FCC ID: PQCM4842A IntelliVue Access Point

 

IntelliVue TRx/TRx+ Transceivers for the Philips IntelliVue Telemetry System with Smart-Hopping Technology Notice Operation of this equipment in the United States re-

quires the prior coordindation with a frequency coor-

dinator designated by the Federal Communications Commission (FCC) for the Wireless Medical Teleme-

try Service. Instructions for Use Part Number: M4841-91001 Printed in the U.S.A. November 2004 First Edition Printing History Notice Equipment specifications are subject to alteration without notice. All changes will be in compliance with regulations governing manufacture of medical equipment. Printed in the USA. Document number: M4841-91001 Copyright 2004 Koninklijke Philips Electronics N.V. All Rights Reserved. OxiCliq and OxiMax are registered trademarks of Nellcor Incorporated. Printing History New editions of this document will incorporate all material updated since the previous edition. Update packages can be issued between editions and contain replacement and additional pages to be merged by a revision date at the bottom of the page. Note that pages which are rearranged due to changes on a previous page are not considered revised. The documentation printing date and part number indicate its current edition. The printing date changes when a new edition is printed. (Minor corrections and updates which are incorporated at reprint do not cause the date to change.) The document part number changes when extensive technical changes are incorporated. First Edition ...............................................................................November 2004 Philips IntelliVue Telemetry System with Smart Hopping Technology is compatible with:

Philips Information Center, software revision F.00 Philips TeleMon Companion Monitor, #A02/A03 ii About this Book About this Book This book contains operating instructions for use of the IntelliVue TRx and TRx+ Transceivers as used with the Philips IntelliVue Telemetry System with Smart-hopping Technology. It also includes operational information for the Telemetry functions of the IntelliVue Information Center. The intended audience is the clinician who uses and/or teaches others to use the equipment in a healthcare environment. For operating information on other functionality of the Information Center, see IntelliVue Information Center Instructions for Use. For preventive maintenance, repair, and test methods for verification of device performance, refer to the Philips IntelliVue Telemetry System Service Kit. This book does not address the Philips M2601B Transmitter or the M2600B Philips Telemetry System. For information on those products, refer to the manual Philips Telemetry System Instructions for Use. NoteUse this product in conjunction with Philips IntelliVue Information Center Instructions for Use and Online Help, and with Philips TeleMon A02/

A03 Companion Monitor Instructions for Use. See also the Philips IntelliVue Telemetry Training Program. Document Conventions Warnings Warning Warning Warnings are information you should know to avoid injuring patients and personnel. Cautions Caution Cautions are information you should know to avoid damaging your equipment and software. iii Product Safety Information Notes NoteNotes contain additional information on use of the Philips IntelliVue Telemetry System. Procedures Procedures are indicated in text by the heading Task Summary followed by the following table:

Step Action 1 2 3 Bold Typeface Objects of actions in procedures appear in bold typeface. Note the following example:

Select the Standby button. Product Safety Information The following general warnings and cautions apply to use of the Philips IntelliVue Transceivers in a Philips IntelliVue Wireless Network. Additional warnings and cautions specific to a particular feature are provided in the appropriate section. Warning Warning For continued safe use of this equipment, it is necessary that the listed instructions are followed. Instructions in this manual in no way supersede established medical procedures. General iv Product Safety Information Warning Warning Do not touch the patient, or table, or instruments, during defibrillation. The battery door must be closed during defibrillation. These steps protect the clinician from high defibrillator voltage. Warning Warning This device is not to be used in the vicinity of electrosurgical units because use may interrupt or interfere with the transmission of signals from the transceiver. Warning Warning This equipment is not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide Warning Warning Do not use patient cables with detachable lead wires that have exposed male pins. Electrocution could result if these pins are plugged into AC power. Warning Warning Use of product accessories (e.g., ECG leadsets, SpO2 sensors) other than those prescribed by Philips could lead to patient injury. Warning Warning To avoid strangulation, do not tie a pouch solely around the patients neck. v Product Safety Information ECG/

Arrhythmia -

All Patients Warning Warning ECG SAFETY FOR ALL PATIENTS Always confirm Information Center observations with clinical observation of the patient before administering interventions. Every lead must be secured to an electrode on the patient. Conductive parts of electrodes must not contact earth or other conductive parts. Philips recommends that you change the lead label only to reflect the physical placement of electrodes. This will ensure a match between the monitored lead and the label, and prevent any possible confusion. When switching between EASI and standard monitoring, there is a loss of data for 30 seconds. vi Product Safety Information Warning Warning ST/AR ARRHYTHMIA SAFETY FOR ALL PATIENTS During complete heart block or pacemaker failure (to pace or capture), tall P-waves (greater than 1/5 of the average R-wave height) can be erroneously counted by the arrhythmia algorithm, resulting in missed detection of cardiac arrest. Learning/Relearning

- If you initiate learning during ventricular rhythm, the ectopics can be incorrectly learned as the normal QRS complex. This can result in missed detection of subsequent events of V-Tach and V-Fib.

- When using EASI ECG monitoring, Relearn happens automatically when there is a LEADS OFF technical alarm. If learning takes place during ventricular rhythm, the ectopics can be incorrectly learned as the normal QRS complex. This can result in missed detection of subsequent events of V-Tach and V-Fib. Be sure to check the beat labels and initiate a relearn to correct. Therefore, when a technical alarm is generated:

1. Respond to the technical alarm [for example, reconnect the electrode(s)]. 2. Ensure that the arrhythmia algorithm is labeling beats correctly. vii Product Safety Information ECG/

Arrhythmia -

Paced Patients Warning Warning ECG SAFETY FOR PACED PATIENTS The output power of the transceiver and other sources of radio frequency energy, when used in the proximity of a pacemaker, can be sufficient to interfere with pacemaker performance. Due to the shielding effects of the body, internal pacemakers are somewhat less vulnerable than external pacemakers. However, caution should be exercised when monitoring any paced patient. In order to minimize the possibility of interference, position electrodes, electrode wires, and the transceiver as far away from the pacemaker as possible. Consult the pacemaker manufacturer for information on the RF susceptibility of their products and the use of their products with the Philips IntelliVue Telemetry System. See the IntelliVue Information Center Instructions for Use for additional information on monitoring paced patients. viii Product Safety Information Warning Warning ST/AR ARRHYTHMIA SAFETY FOR PACED PATIENTS It is possible that pacemaker pulses will not be detected when the ECG analog output of a defibrillator or telemetry unit is plugged into a bedside monitor. This can result in the arrhythmia algorithms failure to detect pacemaker non-capture or asystole. Some pace pulses can be difficult to reject. When this happens, the pulses are counted as a QRS complex, and could result in an incorrect HR and failure to detect cardiac arrest or some arrhythmias. Keep pacemaker patients under close observation.

-- During complete heart block or pacemaker failure (to pace or capture), tall P-waves (greater than 1/5 of the average R-wave height) can be erroneously counted by the arrhythmia algorithm, resulting in missed detection of cardiac arrest.

-- When arrhythmia monitoring paced patients who exhibit only intrinsic rhythm, the monitor can erroneously count pace pulses as QRS complexes when the algorithm first encounters them, resulting in missed detection of cardiac arrest. For patients who exhibit intrinsic rhythm only, the risk of missing cardiac arrest can be reduced by monitoring these patients with the low heart rate limit at or slightly above the basic/demand pacemaker rate. A low heart rate alarm alarms you when the patient begins pacing. Proper detection and classification of the paced rhythm can then be determined.

-- When an external pacemaker is being used on a patient, arrhythmia monitoring is severely compromised due to the high energy level in the pacer pulse. This can result in the arrhythmia algorithms failure to detect pacemaker non-capture or asystole. ix Product Safety Information SpO2 Warning Warning SpO2 SAFETY Always confirm Information Center observations with clinical observation of the patient before administering interventions. Prolonged, continuous monitoring can increase the risk of changes in skin characteristics, such as irritation, reddening, blistering or pressure necrosis, particularly on patients with impaired perfusion and varying or immature skin morphology. Specific attention must be given to sensor site inspection for changes in skin quality, proper optical path alignment and attachment. Check the application site at regular intervals and change the site if any compromise in skin quality should occur. More frequent checking can be required due to an individual patient's condition. Using a sensor during MR imaging can cause severe burns. To minimize this risk, ensure that the cable is positioned so that no inductive loops are formed. If the sensor does not appear to be operating properly, remove it immediately from the patient. Do not use disposable sensors on patients who exhibit allergic reactions to the adhesive. Injected dyes such as methylene blue or intravascular dyshemoglobins such as methemoglobin and carboxyhemoglobin can lead to inaccurate

(over-estimated) measurements. Interference leading to inaccurate measurements can be caused by:

- High levels of ambient light (Hint: cover application site with opaque material)

- Electromagnetic interference

- Excessive patient movement and vibration. x Contents General. 1-iv ECG/ Arrhythmia -All Patients . 1-vi ECG/Arrhythmia - Paced Patients . 1-viii SpO2. 1-x 1. Basic Operation . 1-1 The Philips IntelliVue Telemetry System . 1-2 System Features . 1-3 The IntelliVue Transceiver. 1-3 Transceiver Controls - Front . 1-7 Transceiver Controls - Back . 1-11 Turning the Transceiver On . 1-15 Turning the Transceiver Off . 1-16 Testing intelliVue Transceiver Functionality . 1-17 Self Test . 1-17 Status Check. 1-18 Battery Information. 1-19 Battery Safety Information. 1-19 Inserting/Removing Batteries . 1-20 Checking the Battery Power Level . 1-22 Briefing the Patient . 1-24 Pouch Use . 1-24 Securing the Pouch. 1-25 Showering . 1-26 Transceiver Use with TeleMon A02/A03 . 1-27 2. Alarms . 2-1 Alarm Indicators . 2-2 Testing Alarm Indicators . 2-2 Suspending/Pausing Alarms . 2-2 Resuming/ Unsuspending Alarms . 2-4 Standby Mode . 2-5 Alarm Behavior with Own Bed Overview . 2-7 Physiologic Alarms . 2-9 Technical Alarms (INOPs) . 2-14 Contents-1 3. ECG Monitoring . 3-1 ECG Safety Information . 3-2 Measuring ECG. 3-3 EASI ECG . 3-3 ECG Leadsets. 3-3 ECG Leads Monitored . 3-4 Positioning ECG Electrodes. 3-8 Electrode Placement. 3-10 Connecting the ECG Cable . 3-19 Verifying Electrode Connections . 3-22 Monitoring during Leads Off . 3-23 ECG Fallback. 3-23 Extended Monitoring . 3-24 Relearning . 3-24 Using EASI Leads to Troubleshoot . 3-24 Optimizing ECG Measurement Performance . 3-25 The Telemetry Signal. 3-25 Trouble- shooting Signal Disturbances . 3-26 Dropouts. 3-26 Muscle and Movement Artifact . 3-27 4. ST/AR Arrhythmia & ST Segment Monitoring. 4-1 ST/AR Arrhythmia Algorithm . 4-2 Safety Information . 4-2 ST/AR Arrhythmia Analysis . 4-3 ST/AR ST Segment Algorithm . 4-6 The Measurement. 4-6 Algorithm Processing. 4-8 Displayed ST Data . 4-8 EASI ST Analysis . 4-8 ST Operation . 4-9 ST Alarm Settings . 4-11 5. SpO2 Monitoring . 5-1 SpO2 Safety Information . 5-2 SpO2 Information for the User . 5-3 Pulse Oximetry Measurement . 5-4 Pulse Indication . 5-5 Selecting a SpO2 Sensor . 5-5 Applying the Sensor. 5-9 Contents-2 Sensor Application Safety Information . 5-9 Site Selection . 5-9 Sensor Application . 5-10 Connecting the SpO2 Cable. 5-14 Measuring SpO2. 5-15 Spot Check . 5-15 Continuous . 5-16 SpO2 Measurement when Connected to TeleMon . 5-17 Turning SpO2 Monitoring Off . 5-18 Turning the SpO2 Parameter On/Off . 5-19 SpO2 Parameter Auto ON. 5-19 Understanding SpO2 Alarms . 5-20 Optimizing SpO2 Measurement Performance . 5-21 Optimizing Sensor Performance. 5-22 6. Telemetry Functions at the Information Center . 6-1 Telemetry Controls in the Patient Window . 6-2 Locating the Transceiver (Find Device) . 6-3 To locate a transceiver . 6-3 To silence the sound . 6-3 Patient-Configurable Settings in Telemetry Setup . 6-3 Unit-Configurable Settings . 6-7

. 6-8 7. Maintenance & Troubleshooting . 7-1 Maintenance . 7-2 Basic Monitoring . 7-2 Label Assignment for Replacement Transceiver . 7-2 Transceiver Cleaning, Disinfection, & Cross-Infection Prevention . 7-4 Cleaning the Transceiver . 7-5 Disinfecting the Transceiver. 7-6 Cross-Infection Prevention for the Transceiver . 7-7 Troubleshooting . 7-15 Basic Troubleshooting . 7-15 Testing Alarms . 7-15 Information Signals. 7-15 8. Safety Standards & Specifications . 8-1 Regulatory Information . 8-2 Intended Use . 8-2 Contents-3 Indications for Use . 8-2 Rx . 8-2 Patient Population . 8-2 Safety Standards. 8-2 Essential Performance . 8-3 System Classification. 8-3 FCC Compliance (USA only) . 8-4 AC Power Source. 8-5 Battery Life Specifications . 8-5 Electromagnetic Compatibility . 8-6 Restrictions for Use . 8-8 Radio Specifications . 8-8 M4841A Transceiver . 8-8 WMTS Channel Frequencies . 8-10 Physical Specifications . 8-11 ECG-only Transceiver . 8-11 ECG/SpO2 Transceiver . 8-12 Environmental Specifications . 8-12 M4841A Transceiver . 8-12 Measurement Specifications . 8-13 ECG . 8-13 SpO2. 8-15 SpO2 Sensor Accuracy . 8-16 A. Accessory List. A-1 Accessory Safety. A-2 ECG Accessories. A-2 Electrodes. A-2 Leadsets . A-2 Trunk Cables . A-3 Pouches . A-3 Skin Prep Paper . A-3 Alignment Guides . A-4 Gunk Guards . A-4 SpO2 Accessories . A-4 Reusable Sensors . A-4 Disposable Sensors - Single Use . A-5 Wristband . A-6 B. Sales and Support Offices . B-1 Contents-4 1 Basic Operation I n t r o d u c t i o n This chapter introduces the Philips IntelliVue Telemetry System with Smart-

hopping Technology and the IntelliVue TRx and TRx+ Transceivers. It includes the following sections:

The Philips IntelliVue Telemetry System. 1-2 The IntelliVue Transceiver . 1-3 Turning the Transceiver On . 1-15 Testing intelliVue Transceiver Functionality . 1-17 Battery Information. 1-19 Pouch Use . 1-24 Transceiver Use with TeleMon A02/A03. 1-27 Transceiver Use with TeleMon A02/A03. 1-27 Basic Operation 1-1 The Philips IntelliVue Telemetry System The Philips IntelliVue Telemetry System The Philips IntelliVue Telemetry System with Smart-hopping Technology provides ambulatory and bedside monitoring of ECG and SpO2 parameters over the radio frequency (RF) spectrum newly allocated for medical telemetry applications by the Federal Communications Commission (FCC). The System enables clinically significant data and control information for adult and pediatric patients in healthcare facilities to be received from and sent to the transceiver, a patient-worn device, via a bi-directional RF link over the Wireless Medical Telemetry Service (WMTS) spectrums 1395-1400 MHz and 1427-1432 MHz. The System uses smart-hopping technology to dynamically manage the RF spectrum utilization per transceiver, thus allowing a virtually unlimited number of simultaneously operating transceivers within the Philips IntelliVue Telemetry System. The frequency-agile system changes frequency without user involvement or awareness whenever interference occurs. The System encompasses a number of individual units which connect together to form a complete method of transporting ambulatory patient data to a central repository for subsequent distribution to clinical staff. An installation typically consists of the following components:

M4841A Transceivers, bi-directional patient-worn devices M4842A Access Points (AP), centers for bidirectional communication between the transceivers and the Information Center. IntelliVue Wireless Network (IWN) infrastructure (including M4843A Access Point Controllers, M4844A Sync Units, M4845A Power Supply Units) M3150A IntelliVue Information Center for centralized monitoring M3154A IntelliVue Database Server (optional) for centralized data management M2636A TeleMon A02/A03 Companion Monitor (optional) for local display, NBP measurement and local alarms. The network interconnects Access Points to the Information Center and other central equipment via the same network that connects IntelliVue bedsides to the Information Center. Access points receive signals, and unlike traditional antenna systems, can communicate bidirectionally. Access Points are powered, controlled and managed remotely via the IWN. 1-2 Basic Operation System Features The IntelliVue Transceiver Full patient mobility within the areas defined by the wireless coverage provided by multiple Access Points. Expanded geographic coverage area for a a given patient assigned to an IntelliVue Clinical Network. Physiological data is transported from the transceiver; a reverse data channel enables data to be transported to the transceiver. 3-minute Alarm Pause/Suspend initiated at the transceiver. Standby mode when a patient is away from the unit and not being monitored by the Philips IntelliVue Telemetry System. Find Device feature for locating a lost transceiver within the coverage area. Access Points operating concurrently with the networked bedside wireless capability while sharing some of the ICN infrastructure. Use of the radio spectrums newly allocated by the FCC specifically for medical telemetry applications. Connectivity to TeleMon for display of patient measurements - including NBP - at the bedside. diagram to come System Information Flow/Smart-hopping The IntelliVue Transceiver The Philips IntelliVue transceiver is a patient-worm device for monitoring ECG and SpO2 on adult and pediatric patients in the IntelliVue Telemetry System Basic Operation 1-3 The IntelliVue Transceiver with Smart-Hopping Technology, a cellular infrastructure network. The transceiver combines traditional transmitter features with two-way communication capability with the IntelliVue Information Center. The transceiver is designed to be easy for clinicians to use and comfortable for patients to wear. Colored labels provide departmental identifiers. The leadsets are optimized for ambulating patients, with a cable length of 79 cm (30 inches). Protective covers prevent dirt from accessing unused ECG and SpO2 cable ports, thus simplifying cleaning. The transceiver is available in two models, the ECG only called the IntelliVue TRx, and the ECG-SPO2 version, called the IntelliVue TRx+. The models are listed below and illustrated on the following pages in this chapter. Subsequent tables describe the buttons, indicators, labels, ports, safety symbols & other markings, and auditory information signals of the transceiver respectively. Transceiver Model

(M4841A) IntelliVue TRx IntelliVue TRx+

Measurements ECG ECG, SpO2 The transceiver comes with a start-up kit of batteries, electrodes, and pouches. 1-4 Basic Operation The IntelliVue Transceiver IntelliVue TRx+

IntelliVue TRx+

M2601B M4841A M4841A EASI, 3 5 EASI, 3 5,6 IntelliVue TRx Transceiver - ECG only Note The IntelliVue Transceiver and M2601B Transmitter are similar in appearance. If your hospital uses both, you can distinguish between them by:

Name on the front of the device Label background color (pale gray for transceivers, dark gray for transmitters) Transceiver Features Clinician-selectable 5-lead Standard or EASI leads in same device, at the bedside 6-leadset with two V leads for diagnosing multiple cardiac abnormalities, including wide-QRS complex tachycardias and acute myocardial ischemia/infarction Powered by two AA Alkaline batteries Spot-Check SpO2 without using any control buttons Basic Operation 1-5 The IntelliVue Transceiver Use with Information Center FAST-SpO2 (Fourier Artifact Suppression Technology) for improved motion artifact rejection and low-perfusion performance Audio feedback for Spot Check SpO2 completion and other common tasks Simultaneous operation in system with M2601A Transmitter Two sizes - smaller ECG only version and larger ECG/SpO2 version Battery gauge on transceiver and, if configured, at Information Center Colored labels provide clinical unit identifiers. Leadsets are optimized for ambulating patients, with a cable length of 79 cm (30 in). Gunk guards prevent debris from accessing unused ECG and SpO2 cable ports and the unused TeleMon/Service port, thus simplifying cleaning. Pouch with clear front and flap. The bi-directional capability enables remote control from the Information Center of the following transceiver operations:

From the Telemetry Setup Window:

SpO2 measurement mode (Spot Check, Continuous, or Off) Display and storage of real-time pleth wave (enable/disable) Volume of audible transceiver information signals Find device Suppression of SpO2 technical alarms during NBP measurement From the Patient Window Standby mode Filter bandwidth for ST measurement on/off Alarm Pause/Suspend (enable/disable) From Unit Settings Display of battery gauge (enable/disable) 3-wire Lead Selection The system supports Own Bed Overview, the pairing of a telemetry bed with an IntelliVue Patient Monitor (Release B or higher) for a single patient. Own Bed Overview provides the telemetry-monitor data (waveforms, numerics and alarms) in an integrated form both on the bedside monitor and at the IntelliVue Information Center. Use with TeleMon A02/A03 The transceiver can employ the full functionality of the TeleMon A02/A03 companion monitor, including NBP measurement and local display of alarms. Connection is made through an interface cable, or tether, at the TeleMon service 1-6 Basic Operation The IntelliVue Transceiver port. Please refer to the TeleMon A02/A03 Instructions for Use for general operating instructions and Transceiver Use with TeleMon A02/A03 on page 1-27 for an operational summary. Transceiver Controls - Front IntelliVue TRx+

M4841A EASI, 3 5,6 P1 P2 P3 I1 I2 I3 I4 B1 B2 B3 L1 L2 L3 The labeled items in the diagram include: Buttons (B1-B3);

Indicators (I1-I4); Labels (L1-L4); Ports (P1-P3). Additional Labels, and Safety Symbols & Other Markings (S1-S12, ap-

pear on the back of the transceiver. IntelliVue TRx+ Transceiver - Front View Basic Operation 1-7 The IntelliVue Transceiver Buttons IntelliVue TRx+

M4841A EASI, 3 5,6 Callout Button B1 B1 B2 B3 B2 B3 Power On/Off 1-8 Basic Operation Definition Telemetry Button: Depending on configuration, directs the Information Center to generate a Nurse Call alarm, remote recording, Nurse Call alarm and recording, or none. See Patient-Configurable Settings in Telemetry Setup on page 6-3. NoteDelayed recordings generated by the Telemetry button are stored in Alarm Review at the Information Center. When pressed simultaneously with the Check button, turns Alarm Suspend/Pause on/off (not when tethered to TeleMon). See Suspending/

Pausing Alarms on page 2-2. Check Button. Initiates a Status Check of the Transceiver. See Status Check on page 1-18. When pressed simultaneously with the Telemetry Button, turns Alarm Suspend/Pause on/off (not when tethered to TeleMon). See Suspending/

Pausing Alarms on page 2-2. Silences the Find Device tone.See Telemetry Controls in the Patient Window on page 6-2. Battery Compartment. Insertion of batteries turns transceiver power on; removal of batteries turns power off. See Turning the Transceiver On on page 1-15. Indicators IntelliVue TRx+

M4841A EASI, 3 5,6 I1 I2 I3 I4 Callout Indicator I1 I2 I3 I4 EASI The IntelliVue Transceiver Definition Lead Indicator. Illuminates momentarily during leadset insertion to indicate attached leads. Illluminates when Check button is pressed to indicate attached leads. During a Leads Off condition, illuminates to indicate the lead(s) that need to be reapplied. Momentarily illuminates three alternate lights, indicating the transceiver has no Equipment Label assigned. EASI Indicator. Illuminates momentarily upon insertion of leadset in EASI position. Illuminates when Check button is pressed if EASI is in use. Alarms Suspend/Pause Indicator. Illuminates during 3 minute alarm pause initiated at transceiver or Information Center. Battery Gauge. Illuminates when the EHck button is pressed to indicate the amount of power remaining in the batteries. Valid only for recommended battery type. See Checking the Battery Power Level on page 1-22. Basic Operation 1-9 The IntelliVue Transceiver Labels L1 IntelliVue TRx+

M4841A EASI, 3 5,6 L2 L3 Callout Label IntelliVue TRx M4841A EASI, 3 5,6 L1 L2 L3 Definition Leadset Insertion Guide. Assist in aligning the ECG cable for different leadsets. See Connecting the ECG Cable on page 3-19. NoteIf your unit uses only one monitoring configuration, the transceiver may have special "lock out" plugs that allow only one way to insert the leadset. Device Identification Label. Identifies the device within the IntelliVue Wireless Network. Unit Identification Label. Uses one of seven color-coded labels to identify a clinical unit. Ports P2 P1 IntelliVue TRx+

M4841A EASI, 3 5,6 Callout P3 P1 P2 P3 Definition ECG Leadset Port. Connection for 3-wire or 5-wire leadset. SpO2 Sensor Port. Connection for SpO2 sensor. (IntelliVue TRx+

only) TeleMon/Service Port. Connection for cable to TeleMon Companion Monitor or to Service Tool. Note Ports can be covered with protective covers (gunk guards) when not in use. See Gunk Guards on page -4. 1-10 Basic Operation Transceiver Controls - Back The IntelliVue Transceiver EASI EASI EASI I S E A 1 2 3 4 5 6 FCCID: XXXXXXXX S6 L4 S1 S2 S3 S7-S11 not shown

(inside battery compartment) S4 S5 IntelliVue TRx+ Transceiver - Back View Basic Operation 1-11 The IntelliVue Transceiver L4 Labels EASI EASI I S E A 1 23456 Callout L4 Definition Electrode Placement Diagrams (See Positioning ECG Electrodes on page 3-8.) Safety Symbols &

Other Marks Callout S1 S2 S3 S4 S5 Label FCCID: XXXXXXXX Rx Definition Federal Communications Commission

(FCC) (PTT) label Patient connections are protected against defibrillation (DEFIBRILLATION-

PROOF) and are a TYPE CF APPLIED PART. Prescription device. Non-Ionizing Radiation. Interference to electronic equipment may occur in the vicinity of devices marked with this symbol. Complies with all applicable Canadian and American standards. 1-12 Basic Operation The IntelliVue Transceiver Callout Label Definition S6 S7 S8 S9 S10 S11 Follow operating instructions. Philips Catalog Number Serial Number (inside battery compartment). Needed to identify the equipment during a call to the Response Center. MAC Address of device i REF SN MAC Date of manufacture Battery Polarity Auditory Information Signals The transceiver produces auditory feedback to inform you of measurement and battery conditions. Adjustable sounds can be set to 5 different volume levels or turned off per patient at the Information Center (see Patient-Configurable Settings in Telemetry Setup on page 6-3). Adjustable sounds include Check Basic Operation 1-13 The IntelliVue Transceiver button Standby functions, SpO2 measurement complete, outside of coverage area warning, and the pulse detection tone. Auditory Information Signal Single Tone Definition Self Test passed SpO2 Spot Check measurement successful Single Tone, low pitch Pulse detection successful (when locally initiated) Double Tone Self Test failed SpO2 Spot Check measurement failed Double Tone repeated every 5 seconds Out of range Continuous Double Tone, two pitches Find Device Single Tone (when Check button pressed) Transceiver is associated with sector at Information Center (after Standby). Double Tone (when Check button pressed) Transceiver not associated with sector at Information Center (after Standby). Double Tone and all indicators flashing No equipment label is assigned from Information Center. No monitoring. Fast Double Tone and alternate Leads Off indicators flashing Equipment label is received from Information Center and is awaiting local acknowledgment by Check button press. Volume/Mute Adjustable no yes yes no yes yes no yes yes no no 1-14 Basic Operation Transceiver Safety Information Turning the Transceiver On Warning Warning If another radio medical device is operating at the same frequency as an IntelliVue Transceiver, it is possible that either device will not function properly. Warning Warning Although the transceiver is shielded against Electromagnetic Interference

(EMI), avoid the use of other electrically radiating devices in close proximity to the transceiver because they might interfere with transceiver operation. Warning Warning Place the transceiver in a pouch or over clothing, or both, during patient use. The transceiver should not touch the patients skin during use. Turning the Transceiver On Warning Warning Arrhythmia relearning is initiated whenever the transceiver is powered down for one minute or longer. Be sure to check your patients arrhythmia annotation for accuracy whenever relearn has occurred. The transceiver is powered by two AA alkaline batteries. To turn the transceiver on, insert both batteries. Remove the batteries to turn the power off. The configuration data set by the Service Provider prior to transceiver use is retained after battery removal. Basic Operation 1-15 Turning the Transceiver On When the transceiver is turned on, all indicators illuminate briefly and a sequence of sounds indicates the instrument is ready for use. You should hear a single beep indicating that the self test was passed, followed by a series of double beeps while the transceiver attempts to associate with the Information Center. The cessation of sounds indicates a successful association. If you hear a single double beep or any other sound sequence, the automatic self-test of the device has not passed, or there is another problem. Contact your Service Provider. Sounds at successful start-up Self-test insert batteries 1 beep (pass) Transceiver looking for Info Center beep beep repeated every 3 seconds Connected no beep Turning the Transceiver Off Turn off the transceiver by removing the batteries. A NO SIGNAL technical alarm will be in effect at the Information Center until the device is turned on or until Standby is initiated. Telemetry monitoring can be turned off in the following ways:

Manually, by activating Monitoring Standby at the Information Center

(see Standby Mode on page 2-5). Automatically, if Transceiver RF Auto Shutoff is enabled and there is no ECG signal for 10 minutes. NoteTurning off telemetry monitoring does not turn off the transceiver. Auto Shutoff Automatic Shutoff causes the transceiver to stop broadcasting a radio signal if there is no ECG signal for 10 minutes. This prevents interference with other transceivers in use. The technical alarm text at the Information Center is Transmitter Off. To conserve battery power, remove batteries. 1-16 Basic Operation Testing intelliVue Transceiver Functionality To restart monitoring, insert batteries if necessary, attach leads to the patient and press the Check button to verify association with the Information Center. Testing intelliVue Transceiver Functionality There are two tests of IntelliVue Transceiver functionality:

Self Test -performed automatically each time the transceiver is turned on Status Check - initiated manually by the clinician. Self Test Warning Warning Do not use the transceiver for patient monitoring if it fails the Power On Self Test. A self test of the transceiver functions is automatically performed each time that the transceiver is turned on (that is, batteries are inserted). Self Test Status Passed Auditory Signal (if configured on) Single beep Visual Indicators All indicators illuminate for 3 seconds Failed Double beep One or more indicators do not light up. In Case of Failure If any portion of the self test fails, the transceiver will attempt to report the failure to the monitoring system. In case of failure, use another transceiver, and contact your Service Provider. Basic Operation 1-17 Testing intelliVue Transceiver Functionality Status Check You can check the status of the transceiver indicators at any time. To initiate a Status Check, use the following instructions. Step Action 1 Press the Check button. The following indicators should illuminate for as long as the Check button is depressed. Battery gauge Type of leadset EASI (if in use) If one or more of the expected indicators do not light up, check the following:

Lead block insertion. Make sure the leadset is correctly inserted in the transceiver and the orange line at the base of the cable is not visible (see Connecting the ECG Cable on page 3-19). Power and position of batteries (see Checking the Battery Power Level on page 1-22) Lead positions and connections (see Verifying Electrode Connections on page 3-22) If there is still a problem, contact your Service Provider for assistance. 2 1-18 Basic Operation Battery Information Battery Information Battery Safety Information Warning Warning Use Duracell MN 1500 AA 1.5V Alkaline batteries to ensure specified performance. Outdated, mismatched or poor-quality batteries can give unacceptable performance (e.g., insufficient Battery-Low warning time). The use of fresh high-quality alkaline batteries is strongly recommended. Batteries should be removed from the transceiver at the end of the batterys useful life to prevent leakage. If battery leakage should occur, use caution in removing the battery. The leaked substance may cause eye or skin irritation. Avoid contact with skin. Clean the battery compartment according to instructions in Chapter 7. Maintenance & Troubleshooting. Wash hands. Certain failure conditions, such as short circuits, can cause a battery to overheat during normal use. High temperatures can cause burns to the patient and/or user. If the transceiver becomes hot to the touch, place it aside until it cools. Then remove the batteries and discard them. Have the transceiver operation checked by your Service Provider to identify the cause of overheating. The battery door must be closed during defibrillation. If you receive a BATTERY LOW alarm, the batteries must be promptly replaced. A "Battery Low" condition that is not corrected will result in a transceiver shutdown and cessation of monitoring. Basic Operation 1-19 Battery Information Disposal of Batteries Caution The batteries must be removed if a transceiver will be stored for an extended period of time. ImportantWhen disposing of batteries, follow local laws for proper disposal. Dispose of batteries in approved containers. If local regulations require you to recycle batteries, recycle batteries in accordance with those regulations. Battery Life Battery life is dependent upon:

Condition of the batteries Parameters being monitored - ECG only, ECG and Spot Check SpO2, or ECG and Continuous SpO2. By observing the following guidelines, you can optimize battery life in the transceiver:

REMOVE the batteries when the transceiver is not in use. Disconnect the SpO2 extender cable (if used). (When the SpO2 sensor is disconnected, the SpO2 functionality is automatically powered down, but an extender cable will continue to drain power from the SpO2 electronics.) Warning Warning Arrhythmia relearning is initiated whenever the transceiver is powered down for one minute or longer. Be sure to check your patients arrhythmia annotation for accuracy whenever relearn has occurred. Caution Remove the batteries before storing a transceiver for an extended period of time. Inserting/

Removing Batteries 1-20 Basic Operation Battery Information The battery compartment is located at the bottom of the transceiver behind a swinging door. It accommodates a pair of AA 1.5V Alkaline batteries. Only this type of disposable battery shall be used. ImportantDo not use rechargeable batteries. Use of this type of battery will adversely affect:

Battery gauge performance Battery low warnings Battery life performance Insert batteries into the transceiver using the following procedure. Step Action 1 2 Open the battery compartment by swinging the compartment door 90o counterclockwise into an open hinged position. Insert two AA 1.5V Alkaline batteries, matching the polarity with the +/- indications inside the compartment.

+

+

Note Both batteries are inserted with the + polarity in the same direction. Basic Operation 1-21 Battery Information Step Action Removing the Batteries 3 4 5 Close the battery compartment door. Listen for the start-up sounds. Watch for the indicators on the front of the transceiver to illuminate briefly. Connect/reconnect the patient cables to the transceiver. Batteries should be changed in sets, that is, if you change one battery, change them both. To remove the batteries, simply open the battery compartment door and push from the opening at the back of the compartment to pop the batteries out. Transceiver settings (ECG leadset type, SpO2 mode, volume, etc.) are retained indefinitely when the batteries are removed. If you remove good batteries to turn off the transceiver, keep them together as a set for later re-use so that both batteries will have the same level of power remaining. Batteries should be removed when the transceiver is not in use or is being stored. DO NOT "STORE" BATTERIES BY LEAVING THEM IN THE INCORRECT POLARITY POSITION IN THE TRANSCEIVER. Be careful not to short circuit the batteries. Short circuits are caused when a piece of metal touches both the positive and negative terminals simultaneously

(for example, by carrying batteries in a pocket with loose change). More than a momentary short circuit will generally reduce the battery life. In case of a short circuit, discard both batteries in a pair, or just the shorted one if the batteries are new. Checking the Battery Power Level When the Check button is pressed, the battery gauge on the transceiver indicates the battery power level. It is reliable only when specified batteries (i.e., AA 1.5V Alkaline) are used. The battery gauge is also displayed in the Patient Sector at the Information Center to enable you to closely monitor battery status, for example, at change of shift. 1-22 Basic Operation Important In the following table, battery life times are based on Duracell MN 1500 batteries. Battery life for other brands may be different. Battery Information Battery Gauge Approximate Battery Life Remaining Approximate Operating Time Remaining Functionality 4 green indicators

> 75%

> 34.7 hours Normal operation 3 green indicators

> 50%

> 23.1 hours Normal operation 2 green indicators

> 25%

> 11.6 hours Normal operation 1 green indicator 25% to Low Battery level

> 15 minutes Normal operation

< 15 minutes SpO2 disabled none Transceiver shutdown/

RF shutdown 1 red indicator no indicator Battery Low level to Replace Battery level Replace Battery level

(Check batteries for correct polarity) To check the power level:

Step Action 1 2 Press the Check button to determine the level. If no indicators flash:

1. Check that the batteries are inserted properly. 2. Replace both batteries. 3. If there are still no indicators on the battery gauge, contact your Service Provider. If the indicators illuminate but do not behave as described above, the transceiver has malfunctioned. Contact your Service Provider. Basic Operation 1-23 Briefing the Patient Briefing the Patient Warning Warning Patients should be instructed not to open the battery cover while the transceiver is in use. If the Telemetry button has been configured to generate a Nurse Call, remote recording, or both, instruct the patient to use the button when needed. NoteIf desired, you can turn off patient use of the button at the Information Center. See Patient-Configurable Settings in Telemetry Setup on page 6-3. Pouch Use The transceiver is not designed for direct contact with the patients skin. During normal use, the transceiver should be worn over clothing, in a pocket or, preferably, in a pouch. The carrying pouch is an appropriate means for holding the transceiver. 1-24 Basic Operation Securing the Pouch Step Action Briefing the Patient 1 2 Secure the pouch on the patient with upper ties around the patients head and arm, and lower ties around the patients lower torso. Warning Warning To avoid strangulation, do not tie a pouch solely around the patients neck. Insert the transceiver into the pouch with lead wires and SpO2 sensor cable, if used, exiting from the same side. ImportantDo not coil the cables inside the pouch. They are part of the wireless system, and need to be freely exposed. Basic Operation 1-25 Briefing the Patient Step Action 3 4 Fold the flap down and snap closed. Check that the patient is comfortable wearing the pouch with transceiver. Showering Warning Warning Signal quality and leads off detection may be compromised when showering due to significant patient movement. Appropriate clinical precautions must be taken. The transceiver can be used to monitor a patient in the shower, but only when placed inside a Philips carrying pouch with the flap closed and the snaps secured. The combination of the transceiver and pouch will withstand showering for up to 10 minutes. 1-26 Basic Operation Transceiver Use with TeleMon A02/A03 Drying the Transceiver after Showering After showering, perform the following steps to continue monitoring:

1. Pat dry the leadset connections at the electrodes. 2. Wipe the lead wires with care. 3. 4. 5. If wet, dry the outside of the transceiver with a non-lint producing cloth. If wet, wipe the inside of the battery compartment dry. Dry the batteries. If wet, disconnect the ECG lead block and shake out any water. Dry the connector pin area with a cotton swab. NoteThe transceiver should not be used for monitoring if the battery compartment is wet. Remove the batteries and wipe the compartment dry before continued monitoring use. Accidental Wetting If the transceiver is accidentally immersed in liquid for up to 5 minutes, no damage to the device and no electrical safety issues for the patient will result. Remove the device, dry it off, and follow the procedure for cleaning/disinfection or cleaning/cross-infection prevention under Troubleshooting on page 7-15 as appropriate. Transceiver Use with TeleMon A02/A03 When tethered to TeleMon, the following transceiver operational behavior will be in effect. Alarms ECG Operation SpO2 Operation 3 minute alarm pause/suspend can be initiated only from TeleMon, not from the transceiver or from the Information Center. The Alarm Suspend/

Pause indicator on the transceiver will accurately reflect the current state of alarm pause. Standby mode is not available. Vb, the second V-lead in 6-wire lead-set, is not supported. After a change in leadset, the TeleMon returns to the default ECG settings, and arrhythmia relearn occurs automatically. Be sure to check the monitoring leads after you switch leads. Basic Operation 1-27 Transceiver Use with TeleMon A02/A03 SpO2 is always in continuous mode. Changes in SpO2 mode do not take effect until after the transceiver is disconnected from TeleMon. Mode settings are defined in the following table:

Mode at TeleMon Mode at Disconnected Transceiver Continuous 5-min. 1-min. Manual Continuous Continuous Continuous Spot Check After a change in SpO2 sensor, TeleMon returns to the default ECG settings, and arrhythmia relearn occurs automatically. Be sure to check the monitoring leads after you change the sensor. Transceiver Operational Controls & Indicators When you press the Telemetry button, a Nurse Call alarm, recording, alarm and recording, or neither will be generated, depending on the configuration at the Information Center. When you press the Check button, the transceiver battery gauge indicates full power, regardless of actual battery strength. When you press the Telemetry and Check buttons together, there is no action; a 3-minute alarm pause/suspend can be initiated only from TeleMon. The alarm pause indicator on the transceiver will accurately reflect the current state of alarm pause. When the transceiver is connected to TeleMon, the battery gauge on the transceiver and displayed at the Information Center always indicates "full"

regardless of actual battery power. To update the gauge, disconnect the transceiver and wait several seconds for the updated battery strength to be displayed. Defibrillation In the event of patient defibrillation, it may take several seconds for the ECG trace to reappear on the screen. 1-28 Basic Operation 2 Alarms I n t r o d u c t i o n This chapter describes how to pause/suspend alarms temporarily. It also lists Physiologic (Patient) Alarms and Technical (Inoperative Conditions) Alarms. Both types of alarms are listed alphabetically. Alarm Indicators . 2-2 Suspending/Pausing Alarms . 2-2 Standby Mode. 2-5 Alarm Behavior with Own Bed Overview . 2-7 Physiologic Alarms. 2-9 Technical Alarms (INOPs) . 2-14 Alarms 2-1 Alarm Indicators Alarm Indicators A description of visual and auditory information signals for patient and technical alarms on the Information Center is located in the IntelliVue Information Center Instructions for Use and the Information Center Online Help.The Information Center documentation also includes the default alarm settings and physiological alarm limit ranges Testing Alarm Indicators The visual alarm information signal on the transceiver is the Alarms Suspend icon. During self test, the Alarm Suspend indicator illuminates, and a single tone indicates association with the Information Center. These positive test results indicate that the Alarm Suspend icon on the transceiver is functioning correctly

(see Status Check on page 1-18). Suspending/Pausing Alarms Warning Warning If the Alarms Suspend indicator on the transceiver remains illuminated after the button combination to unsuspend alarms is pressed, a the transceiver malfunction may have occurred. Alarms resume automatically after the 3 minute suspension period, or you can resume them manually at the Information Center. The transceiver should be replaced, and the malfunctioning unit should be sent to your Service Provider. All alarms for a patient can be suspended/paused from the Information Center, from the TeleMon Companion Monitor, or, depending on transceiver configuration, from the transceiver itself. The Alarm Suspend/Pause duration is fixed at 3-minutes. Alarms automatically resume after 3 minutes, and can be reactivated manually earlier. 2-2 Alarms Suspending/Pausing Alarms If connected to TeleMon, alarms can be suspended only from TeleMon, and not from the Information Center, and the Alarms Suspend icon on the transceiver is lit (see Transceiver Controls - Front on page 1-7), and an ALARMS SUSPENDED message appears at TeleMon and the Information Center. ImportantPatient monitoring (display of patient waveforms and numerics) continues for the duration of Alarm Suspend/Pause. Step Action 1 To activate Alarm Pause/Suspend at the transceiver, press the Telemetry and Check buttons simultaneously. While alarms are suspended:

The transceiver illuminates the Alarms Suspend icon. The message ALARMS SUSPENDED (or ALARMS PAUSED) is displayed in the Patient Sector at the Information Center. 2 For instructions on how to pause/suspend alarms from the Information Center, see the IntelliVue Information Center Instructions for Use and the Information Center Online Help. Alarms 2-3 Suspending/Pausing Alarms Resuming/

Unsuspending Alarms Alarms will be resumed automatically after 3 minutes. You can cancel alarm suspend manually before the 3-minute period has expired from the transceiver

(see following directions) or from the Information Center. Step Action 1 Press the Telemetry and Check buttons simultaneously. Auditory alarm indication at the transceiver is switched on. The Alarm Suspend icon is turned off. The message ALARMS SUSPENDED (or ALARMS PAUSED) is removed from the display. 2 Alternately, you can unsuspend alarms at the Information Center. See IntelliVue Information Center Instructions for Use or Online Help for directions. 2-4 Alarms Standby Mode Standby Mode Standby mode is useful when the transceiver is temporarily removed from a patient or when a patient is intentionally moved out of range of an Access Point. Standby suspends monitoring so you wont get any patient alarms or waveforms. It also disables the out of range audio signal. Patient data and current settings are preserved during the Standby period. Standby also serves to turn telemetry monitoring off when a patient is discharged. Patient data is not erased and unit default settings are not in effect until the discharge operation is performed. A bed should be put into Infinite standby until a new patient is connected to the transceiver. Monitoring can then be restarted by a click of the Resume Monitoring button. NoteTo discharge a patient:

Disconnect the patient. Remove batteries from the transceiver. Put bed in Standby. 1. 2. 3. You place a patient in standby mode at the Information Center. You can select the duration of the standby period (Infinite, 4, 3, 2, or 1 hours, 30, 20, or 10 minutes). The approximate time of resumption of monitoring will be displayed. To restart monitoring, click on Resume Monitoring in the Patient Sector. NoteUnless you are discharging a patient, keep the leads attached until the patient is in Standby. If you remove the leads before putting a patient into Standby, youll get an ECG LEADS OFF technical alarm, as well as reminders, if configured. Initiating Standby Step Action 1 2 In the Patient Window or All Controls at the Information Center, select the Standby button. Select the patient destination from the pre-defined list. Alarms 2-5 Standby Mode Step Action 3 4 Depending on your equipment configuration, select the duration of the standby period (30, 20 or 10 minutes; 2, 3 or 4 hours; or infinite). Select the Suspend Monitoring button. This suspends all monitoring and displays the following messages in the Patient Sector: PATIENT LOCATION:xxx (for example, X-ray) and TELEMETRY STANDBY. The approximate time of resumption is also displayed. Resuming Monitoring Step Action 1 2 If the standby period has expired when the patient returns to the unit, monitoring will resume automatically. To verify the resumption of monitoring, press the Check button. You should hear a single beep. If the standby period has not expired when the patient returns to the unit, monitoring must be reactivated manually. Either click Resume Monitoring at the Information Center or press the Check button on the transceiver to establish reassociation. The audible tone (single beep) at the transceiver verifies that monitoring has resumed. NoteWhen you take an EASI patient out of Standby, the lead settings will be reset to the Information Centers default lead settings. 2-6 Alarms Alarm Behavior with Own Bed Overview Alarm Behavior with Own Bed Overview Both the IntelliVue Patient Monitor and the telemetry system source alarms. The following tables summarize alarm behavior when Own Bed Overview is used. For detailed information, see the IntelliVue Patient Monitor Instructions for Use and the IntelliVue Information Center Instructions for Use. Alarm Pause/Suspend When alarms are paused/suspended, the messages and types of alarms affected depend on where the pause/suspend was initiated. If alarms are paused/

suspended from.... Information Center these alarms are paused/

suspended both bedside and telemetry measurements IntelliVue Patient Monitor bedside measurements only and this message appears Information Center: ALARMS PAUSED or ALARMS SUSPENDED Bedside: ALARMS OFF in Overview window and ALARMS PAUSED or ALARMS OFF on the monitor (depending on configuration) Information Center: BED ALARMS PAUSED or BED ALARMS SUSPEND (depending on configuration) Bedside: ALARMS PAUSED or ALARMS OFF Alarms 2-7 Alarm Behavior with Own Bed Overview Alarm Silence When an active alarm is silenced, the types of alarms that are silenced depend on the alarm source and where the silence was initiated. Alarm Source Where Silenced Bedside alarm Bedside Effect at Paired Bedside Alarm is silenced Telemetry alarm Bedside Bedside and/or telemetry alarm Overview Silence Control No effect on telemetry alarms Bedside or telemetry alarm is silenced Effect at Information Center Bedside alarm is silenced. There is no effect on telemetry alarms No effect on telemetry alarms Bedside alarm is silenced (if Silence Overview Alarms is configured) Bedside and/or telemetry alarm Information Center Bedside or telemetry alarm is silenced Bedside or telemetry alarm is silenced NoteIf tethered to TeleMon, silencing an active alarm at TeleMon silences the alarm at TeleMon only. It has no effect on the paired bedside monitor or the Information Center. 2-8 Alarms Physiologic Alarms Alarm/INOPs at the Information Center The alarms and INOPs that are displayed, recorded and stored at the Information Center depend on the type of alarm. Type of Alarm/INOP Effect at Information Center All ECG telemetry alarms and INOPs NoteECG is generated from telemetry when paired. Displayed, recorded (if configured), and stored Bedside ECG INOPs and RESP INOPs Ignored. Not displayed, recorded, or stored Bedside non-ECG alarms and non-ECG INOPs Displayed, recorded (if configured), and stored Physiologic Alarms Physiologic alarms indicate a life-threatening situation or a less urgent situation such as heart rate beyond limits. There are no physiologic alarm signals generated by the transceiver. All physiologic alarms are generated at the IntelliVue Information Center, and all alarm signals must be acknowledged at the Information Center. Arrhythmia alarm chaining and other aspects of alarm behavior, such as alarm levels, setting alarm limits, customizing arrhythmia alarm settings on a per patient basis, switching individual measurement alarms on/off, and reviewing alarm messages, are described in IntelliVue Information Center Instructions for Use. There are two levels of arrhythmia analysis available at the Information Center:

Basic and Enhanced. Enhanced analysis includes Basic alarms. Alarms 2-9 Physiologic Alarms Alarm Text

***ASYSTOLE In the table, Red (***) alarms are listed alphabetically, followed by the Yellow

(**) alarms, the Yellow (*) arrhythmia alarms. Physiologic (Patient) Alarms Priority Condition Red Asystole. No QRS for 4 consecutive seconds

*** BRADY yyy < xxx Red Extreme Bradycardia. HR less than extreme Brady HR Limit

*** DESAT Red

*** EXTREME BRADY Red Very Low SpO2 Saturation. SpO2 value below desaturation limit (10% or 10

"points" below low limit). Extreme Bradycardia. HR less than extreme Brady HR Limit

*** EXTREME TACHY Red Extreme Tachycardia. HR greater than extreme Tachy HR Limit

*** TACHY yyy > xxx Red Extreme Tachycardia. HR greater than extreme Tachy HR Limit

*** VFIB/TACH Red Ventricular Fibrillation. Fibrillatory waveform for 4 consecutive seconds 2-10 Alarms Source ST/AR Basic &

Enhanced Arrhythmia ST/AR Enhanced Arrhythmia SpO2 ST/AR Basic &

Enhanced Arrhythmia ST/AR Basic &

Enhanced Arrhythmia ST/AR Enhanced Arrhythmia ST/AR Basic &

Enhanced Arrhythmia Physiologic Alarms Alarm Text

*** VTACH Physiologic (Patient) Alarms Priority Condition Red Ventricular Tachycardia. Sustained run of PVCs accompanied by a high heart rate

** NURSE CALL Yellow

** SpO2 HIGH

** SpO2 LOW Yellow Yellow

** SpO2 yyy > xxx or Yellow

** SpO2 yyy < xxx or

* HR HIGH Yellow Yellow Patient or nurse button press on the transceiver (when configured for Nurse Call operation) Also initiated if the installation includes a paging system and if the Information Center is configured for paging upon receipt of Nurse Call signal. High SpO2. SpO2 value greater than high SpO2 Limit. Low SpO2. SpO2 value less than low SpO2 Limit. High SpO2. SpO2 value greater than high SpO2 Limit. Low SpO2. SpO2 value less than low SpO2 Limit. High Heart Rate. HR greater than high HR Limit

* HR LOW Yellow Low Heart Rate. HR less than low HR Limit Source ST/AR Basic &

Enhanced Arrhythmia Clinician-

initiated at transceiver or by paging subsystem SpO2 SpO2 SpO2 SpO2 ST/AR Basic &

Enhanced Arrhythmia ST/AR Basic &

Enhanced Arrhythmia Alarms 2-11 Physiologic Alarms Alarm Text

* HR yyy > xxx Physiologic (Patient) Alarms Priority Condition Yellow High Heart Rate. HR greater than high HR Limit

* HR yyy < xxx Yellow Low Heart Rate. HR less than low HR Limit

* IRREGULAR HR Yellow Irregular Heart Rate. Constantly irregular HR.

* MISSED BEAT Yellow Missed Beat. Beat omitted

* MULTI ST Lx, Ly Yellow Multi ST Leads exceeding Limit (EASI mode or when selected). Two ST leads

(Lx=Lead X and Ly=Lead Y) exceed alarm limit elevation or depression for >

60 seconds

* MULTIFORM PVCs Yellow Multiform PVCs

* NON-SUSTAIN VT Yellow Non-Sustained VT. Non-sustained Ventricular Tachycardia

* PACER NOT CAPT Yellow Pacer Not Capture. Missed beat with pace pulse (paced patient). Source ST/AR Enhanced Arrhythmia ST/AR Enhanced Arrhythmia ST/AR Enhanced Arrhythmia ST/AR Enhanced Arrhythmia ST/AR Arrhythmia ST/AR Enhanced Arrhythmia ST/AR Enhanced Arrhythmia ST/AR Basic &

Enhanced Arrhythmia 2-12 Alarms Physiologic Alarms Physiologic (Patient) Alarms Alarm Text Priority Condition

* PACER NOT PACE Yellow Pacer Not Pacing. Missed beat without pace pulse (paced patient).

* PAIR PVCs Yellow Pair of PVCs.

* PAUSE Yellow Pause. No QRS for more than x seconds

* PVC > xx/min Yellow PVCs > xx/min. PVCs greater than Rate Limit

* R-ON-T PVCs Yellow R-on-T PVCs

* RUN PVCs Yellow Run PVCs. Run of PVCs length >= 2

* ST lead > xxx

* ST lead < xxx

* SVT Yellow Yellow Yellow STx > Elevation limit. ST segment is elevated STx < Depression limit. ST segment is depressed. Supra Ventricular Tachycardia. SVT for >

15 seconds Source ST/AR Basic &

Enhanced Arrhythmia ST/AR Enhanced Arrhythmia ST/AR Enhanced Arrhythmia ST/AR Basic &

Enhanced Arrhythmia ST/AR Enhanced Arrhythmia ST/AR Enhanced Arrhythmia ST/AR Arrhythmia ST/AR Arrhythmia ST/AR Enhanced Arrhythmia Alarms 2-13 Technical Alarms (INOPs) Physiologic (Patient) Alarms Alarm Text Priority Condition

* VENT BIGEMINY Yellow Ventricular Bigeminy. Predominant Bigeminy rhythm present.

* VENT RHYTHM Yellow Ventricular Rhythm. Ventricular rhythm present.

* VENT TRIGEMINY Yellow Ventricular Trigeminy. Predominant Trigeminy rhythm present. Source ST/AR Enhanced Arrhythmia ST/AR Enhanced Arrhythmia ST/AR Enhanced Arrhythmia Notes: xxx = limit that was exceeded; yyy = current value.

* NBP alarms are processed independently at the Information Center. The alarm delay from TeleMon to the Information Center is not more than 10 seconds. Technical Alarms (INOPs) Technical Alarms, or INOPs, are sourced at the transceiver, the ST/AR algorithm running at the Information Center, or TeleMon Companion Monitor, and identify inoperative conditions (that is conditions where the system cannot measure or detect alarm conditions reliably). There are three levels of Technical Alarms:

Severe - Monitoring and alarms disabled. Audible tone at the Information Center. Must be acknowledged by a clinician. Hard - Monitoring and alarms are disabled. Audible tone at the Information Center. Soft - Monitoring and alarms remain active. No audible tones are generated. 2-14 Alarms Technical Alarms (INOPs) Technical Alarms (Inoperative Conditions) (in alphabetic order) Alarm Text Priority Condition What to do BATTERY LOW Soft Power is low. Replace batteries promptly to avoid transceiver shutdown and cessation of monitoring. Assess the lead selections, initiate relearn, and validate analyzed rhythm. CANNOT ANALYZE ECG Hard CANNOT ANALYZE ST Soft Arrhythmia algorithm cannot reliably analyze the ECG data on any monitored leads. ST algorithm cannot reliably generate any valid ST values on any monitored lead. Review the ECG signal quality and correct if necessary. Reposition the Is and J points. CHARGE MON BAT Hard TeleMon battery charge is less than or equal to 25%. CUFF NOT DEFLATED Severe Cuff pressure is greater than a specified safety limit for a period of time. Connect TeleMon to AC power and charge battery, or insert battery with charge greater than 25%. Remove cuff from patient and disconnect from tubing. Gently expel any air. If water in cuff, replace cuff. Reconnect, and reapply cuff to patient. NoteIf the alarms are suspended, this INOP will unsuspends them at the Information Center and TeleMon. To clear the INOP message, initiate a new NBP measurement. Alarms 2-15 Technical Alarms (INOPs) Technical Alarms (Inoperative Conditions) (in alphabetic order) Alarm Text Priority Condition What to do ECG EQUIPMENT MALF Hard Failure of the ECG equipment or failure to calibrate ECG. Replace the transceiver or calibrate ECG with Service Tool. ECG LEADS OFF Hard Multiple leads off

<electrode> LEAD OFF Hard Primary lead is off. NoteIf primary lead is MCL, lead will be identified as V in INOP text.

<electrode> LEAD OFF Soft Non-primary lead is off. INVALID LEADSET Hard Bad lead selection switches in the transceiver NO SIGNAL Hard Patient is out of range, radio board has failed, ICN connection failure, or no batteries in transmitter. Reattach ECG leads to patient. Reattach ECG lead to patient. Reattach ECG lead to patient. Replace transceiver case. Use supported leadset. Contact Service. Make sure that the transceiver is in own care-

group range and has good batteries. Replace the transceiver if Power On Self Test fails, and notify Service Provider. Dead battery. No monitoring is occurring. Replace batteries. REPLACE BATTERY Hard, Latched Message remains until acknowle dged by clinician. 2-16 Alarms Technical Alarms (Inoperative Conditions) (in alphabetic order) Alarm Text Priority Condition What to do Technical Alarms (INOPs) SOME ECG ALRMS OFF Soft SpO2T EQUIP MALF SpO2T ERRATIC Hard Hard SpO2T EXTD UPDATE Numeric is replaced by a

-?-. Soft SpO2T INTERFERENCE Hard SpO2T LOW PERFUSION Soft Some yellow arrhythmia alarms have been turned off for this patient. For information only. Malfunction in the SpO2 equipment SpO2 board needs to be replaced. Call Service. Erratic SpO2 measurements, often due to a faulty sensor or invalid SpO2 measurements, or incorrect transducer position The update period of displayed values is extended due to an NBP measurement on the same limb or an excessively noisy signal. Level of ambient light or level of electrical interference are so high that the SpO2 sensor cannot measure SpO2 and pulse rate. Repeat measurement, reposition sensor on patient, or finally, replace sensor. If NBP is not active, check the sensor placement. Reposition the sensor on patient, or replace sensor. Reduce ambient light to sensor or electrical noise sources. Accuracy may be reduced due to low perfusion. Data displayed with ?. Warm the site. Increase perfusion. Change sensor site. Avoid site distal to BP cuff or intra-arterial line. SpO2T NO SENSOR Hard No sensor attached to SpO2 device Attach SpO2 sensor. Alarms 2-17 Technical Alarms (INOPs) Technical Alarms (Inoperative Conditions) (in alphabetic order) Alarm Text Priority Condition What to do SpO2T NOISY SIGNAL Hard SpO2T NON-PULSATILE Hard Excessive patient movements or electrical interference are causing irregular pulse patterns Pulse is too weak or not detectable Reduce movement or electrical noise sources. Check connection to patient. Change sensor site. Avoid site distal to BP cuff or intra-

arterial line. SpO2T SENSOR MALF Hard Malfunction of the SpO2 sensor/adapter-cable Replace sensor. TELEMETRY STANDBY Soft Information Center standby mode timer is active, or patient was not returned to telemetry coverage area. There is no data from bed. Cancelled when patient is removed from Standby. TRANSMITTER MALF Hard Transceiver malfunction Replace and notify Service Provider. TRANSMITTER OFF Hard RF shut off after 10 minutes of leads off Reattach ECG leads to patient. WEAK SIGNAL Soft Patient is at outer range of the radio coverage area. Telemetry pack is receiving a weak signal with high data loss from the AP. Return patient to the radio coverage area. If patient is in close proximity to AP, replace telemetry pack. If condition exists for multiple devices in a specific area, the AP in that area is suspect. Contact Service. 2-18 Alarms 3 ECG Monitoring This chapter covers the specifics of ECG measurement. It includes the following sections:

I n t r o d u c t i o n ECG Safety Information . 3-2 Measuring ECG . 3-3 Positioning ECG Electrodes . 3-8 Connecting the ECG Cable. 3-19 Verifying Electrode Connections . 3-22 Monitoring during Leads Off . 3-23 Optimizing ECG Measurement Performance. 3-25 ECG Monitoring 3-1 ECG Safety Information ECG Safety Information Warning Warning For ALL Patients:

Always confirm Information Center observations with clinical observation of the patient before administering interventions. Every lead must be secured to an electrode on the patient. Conductive parts of electrodes must not contact earth or other conductive parts. Philips recommends that you change the lead label only to reflect the physical placement of electrodes. This will ensure a match between the monitored lead and the label, and prevent any possible confusion. When switching from EASI to standard monitoring, there is a loss of data for 30 seconds. For PACED Patients:

The output power of the transceiver and other sources of radio frequency energy, when used in the proximity of a pacemaker, can be sufficient to interfere with pacemaker performance. Due to the shielding effects of the body, internal pacemakers are somewhat less vulnerable than external pacemakers. However, caution should be exercised when monitoring any paced patient. In order to minimize the possibility of interference, position electrodes, electrode wires, and the transceiver as far away from the pacemaker as possible. Consult the pacemaker manufacturer for information on the RF susceptibility of their products and the use of their products with the Philips IntelliVue Telemetry System. See the IntelliVue Information Center Instructions for Use for additional information on monitoring paced patients. 3-2 ECG Monitoring Measuring ECG Measuring ECG EASI ECG ECG Leadsets The electrocardiogram (ECG) measures the electrical activity of the heart and displays it on the Information Center as a waveform and a numeric. There is no cardiotach within the transceiver; cardiotach analysis resides in the arrhythmia algorithm at the Information Center. Arrhythmia analysis is always turned on for telemetry patients. Arrhythmia analysis is either basic or enhanced, depending on the product configuration. EASI derived 12-lead ECGs and their measurements are approximations to conventional 12-lead ECGs. As the 12-lead ECG derived with EASI is not exactly identical to the 12-lead conventional ECG obtained from an electrocardiograph, it should not be used for diagnostic interpretations. The IntelliVue Transceiver supports 3-, 5-, and 6-wire leadsets. It detects the inserted leadset type and automatically determines the ECG measurement and transmitted leads. The Leadset Insertion Guide on the device will assist you in ensuring the correct measurement during transceiver usage (see Connecting the ECG Cable on page 3-19). The 5-wire leadset can be used for either standard or EASI electrode configurations. The leadsets are compatible with the 5- and 3-

wire leadsets used with the IntelliVue family of monitors and with M2601B transmitters. The electrode placements for the illustrations in this chapter use the AAMI labels and colors and are summarized in the following table. Leadset 3-wire Electrode Color (AAMI) Electrode Location Black White Red LA RA LL ECG Monitoring 3-3 Measuring ECG Leadset 5-wire

(Standard mode) 5-wire (EASI mode) 6-wire Electrode Color (AAMI) Electrode Location Black White Red Green Brown Black White Red Green Brown Black White Red Brown Green Brown/White LA RA LL RL V S I A RL E LA RA LL Va RL Vb ECG Leads Monitored Depending on the leadset connected to the transceiver, a different set of viewable leads are available at the Information Center. The transceiver can 3-4 ECG Monitoring Measuring ECG source up to four raw ECG waves. The transceiver automatically recognizes the leadset connected. If you are using ... these leads can be selected at the Information Center 3-wire I, II, III If lead selection is enabled, sourced waves are received as:

Channel 1 - I Channel 2 = II Channel 3 = III If lead selection is disabled, the sourced wave is II. Default is II. 5-wire (Standard mode) I, II, III, aVR, aVL, aVF, MCL and V Sourced waves are received as:

Channel 1 - I Channel 2 = II Channel 3 = III 5-wire (EASI mode) Defaults are II, V, III. I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6 In EASI mode, the sourced waves are received as:

Channel 1 = Vector 1 (A-I) Channel 2 = Vector 2 (A-S) Channel 3 = Vector 3 (E-S) NoteArrhythmia monitoring is performed only on the primary and secondary leads selected at the Information Center, although you can view and perform ST analysis on all 12 EASI derived leads. ECG Monitoring 3-5 Measuring ECG If you are using ... 6-wire

(not supported in TeleMon) these leads can be selected at the Information Center I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6, V7, V8, V9, V3R, V4R, V5R. Sourced waves are received as:

Channel 1 = II Channel 2 = III Channel 3 = Va Channel 4 = Vb The two chest leads, Va and Vb, can be placed on the patient in any of the V lead positions (V1 through V9, V3R, V4R, V5R). Lead assignment is available at the Information Center. When unassigned, the chest leads use the defaults. Defaults are II, III, Va=V2, Vb=V5. NoteWhen display of the pleth wave is enabled at the Information Center, the second chest lead (Vb) is not available for monitoring due to bandwidth limit. That is, the lead label assigned to Vb cannot be selected for Va even though Vb does not appear to be used. Reconstructed Leads Reconstruction of leads from the sourced wave is defined by the calculations in the following table. EASI reconstructed leads are a linear combination of all three raw EASI leads. Default labels/leads are shown in bold text. ECG Lead 3-Lead 5-Lead Standard 6-Lead Clinical Calculations in terms of electrodes I I I LA-RA 3-6 ECG Monitoring Measuring ECG ECG Lead 3-Lead 5-Lead Standard 6-Lead Clinical Calculations in terms of electrodes II III

-

-

-

-

-

II III MCL aVR aVL aVF V II III

-

aVR aVL aVF Va Vb LL-RA LL-LA Va-LA, C=Va (see Note) RA-(LA+LL)/2 LA-(RA+LL)/2 LL-(LA+RA)/2 C-(RA+LA+LL)/3, where C=V C-(RA+LA+LL)/3, where Va=V2 position Vb-(RA+LA+LL)/3, where Vb

=V5 ECG Monitoring 3-7 Positioning ECG Electrodes Positioning ECG Electrodes Warning Warning Do not mix and match electrodes of different types. In particular, do not use electrodes of dissimilar metals. This helps ensure optimal signal quality. Warning Warning When you are connecting the electrodes or the patient cable, make sure that the connectors never come into contact with other conductive parts, or with earth. In particular, make sure that all of the ECG electrodes are attached to the patient, to prevent them from contacting conductive parts or earth. Warning Warning Non-manufacturer supplied accessories and supplies can corrupt the performance of the equipment. Use only AAMI EC-12 compliant electrodes with this device. Use of electrodes that are non-compliant may provide erroneous results. Caution To protect the transceiver from damage during defibrillation, to ensure accurate ECG information, and to provide protection against signal noise and other interference, use only ECG electrodes and cables specified by Philips. To make it possible to compare measured ECG signals, the electrodes (or leadsets) are placed in standardized positions, forming so-called "leads". To obtain ECG signals optimized for use in diagnosis and patient management in different care environments, different leadsets in varying lead placements can be used. You can use either standard lead placements or EASI lead placements with the transceiver. 3-8 ECG Monitoring Positioning ECG Electrodes When placing electrodes on the patient, choose a flat, non-muscular site where the signal will not be impacted by either movement or bones. Correct lead placement is always important for accurate diagnosis. Especially in the precordial leads, which are close the heart, QRS morphology can be greatly altered if an electrode if moved away from its correct location. In addition to correct positioning of the electrodes, optimal skin preparation prior to electrode placement will help ensure a clear signal for diagnosis. Step Action 1 Prepare the patients skin. Good electrode-to-skin contact is important for a good ECG signal, as the skin is a poor conductor of electricity. Select sites with intact skin, without impairment of any kind. Clip or shave hair from the site as necessary. Wash site with soap and water, leaving no soap residue. Note--Philips does not recommend using ether or pure alcohol, because they dry the skin and increase the resistance. Dry thoroughly. Use ECG skin preparation paper (abrasive) to remove dead skin cells and to improve the conductivity of the electrode site. ECG Monitoring 3-9 Positioning ECG Electrodes Step Action 2 3 Check electrodes for moist gel, and attach to the clips. If you are not using pre-gelled electrodes, apply electrode gel to the electrodes before placement. NoteGel must be moist to provide a good signal. Place the electrodes on the patient according to the lead placement you have chosen (see Electrode Placement following). Place the edge down, then "roll down" the rest of the pad. Press firmly around the adhesive edge toward the center. NoteWhen placing electrodes, choose a flat, non-muscular site where the signal will not be interfered with by either movement or bones. Correct lead placement is always important for accurate measurement, especially in the precordial leads, which are close to the heart. QRS morphology can be greatly altered if an electrode is moved away from its correct location. Electrode Placement Diagrams for 5-lead standard and EASI electrode placement are located on the back of the transceiver. Additional lead placement information is available in the Online Help in the IntelliVue Information Center. Philips recommends that electrodes be changed every 24 hours. 3-10 ECG Monitoring Positioning ECG Electrodes Locating the Fourth Intercostal Space Angle of Lewis For accurate chest electrode placement and measurement, it is important to locate the fourth intercostal space. This can be done using the Angle of Lewis. 1. Locate the second intercostal space by first palpating the Angle of Lewis

(the bony protuberance where the body of the sternum joins the manubrium). This rise in the sternum is where the second rib is attached, and the space just below this is the second intercostal space. 2. Palpate and count down the chest until you locate the fourth intercostal space. ECG Monitoring 3-11 Positioning ECG Electrodes 3-Lead Placement RA LA LL Lead RA LA LL Placement directly below the clavicle and near the right shoulder directly below the clavicle and near the left shoulder on the left lower abdomen 3-12 ECG Monitoring Positioning ECG Electrodes 5-Lead Placement

(Standard Mode) RA LA V1 V2 V3 V4 V5 V6 RL LL Placement directly below the clavicle and near the right shoulder directly below the clavicle and near the left shoulder on the left lower abdomen on the right lower abdomen on the chest, the position depends on your required lead selection. The default position is V2. on the fourth intercostal space at the right sternal border Lead RA LA LL RL V V1 ECG Monitoring 3-13 Positioning ECG Electrodes Lead V2 V3 V4 V5 V6 Placement on the fourth intercostal space at the left sternal border midway between the V2 and V4 electrode positions on the fifth intercostal space at the left midclavicular line on the left anterior axillary line, horizontal with the V4 electrode position on the left anterior axillary line, horizontal with the V4 electrode position 3-14 ECG Monitoring Positioning ECG Electrodes 5-Lead Placement

(EASI Mode) Warning Warning EASI derived 12-lead ECGs and their measurements are approximations to conventional 12-lead ECGs. As the 12-lead ECG derived with EASI is not exactly identical to the 12-lead conventional ECG obtained from an electrocardiograph, it should not be used for diagnostic interpretations. EASI lead placement is supported for adult patients only S E A I Lead Corresponds to Standard Lead Placement E A V LL on the lower sternum at the level of the fifth intercostal space on the left midaxillary line at the same level as the E electrode ECG Monitoring 3-15 Positioning ECG Electrodes Lead Corresponds to Standard Lead Placement S I N LA RA Reference on the upper sternum on the right midaxillary line at the same level as the E electrode can be anywhere, usually below the sixth rib on the right hip NoteMake sure that the D and E electrodes line up vertically on the sternum, and that the I, E and A electrodes align horizontally. 6-Lead Placement A 6-lead placement uses the same four limb leads as 5-lead standard placement, and two precordial leads - referred to at the Information Center as Va and Vb. The default position of Va - the brown lead - is at the V2 position. The default position for Vb - the brown/white lead - is at the V5 position. Your unit may use other precordial leads for Va and Vb. In that situation, you need to assign those new positions in the Patient Window at the Information Center. The Va and Vb default positions can be changed in the configuration at the Information Center on a per patient basis. 3-16 ECG Monitoring Positioning ECG Electrodes RA LA V1 V2 V3 V4 V5 V6 Lead RA LA RL LL Va RL LL Placement directly below the clavicle and near the right shoulder directly below the clavicle and near the left shoulder on the right lower abdomen on the left lower abdomen on the chest, the position depends on your required lead selection. The Philips default position is V2. For other positions, relabel the lead at the Information Center. ECG Monitoring 3-17 Positioning ECG Electrodes Lead Vb V1 V2 V3 V4 V5 V6 Placement on the chest, the position depends on your required lead selection. The Philips default position is V5. For other positions, relabel the lead at the Information Center. on the fourth intercostal space at the right sternal border on the fourth intercostal space at the left sternal border midway between the V2 and V4 electrode positions on the fifth intercostal space at the left midclavicular line on the left anterior axillary line, horizontal with the V4 electrode position on the left anterior axillary line, horizontal with the V4 electrode position 3-18 ECG Monitoring Connecting the ECG Cable Connecting the ECG Cable NoteYour transceiver may have alignment guides to assist you in leadset insertion. Step Action 1 Match the arrow on the ECG cable with the arrow on the Lead Insertion Guide according to the lead type you have chosen, and insert the ECG cable into the transceiver. ImportantMake sure that the cable is pushed completely into the transceiver. When correctly inserted, the orange line at the base of the cable is not visible. 3-wire Match the arrow on the cable with the left arrow (labeled EASI, 3) on the Leadset In-

sertion Guide. NoteLeadset is keyed for only one insertion position. IntelliVue TRx+

M4841A EASI, 3 5.6 ECG Monitoring 3-19 Connecting the ECG Cable Step Action 5-wire Standard Match the arrow on the cable with the right arrow (labeled 5, 6) on the Leadset Insertion Guide. Match the arrow on the cable with the left arrow (labeled EASI, 3) on the Leadset In-

sertion Guide. IntelliVue TRx+

M4841A EASI, 3 5.6 5-wire EASI IntelliVue TRx+

M4841A EASI, 3 5.6 NoteIf you are using a 5-wire leadset in both Standard and EASI modes, insert the protective plug into the open lead port with the wide lip facing the leads. Then, press down firmly so that the plug is securely under the leadset and the orange line is not visible. 3-20 ECG Monitoring Connecting the ECG Cable Match the arrow on the cable with the right arrow (labeled 5,6) on the Leadset Insertion Guide. Step Action 6-wire IntelliVue TRx+

M4841A EASI, 3 5.6 2 Check that the correct Electrode Indicators are lit for the leadset you are using, and that the EASI indicator light is illuminated appropriately. See Verifying Electrode Connections on page 3-22. When using 5-lead standard, the EASI indicator does not When using EASI, the EASI indicator illuminates illuminate. momentarily. 3 For 3-lead, select the lead label(s) at the Patient Window. Cable Disconnection When disconnecting the leadset from the transceiver, grasp the leadset firmly and pull free. Do not pull on the lead wires. ECG Monitoring 3-21 Verifying Electrode Connections Verifying Electrode Connections The electrode indicators enable you to verify that the leads are available for the desired monitoring. Each electrode is color-coded. Pressing and holding the Check button enables you to view the leadset status. During routine use of the transceiver for monitoring, all lead indicators are off. To verify electrode connections, use the following procedure:

Step Action 1 2 Press and hold the Check button for 2 seconds Expected Response:

If 3-wire cable is attached: Red, White and Black indicators illuminate, then all turn off. If 5-wire cable in Standard mode is attached: Red, White, Black, Green & Brown indicators illuminate, then all turn off. If 5-wire cable in EASI mode is attached: Red, White, Black, Green & Brown indicators illuminate, then all turn off. The EASI indicator also illuminates briefly. If 6-wire cable is attached: Red, White, Black, Green, Solid Brown and Brown/White indicators illuminate, then all turn off. If no leadset is attached: all indicators are off. 3 Unexpected Response:

Any other response indicates a problem with the transceiver. Check the leadset connection and/or use a new leadset. If the problem is not corrected, contact your Service Provider. 3-22 ECG Monitoring Monitoring during Leads Off During routine monitoring, the electrode indicators also notify you if one or more leads are not functioning. When a LEADS OFF condition occurs, the transceiver automatically illuminates the indicator corresponding to the missing lead. Monitoring during Leads Off ECG Fallback and Extended monitoring states are supported for the transceiver when the primary and/or secondary leads are in a Leads Off INOP condition. Both these states are entered into after 10 seconds of Leads Off in an attempt to maintain monitoring and arrhythmia analysis. ECG Fallback ECG Fallback occurs when the primary lead is in Leads Off for 10 seconds and a secondary lead is available. ECG Fallback must be configured on by your Service Provider. Multilead Analysis If there is a LEADS OFF technical alarm in the primary lead for > 10 seconds, the active secondary lead becomes the primary lead. The arrhythmia algorithm switches the leads on the display, but relearn does not occur. When the Leads Off condition is corrected, the leads are switched back to their original state. Single Lead Analysis For single lead analysis, if there are two leads available, the secondary lead is made the primary lead until the Leads Off condition is corrected. The arrhythmia algorithm performs a relearn using the available lead. Fallback for EASI If one of the derived EASI leads is in a technical alarm condition, a flat line is displayed. After 10 seconds, the directly acquired EASI AI, AS, or ES lead, depending on which is available, is displayed with the label "ECG". Arrhythmia relearn is performed with transition to or from EASI Fallback monitoring using the available lead(s). ECG Monitoring 3-23 Monitoring during Leads Off Extended Monitoring Extended monitoring occurs when both the primary and secondary leads are in Leads Off for 10 seconds and another lead is available. It becomes the primary lead and the arrhythmia algorithm performs a relearn. Extended Monitoring applies if:

Telemetry is configured for Extended Monitoring ON. The leas set provides more than two leads (e.g., when using a 5-wire leadset ).The leadset must provide more than two leads, and Extended monitoring must be configured on by your Service Provider. Relearning Whenever there is a Leads Off condition, the arrhythmia algorithm performs a Relearn, using the available leads. Warning Warning Since Relearn happens automatically, if learning takes place during ventricular rhythm, the ectopics can be incorrectly learned as the normal QRS complex. This can result in missed detection of subsequent events of V-Tach and V-Fib. For this reason, you should:

1. Respond promptly to any technical alarm. 2. Ensure that the arrhythmia algorithm is labeling beats correctly. Using EASI Leads to Troubleshoot If there is artifact in the ECG waves or a CANNOT ANALYZE ECG technical alarm condition is in effect, you can use the three EASI leads to troubleshoot:

1. Click 12-Lead ECG on the Patient Window, then on 3 EASI Leads. 2. The three directly acquired EASI leads will be displayed so that you can determine which electrodes are causing the problem and need to be replaced. 3-24 ECG Monitoring Optimizing ECG Measurement Performance Optimizing ECG Measurement Performance While telemetry monitoring offers many advantages, it can be a challenge. The reliability and quality of the signal transmission through the air and hospital walls is governed by a number of variables which can be difficult to control. A telemetry system cannot be as dependable as a hardwired bedside monitor that transmits its signal through a wire. The effect of interference on the Philips IntelliVue Telemetry System ranges from a momentary loss of ECG to complete inoperability, depending on the situation. The strength, frequency, and proximity of the source of interference to the transceiver devices or the access point system are factors that determine the degree of severity. In cases where the source of interference is known - for example, cellular phones, magnetic equipment such as MRI, other radio or motorized equipment - removing or moving away from the source of interference will increase the equipment's dependability. Warning Warning Philips IntelliVue Telemetry System should not be used for primary monitoring in applications where the momentary loss of the ECG is unacceptable. In this section, we'll investigate some of the problems affecting ECG signal clarity and when possible, show you how you can greatly enhance performance. ImportantPhilips IntelliVue Telemetry System also emits radio frequencies that can affect the operation of other devices. Contact the manufacturer of other equipment for possible susceptibility to these frequencies. The Telemetry Signal The transceiver worn by the patient acquires the patient's physiological data, amplifies and digitizes it, detects pace pulses and broadcasts this information via radio waves to the Philips IntelliVue Telemetry System. Since the signal passes through the air, it is susceptible to interference from many sources. ECG Monitoring 3-25 Optimizing ECG Measurement Performance Trouble- shooting Signal Disturbances Dropouts Because Philips IntelliVue Telemetry System is a wireless system, under certain conditions RF (Radio Frequency) dropouts can occur. Dropouts result from a weak signal or RF interference. There will be signal drops to the bottom of channel for a minimum of 200 ms to indicate to the clinical user that it is a non-

physiological event. If dropouts are frequent enough to affect the heart rate count, the CANNOT ANALYZE ECG or CANNOT ANALYZE ST technical alarm occurs. The following recording strip is an example of dropouts. If frequent dropouts are occurring, the following section describes some steps you can take to improve performance. Signal Strength The Philips IntelliVue Telemetry System is custom designed for your unit, so reliable signal reception is only possible where there are receiving access points. When the signal is too low, the following technical alarms occur:

CANNOT ANALYZE ECG CANNOT ANALYZE ST WEAK SIGNAL NO SIGNAL To correct, first check the location of the patient. If the patient is not in the coverage area, do one of the following. Return the patient to the specified coverage area. Put telemetry in Standby Mode. See Standby Mode on page 2-5. If the patient is in the coverage area and is stationary, try moving the location of the transceiver from its original location by about 15 cm (6 inches). 3-26 ECG Monitoring Optimizing ECG Measurement Performance Radio Frequency Interference Radio frequency (RF) interference is caused by anything that intrudes into the transmitted electrical signal, such as paging transmitters. You are probably familiar with electrical interference in our homes and cars when it causes signal loss or static with cell phones. These same types of interference can occur with the transmitted telemetry signal. Even though the Philips IntelliVue Telemetry System is designed to resist these effects, interference can occasionally be seen in the form of dropouts. To improve performance, the source of the interference must be identified and eliminated. Muscle and Movement Artifact Muscle and movement artifact differ from radio frequency interference since you can prevent much of the occurrence. Noise on the ECG signal can be caused by many sources, such as interference from other electrical equipment, muscle artifact and respiratory variation. It is up to the clinician to use certain techniques to minimize these types of noise. Use the following table to help you troubleshoot the most common sources of ECG noise. Troubleshooting Common Causes of ECG Noise Problem Cause Remedy 60-Cycle (AC) Interference Poor electrode placement. Possible non-grounded instrument near patient Muscle Artifact Tense, uncomfortable patient. Poor electrode placement. Tremors. Diaphoresis Apply fresh electrodes after recommended skin preparation. Disconnect electrical appliances near patient (one at a time) by pulling wall plugs, to determine faulty grounding. Have engineering check grounding. Make sure patient is comfortable. Check that electrodes are applied on flat non-muscular areas of the torso;

apply fresh electrodes after recommended skin preparation if necessary (see Positioning ECG Electrodes on page 3-8). ECG Monitoring 3-27 Optimizing ECG Measurement Performance Troubleshooting Common Causes of ECG Noise Problem Cause Remedy Irregular Baseline Poor electrical contact. Respiratory interference. Faulty electrodes. Dry electrodes. Apply fresh electrodes after recommended skin preparation if necessary (see Positioning ECG Electrodes on page 3-8). Move electrodes away from areas with greatest movement during respiration. Baseline Wander Movement of patient. Make sure patient is comfortable. Improperly applied electrodes. Respiratory interference. Poor Electrode Contact Loose electrodes. Defective cables. Leadset not firmly connected. Apply fresh electrodes after recommended skin preparation if necessary (see Positioning ECG Electrodes on page 3-8). Check that patient cable is not pulling electrodes. Move electrodes away from areas with greatest movement during respiration. Apply fresh electrodes after recommended skin preparation if necessary (see Positioning ECG Electrodes on page 3-8). Replace cables. 3-28 ECG Monitoring 4 ST/AR Arrhythmia & ST Segment Monitoring I n t r o d u c t i o n This chapter describes the ST/AR algorithms used for telemetry at the Philips Information Center. It includes the following sections:

ST/AR Arrhythmia Algorithm . 4-2 ST/AR provides Heart Rate and PVC Rate numerics and alarm detection for the conditions listed in the following table. There are two detection levels: Basic and Enhanced. Enhanced includes the Basic alarms. 4-4 The Measurement . 4-6 Adjusting ST Measurement Points . 4-9 Establishing ST Reference Beats (Baseline) . 4-11 ST Alarm Settings. 4-11 ST Alarm Settings. 4-11 ST/AR Arrhythmia & ST Segment Monitoring 4-1 ST/AR Arrhythmia Algorithm ST/AR Arrhythmia Algorithm Safety Information Warning Warning FOR ALL PATIENTS During complete heart block or pacemaker failure (to pace or capture), tall P-waves (greater than 1/5 of the average R-wave height) can be erroneously counted by the arrhythmia algorithm, resulting in missed detection of cardiac arrest. Learning/Relearning

- Learning: If you initiate learning during ventricular rhythm, the ectopics can be incorrectly learned as the normal QRS complex. This can result in missed detection of subsequent events of V-Tach and V-Fib.

- Relearning: When using EASI ECG monitoring, Relearn happens automatically when there is a LEADS OFF technical alarm. If learning takes place during ventricular rhythm, the ectopics can be incorrectly learned as the normal QRS complex. This can result in missed detection of subsequent events of V-Tach and V-Fib. Be sure to check the beat labels and initiate a relearn to correct. 1. Respond to the technical alarm [for example, reconnect the electrode(s)]. 2. Ensure that the arrhythmia algorithm is labeling beats correctly. 4-2 ST/AR Arrhythmia & ST Segment Monitoring ST/AR Arrhythmia Algorithm Warning Warning FOR PACED PATIENTS It is possible that pacemaker pulses will not be detected when the ECG analog output of a defibrillator or telemetry unit is plugged into a bedside monitor. This can result in the arrhythmia algorithms failure to detect pacemaker non-capture or asystole. Some pace pulses can be difficult to reject. When this happens, the pulses are counted as a QRS complex, and could result in an incorrect HR and failure to detect cardiac arrest or some arrhythmias. Keep pacemaker patients under close observation.

-- During complete heart block or pacemaker failure (to pace or capture), tall P-waves (greater than 1/5 of the average R-wave height) can be erroneously counted by the arrhythmia algorithm, resulting in missed detection of cardiac arrest.

-- When arrhythmia monitoring paced patients who exhibit only intrinsic rhythm, the monitor can erroneously count pace pulses as QRS complexes when the algorithm first encounters them, resulting in missed detection of cardiac arrest. For patients who exhibit intrinsic rhythm only, the risk of missing cardiac arrest can be reduced by monitoring these patients with the low heart rate limit at or slightly above the basic/demand pacemaker rate. A low heart rate alarm alarms you when the patient begins pacing. Proper detection and classification of the paced rhythm can then be determined.

-- When an external pacemaker is being used on a patient, arrhythmia monitoring is severely compromised due to the high energy level in the pacer pulse. This can result in the arrhythmia algorithms failure to detect pacemaker non-capture or asystole. ST/AR Arrhythmia Analysis For information on arrhythmia detection, refer to the following documentation:

ST/AR Algorithm - Arrhythmia Monitoring Application Note (4522 981 ST/AR Arrhythmia & ST Segment Monitoring 4-3 ST/AR Arrhythmia Algorithm 93051) IntelliVue Information Center Instructions for Use and Online Help The intended use of the ST/AR basic arrhythmia analysis algorithm is to monitor the patients ECG for heart rate and ventricular arrhythmias and to produce events/alarms simultaneously for one or more ECG leads. The arrhythmia algorithm is effective when monitoring both paced and non-paced patients in a clinical environment. IntelliVue Telemetry does not have a dedicated cardiotach. Instead, the arrhythmia cardiotach at the Information Center is used. Therefore, the ST/AR Arrhythmia algorithm is always on for all IntelliVue Telemetry patients, and cannot be turned off. ST/AR provides Heart Rate and PVC Rate numerics and alarm detection for the conditions listed in the following table. There are two detection levels: Basic and Enhanced. Enhanced includes the Basic alarms. Basic & Enhanced Arrhythmia Detection Basic Arrhythmia Detection Enhanced Arrhythmia Detection Asystole Tachy yyy > xxx Vent Bigeminy Vent Fib/Tach Brady yyy < xxx Vent Trigeminy V tach Extreme Brady Extreme Tachy High HR Low HR Non-Sustain VT Multiform PVCs Vent Rhythm Run PVCs Pair PVCs Pause HR yyy > xxx HR yyy < xxx Irregular HR PVCs > 30/min Missed Beat Pacer Not Capturing SVT Pacer Not Pacing R-on-T PVCs 4-4 ST/AR Arrhythmia & ST Segment Monitoring ST/AR Arrhythmia Algorithm Beat classification determined by the ST/AR algorithm is shown on the primary delayed wave in the Arrhythmia Analysis window at the Information Center. To access this window, select Arrhythmia Analysis from the Patient Window. The annotation requires clinical validation of the analyzed heart rhythm. If the analysis is inaccurate, perform a relearn of the rhythm. Annotation Beat Classification Color A I L M N P S V

?

Artifact Inoperative Learning Missed Beat Normal Paced Supraventricular Premature Ventricular Premature Questionable Pacer Mark Blue Red Red Red Blue Blue Blue Red Red Blue When monitoring is initiated, when the Wave 1 lead is changed, or if Relearn is selected, a question mark (?) is displayed next to HR and the annotation L appears on the annotated wave until the HR is calculated and the rhythm is learned. ST/AR Arrhythmia & ST Segment Monitoring 4-5 ST/AR ST Segment Algorithm ST/AR ST Segment Algorithm Warning Warning This device provides ST level change information; the clinical significance of the ST level change information should be determined by a physician. The ST/AR ST algorithm at the Information Center (not available for M3153A) monitors ST segment elevation or depression for each available telemetry ECG lead and produces events/alarms simultaneously. ST values update with every measurement period and enunciate, depending upon the severity of the change, events and alarms as they are detected. The ST/AR ST algorithm is approved for use only with non-paced and atrially-

paced adult telemetry-monitored patients. With EASI monitoring, ST analysis is performed on up to 12 leads, and an additional value of ST index is calculated and displayed (see EASI ST Analysis on page 4-8). Assessment of EASI-

derived 12-lead ST measurement is recommended for adult patients that meet the following parameters:

Ages: 33-82 years Heights: 147 to 185 cm (58 to 73 in) Weights: 53 to 118 kg (117 to 261 lbs) Height to Weight Ratios: 1.41 to 2.99 cm/kg (0.25 to 0.54 in/lb) All ST analysis and ST alarms for telemetry patients are performed by the Information Center. For additional information on ST monitoring, refer to the following documentation:

ST/AR Algorithm - ST Segment Monitoring Application Note (4522 981 92851) Information Center Online Instructions for Use and Online Help The Measurement The ST measurement for each beat complex is the vertical difference between two measurement points. The isoelectric point provides the baseline for the 4-6 ST/AR Arrhythmia & ST Segment Monitoring ST/AR ST Segment Algorithm measurement and the ST point provides the other measurement point. It is positioned with reference to the J-point. R-WAVE PEAK AT 0 MSEC J POINT T P Q S DIFFERENCE =

ST VALUE ISO ELECTRIC POINT DEFAULT =

-80 MSEC ST MEASUREMENT POINT DEFAULT =

J+60 MSEC ST/AR Arrhythmia & ST Segment Monitoring 4-7 ST/AR ST Segment Algorithm Algorithm Processing ST analysis analyzes ECG signals to classify the heart beats. Only beats classified as normal or Supraventricular (atrially paced) are used to calculate ST elevations and depressions. The ST/AR ST algorithm processing includes special ST filtering, beat selection and statistical analysis, calculation of ST segment elevations and depressions, and lead reconstruction and wave generation. When ST analysis is being performed on two leads, the averaged derived and reconstructed ST waves and associated ST segment values are given for up to six leads, depending on the type of patient cable:

3-wire: one lead 5-wire: up to two leads if monitoring a chest and a limb lead 5-wire: up to six leads if monitoring two limb leads with the Philips Transmitter (without EASI monitoring) 5- wire: up to 12 leads if monitoring using EASI NoteNo ST analysis is done on a patient if an electrode falls off. Displayed ST Data EASI ST Analysis ST data displays as values in the Patient Sector and Patient Window. A positive value indicates ST segment elevation; a negative value indicates ST segment depression. You can view ST data in ST Review, Trend Review, and Event Review windows. The Information Center generated ST values presented in the patient sector and Patient Window for EASI derived leads is STindx (ST Index). STindx is a summation of three ST segment measurements, using the leads that can indicate ST segment changes in the different locations of the heart:

anterior lead V2 lateral lead V5 inferior lead aVF Caution Be sure not to duplicate the lead labels. This can result in incorrect ST values being displayed for those leads. 4-8 ST/AR Arrhythmia & ST Segment Monitoring ST Operation Turning ST Monitoring On/

Off ST/AR ST Segment Algorithm The ST Setup Window allows you to turn ST monitoring on or off for all available ECG leads. To turn ST monitoring on at the Information Center, perform the following steps:

Step Action 1 2 3 From the Patient Window, click the All Controls button. From the All Controls Window, click the ST Setup button. From the ST Setup Window, click ST On. You would turn ST monitoring off if:

You are unable to get any lead that is not noisy. Arrhythmias such as atrial fib/flutter cause irregular baseline. The patient is continuously ventricularly paced. The patient has left bundle branch block. Adjusting ST Measurement Points The ST Setup Window enables you to adjust the ST measurement points to ensure accurate data. There are three measurement cursors:

The ISO measurement cursor positions the isoelectric point in relation to the R-wave peak. The J-point cursor positions the J-point in relation to the R-wave peak. The purpose of the J-point is to correctly position the ST measurement point. The ST measurement cursor positions the ST point a fixed distance from the J point. NoteThe ST measurement points may need to be re-adjusted if the patient's heart rate or ECG morphology changes significantly. ST/AR Arrhythmia & ST Segment Monitoring 4-9 ST/AR ST Segment Algorithm Perform the following steps at the Information Center to adjust the ST measurement points:

Step Action 1 2 Access the ST Setup window by clicking on the All Controls button in the Patient Window, then clicking on the ST Setup button. If you need to adjust the ISO (isoelectric) point, place the cursor over the ISO button to access the adjustment arrows. Then use the arrows to position the bar in the middle of the flattest part of the baseline (between the P and Q waves or in front of the P wave). R P T ISO point Q S 4-10 ST/AR Arrhythmia & ST Segment Monitoring ST/AR ST Segment Algorithm Step Action 3 4 Adjust the J point, if necessary, by placing the cursor over the J-

point button to access the adjustment arrows. Then use the arrows to position the bar at the end of the QRS complex and the beginning of the ST segment. R P T SQ J point Adjust the ST point, if necessary, by using the J point as an anchor and placing the bar at the midpoint of the ST segment. Choices are J+0, J+20, J+40, J+60, or J+80. R P T Q S ST point Establishing ST Reference Beats

(Baseline) After adjusting the measurement points, you can establish baseline reference beats for all available leads in the ST Review window at the Philips Information Center. Reference beats enable you to compare waveform changes, for example from admission, or prior to or after treatment. The reference continues to be saved beyond the 24 hour review window, but you can update it to any beat within the last 24 hours. Please refer to the Philips Information Center Instructions for Use18 or on-line Help for directions. ST Alarm Settings All Philips Information Center alarm settings (limits and on/off status) have unit default settings. The Philips Information Center however, lets you set the high and low ST alarm limits for individual patients based on:

ST/AR Arrhythmia & ST Segment Monitoring 4-11 ST/AR ST Segment Algorithm Your assessment of the patient's clinical condition. Unit protocols. Physician orders or medication specified limits. You can make the following adjustments to ST alarm limits to accommodate the clinical condition of individual patients:

Turn all alarms off/on. Adjust the alarm limits:

to specific high and low limits to Smart Limits (see the Philips IntelliVue Information Center Instructions for Use for information on Smart Limits) back to unit default settings. You adjust the ST alarm limits in the ST Alarms Window. Each ST parameter has its own alarm limit. The alarm is triggered when the ST value exceeds its alarm limit for more than 1 minute. The alarm will be a yellow alarm. When more than one ST parameter is in alarm, only one alarm message displays. For multilead alarms when using an EASI transmitter, an alarm is generated if two or more ST leads exceed the alarm limits. The default setting is +/-1.0. The alarm message indicates the two leads that are in greatest violation of the limits, for example, **MULTI ST AVR, V6. If another lead becomes deviant, the message changes but it is considered the same alarm (no new alarm sounds and it is not listed as a new event). See Physiologic Alarms on page 2-9 for a list of all ST alarms. See IntelliVue Information Center Instructions for Use for specifics on alarm management and behavior. Adjusting ST Alarms Make adjustments to ST alarms on the ST Alarms window at the Information Center. Step Action 1 From the Patient Window, select the All Controls button. 4-12 ST/AR Arrhythmia & ST Segment Monitoring ST/AR ST Segment Algorithm Step Action 2 3 From the All Controls window, select the ST Alarms button under Alarm Management and Setup. In the ST Alarms window, adjust alarms as needed. Choices for setting the ST alarm limits are:

Unit SettingsClick on this button if want to have the specific limits that are pre-set for your unit. Smart LimitsClick on this button to set high and low limits around your patient's current ST value. The difference above and below the patient's ST value are pre-set for your unit. NoteSmart Limits can be configured to automatically be activated when the patient is connected. See the IntelliVue Information Center Instructions for Use for additional information on using smart limits. Specified limitsUse these to set the high and low alarm limits based on your assessment of the patient's clinical condition, unit protocols, or physician orders or medication specified limits. A good guideline is + 1.0 mm or - 1.0 mm from the patient's ST, or follow your unit protocol. ST/AR Arrhythmia & ST Segment Monitoring 4-13 ST/AR ST Segment Algorithm 4-14 ST/AR Arrhythmia & ST Segment Monitoring 5 SpO2 Monitoring I n t r o d u c t i o n This chapter provides an introduction to the SpO2 measurement and its application. It includes the following sections:

SpO2 Safety Information . 5-2 Pulse Oximetry Measurement. 5-4 Selecting a SpO2 Sensor. 5-5 Applying the Sensor . 5-9 Connecting the SpO2 Cable . 5-14 Measuring SpO2 . 5-15 Understanding SpO2 Alarms . 5-20 Optimizing SpO2 Measurement Performance . 5-21 SpO2 Monitoring 5-1 SpO2 Safety Information SpO2 Safety Information Warning Warning Always confirm Information Center observations with clinical observation of the patient before administering interventions. Prolonged, continuous monitoring can increase the risk of changes in skin characteristics, such as irritation, reddening, blistering or pressure necrosis, particularly on patients with impaired perfusion and varying or immature skin morphology. Specific attention must be given to sensor site inspection for changes in skin quality, proper optical path alignment and attachment. Check the application site at regular intervals and change the site if any compromise in skin quality should occur. More frequent checking can be required due to an individual patient's condition. Using a sensor during MR imaging can cause severe burns. To minimize this risk, ensure that the cable is positioned so that no inductive loops are formed. If the sensor does not appear to be operating properly, remove it immediately from the patient. Do not use disposable sensors on patients who exhibit allergic reactions to the adhesive. Injected dyes such as methylene blue or intravascular dyshemoglobins such as methemoglobin and carboxyhemoglobin can lead to inaccurate (over-

estimated) measurements. Interference leading to inaccurate measurements can be caused by:

- High levels of ambient light (Hint: cover application site with opaque material)

- Electromagnetic interference

- Excessive patient movement and vibration. 5-2 SpO2 Monitoring SpO2 Information for the User1 SpO2 Safety Information Warning Warning Removal of the SpO2 sensor during Continuous SpO2 monitoring results in a NO SENSOR technical alarm. There is no technical alarm for a "No Sensor" condition in Spot Check mode. The pulse oximeter is calibrated to indicate fractional oxyhemoglobin, and displayed results can range from 0 to 100%. A 10 second averaging filter is used in the calculation of the result. Displayed results are typically updated every second, but the update period can be automatically delayed by up to 30 seconds in the presence of noise. Physiological SpO2 alarm signals will be generated at the central station. The SpO2 low limit can be set between 50 and 99% inclusive, in 1% increments. The SpO2 high alarm limit can be set between 51 and 100% inclusive, in 1%

increments. The maximum delay between the physiological alarm condition and alarm signal generation at the central station is 10 seconds. Pulse rate is also derived from the pulsatile SpO2 measurement, and displayed results can range from 30 to 300 bpm. There is no alarm function for pulse rate. The pleth wave is auto-scaled to maximum display size. It decreases only when the signal quality becomes marginal. Pleth wave size is NOT directly proportional to the pulse volume. 1. A functional tester cannot be used to assess the accuracy of a pulse oximeter sensor or a pulse oximeter monitor. If there is independent demonstration that a particular calibration curve is accurate for the combination of a pulse oximeter monitor and a pulse oximeter sensor, then a functional tester can measure the contribution of a monitor to the total error of a monitor/sensor system. The functional tester can then measure how accurately a particular pulse oximeter monitor is reproducing that calibration curve. SpO2 Monitoring 5-3 Pulse Oximetry Measurement Pulse Oximetry Measurement The ECG-SpO2 TRx+ Transceiver supports an SpO2 sensor connection using Fourier Artifact Suppression Technology (FAST). The FAST algorithm overcomes many of the issues associated with traditional pulse oximetry such as sensitivity to patient movement and intense ambient light. The algorithm offers improved motion artifact rejection as well as performance improvements for patients with low perfusion. SpO2 can be measured continuously, where a value is sent to the Information Center every second, or as a single, individual measurement (Spot Check). The Spot Check measurement will be removed from the Information Center display after 24 hours. If 1-minute or 5-minute sampling rate is selected at TeleMon, the transceiver will provide Continuous SpO2 measurement after disconnection (see Transceiver Use with TeleMon A02/

A03 on page 1-27). The SpO2 parameter measures the arterial oxygen saturation, that is, the percentage of oxygenated hemoglobin in relation to the total hemoglobin. If, for example, a total of 97% of the hemoglobin molecules in the red blood cells of the arterial blood combine with oxygen, then the blood has an oxygen saturation of 97%. The SpO2 numeric that appears on the monitor will read 97%. The SpO2 numeric indicates the percentage of hemoglobin molecules which have combined with oxygen molecules to form oxyhemoglobin. The oxygen saturation is measured using the pulse oximetry method. This is a noninvasive method of measuring the arterial hemoglobin oxygen saturation. It measures how much light, sent from light sources on one side of the sensor, travels through patient tissue (such as a finger or an ear), to a receiver on the other side of the sensor. The amount of light passing through depends on many factors, most of which are constant, such as tissue or venous blood. However one of the factors, the blood flow in the arterioles, varies with time - because it is pulsatile. This measurement principle is used to derive the SpO2 measurement. The numeric that is displayed at the Information Center is the oxygen saturation of the arterial blood - the measurement of light absorption 5-4 SpO2 Monitoring Pulse Indication Selecting a SpO2 Sensor during a pulsation. Correct placement of the sensor is essential for accurate measurements (see Applying the Sensor on page 5-9). During Spot Check measurement, the pulse signal is detected and communicated to you via an auditory signal. The indicator is a single low-pitch tone for each pulse detected. The tone is controlled by the Volume and Mute controls at the Information Center. The pulse indication stops when a measurement is complete. However, since it is possible to have a strong pulse but fail an SpO2 measurement, you should listen for the successful completion of a measurement

(single beep), or a double beep if the measurement fails. The pulse indicator is for information only, and should not be used as an indication for treatment. The indicator is not functional in Continuous measurement mode. Clinical Note: If the transceiver is in Spot Check mode and the sensor light is illuminated but you do not hear a low-pitch sound synchronized with the pulse, readjust the sensor, or move the sensor to another site to provide better detection. Selecting a SpO2 Sensor Philips reusable sensors in adult, pediatric and infant models can be used, as well as Philips and Nellcor disposable sensors. Use only specified sensors (probes) and cables. The following chart and figure Selecting an SpO2 Sensor on page 5-7 guide you in selecting the correct sensor type. To use the figure, find the patients weight on the vertical axes. On the horizontal axis at this weight, the shaded areas indicate that the sensor is a "best choice" for the patient. Unshaded areas indicate a "good choice." For example, the best reusable sensor for a 50 kg patient is the M1191A, applied to the finger or toe. Alternatively, you could use M1194A applied to the ear. Sensor Type When to Use SpO2 Monitoring 5-5 Selecting a SpO2 Sensor Reusable Disposable You can use reusable sensors on different patients after cleaning and disinfecting them. For care and cleaning instructions, see the instructions accompanying the sensors. Reusable sensors should be changed to another site every 2-3 hours or in accordance with your clinical practice guidelines. See the Directions for Use supplied by Nellcor Incorporated for instructions on preparation and application of reusable sensors. Use disposable sensors only once and then discard. However, you can relocate them to a different patient-site if the first location does not give the desired results. Do not reuse disposable sensors on different patients. See the Directions for Use supplied by Nellcor Incorporated for instructions on preparation and application of disposable sensors. Warning Warning When the specified Nellcor sensors are used, the application must be consistent with the sensor manufacturer's own guidelines. 5-6 SpO2 Monitoring Selecting a SpO2 Sensor Patient Weight

( lb ) Adult Adult Adult Pedi Pedi Pedi Pedi Infant 110 88 66 44 33 22 7 Patient Weight

( kg ) Adult Pedi 50 40 30 20 15 10 3 t l u d A i d e P t n a f n I o e N Philips Part #

Oxisensor OxiCliq/OxiMax M1192A M1191A M1194A M1901B N-25 N M1903B D-20 P M1904B D-25 A Reuseable sensor Disposable sensor Preferred sensor types Alternative sensor types Selecting an SpO2 Sensor SpO2 Monitoring 5-7 Selecting a SpO2 Sensor Caution Do not use OxiCliq disposable sensors in a high humidity environment, or in the presence of fluids. These can contaminate sensor and electrical connections, and thereby cause unreliable or intermittent measurements. Do not use disposable sensors on patients who have allergic reactions to the adhesive. If you are using Nellcor sensors, see the directions for use supplied with these sensors. 5-8 SpO2 Monitoring Applying the Sensor Applying the Sensor Sensor Application Safety Information Warning Warning Failure to apply a sensor properly can reduce the accuracy of the SpO2 measurement. Loose/Tight sensor: If a sensor is too loose, it can 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 can be applied. This can result in venous congestion distal from the application site, leading to interstitial edema, hypoxia and tissue malnutrition. Skin irritations or ulcerations can occur as a result of the sensor being attached to one location for too long. To avoid skin irritations and ulcerations, inspect the sensor application site every 2-3 hours, and change the application site at least every 4 hours or according to clinical practice guidelines. Venous Pulsation: Do not apply sensor too tightly as this results in venous pulsation and can severely obstruct circulation and lead to inaccurate measurements. Ambient Temperature: Never apply an SpO2 sensor at ambient temperatures from above 37 oC (99 oF) because this can cause severe burns after prolonged application. Extremities to Avoid: Avoid sites distal to BP cuff or intra-arterial line. Site Selection Avoid sites with impaired perfusion, skin discoloration, excessive motion or nail polish. Avoid placing the sensor in an environment with bright lights (if necessary, cover the sensor with opaque material). Avoid use of excessive pressure at the application site (e.g., sensor applied too tightly, excessive adhesive tape to secure the sensor, clothing or SpO2 Monitoring 5-9 Applying the Sensor restraints that are too tight). These result in venous pulsations and inaccurate measurement, and may severely obstruct circulation. Sensor Application A minimum pulsatile flow must be present at the application site of your patient to obtain measurements. Select an appropriate sensor and apply the sensor properly to avoid incorrect measurements. Applying a small amount of pressure at the application site can improve the measurement. Use one of the preferred application sites for your sensor. Selecting the most suitable sensor and application site will help you to ensure that:

The light emitter and the photo detector are directly opposite each other and that all the light from the emitter passes through the patient's tissues, The application site is of the correct thickness for light to pass through. If the application site is too thick or too thin, an SpO2 NON-PULSATILE technical alarm will occur. You should then select another site as appropriate. Light Emitter Photo Detector Positioning of the Light Emitters and Photo Detector Inspect the application site every 2 to 3 hours or according to clinical practice guidelines to ensure skin integrity and correct optical alignment. If skin integrity changes, move the sensor to another site. Follow the sensors instructions for use, adhering to all warnings and cautions. 5-10 SpO2 Monitoring Applying the Sensor To apply the sensor, use the following directions. Step Action 1 2 3 Select the site and appropriate sensor (see Selecting a SpO2 Sensor on page 5-5). Apply the sensor to the appropriate part of the patients body. NoteThe application site should match the sensor size so that the sensor can neither fall off nor apply excessive pressure. Check that the light emitter and the photo detector are directly opposite each other. All light from the emitter must pass through the patients tissue. Adult Finger sensor

(M1191A) Push the sensor over the fingertip in such a way that the fingertip touches but does not protrude from the end of the sensor. The fingertip must be uppermost and the cable must lie on the back of the hand. This ensures that the light sources cover the base of the fingertip giving the best measurement results. The cable can be held in place by the accompanying wristband. SpO2 Monitoring 5-11 Applying the Sensor Warning Warning Failure to apply the sensor properly can cause incorrect measurement of SpO2. For example, not pushing the sensor far enough over the finger can result in inaccurate SpO2 readings. Pushing the sensor too far, so that the finger protrudes from the sensor, can pinch the finger, resulting in inaccurately low SpO2 readings. Small Adult/

Pediatric Finger sensor

(M1192A) Push the sensor over the fingertip in such a way that the fingertip touches but does not protrude from the end of the sensor. NoteWhen using an M1195A Infant Finger/Toe Sensor, select a finger or toe with a diameter of between 7 and 8 mm (0.27 and 0.31 inches). 5-12 SpO2 Monitoring Applying the Sensor Ear Clip sensor

(M1194A) Clip the probe onto the fleshy part of the ear lobe as shown in the diagram below. The plastic fixing mechanism helps to minimize artifact generated by patient motion. Do not position the probe on cartilage or where it presses against the head. The clip sensor can be used as an alternative if the adult finger sensor does not provide satisfactory results. The preferred application site is the ear lobe, although other application sites with higher perfusion (such as the nostril) can be used. Due to the physiologically lower perfusion in the ear lobe, you should be aware of the reduced accuracy of the measurement and more frequent technical alarms. SpO2 Monitoring 5-13 Connecting the SpO2 Cable Connecting the SpO2 Cable Step Action 1 2 3 4 Connect the sensor cable to IntelliVue TRx+. Connect reusable sensors directly into the transceiver. Connect disposable sensors into the adapter cable, then connect the adapter cable to the transceiver. Remove the protective backing. Ensure that the sensor and connector are positioned away from power cables, to avoid electrical interference. Adjust SpO2 alarms in the patient Window (see Telemetry Controls in the Patient Window on page 6-2). Make other adjustments in the Telemetry Setup Window (see Patient-Configurable Settings in Telemetry Setup on page 6-3). Caution Extension cables: Do not use extension cables with the IntelliVue TRx+. 5-14 SpO2 Monitoring Electrical Interference: Position the sensor cable and connector away from power cables, to avoid electrical interference. Measuring SpO2 Measuring SpO2 Spot Check SpO2 measurements can be made continuously in Continuous mode or manually on an as-needed basis in Spot Check mode, depending on the transceiver configuration. While operating in continuous mode, you can also measure pulse, and display the pleth wave at the Information Center. The SpO2 parameter is turned on by inserting/removing the sensor cable into the transceiver, or by control from the Information Center. SpO2 monitoring consumes considerable electrical energy. If the battery power is not at least 25% full, no measurements of SpO2 can be made. Setting the mode at Continuous or Spot Check is done at TeleMon or is configured using the Service Tool. When the transceiver is configured for Spot Check measurement, use the following instructions to take an individual, manual SpO2 reading from the transceiver. You can also initiate a Spot Check measurement in the Patient Window at the Information Center by selecting the STAT SpO2 icon. NoteSpot Check measurements from the transceiver are inactive when the transceiver is connected to TeleMon. Step Action 1 2 Set SpO2 mode to Spot Check in the Telemetry Setup window. Attach the sensor to the patient. SpO2 Monitoring 5-15 Measuring SpO2 Step Action 3 4 Connect the SpO2 cable to IntelliVue TRx+, and check that:

The SpO2 sensor light turns on. A low-pitch tone detecting each pulse is audible (unless sounds are muted). After approximately 30 seconds, a tone from the transceiver indicates that a measurement has been taken. The value, with the measurement time, is displayed at the Information Center. The sensor light extinguishes. If the measurement was unsuccessful, youll hear a double beep. Remove the sensor cable and reinsert it to retake the measurement. NoteThe SpO2 value and time stamp will remain on the Information Center for 24 hours or until another measurement is taken, with one exception. If the batteries are removed from the transceiver, the Spot Check measurement will be erased from the display, but the SpO2 measurements will be available in Trend Review. 5 To repeat a Spot Check measurement at the bedside, disconnect then reconnect the SpO2 cable to the transceiver. Continuous When the transceiver is configured for Continuous SpO2 measurement, use the following directions to initiate Continuous SpO2 monitoring. Step Action 1 2 3 Set SpO2 mode to Continuous in the Telemetry Setup window. Insert the SpO2 cable into the IntelliVue TRx+, and check that the sensor light turns on. Attach the sensor to the patient. 5-16 SpO2 Monitoring Measuring SpO2 Step Action 4 5 After approximately 15 seconds, the value, with the measurement time, is displayed at the Information Center. NoteThere are no sounds associated with continuous SpO2 measurement. To discontinue monitoring, set SpO2 mode to off at the Information Center. Note If the sensor is removed without discontinuing SpO2 monitoring in the Telemetry Setup Window at the Information Center, an SpO2 NO SENSOR technical alarm will result. Displaying Pulse When operating in Continuous mode, you can view pulse measurements at the Information Center. See Patient-Configurable Settings in Telemetry Setup on page 6-3. NoteIf pulse is turned on, the Patient Sector and Patient Window of the Information Center display the label with "T" (for example, Pulse T) to indicate that the measurement was made via telemetry. Displaying PlethWave The transceiver can be configured to transmit the pleth wave for display at the Information Center. See Patient-Configurable Settings in Telemetry Setup on page 6-3. SpO2 Measurement when Connected to TeleMon When the transceiver is connected to TeleMon:

The SpO2 measurement mode is always Continuous. SpO2 Monitoring 5-17 Measuring SpO2 You can change the mode. Changes to the mode take effect when the transceiver is disconnected from TeleMon. The following settings will be used:

Mode Set at TeleMon Mode when Transceiver is Disconnected Continuous 5-minute 1-minute Manual Continuous Continuous Continuous Spot Check Turning SpO2 Monitoring Off To turn SpO2 monitoring off, disconnect the sensor cable (or adapter cable) from the transceiver. SpO2 enters a power-down mode after the cable is disconnected from the transceiver, thereby conserving battery life. SpO2 should also be turned off at the Information Center. If the transmitter is configured for Continuous SpO2 measurement and the sensor is removed without turning SpO2 off, a SpO2 NO TRANSDUCER technical alarm will result. See ImportantIt is important to disconnect the sensor from the transceiver. Unplugging the sensor from an adapter cable that is connected to the transceiver does NOT provide SpO2 power-down mode. 5-18 SpO2 Monitoring Turning the SpO2 Parameter On/Off SpO2 Parameter Auto ON Measuring SpO2 You can turn SpO2 monitoring on/off at the Information Center. S ee Patient-

Configurable Settings in Telemetry Setup on page 6-3. When SpO2 is turned on, the Patient Sector and Patient Window of the Information Center display a "T" next to the SpO2 numeric (for example, SpO2 T 90%) to indicate that the measurement was made via telemetry. If the transceiver is connected to the TeleMon Companion Monitor, after you turn SpO2 on, be sure to adjust the sample rate to match your patients acuity. When SpO2 monitoring is turned off, setting the sample rate to Spot Check at TeleMon will help you conserve the transmitters battery life. The SpO2 parameter is automatically turned on at the IntelliVue Information Center if a manual SpO2 measurement is initiated at the transceiver while in Spot Check mode or if the SpO2 sensor is inserted into the transceiver while the transceiver is in Continuous SpO2 mode. When a patient is discharged and the transceiver is in Continuous mode, the SpO2 parameter is turned off. To reactivate the SpO2 parameter Auto ON feature from the transceiver, remember to do one of the following when a patient is discharged:

remove the SpO2 cable from the transceiver, wait 15 seconds, then reinsert the cable or if using TeleMon, reset the transceiver to Manual mode. NoteThe SpO2 parameter Auto ON feature only needs to be reactivated when the transceiver is in Continuous mode at discharge. Note SpO2 can always be turned on and off at the IntelliVue Information Center. SpO2 Monitoring 5-19 Understanding SpO2 Alarms Understanding SpO2 Alarms Warning Warning If you measure SpO2 on a limb that has an inflated NBP cuff, a non-

pulsatile SpO2 technical alarm can occur. If the monitor is configured to suppress this alarm, there can be a delay of up to 60 seconds in indicating critical patient status, such as sudden pulse loss or hypoxia. Physiologic SpO2 alarms will be generated and displayed at the Information Center. SpO2 offers high and low limit alarms, and a high priority (red level) oxygen desaturation alarm. The SpO2 low limit can be set between 50 and 99%

inclusive, in 1% increments. The low alarm limit cannot be set below the desat alarm limit. The SpO2 high alarm limit can be set between 51 and 100%

inclusive, in 1% increments. The maximum delay between the physiologic alarm condition and alarm annunciation at the central station is 10 seconds. This means that the monitor will generate an alarm if the averaged numeric value on the display exists beyond the alarm limit for more than 10 seconds. Setting the high SpO2 alarm limit to 100% is equivalent to switching off the high alarm limit. Therefore the upper alarm limit for oxygen saturation must be carefully selected in accordance with accepted clinical practices. The desaturation limit is set automatically at 10 below the Low Limit. SpO2 alarms are non-latching. That is, when an SpO2 limit is exceeded, if the alarm is not silenced, it will reset automatically if the patients alarm condition returns within the limits. This reduces the number of times you will need to reset alarms at the Information Center when an alarm condition has been corrected at the patients side (for example, movement-induced artifact alarms). See Chapter 2, Alarms for a list of all SpO2 alarms. 5-20 SpO2 Monitoring Optimizing SpO2 Measurement Performance Optimizing SpO2 Measurement Performance Refer to this section on problem situations if you have difficulty getting a signal or obtaining accurate measurements. Distortion Ambient light, motion, perfusion or incorrect sensor placement can affect the accuracy of the derived measurements. Arterial Blood Flow The measurement depends on the pulsatile nature of blood flow in the arteries and arterioles; with the following conditions arterial blood flow can be reduced to a level at which accurate measurements cannot be made:

shock hypothermia use of vasoconstrictive drugs anemia Wavelength Absorption The measurement also depends on the absorption of particular light wavelengths by the oxyhemoglobin and reduced hemoglobin. If other substances are present which absorb the same wavelengths, they will cause a falsely high, or falsely low SpO2 value to be measured. For example:

methemoglobin methylene blue indocyanine green*

indiocarmine*

carboxyhemoglobin

*These chemicals are used in dye dilution cardiac output calculations. Ambient Light Very high levels of ambient light can also affect the measurement; an SpO2 INTERFERENCE message will appear on the display. The measurement quality can be improved by covering the sensor with suitable opaque material. Care and Cleaning For care and cleaning instructions, see the instructions accompanying the sensors. SpO2 Monitoring 5-21 Optimizing SpO2 Measurement Performance Optimizing Sensor Performance To get the best results from your SpO2 reusable sensor:

Always handle the sensor and cable with care. The soft finger sleeve houses a sensitive electronic device that can be damaged by harsh treatment. Always protect the cable from sharp-edged objects. Use the wristband that is supplied with your M1191A sensor. By keeping the cable between the finger sensor and the wristband fairly loose, you will maintain good monitoring conditions. Normal wear and tear associated with patient movement and regular sensor cleaning naturally mean that your sensor will have a limited lifetime. However, provided you handle the sensor and its cable with care, you can expect useful service from it for up to two years. Harsh treatment will drastically reduce the lifetime of the sensor. Moreover, Philips Medical Systems warranty agreement shall not apply to defects arising from improper use. 5-22 SpO2 Monitoring 6 Telemetry Functions at the Information Center I n t r o d u c t i o n This chapter describes the telemetry-specific functions at the Information Center. It includes the following sections. For additional information regarding the operation of the Information Center, consult IntelliVue Information Center Instructions for Use. NoteST functions performed at the IntelliVue Information Center are described in Chapter 4. Telemetry Controls in the Patient Window . 6-2 Telemetry Controls in the Patient Window . 6-2 Patient-Configurable Settings in Telemetry Setup . 6-3 Unit-Configurable Settings. 6-7 Telemetry Functions at the Information Center 6-1 Telemetry Controls in the Patient Window Telemetry Controls in the Patient Window The Patient Window at the Information Center (accessed from the Patient Window control in the Patient Sector) includes controls for a number of telemetry operations. For detailed instructions on these operations, see the IntelliVue Information Center Instructions for Use or the Online Help. To View ECG, SpO2 or NBP Alarm Limits Move the cursor over the HR or SpO2 label to display the current high and low alarm limits. To Change ECG, SpO2 or NBP Alarm Limits Move the cursor over the High or Low numeric to display up/down arrow controls for adjusting the limit. After adjusting the limit, move the cursor away from the area to dismiss the limit controls. To Change ECG Waveform Size Move the cursor over the ECG waveform to display the ECG Waveform Size popup. Select the label from the label list. To Select Lead Label Move the cursor over the ECG waveform to display the Lead Selection popup. Select the label from the label list. ImportantDo not set the primary and secondary channels to the same lead. To Change Va and Vb Lead Default Settings (6-lead only) Move the cursor over the ECG waveform to display the Lead Selection popup. Select the label from the label list. For Va or Vb, select Va or Vb, then select the lead to be assigned. ImportantDo not set the primary and secondary channels to the same lead. To Initiate a Spot Check Measurement Move the cursor over the SpO2 label. Then click on the Spot Check icon (finger with sensor). To Initiate Monitor Standby See instructions under Standby Mode on page 2-5. 6-2 Telemetry Functions at the Information Center Locating the Transceiver (Find Device) Locating the Transceiver (Find Device) The Find Device feature enables you to generate a continuous double tone (two pitches) at the transceiver to assist in locating a missing device. This function is initiated in the Telemetry Setup Window at the Information Center. Find Device requires that the transceiver has good working batteries and is within the coverage area To locate a transceiver Step Action 1 2 From the Patient Window, select All Controls -> Telemetry Setup. Click the Find Device button to generate a repeated tone at the transceiver. To silence the sound Step Action 1 Press both the Check button to turn off the sound. Patient-Configurable Settings in Telemetry Setup The Telemetry Setup window enables you to configure the transceiver for patient-specific settings. To access this window, from the Patient Window click All Controls, then Telemetry Setup. Telemetry Functions at the Information Center 6-3 Patient-Configurable Settings in Telemetry Setup The following settings can be adjusted in this window. Function Patient-Configurable Settings in Telemetry Setup Control Telemetry Button Determine the Information Center response when Telemetry Button is pressed. Setting Choices Nurse Call - generate nurse call alarm Default Nurse Call Record - generate a recording strip Nurse Call and Record -

generate nurse call alarm and recording strip None 1 (low), 2, 3, 4, 5 (high) 3 enable disable (mute) enable Telemetry Device Volume Set the volume level for all adjustable sounds on the transceiver. NoteThis control is grayed out if configured as such in Unit settings how is this done?. Telemetry Device Volume Mute Enable/disable all adjustable sounds on the transceiver. This control is grayed out if disabled in Unit Settings. 6-4 Telemetry Functions at the Information Center Patient-Configurable Settings in Telemetry Setup Patient-Configurable Settings in Telemetry Setup Control SpO2 Mode Function Determine the transceiver SpO2 behavior. Setting Choices Off - Stops monitoring of the SpO2 parameter Default Spot Check NoteFor Off or Spot Check mode, Pulse is automatically set to disable. Spot Check - Provides manual measurements so the clinician can check as needed. Measurement initiated by plugging the SpO2 cable into the transceiver or by selecting STAT SpO2 icon in the Patient Window. Continuous - Sends an SpO2 parameter value to the Information Center every second. Telemetry Functions at the Information Center 6-5 Patient-Configurable Settings in Telemetry Setup Patient-Configurable Settings in Telemetry Setup Control Suppress SpO2 INOPs with NBP Function Enable/disable the SpO2 algorithm to detect NBP running and suppress sending technical alarms from the transceiver for 60 seconds. enable disable Setting Choices Warning Warning If you measure SpO2 on a limb that has an inflated NBP cuff, a non-pulsatile SpO2 technical alarm can occur. If the monitor is configured to suppress this alarm, there can be a delay of up to 60 seconds in indicating critical patient status, such as sudden pulse loss or hypoxia. Pleth Wave Pulse enable disable Enable/disable the transmission of the Pleth wave (and its subsequent display) to the Information Center. For Continuous SpO2 mode only. NoteWhen enabled, the Pleth wave will replace the Vb wave in the Patient Window during 6-lead monitoring Enable/disable the transmission of the Pulse parameter (and its subsequent display) to the Information Center. For Continuous SpO2 mode only. enable disable 6-6 Telemetry Functions at the Information Center Default enable disable

(Pleth is not displayed.) disable

(Pulse is not displayed.) Unit-Configurable Settings Default enable Patient-Configurable Settings in Telemetry Setup Control SpO2 Alarm Function Enable/disable the display of SpO2 alarms on the Information Center Setting Choices enable disable

(none) Unit Settings Change current settings back to last saved clinical unit settings Unit-Configurable Settings Unit Settings provide access to clinical configuration items that affect all patients on an Information Center. When unit settings are changed, in general they do not affect current patient settings. A discharge is needed for the settings to take effect, with the following exceptions: standby duration and telemetry frequency. Telemetry specific settings are listed in the following table. They are accessed through All Controls -> Unit Settings -> Telemetry Setup. All other unit settings are described in IntelliVue Information Center Instructions for Use. Unit Settings require a password, and the displays are in English. Telemetry Functions at the Information Center 6-7 Unit-Configurable Settings Unit Settings - Telemetry Setup Control Patient Type Function Set patient type used for alarm limits Telemetry Button Determine the Information Center response when Telemetry Button is pressed. Default Adult Nurse Call Settings Adult Pediatric Nurse Call - generate nurse call alarm Record - generate a recording strip Both - generate nurse call alarm and recording strip None - ignore button Telemetry Device Volume Set the volume level for all adjustable sounds on the transceiver. 1 (low) to 5 (high) 3 Telemetry Device Volume Mute Enable/disable all adjustable sounds on the transceiver. enable (unchecked) = sound mute disable (checked) = mute Standby Duration Sets the standby duration on the device. Infinite Infinite 10 minutes 20 minutes 30 minutes 1 hour 2 hours 3 hours 4 hours 6-8 Telemetry Functions at the Information Center Function Unit Settings - Telemetry Setup Control Enable Remote Suspend Enable/disable alarm pause/

suspend at the transceiver. Battery Gauge on Information Center SpO2 Mode Display/disable a battery gauge for each assigned device on the Information Center. NoteDo not enable if rechargeable batteries are being used. Determine the transceiver SpO2 behavior. NoteWhen the mode is set to Off or Spot Check, Pulse is automatically set to disable. Unit-Configurable Settings Default disable enable

(battery gauge is displayed) Spot Check Settings enable disable enable disable Off - Stops monitoring of the SpO2 parameter Spot Check - Provides manual measurements so the clinician can check as needed. The SpO2 measurement is initiated by plugging the SpO2 cable into the transceiver or initiated by selecting STAT SpO2 icon in the Patient Window. Continuous - Sends an SpO2 parameter value to the Information Center every second. Telemetry Functions at the Information Center 6-9 Unit-Configurable Settings Unit Settings - Telemetry Setup Control Suppress SpO2 Inops with NBP Function Enable/disable the SpO2 algorithm to detect NBP running and suppress sending technical alarms from the transceiver for 60 seconds. Settings enable disable Default enable Warning Warning If you measure SpO2 on a limb that has an inflated NBP cuff, a non-pulsatile SpO2 technical alarm can occur. If the monitor is configured to suppress this alarm, there can be a delay of up to 60 seconds in indicating critical patient status, such as sudden pulse loss or hypoxia. Enable/disable the transmission of the Pleth wave (and its subsequent display) to the Information Center. For Continuous Mode only. enable disable disable

(Pleth is not displayed.) Pleth Wave Note When Pleth Wave display is enabled, the Pleth wave will replace the Vb wave in the Patient Window during 6-lead monitoring. 6-10 Telemetry Functions at the Information Center Unit-Configurable Settings Unit Settings - Telemetry Setup Control Pulse Function Enable/disable the transmission of the Pulse parameter (and its subsequent display) to the Information Center. For Continuous Mode only. Settings enable disable SpO2 Alarm Enable/disable the display of SpO2 alarms on the Information Center enable disable SpO2 Limits High Increment/decrement SpO2 high alarm limit by 1 (in %). SpO2 Limits Low Increment/decrement SpO2 low alarm limit by 1 (in %). Limit maximum is 100. Limit minimum is 51 (adult) or 31

(pediatric). High and low limit must be at least 1%

apart. Limit maximum is 99. Limit minimum is 50 (adult) or 30

(pediatric). High and low limit must be at least 1%

apart. Default disable

(Pulse is not displayed.) enable 100 (adult, pediatric) 90 (adult, pediatric) 3-wire Set the unit default lead label. I, II, III 5-wire, ECG1 Set the unit default lead label. 5-wire, ECG2 Set the unit default lead label. I, II, III, MCL, AVR, AVL, AVF, V I, II, III, MCL, AVR, AVL, AVF, V 5-wire, ECG3 Set the unit default lead label. I, II, III, V II II V III Telemetry Functions at the Information Center 6-11 Unit-Configurable Settings Unit Settings - Telemetry Setup Control 6-wire, Va Function Set the unit default lead label. 6-wire, Vb Set the unit default lead label. 6-wire, ECG1 Set the unit default lead label. 6-wire, ECG2 Set the unit default lead label. 6-wire, ECG3 Set the unit default lead label. 6-12 Telemetry Functions at the Information Center Default V2 Settings V1, V2, V3, V4, V5, V6, V7, V8, V9, V3R, V4R, V5R NoteIf ECGx matches Va, then as Va is changed, ECGx changes also. V5 V1, V2, V3, V4, V5, V6, V7, V8, V9, V3R, V4R, V5R NoteIf ECGx matches Vb, then as Vb is changed, ECGx changes also. I, II, III, MCL, AVR, AVL, AVF, V1, V2, V3, V4, V5, V6, V7, V8, V9, V3R, V4R, V5R I, II, III, MCL, AVR, AVL, AVF, V1, V2, V3, V4, V5, V6, V7, V8, V9, V3R, V4R, V5R I, II, III, MCL, AVR, AVL, AVF, V1, V2, V3, V4, V5, V6, V7, V8, V9, V3R, V4R, V5R II; V lead choice is determined by Va and Vb settings. V2; V lead choice is determined by Va and Vb settings. III; V lead choice is determined by Va and Vb settings. Unit Settings - Telemetry Setup Control 6-wire, ECG4 Function Set the unit default lead label. Unit-Configurable Settings Settings I, II, III, MCL, AVR, AVL, AVF, V1, V2, V3, V4, V5, V6, V7, V8, V9, V3R, V4R, V5R Default V5; V lead choice is determined by Va and Vb settings. 5-wire EASI, ECG1 5-wire EASI, ECG2 Set the unit default lead label. Set the unit default lead label. I, II, III, AVR, AVL, AVF, V1, V2, V3, V4, V5, V6 I, II, III, AVR, AVL, AVF, V1, V2, V3, V4, V5, V6 II V2 Telemetry Functions at the Information Center 6-13 Unit-Configurable Settings 6-14 Telemetry Functions at the Information Center 7 Maintenance & Troubleshooting I n t r o d u c t i o n All installation tasks are performedy by Service personel and are described in detail in the service documentation accompanying the system. This chapter provides procedures for maintaining the equipment, assigning labels for replacement transceivers, keeping the transceiver clean, and troubleshooting common problems. It includes the following sections:

Maintenance . 7-2 Transceiver Cleaning, Disinfection, & Cross-Infection Prevention. 7-4 Troubleshooting . 7-15 Maintenance & Troubleshooting 7-1 Maintenance Maintenance Basic Monitoring Before beginning monitoring on a patient:

Check for any mechanical damage. Check all the external leads, plug-ins and accessories. Check all the functions of the instrument which are needed to monitor the patient. Ensure that the instrument is in good, working order. Do not use the Philips IntelliVue Telemetry Monitoring System for any monitoring procedure on a patient if you identify features which demonstrate impaired functioning of the instrument. Contact the Service Provider. Warning Warning 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. Label Assignment for Replacement Transceiver In order to operate within the wireless system, each telemetry device must have an equipment label assigned at the Information Center. The Assign Label function enables you to unassign a label from a lost transmitter, and re-assign that label to a replacement transmitter. Labels are limited to those available in an individual clinical unit. The Label Assignment function requires a password for access, and its controls are available in English only. 7-2 Maintenance & Troubleshooting Maintenance To Re-assign a Label from a (Lost) Device to a Replacement Transceiver Step Action 1 2 3 4 5 6 Clear the sector that the original Equipment Label was assigned to.

(Patient Window -> Sector Setup -> Clear the Sector). NoteThis step ensures that no patient is being monitored by the original (lost) device. Select All Controls, then Label Assignment. Enter password. NoteThe remaining screens will be in English only. Insert batteries into the replacement device. You should hear a double beep, indicating that the transceiver has no Equipment Label assigned. Select the MAC address of the replacement device from the New Devices list. NoteThe transceiver MAC address is located inside the battery compartment. Select the Equipment Label that was assigned to the units former device from Devices Labels list. Maintenance & Troubleshooting 7-3 Transceiver Cleaning, Disinfection, & Cross-Infection Prevention Step Action 7 8 Select Assign Label to initiate programming of the Equipment Label into the replacement telemetry device

- AND -

within 10 seconds, press the Check button on the telemetry device. NoteIf 10 seconds pass without a button push, then repeat this step. What about clicking OK at the prompt? THIS LABEL HAS ALREADY BEENASSIGNED TO A PWD WITH A DIFFERENT MAC ADDRESS. When the telemetry device has completed the normal power-up sequence, an Assignment Complete message is displayed and the the label is marked as being assigned. The device is now ready to connect to the wireless network. Go back into Sector Setup, and select the Bed Label and Equipment Label, followed by OK. The transceiver is now ready for patient monitoring. Transceiver Cleaning, Disinfection, & Cross-Infection Prevention The procedures in this section keep the transceiver clean and provide protection against infectious agents and bloodborne pathogens. Both the outside of the transceiver and the inside of the battery compartment must be kept free of dirt, dust, and debris. The procedures in this section cover the following activities:

Cleaning: removing visible surface decontamination from the device 7-4 Maintenance & Troubleshooting Transceiver Cleaning, Disinfection, & Cross-Infection Prevention Disinfection: protecting cleaned devices against infectious agents and bloodborne pathogens by a chemical agent. Cross-Infection Prevention: using ETO gas treatment to decontaminate cleaned equipment. ImportantAfter exposure, the transceiver must be cleaned, followed by either Disinfection or Cross-Infection Prevention procedures according to hospital protocols, before continued use in monitoring. Cleaning the Transceiver Caution Do not use any abrasive cleaning materials or overly vigorous cleaning actions on any part or component of the IntelliVue TRx or TRx+ transceiver. Use of abrasive cleansers and abrasive cleaning actions will damage the components. Perform the following steps to clean the transceiver of visible surface contamination. Step Action 1 2 3 4 5 6 Remove the batteries and any cables or accessories. Soak the transceiver in water for up to 5 minutes to soften any dried debris, if necessary. Rinse the transceiver in water. Flush device orifices with a forceful water stream to remove any residue in the openings. Allow to air-dry, or dry with a non-lint producing cloth. Continue with either Disinfection or Cross-Infection Prevention procedure, according to your hospitals protocol. Maintenance & Troubleshooting 7-5 Transceiver Cleaning, Disinfection, & Cross-Infection Prevention Disinfecting the Transceiver Warning Warning To prevent fire, provide adequate ventilation and do not permit smoking when disinfecting the device with a flammable liquid, such as alcohol. Caution Remove the batteries and any cables or accessories before you disinfect the transceiver. The transceiver can be disinfected by two methods: wiping or soaking. If the device has areas that are difficult to disinfect, soaking for up to five minutes is recommended. The approved disinfection agents are:

Isopropryl Alcohol, >70%

Sodium Hypochlorite, 10% solution prepared within 24 hours (for wiping only) Equipment must be cleaned (see Cleaning the Transceiver on page 7-5) before this disinfection by wiping or soaking is performed. Wiping the Transceiver Step Action 1 2 Remove the batteries and any cables or accessories. Wipe the transceiver clean by using a cloth dampened modestly with one of the following approved cleaning agents:

Isopropyl Alcohol (> 70%) Sodium Hypochlorite (chlorine bleach), 10% solution prepared within 24 hours. 7-6 Maintenance & Troubleshooting Soaking the Transceiver Transceiver Cleaning, Disinfection, & Cross-Infection Prevention Step Action 3 4 Wipe all disinfected surfaces with distilled water to remove any residue. Allow to air-dry, or dry with a non-lint producing cloth. Caution Do not soak the equipment in cleansers other than Isopropyl Alcohol, or soak longer than five minutes. Soaking the transceiver for longer than five minutes or in cleansers other than Isopropyl Alcohol can severely damage the device. Step Action 1 2 3 4 Remove the batteries and any cables or accessories. Soak the device in Isopropyl Alcohol (> 70%) for up to five minutes. NoteThe battery compartment can be closed or open during soaking. Dip all cleaned surfaces in bowl of distilled water to remove any residue. Dry the equipment with a non-lint producing cloth. Cross-Infection Prevention for the Transceiver The transceiver can be subjected to one ETOH cross-infection prevention process four times per year for 2 years. Completion of this procedure achieves a cross-infection prevention assurance level of 10E-6. Equipment must be cleaned (see Cleaning the Transceiver on page 7-5) before this procedure is performed. Maintenance & Troubleshooting 7-7 Transceiver Cleaning, Disinfection, & Cross-Infection Prevention NoteIf there is concern over cross-contamination due to leadsets or sensors, new leadsets or sensors should be used. Equipment and Materials Warning Warning EO is highly explosive, toxic, and a potential occupational carcinogenic and reproductive hazard. Handle it with extreme care, following U.S. Occupational Safety and Health Administration (OSHA) standards for EO

(29 CFR 1910.1047)*. Personnel exposure and/or room air must be monitored per OSHA standards. Vent sterilizer gas outdoors or to a suitable, evacuated container for reprocessing, depending upon state, provincial, or country environmental regulations. Do not vent sterilant indoors. Vent aerator exhaust only to the outdoors.

* See References on page 7-12. 7-8 Maintenance & Troubleshooting Transceiver Cleaning, Disinfection, & Cross-Infection Prevention Use the following equipment and material to process the transceiver:

1. Ethylene Oxide (Allied Signal Oxyfume-2002), heretofore referred to as EO. manufacturers. 2. Gas sterilizer, made by American Sterilizer Company or other 3. Mechanical aerator. The intake air for the aeration chamber must be routed through bacterial filters, and the exhaust air must be vented outside the building. NoteAvailable combination sterilizer/aerators bypass the problem of personnel exposure to EO during transfer of treated material to a separate aeration cabinet. Cross-

Infection Process The following generic procedure can be used to supplement the sterilizer and aerator manufacturers instructions, although the processing times, temperatures, and pressure must be the same as those given in this procedure. ImportantIn order to complete this stage of the process safely, harmful residue gas must be dissipated through aeration. Step Action 1 2 3 4 5 6 Remove any obvious contamination from the equipment to be processed using approved cleaners. Individually package each transceiver in standard central supply room (CSR) wrapping material secured with EO color-change indi-

cator tape. Apply -26 inHg +/- 1 (-12.77 psig +/- .49) vacuum to the empty sterilizer chamber two times, to remove any residual EO or mois-

ture. Vent the vacuum pump to the outdoors to avoid toxic hazards to personnel. Insert the equipment to be processed into the gas sterilizer. Heat the chamber and its contents to 54.4 +/- 2.8oC (130 +/- 5oF). Apply -26 inHg +/- 1 (-12.77 psig +/- .49) vacuum to the sterilizer chamber. Maintenance & Troubleshooting 7-9 Transceiver Cleaning, Disinfection, & Cross-Infection Prevention Step Action 7 8 9 Humidify the chamber at 50% +/- 10% relative humidity for 20 to 30 minutes. Taking a minimum of five minutes, slowly introduce EO sterilant until the sterilizer unit pressure gauge reaches 11 +/- 1 psig. NoteAt this pressure, the concentration of sterilant in the chamber will be 600 +/- 50 mg/liter, regardless of the chamber size. Process the equipment to be processed as follows:

Pressure: 11 +/- 1 psig (established in the preceding step). Time: 2-3 hours Temperature: 54.4 +/- 2.8oC (130 +/- 5oF) 10 Extract the gas mixture from the sterilizer as follows:

Warning Warning Comply with OSHA standards*. Do not vent sterilizer gas to the room, but vent only outdoors or to a suitable, evacuated container, depending upon state, provincial, or country environ-

mental regulations. (If the mixture is captured, it can be sepa-

rated commercially and the component gases re-used.)

* See References on page 7-12. a. Pump the gas mixture out of the chamber until you ob-

tain a vacuum of -26 inHg +/- 1 (-12.77 psig +/-.49), re-

turning the mixture to a suitable evacuated container. b. Return the sterilizer chamber to ambient pressure by in-

troducing air that has been bacterially filtered. 7-10 Maintenance & Troubleshooting Transceiver Cleaning, Disinfection, & Cross-Infection Prevention Step Action 11 Air-wash the chamber and material as follows:

a. Apply -26 inHg +/- 1 (-12.77 psig +/- .49) vacuum to the chamber and processed material again, to remove residu-

al EO. The vacuum pump must be vented to the out-

doors. b. Return the sterilized chamber to ambient pressure by in-

troducing air that has been bacterially filtered. 12 Continue with the Aeration Procedure (following). Aeration Procedure Warning Warning To avoid chemical burns and toxic effects, the equipment must be aerated after sterilization, as described. The aerator must have bacterial filters and outdoor venting.*

See References on page 7-12. Maintenance & Troubleshooting 7-11 Transceiver Cleaning, Disinfection, & Cross-Infection Prevention Aerate the processed equipment by performing the following steps:

Step Action 1 To dissipate residual EO, aerate the processed equipment with air that has been bacterially filtered, using a mechanical aerator or combination sterilizer/aerator as follows:1 Time: 8-9 hours Temperature: 54.4 +/- 2.8oC (130 +/- 5oF) Ventilation Frequency: At least 30 air exchanges per hour. 2 Continue with the Test Procedure (following). 1 These values will produce EO and Ethylene Chlorohydrin residual levels in the transceiver and patient cable plastic that meet ISO 10993-7 in conjunction with AAMI Technical Information Report 19, that the FDA currently endorses. References OSHA: Standard for acceptable levels of personnel exposure to Ethylene Oxide Gas: 1 ppm on an eight-hour time-weighted average basis. Reference: U.S.A. Federal Regulations 49 FR 25734/29 CFR Part 1910.1047, June 22, 1984; final approval 50 FR 9800/2- CFR Part 1910.1047, March 12, 1985. Test Procedure Caution You must perform this test each time you put a transceiver through the cross-

infection prevention procedure. This test allows you to verify that patient information for both ECG and SpO2 (if you are monitoring pulse oximetry) appear at the information center and at the bedside. You can use this procedure with a patient simulator. 7-12 Maintenance & Troubleshooting Transceiver Cleaning, Disinfection, & Cross-Infection Prevention NoteThis test assumes that the telemetry system and Information Center are fully installed, and that you have performed the procedure to learn the transceiver identity code. Test the transceiver by performing the following steps. If the test indications do not appear, refer to your Service Provider. Step Action 1 2 Perform a mechanical inspection of the transceiver (connectors, battery door opening and closing, Telemetry and Check buttons). At the Information Center, select the telemetry bedside you are testing. Maintenance & Troubleshooting 7-13 Transceiver Cleaning, Disinfection, & Cross-Infection Prevention Step Action 3 Test the transceiver:

a. Put fresh batteries in the transceiver and close the bat-

tery door Result: All six lead lights should flash, and one light should remain on. b. Attach a leadset to the ECG port, and attach an SpO2 sensor to the SpO2 port. If an ECG simulator is avail-

able, attach the ECG leads to the simulator and the SpO2sensor to yourself. At TeleMon, set the SpO2 sam-

ple rate to Continuous. Result: An ECG trace and SpO2 information should be visible on the Information Center display. All transceiv-

er lights should be off. c. Disconnect the Right Arm lead for standard ECG or the I electrode for EASI. Result: The RA LED or the I lead LED should turn on, and a Leads Off INOP should appear on the display at the Information Center. d. Reconnect the electrode. a. Connect the transceiver to TeleMon and observe the ECG waveform and SpO2 numerics on the TeleMon dis-

play. Result: The ECG waveform and SpO2 numerics should be displayed on the TeleMon screen. 4 7-14 Maintenance & Troubleshooting Troubleshooting Troubleshooting Basic Troubleshooting For problems with... see... ECG measurement Optimizing ECG Measurement Performance on page 3-25 Technical Alarms (INOPs) on page 2-14 SpO2 measurement Optimizing SpO2 Measurement Performance on page 5-21 Optimizing Sensor Performance on page 5-22 Technical Alarms (INOPs) on page 2-14 Batteries Battery Information on page 1-19 Nurse call Self Test on page 1-17 Nurse Call may have been turned off for the patient. See Patient-Configurable Settings in Telemetry Setup on page 6-3 for directions on how to turn it on. Testing Alarms Visual and auditory alarms appear at the Information Center. One method of verifying visual and auditory alarms at the Information Center is to connect the transceiver to an ECG or ECG/SpO2 simulator. By varying the ECG rate and SpO2 value, alarms can be generated and confirmed for proper operation. Information Signals If there is a connection failure within the IWN/Philips IntelliVue Telemetry System, an information signal will be generated. This information signal will be displayed on the Information Center where the affected wireless patient Maintenance & Troubleshooting 7-15 Troubleshooting monitoring device(s) (transceiver, access point, access point controller, portable bedside monitor) is assigned, as well as on all other Information Centers connected to a common Database Server. The condition causing the failure will be described in the Wireless Status Log, which is available in Service Mode. See the tables below. Information Signal Description What to Do Intermittent disruption or failure in communications between one or more patient monitoring wireless devices and the Information Center. Contact Service. NoteDetails about the communication disruption are available in the Wireless Status Log (see following table). Information Signal Wireless monitoring loss -

Contact Service NoteThis information signal appears on ALL Information Centers connected to a common Database Server. Note: CTS refers to Philips IntelliVue Telemetry System. Wireless Status Log Messages Wireless Status Log Text Cause Notes CTS Near Area Capacity <ap name>

CTS Tele AP Malfunction <ap name>

Alert cleared when number of connects is below configured threshold. No alert is sent when AP ethernet fails. AP is near usable capacity. Alert sent when AP DECT processor fails or when a software fault is detected. 7-16 Maintenance & Troubleshooting Troubleshooting Note: CTS refers to Philips IntelliVue Telemetry System. Wireless Status Log Messages Wireless Status Log Text Cause Notes Alert cleared when master APC sees the keep-alive or registration message from that APC again. Alert cleared when all AP have unique IP address CTS TELE APC Malfunction <apc name>

CTS Tele Duplicate IP Address

<device name>

CTS Excessive ARQ retries <device name>

Alert sent when this AP detects that its partnered APC has failed. Duplicate IP address has been detected on the CTS network. Sent when the number of retries at ARQ level exceeds the specified threshold. CTS Tele Excessive Handover <ap name>

Excessive handover of the transceiver. CTS Tele Master APC Malfunction Alert sent when the AP cannot find a master APC. Alert cleared when handovers per minute is below configured threshold. Alert cleared when AP receives an announcement packet again. CTS Tele Max Area Capacity <ap name>

Alert sent when the AP reaches maximum capacity. Alert cleared when number of connects is reduced below maximum limit. CTS Tele NO SYNC <ap name>

Loss of local or remote sync to Access Points Excessive Data Loss <ap name>

Excessive data loss on link. Alert cleared when data loss is below configured threshold. Maintenance & Troubleshooting 7-17 Troubleshooting 7-18 Maintenance & Troubleshooting 8 Safety Standards & Specifications I n t r o d u c t i o n This chapter describes the regulatory standards that the product complies with, along with product and measurement specifications. It includes the following sections:

Regulatory Information. 8-2 Battery Life Specifications . 8-5 Electromagnetic Compatibility. 8-6 Radio Specifications . 8-8 Physical Specifications . 8-11 Measurement Specifications. 8-13 Safety Standards & Specifications 8-1 Regulatory Information Regulatory Information Intended Use Indications for Use Rx Patient Population The device is intended to provide ambulatory and bedside monitoring of ECG and SpO2 parameters of adult and pediatric patients in professional healthcare facilities. It is intended to be used by trained healthcare personnel. It is not intended for home use. This device is a US-only device and is not for use in Canada or the European Union. Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring, recording and alarming of multiple physiological parameters of adult and pediatric patients in transport and hospital environments. Federal Law restricts this device to sale by or on the order of a physician. This device is not for use with infant or neonatal patients. Use of the transceiver is restricted to one patient at a time. The transceiver and related accessories are in compliance with the relevant requirements of EN ISO 10993-1 for Biocompatibility. The transmitter is not designed for direct contact with the patients skin. The accompanying pouch is the appropriate means for holding the transmitter. Safety Standards The device complies with the following safety requirements for medical electrical equipment:

IEC 601-1:1988 + A1:1991 + A2:1995 General Requirements for Safety

(with worldwide deviations, including U.S. deviations) IEC 60601-1-1:2000 System Safety IEC 60601-1-2:2001 Electromagnetic Compliance IEC 60601-1-4:1996 Safety for Programmable Electrical Medical Systems IEC 60601-2-49:2001 Multi-parameter Monitor Safety 8-2 Safety Standards & Specifications Regulatory Information ISO 10993-1:2003 Biocompatibility (for lead wires and pouch) ISO 9919:1992 Pulse Oximeters EN 865:1997 Particular Requirements for Pulse Oximeters AAMI EC 13:2002 Performance Standard, Cardiac Monitors Essential Performance The IntelliVue Telemetry System provides Essential Performance (EP) under normal operating conditions (includes EMC exposure) only as a complete Medical Electrical System, consisting of the M4841A Transceiver, the M2636 TeleMon with Option A02/A03 Companion Monitor (optional), the IntelliVue Telemetry Network Infrastructure, and the M3150A Information Center. The Philips IntelliVue Telemetry System achieves its Essential Performance exclusively through alarm generation at the M3150 Information Center. The Philips IntelliVue Telemetry System protects the patient from unacceptable immediate clinical risk by generating specific Physiological Alarms when appropriate. If the System cannot generate Physiological Alarms, then relevant Severe or Hard Technical Alarms (Inoperative Conditions) will be created. System Classification The M4841A Transceiver is an FDA Class II device. It has the following characteristics. Characteristic Definition Internally Powered Equipment The M4841A transceiver is an internally powered device. Continuous Operation All equipment is Ordinary Equipment, IPX0, and provides continuous operation Type CF Defibrillation Proof The M4841A transceiver is Type CF Defibrillation Proof relative to ECG and SpO2 patient applied parts. Safety Standards & Specifications 8-3 Regulatory Information Characteristic Water Resistance Definition When placed inside a Philips carrying pouch with the flap closed and snaps secured, the M4841A transceiver is rated IPX3 as per IEC 60529:1989

(+A1:1999): Protected against spraying water. The combination of the transceiver and pouch will withstand showering for up to 10 minutes. The transceiver will not be damaged if it is accidentally immersed in liquid for up to 5 minutes. Warning Warning If the transceiver is used while showering a patient or is accidentally submerged in liquid, detection of leads off conditions may be compromised. Appropriate clinical precautions must be taken. FCC Compliance

(USA only) Operation of this equipment requires the prior coordination with a frequency coordinator designated by the FCC for the Wireless Medical Telemetry Service. The transceiver and the Philips IntelliVue Telemetry System are subject to radio frequency interference. In the event of suspected radio frequency interference with your device, contact your Service Provider. The FCC requires the following statement for this device:

The Philips IntelliVue Telemetry System complies with Part 15 of the Federal Communications Commission (FCC) Rules. Operation is subject to the following two conditions:

1. This device may not cause harmful radio frequency interference to a a primary licensed user (radio and television stations), and 2. This device must accept any interference received from a primary licensed user, including interference that may cause undesired operation. 8-4 Safety Standards & Specifications Battery Life Specifications Pursuant to Part 15.21 of the FCC Rules, 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. AC Power Source The system is not intended for connection to the public mains as defined in CISPR11. Battery Life Specifications Battery Type Equipment Specification Battery Type 2 fresh AA disposable alkaline batteries Battery Life NoteThe battery life specifications listed below are based on Duracell MN 1500 batteries. Battery life for other brands may differ. Operating Mode Battery Life ECG Only 48.7 hours ECG/SpO2 Continuous 16.8 hours ECG/SpO2 Spot Check between 16.8 hours and 48.7 hours, depending on usage rate Safety Standards & Specifications 8-5 Electromagnetic Compatibility Battery Gauge Battery Gauge Approximate Battery Life Remaining 4 green indicators

> 75%

3 green indicators

> 50%

2 green indicators

> 25%

1 green indicator 25% to Low Battery level 1 red indicator no indicator Low Battery level to Replace Battery level Replace Battery level

(Check batteries for correct polarity) Approximate Operating Time Remaining

> 34.7 hours

> 23.1 hours

> 11.6 hours

> 15 minutes Disabled Functions ___ ___ ___ ___

< 15 minutes SpO2 none Transceiver shutdown/

RF shutdown Electromagnetic Compatibility Medical electrical equipment can either generate or receive electromagnetic interference. This product has been evaluated for electromagnetic compatibility

(EMC) with the appropriate accessories according to IEC 60601-1-2:2001, the international standard for EMC for medical electrical equipment. This IEC standard has been adopted in the European Union as the European Norm, EN 60601-1-2:2001. 8-6 Safety Standards & Specifications Electromagnetic Compatibility Radio frequency (RF) interference from nearby transmitting devices can degrade performance of the product. Electromagnetic compatibility with surrounding devices should be assessed prior to using the product. Fixed, portable, and mobile radio frequency communications equipment can also affect the performance of medical equipment. See your Service Provider for assistance with the minimum recommended separation distance between RF communications equipment and the product. The cables, sensors/transducers, and other accessories for which compliance is claimed are listed in the Service and User documentation accompanying the product. Warning Warning The use of accessories, transducers and cables other than those specified in the product service and user documentation can result in increased emissions or decreased immunity of the product. Warning Warning The product should not be used next to or stacked with other equipment. If you must stack the product or , you must check that normal operation is possible in the necessary configuration before the product is used. Reducing Electromagnetic Interference The transceiver and associated accessories can be susceptible to interference from other RF energy sources and continuous, repetitive, power line bursts. Examples of other sources of RF interference are other medical electrical devices, cellular products, information technology equipment, and radio/

television transmission. If interference is encountered, as demonstrated by artifact on the ECG or dramatic variations in physiological parameter measurement values, attempt to locate the source. Assess the following:

Is the interference due to misplaced or poorly applied electrodes or sensors? If so, re-apply electrodes and sensors correctly according to directions in Chapter 3. ECG Monitoring. Safety Standards & Specifications 8-7 Radio Specifications 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?

Do parameter measurement values change dramatically when the AC line cord is unplugged?

Once the source is located, attempt to attenuate the interference by distancing the transceiver from the source as much as possible. If assistance is needed, contact your local service representative. Restrictions for Use Artifact on ECG and other physiological waveforms caused by electromag-

netic interference should be evaluated by a physician or physician authorized personnel to determine if it will negatively impact patient diagnosis or treat-

ment. Radio Specifications M4841A Transceiver Parameter Specification Frequency Ranges Bands 1395-1400 MHz and 1427-1432 MHz Channel Spacing: 1.6 MHz RF Output Power 8 dBM +2/-3 dB (3.2 mW to 10 mW), into Antenna load @ nominal battery voltage RF Output Power control 8-8 Safety Standards & Specifications Transceiver chain gain shall be calibrated at time of manufacture (env temp 25+/- 5 oC) Over power algorithm deployed to prevent excess power and also includes temperature compensation. Radio Specifications Parameter Specification RF Overpower trip point

> 10 dBm Transceiver Frequency Accuracy during normal operation

+/- 15 kHz relative to channel frequency, includes temperature compensation and aging effects Reference Frequency Calibration

< 4 ppm set a time of manufacture (env temp 25 +/- 5 oC) Modulation Type FSK with Root Raised Cosine filtering Modulation Deviation Bit 1: +288 kHz +/- 25 kHz relative to channel frequency Bit 0: -288 kHz +/- 25 kHz relative to channel frequency Transmitter Output Broadband Noise

<-58.9 dBm in 1 MHz band, outside channel in use Out of Band Spurious Emission Levels

<= 1394 MHz, >= 1401 MHz

<= 1428 MHz, >= 1433 MHz

<-41 dBm in 1 MHz bandwidth for FCC limit Limits measured into 50 Ohms load:

(< -43 dBc referred to transceiver power of +8 dBm over 25 oC to 55 oC, excluding duty cycle effects defined below)

(< -40 dBc over 0 oC to <25 oC, excluding duty cycle effects defined below) Transceiver duty cycle reduces effective spurious emissions:

Transceiver RM at 1/64 duty cycle = 18 dB reduction Access Point RM at 16 connections, 50% duty cycle = 6 dB reduction Safety Standards & Specifications 8-9 Radio Specifications WMTS Channel Frequencies 1395 to 1400 MHz 1427 to 1432 MHz Parameter Specification Lower band edge 1395 MHz Channel 1 Channel 2 Channel 3 Upper band edge Channel spacing 1395.8977 MHz 1397.4970 MHz 1399.0963 MHz 1400 MHz 1.6 MHz Parameter Specification Lower band edge 1427 MHz Channel 4 Channel 4a (*) Channel 5 (**) Channel 6 (**) 1427.8979 MHz 1429.2410 MHz 1429.4972 MHz 1431.0965 8-10 Safety Standards & Specifications Physical Specifications Parameter Specification Upper band edge 1432 MHz

* Available in special geographic area only

** Not available in special geographic areas Physical Specifications ECG-only Transceiver Parameter Specification Height Width Depth Weight without batteries or leadset with batteries and 5-

wire leadset 140 mm 75 mm 28.5 mm

<165 g (5.8 oz.)

<284 g (10 oz.) Volume 215 cm3 Safety Standards & Specifications 8-11 Environmental Specifications ECG/SpO2 Transceiver Parameter Specification Height Width Depth 140 mm 88 mm 37 mm Weight without batteries or leadset with batteries and 5-

wire leadset

<205 g (7.2 oz.)

<324 g (11.5 oz.) Volume 300 cm3 Environmental Specifications M4841A Transceiver Parameter Specification Temperature Operating Storage Humidity Operating Storage 0 to 37 oC (32 to 99 oF)

-40 oC to 60 oC (-40 to 120 oF) without batteries

< 95% RH at 40 oC (104 oF) non-condensing

< 90% RH at 60 oC (120 oF) without batteries 8-12 Safety Standards & Specifications Measurement Specifications Parameter Altitude Operating &

Non-operating Specification 0 to 3,048 m (10,000 ft) Measurement Specifications ECG Parameter ECG channel transmitted Leads 3 electrodes 5 electrodes 5 electrodes, EASI 6 electrodes Resolution ECG Input Specification Channel #1 - I, II, or III Channel #1 - II Channel #2 - III Channel #3 - MCL Channel #1 - Vai Channel #2 - Vas Channel #3 - Ves Channel #1 - II Channel #2 - III Channel #3 - Va Channel #4 - Vb 5 V Differential, defibrillator protected against 400 joules discharge into a 50 ohm load Input Impedance

> 5 megohms (@ 10 Hz Safety Standards & Specifications 8-13 Measurement Specifications Parameter Specification Input Dynamic Range

+/- 9 mV DC Offset Range

+/- 320 mV CMRR

> 90 dB @ 50, 60 Hz Bandwidth +/- 3 dB 0.05 to 40 Hz Gain Accuracy

+/- 5% at 25 oC (77 oF) Noise Referred to ECG Input AAMI: 30 V Lead Wires 3, 5 or 6-wire leadset. 5-lead compatible with IntelliVue Patient Monitor, AAMI or IEC color code Time to baseline from Defibrillator AAMI: 5 s max (until ECG wave is on display but not yet centered, monitoring bandwidth) Pacer Rejection Performance

(Pace pulses with no tails) Positive pacers Negative pacers Amplitude Width

+2 to +700 mV 0.1, 0.2, 0.5 and 1.0 ms

+2 to +500 mV 1.5 ms

+2 to +400 mV 2 ms Amplitude Width

-2 to -700 mV 0.1, 0.2, 0.5 and 1.0 ms

-2 to -500 mV 1.5 ms

-2 to -400 mV 2 ms EMC Performance limits, radiated immunity 46.262 to 55.326 MHz pass at reduced level is 0.4336 V/m. 165 to 195.6 MHz pass at reduced level is 2.4 V/

m. 8-14 Safety Standards & Specifications SpO2 Parameter SpO2 Measurement Range SpO2 Accuracy Measurement Specifications Specification 0 to 100%

+/- 2.5% (1 Standard deviation) with Philips reusable sensor (M1191A, M1192A): 70 -

100 %

+/- 4% (1 Standard deviation) with Philips reusable sensor (M1194A): 70 - 100 %

+/- 3% (1 Standard deviation) with Nellcor Oxisensor D-25 and D-20 sensors: 80 - 100 %

SpO2 Resolution 1%

SpO2 Numerics -

Averaging 10 seconds SpO2 & Pulse Numerics

- Update Rate Transmitted once per second Pleth Wave - sampling rate 125 sps Technical Alarms

(INOPs) Triggered if the sensor is disconnected, if a pulse is not detected, if the signal is noisy, if light interference is detected, if the sensor is defective, if the measurement is erratic, or if the module is malfunctioning Pulse Rate Measurement

(available only with Continuous SpO2) Range: 30 to 300 bpm Accuracy: +/- 2%

Resolution: 1 bpm Safety Standards & Specifications 8-15 Measurement Specifications SpO2 Sensor Accuracy

. Parameter Display of SpO2 numerics NIBP INOP suppression feature Specification SpO2 date values are displayed as xxx % SpO2 to meet ISO/EN standard EN 865 If enabled, detection of a NIBP measurement on the same limb and the corresponding suppression of SpO2 inops (for max of 60 seconds) Type Description Philips Reusable Sensors Adult Finger Adult Finger Adult Finger Pediatric Finger Pediatric Finger Adult/Pediatric Ear Adult/Pediatric Ear Model Number M1191A M1191AL M1191NL M1192A M1192N M1194A M1194N Accuracy%

Arms (70-100%

Range) 2.0 2.0 2.0 2.0 2.0 3.0 3.0 8-16 Safety Standards & Specifications Measurement Specifications Model Number Accuracy%

Arms (70-100%

Range) M1901B M1903B M1904B 3.0 3.0 3.0 Type Description Philips Disposable Sensors Adult Finger Pediatric Finger Adult Finger Safety Standards & Specifications 8-17 Measurement Specifications Type Description Model Number Accuracy%

Arms (70-100%

Range) Nellcor Disposable Sensors

(not available from Philips) OxiCliq A, Adult OxiCliq N, Adult >40 kg

(88 lb) OxiCliq P, Pediatric OxiMax MAX-A, Adult

>30 kg (66 lb) OxiMax MAX-AL, Adult

>30 kg (>66 lb) OxiMax MAX-N, Adult

>40 kg (>88 lb) N/A N/A N/A N/A N/A N/A OxiMax MAX-P, Pediatric N/A Oxisensor II D-20, Pediatric 10-50 kg (22-110 lb) Oxisensor II D-25, Adult

>30 kg (>66 lb) Oxisensor II N-25, Adult

>40 kg (>88 lb) N/A N/A N/A 3.0 3.0 3.0 3.0 3.0 3.0 3.0 3.0 3.0 3.0 8-18 Safety Standards & Specifications A Accessory List I n t r o d u c t i o n This appendix lists all accessories that can be used with the transceiver. For additional information on connecting and using the clinical accessories, see the individual parameter chapters. NoteAccessories are subject to change. To get the latest accessories, visit the Philips Medical Supplies website located at the following address: http://shop.medical.philips.com.or your local Philips representative. Accessory List A-1 Accessory Safety Accessory Safety Warning Warning Philipss approval: Use only Philips-approved accessories. Reuse: Never reuse disposable sensors, accessories and so forth that are intended for single use, or single patient use only. Packaging: Do not use a sterilized accessory if the packaging is damaged. ECG Accessories Electrodes Order Number Description M2202A 40489E 40493D 40493E Radio Translucent Foam Electrodes, 60 packages of 5

(300 per box) Paper Tape Electrodes, 10 packages of 30 (300 per box) Foam Electrodes, 60 packages of 5 (300 per box) Foam Electrodes, 10 packages of 30 (300 per box) Order Number Description 9898 031 33831 AAMI 3-wire Leadset, Snap 79 cm (30 ) Leadsets A-2 Accessory List A S a e s l a n d S u p p o r t ECG Accessories Order Number Description 9898 031 33841 AAM 3-wire Leadset, Grabber 79 cm (30 ) 9898 031 33871 AAMI 5-wire Leadset, Snap 79 cm (30 ) 9898 031 33881 AAMI 5-wire Leadset, Grabber 79 cm (30 ) 9898 031 37241 AAMI 5-wire Color Leadset, Snap 79 cm (30 ) 9898 031 37251 AAMI 5-wire Color Leadset, Grabber 79 cm (30 ) 9898 031 33911 AAMI 6-wire Leadset, Snap 79 cm (30 ) 9898 031 33921 AAMI 6-wire Leadset Grabber 79 cm (30 ) 9898 031 37281 AAMI 6-wire Color Leadset, Snap 79 cm (30 ) 9898 031 37291 AAMI 6-wire Color Leadset, Grabber 79 cm (30 ) Order Number Description 9898 031 37841 5-lead Trunk Cable Order Number Description 9898 031 37831 Telemetry Pouch, with flap, box of 50 9898 031 40371 Telemetry Pouch, with flap, case of 200 Order Number Description 9898 031 34771 Skin Preparation Sheets, 10 preps/sheet, package of 10 sheets Accessory List A-3 Trunk Cables Pouches Skin Prep Paper SpO2 Accessories Alignment Guides Gunk Guards Order Number Description 9898 031 40401 Single Alignment Guide, package of 10 9898 031 40411 Single Tethered Alignment Guide, package of 10 9898 031 40421 Double Alighment Guide, package of 10 Order Number Description 9898 031 40431 9898 031 40441 9898 03140451 ECG Gunk Guard, package of 10 SpO2 Gunk Guard, package of 10 Serial SpO2 Gunk Guard, package of 10 SpO2 Accessories Reusable Sensors Order Number Description M1191A M1191AL M1191NL M1192A Philips Adult Finger Sensor, 2 m (6.6 feet) Philips Adult Finger Sensor, 3 m (9.8 feet) Philips Adult Finger Sensor, 3 m (9.8 feet) Philips Pediatric Finger Sensor, 1.5 m (4.9 feet) A-4 Accessory List A S a e s l a n d S u p p o r t SpO2 Accessories Order Number Description M1192N M1194A M1194N Philips Pediatric Finger Sensor, 1.5 m (4.9 feet) Philips Adult & Pediatric Ear Sensor, 1.5 m (4.9 feet) Philips Adult & Pediatric Ear Sensor, 1.5 m (4.9 feet) Disposable Sensors -

Single Use NoteOxiCliq, OxiMax and Oxisensor II sensors are not available from Philips in the USA or Canada. Adapter cables are not available from Philips in Canada or Japan. In those countries, contact Nellcor Incorporated directly. Order Number Description M1901B M1903B M1904B Philips Adult >40 kg (>88 lb) Philips Pediatric 10-50 kg (22-110 lb) Philips Adult >30 kg (>66 lb) N/A from Philips

*Nellcor Adhesive OxiCliq A, Adult N/A from Philips

*Nellcor Adhesive OxiCliq N, Adult >40kg (>88 lb) N/A from Philips

*Nellcor Adhesive OxiCliq P, Pediatric N/A from Philips N/A from Philips N/A from Philips N/A from Philips N/A from Philips N/A from Philips N/A from Philips M1943A M1943AL

*Nellcor OxiMax MAX-A, Adult >30 kg (>66 lb)

*Nellcor OxiMax MAX-AL, Adult >30 kg (>66 lb)

*Nellcor OxiMax MAX-N, Adult >40 kg (>88 kg)

*Nellcor OxiMax MAX-P, Pediatric 10-50 kg (22-110 lb)

*Nellcor Oxisensor II D-20, Pediatric 10-50 kg (22-110 lb)

*Nellcor Oxisensor II D-25, Adult >30 kg (>66 lb)

*Nellcor Oxisensor II N-25, Adult >40 kg (>88 lb) Adapter cable for Nellcor SpO2 sensor, 2 m (6.6 ft) Adapter cable for Nellcor SpO2 sensor, 3 m (9.8 ft) Accessory List A-5 SpO2 Accessories Wristband Order Number Description

* Uses reusable OC-3 Sensor Cable. Order Number Description M1627A Wristband, package of 10 A-6 Accessory List B Sales and Support Offices I n t r o d u c t i o n Please call your local sales office listed in your telephone directory or a regional office listed below for the location of your nearest sales office. CORPORATE HEADQUARTERS:

Philips Medical Systems Netherlands B.V. Postbus 10.000 5680 DA Best Netherlands UNITED STATES:

Philips Medical Systems 3000 Minuteman Road Andover, MA 01810

(800) 934-7372 CANADA:

Philips Medical Systems 2660 Matheson Blvd. E. Mississauga, Ontario L4W 5M2

(800) 291-6743 EUROPE, MIDDLE EAST AND AFRICA:

Philips Medizinsysteme Bblingen GmbH Cardiac and Monitoring Systems Hewlett-Packard Str. 2 71034 Bblingen Germany Fax: (+49) 7031 463 1552 Sales and Support Offices B-1 LATIN AMERICA HEADQUARTERS:

Philips Medical Systems 5200 Blue Lagoon Drive 9th Floor Miami, FL 33126

(305) 267-4220 ASIA PACIFIC HEADQUARTERS:

Philips Medical Systems 24F Cityplaza One 1111 King's Road Taikoo Shing, Hong Kong

(+852) 3197 7777 B-2 Sales and Support Offices Index A alarms behavior with Own Bed Overview 2-7 indicators, 2-2 physiologic, 2-10 SpO2, 5-20 technical, 2-15 testing, 7-15 auditory info signals, 1-13 B battery life, 1-23, 8-5 safety, 1-19 type, 1-21 C continuous SpO2, 5-16 Controls 1-28 controls buttons, 1-8 indicators, 1-9 labels,back, 1-12 labels,front, 1-10 on/off, 1-15 other marks, 1-12 ports, 1-10 volume, 6-4, 6-8 controls, 1-7 D dropouts, 3-26 E electromagnetic interference, 8-6 F find device, 6-3 I Information Center transceiver use with, 1-6 INOP messages ST 4-11 INOPs, see technical alarms 2-15 intended use ST/AR, 4-3 transceiver, 8-2 L lead placement, 3-12 N noise eliminating, 3-27 O on/off, 1-15 ordering information ECG supplies, A-2 SpO2 supplies, A-4 Own Bed Overview alarm behavior 2-7 own bed overview, 6-2, 6-3 P pacing safety, 1-ix patient window, 6-2 pause, 2-2 pleth wave display, 5-17, 6-6, 6-10 pouch, 1-24 pulse on/off, 6-6, 6-11 pulse wave display, 5-17, 6-6, 6-11 R RF interference, 3-27 S safety battery, 1-19 ECG, 1-vi general, 1-iv Index-1 standby mode, 2-5 suspend, 2-2 symbols, 1-11 system messages T technical alarms, 2-15 telemetry setup, 6-3 TeleMon see information signals, 7-15 SpO2 measurement modes 5-17 transceiver use with, 1-6 testing alarm indicators, 2-2 alarms, 1-17 self test, 1-17 status check, 1-18 transceiver auditory info signals, 1-13 controls, 1-7 troubleshooting 3-27 information signals, 7-15 SpO2, 5-21 TRx, TRx+

definition, 1-4 turn on/off SpO2 parameter 5-19 V volume setup, 6-4, 6-8 volume, 6-4, 6-8 paced, 1-viii, 4-3 pouch, 1-25 SpO2 sensor, 5-9 SpO2, 1-x, 5-2 ST/AR arrhythmia, 1-vii ST/AR, 1-vii, 4-2 symbols, 1-12 transceiver, 1-15 sensor ear clip, 5-13 finger, 5-11 sensors selecting 5-22 service log, 7-16 signal strength, 3-26 sounds see auditory info signals 1-13 start-up, 1-16 SpO2 auto on/off 5-19 continuous, 5-16 on/off, 5-18 sensor application, 5-9 sensor selection, 5-5 spot check, 5-15 turn parameter on/off 5-19 SpO2 inop suppression, 6-6, 6-10 SpO2 mode, 6-5, 6-9 SpO2 monitoring, 5-4 spot check, 5-15 ST adjusting measurement points, 4-9 alarm adjustments, 4-12 measurement, 4-6 smart limits, 4-13 turning on/off monitoring, 4-9 ST/AR intended use, 4-3 STanalysis, 4-6 Index-2