OBRTBV1, granted on 07/11/2013 TO WHOM IT MAY CONCERN _ Pursuant to KDB 388624 D02 (Pre-Approval Guidance List) v18r03, Notification 202109-001, respectively, we, Philips Medizin Systeme Bblingen GmbH hereby declare that our product can meet the following items:

Comment _ Notification 202109-001 item 1) The requirements of 2.1043 are fulfilled, i.e., the devices block functions for the fundamental frequency, primary modulator circuit, maximum power, or field strength ratings shall remain unchanged. 2) Transmitter PCB layout and parts changes are only permitted if there is no change in identifying a devices form, functional specification, as initially granted or previously approved under a Class II permissive change. 3) PCB changes are limited to non-

substantive modifications layout changes to the same size physical circuit board previously granted. 4) C2PCPX is not permitted to add, remove, augment, or change capabilities, such as transmitters, increased bandwidth, additional rule parts, bands, etc. 5) In the PAG submission for item C2PCPX, the applicant shall provide complete information on testing demonstrating that the proposed changes for fundamental confirmed Philips Medizin Systeme Bblingen GmbH Hewlett-Packard-Strasse 2, 71034 Bblingen, Germany, Tel +49(0)7031 463-0, Fax +49(0)7031 463-2202 Geschftsfhrer: Dr. Dieter Haase (Sprecher), Gnter Gegner, Sang Do Kim, Florian Kuhn Registergericht Stuttgart Reg.-Nr. HRB 245187, Sitz der Gesellschaft: Bblingen, www.philips.com/healthcare Date: 2014-03-17 Page: 2 _ emissions are unchanged within the normal, acceptable tolerances and out-of-band;

emissions do not exceed the appropriate limits. 6) The modified device shall not be marketed under the existing grant of certification before confirmation that the C2PCPX PAG is approved and granted. 7) Software Defined Radio (SDR) grants that use the C2PCPX procedure are not permitted to make subsequent Class III permissive changes. 8) The C2PCPX PAG procedure has no impact on the provisions of V) of this publication for non-SDR software-only changes; thus, adding an equipment class when related to rule changes is still permitted. 9) Class I permissive changes are not permitted under this C2PCPX procedure. _ If you have any questions feel free to contact us at the address shown below. Sincerely,

(date, signature) Anna Brouhard, Principle Regulatory Affairs Specialist Radio Frequency, HPM Philips Medizin Systeme Bblingen GmbH Hewlett-Packard-Strasse 2 71034 Bblingen, Germany 004970314630

 

 

Federal Communication Commission Equipment Authorization Devision, Application Processing Branch 7435 Oakland Mills Road Columbia, MD 21048 Certification and Engineering Bureau Innovation, Science and Economic Development Canada Spectrum Engineering Branch 3701 Carling Avenue, Building 94 Ottawa, Ontario K2H 8S2 _ Date: 11-December 2023 _ Class 2 Permissive Change (C2PC) Request Letter FCC ID: PQC-OBRTBV1, granted on 07/11/2013 IC: 3549C-OBRTBV1, HVIN(s): 866075/866076/866077, granted on 07/17/2013 TO WHOM IT MAY CONCERN Pursuant to CFR 2.1043 and RSP-100 (Issue 12), section 10.2 we, Philips Medizin Systeme Bblingen GmbH hereby requests a Class 2 Permissive Change. Reason: Hardware Change Modifications:

Existing TCXO will be replaced with a new TCXO (redesign) of the same supplier. Both TCXO are almost identical. There are only minor differences with low risk. The essential performance criteria, namly frequency and frequency drift are identical. The following new exhibits will be uploaded:

1-5667_23-01-01_AnnexD.pdf 1-5667_23-01-02-A.pdf 1-5667_23-01-06_SAR_FCC.pdf 1-5667_23-01-06_SAR_ISED.pdf Philips Medizin Systeme Bblingen GmbH Hewlett-Packard-Strasse 2, 71034 Bblingen, Germany, Tel +49(0)7031 463-0, Fax +49(0)7031 463-2202 Geschftsfhrer: Dr. Dieter Haase (Sprecher), Gnter Gegner, Sang Do Kim, Florian Kuhn Registergericht Stuttgart Reg.-Nr. HRB 245187, Sitz der Gesellschaft: Bblingen, www.philips.com/healthcare Date: 2014-03-17 Page: 2

1-5667_23-01-02_Test report cover sheet.pdf 1-5667_23-01-06 RSS-102 Annex C.pdf 453564254601-A-ADWG_CTC 453564254601-A-SCHM_CTC AV_IFU_ENG_L3_A0010_453564898421_compr N) FCC - Long-Term Confidentiality Request Letter - V1.1_Transd_signed Q) 2.911(d)(5) Attestation 2.911(d)(7) - Designated US agent for service of process(signed) S) ISED - Application Cover Letter - V2.2_Transducer_signed Canada - Representative Attestation Letter - SIGNED (002) signed Canada - Confidentiality Request Letter (2023-08-04)_Transd_signed V) ISED - RSP-100 Annex A (Application Letter) - V2.2_Transd C2PCPX Letter according to Notification 202109-001 _ _

(signature) Anna Brouhard, Principle Regulatory Affairs Specialist Radio Frequency, HPM Philips Medizin Systeme Bblingen GmbH Hewlett-Packard-Strasse 2 71034 Bblingen, Germany 004970314630

 

 

LONG-TERM CONFIDENTIALITY REQUEST for Certification Service in the USA Federal Communication Commission Equipment Authorization Division, Application Processing Branch 7435 Oakland Mills Road Columbia, MD 21048 TO WHOM IT MAY CONCERN Pursuant to Paragraphs 0.457 and 0.459 of the Commissions Rules (47 C.F.R.) and Section 552(b)(4) of the Freedom of Information Act, we request Long-Term Confidentiality for the following product:

Grantee Code Equipment Product Code Check your GC here. Click Grantee Search. FCC ID:

For the product stated above, we request Long-Term Confidentiality for exhibits which contain Block Diagram, Operational Description, Parts List/Tune Up Info, Schematics, SDR Software/Security Info. The above exhibits contain our benefit to our competitors. This information will not be publicly available. trade secrets and proprietary information If you have any questions, please feel free to contact us at the address shown below. Sincerely, Company Name:

Company Address:

Contact Name:

Signature:

Phone:

Fax:

E-mail:

Signature Date:

that could be of Document Version 1.1 2020-10-30

 

 

Von:

An:

Betreff:

Datum:

oetech@fcc.gov Unger, Julia Response to Inquiry to FCC (Tracking Number 729778) Freitag, 23. Dezember 2022 15:44:18 Sie erhalten nicht oft eine E-Mail von oetech@fcc.gov. Erfahren Sie, warum dies wichtig ist Caution: This e-mail originated from outside of Philips, be careful for phishing. Inquiry on 12/22/2022 :

Inquiry:

Dear Sir or Madame, In our Sub-1GHz circuit we have a TCXO in the RF circuit. We plan to replace the existing TCXO with a new TCXO (redesign) of the same supplier. The redesign of the TCXO is necessary because some parts of the previous TCXO are no longer available on the market. Attached to this inquiry is a comparison of the datasheets of both TCXOs, which shows that they are almost identical. There are only minor differences with low risk. The essential performance criteria, namely frequency and frequency drift are identical. Frequency drift over temperature is even better. We would like to know whether a permissive change is triggered here? And if so, which class?

Additional information can be provided if required. Best regards, Julia Unger FCC response on 12/23/2022 Hello, This change can be accomplished via a C2PCPX. For more information on how to do a C2PCPX please reference Notification 202109-001. Attachment Details:

Do not reply to this message. Please select the Reply to an Inquiry Response link from the OET Inquiry System to add any additional information pertaining to this inquiry.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

PHILIPS 19 November 2020 Declaration RF equality Avalon CL Transducer 866075, 866076, and 866077 To Whom It May Concern:

Product: Avalon CL Transducers FCC ID: PQC-OBRTBV1 We hereby declare, that the RF related part of 866075, 866076, and 866077 are identical. They only differ in the frontend functionality:

866075 has a Toco, Maternal Pulse, and ECG functionality. 866076 is with an Ultrasound Doppler Frontend and 866077 is a subpart of the 866075 without the Toco functionality. These frontend boards are completely separate and connected via 2 connectors to the CPU boards where the RF part is located. Sincerely 7 Christian Noguefa Quality & Regulbtory Affairs Philips Medizin Systeme Bblingen GmbH Hewlett-Packard-Str, 2 71034 Boblingen, Germany Tel.: +49 7031 463-2316 Fax.: +49 7031 463-2442 E-Mail: christian.noguera@philips.com Philips Medizin Systeme Bblingen GmbH Hewlett-Packard-Strasse 2, 71034 Bblingen, Germany, Tel +49(0)7031 463-0, Fax +49(0)7031 463-2202 Geschaftsfilhrer: Dr. Dieter Haase (Sprecher), Dr. Peter Ziese, Matthijs de Groot Registergericht Stuttgart Reg.-Nr. HRB 245187, Sitz der Gesellschaft: Bblingen, www.philips.com/healthcare

 

 

PHILIPS 9 November. 2020 Federal Communication Commission Equipment Authorization Division, Application Processing Branch 7435 Oakland Mills Road Columbia, MD 21048 Certification and Engineering Bureau Industry Canada Spectrum Engineering Branch 3701 Carling Avenue, Building 94 Ottawa, Ontario K2H 882 PCII Request / Re-assessment Wireless Transducer (Model Id. 866075, 866076, 866077), FCC ID: PQC-OBRTBV1 granted on July 11, 2013 and IC: 3549C-OBRTBV1 granted on July 11, 2013 TO WHOM IT MAY CONCERN Pursuant to CFR 2.1043 and RSP-100, Philips Medizin Systeme Bblingen GmbH hereby requests a Permissive Change Class II / Re-assessment. Reason:

Due to material discontinuance, the RF switch which toggles between RX and TX has to be replaced (drop-in replacement). Paty a cy Philips Medizin Systeme Boblingen GmbH. Hewlett-Packard-Strasse 2, 71034 Bablingen, Germany, Tel +49(0)7031 463-0, Fax +49(0)7031 463-2202 Geschftsfiihrer: Dr, Dieter Haase (Sprecher), Dr. Peter Ziese, Matthijs de Groot Registergericht Stuttgart Reg.-Nr. HRB 245187, Sitz der Gesellschaft: Boblingen, www.philips.com/healthcare PHILIPS Modifications:

Model Ids. 866075, 866076, 866077:

Ref. Des Current New U220 Renesas UPG2214TB-A CEL CG2179M2-C4 Sincerely, Christian Noguera Quality & Regulatoty Affairs Philips Medizin Systeme Bblingen GmbH Hewlett-Packard-Str. 2 E-Mail: christian.noguera@philips.com Philips Medizin Systeme Bblingen GmbH Hewlett-Packard-Strasse 2, 71034 Boblingen, Germany, Tel +49(0)7031 463-0, Fax +49(0)7031 463-2202 Geschftsfihrer: Dr. Dieter Haase (Sprecher), Dr. Peter Ziese, Matthijs de Groot 71034 Boblingen, Germany Tel.: +49 7031 463-2316 Fax.: +49 7031 463-2442 Registergericht Stuttgart Reg.-Nr. HRB 245187, Sitz der Gesellschaft: Bblingen, www.philips.com/healthcare