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SRRAV1
Users Manual
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Philips Medical Systems North America SRRAV1 Users Manual

Draft - 1 Aug 08
IntelliVue TRx/TRx+ Transceivers
for the ITS4840A/ITS4850A IntelliVue Telemetry System
Notice (ITS4842A, TRx4841A)
These devices comply with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) these devices may not cause harmful interference, and (2) these devices must accept any interference received, including interference that may cause undesired operation.
Notice (ITS4852A, TRx4851A)
These devices comply with part 15 of the FCC Rules, ETSI, RSS-210, and other international radio standards that govern operation in the ISM band. Operation is not subject to WMTS rules.
Instructions for Use
Draft - 1 Aug 08
Notice Document number: 453564087761, First Edition
Printed in the USA. © Copyright 2008 Koninklijke Philips Electronics N.V. All Rights Reserved.
Reproduction in whole or in part is prohibited without the prior written consent of the copyright holder.
Philips Medical Systems Nederland B.V. reserves the right to make changes in specifications and/or to discontinue any product at any time without notice or obligation and will not be liable for any consequences resulting from the use of this publication.
Equipment specifications are subject to alteration without notice. All changes will be in compliance with regulations governing manufacture of medical equipment.
OxiCliq Duracell
®
and OxiMax® are registered trademarks of Nellcor Incorporated.
®
is a registered trademark of Duracell International Incorporated.
Manufacturer Philips Medical Systems
3000 Minuteman Road Andover, MA 01810-1099 (978) 687-1501
ii
Draft - 1 Aug 08
Printing History
Printing History
New editions of this document will incorporate all material updated since the previous edition. Update packages can be issued between editions and contain replacement and additional pages to be merged by a revision date at the bottom of the page. Note that pages which are rearranged due to changes on a previous page are not considered revised.
The documentation printing date and part number indicate its current edition. The printing date changes when a new edition is printed. (Minor corrections and updates which are incorporated at reprint do not cause the date to change.) The document part number changes when extensive technical changes are incorporated.
First Edition...............................................................................September 2008
IntelliVue TRx4841A C.00 Transceivers are compatible with:
IntelliVue Telemetry System, Revision A.00 and B.00 IntelliVue Information Center, Software Revision F.00 and later M2636C TeleMon Companion Monitor, Revision C.00 (full functionality requires IIC Rev. L.00 and monitor revisions listed here) IntelliVue MP5 Patient Monitor, Revision G.00 and later
IntelliVue TRx4851A C.00 Transceivers are compatible with:
IntelliVue Telemetry System, Revision B.00 IntelliVue Information Center, Software Revision J.0 0 and later M2636C TeleMon Companion Monitor, Revision C.00 (full functionality requires IIC Rev. L.00 and monitor revisions listed here) IntelliVue MP5 Patient Monitor, Revision G.00 and later
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Draft - 1 Aug 08
About this Book
About this Book
This book contains operating instructions for use of the IntelliVue TRx and TRx Hopping Technology. It also includes operational information for the telemetry functions of the IntelliVue Information Center. The intended audience is the clinician who uses and/or teaches others to use this equipment in a healthcare environment.
+
Transceivers as used with the IntelliVue Telemetry System with Smart-
Additional resources for Philips products used in conjunction with the IntelliVue TRx and TRx
• IntelliVue Information Center Instructions for Use
• IntelliVue Information Center Online Help
• M2636C TeleMon Companion Monitor Instructions for Use
• IntelliVue Telemetry System Training Program
• IntelliVue MP5 Patient Monitor Instructions for Use
• IntelliVue MP2 Patient Monitor Instructions for Use
• IntelliVue X2 Patient Monitor Instructions for Use
For preventive maintenance, repair, and test methods for verification of device performance, refer to the IntelliVue Telemetry System Service Kit.
+
Transceivers include:
iv
Draft - 1 Aug 08
About this Book
Document Conventions
The following document conventions are used throughout this manual to identify specific safety and operational information.
Warnings
WarningWarning
Warnings are information you must know to avoid injuring patients and personnel.
Cautions
Caution
Cautions are information you must know to avoid damaging your equipm ent and software.
Notes
Note—Notes contain additional information on use of the IntelliVue Telemetry
System.
Procedures
Procedures are indicated in the following table:
Step
Action
1 2 3
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Draft - 1 Aug 08
About this Book
vi
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Contents
1. Introducing IntelliVue Telemetry. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
The IntelliVue Transceiver. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
Transceiver Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
Transceiver Models . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
IntelliVue Telemetry System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
Bi-directional Capability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
Smart-hopping Technology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5
Spectrum Sharing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8
IntelliVue Clinical Network . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8
Transceiver Use with Other Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9
2. Product Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
General Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
Battery. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
ECG. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6
For Paced Patients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8
ST/AR Arrhythmia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8
For Paced Patients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-10
ST/AR ST Segment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11
ST/AR QT Interval . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12
SpO
2
Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-16
Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-17
3. Transceiver Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
Transceiver Controls - Front. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
Buttons. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
Power On/Off. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4
Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4
Labels. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5
Ports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6
Transceiver Controls - Back . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7
Labels. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8
Safety Symbols & Other Marks. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8
Audible Tones. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10
Clinical Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-11
Contents-1
Draft - 1 Aug 08
Adjustable Sounds . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-12
Service Sounds. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-13
4. Basic Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
Transceiver Safety Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
Turning the Transceiver On/Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
Turning On. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
Turning Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
Standby Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Briefing the Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6
Pouch Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7
Securing the Pouch. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7
Showering . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10
Testing Transceiver Functionality. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11
Self Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11
Status Check. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12
Battery Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-13
Battery Safety Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-13
Inserting/Removing Batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-14
Checking the Battery Power Level . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-17
5. Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
Alarm Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
Testing Alarm Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
Suspending/Pausing Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
Unsuspending& Resuming Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4
Physiologic Alarms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4
Technical Alarms (INOPs) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-10
6. ECG Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
ECG Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
For Paced Patients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3
Measuring ECG. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4
ECG Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4
ECG Leads Monitored. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-6
Positioning ECG Electrodes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-10
Locating the Fourth Intercostal Space . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-12
3-Wire Placement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-13
5-Wire Placement (Standard Mode) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-14
5-Wire Placement (EASI Mode) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-16
Contents-2
Draft - 1 Aug 08
6-Wire Placement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-17
Connecting the ECG Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-21
Cable Disconnection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-24
Verifying Electrode Connections. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-25
Monitoring during Leads Off. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-27
ECG Fallback . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-27
Relearning. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-28
Using EASI Leads to Troubleshoot . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-28
Optimizing ECG Measurement Performance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-29
Dropouts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-30
Muscle and Movement Artifact . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-32
7. ST/AR Arrhythmia
Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
ST/AR Arrhythmia Algorithm. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2
Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2
Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2
For Paced Patients. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3
Intended Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4
ST/AR Arrhythmia Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-5
ST/AR ST Segment Algorithm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-7
Intended Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-7
The Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-8
Algorithm Processing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-8
Displayed ST Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-9
EASI ST Analysis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-9
ST Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-9
ST Alarm Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-12
ST/AR QT Interval Algorithm. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-14
Intended Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-14
What is QT Interval Monitoring. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-15
QT Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-16
QT Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-17
How the QT Analysis Algorithm Works . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-18
Adjusting QT Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-18
Limitations for QT Monitoring. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-23
8. SpO2 Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
SpO2 Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2
Information for the User . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3
SpO
2
Contents-3
Draft - 1 Aug 08
Pulse Oximetry Measurement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5
Pulse Tone Indication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-6
Selecting a SpO
Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-7
2
Applying the Sensor. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-11
Sensor Application Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-11
Site Selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-12
Sensor Application. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-12
Connecting the SpO Measuring SpO
Cable. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-15
2
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-16
2
Spot Check Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-17
Continuous Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-18
When Connected to TeleMon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-19
Turning SpO
Enable/Disable at Information Center . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-20
SpO
2
Auto ON at Information Center . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-20
SpO
2
Understanding SpO Optimizing SpO
Monitoring Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-19
2
Alarms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-20
2
Measurement Performance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-22
2
9. Telemetry Functions at the Information Center & TeleMon. . . . . . . . . . . . 9-1
Telemetry Functions at the Information Center . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2
Telemetry Controls in the Patient Window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2
Locating the Transceiver (Find Device) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3
Viewing Device Location in the Patient Window (optional). . . . . . . . . . . . . . . . . . . . . . . . 9-4
Viewing Device Location History (optional). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-4
Using the Device Location Client (optional). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-5
Patient Configurable Settings in Telemetry Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-6
Unit-Configurable Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-9
RF Auto Shutoff . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-18
Transceiver Operation when Connected to TeleMon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-19
10. Pairing Monitoring Devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1
Device Revision Pairing Functionality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-3
Pairing Networked Devices. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-3
Pairing at the Information Center. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-3
Pairing with a Direct Connection to the MP5 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-4
Pairing at the IntelliVue Patient Monitor. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-5
Unpairing the Monitor and Transceiver . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-7
Alarm Behavior (Networked) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-8
Alarm Behavior (Networked with Cable or Short-Range Radio Connection) . . . . . . . . 10-12
Paired Device Synchronized Alarm Settings (Networked) . . . . . . . . . . . . . . . . . . . . . . . 10-14
Contents-4
Draft - 1 Aug 08
Pairing Non-networked Devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-16
Pairing with a Direct Connection to the MP5/MP5T . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-17
Pairing with a Short- Range Radio Connection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-17
Unassigning Transceiver with SRRA at the Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-19
Alarm Behavior (Non-networked) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-19
More Bed Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-21
Short- Range Radio Error Conditions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-22
11. Maintenance, Cleaning & Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . 11-1
Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-2
Basic Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-2
Testing Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-2
Label Assignment for Replacement Transceiver . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-2
Cleaning and Sterilization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-4
Cleaning the Transceiver . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-5
EO Sterilization. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-7
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-14
Basic Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-14
Information Signals. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-15
12. Safety Standards & Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-1
Regulatory Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-2
Intended Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-2
Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-2
Rx . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-2
Patient Population. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-2
Authorized EU Representative . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-2
Safety Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-3
Essential Performance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-3
System Classification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-4
FCC Compliance (M4840A/USA only) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-4
Industrie Canada Compliance (Canada) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-5
AC Power Source . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-5
Software Hazard Prevention. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-5
Electromagnetic Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-5
Reducing Electromagnetic Interference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-7
Restrictions for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-7
Battery Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-8
Radio Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-9
TRx4841A . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-9
Contents-5
Draft - 1 Aug 08
TRx4851A . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-10
SRRA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-12
Physical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-13
ECG-only Transceiver . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-13
ECG/SpO
SRRA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-14
Environmental Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-15
Measurement Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-16
ECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-16
SpO SpO
Transceiver. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-13
2
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-18
2
Sensor Accuracy. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-20
2
A. Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1
Accessory Safety. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1
Transceiver Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2
Pouches . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2
Protective Covers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2
Monitor Interface Cable. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2
Short Range-Radio Adapter. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3
ECG Accessories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3
Electrodes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3
Skin Prep Paper . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3
Leadsets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-4
Alignment Guides . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-5
Detachable Shields. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-5
Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-6
SpO
2
Reusable Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-6
Disposable Sensors - Single Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-7
Adapter Cables. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-9
Wristband. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-9
B. Sales and Support Offices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1
Contents-6
Draft - 1 Aug 08
1

Introducing IntelliVue Telemetry

This chapter introduces the IntelliVue TRx and TRx+ Transceivers, the patient­worn device of the IntelliVue Telemetry System with Smart-Hopping Technology. It includes the following sections:
• The IntelliVue Transceiver. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
• IntelliVue Telemetry System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
• IntelliVue Clinical Network . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8
• Transceiver Use with Other Equipment . . . . . . . . . . . . . . . . . . . . . . . . 1-9
Introduction
Introducing IntelliVue Telemetry 1-1
Draft - 1 Aug 08

The IntelliVue Transceiver

The IntelliVue Transceiver
The IntelliVue Transceiver is a patient-worn device for monitoring ECG and
on adult and pediatric patients within the IntelliVue Telemetry System.
SpO
2
The transceiver combines traditional transmitter features with communication to and from the IntelliVue Information Center.

Transceiver Features

Transceiver Models

• EASI/Standard and Standard only (No EASI) selectable in one device.
• 6-lead with two V-leads for diagnosing multiple cardiac abnormalities, including wide-QRS complex tachycardias and acute myocardial ischemia/infarction.
• Small, lightweight ECG-only device.
• Audio feedback for out-of-range and lost device.
• Battery gauge on device and at Information Center.
• Powered by 2 AA batteries.
• Alarm suspend and resume from standby at device and Information Center.
•SpO
• Easy for clinicians to use and comfortable for patients to wear.
• Protective covers preventing debris from accessing unused ports.
• Pouch with clear front that closes securely.
• Simultaneous operation in network with M2601B Transmitter.
• Communication with IntelliVue Patient Monitors via Short-Range Radio
The transceiver is available in two models for each radio frequency spectrum in which they operate (TRx4841A - 1.4 GHz; TRx4851A - 2.4 GHz):
• TRx - ECG Only
•TRx
Spot Check measurement without using any controls.
2
connection (MP5/MP5T, MP2 and X2 monitors only)
+
- ECG and SpO
2
1-2 Introducing IntelliVue Telemetry
Draft - 1 Aug 08
The IntelliVue Transceiver
.
front
back
+
+
M2601B
IntelliVue TRx
IntelliVue TRx M4841A
M4841A
EASI, 3
5
EASI, 3
5,6
IntelliVue TRx Transceiver - ECG Only
IntelliVue TRx
M4841A
+
EASI, 3
front
5,6
back
EASI
EASI
I
FCCID: XXXXXXXX
EASI
EASI
I
S
E
2
1
3
445566
S
E
1
FCCID: XXXXXXXX
A
A
2 3
445566
IntelliVue TRx
+
Transceiver - ECG/SpO
2
Introducing IntelliVue Telemetry
1-3
Draft - 1 Aug 08

IntelliVue Telemetry System

IntelliVue Telemetry System
The IntelliVue Telemetry System with Smart-Hopping Technology uses cellular architecture to provide two-way communication between transceivers and the IntelliVue Information Center. Smart-hopping technology dodges interference and seeks out the strongest available signal to achieve seamless connections wherever patients roam on the clinical network. The system connects a number of individual devices to form a complete method of transporting patient data to a central repository for subsequent distribution to clinical staff. Full patient mobility is available within the areas defined by the wireless coverage of the multiple Access Points.
Bi­directional Capability
Telemetry transmits the patient’s measurements using radio waves. The signals obtained from the patient travel from the transceiver to an access point in the ceiling or wall and then to the Information Center. Bi-directional capability enables you to remotely control certain transceiver functions from the Information Center. Physiological data is transported from the transceiver, and a reverse data channel enables data to be transported to the transceiver. Bi­directional operations include the following:
• Change SpO
• Enable or disable display of the pleth wave.
• Adjust the transceiver volume, or turn it off.
• Find Device feature for locating a lost transceiver within the coverage area.
• Suppress SpO
• Return from Standby mode after a patient is away from the unit and not being monitored by the IntelliVue Telemetry System.
• Configurable Alarm Pause/Suspend time initiated at the transceiver as well as the Information Center.
• Transceiver location information displayed at the Information Center.
• Transceiver out of area notification at the Information Center.
measurement mode, or turn SpO2 measurement off.
2
technical alarms (INOPS) during NBP measurement.
2
1-4 Introducing IntelliVue Telemetry
Draft - 1 Aug 08
IntelliVue Telemetry System
Smart­hopping Technology
Bi-directional Signal Flow in the IntelliVue Telemetry System
Smart-hoppingTM technology provides dynamic management of the RF spectrum used by each transceiver. This technology allows a virtually unlimited number of transceivers to operate simultaneously within the IntelliVue Telemetry System by creating a frequency-agile system that changes frequency without user involvement or awareness whenever interference occurs.
Introducing IntelliVue Telemetry
1-5
Draft - 1 Aug 08
IntelliVue Telemetry System
Smart-hopping enables the signal to avoid wireless interference. When baseline noise is low (see illustrations following), telemetry signals reside in their frequency/time slot locations. If excessive interference occurs, degrading the signal, the telemetry signal then “hops” over the interference to a location that provides optimal signal-to-noise performance.
In cases of excessive intermittent wireless interference, such as machinery operation or construction activity, you should identify patterns of interference. This information may assist your service provider in helping you resolve a problem with interference.
Desired Signal
Baseline Noise Interference
1395
1-6 Introducing IntelliVue Telemetry
1400
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IntelliVue Telemetry System
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’Hop’ to New Frequency/Time Slot
Introducing IntelliVue Telemetry
1-7
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IntelliVue Clinical Network

Spectrum Sharing

The ITS4840A IntelliVue Telemetry System operates in the Wireless Medical Telemetry Service bands (WMTS - USA only). WMTS uses radio frequency spectrum which was allocated by the FCC for medical telemetry applications, with a reduced potential for harmful interference. Although WMTS is managed by a frequency coordination process, this coordination and licensing does not grant the user an exclusive right to the spectrum on which their system operates, and is subject to the terms and conditions of the FCC license. Other WMTS and non-medical FCC licensees, as well as government agencies, may be legally authorized to use this licensed spectrum.
The ITS4850A IntelliVue Telemetry System operates in the 2.4 GHz ISM band, with up to six RF channels using a similar Smart-hopping technology as described on page 1-5. The system also scans the selected six RF channels to determine whether the spectrum is sufficiently clear. If the system is too congested, a system level alert is provided.
IntelliVue Clinical Network
The IntelliVue Clinical Network (ICN) is the communication infrastructure necessary to tie together all the patient monitoring systems within an organization. This includes getting information to and from the IntelliVue Information Center(s).
Patients can be monitored within the defined coverage areas. When a patient goes out of range, an auditory out-of-range indicator sounds at the transceiver, and a "No Signal" technical alarm at the Information Center notifies the clinical staff.
The Network can include both wired and wireless devices. An installation typically includes the following components:
1-8 Introducing IntelliVue Telemetry
• IntelliVue Clinical Network infrastructure.
• TRx4841A/TRx4851A Transceivers, bi-directional patient-worn devices.
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Transceiver Use with Other Equipment

• ITS4842A/ITS4852A Access Points (AP), placed within the areas with
defined coverage. APs are centers for bidirectional communication between the transceivers and the Information Center.
• M3150B IntelliVue Information Center for centralized monitoring.
• ITS4843A/ITS4853A Core Access Points (optional) for expanded
coverage.
• M3154A IntelliVue Database Server (optional) for centralized data
management.
• M2636C TeleMon Companion Monitor (optional) for local alarms, NBP
measurement, and bedside display of patient data.
• M8105A MP5, M8102A MP2, and M3002A X2 IntelliVue Patient
Monitors (optional) for bedside display of patient data being sourced from the transceiver.
Transceiver Use with Other Equipment
IntelliVue
Information
Center
TeleMon The transceiver can employ the full functionality of the M2636C TeleMon
The transceiver’s bi-directional capability enables remote control from the Information Center for alarm, setup, and general monitoring functions. In addition, the system supports Telemetry Overview, the pairing of a telemetry bed with an IntelliVue Patient Monitor for bedside ECG viewing of a single patient. Telemetry Overview provides the telemetry-monitored waveforms, numerics, and alarms in an integrated form both on the bedside monitor and at the IntelliVue Information Center. See “Chapter 10. Pairing Monitoring Devices” for operating and configuration information.
Companion Monitor, including NBP measurement and local display of alarms. Connection is made through an interface cable at the Monitor/Service port on the transceiver. Please refer to “Transceiver Operation when Connected to TeleMon” on page 9-19 for an operational summary, and the M2636C TeleMon Instructions for Use for general operating instructions.
Introducing IntelliVue Telemetry
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Transceiver Use with Other Equipment
Patient
Bedside
Monitors
M2601B
Transmitters
Remote control of monitoring parameters such as NBP, SpO2, Alarm Suspend, and Relearn, as well as limited overview of waves and data are supported through Patient Bedside Monitors equipped with IntelliVue Instrument Telemetry. Please refer to the Instructions for Use for the specific Patient Monitor for operating information.
Patient Data can be sourced directly from the transceiver to MP5/MP5T, MP2 or X2 Patient Monitors. The connection is made through a monitor interface cable (MP5/MP5T only) or short range radio adapter (SRRA) inserted in the Monitor/ Service port and connected to the monitor. Non-networked MP5/MP5T monitors can source patient data that includes SpO temperature measurements to the Information Center. Please refer to the MP5 Instructions for Use for additional information.
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If your hospital uses TRx and/or TRx you can distinguish between them by:
• Name on the front of the device (TRx or M2601B)
• Label color (light gray for transceivers, dark gray for transmitters)
Transceivers and M2601B Transmitters,
, NBP and predictive
2
1-10 Introducing IntelliVue Telemetry
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2

Product Safety

This chapter consolidates the safety warnings that apply to use of the IntelliVue Transceivers in a IntelliVue Clinical Network. These warnings are repeated throughout the book in context where relevant. The chapter includes the following sections:
• General Safety. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
• Battery. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
• ECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6
• ST/AR Arrhythmia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8
• ST/AR ST Segment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11
•SpO
• Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-16
• Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-17
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12
2
Introduction
Product Safety 2-1
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General Safety

General Safety
The IntelliVue Telemetry System should not be used for primary monitoring in applications where the momentary loss of the ECG is unacceptable.
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.
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.
WarningWarning
WarningWarning
WarningWarning
WarningWarning
This device is not to be used in the vicinity of electrosurgical units because such use may interrupt or interfere with the transmission of signals from the transceiver.
WarningWarning
This equipment is not suitable for use in the presence of a flammable anesthetic mixture with air, or with oxygen or nitrous oxide
2-2 Product Safety
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General Safety
WarningWarning
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.
WarningWarning
The system is not completely immune from radio interference although it is designed to minimize interference through smart hopping. Sources of interference that may be a problem include failing fluorescent lights and construction equipment. See “Electromagnetic Compatibility” on page 12-5.
WarningWarning
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 on patients.
WarningWarning
Do not use the transceiver for patient monitoring if it fails the Power On Self Test.
WarningWarning
When the patient is showering, signal quality and leads off detection may be compromised due to significant patient movement. Appropriate clinical precautions must be taken.
Product Safety
2-3
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General Safety
WarningWarning
If the Alarms Suspend indicator on the transceiver remains illuminated after the button combination to unsuspend alarms is pressed, a transceiver malfunction may have occurred. (Alarms resume automatically after the configured alarm suspend duration, or you can resume them manually at the Information Center.) The transceiver should be replaced, and the malfunctioning unit should be sent to your service provider.
WarningWarning
If the remote Silence key in the Overview window is enabled for IntelliVue monitors connected to the Information Center, remote silencing for these beds may be enabled in other clinical units
WarningWarning
Place the transceiver in a pouch or over clothing, or both, during patient use. The transceiver should not touch the patient’s skin during use.
WarningWarning
To avoid the risk of strangulation, do not tie a pouch solely around the patient’s neck.
WarningWarning
Patients should be instructed not to open the battery compartment while the transceiver is in use.
WarningWarning
Failure on the part of the responsible individual hospital or institution employing the use of this equipment to implement satisfactory maintenance as needed may cause undue equipment failure and possible health hazards.
2-4 Product Safety
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Battery

Battery
WarningWarning
The battery door must be closed during defibrillation.
WarningWarning
Use Duracell Alkaline Batteries, size AA, MN 1500, 1.5V, to ensure specified performance. Outdated, mismatched, or poor-quality batteries can give unacceptable performance (e.g., insufficient Battery-Low warning time). The use of fresh high-quality alkaline batteries is strongly recommended.
WarningWarning
Certain failure conditions, such as short circuits, can cause a battery to overheat during use. High temperatures can cause burns to the patient and/ or user. If the transceiver becomes hot to the touch, place it aside until it cools. Then remove the batteries and discard them. Have the transceiver operation checked by your service provider to identify the cause of overheating.
WarningWarning
If you receive a BATTERY LOW alarm, the batteries must be promptly replaced. A “Battery Low” condition that is not corrected will result in a transceiver shutdown and cessation of monitoring.
Product Safety
2-5
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ECG
ECG
WarningWarning
Batteries should be removed from the transceiver at the end of the battery’s useful life to prevent leakage.
If battery leakage should occur, use caution in removing the battery. The leaked substance may cause eye or skin irritation. Avoid contact with skin. Clean the battery compartment according to instructions in “Chapter 11. Maintenance, Cleaning & Troubleshooting”. Wash hands.
WarningWarning
Always confirm Information Center observations with clinical observation of the patient before administering interventions.
WarningWarning
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.
WarningWarning
Do not mix and match electrodes of different types. In particular, do not use electrodes of dissimilar metals. This helps ensure optimal signal quality.
2-6 Product Safety
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ECG
WarningWarning
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.
WarningWarning
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
WarningWarning
When switching between EASI and standard monitoring, there is a loss of data for 30 seconds.
Product Safety
2-7
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ST/AR Arrhythmia

For Paced Patients

WarningWarning
The output power of the transceiver and other sources of radio frequency energy, when used in the proximity of a pacemaker, can be sufficient to interfere with pacemaker performance. Due to the shielding effects of the body, internal pacemakers are somewhat less vulnerable than external pacemakers. However, caution should be exercised when monitoring any paced patient.
In order to minimize the possibility of interference, position electrodes, electrode wires, and the transceiver as far away from the pacemaker as possible.
Consult the pacemaker manufacturer for information on the RF susceptibility of their products and the use of their products with the IntelliVue Telemetry System. See the IntelliVue Information Center Instructions for Use for additional information on monitoring paced patients.
ST/AR Arrhythmia
WarningWarning
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.
2-8 Product Safety
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