FCC ID: PQCM2601B Medical Telemetry Transmitter

 

Philips Telemetry System with the M2601B Transmitter and Telemetry Functions at the IntelliVue Information Center Notice Operation of this equipment requires the prior coordination with a frequency coordinator designated by the FCC for the Wireless Medical Telemetry Service. Instructions for Use Part Number: M2600-92201 Printed in the U.S.A. November 2004 First Edition 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: M2600-92201 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 incorporate all material updated since the previous edition. Update packages may be issued between editions and contain replacement and additional pages to be merged by a revision date at the bottom of the page. Pages that 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 Telemetry System, model M2600B is compatible with:

M2604A Philips Mainframe, #01D or #0EU, revision E.00.19 Philips Information Center, revisions F.00, E.01, E.00, D.01, D.00 M2636B TeleMon Companion Monitor, Options A02/A03 Philips Transmitter, model M2601A Philips Transmitter, model M1400A/B/J NoteSome features are not available on all products. ii About this Book About this Book This book contains operating instructions for use of the M2601B Transmitter, a part of the Philips Telemetry System. 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 the IntelliVue Information Center Instructions for Use (order number M3150-9001F). For preventive maintenance, repair, and test methods for verification of device performance, refer to the M2600B Philips Telemetry System Service Guide in the M2600B Documentation Kit, shipped with the product (order number M2600-90323). This book does not address Philips IntelliVue TRx transceivers or the Philips IntelliVue Telemetry System. For information on those products, refer to the manual Philips IntelliVue Telemetry System Instructions for Use (order number M4841-91001). NoteStandard and EASI M2601A Transmitters can be used with the Philips Telemetry System and can operate simultaneously with M2601B Transmitters. Whats New on page 1-2 summarizes the differences between the M2601B and M2601A transmitters. iii About this Book Document Conventions 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:

Click the Standby button. 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. Notes NoteNotes contain additional information on Philips Telemetry System usage. iv Product Safety Information Product Safety Information The warnings below refer to the following devices:

Philips M2601B Transmitter Philips Telemetry System IntelliVue Information Center 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. 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 electrosurgery units because use may interrupt or interfere with the transmission of signals from the transmitter. 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. v Product Safety Information 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 lead sets, SpO2 sensors) other than those prescribed by Philips could lead to patient injury. Warning Warning Strangulation Hazard! Under no circumstances should any pouch be tied solely around a patients neck. 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 ECG SAFETY FOR PACED PATIENTS The output power of the M2601B Transmitter 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 transmitter 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 Telemetry System. See the IntelliVue Information Center Instructions for Use for additional information on monitoring paced patients. vii 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. 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 alerts 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 x Contents 1. Introduction to the Philips Telemetry System. 1-1 Whats New. 1-2 New Transmitter . 1-2 Connection to TeleMon . 1-4 Own Bed Overview . 1-4 Indications for Use . 1-5 Regulatory Information . 1-6 System Overview . 1-7 Transmitters. 1-9 M2601B Transmitter Features . 1-10 Transmitter Controls - Front . 1-11 Transmitter Controls - Back. 1-15 Sounds . 1-18 Transmitter Safety Information . 1-18 Briefing the Patient . 1-19 Pouch Use . 1-19 Securing the Pouch. 1-20 Showering . 1-21 Making Monitoring Adjustments . 1-22 Turning the Transmitter On/Off. 1-22 Turning Telemetry Monitoring On/Off . 1-23 Transmitter Auto Shutoff. 1-23 Turning Nurse Call On/Off . 1-23 Standby Mode . 1-24 Use with TeleMon B, Options A02/A03. 1-25 Operation with TeleMon . 1-25 Testing the Transmitter Functionality. 1-27 Self Test . 1-27 Status Check. 1-28 Battery Information. 1-29 Battery Safety Information. 1-29 Inserting/Removing Batteries . 1-31 Checking the Battery Power Level . 1-32 Receiver Module . 1-34 Receiver Mainframe . 1-35 Antenna System. 1-36 Contents-1 2. Alarms . 2-1 Alarm Indicators . 2-2 Pause/Suspend Alarms . 2-2 Alarm Behavior with Own Bed Overview . 2-3 Physiologic (Patient) Alarms . 2-6 Technical Alarms (INOPs) . 2-11 3. ECG & ST/AR Measurement . 3-1 Measuring ECG. 3-2 EASI ECG . 3-2 ECG Lead Sets . 3-2 ECG Leads Monitored . 3-4 Setting Up for ECG Monitoring . 3-7 Positioning ECG Electrodes. 3-8 Connecting the ECG Cable . 3-14 Verifying Electrode Connections . 3-17 Making ECG Adjustments . 3-18 Changing Lead/Label. 3-18 Adjusting Wave Size . 3-19 Monitoring During Leads Off . 3-19 Lead Fallback. 3-19 Extended Monitoring . 3-20 Relearning . 3-20 Using EASI Leads to Troubleshoot . 3-21 Optimizing System Performance . 3-22 The Telemetry Signal. 3-22 Troubleshooting Signal Disturbance . 3-23 Dropouts. 3-23 Muscle and Movement Artifact . 3-24 ECG Safety Information . 3-27 ST/AR Arrhythmia Analysis. 3-28 ECG and ST/AR Alarms . 3-30 ST/AR Arrhythmia Safety Information . 3-31 4. ST/AR ST Segment Monitoring. 4-1 ST/AR ST Algorithm . 4-2 Intended Use . 4-2 Patient Population . 4-2 The Measurement. 4-3 How the Algorithm Works. 4-4 Contents-2 Displayed ST Data . 4-4 EASI ST Analysis. 4-4 Adjusting Measurement Points . 4-5 Establishing ST Reference Beats (Baseline) . 4-7 Turning ST On/Off. 4-7 ST Alarms . 4-8 ST Alarm Adjustments . 4-9 5. SpO2 Monitoring. 5-1 About the Pulse Oximetry Measurement . 5-2 Pulse Indication. 5-3 SpO2 Information for the User . 5-4 Preparing for Telemetry SpO2 Monitoring . 5-7 SpO2 Sensors . 5-8 Disposable Sensors . 5-8 Reusable Sensors . 5-8 Selecting an SpO2 Sensor . 5-9 Applying the Sensor. 5-12 Sensor Application Safety Information . 5-12 Adult Finger Sensor (M1191A) . 5-14 Small Adult/Pediatric Finger Sensor (M1192A) . 5-15 Ear Clip Sensor (M1194A) . 5-16 Connecting the SpO2 Cable. 5-17 Making SpO2 Measurements . 5-18 SpO2Measurement when Connected to TeleMon . 5-18 Making a Spot Check Measurement. 5-19 Monitoring SpO2 Continuously . 5-20 Turning SpO2 Monitoring Off . 5-20 Turning the SpO2 Parameter On/Off . 5-21 SpO2 Parameter Auto ON. 5-22 Turning SpO2 Alarms On/Off. 5-22 Turning the Pulse Parameter On/Off . 5-23 Measurement Limitations . 5-24 Optimizing Sensor Performance . 5-25 SpO2 Alarms and Technical Alarms . 5-25 Contents-3 6. Maintenance and Configuration . 6-1 Troubleshooting . 6-2 Basic Troubleshooting . 6-2 Testing Alarms. 6-2 Maintenance . 6-3 Transmitter Cleaning, Disinfection, & Cross-Infection Prevention . 6-4 Cleaning the Transmitter . 6-4 Disinfecting the Transmitter . 6-5 Cross-Infection Prevention for the Transmitter . 6-7 Receiver Mainframe Cleaning . 6-15 Configuration . 6-16 Configuration Settings. 6-17 M2604A Mainframe . 6-17 Philips M2601B Transmitter . 6-19 Changing the Configuration. 6-19 7. System Safety and Specifications. 7-1 Product Safety . 7-2

. 7-2 System Classification. 7-3 Essential Performance . 7-4 Philips Telemetry System Warnings. 7-4 Electromagnetic Compatibility . 7-5 M2600B Philips Telemetry System Testing . 7-5 FCC Compliance (USA only) . 7-7 Canadian Radio Equipment Compliance (Canada Only) . 7-7 System Symbols . 7-9 Type CF Defibrillation Proof. 7-14 Installation and Maintenance Safety . 7-14 Installation . 7-14 Preventive Maintenance. 7-18 End of Life . 7-18 Additional Safety Information . 7-19 System Specifications . 7-20 Battery Life Specifications. 7-20 Environmental Specifications . 7-21 Electrical Power Specifications . 7-22 Antenna System Specifications . 7-26 Measurement Specifications . 7-30 Contents-4 A. Optional Patient Monitor/Holter Interface (Analog Output) . A-1 Overview . A-2 Correct Labeling . A-2 Analog Output Bedside Monitor Cables . A-3 Lead Placement and Selection . A-5 Using Non-Standard Lead Placement. A-5 Controls for Telemetry Setup. A-6 Functionality with Paced Waves . A-6 Technical Alarms (Inoperative Conditions). A-7 Holter Interface . A-8 B. Accessory List . B-1 Accessory Safety . B-1 ECG Accessories . B-2 SpO2 Accessories . B-4 C. Sales and Support Offices . C-1 Contents-5 Contents-6 1 Introduction to the Philips Telemetry System I n t r o d u c t i o n This chapter introduces the Philips Telemetry System. It includes the following sections:

Whats New. 1-2 Indications for Use . 1-5 System Overview . 1-7 Transmitters. 1-9 Briefing the Patient . 1-19 Making Monitoring Adjustments . 1-22 Use with TeleMon B, Options A02/A03. 1-25 Testing the Transmitter Functionality. 1-27 Battery Information. 1-29 Receiver Module . 1-34 Receiver Mainframe . 1-35 Antenna System . 1-36 Introduction to the Philips Telemetry System 1-1 Whats New Whats New This section highlights the differences between the M2600B Philips Telemetry System, utilizing the M2601B Transmitter and the Philips M2600A Telemetry System, Release C, utilizing the M2601A Transmitter. New Transmitter The main difference between the two systems is the introduction of the new M2601B transmitter. Differences Between Transmitters Function The following table summarizes the differences between the two transmitters. M2601B One transmitter for both Standard and EASI monitoring -- clinician simply changes the ECG lead set position FAST (Fourier Artifact Suppression Technology) SpO2 algorithm Continuous and Spot Check (Manual) SpO2 measurements M2601A Separate Standard or EASI versions of transmitter Traditional (not motion tolerant) SpO2 algorithm Continuous, Spot Check (Manual), and Intermittent (1- and 5-minute) SpO2 measurements 1-2 Introduction to the Philips Telemetry System Whats New Controls &

Indicators M2601B Spot Check SpO2 initiated by inserting sensor cable M2601A Manual measurement initiated by button push on transmitter Auditory feedback for Spot Check and self test N/A Two electrode placement diagrams show both Standard and EASI placement One electrode placement diagram appropriate for the transmitter: either Standard or EASI placement Check button for verifying transmitter status: lead set type, battery level, EASI indicator (if in use) N/A Battery gauge to indicate power level N/A Audible volume/mute configurations Audible pulse detection during Spot Check measurement Unit designator label on battery compartment N/A N/A N/A Physical Smaller and lighter ECG-only transmitter ECG/SpO2 transmitter approximately same size as the M2601A One-size transmitter (ECG-only or ECG/SpO2) Power Source Battery Type: 2 AA Alkaline Battery Types: 1 9-volt Alkaline, Lithium, Zinc Air No Support for Battery Extender Compatible with Battery Extender Accessories New 5-wire lead sets, with color-

coded lead wires available Introduction to the Philips Telemetry System 1-3 Whats New Connection to TeleMon Own Bed Overview The M2601B Transmitter also has a different method of connecting to the TeleMon Companion Monitor:

M2601B: Transmitter is connected to the outside of TeleMon via a 3-

meter tether cable. M2601A: Transmitter is docked in TeleMon. The system supports the concept of Own Bed Overview, the pairing of a telemetry bed and an IntelliVue Patient Monitor (Release B.1 or higher) for a single patient. Own Bed Overview provides the telemetry-monitor data

(waveforms, parameters, and alarms) in an integrated form both on the bedside monitor and at the IntelliVue Information Center. Own Bed Overview is available with both the M2601B and M2601A transmitters. Information on Own Bed Overview can be found in the IntelliVue Patient Monitor Instructions for Use and the IntelliVue Information Center Instructions for Use. In this book, Alarm Behavior with Own Bed Overview on page 2-3 summarizes alarm functionality with Own Bed Overview. 1-4 Introduction to the Philips Telemetry System Indications for Use Indications for Use The paragraphs below are the elements of the indications for use statement for the Philips Telemetry System. Condition The licensed clinician decides that the Philips Telemetry System should be used to monitor the patient. Prescription Versus Over-

the-Counter Part of the Body or Type of Tissue with which the Device Interacts Frequency of Use Physiological Purpose Patient Population The Philips Telemetry System is a prescription device. The ECG signal is obtained from accessory electrodes in contact with the patients skin. The SpO2 signal is obtained from an accessory sensor in contact with the patients skin. As prescribed by a licensed physician. To monitor the ECG and SpO2 of patients on the order of a licensed physician. Adult and pediatric patients. Introduction to the Philips Telemetry System 1-5 Indications for Use Intended Use The Philips Telemetry System is a comprehensive ambulatory system solution for the intermediate care unit for adult and pediatric patients. The foundation of the system is a transmitter that can capture and transmit ECG signals and SpO2 values (if available) that are then processed and displayed on the IntelliVue Information Center. The Information Center generates alarms and recordings, thus notifying clinicians of changes in patients' conditions. The Telemetry System communicates with other devices via the Philips patient care system. Warning Warning United States law restricts this device to sale by or on the order of a physician. This product is intended for use in health care facilities by trained health care professionals. It is not intended for home use. Regulatory Information This device is not for use with infant or neonatal patients. The transmitter 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. Use of the transmitter is restricted to one patient at a time. The system is not intended to be connected to public mains as defined in CISPR 11. 1-6 Introduction to the Philips Telemetry System System Overview System Overview The Philips Telemetry System is used with the IntelliVue Information Center to provide multi-parameter measurements for transitional care and other ambulatory monitoring environments for adult and pediatric patients. The system:

Enunciates patient monitoring alarms. Monitors adult and pediatric patients ECG. Measures pulsatile arterial oxygen saturation (SpO2) and pulse rate, if Provides ST/AR arrhythmia detection. available. Enables viewing of ECG and SpO2 measurements and waveforms at the patients side when connected to the TeleMon Companion Monitor. Makes ST segment measurements. The Philips Telemetry System consists of:

A transmitter for each patient. An antenna system. A receiver for each transmitter. A mainframe housing up to eight receivers. Other possible items include:

The TeleMon Companion Monitor: TeleMon can be used to view waveforms and heart rate and SpO2 numerics as well as measure NBP. For more information see the Philips TeleMon B A02/A03 Companion Monitor Instructions for Use. See the Philips Telemetry System Service Guide or your local trained service professional for assistance. Introduction to the Philips Telemetry System 1-7 System Overview M2601B EASI, 3 5 Philips Telemetry System Dual-Band Operation The Philips Telemetry System (M2600B) can operate in both the 406-480 MHz and 590-614 MHz ranges. The exact operating frequency for each transmitter/

receiver pair is set so as to meet specific customer needs, while maintaining compliance with local and international radio regulations. For United States operation, the M2600B will operate only in the protected, dedicated Wireless Medical Telemetry Service (WMTS) band (608-614 MHz). 1-8 Introduction to the Philips Telemetry System Transmitters Transmitters The following Philips transmitters can be used with the Philips Telemetry System:

ECG-only transmitter ECG/SpO2 transmitter Standard and EASI M2601A transmitters can also be used. These transmitters can operate simultaneously with M2601B transmitters. For operating information, refer to the Instructions for Use for the Philips Telemetry System

(part number M2600-9001C). NoteWhats New on page 1-2 summarizes the differences between the M2601B and M2601A transmitters. The M2601B Transmitter models are illustrated on the following pages in this chapter. Subsequent tables describe the controls, indicators, markings, and audible sounds respectively. If your hospital uses both the M2601B Transmitter and IntelliVue TRx devices The M2601B Transmitter and M4841A TRx Transceiver are similar in appearance. You can distinguish between them by:

Name on the front of the device Label color (dark gray for M2601B and pale gray for TRx) Introduction to the Philips Telemetry System 1-9 Transmitters M2601B Transmitter Features Clinician-selectable Standard or EASI leads in same transmitter, at the bedside. Powered by two AA Alkaline batteries. Spot Check SpO2 without using any control buttons. FAST-SpO2 (Fourier Artifact Suppression Technology) for improved motion artifact rejection and low-perfusion performance. Simultaneous operation in system with M2601A Transmitter. Two sizes - smaller ECG-only version and larger ECG-SpO2 version. Battery gauge on transmitter. Designed to be ergonomic and comfortable for patients to wear. Colored labels provide clinical unit identifiers. Lead sets are optimized for ambulating patients, with a cable length of 79 cm (30 in). Gunk guards prevent dirt from accessing unused ECG and SpO2 cable ports and the unused TeleMon/Service port, thus simplifying cleaning. New pouches with clear front and flaps. M2601B EASI, 3 5 EASI I S E A FCCID: XXXXXXXX CANADA IC: XXXX

0123 i Front View Back View M2601B Transmitter - ECG only 1-10 Introduction to the Philips Telemetry System Transmitter Controls -

Front Transmitters i iii a b c d M2601B EASI, 3 5 ii C A B 1 2 3 ECG/SpO2 Transmitter - Front View The labeled items in the diagram above include:

Transmitter controls (A-C) Indicators (a-d) Labels (1-3) Ports (i-iii) These items are defined on subsequent tables. Introduction to the Philips Telemetry System 1-11 Transmitters Controls Callout Control A Definition Telemetry Button: Depending on the configuration, this multi-function button directs the Information Center to generate a Nurse Call, central recording, both, or none. If desired, you can turn Nurse Call off for individual patients at the Information Center by using the Telemetry Setup Window. See Turning Nurse Call On/Off on page 1-23 for additional information. NoteRecordings generated by the telemetry button are stored in Alarm Review at the Information Center. NoteIf the installation includes a paging system and if the Information Center is configured for paging upon receipt of Nurse Call, a Nurse Page signal will be initiated. Check Button. Checks the status of the transmitter. When pressed, the battery gauge, lead set type, and EASI (if in use) indicators illuminate. B C Power On/Off Battery Compartment. Battery insertion turns power on; battery removal turns power off. 1-12 Introduction to the Philips Telemetry System Indicators Callout Indicator Definition Transmitters a b c d Lead Indicator. Lights momentarily to display leads attached when lead set is inserted or when the Check button is pressed. When a Leads Off condition occurs, the light(s) indicate the lead(s) that need to be reapplied. The light(s) remain on until the Leads Off condition ends. EASI NoteThe 6th indicator (left-most LED) is not used for the M2601B Transmitter. EASI Indicator. Illuminates momentarily upon insertion of lead set in EASI position. Lit by Check button when EASI is in use. Alarms Pause/Suspend Indicator. Inactive. NoteIf the transmitter is connected to the TeleMon Companion Monitor this indicator is lit during 3 minute alarm pause period initiated at TeleMon. Battery Gauge. When the Check button is pressed, indicates the amount of power remaining in the batteries. Valid only for recommended battery type. NoteSee Checking the Battery Power Level on page 1-32. Introduction to the Philips Telemetry System 1-13 Transmitters Front Labels Callout 1 2 3 Ports Label Definition M2601B EASI, 3 5 Lead Set Insertion Guide. See Connecting the ECG Cable on page 3-

14. Device Identification Label Unit Identification Label. (one of seven colors). Color-coded sticker. Callout i ii iii Definition ECG Lead Set Port. Connection for 3-wire or 5-wire lead set. SpO2 Sensor Port. Connection for SpO2 sensor. TeleMon/Service Port. Connection for cable to TeleMon Companion Monitor or to Service Tool. 1-14 Introduction to the Philips Telemetry System Transmitter Controls -

Back Transmitters A EASI EASI EASI I S E A FCCID: XXXXXXXX CANADA IC: XXXX

0123 1 2 8-11 not shown

(inside battery compartment) 6 i 5 7 5 3 4 ECG/SpO2 Transmitter - Back View TO TRANSLATORS: use appropriate graphic showing electrode colors

(IEC graphics are in "13 August graphics IEC"). The labeled items in the diagram above include:

Labels (A) Safety symbols and other markings (1-11) These items are defined on subsequent tables. Introduction to the Philips Telemetry System 1-15 Transmitters Back Labels Callout A Definition Electrode Placement Diagrams (See Positioning ECG Electrodes on page 3-8.) Safety Symbols and Other Markings Callout 1 Label

2 3 4 5 Rx i Definition Considered Class 2 radio equipment per Directive 1999/5/EC for which Member States may apply restrictions on putting the device into service or placing it on the market. This device is intended to be connected to the publicly available interfaces (PAI) for use throughout the EEA. Compliance to Council Directive 93/42/EEC

(MDD). The transmitter patient connections are protected against defibrillation

(DEFIBRILLATION-PROOF) and are a TYPE CF APPLIED PART. Prescription device. Follow operating instructions. 1-16 Introduction to the Philips Telemetry System Transmitters Callout 6 Label Definition Non-Ionizing Radiation. Interference to electronic equipment may occur in the vicinity of devices marked with this symbol. 7 8 9 10 11 Complies with all applicable Canadian and American standards. Serial Number. Needed to identify the equipment during a call to the Response Center. Philips Catalog Number. MAC Address of device. Date of manufacture. SN REF MAC Introduction to the Philips Telemetry System 1-17 Transmitters Sounds Transmitter Safety Information The transmitter produces auditory information signals to inform you of measurement and battery conditions. The main tone, which can be set to one of 5 different volume settings or turned off, is configurable. In addition, a lower pitched tone is used to identify a pulse beat occurring during an SpO2 Spot Check measurement. Auditory Information Signal Definition Beep Beep Beep Boop Power On Self Test Passed SpO2 Spot Check Measurement Complete Power On Self Test Failed SpO2 Spot Check Measurement Failed Boop signal corresponding to detected Pulse

(during SpO2 Spot Check measurement only) Warning Warning If another radio medical device is operating at the same frequency as the transmitter, it is possible that either device will not function properly. Warning Warning Although the transmitter is shielded against Electromagnetic Interference

(EMI), avoid the use of other electrically radiating devices in close proximity to the transmitter, which might interfere with transmitter operation. Warning Warning Place the transmitter in a pouch or over clothing, or both, during patient use. The transmitter should not touch the patients skin during use. 1-18 Introduction to the Philips Telemetry System Briefing the Patient Briefing the Patient Warning Warning Patients should be instructed not to open the battery cover while the transmitter is in use. If the Telemetry button has been configured to generate a Nurse Call, recording at the Information Center, or both, instruct the patient to use the button when needed. NoteIf desired, the clinician can turn off patient use of the button at the Information Center. See Turning Nurse Call On/Off on page 1-23. Pouch Use The transmitter is not designed for direct contact with the patients skin. During normal use, the transmitter should be worn over clothing, in a pocket or, preferably, in a pouch. The carrying pouch is an appropriate means for holding the transmitter. Introduction to the Philips Telemetry System 1-19 Briefing the Patient Securing the Pouch Task Summary Step Action 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 transmitter 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 antenna system and need to be freely exposed. 1-20 Introduction to the Philips Telemetry System Briefing the Patient Step Action 3 4 Fold the flap down and snap closed. Check that the patient is comfortable wearing the pouch with transmitter. 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 transmitter 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 transmitter and pouch will withstand showering for up to 10 minutes. Introduction to the Philips Telemetry System 1-21 Making Monitoring Adjustments Drying the Transmitter after Showering After showering, perform the following steps to continue monitoring:

1. Pat dry the lead set connections at the electrodes. 2. Wipe the lead wires with care. 3. 4. 5. If wet, dry the outside of the transmitter 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 transmitter 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 transmitter 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 Transmitter Cleaning, Disinfection, & Cross-Infection Prevention on page 6-4 as appropriate. Making Monitoring Adjustments Turning the Transmitter On/Off The transmitter is powered by two AA alkaline batteries. To turn the transmitter on, insert both batteries. Remove the batteries to turn the power off. NoteTransmitter settings (SpO2 mode, audible tone volume, etc.) set using the Service Tool/TeleMon are retained indefinitely after battery removal. 1-22 Introduction to the Philips Telemetry System Turning Telemetry Monitoring On/Off Transmitter Auto Shutoff Making Monitoring Adjustments Telemetry monitoring can be turned on or off in one of two ways:

Manually, by activating Monitoring Standby at the IntelliVue Information Center (see Standby Mode on page 1-24). Automatically, if Auto Shutoff is enabled at the transmitter and if all leads are off for 10 minutes (see Transmitter Auto Shutoff on page 1-23). NoteTurning telemetry monitoring off does not turn the transmitter off. Turn the transmitter off by removing the batteries. A service feature of the transmitter is RF Automatic Shutoff, which causes the transmitter to stop broadcasting a radio signal if all leads are off for 10 minutes. This prevents interference with other transmitters in use. The technical alarm message at the Information Center is TRANSMITTER OFF. To restart monitoring, attach leads to the patient. Automatic Shutoff can be configured off. Batteries must be removed when the transmitters are not in use to prevent RF interference and unnecessary battery drain. NoteAutomatic Shutoff does not save battery life. In order to allow an automatic turn-on when the leads are reattached, transmitter functions are not completely disabled in this mode. To extend battery life, remove the batteries when the transmitter is not in use. Turning Nurse Call On/Off If the Telemetry button on the transmitter is configured for a Nurse Call alarm, you can inhibit the alarm for individual patients by using the Telemetry Setup Window on the Information Center. If your system is configured for both a Nurse Call alarm and a recording, only the Nurse Call alarm is inhibited by turning it off: recordings are still made. Task Summary Turn the Telemetry button on the transmitter on or off by performing the following steps:

Step Action 1 On the Patient Window click the All Controls button. Introduction to the Philips Telemetry System 1-23 Making Monitoring Adjustments Step Action 2 3 On the All Controls Window click Telemetry Setup. On the Telemetry Setup Window turn the Telemetry button on or off by clicking in the Telemetry Button Allow Calls checkbox. A check mark in the checkbox indicates that the Telemetry button is on. Standby Mode When a patient is temporarily off the unit or out of antenna range you can suspend monitoring by placing telemetry in Standby mode. Standby suspends monitoring, and you wont get any waveforms or alarms. NoteIf you remove the leads before putting a patient into Standby, youll get a LEADS OFF technical alarm, and reminders if configured. Warning Warning If you put telemetry in Standby mode, you must remember to turn monitoring back on when the patient returns to the unit. NoteWhen you take an EASI transmitter out of Standby, the lead settings revert back to the centrals default lead settings (i.e., II and V2). Task Summary Place a patient in Standby by performing the following steps:

Step Action 1 2 On the Patient Window click the Standby button. Select the patients location from the pre-defined list. 1-24 Introduction to the Philips Telemetry System Use with TeleMon B, Options A02/A03 Step Action 3 4 Click the Suspend Monitoring button. This suspends all monitoring and displays the following message in the Patient Sector TELEMETRY STANDBY and the location (for example, X-Ray). NoteBe sure to take the bed out of Standby before discharging. Since Standby is associated with the equipment assigned to a bed, if a patient is discharged and the bed is in Standby mode, that equipment will be in Standby for the next patient, and monitoring will continue to be interrupted. When the patient comes back, restart monitoring by clicking on Resume Monitoring in the Patient Sector. Use with TeleMon B, Options A02/A03 The M2601B Transmitter can employ the full functionality of the TeleMon B

(Options A02 orA03) Companion Monitor, including NBP measurement and local display of alarms. Connection is made through an interface cable at the TeleMon/Service port. Please refer to the Philips TeleMon B A02/A03 Companion Monitor Instructions for Use for operating instructions. NoteOption A02 can be used with either the M2601B transmitter tethered to the monitor or the M2601A transmitter docked to it. Option A03 can be used only with the M2601B transmitter tethered to the monitor. (TeleMon B Options A02/A03 units are distinguished by a gray front bezel; while Option A01 units have a dark green front bezel.) Operation with TeleMon When the transmitter is tethered to TeleMon:

Standby mode is not available. 3-minute alarm pause/suspend is available from TeleMon. The alarm pause indicator on the transmitter will accurately reflect the current state of alarm pause at TeleMon. Introduction to the Philips Telemetry System 1-25 Use with TeleMon B, Options A02/A03 After a change in lead set or SpO2 sensor, TeleMon returns to the default ECG settings. Be sure to check the monitoring leads after you switch leads or sensor. Arrhythmia relearn will occur at TeleMon automatically if the lead set is changed. When the Check button is pressed, the transmitter battery gauge indicates full regardless of battery state. The transmitter receives operating power from TeleMon when tethered/

docked. NoteBatteries are not being charged when the transmitter is tethered/

docked. SpO2 Operation When the transmitter is connected to TeleMon, SpO2 operation is always switched to Continuous mode unless SpO2 is turned off. TeleMon can also be used to change the SpO2 operating mode when the transmitter is tethered. See SpO2Measurement when Connected to TeleMon on page 5-18. Defibrillation In the event of patient defibrillation, it may take several seconds for the ECG trace to appear on the screen. 1-26 Introduction to the Philips Telemetry System Testing the Transmitter Functionality Testing the Transmitter Functionality There are two tests of the transmitter functionality:

Self Test - performed automatically each time the transmitter is turned on. Status Check - initiated manually by the clinician. Self Test Warning Warning Do not use the transmitter for patient monitoring if it fails the Power On Self Test. A self test of the transmitter functions is automatically performed each time that the transmitter is turned on (that is, batteries are inserted). Self Test Status Auditory Signal (if configured on) Visual Indicators Passed Failed Single beep Double beep tone All LEDs illuminate for 3 seconds One or more indicators do not light up. In Case of Failure If any portion of the self test fails, the transmitter will attempt to report the failure to the monitoring system. In case of failure, use another transmitter, and contact your Service Provider. Introduction to the Philips Telemetry System 1-27 Testing the Transmitter Functionality Status Check You can check the status of the transmitter indicators at any time. Task Summary To initiate a Status Check, use the following instructions. Step Action 1 2 3 4 Press the Check button. The following indicators should illuminate for as long as the Check button is depressed. Battery gauge Type of lead set EASI (if in use) If one or more of the expected indicators do not light up, check the following:

Make sure the lead set block is correctly inserted in the transmitter and the orange line at the base of the cable is not visible (see Connecting the ECG Cable on page 3-14) Power and position of batteries (see Checking the Battery Power Level on page 1-32) Lead positions and connections (see Verifying Electrode Connections on page 3-17) If there is still a problem, contact your Service Provider for assistance. 1-28 Introduction to the Philips Telemetry System 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-Weak warning time). The use of fresh high-quality alkaline batteries is strongly recommended. Batteries should be removed from the transmitter at the end of the batterys useful life to prevent leakage. If battery leakage should occur, use caution in removing the batteries. The leaked substance may cause eye or skin irritation. Avoid contact with skin. Clean the battery compartment according to instructions in Chapter 6. Maintenance and Configuration. 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 transmitter becomes hot to the touch, place it aside until it cools. Then remove the batteries and discard them. Have the transmitter 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 WEAK alarm, the batteries must be promptly replaced. A "Battery Weak" condition that is not corrected will result in transmitter shutdown and cessation of monitoring. Be careful not to short circuit the battery. Short circuiting is caused when a piece of metal connects both positive and negative terminals together. More than a momentary short circuit will generally reduce the battery life. Introduction to the Philips Telemetry System 1-29 Battery Information Disposal of Batteries Caution The battery must be removed if a transmitter 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 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 Philips transmitter:

REMOVE THE BATTERIES when the transmitter is not in use. If using TeleMon, see the Philips TeleMon B A02/A03 Companion Monitor Instructions for Use, page 3-7. NoteAutomatic Shutoff of the transmitter does not eliminate battery usage. In order to allow an automatic turn-on, the transmitter ECG and SpO2 functions are not completely disabled in this mode. NoteThe Battery Extender for the M2601A Transmitter cannot be used with the M2601B Transmitter to extend battery life. 1-30 Introduction to the Philips Telemetry System Battery Information Inserting/

Removing Batteries The battery compartment is located at the bottom of the transmitter and 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. Task Summary Insert batteries into the transmitter using the following procedure. Step Action 1 2 Open battery compartment by swinging the compartment door 90o into an open hinged position. Insert two disposable AA 1.5V Alkaline batteries, matching the polarity with the +/- indications inside the compartment.

Both batteries are inserted with the + ends in the same direction. 3 Close the battery compartment door. Introduction to the Philips Telemetry System 1-31 Battery Information Checking the Battery Power Level Batteries should be changed in sets, that is, if you change one battery, change them both. If you remove good batteries to turn off the transmitter, 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 transmitter is not in use or is being stored. DO NOT STORE BATTERIES BY LEAVING THEM IN THE INCORRECT POLARITY POSITION INSIDE THE TRANSMITTER. 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. When the Check button is pressed, the battery gauge on the transmitter indicates the battery power level. The approximate battery life remaining indicated by the gauge is given in the table below. The percentages and times are for ECG operation only. NoteThe battery life times are based on Duracell MN 1500 batteries. Battery life for other brands may be different. Battery Gauge 4 green indicators Approximate Battery Life Remaining (ECG Only)

>75%

Approximate Operating Time Remaining

>30.4 hours Functionality Normal operation Normal operation Japanese version: >33 hours

>20.3 hours Japanese version: >22 hours 3 green indicators

>50%

1-32 Introduction to the Philips Telemetry System Battery Information Functionality Normal operation Normal operation Japanese version: >11 hours

>15 minutes

<15 minutes SpO2 disabled Transmitter shutdown Battery Gauge 2 green indicators Approximate Battery Life Remaining (ECG Only)

>25%

Approximate Operating Time Remaining

>10.1 hours 1 green indicator 25% to BATTERY WEAK level 1 red indicator BATTERY WEAK level to REPLACE BATTERY level no indicator REPLACE BATTERY level

(Check batteries for correct polarity) Task Summary To check the power level, use the following instructions. Step Action 1 2 3 Insert batteries if the transmitter is not already on. Press the Check button to determine the level. (See Checking the Battery Power Level on page 1-32.):

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 in Step 2 above, the transmitter has malfunctioned. Contact your Service Provider. Introduction to the Philips Telemetry System 1-33 Receiver Module Receiver Module The Philips receiver modules are housed in the receiver mainframe. Each receiver module is dedicated to a specific transmitter by an internal identity code. This prevents another patient's waveform from being erroneously transmitted and displayed. The receiver acquires the ECG and SpO2 signals from the transmitter and sends them to the receiver mainframe. Receiver Mainframe Receiver Module Front Cover 1-34 Introduction to the Philips Telemetry System Receiver Mainframe Receiver Mainframe The Philips receiver mainframe houses up to eight receiver modules. For each receiver, the receiver mainframe calculates the heart rate, and sends the waveform, patient alarms, technical alarms, and status messages over the Philips patient care system to the IntelliVue Information Center for display and recording. If SpO2 is available, the transmitter processes the data and sends it to the IntelliVue Information Center via the network as well. Turning the Receiver Mainframe On or Off The receiver mainframe must be turned on for individual transmitters and receivers to work. To turn the receiver mainframe on, the power cord must be attached and connected to an AC outlet. A green LED on the rear of the Mainframe will light then. If the receiver mainframe is turned off, the light and all receiver modules are off. Receiver Mainframe Malfunction Light A red light on the front panel of the mainframe illuminates when either the mainframe or one of the receivers has malfunctioned. Depending on the problem, you may see the message, NO DATA FROM BED or RECEIVER MALF, in single or multiple patient sectors. Contact your Service Provider. When the mainframe is first turned on, the red light flashes. If no problems are detected, the flashing stops and the light turns off. Channel Frequencies The frequency of Philips transmitters and receivers are programmable, thus enabling changes in frequency if interference is detected. In case of interference, contact service. Retaining Telemetry Settings If power to the receiver mainframe is interrupted or turned off, settings controlled by the mainframe such as leads may be affected. If the receiver mainframe is turned off for less than three hours, your settings should still be in effect. If the mainframe is turned off for more than three hours, your settings revert to default, that is, to the configured settings at installation. Introduction to the Philips Telemetry System 1-35 Antenna System Antenna System The telemetry antenna system is custom-designed for your unit to ensure adequate coverage, therefore the telemetry signal can only be received where there are receiving antennas. After it is received by the antenna system, it is sent to the receiver which recovers the patient's ECG and optional SpO2. This information is then sent to a monitoring display. 1-36 Introduction to the Philips Telemetry System 2 Alarms I n t r o d u c t i o n This chapter describes alarm behavior and lists Physiologic Alarms (Patient Alarms) and Technical Alarms (Inoperative Conditions). Both types of alarms are listed alphabetically. Alarm Indicators . 2-2 Pause/Suspend Alarms . 2-2 Alarm Behavior with Own Bed Overview . 2-3 Physiologic (Patient) Alarms . 2-6 Technical Alarms (INOPs) . 2-11 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 Online Help. The Information Center documentation also includes the default alarm settings and physiological alarm limit ranges. Pause/Suspend Alarms All alarms for a patient can be paused/suspended from the Information Center, or from the TeleMon Companion Monitor, if connected. See the Instructions for Use for the Information Center or TeleMon for directions. If connected to TeleMon, alarms can be suspended only from TeleMon, and not from the Information Center. If alarms are suspended from TeleMon, the Alarms Suspend icon on the transmitter is lit (see Transmitter Controls - Front on page 1-11) and an ALARMS SUSPENDED message appears at TeleMon and the Information Center. 2-2 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 OFF or BED ALARMS SUSPEND (depending on configuration) Bedside: ALARMS PAUSED or ALARMS OFF Alarms 2-3 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. 2-4 Alarms Alarm Behavior with Own Bed Overview 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 Alarms 2-5 Physiologic (Patient) Alarms Physiologic (Patient) Alarms There are no physiologic (patient) alarm signals generated by the transmitter. 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. If arrhythmia is turned off at the Information Center, the cardiotach is available on the telemetry mainframe for the following alarms: Asystole, V-fib, High HR, Low HR. There are two levels of arrhythmia analysis available at the Information Center:

Basic and Enhanced. Enhanced analysis includes Basic alarms. In the table Red (***) alarms are listed alphabetically, followed by the Yellow

(**) alarms, then Yellow (*) arrhythmia alarms. NoteIn Release D.00/D.01/E.00/E.01 of the IntelliVue Information Center, yellow ST/AR arrhythmia alarms are indicated by (**) rather than (*). 2-6 Alarms Physiologic (Patient) Alarms Physiologic (Patient) Alarms Alarm Text Priority Condition

***ASYSTOLE Red Asystole. No QRS for 4 consecutive seconds

*** BRADY yyy <xxx Red

*** EXTREME BRADY Red

*** EXTREME TACHY Red

*** TACHY yyy < xxx Red

*** VFIB

*** V-FIB/TACH

*** V-TACH Red Red Red Extreme Bradycardia. HR <

extreme Brady HR Limit Extreme Bradycardia. HR <

extreme Brady HR Limit Extreme Tachycardia. HR >

extreme Tachy HR Limit Extreme Tachycardia. HR >

extreme Tachy HR Limit Ventricular Fibrillation. Fibrillatory waveform for 4 consecutive seconds Ventricular Fibrillation. Fibrillatory waveform for 4 consecutive seconds Source ST/AR Basic and Enhanced Arrhythmia Mainframe cardiotach ST/AR Enhanced Arrhythmia ST/AR Basic and Enhanced Arrhythmia ST/AR Basic and Enhanced Arrhythmia ST/AR Enhanced Arrhythmia Mainframe cardiotach ST/AR Basic and Enhanced Arrhythmia Ventricular Tachycardia. Sustained run of PVCs accompanied by a high heart rate ST/AR Basic and Enhanced Arrhythmia

** HIGH HR Yellow High Heart Rate. HR > high HR Limit Mainframe cardiotach Alarms 2-7 Physiologic (Patient) Alarms Alarm Text

** LOW HR Physiologic (Patient) Alarms Priority Condition Source Yellow Low Heart Rate. HR < low HR Limit Mainframe cardiotach

** NURSE CALL Yellow

** SpO2 yyy > xxx Yellow

** SpO2 yyy < xxx Yellow

* HR yyy > xxx

* HR yyy < xxx Yellow Yellow

* IRREGULAR HR Yellow Telemetry button press on the transmitter (when configured for Nurse Call operation) Clinician/patient-

initiated at the transmitter High SpO2. SpO2 value greater than high SpO2 Limit Low SpO2. SpO2 value less than low SpO2 Limit High Heart Rate. HR > high HR Limit SpO2 SpO2 ST/AR Enhanced Arrhythmia Low Heart Rate. HR < low HR Limit ST/AR Enhanced Arrhythmia Irregular Heart Rate. Constantly irregular HR. ST/AR Enhanced Arrhythmia

* LOW HR Yellow Low Heart Rate. HR < low HR Limit

* MISSED BEAT Yellow Missed Beat. Beat omitted

* MULTI ST Ld X, Ld Y Yellow Multi ST Leads exceeding Limit

(EASI mode or when selected). Two ST leads (Ld X, Ld Y) exceed elevation or depression for > 60 seconds

* MULTIFORM PVCs Yellow Multiform PVCs ST/AR Basic and Enhanced Arrhythmia ST/AR Enhanced Arrhythmia ST/AR Arrhythmia ST/AR Enhanced Arrhythmia 2-8 Alarms Physiologic (Patient) Alarms Physiologic (Patient) Alarms Alarm Text Priority Condition

* NON-SUSTAIN VT Yellow

* PACER NOT CAPT Yellow

* PACER NOT PACE Yellow Non-Sustained VT. Non-

Sustained Ventricular Tachycardia Pacer Not Capture. Missed beat with pace pulse (paced patient). Pacer Not Pacing. Missed beat without pace pulse (paced patient).

* PAIR PVCs Yellow Pair of PVCs.

* PAUSE Yellow Pause. No QRS for > x seconds

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

* R-ON-T PVCs Yellow R-on-T PVCs Source ST/AR Enhanced Arrhythmia ST/AR Basic and Enhanced Arrhythmia ST/AR Basic and Enhanced Arrhythmia ST/AR Enhanced Arrhythmia ST/AR Enhanced Arrhythmia ST/AR Basic and Enhanced Arrhythmia ST/AR Enhanced Arrhythmia

* RUN PVCs

* ST lead > xxx

* ST lead < xxx

* SVT Yellow Yellow Yellow Yellow Run PVCs. Run of PVCs length

>= 2 ST/AR Enhanced Arrhythmia STx > Elevation limit. ST segment is elevated STx < Depression limit. ST segment is depressed. ST/AR Arrhythmia ST/AR Arrhythmia Supra Ventricular Tachycardia. SVT for > 15 seconds ST/AR Enhanced Arrhythmia Alarms 2-9 Physiologic (Patient) Alarms Physiologic (Patient) Alarms Alarm Text Priority Condition

* VENT BIGEMINY Yellow Ventricular Bigeminy. Predominant Bigeminy rhythm present. Source ST/AR Enhanced Arrhythmia

* VENT RHYTHM Yellow

* VENT TRIGEMINY Yellow Ventricular Rhythm. Ventricular rhythm present. ST/AR Enhanced Arrhythmia Ventricular Trigeminy. Predominant Trigeminy rhythm present. ST/AR Enhanced Arrhythmia 2-10 Alarms Technical Alarms (INOPs) Technical Alarms (INOPs) Technical Alarms, or INOPs, are sourced at the transmitter or TeleMon Companion Monitor, and identify inoperative conditions. There are three types of Technical Alarms. Severe technical alarms must be acknowledged by a clinician. A Hard technical alarm indicates that monitoring and alarms are disabled and generates an audible tone at the Information Center. With a Soft technical alarm, monitoring and alarms remain active, and no audible tone is generated. Technical Alarms (INOPs) Alarm Text Priority Condition What to do

##nnn/nnn(nnn)nnn

(RF technical alarm) Soft ARRHY REQUIRED Hard Used by service in troubleshooting the radio signal Arrhythmia monitoring was turned off for an EASI transmitter. BATTERY WEAK Soft Weak batteries CANNOT ANALYZE ECG Hard Arrhythmia algorithm cannot reliably analyze the ECG data on any monitored leads. Contact Service Provider. Turn arrhythmia monitoring on or move lead set to the Standard ECG position if arrhythmia monitoring is not desired. Replace batteries promptly to avoid transmitter shutdown and cessation of monitoring. Assess the lead selections, initiate relearn, and validate analyzed rhythm. NoteSee Optimizing System Performance on page 3-22. Alarms 2-11 Technical Alarms (INOPs) Alarm Text Priority Condition What to do Technical Alarms (INOPs) CANNOT ANALYZE ST Soft ECG EQUIP MALF Hard ST algorithm cannot reliably generate any valid ST values on any monitored lead. Assess the lead selections. NoteSee Optimizing System Performance on page 3-22. Failure of the ECG equipment or failure to calibrate ECG Replace transmitter or calibrate ECG with Service Tool. INTERFERENCE Hard Interference due to outside source INVALID LEADSET Hard INVALID SIGNAL E01 Hard Bad lead selection switches in transmitter Receiver is picking up a duplicate frequency. Check that there are no transmitters stored with batteries inserted. Change the Philips transmitter and receiver frequency. Contact Service Provider. Replace transmitter case. Use supported lead set. When the transmitter is not being used, turn telemetry monitoring off for the bed. If the situation continues, contact Service. If this is a new transmitter, the system must learn the new transmitter ID code -

contact Service Provider. LEADS OFF Hard Single or multiple leads off Reattach ECG leads to patient. 2-12 Alarms Alarm Text Priority Condition What to do Technical Alarms (INOPs) Technical Alarms (INOPs) NO RECEIVER Hard Receiver absent or malfunctioning NO SIGNAL Hard Patient is out of range, radio board has failed, no batteries in transmitter, or batteries inserted incorrectly. This message appears after the mainframe is turned on and indicates the absence of a receiver or a receiver is faulty. Contact Service Provider. Make sure that the transmitter is in range. Check batteries for correct insertion. Replace transmitter if Power On Self Test fails, and notify Service Provider. RECEIVER MALF Hard Receiver is malfunctioning. Contact Service Provider. REPLACE BATTERY Hard, Latched Message remains until acknowledged by clinician. Batteries are unable to power the transmitter, or batteries are inserted backwards. No monitoring is occurring. Replace batteries/check batteries for correct insertion. SpO2 EQUIP MALF Hard SpO2 ERRATIC Hard Malfunction in the SpO2 hardware Erratic SpO2 measurements, often due to a faulty sensor or invalid SpO2 measurements, or incorrect sensor position SpO2 board needs to be replaced. Call Service Provider. Repeat measurement, reposition sensor on patient, or finally, replace sensor. Alarms 2-13 Technical Alarms (INOPs) Alarm Text Priority Condition What to do Technical Alarms (INOPs) SpO2 INTERFERENCE Hard SpO2 NO TRANSDUCER Hard SpO2 NOISY SIGNAL Hard SpO2 NON-PULSATILE Hard Level of ambient light or level of electrical interference are so high that the SpO2 sensor cannot measure SpO2 and pulse rate. No sensor attached to SpO2 device Excessive patient movements or electrical interference are causing irregular pulse patterns Pulse is too weak or not detectable Reduce ambient light to sensor or electrical noise sources. Conceal/cover sensor with opaque non-white cover. Attach SpO2 sensor. Reduce movement or electrical noise sources. Check connection to patient. Change sensor site. Avoid site distal to BP cuff or intra-

arterial line. SpO2 TRANS MALF Hard Malfunction of the SpO2 sensor/adapter-cable Replace sensor. 2-14 Alarms Alarm Text TEL CANNOT ANALYZE Technical Alarms (INOPs) Technical Alarms (INOPs) Priority Condition What to do Hard INOP Shorts bursts of data corruption inhibiting an accurate HR count. (Often accompanied by WEAK SIGNAL, NO SIGNAL, or INTERFERENCE INOPs.) TRANSMITTER MALF Hard Transmitter malfunction Check that there are no transmitters stored with batteries. Check to see if the patient is in the coverage area, and return patient if needed. If the patient is in the coverage area and is stationary, move the transmitter or patient about 6 inches (15 cm.). If the situation persists, contact Service Provider. Replace transmitter and notify Service Provider. Alarms 2-15 Technical Alarms (INOPs) Alarm Text Priority Condition What to do Technical Alarms (INOPs) TRANSMITTER OFF WEAK SIGNAL Soft Soft RF shut off after 10 minutes of leads off Reattach ECG leads to patient. Weak RF signal received at Telemetry Mainframe from transmitter Move transmitter into RF coverage area and re-check transmitter. If condition exists in close proximity to the antenna, replace transmitter. Check to see if the patient is in the coverage area, and return patient if needed. If the patient is in the coverage area and is stationary, move the transmitter or patient about 6 inches (15 cm.). If the situation persists, contact Service Provider. 2-16 Alarms 3 ECG & ST/AR Measurement This chapter covers the specifics of ECG measurement, as well as arrhythmia monitoring using the ST/AR algorithm. It includes the following sections:

Measuring ECG. 3-2 Setting Up for ECG Monitoring . 3-7 Connecting the ECG Cable . 3-14 Verifying Electrode Connections . 3-17 Making ECG Adjustments . 3-18 Monitoring During Leads Off . 3-19 Optimizing System Performance . 3-22 ECG Safety Information . 3-27 ST/AR Arrhythmia Analysis. 3-28 TO TRANSLATORS for geographies where IEC ECG lead sets are used:

Please use the graphics showing IEC electrode colors (see "13 August graphics IEC.fm"). Also, if needed, change the electrode colors in the text to conform to the IEC colors. Note that the graphics and text in this chapter say "V1, V2, V3....." for the chest lead designations. For IEC please substitute "C2, C2, C3, etc.". ECG & ST/AR Measurement 3-1 Measuring ECG Measuring ECG 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 transmitter: cardiotach analysis resides in the telemetry mainframe. The type of ECG analysis depends on whether or not arrhythmia analysis is on or off at the Information Center. When arrhythmia is turned on at the Information Center, the cardiotach is included as part of arrhythmia analysis in the Information Center for standard lead placement. When arrhythmia is turned off at the Information Center, the cardiotach is available on the telemetry mainframe. NoteArrhythmia analysis must be turned on at the Information Center when using EASI mode. ECG Lead Sets The M2601B Transmitter supports two different lead sets (see Connecting the ECG Cable on page 3-14). It detects the inserted lead set type and automatically determines the ECG measurement and transmitted leads. The Lead Set Insertion Guide on the device will assist you in ensuring the correct measurement during transmitter usage (see Connecting the ECG Cable on page 3-14). The 5-wire lead set can be used for either Standard or EASI electrode configurations. The lead sets are compatible with the 5- and 3-wire lead sets used with the IntelliVue family of monitors. ImportantM2601B Transmitter lead sets are not compatible with M2601A Transmitters. The electrode placements for the illustrations in this chapter use the AAMI labels and colors. 5-wire lead sets are available with the lead-wire color option. The following table lists the AAMI and IEC electrode locations and colors. 3-2 ECG & ST/AR Measurement Electrode Locations and Colors Lead Set Type 3-wire 5-wire

(in Standard Mode)

(in EASI Mode) Electrode Location LA RA LL LA RA LL RL V S I A N E AAMI Electrode Color Black White Red Black White Red Green Brown Black White Red Green Brown Measuring ECG IEC Electrode Color Yellow Red Green Yellow Red Green Black White Yellow Red Green Black White ECG & ST/AR Measurement 3-3 Measuring ECG ECG Leads Monitored Depending on the lead set connected to the transmitter, a different set of viewable leads are available at the Information Center. The transmitter can source up to four raw ECG waves. The transmitter automatically recognizes the lead set connected. If you are using ... these leads are available 3-wire If Lead Select is configured off:

Default is II. To monitor a different lead, change the electrode placement to the lead you want. Then, at the Information Center, select the lead label that reflects the electrode placement. Choices are I, II, or III. NoteThe raw ECG is received on Channel 1 as II. If Lead Select is configured on:

Default is II. If tethered to TeleMon, you can select a different lead at TeleMon without moving the electrodes. Choices are I, II, or III. NoteThe raw ECG is received on Channel 1 as I, II, or III, depending on which lead is selected. 3-4 ECG & ST/AR Measurement Measuring ECG If you are using ... these leads are available 5-wire (Standard Mode) I, II, III, aVR, aVL, aVF, MCL, and V Defaults are II, V, III In Standard mode, the raw ECG waves are received as:

Channel 1 = Lead II Channel 2 = Lead III Channel 3 = Lead MCL Lead selection is available at the Information Center. ImportantDo not set the primary and secondary channels to the same lead. 5-wire (EASI Mode) I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6 EASI 12-lead selection is available at the Information Center. 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) Although you can view and perform ST analysis on all 12 EASI derived leads, arrhythmia monitoring is performed only on the primary and secondary leads selected at the Information Center. ECG & ST/AR Measurement 3-5 Measuring ECG Reconstructed Leads Reconstruction of 3 and 5 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. ECG Lead 3-wire I II III

ECG Lead Reconstruction 5-wire Standard I II III MCL aVR aVL aVF V Clinical Calculations in terms of electrodes LA-RA LL-RA LL-LA Va-LA, C=Va RA-(LA+LL)/2 LA-(RA+LL)/2 LL-(LA+RA)/2 C-(RA+LA+LL)/3, C=Va 3-6 ECG & ST/AR Measurement Setting Up for ECG Monitoring Setting Up for ECG Monitoring Task Summary Step Action 1 2 3 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 site, as necessary Wash site with soap and water, leaving no soap residue. NotePhilips 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. Check electrodes for moist gel, and attach to the clips/grabbers. 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 on page 3-8). 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. ECG & ST/AR Measurement 3-7 Setting Up for ECG Monitoring 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. This helps maintain maximum electrical patient safety. 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 transmitter 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. Electrode Placement Diagrams for Standard 5-wire and EASI electrode placement are located on the back of the transmitter. Additional lead placement information is available in the Online Help in the IntelliVue Information Center. Philips recommends that electrodes be changed every 24 hours. 3-8 ECG & ST/AR Measurement Setting Up for ECG Monitoring Locating the Fourth Intercostal Space Angle of Lewis For accurate chest electrode placement and measurement, it is important to first 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 & ST/AR Measurement 3-9 Setting Up for ECG Monitoring 5-wire Placement

(Standard Mode) V1 V2 V3 V4 V5 V6 Lead RA LA RL LL V V1 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 default position is V2. on the fourth intercostal space at the right sternal border 3-10 ECG & ST/AR Measurement Setting Up for ECG Monitoring 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 ECG & ST/AR Measurement 3-11 Setting Up for ECG Monitoring 5-wire 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 N Lead Corresponds to Standard Lead Placement E A S I N V LL LA RA Reference 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 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 3-12 ECG & ST/AR Measurement Setting Up for ECG Monitoring 3-wire Placement 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 ECG & ST/AR Measurement 3-13 Connecting the ECG Cable Connecting the ECG Cable Task Summary NoteYour transmitters may have alignment guides that assist lead set insertion. Step Action 1 Match the arrow on the ECG cable with the arrow on the Lead Set Insertion Guide according to the lead type you have chosen, and insert the ECG cable into transmitter. ImportantMake sure that the cable is pushed completely into the transmitter. When correctly inserted, the orange line at the base of the cable is not visible. 3-wire:

Orange line M2601B EASI, 3 5 Match the arrow on the cable with the left arrow

(labeled EASI, 3) on the Lead Set Insertion Guide. 3-14 ECG & ST/AR Measurement Connecting the ECG Cable Step Action 5-wire NoteIf you are using the 5-wire lead set 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 lead set and the orange line is not visible. Standard Mode:

Orange line M2601B EASI, 3 5 Match the arrow on the cable with the right arrow

(labeled 5) on the Lead Set Insertion Guide. EASI Mode:

Orange line M2601B EASI, 3 5 Match the arrow on the cable with the left arrow

(labeled EASI, 3) on the Lead Set Insertion Guide. ECG & ST/AR Measurement 3-15 Connecting the ECG Cable Step Action 2 Check that the correct lead indicators are lit for the lead set you are using, and that the EASI indicator light is illuminated appropriately. See Verifying Electrode Connections on page 3-17. ImportantWhen using 5-wire Standard, note that the EASI indicator does not illuminate. When using EASI, the EASI indicator should illuminate for 5 seconds after the lead set is inserted (as well as when the Check button is pressed). Cable Disconnection When disconnecting the lead set from the transmitter, grasp the lead block firmly and pull free. Do not pull on the lead wires. 3-16 ECG & ST/AR Measurement Verifying Electrode Connections Verifying Electrode Connections The electrode indicator LEDs (Light Emitting Diodes) 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 lead set status. During routine use of the transmitter for monitoring, all LEDs are off. Task Summary 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 LEDs illuminate, then all turn off. If 5-wire cable in Standard mode is attached: Red, White, Black, Green & Brown LEDs illuminate, then all turn off. If using EASI: Red, White, Black, Green & Brown LEDs illuminate, then all turn off. The EASI indicator also illuminates briefly. If no lead set is attached: all LEDs are off. 3 Unexpected Response:

Any other response indicates a problem. Check the lead block connection and/or use a new lead set. If the problem is not corrected, contact your Service Provider. ECG & ST/AR Measurement 3-17 Making ECG Adjustments During routine monitoring, the electrode indicators also notify you if one or more leads are not functioning. When a LEADS OFF condition occurs, the transmitter automatically illuminates the indicator corresponding to the missing lead. Making ECG Adjustments You can make the following adjustments from the IntelliVue Information Center:

Change the lead or the lead label. Change the wave size. With 5-wire lead sets, you can monitor two leads. With a 3-wire lead set you can monitor one lead. When monitoring two leads, the first lead is the primary lead. Singlelead arrhythmia analysis uses this lead. It is also the lead used for alarm and delayed recordings. Multilead analysis uses both leads. If you are not receiving a good ECG wave and the electrodes are securely attached, you should try changing the lead in which you are monitoring. Bandwidth Bandwidth is not user adjustable, but is assigned automatically by the Information Center. The settings are:

Setting Bandwidth ST off ST on Monitor (0.5 to 40 Hz) ST (0.05 to 40 Hz) Changing Lead/Label To change the lead/label place your cursor over the wave in the Patient Window. For a 3-wire lead set, apply the electrodes to monitor the lead you want and select the label from the pop-up box to match the placement. 3-18 ECG & ST/AR Measurement Adjusting Wave Size Monitoring During Leads Off NoteIf the TeleMon Companion Monitor is available, you can change the lead on a 3-wire lead set (if configured for Lead Select). See ECG Leads Monitored on page 3-4. For a 5-wire lead set, you can change the lead without moving the electrodes. To change the amplitude of the ECG wave on the display or for recordings, place your cursor over the wave in the Patient Window and select the size you want from the pop-up box. There are five sizes available: 1/4 (smallest), 1/2, 1, 2, and 4 (largest). You can use the 1 mV cal bar on the Patient Window to check the height of the R-wave. If the wave is not at least 0.5 mV high (one-half the size of the cal bar), change the lead. 0.5 mV 1 mV Monitoring During Leads Off ECG Fallback and Extended Monitoring occur when the primary and/or secondary leads are in a Leads Off condition for >10 seconds. The system performs this action in an attempt to maintaining monitoring and arrhythmia analysis. Lead Fallback is used if the primary or secondary lead is available. Extended Monitoring is used if neither is available. Lead Fallback Lead Fallback is configured on or off by your Service Provider. ECG & ST/AR Measurement 3-19 Monitoring During Leads Off Multilead Analysis If the system is using multilead analysis, the active secondary lead becomes the primary lead, and the arrhythmia algorithm switches the leads on the display. When the Leads Off condition is corrected, the leads are switched back to their original state. Arrhythmia Relearn does not occur. Singlelead Analysis Fallback for EASI For singlelead analysis, if there are two leads available, the other lead is made the primary lead until the Leads Off condition is corrected. The arrhythmia algorithm performs a Relearn. 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" and is analyzed by the arrhythmia algorithm. Arrhythmia Relearn occurs with transition to/from EASI Lead Fallback. Extended Monitoring When both the primary and secondary leads have a Leads Off condition, if another lead is available it becomes the primary lead and the system does a Relearn. This is called Extended Monitoring. Extended Monitoring applies if:

Telemetry is configured for Extended Monitoring ON. The lead set provides more than two leads (i.e., when using a 5-wire lead set). 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. 3-20 ECG & ST/AR Measurement Monitoring During Leads Off Using EASI Leads to Troubleshoot If there is artifact in the ECG waves or a CANNOT ANALYZE ECG technical alarm condition, 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. ECG & ST/AR Measurement 3-21 Optimizing System Performance Optimizing System 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 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 transmitters or the antenna 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 system's dependability. Warning Warning The Philips 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. NoteThe Philips Telemetry System also emits radio frequencies (defined in Chapter 7, System Safety and Specifications) that may affect the operation of other devices. Contact the manufacturer of other equipment for possible susceptibility to these frequencies. The Telemetry Signal The transmitter 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 antenna system. Since the signal passes through the air, it is susceptible to interference from many sources. 3-22 ECG & ST/AR Measurement Optimizing System Performance Troubleshooting Signal Disturbance Dropouts Because the telemetry system is a wireless system, under certain conditions RF 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 TEL CANNOT ANALYZE, as well as CANNOT ANALYZE ECG or CANNOT ANALYZE ST technical alarms occur. 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 antenna system is custom designed for your unit, so reliable signal reception is only possible where there are receiving antennas. When the signal is too low, the following technical alarms occur:

TEL CANNOT ANALYZE CANNOT ANALYZE ECG CANNOT ANALYZE ST WEAK SIGNAL NO SIGNAL To correct, first check the location of the patient. If not in the coverage area, do one of the following. Return the patient to the specified antenna coverage area. Put telemetry in Standby mode. See Standby Mode on page 1-24. ECG & ST/AR Measurement 3-23 Optimizing System Performance Warning Warning If you put telemetry in Standby mode, you must remember to turn monitoring back on when the patient returns to the unit. If the patient is in the coverage area and is stationary, try moving the location of the transmitter or patient about 6 inches (15 cm.). Radio Frequency Interference Radio frequency (RF) interference is caused by anything that intrudes into the transmitted electrical signal, such as paging transmitters. We are all familiar with electrical interference in our homes and cars when it causes signal loss or static on a cell phone. These same types of interference can occur with the transmitted telemetry signal. Even though the Philips 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 respiration variation. It is up to the clinician to use certain techniques to minimize these types of noise. 3-24 ECG & ST/AR Measurement Optimizing System Performance Use the following table to help you troubleshoot the most common sources of ECG noise. Problem Cause Remedy 60-Cycle (AC) Interference Poor electrode placement. Re-apply electrodes Muscle Artifact Possible non-grounded instrument near patient. Tense, uncomfortable patient. Poor electrode placement. Tremors. Diaphoresis. Irregular Baseline Poor electrical contact. Respiratory interference. Faulty electrodes. Dry electrodes. 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; re-apply the electrodes if necessary, using good skin preparation (see Setting Up for ECG Monitoring on page 3-7). Re-apply electrodes, using good skin preparation (see Setting Up for ECG Monitoring on page 3-7). Move electrodes away from areas with greatest movement during respiration. ECG & ST/AR Measurement 3-25 Optimizing System Performance Problem Cause Remedy Baseline Wander Movement of patient. Make sure patient is comfortable. Improperly applied electrodes. Respiratory interference. Poor Electrode Contact Loose electrodes. Defective cables. Lead set not firmly connected. Re-apply electrodes, using good skin preparation (see Setting Up for ECG Monitoring on page 3-7). Check that patient cable is not pulling electrodes. Move electrodes away from areas with greatest movement during respiration. Change electrodes, using good skin preparation (see Setting Up for ECG Monitoring on page 3-7). Replace cables. 3-26 ECG & ST/AR Measurement 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 should be secured to an electrode on the patient. Conductive parts of electrodes should 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. ECG & ST/AR Measurement 3-27 ST/AR Arrhythmia Analysis Warning Warning FOR PACED PATIENTS The output power of the transmitter 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 transmitter 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 Telemetry System. See the IntelliVue Information Center Instructions for Use for additional information on monitoring paced patients. ST/AR Arrhythmia Analysis For information on arrhythmia detection and ST monitoring, refer to the following:

IntelliVue Information Center Instructions for Use and Online Help ST/AR Algorithm - Arrhythmia Monitoring Application Note (4522 981 93051). ST/AR Algorithm - ST Segment Monitoring Application Note (4522 981 92851). 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 3-28 ECG & ST/AR Measurement ST/AR Arrhythmia Analysis algorithm is effective when monitoring both paced and non-paced patients in a clinical environment. ST/AR provides Heart Rate and PVC Rate numerics and alarm detection for the conditions listed in the table below. There are two levels: Basic and Enhanced. Enhanced includes the Basic alarms. See Physiologic (Patient) Alarms on page 2-6 for arrhythmia alarm text and descriptions. Basic & Enhanced Arrhythmia Detection Basic Arrhythmia Detection Asystole V Fib/Tach V Tach Extreme Brady Extreme Tachy High HR Low HR Enhanced Arrhythmia Detection Tachy yyy > xxx Vent Bigeminy Brady yyy < xxx Vent Trigeminy Non-Sustain VT Multiform PVCs Vent Rhythm Run PVCs Pair PVCs Pause HR yyy > xxx HR yyy < xxx Irregular HR PVCs > xx/min Missed Beat Pacer Not Capturing SVT Pacer Not Pacing R-on-T PVCs ECG & ST/AR Measurement 3-29 ST/AR Arrhythmia Analysis Beat classification determined by the ST/AR algorithm is shown on the primary delayed wave in Arrhythmia Analysis at the Information Center. To access the waves with beat annotations, 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 Beat Supraventricular Premature Ventricular Premature Questionable Pacer Mark Blue Red Red Red Blue Blue Blue Red Red Blue When monitoring is initiated, when the Channel 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. ECG and ST/

AR Alarms See Chapter 2, Alarms for a list of all ECG and arrhythmia alarms. 3-30 ECG & ST/AR Measurement ST/AR Arrhythmia Analysis ST/AR Arrhythmia 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

--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. 1. Respond to the technical alarm [for example, reconnect the electrode(s)]. 2. Ensure that the arrhythmia algorithm is labeling beats correctly. ECG & ST/AR Measurement 3-31 ST/AR Arrhythmia Analysis 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. 3-32 ECG & ST/AR Measurement 4 ST/AR ST Segment Monitoring I n t r o d u c t i o n This chapter describes the ST/AR ST algorithm for telemetry of the IntelliVue Information Center. It includes the following sections:

ST/AR ST Algorithm . 4-2 Adjusting Measurement Points. 4-5 Establishing ST Reference Beats (Baseline) . 4-7 Turning ST On/Off . 4-7 ST Alarms. 4-8 ST/AR ST Segment Monitoring 4-1 ST/AR ST Algorithm ST/AR ST Algorithm Intended Use Patient Population The intended use of the ST/AR ST algorithm for the IntelliVue Information Center is to monitor ST segment elevation or depression for each available telemetry ECG lead and produce 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. You can perform ST analysis on both non-paced and atrially paced patients. The ST/AR ST algorithm is approved only for adult telemetry-monitored patients. With EASI monitoring, ST analysis is performed on up to 12 leads. NoteStudies have validated the maximal EASI derived ST measurements on male and female patients with ages from 33 to 82, heights 147 to 185 cm (58 to 73 in), weights 53 to 118 kg (117 to 261 lb) and height-to-weight ratios of 1.41 to 2.99 cm/kg (0.25 to 0.54 in/lb). 4-2 ST/AR ST Segment Monitoring ST/AR ST Algorithm 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 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 Warning Warning This device provides ST level change information; the clinical significance of the ST level change information should be determined by a physician. ST/AR ST Segment Monitoring 4-3 ST/AR ST Algorithm How the Algorithm Works Displayed ST Data EASI ST Analysis 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. ST analysis uses the ST/AR arrhythmia beat classification to select only normal and atrially paced beats for its analysis. 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. ST data displays as values in the Patient Sector and Patient Window. A positive value indicates ST segment elevation; a negative value indicates depression. You can view ST data in ST Review, Trend Review, and Event Review windows. ST/AR ST analysis for EASI derived transmitters is done on all 12 leads. The value presented in the patient sector and Patient Window is STindx. 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. 4-4 ST/AR ST Segment Monitoring Adjusting Measurement Points Adjusting Measurement Points The ST Setup Window allows 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 adjusted if the patient's heart rate or ECG morphology changes significantly. Task Summary Perform the following steps 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 ST/AR ST Segment Monitoring 4-5 Adjusting Measurement Points 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 place 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 4-6 ST/AR ST Segment Monitoring Establishing ST Reference Beats (Baseline) 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 IntelliVue 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 IntelliVue Information Center Instructions for Use or Online Help for directions. Turning ST On/Off The ST Setup Window allows you to turn ST monitoring on/off for all available ECG leads. 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. Task Summary To turn ST monitoring on/off perform the following steps:

Step Action 1 2 Access the ST Setup Window by clicking the All Controls button on the Patient Window then clicking the ST Setup button. If you want to turn all ST monitoring on/off click ST On. ST/AR ST Segment Monitoring 4-7 ST Alarms ST Alarms All IntelliVue Information Center alarm settings (limits and on/off status) have unit default settings. The Information Center however, lets you set the high and low ST alarm limits for individual patients based on:

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 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 Chapter 2, Alarms for a list of all ST alarms. NoteSee the IntelliVue Information Center Instructions for Use for specifics on alarm management and behavior. 4-8 ST/AR ST Segment Monitoring ST Alarms ST Alarm Adjustments Task Summary Make adjustments to ST alarms on the ST Alarms window. Step Action 1 2 Access the ST Alarms window by clicking on the All Controls button in the Patient Window then clicking the ST Alarms button under Alarm Management and Setup. Make the adjustments on the ST Alarms window. 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 ST Segment Monitoring 4-9 ST Alarms 4-10 ST/AR 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:

About the Pulse Oximetry Measurement . 5-2 Preparing for Telemetry SpO2 Monitoring. 5-7 SpO2 Sensors . 5-8 Selecting an SpO2 Sensor. 5-9 Applying the Sensor . 5-12 Connecting the SpO2 Cable . 5-17 Making SpO2 Measurements . 5-18 Measurement Limitations . 5-24 Optimizing Sensor Performance. 5-25 SpO2 Alarms and Technical Alarms. 5-25 SpO2 Monitoring 5-1 About the Pulse Oximetry Measurement About the Pulse Oximetry Measurement The M2601B transmitter supports an SpO2 sensor connection using Fourier Artifact Suppression Technology (FAST). The FAST algorithm provides superior motion artifact rejection and low-perfusion performance. 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 is selected at TeleMon, the M2601B Transmitter will provide Continuous SpO2 measurement (see SpO2Measurement when Connected to TeleMon on page 5-18). 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. The amount of light getting 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 during a pulsation. 5-2 SpO2 Monitoring Pulse Indication About the Pulse Oximetry Measurement During Spot Check measurement, the pulse signal is detected and communicated to you via an auditory signal. The indicator is a single low-pitched tone for each pulse detected. The tone (volume, mute) is configured. 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; it should not be used an indication for treatment. The indicator is not functional in Continuous measurement mode. Clinical Note: If you are in Spot Check mode and the sensor light is illuminated but you do not hear a pulse indication sound synchronized with the pulse, readjust the sensor, or move the sensor to another site to find better detection. SpO2 Monitoring 5-3 About the Pulse Oximetry Measurement SpO2 Information for the User1 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 Information Center. 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 Information Center is 10 seconds. Pulse rate is also derived from the pulsatile SpO2 measurement, and displayed results can range from 30 to 300 b/min. There is no alarm function for pulse rate. The pleth wave (on the TeleMon Companion Monitor, if available) 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. 5-4 SpO2 Monitoring SpO2 Safety Information About the Pulse Oximetry Measurement Warning Warning 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. Avoid placing the SpO2 sensor on any extremity with an arterial catheter, or intravascular venous infusion line. 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. SpO2 Monitoring 5-5 About the Pulse Oximetry Measurement Warning Warning Removal of the SpO2 sensor during Continuous SpO2 monitoring results in a SpO2 NO TRANSDUCER technical alarm. There is no technical alarm for a "No sensor" condition in Spot Check mode. 5-6 SpO2 Monitoring Preparing for Telemetry SpO2 Monitoring Preparing for Telemetry SpO2 Monitoring The Philips Telemetry System provides remote monitoring of SpO2 measurement for adult and pediatric patients. You need to prepare your telemetry patient and perform setup tasks for the measurement to display at the IntelliVue Information Center or the TeleMon Companion Monitor. Task Summary Perform the following steps to set up for telemetry SpO2 monitoring:

Step Action 1 2 3 4 5 6 Select the site and appropriate sensor (see Selecting an SpO2 Sensor on page 5-9). Attach the sensor cable to the transmitter (see Connecting the SpO2 Cable on page 5-17 Attach the transducer cable to the transmitter. Plug reusable transducers directly into the transmitter. Plug disposable transducers into the adapter cable, then plug the adapter cable into the transmitter. Remove the protective backing. Attach the sensor to the appropriate part of the patient's body. If connected to TeleMon, use the pleth wave to check the signal quality. Adjust SpO2 alarms in the Patient Window. Make other adjustments in the Telemetry Setup Window. SpO2 Monitoring 5-7 SpO2 Sensors SpO2 Sensors Disposable Sensors Reusable Sensors Only use disposable sensors 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. Disposable sensors are not available as Philips Medical Systems parts in the USA or Canada. Contact Nellcor Incorporated at 1-800-635-5267 or 1-888-744-1414. 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 regularly. 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. 5-8 SpO2 Monitoring Selecting an SpO2 Sensor Selecting an 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. Selecting an SpO2 Sensor on page 5-10 is a guide in selecting the correct sensor type. To use the figure, find the patients weight on the vertical axis. 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 SpO2 Monitoring 5-9 Selecting an SpO2 Sensor 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 Adult Adult Patient Weight

( lb ) Adult Pedi Pedi Pedi Pedi Infant 110 88 66 44 33 22 7 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 5-10 SpO2 Monitoring Selecting an 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. SpO2 Monitoring 5-11 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. A minimum pulsatile flow must be present at the application site of your patient to obtain measurements. 5-12 SpO2 Monitoring Applying the Sensor 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 photodetector 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 Emitter 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. SpO2 Monitoring 5-13 Applying the Sensor Adult Finger Sensor

(M1191A) Place 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. Warning Warning Failure to apply the sensor properly may cause incorrect measurement of SpO2. For example, not placing the sensor far enough over the finger can result in inaccurate SpO2 readings. Placing the sensor too far, so that the finger protrudes from the sensor, can pinch the finger, resulting in inaccurately low SpO2 readings. 5-14 SpO2 Monitoring Applying the Sensor Place the sensor over the fingertip in such a way that the fingertip touches but does not protrude from the end of the sensor. Small Adult/

Pediatric Finger Sensor

(M1192A) SpO2 Monitoring 5-15 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. 5-16 SpO2 Monitoring Connecting the SpO2 Cable Connecting the SpO2 Cable Task Summary Step Action 1 Connect the sensor cable to the transmitter. If you are using a disposable sensor, plug the sensor into the adapter cable and plug this cable into the transmitter. Plug reusable sensors directly into the transmitter 2 Ensure that the sensor and connector are positioned away from power cables, to avoid electrical interference. Caution Extension cables: Do not use extension cables with the transmitter. Electrical Interference: Position the sensor cable and connector away from power cables, to avoid electrical interference. SpO2 Monitoring 5-17 Making SpO2 Measurements Making SpO2 Measurements SpO2 measurements can be made continuously, or manually on an as-needed basis (Spot Check). The SpO2 parameter is turned on/off by inserting/removing the sensor cable into the transmitter. 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. SpO2Measurement when Connected to TeleMon When the M2601B transmitter is connected to TeleMon:

The measurement mode is always Continuous. You can change the mode. Changes to the mode take effect when the transmitter is disconnected from TeleMon. The following settings will be used:

Mode Setting at TeleMon Mode at Disconnected Transmitter Continuous 5-minute 1-minute Manual Continuous Continuous Continuous Spot Check NoteWhen using the M2601A Transmitter, 5-minute and 1-minute settings are available when disconnected from TeleMon. If the transmitter had been set to Continuous or Spot Check before connection to TeleMon, it returns to the setting it had when the transmitter is disconnected

(provided that it wasnt changed when connected). 5-18 SpO2 Monitoring Making SpO2 Measurements Making a Spot Check Measurement When the transmitter is configured for Spot Check measurement, use the following instructions to take an individual, manual SpO2 reading from the transmitter. Task Summary Step Action 1 2 3 Attach the sensor to the patient. Connect the SpO2 cable to the transmitter, and check that:

The SpO2 sensor light turns on. A low-pitched tone detecting each pulse is audible (unless sounds are muted). After approximately 30 seconds, a tone from the transmitter indicates that a measurement has been completed successfully

(single beep), or failed (double beep). If failed, you must retake the measurement. The value, with the measurement time, is displayed at the Information Center, and the sensor light extinguishes. 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 transmitter, the Spot Check measurement will be erased from the display, but the SpO2 measurements will be available in Trend Review. 4 To repeat a Spot Check measurement at the bedside, disconnect then reconnect the SpO2 cable to the transmitter. SpO2 Monitoring 5-19 Making SpO2 Measurements Monitoring SpO2 Continuously When the transmitter is configured for Continuous SpO2 measurement, use the following directions to initiate Continuous SpO2 monitoring. Task Summary Step Action 1 2 3 4 Insert the SpO2 cable to the transmitter, and check that the sensor light turns on. Attach the sensor to the patient. 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. If TeleMon is available, connect and change the setting to Spot Check. Turning SpO2 Monitoring Off To turn SpO2 monitoring off, disconnect the sensor cable from the transmitter. SpO2 enters a power-down mode after the cable is disconnected from the transmitter, 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. ImportantIt is important to disconnect the sensor from the transmitter. Unplugging the sensor from an adapter cable that is connected to the transmitter does NOT provide SpO2 power-down mode. 5-20 SpO2 Monitoring Making SpO2 Measurements Turning the SpO2 Parameter On/Off You can turn the SpO2 parameter on/off at the Information Center by using the Telemetry Setup Window. NoteIf SpO2 is turned on, the Patient Sector and Patient Window of the Information Center display the numeric with "T" (for example, SpO2 T 90%) to indicate that the measurement was made via telemetry. Turning the SpO2 parameter off at the Information Center also turns off:

SpO2 alarms SpO2 display of numerics SpO2 trending If the transmitter is connected to the TeleMon Companion Monitor, after you turn SpO2 on, you should adjust the sample rate to match your patients acuity. NoteAfter you turn SpO2 off, setting the sample rate to Spot Check at TeleMon will help you conserve the transmitters battery life. Task Summary Turn the SpO2 parameter on or off manually by performing the following steps:

Step Action 1 2 3 On the Patient Window click the All Controls button. On the All Controls Window click the Telemetry Setup button. On the Telemetry Setup Window, under SpO2, turn the parameter on or off by clicking in the Parameter ON checkbox. A check mark in the checkbox indicates that SpO2 monitoring is on. SpO2 Monitoring 5-21 Making SpO2 Measurements SpO2 Parameter Auto ON Turning SpO2 Alarms On/

Off Task Summary The SpO2 parameter is automatically turned on at the IntelliVue Information Center if a manual SpO2 measurement is initiated at the transmitter while in Spot Check mode or the SpO2 sensor is inserted into the transmitter while the transmitter is in Continuous SpO2 mode. When a patient is discharged and the transmitter is in Continuous mode, the SpO2 parameter is turned off. To reactivate the SpO2 parameter Auto ON feature from the transmitter, remember to do one of the following when a patient is discharged:

remove the SpO2 cable from the transmitter, wait 15 seconds, then reinsert the cable or if using TeleMon, reset the transmitter to Spot Check mode. NoteThe SpO2 parameter Auto ON feature only needs to be reactivated when the transmitter is in Continuous mode at discharge. Note SpO2 can always be turned on and off at the IntelliVue Information Center. You can turn SpO2 alarms on or off by using the Telemetry Setup Window. Turn SpO2 alarm on or off by performing the following steps:

Step Action 1 2 3 On the Patient Window click the All Controls button. On the All Controls Window click the Telemetry Setup button. On the Telemetry Setup Window, under SpO2, turn alarms on or off by clicking in the Alarm ON checkbox. A check mark in the checkbox indicates that SpO2 alarms are on. 5-22 SpO2 Monitoring Making SpO2 Measurements Turning the Pulse Parameter On/Off If monitoring SpO2 continuously, the Pulse parameter is available at the IntelliVue Information Center. You can turn the SpO2 pulse parameter on or off by using the Telemetry Setup Window. Task Summary Turn the pulse parameter on or off by performing the following steps:

Step Action 1 2 3 On the Patient Window click the All Controls button. On the All Controls Window click the Telemetry Setup button. On the Telemetry Setup Window, under Pulse, turn parameter on or off by clicking in the Parameter ON checkbox. A check mark in the checkbox indicates that pulse monitoring is on. 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. SpO2 Monitoring 5-23 Measurement Limitations Measurement Limitations 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 may 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 may 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. See Appendix B, Accessory List for ordering information. 5-24 SpO2 Monitoring Optimizing Sensor 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. SpO2 Alarms and Technical Alarms 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. SpO2 Monitoring 5-25 SpO2 Alarms and Technical Alarms 5-26 SpO2 Monitoring 6 Maintenance and Configuration I n t r o d u c t i o n This chapter describes how to maintain the telemetry equipment and configure the system. It includes the following sections:

Troubleshooting . 6-2 Maintenance. 6-3 Transmitter Cleaning, Disinfection, & Cross-Infection Prevention . 6-4 Receiver Mainframe Cleaning . 6-15 Configuration . 6-16 Configuration Settings . 6-17 Maintenance and Configuration 6-1 Troubleshooting Troubleshooting Basic Troubleshooting For problems with... refer to ECG measurement Optimizing System Performance on page 3-22 Technical Alarms (INOPs) on page 11 SpO2 measurement Measurement Limitations on page 5-24 Technical Alarms (INOPs) on page 11 Batteries Battery Information on page 1-29 Nurse Call Alarm Status Check on page 1-28 Nurse Call may have been turned off for the patient. See Turning Nurse Call On/Off on page 1-23. 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 transmitter to an ECG or ECG/SpO2 simulator. By varying the ECG rate and SpO2 value, alarms can be generated and confirmed for proper operation. 6-2 Maintenance and Configuration Maintenance Maintenance 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. Ensure that any needed gunk guards are in place. ImportantDo not use the Philips Telemetry Monitoring System for any monitoring procedure on a patient if you identify features which demonstrate impaired functioning of the instrument. Contact the hospital biomedical engineer, or your 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. Maintenance and Configuration 6-3 Transmitter Cleaning, Disinfection, & Cross-Infection Prevention Transmitter Cleaning, Disinfection, & Cross-Infection Prevention The procedures in this section keep the transmitter clean and provide protection against infectious agents and bloodborne pathogens. Both the outside of the transmitter 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 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 transmitter must be cleaned, followed by either Disinfection or Cross-Infection Prevention procedures according to hospital protocols, before continued use in monitoring. Cleaning the Transmitter Caution Do not use any abrasive cleaning materials or overly vigorous cleaning actions on any part or component of the transmitter. Use of abrasive cleansers and abrasive cleaning actions will damage the components. Task Summary Perform the following steps to clean the transmitter of visible surface contamination. Step Action 1 2 Remove the batteries and any cables or accessories. Soak the transmitter in water for up to 5 minutes to soften any dried debris, if necessary. 6-4 Maintenance and Configuration Transmitter Cleaning, Disinfection, & Cross-Infection Prevention Step Action 3 4 5 6 Rinse the transmitter 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. Disinfecting the Transmitter 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 transmitter. The transmitter 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 Acohol, >70%

Sodium Hypochlorite, 10% solution prepared within 24 hours (for wiping only) Equipment must be cleaned (see Cleaning the Transmitter on page 6-4) before this procedure is performed. Maintenance and Configuration 6-5 Transmitter Cleaning, Disinfection, & Cross-Infection Prevention Wiping the Transmitter Step Action 1 2 3 4 Remove the batteries and any cables or accessories. Wipe the transmitter 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. Wipe all disinfected surfaces with distilled water to remove any residue. Allow to air-dry, or dry with a non-lint producing cloth. Soaking the Transmitter Caution Do not soak the equipment in cleansers other than Isopropyl Alcohol, or soak longer than five minutes. Soaking the transmitter for longer than five minutes or in cleansers other than Isopropyl Alcohol can severely damage the device. Step Action 1 2 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. 6-6 Maintenance and Configuration Transmitter Cleaning, Disinfection, & Cross-Infection Prevention Step Action 3 4 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 Transmitter Equipment and Materials The transmitter 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 Transmitter on page 6-4) before this procedure is performed. NoteIf there is concern over cross-contamination due to leadsets or sensors, new lead sets or sensors should be used. 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 6-12. Maintenance and Configuration 6-7 Transmitter Cleaning, Disinfection, & Cross-Infection Prevention Use the following equipment and material to process the transmitter:

1. Ethylene Oxide (Allied Signal Oxyfume-2002), heretofore referred to 2. Gas sterilizer, made by American Sterilizer Company or other as EO. manufacturers. 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. Task Summary Step Action 1 2 3 4 5 Remove any obvious contamination from the equipment to be processed using approved cleaners. Individually package each transmitter 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). 6-8 Maintenance and Configuration Transmitter Cleaning, Disinfection, & Cross-Infection Prevention Step Action 6 7 8 9 Apply -26 inHg +/- 1 (-12.77 psig +/- .49) vacuum to the sterilizer chamber. 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 6-12. 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. Maintenance and Configuration 6-9 Transmitter 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 6-12. 6-10 Maintenance and Configuration Transmitter Cleaning, Disinfection, & Cross-Infection Prevention Task Summary 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 transmitter 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 transmitter 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. Maintenance and Configuration 6-11 Transmitter 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 transmitter identity code. Task Summary Test the transmitter 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 transmitter (connectors, battery door opening and closing, Telemetry and Check buttons). At the Information Center, select the telemetry bedside you are testing. 6-12 Maintenance and Configuration Transmitter Cleaning, Disinfection, & Cross-Infection Prevention Step Action 3 Test the transmitter:

a. Put fresh batteries in the transmitter and close the battery door. Result: All indicator lights on the front of the transmitter light momentarily, and you will hear a single beep. b. Attach a lead set 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 transmit-

ter 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 transmitter 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 Maintenance and Configuration 6-13 Receiver Mainframe Cleaning Receiver Mainframe Cleaning The receiver mainframe should be kept free of dust and dirt. You can only clean the outside of the receiver mainframe. Wipe the outside of the receiver mainframe clean by wetting a damp cloth or rag with one of the following approved cleaning agents:

Soap and Water Isopropyl Alcohol (> 70%) Ethyl Alcohol (> 70%) Hydrogen Peroxide Sodium Hypochlorite (chlorine bleach), 5% solution Sodium Hypochlorite (chlorine bleach), 10% solution prepared within 24 hours Cidex Windex Lysol Wipe all cleaned surfaces with distilled water to remove any residue. Allow to air-dry, or dry with a non-lint producing cloth before use. 6-14 Maintenance and Configuration Configuration Configuration How your telemetry system performs depends in large part on the configuration choices made during system installation. This chapter provides a summary of the factory-set defaults and the alternative configuration choices that relate to clinical practice. Configuration for the telemetry system is performed at the receiver mainframe, except for Philips transmitters, which are configured at the TeleMon Companion Monitor or using the Service Configuration Tool. All receiver settings, except frequency, pertain to all receivers in the mainframe. Two of the most frequently performed configuration procedures are also included in this chapter. For complete configuration information, including the impact of individual choices, refer to the Philips Telemetry System Installation and Configuration Guide in the M2600B Documentation Kit (M2600-90323). Maintenance and Configuration 6-15 Configuration Settings Configuration Settings M2604A Mainframe The following table lists the mainframe configuration settings used by the IntelliVue Information Center. NoteThe IntelliVue Information Center does not use the following settings:

HR Alarm Limits Lead Fallback Bandwidth ST Settings Item GENERAL ALARM PARAMETERS Factory Default User Choices Alarm Suspend Alarm Reminder 3 Minutes 3 Minutes, Infinite ON ON, OFF only applies to:

SpO2 ECG if not arrhythmia monitored GENERAL ECG PARAMETERS Extended Monitoring ON ON, OFF 6-16 Maintenance and Configuration Configuration Settings Item M2601X SERIES TRANSMITTERS ECG PARAMETERS Factory Default User Choices Lead Selection - 5 Electrode Primary = II Secondary = V Primary = I, II, III, aVR, aVL, aVF, MCL, V Secondary = I, II, III, aVR, aVL, aVF, MCL, V, OFF NoteThe ECG primary and secondary must be different lead types, and the primary cannot be OFF. Lead Labelling - 3 Electrode SpO2 PARAMETERS SpO2 Alarm Limits GENERAL PARAMETERS Telemetry Button Function Language Primary = II Primary = I, II, III, MCL High: 100 percent Low: 90 percent High Range = 51-100 percent Low Range = 50-99 percent (increment of 1) Nurse Call and Record English Nurse Call, Record, Both, Disabled English, German, French, Dutch, Spanish, Swedish, Italian, Japanese, Norwegian, Danish, Finnish, Portuguese For configuration of the following items, see the Philips Telemetry System Installation and Configuration Guide in the M2600B Documentation Kit. Auto Self Test Self-test Strip SDN Unit Number SDN Branch Number Country Code Locale Code Frequencies Maintenance and Configuration 6-17 Configuration Settings Philips M2601B Transmitter The following table lists the configuration settings for the Philips M2601B Transmitter. Item Lead Selection 3-wire lead set Automatic Shutoff (after 10 minutes) Factory Default No Yes User Choices Yes, No No, Yes For configuration of the following items, see Philips Telemetry System Installation and Configuration Guide Country Code Locale Code Frequencies Changing the Configuration Configuration changes require the TeleMon Companion Monitor or the Service Configuration Tool. If configuration is required (for example to match a replacement Philips transmitter to others in the unit or to change the frequency in case of excessive interference) contact the Service Provider or consult the TeleMon Service Manual. 6-18 Maintenance and Configuration 7 System Safety and Specifications I n t r o d u c t i o n This chapter provides information on regulatory requirements compliance for patient safety, safety-oriented installation and maintenance procedures, and specifications for the Philips Telemetry System. It includes the following sections:

Product Safety. 7-2 Philips Telemetry System Warnings. 7-4 Electromagnetic Compatibility. 7-5 System Symbols . 7-9 Installation and Maintenance Safety. 7-14 Additional Safety Information . 7-19 System Specifications. 7-20 System Safety and Specifications 7-1 Product Safety Product Safety

0123 The M2600B Philips Telemetry System, complies with the requirements of the Council Directive 93/42/EEC of 14 June 1993 concerning medical devices and carries CE-marking accordingly. (

The following symbol equipment per Directive 1999/5/EC for which Member States may apply restrictions on putting the device into service or placing it on the market. This system is intended to be connected to the publicly available interfaces (PAI) for use throughout EEA. means that this device is considered Class 2 radio 0123

) The Philips Telemetry System also complies with the following international safety requirements for medical electrical equipment:

IEC 601-1:1998 + 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 Interference IEC 60601-1-4:1996 Safety for Programmable Electrical Medical Systems IEC 60601-2-49:2001 Multi-parameter Monitor Safety EN 865:1997 Particular Requirements for Pulse Oximeters AAMI Voluntary Performance Standards for Cardiac Monitors: EC 13:

2002, Clauses 4.2.8 and 5.2.8 The system is protected against the effects of defibrillation. This system provides continuous operation when in use. The following accessories and system components are independently CE marked to the Medical Device Directive. They are not covered by the CE marking of the Philips Telemetry System:

All SpO2 accessories and equipment ECG electrodes ECG lead sets 7-2 System Safety and Specifications Product Safety Authorized EU Representative:

Philips Medizinsysteme Boeblingen GmbH Hewlett-Packard Str. 2 D-71034 Boeblingen Germany System Classification Class I Equipment M2604A Receiver Mainframe Class II Equipment 453563647161 Universal Power Converter (UPC) Characteristic Definition Internally Powered Equipment The M2601B Transmitter is an internally powered device. Continuous Operation All equipment is Ordinary Equipment, IPX0, and provides continuous operation. Type CF Defibrillation Proof Water Resistance The M2601B Transmitter is Type CF Defibrillation Proof relative to ECG and SpO2 patient applied parts. When placed inside a Philips carrying pouch with the flap closed and snaps secured, the transmitter is rated IPX3,as per IEC 60529:1989 (+A1:1999):

Protected against splashing water. The combination of the transmitter and pouch will withstand showering for up to 10 minutes. The transmitter will not be damaged if it is accidentally immersed in liquid for up to 5 minutes. System Safety and Specifications 7-3 Philips Telemetry System Warnings Essential Performance The Philips Telemetry System provides Essential Performance (EP) under normal operating conditions (includes EMC exposure) only as a complete Medical Electrical System, consisting of the M2601B Patient-Connected Device, M2636B TeleMon (opt. A02, A03) Companion Monitor (Optional), M2603A/M2604A Receiver/Mainframe, and M3150A IntelliVue Information Center. The system achieves its Essential Performance exclusively through alarm generation at the Information Center. The 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 Technical Alarms (INOPs) will be created. Philips Telemetry System Warnings The warnings and cautions described below refer to the following devices:

Philips M2601B Transmitter Philips Telemetry System IntelliVue Information Center 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. 7-4 System Safety and Specifications Electromagnetic Compatibility Warning Warning Do not install or use power modules for analog output and antennas within a 2.44 m (8 ft.) radius of the patient. This helps ensure patient electrical safety. Caution Installation and setup must be performed by a Philips Medical Systems service representative or designee according to the instructions in Philips Telemetry Installation & Configuration Guide, which can be found in the M2600B Documentation Kit (order number M2600-90323). Electromagnetic Compatibility M2600B Philips Telemetry System Testing The electromagnetic compatibility (EMC) validation of the Philips M2600B Telemetry System included testing performed according to the international standard for EMC with medical devices. See the Manufacturers Declaration for details. 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. 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 System Safety and Specifications 7-5 Electromagnetic Compatibility 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 Appendix B. Accessory List in this Instructions for Use and in the Philips Telemetry System Service Guide. Warning Warning The use of accessories, transducers and cables other than those specified in the Philips Telemetry System 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, you must check that normal operation is possible in the necessary configuration before the product is used. Reducing Electromagnetic Interference The system 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 & ST/AR Measurement. 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?

7-6 System Safety and Specifications Electromagnetic Compatibility Once the source is located, attempt to attenuate the interference by distancing the product from the source as much as possible. If assistance is needed, contact your local Service Provider. Restrictions for Use Artifact on ECG and other physiological waveforms caused by electromagnetic interference should be evaluated by a physician or physician authorized personnel to determine if it will negatively impact patient diagnosis or treatment. 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 FCC requires the following statement for this device:

The Philips M2600B Telemetry System complies with Part 15 of the Federal Communications Commission (FCC) Rules. Operation is subject to the following two conditions:

This device may not cause harmful radio frequency interference to a primary licensed user (radio and television stations), and This device must accept any interference received from a primary licensed user, including interference that may cause undesired operation. 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. For operation in 608-614 MHz This telemetry device is only permitted for installation in hospitals and health care facilities. This device shall not be operated in mobile vehicles (even ambulances and other vehicles associated with health care facilities). The installer/user of this device shall ensure that it is at least 80 km from the Penticton radio astronomy station (British Columbia latitude: 49 19 12 N, longitude 118 59 56 W). For medical telemetry systems not meeting this 80 km separation (e.g., the Okinagan Valley, British Columbia) the installer/user must coordinate with and obtain the written concurrence of the Director of the Penticton radio astronomy station before the equipment can be installed or operated. The Penticton contact is Tel: 250-493-2277; FAX: 250-493-7767. System Safety and Specifications 7-7 Canadian Radio Equipment Compliance

(Canada Only) Electromagnetic Compatibility For operation outside 608-614 MHz Contact your local Industry Canada offices as licensure is required. To provide maximum RF shielding and minimum RF interference to the licensed service, this device should be operated indoors and away from windows. 7-8 System Safety and Specifications System Symbols System Symbols The following is an explanation of the symbols found on the hardware components of the Philips Telemetry System:

Symbol REF Explanation AC Line Current. Active Antenna Combiner. Antenna Input. Attention. See Instructions for Use. Bandpass Filter Battery Polarity Catalog Number System Safety and Specifications 7-9 System Symbols Symbol Explanation Class 2 Equipment Data In Data In, Data Out Data Out Date of Manufacture DC Voltage 2 Do Not Reuse. Use Only Once. Dispose of properly after use in accordance with local regulations. Electrical Input 7-10 System Safety and Specifications Symbol Explanation System Symbols Electrical Output. Equipotential Grounding System. Follow Operating Instructions. Frequency Converter Fuse Input. Grounding system. Indoor Use Only Line Amplifier MAC Address of Device i MAC System Safety and Specifications 7-11 System Symbols Symbol Explanation Non-ionizing Radiation Power On/Off Product Option Protective Earth (Ground) Power Tee Receiver Mainframe Malfunction Receiver Mainframe. For future use. SN Serial Number Type CF Defibrillation Proof 7-12 System Safety and Specifications System Symbols Symbol IPX0 Explanation The M2600B is rated IPXO in degrees of protection by enclosures; not protected against ingress of water. Complies with applicable Canadian and American medical safety standards. Compliance to Council Directive 93/42/EEC

(Medical Device Directive) Class 2 Radio equipment identifier (1999/5/EC):

Member states may apply restrictions on putting this device into service or placing on the market. This device is intended to be connected to the publicly available interfaces (PAI) for use throughout the EEA Federal Law restricts this device in the United States to sale by or on the order of a physician. 0123

Rx System Safety and Specifications 7-13 Installation and Maintenance Safety Type CF Defibrillation Proof The following symbol identifies a device that is Type CF Defibrillation Proof. TYPE CF DEFIBRILLATION PROOF Type CF Defibrillation Proof equipment is protected against defibrillation

(DEFIBRILLATION-PROOF) and is a TYPE CF APPLIED PART. Installation and Maintenance Safety Installation Environment Caution Installation and setup must be performed by a Philips Medical Systems service representative or designee, except for transmitters purchased individually. These can be installed by hospital personnel according to instructions in the Installation and Configuration Guide included in the M2600B Documentation Kit. Follow the instructions below to ensure a completely safe electrical installation. The environment where the Philips Telemetry System will be used should be relatively free from vibration, dust, corrosive or explosive gases, extremes of temperature, humidity, and so on. For a cabinet mounted installation, allow sufficient room at the front for operation and sufficient room at the rear for servicing with the cabinet access door open. The Philips Telemetry System operates within specifications at ambient temperatures between 0C (32oF) and 55C (131oF). The transmitter ambient temperature specification is between 0C (32oF) and 37oC (99oF). Ambient temperatures which exceed these limits could effect the accuracy of the 7-14 System Safety and Specifications Grounding Installation and Maintenance Safety instrument and cause damage to the components and circuits. Allow at least 5 cm (2 inches) clearance around the instrument for proper air circulation. To protect hospital personnel, the cabinet of the Philips Telemetry System must be grounded. Accordingly, the system is equipped with a detachable 3-wire cable which grounds the instrument to the power line ground (protective earth) when plugged into an appropriate 3-wire receptacle. If a 3-wire receptacle is not available, consult the hospital electrician. Warning Warning Do not use a 3-wire to 2-wire adapter with this instrument. This ensures optimal electrical safety. Condensation Make sure that during operation, the instrument is free of condensation. Condensation can form when equipment is moved from one building to another, thus being exposed to moisture and difference in temperature. Warning Warning Possible explosive hazard if used in the presence of flammable anesthetics. System Safety and Specifications 7-15 Installation and Maintenance Safety Receiver Mainframe Rear Panel The rear panel of the receiver mainframe is shown below. SDN Connectors CPC Configuration Connector Cover Power Supply Antenna Input Signal Connector Not Used CPC Board Analog Output Connector

(optional) Green ON AC Power Connector Protective Equipotential Earth Grounding Lug

(Ground) The back of the mainframe should be removed only by qualified service personnel. To remove the protective cover, unfasten screws, remove tab(s) from slot(s), and lift the cover section off. Connectors The connectors on the rear panel of the receiver mainframe are:

Connector AC Power Analog Output (Patient Monitor/Holter Interface)

- optional Antenna Input Signal Description 3-pin connector, used to input the local line voltage. Mainframe plug is a standard IEC mains inlet receptacle. High-density 50-pin SCSI connector to send analog signal to output connector box BNC coaxial connector. Max voltage +25V DC 7-16 System Safety and Specifications Installation and Maintenance Safety Connector Equipotential Grounding Lug SDN Description Grounding stud connector, used to equalize the grounding potential between products (see Secondary Ground Wire, below) Upstream and downstream connectors that connect to the Philips monitoring network Secondary Ground Wire A secondary ground wire is provided with this instrument to comply with IEC-

60601-1-1. This wire ensures against excessive chassis leakage current in the event of a single fault in the health care facility's primary grounding means. It is recommended that the secondary ground wire be used to connect the Equipotential Grounding Lug to a ground source separate from the primary grounding source found in the instrument's power source. NoteAfter servicing, be certain to reconnect the secondary ground wire. Warning Warning Removal of the secondary grounding wire from the rear of the product voids the IEC approval. Lifting the Receiver Mainframe The weight of the receiver mainframe is 13.8 kg (30.5 lb.). When carrying the mainframe, please use proper lifting techniques Antenna Amplifiers The antenna amplifiers must be operated only with the Power Supply (AC/DC Adapter), and must be operated at a minimal distance of 2.43 meters (8 feet) from the patient. M26XXA/M14XX Series Antenna Components For all voltages, use part number 453563647161. Patient Monitor/Holter Interface Option If using the optional Patient Monitor/Holter Interface (Analog Output), the connector box must only be operated with the appropriate power supply) and must be operated at a minimum distance of 2.43 meters (8 feet) from the patient. System Safety and Specifications 7-17 Installation and Maintenance Safety For all voltages, use Universal Power Converter (UPC), part number 453563647161. Preventive Maintenance End of Life Preventive maintenance should be performed by a qualified service person. The Safety and Performance Tests, and what to do if the equipment does not meet these specifications, are described in the Philips Telemetry System Service Guide in the M2600B Documentation Kit. Contact your biomedical department if your equipment needs testing for safety or performance. There is no specific, predetermined end of life to the Philips Telemetry System or any of its component products. Philips Medical Systems provides service, support and replacement parts and assemblies throughout the support life of the products that allow them to be repaired should any component of the system fail. Please refer to the Philips Telemetry System Service Guide for instructions on how to obtain service or replacement parts and for instructions on preventative maintenance. Your local Philips Medical Systems sales or service representative can provide you information regarding the support life of your products. 7-18 System Safety and Specifications Additional Safety Information Additional Safety Information Warning Warning The equipment is not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide. Warning Warning This device is not to be used in the vicinity of electrosurgery units because use may interrupt or interfere with the transmission of signals from the transmitter. 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 Strangulation Hazard! Under no circumstances should any pouch be tied solely around a patients neck. 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. Software Hazard Prevention The minimization of hazards arising from errors in the software program is documented in the following reports:

TO TRANSLATORS: text will follow. System Safety and Specifications 7-19 System Specifications System Specifications This section lists the specifications for battery life, environmental and electrical power specifications for the hardware components of the system, and measurement specifications. For complete specifications, see the M2600B Documentation Kit. Battery Life Specifications Equipment Specification Battery Type 2 fresh disposable AA alkaline batteries NoteThe battery life times listed below are based on Duracell MN 1500 batteries. Battery life for other brands may be different. Operating Mode Battery Life Battery Life Japanese Version ECG Only 39.6 hours, typically 44.71 hours, typically ECG/SpO2 Continuous 16.7 hours, typically 17.01 hours, typically ECG/SpO2 Spot Check between 14 hours and 41 hours, depending on usage rate between 15 hours and 45 hours, depending on usage rate 7-20 System Safety and Specifications System Specifications Environmental Specifications For all hardware components of the Philips Telemetry System except Philips transmitters and reusable pulse oximetry sensors Operating Temperature Range: 0 to 55C (32 to 131F) Altitude Range: Up to 4570 m (15,000 ft.) Humidity Range: 15 to 95% relative humidity Storage Temperature Range: -40 to +70C (-40 to +158F) Altitude Range: Up to 4570 m (15, 000 ft.) Humidity Range: 90% relative humidity maximum For Philips Transmitters Operating Temperature: 0 to 37 oC (32 to 99 oF) Operating Humidity: < 95% RH at 40 oC (104 oF) non-condensing Storage Temperature: -40 oC to 60 oC (-40 to 120 oF) without batteries Storage Humidity: < 90% RH at 60 oC (120 oF) without batteries Altitude, Operating and Non-operating: 0 to 3048 m (10,000 ft.) For Philips Reusable Pulse Oximetry Sensors Operating Temperature Range: 15-37C (50-98.6 F) Altitude Range: Up to 4570 m (15,000 ft.) Humidity Range: 95% relative humidity at 37 C (98.6 F) maximum Storage Temperature Range: -40 to 70 C (-40 to 158 F) Altitude Range: Up to 4570 m (15,000 ft.) Storage Humidity: 95% relative humidity at 65 C (150 F) maximum Water Resistance The transmitter can be used to monitor a patient in the shower for up to 10 minutes only when placed inside a Philips carrying pouch with the flap closed and snaps secured. The transmitter will not be damaged if it is accidentally immersed in liquid for up to 5 minutes. System Safety and Specifications 7-21 System Specifications After showering, perform the following steps to continue monitoring:

4. Pat dry the lead set connections at the electrodes. 5. Wipe the lead wires with care. 6. 7. 8. If wet, dry the outside of the transmitter 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 transmitter should not be used for monitoring if the battery compartment is wet. Remove the batteries and wipe the compartment dry before continued monitoring use. Warning Warning If the transmitter is used while showering a patient or is accidentally immersed in liquid, detection of "leads off" conditions may be compromised. Appropriate clinical precautions should be taken. Electrical Power Specifications M2601B Transmitters NoteSpecifications for earlier releases of the product may vary slightly. Frequency Range 406-480 MHz and 590-614 MHz, depending on option Synthesizer Step Size 12.5 KHz RF Output Power @ 25oC Non-Japan transmitter: option #001 to option # 008: 6.5 dBm, +1.6/-2.0 dB (2.8 mW to 6.5 mW) not to exceed 10 dBm into Antenna load Japan only: +0.8/-3.0 dBm (0.5 mW to 1.2 mW) into Antenna load RF Output Power @ 0 - 45oC RF Output Power @ 25oC +/- 1.25 dB into Antenna load Adjacent Channel Power

< - 65 dBm at 25 KHz offset Harmonic Levels (into Antenna) For ETSI & CISPR-11 standards 7-22 System Safety and Specifications System Specifications 47 - 118 MHz: < -54 dBm 118 - 174 MHz: < -46 dBm 174 - 230 MHz: < -54 dBm 230 - 470 MHz: < -38 dBm (excluding channel output) 470 - 862 MHz: < -54 dBm (excluding channel output) 862 - 1000 MHz: < -38 dBm

> 1000 MHz: < -30 dBm Frequency Accuracy Frequency @25oC +/- 2.5 ppm @ (0 - 45oC) Occupied Bandwidth

< 10 KHz Data Rate 9600 bits per second Modulation Type GMSK RF Specifications in 608-614 WMTS Band Frequency Ranges Option Band #037: 608 - 614 MHz (WMTS) RF Output Power @ 25oC 6.5 dBm, +1.6/-2.0 dB (2.8 mW to 6.5 mW) not to exceed 10 dBm into Antenna load RF Output Power @ 0 - 45oC RF Output Power @ 25oC +/- 1.25 dB into Antenna load Adjacent Channel Power

< - 65 dBm at 25 KHz offset Harmonic Levels (into Antenna) For FCC & Canadian standards 30 - 88 MHz: < -56 dBm (< 50 dBm in US) 88 - 174 MHz: < -52 dBm (< 50 dBm in US) 174 - 230 MHz: < -54 dBm (< 50 dBm in US) 230 - 960 MHz: < -50 dBm (excluding channel output)

> 960 MHz: < -42 dBm System Safety and Specifications 7-23 System Specifications Defibrillator Protection Transmitter ECG input protected against 400 joules discharge into 50 Ohm load Batteries Two disposable 1.5V Alkaline batteries M2604A Receiver Main Frame with 453563489161 Power Supply Input Voltage 100-240 VAC Frequency Range 50 to 60 Hz Power Consumption For M2604A: 110 VA maximum, average with 8 M2603A receiver modules Controls Front Panel: none Rear Panel: none Indicators Front Panel: Green Instrument Power On LED Red Instrument Malfunction LED Rear Panel: Green Power Supply On LED Connections (rear) AC Power connector Analog Output connector Antenna Input Signal connector Grounding lug Downstream SDN connector Upstream SDN connector CPC Configuration connector Radiated Immunity 3 Volts/Meter outside of operating receiver bands 7-24 System Safety and Specifications System Specifications M2603A Receiver Module Frequency Tuning Programmable, synthesizer, PLL controlled. Channel Spacing 25 kHz. Carrier Frequency Range Frequency range depends on transmitter option Patient Monitor Holter Recorder Interface

(Analog Output) Option J01 Power Module 453563647161 Input Voltage 100-240 VAC +/- 10%

Frequency Range 47 - 63 Hz. Power Consumption 33 VA maximum Analog Output Gain (from output of receiver module) High-level outputs: 500 + 5%

Low-level outputs: 1 +7%/-6%

Inoperative Mode (Technical Alarm Condition) Output Level High-level output: 10.8 volts + 1.2 volts Low-level output: >100 megohms with respect to reference electrode Delay from Transmitter Input to Analog Output 400 milliseconds max -- Philips transmitter Not intended for use with synchronized cardioversion due to processing delay. Indicators Output Connector Box; Status and Power LEDs Connections Output Connector Box: Input (50-pin jack); Input (Power Module); Output (8 pairs of 9-pin D connectors) Analog Output Card: Output (50-pin jack) System Safety and Specifications 7-25 System Specifications Bedside Attenuator: Output (3-conductor phone jack) Holter Attenuator: Output (set of 5-button connectors) ECG Bandwidth M2601B: 0.5 - 40 Hz To ensure proper operation, installation and setup must be performed by a Philips Medical Systems service representative or designee according to the instructions in Patient Monitor/

Holter Recorder Interface (Analog Output) Installation Note (part number M2600-90194). Antenna System Specifications M2606A Line Amplifier Input Voltage 19-32 VDC Current Requirements 38 mA, maximum Power Consumption 0.75 Watts, average RF Frequency Range 406-650 MHz RF Gain 12.0 dB typical at 406 MHz 12.7 dB typical at 465 MHz 13.3 dB typical at 611 MHz 13.2 dB typical at 650 MHz Indicators Green LED indicates DC power is applied to the RF Output connector. Yellow LED indicates DC power is applied to the RF Input connector. 7-26 System Safety and Specifications M2607A Multiple Unit Power Supply M2608A Active Antenna/

Combiner System Specifications NoteM2607A specifications cover both power module and power tee. Input Voltage CE Mark Power Module 453563647161: 100-240 VAC +/- 10%

Frequency Range 47-63 Hz RF Frequency Range 406-650 MHz Power Consumption 33 VA maximum Output Voltage 23 VDC nominal Output Current 1 Amp maximum (Limited by the circuit breaker in the power tee) Indicators Green LED is on when power is present. Input Voltage 19 - 32 VDC Input Current 62 mA maximum Power Consumption 1.1 Watts average (2.0 Watts maximum) RF Frequency Range 406-650 MHz RF Gain Antenna Port Line Port 9.7 dB +/- 1.0 dB at 406 MHz 10.2 dB +/- 1.0 dB at 465 MHz 9.7 dB +/- 1.0 dB at 611 MHz 9.7 dB +/- 1.5 dB at 650 MHz 3.2 dB +/- 0.7 dB at 406 MHz 3.5 dB +/- 0.3 dB at 465 MHz 3.9 dB +/- 0.7 dB at 611 MHz 4.0 dB +/- 0.7 dB at 650 MHz Indicators Green LED indicates DC power/signal cable connected correctly. System Safety and Specifications 7-27 System Specifications Red LED indicates DC power/signal cable connected incorrectly. M2609A Attenuator Current Carrying Capacity Maximum DC Voltage: +30 VDC maximum Maximum DC Current: 1 A maximum RF Frequency Range:

406-650 MHz RF Attenuation 1-9 dB in increments of 1 dB, based on option M2612A Bandpass Filter Current Carrying Capacity Maximum DC Voltage: 32 Volts Maximum DC Current: 1 A Power Requirements Negligible RF Frequency Range

#004 430-440 MHz

#005 440-450 MHz

#006 450-460 MHz

#007 460-470 MHz

#034 590-596 MHz

#035 596-602 MHz

#036 602-608 MHz

#037 608-614 MHz Indicators Green LED is ON when power is present. M2616A External Frequency Converter Input Voltage CE Mark Power Module 453563647161: 100-240 VAC +/- 10%

Frequency Range 47-63 Hz 7-28 System Safety and Specifications System Specifications Power Consumption 14.0 VA maximum RF Input Frequency Range 590-632 MHz RF Output Frequency Ranges

#130 460-502 MHz

#136 454-496 MHz

#142 448-490 MHz

#148 442-484 MHz

#154 436-478 MHz

#160 430-472 MHz

#166 424-466 MHz Indicators Green LED is ON when power is present. System Safety and Specifications 7-29 System Specifications Measurement Specifications ECG ECG channel transmitted leads 3 electrodes Channel #1: I, II, or III 5 electrodes Channel #1: II Channel #2: III Channel #3: MCL 5 electrodes, EASI Channel #1: Vai Channel #2: Vas Channel #3: Ves Resolution 5 V ECG Input Differential, defibrillator protected against 400 joules discharge into a 50 ohm load Input Impedance

> 5 megohms (@ 10 Hz Input Dynamic Range

+/- 9 mmV (EASI mode, +/-4.7mV) DC Offset Range

+/- 320 mV CMRR

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

+/- 5% at 25oC (77oF) Noise Referred to ECG Input AAMI: 30 V 7-30 System Safety and Specifications System Specifications Lead Wires 3 or 5-wire set. 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 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 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 EMC Performance limits, radiated immunity Meets Essential Performance, No HR, PVC or Alarm error. But may observe some waveform disturbance in the range 45.00 to 65.00 MHz at levels greater than 2.0 Vrms. Cardiotach Alarm (Standard ECG only) Information Center selectable, in 5 b/min. increments. High: 20 - 250 b/min. Low: 15 - 245 b/min. Cardiotach Display (Standard ECG only): 15 - 300 b/min. Accuracy Gain: +/- 5% at 25o C (77o F) Cardiotach (Standard ECG only): +/- 3 beats plus +/- 2% of heart rate for constant rate input. At fewer than 15 b/min., the heart rate indication is 0. Cardiotach Alarm (Standard ECG only): +/- 1 b/min., of displayed value Display Displayed values are presented in whole numbers. System Safety and Specifications 7-31 System Specifications SpO2 Measurement Range (Calibration and Display) 0-100%

Display of SpO2Numerics SpO2 values are displayed as xxx % SpO2 to meet ISO/EN standard EN 865 Accuracy See tables, following Resolution 1%

SpO2 Numerics Averaging 10 seconds SpO2 & Pulse Numerics - Update Rate Transmitted once per second Pleth Wave - Sampling Rate 125 sps Technical Alarms 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 - 300 b/min. Accuracy: +/- 2%

Resolution: 1 b/min. Calibration Automatic self-calibration when device is turned on. The pulse oximeter is calibrated to display functional saturation. 7-32 System Safety and Specifications Sensor Accuracy

. Type Description Philips Reusable Sensors Adult Finger Adult Finger Adult Finger Pediatric Finger Pediatric Finger Adult/Pediatric Ear Adult/Pediatric Ear Type Description Philips Disposable Sensors Adult Finger Pediatric Finger Adult Finger System Specifications Accuracy%

Arms (70-100%

Range) 2.0 2.0 2.0 2.0 2.0 3.0 3.0 Accuracy%

Arms (70-100%

Range) 3.0 3.0 3.0 Model Number M1191A M1191AL M1191NL M1192A M1192N M1194A M1194N Model Number M1901B M1903B M1904B System Safety and Specifications 7-33 System 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) OxiMax MAX-P, Pediatric 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 N/A N/A N/A N/A 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 7-34 System Safety and Specifications A Optional Patient Monitor/

Holter Interface (Analog Output) I n t r o d u c t i o n This chapter describes the optional Patient Monitor/Holter Interface (Analog Output). It includes the following sections:

Overview. A-2 Analog Output Bedside Monitor Cables. A-3 Lead Placement and Selection . A-5 Controls for Telemetry Setup . A-6 Functionality with Paced Waves. A-6 Technical Alarms (Inoperative Conditions) . A-7 Holter Interface. A-8 A-1 Overview Overview Correct Labeling A-2 The optional Patient Monitor/Holter Interface (Analog Output) gives the Philips Telemetry System the capability of providing ECG outputs to bedside monitors, holter monitors, and other recording devices. This option is not available for telemetry systems with EASI monitoring. Warning Warning The Patient Monitor/Holter Interface (Analog Output) Option is intended for display and recording purposes only. The following should not be used with this option:

- Synchronized cardioversion

- Intra-aortic balloon pump Inherent delays in the telemetry transmitter, receiver, and the analog output processing cause significant time lags between actual ECG occurrence and the signal required to trigger the defibrillator or intra-

aortic balloon pump. Failure to adhere to this warning could cause serious injury to the patient. To ensure correct lead labeling at the bedside monitor, the following should be used:

Correct bedside monitor cable. See the table on page A-4. Standard lead placement Valid lead selection at the bedside monitor. See Lead Placement and Selection on page A-5. Not adhering to these recommendations may result in mislabeled leads or an invalid display. Analog Output Bedside Monitor Cables Analog Output Bedside Monitor Cables To connect the telemetry transmitter to the bedside monitor via the optional Patient Monitor/Holter Interface (Analog Output), you will need an analog output bedside monitor cable. The end of the cable that connects to the bedside monitor will have either a small 12-pin connector or a larger 8-pin connector (See the illustration below). The other end of the cable has a phone plug connector, and it plugs into the wallplate. NoteWhen using the analog output option for the Philips Telemetry System, this cable will replace the bedside monitor patient cable. 8 Pin 12 Pin There are four different analog output bedside monitor cables. The cable you use depends upon whether the input connector on your bedside monitor is 8-pin or 12-pin and whether your transmitter lead set is 3- or 5-wire. The table on page A-5 summarizes the proper cable selection. The 3-wire cables can be distinguished from the 5-wire cable by the attached label (see page A-5). The lead set type also determines which are the valid leads to be selected at the bedside. Appropriate use of each cable type is illustrated on a label attached to the cable (see page A-5). A-3 Analog Output Bedside Monitor Cables The following table shows all available analog output bedside monitoring cables. Lead Set 3-wire lead set 5-wire lead set Bedside Monitor Cable Connector Analog Output Bedside Monitor Cable 8-pin (large) 12-pin (small) 8-pin (large) 12-pin (small) HP78599AI-#K71 HP78599AI-#K72 HP78599AI-#K73 HP78599AI-#K74 Caution To ensure correct lead labeling at the bedside monitor, it is important that you use the correct bedside monitor cable. A-4 Lead Placement and Selection Lead Placement and Selection To ensure valid waves with the correct lead label, you must remember to use the following:

Standard lead placement (shown on the telemetry transmitter case and in further detail in IntelliVue Information Center or TeleMon On-line Help). Valid lead selection (performed at the bedside monitor) The following table summarizes recommended lead placement and selection. Lead Set Lead Placement Valid Lead Selection on Bedside Monitor 3-wire 5-wire Standard Standard II II, MCL Caution To ensure correct lead labeling at the bedside monitor, standard lead placement and valid lead selection must be used. Not adhering to these recommendations may result in mislabeled leads or an invalid display. Using Non-

Standard Lead Placement With the 3- and 5-wire lead set, you can use non-standard lead placement, but you must still use a valid lead label selection at the bedside monitor. This will give you the desired waveform, but it will result in a mislabeled lead at the bedside monitor. A-5 Controls for Telemetry Setup Controls for Telemetry Setup The interaction with ECG depends on how the system is installed. If it is installed so that you can make changes from the IntelliVue Information Center, the interface for lead and size selection is the same as described in Changing Lead/Label on page 3-18. If not, make adjustments at the bedside monitor. Functionality with Paced Waves In order for paced waves to be processed correctly by bedside monitors using the analog outputs, the pace pulses must be artificially reconstructed and inserted into the analog output signals. The synthesized pace pulse is very narrow and may not be visible at the bedside display, depending on the type of monitor used. Warning Warning To ensure proper cardiotach performance, diagnostic bandwidth (filter off) should be selected at the bedside monitor when monitoring paced patients with a transmitter. A-6 Technical Alarms (Inoperative Conditions) Technical Alarms (Inoperative Conditions) With the Patient Monitor/Holter Interface (Analog Output) Option, the following telemetry technical alarms (inoperative conditions) will appear as a LEADS OFF message at the bedside monitor. 1. LEADS OFF 2. NO SIGNAL 3. TEL CANNOT ANALYZE 4. REPLACE BATTERY 5. INTERFERENCE 6. RECEIVER MALF 7. NO RECEIVER 8. TRANSMITTER MALF 9. ECG EQUIP MALF 10. TRANSMITTER OFF INVALID LEAD SET 11. If telemetry controls are located at the bedside monitor, (see Controls for Telemetry Setup on page A-6, these technical alarms appear as a LEADS OFF message at the IntelliVue Information Center. NoteSee Chapter 2, Alarms for information about the specific alarm messages. A-7 Holter Interface Holter Interface If you are using a holter monitor, it should be connected to a holter wallplate. Warning Warning Using a holter wallplate to interface to a bedside monitor could result in mislabeled leads. A-8 B Accessory List I n t r o d u c t i o n This appendix lists all ECG and SpO2 accessories that can be used with the transmitter. For additional information on connecting and using these 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. Accessory Safety Warning Warning Reuse: Never reuse disposable sensors, accessories and so forth that are intended for single use, or single patient use only. Philipss approval: Use only Philips-approved accessories. Packaging: Do not use a sterilized accessory if the packaging is damaged. B-1 ECG Accessories ECG Accessories Electrodes Order Number Description M2202A 40489E 40493D 40493E 60 packages of 5 radio translucent foam electrodes (300 per box) 10 packages of 30 paper tape electrodes (300 per box) 60 packages of 5 foam electrodes (300 per box) 10 packages of 30 foam electrodes (300 per box) Order Number Description 989803133831 3-wire, patient cable set, 79 cm (30), AAMI, Snap 989803133841 3-wire, patient cable set, 79 cm (30), AAMI, Grabber 989803133851 3-wire, patient cable set, 79 cm (30), IEC, Snap 989803133861 3-wire, patient cable set, 79 cm (30), IEC, Grabber 989803133871 5-wire, patient cable set, 79 cm (30), AAMI, Snap 989803133881 5-wire, patient cable set, 79 cm (30), AAMI, Grabber 989803133891 5-wire, patient cable set, 79 cm (30), IEC, Snap 989803133901 5-wire, patient cable set, 79 cm (30), IEC, Grabber 989803137241 989803137251 Colored 5-wire, patient cable set, 79 cm (30), AAMI, Snap Colored 5-wire, patient cable set, 79 cm (30), AAMI, Grabber Lead Sets B-2 ECG Accessories Order Number Description 989803137261 989803137271 Colored 5-wire, patient cable set, 79 cm (30), IEC, Snap Colored 5-wire, patient cable set, 79 cm (30), IEC, Grabber Order Number Description 989803134771 Skin preparation sheets, 10 preps/sheet, 10 sheets/

package Order Number Description 989803140401 Single, package of 10 989803140411 Single tethered, package of 10 989803140421 Double, package of 10 Order Number Description 989803140431 989803140441 ECG, package of 10 SpO2, package of 10 Skin Prep Paper Alignment Guides Gunk Guards B-3 SpO2 Accessories Pouches Trunk Cable Order Number Description 989803137831 Telemetry pouch, box of 50 989803140371 Telemetry pouch, case of 200 Order Number Description 989803137841 5-wire ECG trunk cable SpO2 Accessories Reusable Sensors Order Number Description M1191A M1191AL M1191NL M1192A M1192N M1194A M1194N Philips Adult finger, 2 m (6.6 feet) Philips Adult finger, 3 m (9.8 feet) Philips Adult finger, 3 m (9.8 feet) Philips Pediatric finger 1.5 m (4.9 feet) Philips Pediatric finger, 1.5 m (4.9 feet) Philips Adult & Pediatric ear, 1.5 m (4.9 feet) Philips Adult & Pediatric ear, 1.5 m (4.9 feet) B-4 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. SpO2 Accessories 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

*Nellcor OxiMax MAX-A, Adult >30 kg (>66 lb) N/A from Philips

*Nellcor OxiMax MAX-AL, Adult >30 kg (>66 lb) N/A from Philips

*Nellcor OxiMax MAX-N, Adult >40 kg (>88 kg) N/A from Philips N/A from Philips

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

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

110 lb) N/A from Philips

*Nellcor Oxisensor II D-25, Adult >30 kg (>66 lb) N/A from Philips M1943A M1943AL

*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)

* Uses reusable OC-3 Sensor Cable. B-5 SpO2 Accessories Wristband Order Number Description M1627A 10 bands per pack B-6 C Sales and Support Offices I n t r o d u c t i o n For more information, please call your local Philips Medical Systems sales office listed in your telephone directory or a Philips Medical Systems 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 Canada 281 Hillmount Road Markham, ON L6C 2S3

(800) 291-6743 Europe, Middle East and Africa Philips Medizinsysteme Bblingen GmbH Cardiac and Monitoring Systems Hewlett-Packard Str. 2 71034 Boeblingen Germany Fax: (+49) 7031 463 1552 C-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 Kings Road Taikoo Shing, Hong Kong

(+852) 3197 7777 C-2 A accessories ECG, B-2 ordering information, B-1 SpO2, B-4 alarms behavior with Own Bed Overview, 2-3 list of physiologic, 2-6 list of technical (INOPs), 2-11 pause/suspend, 2-2 SpO2, turn on/off, 5-22 testing, 6-2 ambient light effect on SpO2, 5-24 analog output, 7-17 bedside monitor cables, A-3 INOPs, A-7 lead labeling, A-2 lead placement and selection, A-5 making adjustments, A-6 use with paced waves, A-6 antenna amplifiers, 7-17 arrhythmia ST/AR algorithm, 3-28 artifact, muscle and movement, 3-24 auditory signals definition, 1-18 automatic shutoff transmitter, 1-23 B batteries disposal, 1-30 gauge indicators, 1-32 life, 1-30 power level, 1-32 safety information, 1-29 C Check Button, 1-12 classification information, 7-3 cleaning receiver mainframe, 6-15 system, 6-3 compliance Canadian radio equipment, 7-7 FCC, 7-7 system, 7-2 configuration changing, 6-19 settings, 6-17 connectors receiver mainframe, 7-16 continuous SpO2 measurement, 5-20 D defibrillation type of proof against, 7-14 dropouts, 3-23 E EASI sourced waves, 3-5 ST, 4-2 ECG changing lead/labels, 3-18 lead sets, 3-2 leads available, 3-4 measurement, 3-2 minimizing artifact (noise), 3-24 reconstructed leads, 3-6 RF interference, 3-24 safety information, 3-27 signal too low, 3-23 ECG monitoring electrode site preparation, 3-7 optimizing performance, 3-22 preparation for, 3-7 1 ECG noise ECG waves troubleshooting, 3-24 changing size, 3-19 electromagnetic compatibility, 7-5 essential performance, 7-4 EU representative, address, 7-3 Extended Monitoring, 3-20 F fallback EASI, 3-20 multilead/singlelead analysis, 3-20 FAST SpO2 algorithm, 5-2 G grounding, telemetry, 7-15 H Holter Interface option see analog output I indications for use, 1-5 instructions to patient, 1-19 IntelliVue TRx transceiver, 1-9 L labels changing ECG, 3-18 lead sets, 3-2 capabilities, 3-18 leads changing, 3-18 leads off monitoring during, 3-19 M M2600B Philips Telemetry System new functionality, 1-2 Index 2 maintenance preventive, 7-18 system, 6-3 measurement points, ST, 4-3 N noise eliminating, 3-24 Nurse Call turn on/off, 1-23 O Own Bed Overview alarm behavior, 2-3 description, 1-4 P paced patients safety, 3-32 using analog outputs, A-6 patient instructions to, 1-19 skin preparation, 3-7 see analog output pause/suspend alarms, 2-2 pouch how to use, 1-20 securing, 1-20 power pulse specifications, 7-22 audio signal, 5-23 turn on/off, 5-23 R receiver mainframe, 1-35 cleaning, 6-15 connectors, 7-16 rear panel, 7-16 Patient Monitor/Holter Interface option retaining settings, 1-35 turning on/off, 1-35 RF interference, 3-23, 3-24 reducing, 7-6 restrictions for use, 7-7 S safety accessories, B-1 installation, 7-14 maintenance, 7-14 pacing, 3-32 pouch, 1-20 ST/AR arrhythmia, 3-31 safety information, 7-19 sensors adult finger, 5-14 application safety information, 5-12 applying, 5-12 ear clip, 5-16 positioning, 5-13 selecting, 5-25 small adult/pediatric, 5-15 showering drying transmitter, 1-22 use of transmitter, 1-21 signal too low (ECG) action to take, 3-23 Smart Limits ST, 4-9 sounds description of, 1-18 specifications analog output, 7-25 antenna system, 7-26 battery life, 7-20 ECG measurements, 7-30 environmental, 7-21 environmental, SpO2 sensors, 7-21 environmental, transmitter, 7-21 mainframe, 7-24 Patient Monitor or Holter Interface, 7-25 power, 7-22 receiver module, 7-25 SpO2 measurements, 7-32 SpO2 sensors, 7-33 transmitter, power, 7-22 SpO2 alarm behavior, 5-25 alarms, turn on/off, 5-22 ambient light, effect of, 5-24 applying sensors, 5-12 auto on/off, 5-22 continuous measurement, 5-20 FAST algorithm, 5-2 measurement limitations, 5-24 measurement method, 5-2 obtaining accurate measurements, 5-24 preparation for monitoring, 5-7 reusable sensors, 5-8 selecting sensors, 5-12 spot check measurements, 5-19 troubleshooting, 5-24 turn on/off, 5-20 turn parameter on/off, 5-21 types of measurements, 5-18 types of sensors SpO2 disposable sensors, 5-8 spot check measurements, 5-19 ST alarm adjustments, 4-9 analysis, 4-2 EASI analysis, 4-4 intended use, 4-2 measurement, 4-3 patient population, 4-2 smart limits, 4-9 turn on/off, 4-7 viewing data, 4-4 3 ST/AR arrhythmia analysis, 3-28 standby mode, 1-24 symbols explanation of, 7-9 system classification, 7-3 compliance, Canadian radio equipment, 7-7 components, 1-7 diagram of, 1-8 electromagnetic compatibility, 7-5 environmental specifications, 7-21 essential performance, 7-4 FCC compliance, 7-7 indications for use, 1-5 intended use, 1-6 regulatory information, 1-6 RF interference, 7-6 safety compliance, 7-2 symbols, 7-9 transmitters used with, 1-9 warnings, 7-4 T technical alarms analog output, A-7 telemetry changing lead/label, 3-18 dropouts, 3-23 grounding, 7-15 muscle and movement artifact, 3-24 noise, 3-24 on/off, 1-34 Patient Monitor/Holter Interface option, 7-17 receiver mainframe, 7-16 retaining settings, 1-35 RF INOPs, 3-23 standby mode, 1-24 suspending monitoring, 1-24 Index 4 Telemetry button, 1-12, 1-23 TeleMon operation when connected, 1-25 SpO2 measurement modes, 5-18 use with M2601A/B transmitter, 1-25 transmitter automatic shutoff, 1-23 battery disposal, 1-30 battery life, 1-30 controls on back, 1-15 controls on front, 1-11 M2601A, 1-9 M2601B and M2601A comparison, 1-2 M2601B features, 1-10 pouch use, 1-19 safety warnings, 1-18 sounds, 1-18 turning on/off, 1-22 use in shower, 1-21 wetting, 1-22 where worn, 1-19 troubleshooting, 6-2 ECG noise, 3-24 SpO2, 5-24 turn on/off pulse parameter, 5-23 SpO2, 5-20 SpO2 alarms, 5-22 SpO2 parameter, 5-21 ST, 4-7 transmitter, 1-22 W warnings system, 7-4 waves wetting changing size on display/recordings, 3-19 use of transmitter, 1-22