Philips Medical Systems North America 4851 Medical telemetry patient worn device User Manual M4841 91001

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Date Submitted	2006-11-21 00:00:00
Date Available	2007-05-07 00:00:00
Creation Date	2006-11-20 10:14:21
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Document Lastmod	2006-11-20 16:12:38
Document Title	M4841 91001.book
Document Creator	FrameMaker 7.0
Document Author:	usd03535

IntelliVue TRx/TRx+ Transceivers
for the ITS4840A/ITS4850A IntelliVue Telemetry
System
Notice (ITS4840A)
This system complies with part 15 of the FCC Rules.
Operation is subject to the condition that this device
does not cause harmful interference.
Operation of this equipment in the United States
requires the prior coordination with a frequency
coordinator designated by the Federal Communications
Commission (FCC) for the Wireless Medical Telemetry
Service (WMTS).
Notice (ITS4850A)
This system complies with part 15 of the FCC Rules,
ETSI, RS-210, and other international radio standards
that govern operation in the ISM band. Operation is not
subject to WMTS rules.
Instructions for Use
Part Number: M4841-9001J
Printed in the U.S.A. December 2006
First Edition
Printing History
Notice
Document number: M4841-9001J, First Edition
Printed in the USA.
© Copyright 2004, 2005, 2006 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® and OxiMax® are registered trademarks of Nellcor Incorporated.
Duracell® is a registered trademark of Duracell International Incorporated.
Manufacturer
Philips Medical Systems
3000 Minuteman Road
Andover, MA 01810-1099
(978) 687-1501
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.)
ii
About this Book
The document part number changes when extensive technical changes are
incorporated.
First Edition...............................................................................December 2006
IntelliVue TRx4841A Transceivers are compatible with:
IntelliVue Telemetry System, Revision A.00
IntelliVue Information Center, Software Revisions F.00, G.00, H.00 and
J.00
M2636C TeleMon Companion Monitor, Revision A.00, B.00 and C.00
IntelliVue MP5 Patient Monitor, Revision E.00
IntelliVue TRx4851A Transceivers are compatible with:
IntelliVue Telemetry System, Revision B.00
IntelliVue Information Center, Software Revision J.00
M2636C TeleMon Companion Monitor, Revision C.00
IntelliVue MP5 Patient Monitor, Revision E.00
About this Book
This book contains operating instructions for use of the IntelliVue TRx and
TRx+ Transceivers as used with the IntelliVue Telemetry System with SmartHopping 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.
Additional resources for Philips products used in conjunction with the
IntelliVue TRx and TRx+ Transceivers include:
•
•
•
•
IntelliVue Information Center Instructions for Use
IntelliVue Information Center Online Help
M2636C TeleMon Companion Monitor Instructions for Use
IntelliVue Telemetry System Training Program
iii
About this Book
•
IntelliVue MP5 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.
iv
About this Book
Document
Conventions
The following document conventions are used throughout this manual to
identify specific safety and operational information.
Warnings
Warning
Warnings are information you must know to avoid injuring patients and
personnel.
Cautions
Caution
Cautions are information you must know to avoid damaging your equipment
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
About this Book
vi
Contents
1. Introducing IntelliVue Telemetry. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
The IntelliVue Transceiver. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Transceiver Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Transceiver Models . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
IntelliVue Telemetry System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Bi-directional Capability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Smart-hopping Technology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Spectrum Sharing
(USA Only) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
IntelliVue Clinical Network . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Transceiver Use with Other Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1-2
1-2
1-2
1-4
1-4
1-5
1-6
1-8
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
SpO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11
Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-14
Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-16
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
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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
Turning the Transceiver Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
Standby Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Briefing the Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6
Pouch Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7
Securing the Pouch. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7
Showering . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-9
Testing Transceiver Functionality. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10
Self Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10
Status Check. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11
Battery Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12
Battery Safety Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12
Inserting/Removing Batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-13
Checking the Battery Power Level . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-15
5. Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
Alarm Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Testing Alarm Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Suspending/Pausing Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Unsuspending& Resuming Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Physiologic Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Technical Alarms (INOPs) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5-2
5-2
5-2
5-3
5-4
5-9
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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5
Positioning ECG Electrodes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-9
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
6-Wire Placement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Connecting the ECG Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Cable Disconnection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Verifying Electrode Connections. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Monitoring during Leads Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
ECG Fallback . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Extended Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Relearning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Using EASI Leads to Troubleshoot . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Optimizing ECG Measurement Performance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Dropouts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Muscle and Movement Artifact . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6-18
6-22
6-24
6-25
6-26
6-26
6-27
6-27
6-27
6-28
6-29
6-31
7. ST/AR Arrhythmia & ST Segment Monitoring. . . . . . . . . . . . . . . . . . . . . . . 7-1
ST/AR Arrhythmia Algorithm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2
Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2
For Paced Patients. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3
ST/AR Arrhythmia Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4
ST/AR ST Segment Algorithm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-7
The Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-7
Algorithm Processing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-8
Displayed ST Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-9
EASI ST Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-9
ST Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-9
ST Alarm Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-11
8. SpO2 Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
SpO2 Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2
SpO2 Information for the User . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3
Pulse Oximetry Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4
Pulse Tone Indication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5
Selecting a SpO2 Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-6
Applying the Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-10
Sensor Application Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-10
Site Selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-10
Sensor Application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-11
Connecting the SpO2 Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-14
Measuring SpO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-15
Spot Check Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-15
Continuous Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-16
Contents-3
When Connected to TeleMon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
When Connected to the MP5 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Turning SpO2 Monitoring Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
SpO2 Enable/Disable at Information Center . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
SpO2 Auto ON at Information Center . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Understanding SpO2 Alarms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Optimizing SpO2 Measurement Performance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
8-17
8-18
8-18
8-19
8-19
8-20
8-20
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 History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-4
Patient-Configurable Settings in Telemetry Setup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-4
Unit-Configurable Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-8
RF Auto Shutoff. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-16
Transceiver Operation when Connected to TeleMon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-16
10. Pairing with IntelliVue Patient Monitors . . . . . . . . . . . . . . . . . . . . . . . . . 10-1
Pairing with a Direct Connection to the MP5 Patient Monitor . . . . . . . . . . . . . . . . . . . . . . . . .
Pairing at the Information Center . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Alarm Behavior with Telemetry Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Paired Device Synchronized Alarm Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
10-2
10-3
10-3
10-6
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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-6
Alternate Cleaning and Disinfection Methods. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-11
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-12
Basic Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-12
Information Signals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-13
12. Safety Standards & Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-1
Regulatory Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-2
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-2
Contents-4
Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-2
Rx . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-2
Patient Population . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-2
Safety Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-3
Essential Performance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-3
System Classification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-4
FCC Compliance (USA only). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-4
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 &
TRx4851A Transceiver. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-9
WMTS Channel Frequencies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-10
Physical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-11
ECG-only Transceiver . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-11
ECG/SpO2 Transceiver . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-12
Environmental Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-13
TRx4841A & TRx4851A Transceiver . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-13
Measurement Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-14
ECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-14
SpO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-16
SpO2 Sensor Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-18
A. Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1
Accessory Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2
Transceiver Accessories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2
Pouches . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2
Protective Covers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3
ECG Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3
Electrodes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3
Leadsets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3
Alignment Guides . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-4
Skin Prep Paper. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-5
SpO2 Accessories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-5
Reusable Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-5
Disposable Sensors - Single Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-7
Contents-5
Adapter Cables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-7
Monitor Interface Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-8
Wristband . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-8
B. Sales and Support Offices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1
Contents-6
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
Introducing IntelliVue Telemetry
1-1
Introduction
Introducing IntelliVue Telemetry
The IntelliVue Transceiver
The IntelliVue Transceiver
The IntelliVue Transceiver is a patient-worn device for monitoring ECG and
SpO2 on adult and pediatric patients within the IntelliVue Telemetry System.
The transceiver combines traditional transmitter features with communication to
and from the IntelliVue Information Center.
Transceiver
Features
•
•
•
•
•
•
•
•
•
•
•
•
Transceiver
Models
The transceiver is available in two models for each radio frequency spectrum in
which they operate (TRx4841A - 1.4 GHz; TRx4851A - 2.4 GHz):
•
•
1-2
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.
SpO2 Spot Check measurement without using any controls.
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.
TRx - ECG Only
TRx+ - ECG and SpO2
Introducing IntelliVue Telemetry
The IntelliVue Transceiver
front
M2601B
IntelliVue
TRx+
M4841A
back
EASI, 33 5
EASI,
5,6
EASI
EASI
1 23
44
56
56
FCCID: XXXXXXXX
IntelliVue TRx Transceiver - ECG Only
front
IntelliVue TRx+
M4841A
EASI, 3
back
EASI
5,6
EASI
344
55
66
FCCID: XXXXXXXX
IntelliVue TRx+ Transceiver - ECG/SpO2
Introducing IntelliVue Telemetry
1-3
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:
•
•
•
•
•
•
•
•
•
1-4
Change SpO2 measurement mode, or turn SpO2 measurement off.
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 SpO2 technical alarms (INOPS) during NBP measurement.
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.
Introducing IntelliVue Telemetry
IntelliVue Telemetry System
Bi-directional Signal Flow in the IntelliVue Telemetry System
Smarthopping
Technology
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
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.
Normal Operation
1-6
Introducing IntelliVue Telemetry
IntelliVue Telemetry System
Excessive Interference
’Hop’ to New Frequency/Time Slot
Introducing IntelliVue Telemetry
1-7
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
•
IntelliVue Clinical Network infrastructure.
•
TRx4841A/TRx4851A Transceivers, bi-directional patient-worn devices.
•
ITS4842A/ITS4852A Access Points (AP), placed within the areas with
defined coverage. APs are centers for bidirectional communication
Introducing IntelliVue Telemetry
Transceiver Use with Other Equipment
between the transceivers and the Information Center.
•
M3150B IntelliVue Information Center for centralized monitoring.
•
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 IntelliVue Patient Monitor (optional) for bedside display
of patient data being sourced from the transceiver.
Transceiver Use with Other Equipment
IntelliVue
Information
Center
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 (Release B.10 or higher) for bedside
ECG viewing of a single patient. Telemetry Overview provides the telemetrymonitored waveforms, numerics, and alarms in an integrated form both on the
bedside monitor and at the IntelliVue Information Center. See “Chapter 10.
Pairing with IntelliVue Patient Monitors” for operating and configuration
information.
The transceiver can employ the full functionality of the M2636C TeleMon
Companion Monitor, including NBP measurement and local display of alarms.
Connection is made through an interface cable at the TeleMon/Service port on
the transceiver. Please refer to “Transceiver Operation when Connected to
TeleMon” on page 9-16 for an operational summary, and the M2636C TeleMon
Instructions for Use for general operating instructions.
Introducing IntelliVue Telemetry
1-9
Transceiver Use with Other Equipment
Patient
Bedside
Monitors
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 a bi-directional radio interface.
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 the M8105 MP5
Patient Monitor. The connection is made through a monitor interface cable
inserted in the Telemon/Service Port and connected to the MP5. Please refer to
the MP5 Instructions for Use for additional information.
M2601B
Transmitters
If your hospital uses TRx and/or TRx+ Transceivers and M2601B Transmitters,
you can distinguish between them by:
•
•
1-10
Name on the front of the device (TRx or M2601B)
Label color (light gray for transceivers, dark gray for transmitters)
Introducing IntelliVue Telemetry
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
SpO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11
Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-14
Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-16
Product Safety
2-1
Introduction
Product Safety
General Safety
General Safety
Warning
The IntelliVue Telemetry System should not be used for primary
monitoring in applications where the momentary loss of the ECG is
unacceptable.
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
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
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.
Warning
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
General Safety
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
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.
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 on
patients.
Warning
Do not use the transceiver for patient monitoring if it fails the Power On
Self Test.
Warning
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
General Safety
Warning
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.
Warning
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
Warning
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.
Warning
To avoid the risk of strangulation, do not tie a pouch solely around the
patient’s neck.
Warning
Patients should be instructed not to open the battery compartment while
the transceiver is in use.
Warning
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
Battery
Battery
Warning
The battery door must be closed during defibrillation.
Warning
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.
Warning
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.
Warning
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
ECG
Warning
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.
ECG
Warning
Always confirm Information Center observations with clinical observation
of the patient before administering interventions.
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.
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.
2-6
Product Safety
ECG
Warning
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.
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
Warning
When switching between EASI and standard monitoring, there is a loss of
data for 30 seconds.
Product Safety
2-7
ST/AR Arrhythmia
For Paced
Patients
Warning
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
Warning
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
ST/AR Arrhythmia
Warning
Learning
If you initiate learning during ventricular rhythm, the ectopics can be
incorrectly learned as the normal QRS complex. This can result in missed
detection of subsequent events of V-Tach and V-Fib.
Warning
Relearning
Arrhythmia relearning is initiated whenever the transceiver is powered
down for one minute or longer or whenever it is directly connected/
disconnected to an IntelliVue MP5 Patient Monitor. Be sure to check your
patient’s arrhythmia annotation for accuracy whenever relearn has
occurred.
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.
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.
Product Safety
2-9
ST/AR Arrhythmia
For Paced
Patients
Warning
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.
Warning
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.
Warning
For 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. 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.
Warning
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 algorithm’s failure to detect
pacemaker non-capture or asystole.
2-10
Product Safety
ST/AR ST Segment
Warning
It is possible that pacemaker pulses will not be detected when the ECG
analog output of a defibrillator is plugged into a bedside monitor. This can
result in the arrhythmia algorithm’s failure to detect pacemaker noncapture or asystole.
ST/AR ST Segment
Warning
This device provides ST level change information; the clinical significance
of the ST level change information should be determined by a physician.
SpO2
Warning
Always confirm Information Center observations with clinical observation
of the patient before administering interventions.
Warning
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.
Product Safety
2-11
SpO2
Warning
Do not use disposable sensors on patients who exhibit allergic reactions to
the adhesive.
Warning
Prolonged, continuous SpO2 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.
Warning
Injected dyes such as methylene blue or intravascular dyshemoglobins such
as methemoglobin and carboxyhemoglobin can lead to inaccurate (overestimated) measurements.
Warning
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.
2-12
Product Safety
SpO2
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
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.
Warning
When the specified Nellcor® sensors are used, the application must be
consistent with the sensor manufacturer's own guidelines.
Warning
If you measure SpO2 on a limb that has an inflated NBP cuff, a nonpulsatile SpO2 technical alarm can occur. If the monitor is configured to
suppress this alarm, there can be a delay of up to 60 seconds in indicating
critical patient status, such as sudden pulse loss or hypoxia.
Product Safety
2-13
Cleaning
Warning
Removal of the SpO2 sensor during Continuous SpO2 monitoring results in
a "No Sensor" technical alarm. Silencing this technical alarm turns the
SpO2 measurement off. There is no technical alarm for a “No Sensor”
condition in Spot Check mode.
Warning
This equipment is not suitable for use in the presence of a flammable
anesthetic mixture or oxygen concentrations greater than 25% (or partial
pressures greater than 27,5 kPa /206.27 mmHg).
Cleaning
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 11-9.
2-14
Product Safety
Cleaning
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 environmental regulations. (If the mixture is
captured, it can be separated commercially and the component gases reused.)
* See “References” on page 11-9.
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 11-9
Product Safety
2-15
Accessories
Accessories
Warning
Use only Philips-approved accessories. Use of product accessories (ECG
leadsets, SpO2 sensors, etc.) other than those specified in this manual may:
- lead to patient injury
- result in increased electromagnetic emissions or decreased immunity of
the product
Warning
Reuse: Never reuse disposable sensors, accessories and so forth that are
intended for single use, or single patient use only.
Packaging: Do not use a sterilized accessory if the packaging is damaged.
Warning
Alignment guides may present a choking hazard. Handle with appropriate
care.
Warning
The SpO2 and Telemon/Service Port protective covers may present a
choking hazard. Handle with appropriate care.
2-16
Product Safety
This chapter describes the clinical controls of the transceiver. These controls
include buttons, visual and auditory indicators, ports, and safety labelling
located on the front and back of the device. The chapter includes the following
sections:
•
•
•
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
•Adjustable Sounds . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-12
•Service Sounds . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-13
Note—For the purpose of the following diagrams, the transceiver model shown
is the TRx4841A with SpO2.
Transceiver Controls
3-1
Introduction
Transceiver Controls
Transceiver Controls - Front
Transceiver Controls - Front
P1
L1
P2
TRx4851A
I1
I2
B1
I3
I4
B2
L2
L3
P3
O1
The labeled items in the diagram include:
•
•
•
•
•
Buttons (B1-B2)
Power On/Off (O1)
Indicators (I1-I4)
Labels (L1-L3)
Ports (P1-P3)
IntelliVue TRx+ Transceiver - Front View
3-2
Transceiver Controls
Transceiver Controls - Front
Buttons
IntelliVue TRx+
M4841A
EASI, 3 5,6
Callout
B1
B2
Button
Definition
B1
Telemetry Button
• Depending on configuration, directs the
Information Center to generate a Nurse Call
alarm, remote recording, both Nurse Call
alarm and recording, or none. See
“Telemetry Functions at the Information
Center” on page 9-2.
Note—Delayed recordings generated by the
Telemetry button are stored in Alarm
Review at the Information Center.
• When pressed simultaneously with the
Check button, turns Alarm Suspend/Pause
on/off (not when connected to TeleMon or
IntelliVue MP5 Patient Monitor). See
“Suspending/Pausing Alarms” on page 5-2.
B2
Check Button
• Initiates a Status Check of the transceiver.
See “Status Check” on page 4-12.
• Resumes monitoring after Standby. See
“Standby Mode” on page 4-4
• Indicates association with the Information
Center (single beep). See “Audible Tones”
on page 3-10.
• When pressed simultaneously with the
Telemetry button, turns Alarm Suspend/
Pause on/off (if configured and not when
connected to TeleMon or IntelliVue MP5
Patient Monitor). See “Suspending/Pausing
Alarms” on page 5-2.
• Silences the Find Device tone. See
“Locating the Transceiver (Find Device)”
on page 9-3.
Transceiver Controls
3-3
Transceiver Controls - Front
Power On/
Off
IntelliVue TRx+
M4841A
EASI, 3 5,6
Callout
Battery Door
to Access
O1
Power On/Off
O1
Definition
Power On/Off
Insertion of batteries turns transceiver power on;
removal of batteries turns power off. See “Turning
the Transceiver On/Off” on page 4-2.
Indicators
I1
I2
I3
I4
3-4
IntelliVue TRx+
M4841A
EASI, 3 5,6
Callout
I1
Transceiver Controls
Indicator
Definition
Lead Indicator
• Illuminates momentarily during
leadset insertion to indicate attached
leads.
• Illuminates when Check button is
pressed to indicate attached leads.
• During a Leads Off condition,
illuminates to indicate the lead(s) that
need to be reapplied. Green indicator
only on indicates all leads are off.
• Momentarily illuminates three
alternate lights, indicating the
transceiver has no Equipment Label
assigned. Accompanied by “Unlabeled
Device” tone. See “Label Assignment
for Replacement Transceiver” on page
11-2.
Transceiver Controls - Front
Callout
Indicator
I2
EASI
Definition
EASI Indicator
• Illuminates momentarily upon
insertion of leadset in EASI position.
• Illuminates when Check button is
pressed if EASI is in use.
I3
Alarms Suspend/Pause Indicator
Illuminates during alarm pause period
initiated at transceiver, Information Center,
or TeleMon.
I4
Battery Gauge
Illuminates when the Check button is
pressed, indicating the amount of power
remaining in the batteries.
Note—Valid only for recommended battery
type. See “Checking the Battery Power
Level” on page 4-16.
Labels
IntelliVue TRx+
M4841A
L1
EASI, 3 5,6
Callout
Label
Definition
L1
L2
L3
IntelliVue TRx
TRx4841A
EASI, 3 5,6
Leadset Insertion Guide
Assists in aligning the ECG cable for
different leadsets. See “Connecting the ECG
Cable” on page 6-22.
Note—If your unit uses only one monitoring
configuration, the transceiver may have
special alignment guides that allow only one
leadset insertion position.
Warning—Alignment guides may present a
choking hazard. Handle with appropriate
care.
Transceiver Controls
3-5
Transceiver Controls - Front
Callout
Label
Definition
L2
Device Identification Label
Identifies the device to the IntelliVue
Clinical Network.
L3
Unit Identification Label
Uses one of seven color-coded labels for
visual identification of a clinical unit.
Ports
P2
P1
IntelliVue TRx+
M4841A
P3
EASI, 3 5,6
Callout
Definition
P1
ECG Leadset Port
Connection for 3-, 5-, or 6-wire leadset.
P2
SpO2 Sensor Port (IntelliVue TRx+ only)
Connection for SpO2 sensor. See Note.
P3
TeleMon/Service Port
Connection for cable to the TeleMon Companion Monitor, MP5
IntelliVue Patient Monitor, or to the Service Tool. See Note.
Note—The SpO2 and TeleMon/Service Ports can be covered with protective
covers when not in use. These are listed in “Appendix A. Accessories”.
Warning—The SpO2 and Telemon/Service Port protective covers may present
a choking hazard. Handle with appropriate care.
3-6
Transceiver Controls
Transceiver Controls - Back
Transceiver Controls - Back
S8-S13 not shown
(inside battery compartment)
EASI
EASI
L1
L2
S1
S6
S2
S4
S3
S5
S7
The labeled items in the diagram include:
• Labels (L1-L2)
• Safety symbols and other marks (S1-S13)
IntelliVue TRx+ Transceiver - Back View
Transceiver Controls
3-7
Transceiver Controls - Back
Labels
L1
Callout
EASI
EASI
L2
Definition
12 6
345
Safety
Symbols &
Other Marks
L1
Electrode Placement Diagram for EASI
See “5-Wire Placement (EASI Mode)” on page 6-16.
L2
Electrode Placement Diagram for Standard ECG
See “5-Wire Placement (Standard Mode)” on page 6-14.
Callout
S1
EASI
EASI
Label
Definition
FCC ID: PQCXXXXX
IC: 3549B-XXXX
Federal Communications Commission
(FCC) ID
Canadian ID
S1-13
12 6
345
S2
Non-Ionizing Radiation
Interference to electronic equipment may
occur in the vicinity of devices marked with
this symbol.
S3
Disposal
Dispose of in accordance with the local
country’s requirements.
S4
Follow operating instructions.
3-8
Transceiver Controls
Transceiver Controls - Back
Callout
S5
Label
Definition
Rx
Prescription Device
S6
Canadian and American standards
compliance
Complies with applicable Canadian and
American standards.
S7
Defibrillation Proof
Patient connections are protected against
defibrillation (DEFIBRILLATIONPROOF) and are a TYPE CF APPLIED
PART.
Labels on Inside of Battery Compartment
S8
REF
Catalog Number
Use to identify the equipment during a call
to the Philips Response Center.
SN
Serial Number
Use to identify the equipment during a call
to the Philips Response Center.
S9
S10
MAC Address of device
MAC
Transceiver Controls
3-9
Audible Tones
Callout
Label
Definition
S11
Date of manufacture
S12
Battery Polarity
S13
Attention! See Instructions for Use.
Audible Tones
The transceiver produces six different auditory information signals to inform
you of measurement and transceiver conditions during normal use. Most are
generated automatically.
3-10
Transceiver Controls
Audible Tones
Clinical Use
Auditory
Information
Signal
Sound
How Used
Sound 1
beep
•
Indicates successful Self-Test at power
on.
• Indicates successful SpO2 Spot Check
measurement when measurement is
initiated at the transceiver.
• If the Check button is pressed, confirms
that the transceiver is in contact with the
Information Center (e.g., when transceiver
is brought back into range).
Indicates pulse detected during Spot Check
SpO2 measurement.
Note—The pulse tone can be muted from the
Information Center. See “Patient Configurable
Settings in Telemetry Setup” on page 9-4.
Sound 2
low-pitch
tone
Sound 3
alternating
Continuous tone to help you locate a missing
transceiver. Initiated by clicking Find Device in
pitch
repeated tone the Telemetry Setup window. Tone continues
until Check button is pressed and held for 6
seconds, batteries are removed, or batteries
completely discharge.
Sound 4
beep beep
•
•
•
Indicates failed Self-Test at power on.
Indicates failed SpO2 Spot Check
measurement when measurement is
initiated at the transceiver.
If it sounds when the Check button is
pressed, it indicates that the transceiver is
not in contact with the Information
Center.
Transceiver Controls
3-11
Audible Tones
Auditory
Information
Signal
Adjustable
Sounds
How Used
Sound 5
beep beep
every 5
seconds
Indicates transceiver is out of range or not
associated with a sector. Sound stops when
contact is re-established with the Information
Center, or it can be silenced by pressing the
Check button for six seconds.
Sound 6
beep beep
every 2
seconds
Indicates that the leadset is not inserted
correctly.
Some transceiver sounds can be set to 5 different volume levels (see “Patient
Configurable Settings in Telemetry Setup” on page 9-4). The adjustable sounds
include SpO2 Spot Check measurement complete/fail, Check/Standby functions,
and pulse detection tone. The Spot Check and pulse detection tones can be
turned off (muted) on a per patient basis in the Telemetry Setup window.
Auditory
Signal
(sound)
3-12
Sound
Function
How Used
Sound 1
(beep)
Spot Check
Announces a successful SpO2 Spot Check
measurement.
Sound 1
(beep)
No Mute
Check
Button
Confirms contact with the Information Center.
Sound 2
(low pitch
tone)
Pulse
Detection
Tone
Indicates pulse during SpO2 Spot Check
measurement.
Transceiver Controls
Audible Tones
Service
Sounds
Two additional sounds that you may hear occur during the labelling of
transceiver devices within the IntelliVue Clinical Network. The volume of these
sounds is not adjustable, and cannot be turned off. See “Label Assignment for
Replacement Transceiver” on page 11-2.
Service Sound
Description
beep beep repeated every
3 seconds, and all visual
indicators flashing
Unlabeled Device.
Equipment Label needs to be assigned at
Information Center. No monitoring.
Fast beep beep and
alternate Leads Off
indicators flashing
Unacknowledged Labeled Device.
Equipment label has been assigned at
Information Center; press the Check button to
complete label assignment. No monitoring.
Transceiver Controls
3-13
Audible Tones
3-14
Transceiver Controls
This chapter describes the basic operation of the transceiver. It includes the
following sections:
•
•
•
•
•
Transceiver Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
Turning the Transceiver On/Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
Briefing the Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6
Testing Transceiver Functionality . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10
Battery Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12
Basic Operation
4-1
Introduction
Basic Operation
Transceiver Safety Information
Transceiver Safety Information
Warning
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.
Warning
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.
Turning the Transceiver On/Off
Warning
Arrhythmia relearning is initiated whenever the transceiver is powered
down for one minute or longer. Be sure to check your patient’s arrhythmia
annotation for accuracy whenever relearn has occurred.
Turning On
The transceiver is powered by two AA alkaline batteries. To turn the transceiver
on, insert both batteries. When batteries are inserted:
1. All indicators illuminate briefly.
2. A sequence of sounds indicates the instrument is ready for use.
a. a single beep, indicating that the self test was passed.
b. a series of double beeps, indicating the transceiver is attempting to
establish contact with the Information Center.
4-2
Basic Operation
Turning the Transceiver On/Off
c. cessation of sounds, indicating a successful association with the
Information Center.
Sounds at Successful Start-up
Transceiver
performs
self-test
Insert batteries
One beep
Test passed
Transceiver
searches for
Information
Center
Transceiver
connected
with
Information
Center
Two beeps
every 5 seconds
Beeping stops
d. If you hear any other sound sequence, either the device has failed the
automatic Self-Test (in which case you should use a replacement
device), or the device cannot establish contact with the Information
Center (check that a sector has been assigned to the device, and that
the device is within the coverage area).
Turning the
Transceiver
Off
Turn off the transceiver by removing the batteries. A "No Signal" technical
alarm will be in effect at the Information Center until the device is reactivated or
until Standby is initiated.
The configuration data set by the service provider prior to transceiver use is
retained after battery removal.
RF Auto
Shutoff
When RF Auto Shutoff is enabled (default), the transceiver stops broadcasting a
radio signal in order to prevent interference with other transceivers in use. This
condition occurs if there is no ECG signal for 10 minutes and the SpO2 sensor
cable is not inserted in the SpO2 sensor port. The technical alarm, "No Signal",
followed by the "Transmitter Off" INOP will be displayed at the Information
Center. Remove the batteries to conserve battery charge. However, if there is no
ECG signal for 10 minutes but the SpO2 cable is inserted, the transceiver does
not stop broadcasting the signal.
Basic Operation
4-3
Turning the Transceiver On/Off
To restart monitoring, insert batteries (if needed), attach leads to the patient,
insert the SpO2 sensor cable in the SpO2 sensor port and press the Check button
to verify association with the Information Center.
This feature must be enabled by your service provider.
Standby
Mode
Standby mode is used to temporarily suspend monitoring at the Information
Center, for example, when a patient goes out of access point range or is
discharged.
Standby does not power down the transceiver, so if the standby period is
prolonged, you should remove the batteries.
Initiating
Standby
Step
Action
Do not remove the leads until after the patient is in Standby. This
will avoid an "ECG Leads Off" technical alarm, as well as
reminders, if configured.
In the Patient Window, select the Standby button.
Select the duration of the standby period (depending on your
system’s configuration: Infinite, 4 Hours, 3 Hours, 2 Hours, 1 Hour,
30 Minutes, 20 Minutes, or 10 Minutes).
Note—If the patient will be discharged, select “Infinite” as the
standby duration.
4-4
Basic Operation
Turning the Transceiver On/Off
Step
Action
Select the appropriate location, then select Suspend Monitoring.
The message “Telemetry Standby” and location, if selected, are
displayed in the sector.
Note—If the transceiver is paired with an IntelliVue Patient
Monitor, monitoring will be suspended at both the transceiver and
the IntelliVue Patient Monitor as well as at the Information Center.
The messages "Monitor Standby" and "Telemetry Standby" will be
displayed in the patient sector. If paired directly with an IntelliVue
MP5 Patient Monitor, the message "Monitor Standby" only will be
displayed.
Resuming
Monitoring
Step
Action
If the standby period has not expired:
• Press the Check button to re-establish contact with the
Information Center. The single beep at the transceiver
verifies that monitoring has resumed.
• If you hear a double beep, click Resume Monitoring at the
Information Center. If there’s still no association, contact the
service provider.
If the standby period has expired:
• Monitoring resumes automatically if the patient is in the
coverage area. Press the Check button to verify the
resumption of monitoring. You should hear a single beep.
If a new patient is connected:
• Press the Check button, or select the Resume Monitoring in
the appropriate patient sector.
Important—When an EASI patient comes out of Standby, the lead
settings are reset to the default EASI leads.
Basic Operation
4-5
Briefing the Patient
Briefing the Patient
Warning
Patients should be instructed not to open the battery compartment while
the transceiver 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.
If desired, you can turn off patient use of the button at the Information Center.
See “Patient Configurable Settings in Telemetry Setup” on page 9-4.
4-6
Basic Operation
Briefing the Patient
Pouch Use
The transceiver is not intended for direct contact with the patient’s skin. During
normal use, the transceiver should be worn over clothing, in a pocket or,
preferably, in a pouch. The carrying pouch with clear front is an appropriate
means for holding the transceiver. See Appendix A, “Accessories” for ordering
information.
Securing
the Pouch
Step
Action
Insert the transceiver into the pouch with lead wires and SpO2
sensor cable, if used, exiting from the top opening of the pouch.
Pinch the velcro enclosures together to close the pouch around the
cables.
Important—Do not coil the cables inside the pouch. They are part of
the wireless system, and need to be freely exposed.
Basic Operation
4-7
Briefing the Patient
Step
Action
Turn the pouch so that the opening is facing downward. This
protects the transceiver from fluid and debris. Secure the pouch on
the patient with the upper ties around the patient’s head and arm and
the lower ties around the patient’s torso.
Warning
To avoid the risk of strangulation, do not tie a pouch solely
around the patient’s neck.
Place Tie
arm.
a under the
b Place Tie b around the
neck. Tie a and b
together around the neck.
Tie c and d together around
the torso.
4-8
Basic Operation
Briefing the Patient
Step
Action
Check that the patient is comfortable wearing the pouch with
transceiver.
Basic Operation
4-9
Briefing the Patient
Showering
Warning
When the patient is showering, signal quality and leads off detection may be
compromised due to significant movement. Appropriate clinical
precautions must be taken.
The transceiver can be used to monitor a patient in the shower, but only when
placed inside a Philips carrying pouch and secured on the patient as described
above. The combination of the transceiver and pouch will withstand showering
for up to 10 minutes.
Drying the
Transceiver
after
Showering
After showering, perform the following steps to continue monitoring:
1.
2.
3.
4.
5.
Pat dry the leadset connections at the electrodes.
Wipe the lead wires with care.
If wet, dry the outside of the transceiver with a non-lint producing cloth.
If wet, wipe dry the inside of the battery compartment. Dry the batteries.
If wet, disconnect the ECG leadset and shake out any water. Dry the
connector pin area with a cotton swab.
Note—The transceiver should not be used for monitoring if the battery
compartment is wet. Remove the batteries and wipe the compartment dry before
continued monitoring use.
Accidental
Wetting
4-10
If the transceiver is accidentally immersed in liquid for up to 5 minutes, no
damage to the device and no electrical safety issues for the patient will result.
Remove the device, dry it off, and follow the procedure for cleaning/sterilization
under “Cleaning and Sterilization” on page 11-4 as needed.
Basic Operation
Testing Transceiver Functionality
Testing Transceiver Functionality
There are two tests of IntelliVue Transceiver functionality:
•
•
Self Test - performed automatically each time the transceiver is turned on.
Status Check - initiated manually by the clinician.
Self Test
Warning
Do not use the transceiver for patient monitoring if it fails the Power On
Self Test.
Caution
Do not insert a leadset during a self-test. The leadset can be inserted before or
after the self-test.
A self test of the transceiver functions is automatically performed each time that
the transceiver is turned on (that is, when batteries are inserted). This test should
be performed before ECG leads and/or an SpO2 sensor is attached.
Self Test
Status
In Case of
Failure
Auditory
Signal
Visual Indicators
Passed
beep
All indicators illuminate for 3 seconds.
Failed
beep beep
One or more indicators do not light up.
If any portion of the self test fails, the transceiver will attempt to report the
failure to the monitoring system. In case of failure, use another transceiver, and
contact your service provider.
Basic Operation
4-11
Testing Transceiver Functionality
Status
Check
You can check the status of the transceiver indicators at any time.
Initiating a
Status Check
Step
Action
Press the Check button.
The following indicators should illuminate for as long as the Check
button is depressed.
• Battery gauge
• Type of leadset
• EASI (if in use)
4-12
Basic Operation
If one or more of the expected indicators do not light up, check the
following:
• Power and position of batteries (see “Checking the Battery
Power Level” on page 4-15).
• Leadset insertion. Make sure the leadset is correctly inserted
in the transceiver and the colored line at the base of the cable
is not visible (see “Connecting the ECG Cable” on page 622).
• Lead positions and connections (see “Verifying Electrode
Connections” on page 6-25).
If there is still a problem, contact your service provider for
assistance.
Battery Information
Battery Information
Battery
Safety
Information
Warning
The battery door must be closed during defibrillation.
Warning
Use Duracell Alkalaine 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.
Warning
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.
Warning
If you receive a BATTERY LOW alarm, the batteries must be promptly
replaced. A “Battery Low” condition that is not corrected will result in a
transceiver shutdown and cessation of monitoring.
Basic Operation
4-13
Battery Information
Warning
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.
Inserting/
Removing
Batteries
Warning
Arrhythmia relearning is initiated whenever the transceiver is powered
down for one minute or longer. Be sure to check your patient’s arrhythmia
annotation for accuracy whenever relearn has occurred.
Caution
Remove the batteries before storing a transceiver for an extended period of time.
The battery compartment is located at the bottom of the transceiver behind a
swinging door. It accommodates a pair of AA 1.5V Alkaline batteries. Only this
type of disposable battery should be used.
Important—Do not use rechargeable batteries. Use of this type of battery will
adversely affect:
•
•
•
4-14
Basic Operation
Battery gauge performance
Battery low warnings
Battery life performance
Battery Information
Inserting the
Batteries
Insert batteries into the transceiver using the following procedure.
Step
Action
Open the battery compartment by swinging the compartment door
90o counterclockwise into an open hinged position.
Insert two AA 1.5V Alkaline batteries, matching the polarity with
the +/- indications inside the compartment.
Note— Both batteries are inserted with the + polarity in the same
direction.
Close the battery compartment door.
Listen for the start-up sounds. (See “Turning On” on page 4-2).
Watch for the indicators on the front of the transceiver to illuminate
briefly.
Connect the patient cables to the transceiver.
Basic Operation
4-15
Battery Information
Removing the
Batteries
To remove the batteries, open the battery compartment door and push from the
opening at the back of the compartment to pop the batteries out. Transceiver
settings (ECG leadset type, SpO2 mode, volume, etc.) are retained indefinitely
when the batteries are removed.
If you remove good batteries to turn off the transceiver, keep them together as a
set for later re-use so that both batteries will have the same level of power
remaining.
Batteries should be removed when the transceiver is not in use or is being stored.
Important—DO NOT “STORE” BATTERIES BY LEAVING THEM IN THE
INCORRECT POLARITY POSITION IN THE TRANSCEIVER.
Be careful not to short circuit the batteries. Batteries can get hot when shorted.
Short circuits are caused when a piece of metal touches both the positive and
negative terminals simultaneously. 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.
Disposal of
Batteries
Checking
the Battery
Power Level
When disposing of batteries, follow local laws for proper disposal. Dispose of
batteries in approved containers. If local regulations require you to recycle
batteries, recycle batteries in accordance with those regulations.
When the Check button is pressed, the battery gauge on the transceiver indicates
the battery power level. It is reliable only when specified batteries (i.e., AA 1.5V
Alkaline) are used. The battery gauge is also displayed in the Patient Sector at
the Information Center (if configured) to enable you to closely monitor battery
status, for example, after a change of shift.
To check the power level:
Step
4-16
Basic Operation
Action
Press the Check button to determine the level (see Battery Levels
following).
Battery Information
Step
Action
If no indicators flash:
1. Check that the batteries are inserted properly.
2. Replace both batteries.
3. If there are still no indicators on the battery gauge, contact
your service provider.
If the indicators illuminate but do not behave as described above,
the transceiver has malfunctioned. Contact your service provider.
Battery Levels
Battery Gauge
Approximate
Battery Life*
Remaining
Approximate
Operating
Time*
Remaining
Functionality
4 green indicators
> 75%
> 34.7 hours
Normal operation
3 green indicators
> 50%
> 23.1 hours
Normal operation
2 green indicators
> 25%
> 11.6 hours
Normal operation
1 green indicator
25% to Battery
Low level
> 15 minutes
Normal operation
1 red indicator
Battery Low
level to
Replace
Battery level
< 15 minutes
Normal operation
(see note)
no indicator
Replace
Battery level
(Check
batteries for
correct
polarity)
none
Transceiver
shutdown/RF
shutoff
Basic Operation
4-17
Battery Information
Battery Gauge
Approximate
Battery Life*
Remaining
Approximate
Operating
Time*
Remaining
Functionality
* Battery life times are based on use of Duracell MN 1500 batteries in a TRx
transceiver. Times for TRx+ are somewhat lower. Life times when other
battery brands are used may be different.
Note—For the TRx+ transceiver, SpO2 functionality is disabled when the red
light (Battery Low) is lit.
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.
You can optimize battery life by:
•
•
4-18
Basic Operation
Removing the batteries when the transceiver is not in use. Keep them
paired for future use.
Disconnecting the SpO2 adapter cable, if used. When the SpO2 sensor is
disconnected, the SpO2 functionality is automatically powered down, but
if an adapter cable is still connected, it will continue to drain power from
the SpO2 electronics.
This chapter lists Physiologic (Patient) Alarms and Technical (Inoperative
Condition) Alarms. It also describes how to pause/suspend alarms temporarily.
It includes the following sections:
•
•
•
•
Alarm Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
Suspending/Pausing Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
Physiologic Alarms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4
Technical Alarms (INOPs) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-9
Alarms
5-1
Introduction
Alarms
Alarm Indicators
Alarm Indicators
A description of visual and auditory information signals for patient and technical
alarms on the Information Center is located in the IntelliVue Information Center
Instructions for Use and the Information Center Online Help.The Information
Center documentation also includes the default alarm settings and physiological
alarm limit ranges. Alarm behavior specific to the use of the transceiver paired
with an IntelliVue Patient Monitor is described in “Chapter 10. Pairing with
IntelliVue Patient Monitors”.
Testing
Alarm
Indicators
The visual alarm information signal on the transceiver is the Alarms Suspend
icon. During self test, the Alarm Suspend indicator illuminates briefly, and a
single tone indicates association with the Information Center. These positive test
results indicate that the Alarm Suspend icon on the transceiver is functioning
correctly (see “Self Test” on page 4-11).
Suspending/Pausing Alarms
Warning
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 suspend duration time, or you can resume them manually at the
Information Center.) The transceiver should be replaced, and the
malfunctioning unit should be sent to your service provider.
All alarms for a patient can be suspended/paused from the Information Center,
from the TeleMon Companion Monitor, or, depending on transceiver
configuration, from the transceiver itself. The Alarm Suspend/Pause duration is
configurable with a default of two minutes. Alarms automatically resume after
the configured suspend duration time, or can be reactivated manually earlier.
5-2
Alarms
Suspending/Pausing Alarms
If the transceiver is connected to TeleMon or the MP5 IntelliVue Patient
Monitor, alarms can be suspended only from TeleMon, and not from the
Information Center. The Alarms Suspend icon on the transceiver is lit (see
“Transceiver Controls - Front” on page 3-2), and an "Alarms Suspended"
message appears at TeleMon and the Information Center. Patient monitoring
(display of patient waveforms and numerics) continues for the duration of Alarm
Suspend/Pause.
Step
Action
Press the Telemetry and Check buttons simultaneously to activate
Alarm Suspend/Pause.
While alarms are suspended:
• The transceiver illuminates the Alarms Suspend icon.
•
The message "Alarms Suspended" (or "Alarms Paused") is
displayed in the Patient Sector at the Information Center.
Note—For paired bedsides in Telemetry Overview, the
message is "Tele Alarms Suspend".
For instructions on how to suspend/pause alarms from the
Information Center, see the IntelliVue Information Center
Instructions for Use and the Information Center Online Help.
For instructions on how to suspend/pause alarms from TeleMon or
the MP5, see their respective Instructions for Use.
Unsuspending
& Resuming
Alarms
Alarms will be resumed automatically after the configured suspend duration
time. You can cancel alarm suspend manually before the configured suspend
Alarms
5-3
Physiologic Alarms
duration time has expired from the transceiver (see following directions) or from
the Information Center.
Step
Action
Press the Telemetry and Check buttons simultaneously until the
indicator turns off.
•
•
The Alarm Suspend icon is turned off.
The message "Alarms Suspended" (or "Alarms Paused") is
removed from the Information Center display.
Alternately, you can unsuspend alarms at the Information Center.
See IntelliVue Information Center Instructions for Use or Online
Help for directions.
For instructions on how to resume alarms from TeleMon, see the
TeleMon Instructions for Use.
Physiologic Alarms
Physiologic alarms indicate a life-threatening situation or a less urgent situation
such as heart rate beyond limits. There are no physiologic alarm signals
generated by the transceiver.
All physiologic alarms are generated at the IntelliVue Information Center,
and all alarm signals must be acknowledged at the Information Center.
Arrhythmia alarm chaining and other aspects of alarm behavior, such as alarm
levels, setting alarm limits, customizing arrhythmia alarm settings on a per
patient basis, switching individual measurement alarms on/off, and reviewing
alarm messages, are described in IntelliVue Information Center Instructions for
Use.
There are two levels of arrhythmia analysis available at the Information Center:
Basic and Enhanced. Enhanced analysis includes Basic alarms.
5-4
Alarms
Physiologic Alarms
NBP alarms are listed in the TeleMon Instructions for Use and the Information
Center Online Help.
In the following table, Red (***) alarms are listed alphabetically, followed by
the Yellow (**) alarms, and the Yellow (*) arrhythmia alarms.
Physiologic (Patient) Alarms
Alarm Text
Priority
Condition
Source
***ASYSTOLE
Red
Asystole.
No QRS for 4 consecutive seconds
ST/AR
Basic &
Enhanced
Arrhythmia
*** BRADY yyy < xxx
Red
Extreme Bradycardia.
Heart Rate (yyy) less than Extreme Brady
limit (xxx)
ST/AR
Enhanced
Arrhythmia
*** DESAT
Red
Very Low SpO2 Saturation.
SpO2 value below Desaturation limit
SpO2
Note—Desat limit is set 10 points below
low limit.
*** TACHY yyy > xxx
Red
Extreme Tachycardia.
Heart Rate (yyy) greater than Extreme
Tachy limit
ST/AR
Basic &
Enhanced
Arrhythmia
*** V-FIB/TACH
Red
Ventricular Fibrillation.
Fibrillatory wave (sinusoidal wave
between 2-10 Hz) for 4 consecutive
seconds
ST/AR
Basic &
Enhanced
Arrhythmia
*** V-TACH
Red
Ventricular Tachycardia.
Consecutive PVCs greater than or equal to
V-Tach Run limit and Heart Rate greater
than V-Tach limit (xxx)
ST/AR
Basic &
Enhanced
Arrhythmia
Alarms
5-5
Physiologic Alarms
Physiologic (Patient) Alarms
Alarm Text
Priority
Condition
Source
** MULTI ST Lx, Ly
Yellow
Two ST leads (Lx and Ly) exceed alarm
limit elevation or depression for > 60
seconds (EASI mode or when selected).
ST/AR ST
** NURSE CALL
Yellow
The Telemetry button on the transceiver
has been pressed (and the system is
configured to alarm and the Telemetry
button is on.
Also initiated if the installation includes a
paging system and the Information Center
is configured for paging upon receipt of
Nurse Call signal.
Note—For IntelliVue Information Centers
Release J and later, Nurse Call is a
yellow, one star (*) alarm.
Clinicianinitiated at
transceiver
or by
paging
subsystem
** SpO2T yyy > xxx
Yellow
High SpO2.
SpO2 value (yyy) greater than high SpO2
limit (xxx).
SpO2
** SpO2T yyy < xxxx
Yellow
Low SpO2.
SpO2 value (yyy) less than low SpO2 limit
(xxx).
SpO2
** ST lead > xxx
Yellow
STlead is greater than the Elevation limit.
ST/AR
** ST lead < xxx
Yellow
STlead is less than the Depression limit.
ST/AR
* HR yyy > xxx
Yellow
Heart Rate (yyy) greater than the upper
Heart rate limit (xxx).
ST/AR
Basic &
Enhanced
Arrhythmia
* HR yyy < xxx
Yellow
Heart Rate (yyy) lower than the lower
Heart Rate limit (xxx).
ST/AR
Basic &
Enhanced
Arrhythmia
5-6
Alarms
Physiologic Alarms
Physiologic (Patient) Alarms
Alarm Text
Priority
Condition
Source
* IRREGULAR HR
Yellow
Consistently irregular rhythm (irregular
R-R intervals).
ST/AR
Enhanced
Arrhythmia
* MISSED BEAT
Yellow
No beat detected for 1.75 x average R-R
interval for Heart Rate greater than 120,
or no beat for 1 second with Heart Rate
greater than 120 (non-paced patient only).
ST/AR
Enhanced
Arrhythmia
* MULTIFORM PVCs
Yellow
The occurrence of two differently shaped
Vs, each occurring at least twice within
the last 300 beats as well as each
occurring at least once within the last 60
beats.
ST/AR
Enhanced
Arrhythmia
* NON-SUSTAIN VT
Yellow
A run of Vs having a ventricular Heart
Rate greater than V-Tach limit but lasting
for less than the V-Tach Run limit.
ST/AR
Enhanced
Arrhythmia
* PACER NOT CAPT
Yellow
No QRS for 1.75 x the average R-R
interval with Pace Pulse (paced patient
only).
ST/AR
Basic &
Enhanced
Arrhythmia
* PACER NOT PACE
Yellow
No QRS and Pace Pulse for 1.75 x the
average R-R interval (paced patient only).
ST/AR
Basic &
Enhanced
Arrhythmia
* PAIR PVCs
Yellow
Two consecutive PVCs between nonPVCs.
ST/AR
Enhanced
Arrhythmia
* PAUSE
Yellow
No QRS detected for x seconds. Choices
of >1.5 to 2.5 seconds.
ST/AR
Enhanced
Arrhythmia
Alarms
5-7
Physiologic Alarms
Physiologic (Patient) Alarms
Alarm Text
Priority
Condition
Source
* PVCs >xxx/MIN
Yellow
PVCs within one minute exceed by the
PVCs/min limit (xxx).
ST/AR
Basic &
Enhanced
Arrhythmia
* R-ON-T PVCs
Yellow
For Heart Rate less than 100, a PVC with
R-R interval less than 1/3 the average
interval followed by a compensatory
pause of 1.25 x average R-R interval, or 2
such Vs without a compensatory pause
occurring within 5 minutes of each other.
(When Heart Rate is greater than 100, 1/3
R-R interval is too short for detection.)
ST/AR
Enhanced
Arrhythmia
* RUN PVCs
Yellow
Run of PVCs greater than or equal to 2.
ST/AR
Enhanced
Arrhythmia
* SVT
Yellow
Run of SVPBs greater than or equal to
SVT Run limit and with SVT Heart Rate
greater than the SVT Heart Rate limit.
ST/AR
Enhanced
Arrhythmia
* VENT BIGEMINY
Yellow
A dominant rhythm of N, V, N, V (where
N= supraventricular beat, V=ventricular
beat).
ST/AR
Enhanced
Arrhythmia
* VENT RHYTHM
Yellow
A dominant rhythm of adjacent Vs greater
than Vent Rhythm limit and ventricular
Heart Rate less than V-Tach limit.
ST/AR
Enhanced
Arrhythmia
* VENT TRIGEMINY
Yellow
A dominant rhythm of N, N, V, N, N, V
(where N=supraventricular beat,
V=ventricular beat).
ST/AR
Enhanced
Arrhythmia
5-8
Alarms
Technical Alarms (INOPs)
Technical Alarms (INOPs)
Technical Alarms, or INOPs (inoperative conditions), are sourced at the
transceiver, the ST/AR algorithm running at the Information Center, or TeleMon
Companion Monitor. They identify inoperative conditions (that is conditions
where the system is not operating properly and therefore cannot measure or
detect alarm conditions reliably). There are four levels of Technical Alarms:
•
•
•
•
Severe - Monitoring and alarms disabled. Audible tone at the Information
Center. Must be acknowledged by a clinician.
Hard - Monitoring and alarms are disabled. Audible tone at the
Information Center.
If the hard INOP is "latched", the sound will be silenced, but the message
will remain on the display until resolution of the offending condition.
Soft - Monitoring and alarms remain active. No audible tones are
generated.
Red/Yellow - Replace Battery and ECG Leads Off INOPs may be
configured to display as either Red or Yellow Technical Alarms.
In the following table, technical alarms are listed alphabetically.
Technical Alarms (Inoperative Conditions)
Alarm Text
Priority
Condition
What to do
BATTERY LOW
BATTERY LOW T
Soft
Battery power is low.
There is less than 15 minutes
of monitoring time
remaining. Replace batteries
promptly to avoid transceiver
shutdown and cessation of
monitoring.
CANNOT ANALYZE
ECG
Hard
Arrhythmia algorithm
cannot reliably analyze the
ECG data on any
monitored leads.
Assess the lead selections,
initiate relearn, and validate
analyzed rhythm. Check
other INOPs for possible
source of problem.
Alarms
5-9
Technical Alarms (INOPs)
Technical Alarms (Inoperative Conditions)
Alarm Text
Priority
Condition
What to do
CANNOT ANALYZE ST
Soft
ST algorithm cannot
reliably generate any valid
ST values on any
monitored lead.
Review the ECG signal
quality and correct if
necessary. Reposition the
ISO and J points.
ECG EQUIP MALF
Hard
Failure of the ECG
equipment or failure to
calibrate ECG.
•
•
•
ECG LEADS OFF
Note—This INOP may also
be configured to display as
a Red or Yellow Technical
Alarm.
Hard
 LEAD OFF
Hard
Remove leadset.
Remove and re-insert
batteries. Let SelfTest complete before
reinserting leadset.
Replace the
transceiver.
Contact Service.
Multiple leads are off.
Reattach ECG leads to
patient.
Single lead is off.
Reattach ECG lead to
patient.
Note—If primary lead is
MCL, lead will be
identified as V/C in INOP
text.
INVALID LEADSET
Hard
•
•
•
NO ARRHYTHMIA
5-10
Alarms
Soft
Wrong leadset.
Leadset inserted
incorrectly.
Bad lead selection
switches in the
transceiver.
All basic ST/AR ECG
alarms have been turned
off.
•
•
•
Check for appropriate
leadset.
Check for correct
insertion.
Contact Service.
Turn arrhythmia alarms on.
Technical Alarms (INOPs)
Technical Alarms (Inoperative Conditions)
Alarm Text
Priority
NO SIGNAL
Hard
Condition
•
•
•
•
Patient is out of
range, or
No batteries in
transceiver, or
Transceiver has
failed, or
Connection to
Database Server has
failed.
What to do
•
•
•
•
Make sure that the
transceiver is in range
and has good batteries.
Replace the transceiver
if Power On Self Test
fails.
Put bed in Standby.
Contact Service.
REPLACE BATTERY
REPLACE BATTERY T
Note—This INOP may also
be configured to display as
a Red or Yellow Technical
Alarm.
Hard,
Latched
Dead battery. No
monitoring is occurring.
Replace batteries.
SOME ECG ALRMS OFF
Soft
Some yellow arrhythmia
alarms have been turned off
for this patient.
For information only.
SpO2T EQUIP MALF
Hard
Malfunction in the SpO2
equipment
Call Service.
SpO2T ERRATIC
Hard
Erratic SpO2
measurements, often due to
a faulty sensor or invalid
SpO2 measurements, or
incorrect transducer
position
Repeat measurement,
reposition sensor on patient,
or finally, replace sensor.
Alarms
5-11
Technical Alarms (INOPs)
Technical Alarms (Inoperative Conditions)
Alarm Text
Priority
Condition
What to do
SpO2T EXTD UPDATE
Numeric is replaced by a
-?-.
Soft
The update period of
displayed values is
extended due to an NBP
measurement on the same
limb or an excessively
noisy signal.
If NBP is not active, check
the sensor placement.
Reposition the sensor on
patient, or replace sensor.
SpO2T INTERFERENCE
Hard
Level of ambient light or
level of electrical
interference are so high that
the SpO2 sensor cannot
measure SpO2 and pulse
rate.
Reduce ambient light to
sensor or electrical noise
sources.
SpO2T LOW PERFUSION
Soft
Accuracy may be reduced
due to low perfusion. Data
displayed with ?.
Increase perfusion. Change
sensor site. Avoid site distal
to BP cuff or intra-arterial
line. Warm the site.
SpO2T NO SENSOR
Note—Silencing this
technical alarm turns off
the SpO2 measurement.
Hard
No sensor attached to SpO2
device
Attach SpO2 sensor.
SpO2T NOISY SIGNAL
Hard
Excessive patient
movements or electrical
interference are causing
irregular pulse patterns
Reduce movement or
electrical noise sources.
SpO2T NON-PULSATILE
Note—When paired
directly with an IntelliVue
MP5 Patient Monitor, the
INOP will display as
SpO2T SENSOR OFF.
Hard
Pulse is too weak or not
detectable
Check connection to patient.
Change sensor site. Avoid
site distal to BP cuff or intraarterial line.
5-12
Alarms
Technical Alarms (INOPs)
Technical Alarms (Inoperative Conditions)
Alarm Text
Priority
Condition
What to do
SpO2T SENSOR MALF
Hard
Malfunction of the SpO2
sensor/adapter cable
Replace sensor.
TELEMETRY STANDBY
Soft
Information Center standby
mode timer is active, or
patient was not returned to
telemetry coverage area.
There is no data from bed.
Cancelled when patient is
removed from Standby.
TRANSMITTER MALF
Hard
Transceiver malfunction
Replace and notify service
provider.
TRANSMITTER OFF
Hard
RF Auto Shutoff after 10
minutes of all leads of and
no SpO2 sensor connected.
TELE WEAK SIGNAL
Soft
•
•
•
Patient is at outer
range of the radio
coverage area.
Telemetry pack is
receiving a weak
signal with high data
loss from the AP.
Condition exists for
multiple devices in a
specific area
•
•
•
•
•
•
Reattach ECG leads to
patient.
Reattach SpO2 sensor.
Press the Check
button.
Return patient to the
coverage area.
If patient is in close
proximity to AP,
replace telemetry pack.
Contact service.
The AP covering the
specific area is
suspect. Contact
service.
Alarms
5-13
Technical Alarms (INOPs)
5-14
Alarms
This chapter covers the specifics of ECG measurement. It includes the
following sections:
•
•
•
•
•
•
•
ECG Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
Measuring ECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4
Positioning ECG Electrodes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-9
Connecting the ECG Cable. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-22
Verifying Electrode Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-25
Monitoring during Leads Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-27
Optimizing ECG Measurement Performance . . . . . . . . . . . . . . . . . . . 6-29
ECG Monitoring
6-1
Introduction
ECG Monitoring
ECG Safety Information
ECG Safety Information
Warning
Always confirm Information Center observations with clinical observation
of the patient before administering interventions.
Warning
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.
Warning
When switching from EASI to standard monitoring, there is a loss of data
for 30 seconds.
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
6-2
ECG Monitoring
ECG Safety Information
For Paced
Patients
Warning
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.
Caution
During defibrillation, monitoring may be temporarily interrupted or distorted. It
may take several seconds for the ECG trace to reappear on the screen. After
defibrillation, the device will continue to monitor as before; the device settings
will not be affected.
ECG Monitoring
6-3
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.
In order to compare measured ECG signals, the electrodes (or leadsets) are
placed in standardized positions, forming so-called “leads”. To obtain ECG
signals optimized for use in diagnosis and patient management in different care
environments, different leadsets in varying lead placements are used. Both
standard lead and EASI lead placements can be used with the transceiver.
ECG
Configuration
The IntelliVue Transceiver supports 3-, 5-, and 6-wire leadsets. The 5-wire
leadset can be used for either standard or EASI electrode configurations.
The transceiver leadset configuration choices are as follows:
•
Leadset Mode = ALL (default)
This configuration allows you to switch the leadset type and position during
use. The transceiver will automatically reconfigure itself accordingly.
•
Leadset Mode = EASI ONLY
In this configuration only the use of the 5-wire leadset in the EASI position is
allowed.
•
Leadset Mode = NO EASI
In this configuration the use of 3- and 6-wire leadsets is allowed along with the
use of the 5-wire leadset in the standard position only.
•
Leadset Mode = 3 WIRE ONLY
In this configuration, only the use of the 3-wire leadset is allowed.
The transceiver detects the inserted leadset type and automatically determines
the ECG measurement and transmitted leads. The Leadset Insertion Guide on
the device will assist you in ensuring the correct measurement during
6-4
ECG Monitoring
Measuring ECG
transceiver usage. If the transceiver senses the insertion of a leadset not
matching the current configuration, the transceiver will source the ECG per the
leadset detected and issue and auditory signal to indicate the condition. An
INVALID LEADSET INOP is generated at the Information Center.
There is no cardiotach within the transceiver; cardiotach analysis resides in the
arrhythmia algorithm at the Information Center. Therefore, arrhythmia analysis
is always turned on for telemetry patients. Arrhythmia analysis is either Basic or
Enhanced, depending on the product configuration.
ECG Leads
Monitored
Depending on the leadset connected to the transceiver, a different set of
viewable leads are available at the Information Center. The transceiver can
source up to four raw ECG waves.
If you are using ...
these leads can be selected at the
Information Center
3-wire
I, II, III
Sourced (raw) waves are received as:
• Channel 1 = I, II, or III
Default is II.
5-wire (Standard mode)
I, II, III, aVR, aVL, aVF, MCL and V
Sourced (raw) waves are received as:
• Channel 1 = II
• Channel 2 = III
• Channel 3 = MCL
Defaults are II, V, III.
ECG Monitoring
6-5
Measuring ECG
If you are using ...
5-wire (EASI mode)
these leads can be selected at the
Information Center
I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5,
V6
In EASI mode, the sourced (raw) waves are
received as:
• Channel 1 = Vector 1 (A-I)
• Channel 2 = Vector 2 (A-S)
• Channel 3 = Vector 3 (E-S)
Defaults are II, V2, III, V5.
Note—Arrhythmia monitoring is performed only
on the primary and secondary leads selected at
the Information Center, although you can view
and perform ST analysis on all 12 EASI derived
leads.
6-6
ECG Monitoring
Measuring ECG
If you are using ...
6-wire
(Vb is not supported on
TeleMon and is only
supported on MP5 Patient
Monitors with 12-Lead
option)
these leads can be selected at the
Information Center
I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5,
V6, V7, V8, V9, V3R, V4R, V5R.
Sourced (raw) waves are received as:
• Channel 1 = II
• Channel 2 = III
• Channel 3 = Va
• Channel 4 = Vb
Defaults are II, Va = V2, III,Vb = V5.
The two chest leads, Va and Vb, can be placed
on the patient in any of the V lead positions (V1
through V9, V3R, V4R, V5R). Lead assignment
is available at the Information Center. When
unassigned, the chest leads use the defaults.
Note—The lead label assigned to Vb cannot be
selected for Va even though Vb does not appear
to be used.
Note—When display of the pleth wave is
enabled at the Information Center, the second
chest lead (Vb) is not available for monitoring.
ECG Monitoring
6-7
Measuring ECG
Reconstructed
Leads
Reconstruction of leads from the sourced wave is defined by the calculations in
the following table. EASI reconstructed leads are a linear combination of all
three raw EASI leads.
ECG Lead
3-Wire
6-8
ECG Monitoring
5-Wire
Standard
6-Wire
Clinical Calculations
in terms of electrodes
LA-RA
II
(default)
II
(default)
II
(default)
LL-RA
III
III
(default)
III
(default)
LL-LA
MCL
aVR
aVR
RA-(LA+LL)/2
aVL
aVL
LA-(RA+LL)/2
aVF
aVF
LL-(LA+RA)/2
(default)
V-LA, where V=C
V-(RA+LA+LL)/3, where V=C
Va
Va-(RA+LA+LL)/3, where
Va=V2 (default) position
Vb
Vb-(RA+LA+LL)/3, where Vb
=V5 (default) position
Positioning ECG Electrodes
Positioning ECG Electrodes
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
Non-manufacturer supplied accessories and supplies can corrupt the
performance of the equipment. Use only AAMI EC-12 compliant electrodes
with this device. Use of electrodes that are non-compliant may provide
erroneous results.
Caution
To protect the transceiver from damage during defibrillation, to ensure accurate
ECG information, and to provide protection against signal noise and other
interference, use only ECG electrodes and cables specified by Philips.
Correct lead placement is always important for accurate diagnosis. Especially in
the precordial leads, which are close the heart, QRS morphology can be greatly
altered if an electrode is moved away from its correct location. Each electrode is
color-coded. Use the diagrams for 5-lead standard and EASI placement on the
back of the transceiver and in this section for guidance. Additional lead
placement information is available in the Online Help at the IntelliVue
Information Center.
When placing electrodes on the patient, choose a flat, non-muscular site where
the signal will not be impacted by either movement or bones.
Philips recommends that electrodes be changed every 24 hours.
ECG Monitoring
6-9
Positioning ECG Electrodes
The labels and colors of the ECG electrodes differ according to the standards
that apply for your hospital. The electrode placement references and
illustrations in this chapter use the AAMI labels and colors. See the table below
for additional label and color information.
Electrode Labels
Electrode Colors
AAMI
EASI
IEC
AAMI
IEC
RA
White
Red
LA
Black
Yellow
LL
Red
Green
RL
Green
Black
V/Va
C/Ca
Brown
White
Vb
Cb
Brown/White
White/Red
V2
C2
Brown/Yellow
White/Yellow
V3
C3
Brown/Green
White/Green
V4
C4
Brown/Blue
White/Brown
V5
C5
Brown/Orange
White/Black
V6
C6
Brown/Violet
White/Violet
In addition to correct positioning of the electrodes, optimal skin preparation
prior to electrode placement will help ensure a clear signal for diagnosis.
6-10
ECG Monitoring
Positioning ECG Electrodes
Step
Action
Prepare the patient’s skin. Good electrode-to-skin contact is
important for a good ECG signal, as the skin is a poor conductor of
electricity.
• Select sites with intact skin, without impairment of any kind.
• Clip or shave hair from the site as necessary.
• Wash site with soap and water, leaving no soap residue.
Note--Philips does not recommend using ether or pure
alcohol, because they dry the skin and increase the resistance.
• Dry thoroughly.
• Use ECG skin preparation paper (abrasive) to remove dead
skin cells and to improve the conductivity of the electrode
site.
Check electrodes for moist gel, and attach to the clips. If you are not
using pre-gelled electrodes, apply electrode gel to the electrodes
before placement.
Note—Gel must be moist to provide a good signal.
Place the electrodes on the patient according to the lead placement
you have chosen (see the electrode placement diagrams following).
Place the edge down, then “roll down” the rest of the pad. Press
firmly around the adhesive edge toward the center.
ECG Monitoring
6-11
Positioning ECG Electrodes
Locating the
Fourth
Intercostal
Space
Angle of Lewis
For accurate chest electrode placement and measurement, it is important to
locate the fourth intercostal space. This can be done using the Angle of Lewis.
1. Locate the second intercostal space by first palpating the Angle of Lewis
(the bony protuberance where the body of the sternum joins the
manubrium). This rise in the sternum is where the second rib is attached,
and the space just below this is the second intercostal space.
2. Palpate and count down the chest until you locate the fourth intercostal
space.
6-12
ECG Monitoring
Positioning ECG Electrodes
3-Wire
Placement
RA
LA
LL
Lead
Placement
RA
directly below the clavicle and near the
right shoulder
LA
directly below the clavicle and near the
left shoulder
LL
on the left lower abdomen
ECG Monitoring
6-13
Positioning ECG Electrodes
5-Wire
Placement
(Standard
Mode)
RA
LA
V1
V2
V3
V4 V5 V6
RL
6-14
ECG Monitoring
LL
Lead
Placement
RA
directly below the clavicle and near the
right shoulder
LA
directly below the clavicle and near the
left shoulder
LL
on the left lower abdomen
RL
on the right lower abdomen
on the chest, the position depends on your
required lead selection. The typical
position is V1, although this may vary
according based on your hospital’s
protocol.
Positioning ECG Electrodes
Lead
Placement
V1
on the fourth intercostal space at the right
sternal border
V2
on the fourth intercostal space at the left
sternal border
V3
midway between the V2 and V4 electrode
positions
V4
on the fifth intercostal space at the left
midclavicular line
V5
on the left anterior axillary line, horizontal
with the V4 electrode position
V6
on the left midaxillary line, horizontal
with the V4 electrode position
ECG Monitoring
6-15
Positioning ECG Electrodes
5-Wire
Placement
(EASI Mode)
6-16
ECG Monitoring
Lead
Corresponds
to Standard
Lead
on the lower sternum at the
level of the fifth intercostal
space
LL
on the left midaxillary line
at the same level as the E
electrode
LA
on the upper sternum
RA
on the right midaxillary
line at the same level as the
E electrode
Placement
Positioning ECG Electrodes
Lead
Corresponds
to Standard
Lead
Reference
Placement
can be anywhere, usually
below the sixth rib on the
right hip
Note—Make sure that the S and E electrodes line up
vertically on the sternum, and that the I, E and A
electrodes align horizontally.
ECG Monitoring
6-17
Positioning ECG Electrodes
6-Wire
Placement
6-lead placement uses the same four limb leads as 5-lead standard placement,
and two precordial leads - referred to at the Information Center as Va and Vb.
The default position of Va - the brown lead - is at the V2 position.
The default position for Vb - the brown/white lead - is at the V5 position.
The lead placement for the Va and Vb lead labels must be appropriate. If your
unit uses other precordial leads for Va and Vb, they may be assigned in Unit
Settings as defaults for your whole unit, or you may need to assign the new
positions on a per-patient basis in the Patient Window at the Information Center
(see “Telemetry Controls in the Patient Window” on page 9-2).
RA
LA
V1
ECG Monitoring
V4 V5 V6
LL
RL
6-18
V2
V3
Lead
Placement
RA
directly below the clavicle and near the
right shoulder
Positioning ECG Electrodes
Lead
Placement
LA
directly below the clavicle and near the
left shoulder
RL
on the right lower abdomen
LL
on the left lower abdomen
Va
on the chest, the position depends on
your required lead selection (see
below). The default position is V2. For
other positions, relabel the lead at the
Information Center.
Vb
on the chest, the position depends on
your required lead selection (see
below). The default position is V5. For
other positions, relabel the lead at the
Information Center.
ECG Monitoring
6-19
Positioning ECG Electrodes
6-20
ECG Monitoring
Lead
Placement
V1
on the fourth intercostal space at the right sternal
border
V2
on the fourth intercostal space at the left sternal
border
V3
midway between the V2 and V4 electrode
positions
V4
on the fifth intercostal space at the left
midclavicular line
V5
on the left anterior axillary line, horizontal with
the V4 electrode position
V6
on the left anterior axillary line, horizontal with
the V4 electrode position
Positioning ECG Electrodes
V7
on the left posterior axillary line, straight line
from V6
V8
on the left midscapular line, straight line from
V7
V9
on the left paraspinal line, straight line from V8
V3R
midway between the V1 and V4R electrode
positions
V4R
on the fifth intercostal space at the right
midclavicular line
V5R
on the right anterior axillary line, straight line
from V4R
ECG Monitoring
6-21
Connecting the ECG Cable
Connecting the ECG Cable
Caution
Do not insert a leadset in the transceiver during a self-test. The leadset should
be inserted either before the transceiver is powered up, or after the device has
established connection with the Information Center.
Step
Action
Match the arrow on the ECG cable with the arrow on the Lead
Insertion Guide according to the lead type you have chosen, and
insert the ECG cable into the transceiver.
Important—Make sure that the cable is pushed completely into
the transceiver, otherwise the device may not detect the proper
leadset type. When correctly inserted, the colored line at the
base of the cable is not visible.
3-wire
Match the arrow on the cable
with the left arrow (labeled
EASI, 3) on the Leadset Insertion Guide.
colored
line
Note—Leadset is keyed for
IntelliVue TRx
M4841A
6-22
ECG Monitoring
EASI, 3 5.6
only one insertion position.
Connecting the ECG Cable
Step
Action
5-wire Standard
Match the arrow on the cable
with the right arrow (labeled 5,
6) on the Leadset Insertion
Guide.
colored
line
line
IntelliVue TRx
M4841A
EASI, 3 5.6
5-wire EASI
Match the arrow on the cable
with the left arrow (labeled
EASI, 3) on the Leadset Insertion Guide.
colored
line
IntelliVue TRx
M4841A
EASI, 3 5.6
Note—If you are using a 5-wire leadset in both Standard and EASI
modes, insert the alignment guide into the open lead port with the
wide lip facing the leads. Then, press down firmly so that the guide
is securely under the leadset and the colored line is not visible.
ECG Monitoring
6-23
Connecting the ECG Cable
Step
Action
Check that the correct Electrode Indicators are lit for the leadset you
are using, and that the EASI indicator light is illuminated
appropriately. See “Verifying Electrode Connections” on page 6-25.
•
When using 5-lead standard, the EASI indicator does not
illuminate.
When using EASI, the EASI indicator illuminates momentarily.
6-wire
Match the arrow on the cable
with the right arrow (labeled
5,6) on the Leadset Insertion
Guide.
colored
line
IntelliVue TRx
M4841A
Cable
Disconnection
6-24
EASI, 3 5.6
For 6-lead, select the lead label(s) at the Patient Window.
When disconnecting the leadset from the transceiver, grasp the leadset block
firmly and pull free. Do not pull on the lead wires.
ECG Monitoring
Verifying Electrode Connections
Verifying Electrode Connections
The electrode indicators enable you to verify that the leads are available for the
desired monitoring. Pressing and holding the Check button enables you to view
the leadset status. During routine use of the transceiver for monitoring, all lead
indicators are off.
To verify electrode connections, use the following procedure:
Step
Action
Press and hold the Check button for 2 seconds
ECG Monitoring
6-25
Verifying Electrode Connections
Step
Action
Expected Response:
•
•
•
•
•
If 3-wire cable is attached: Red, White and Black indicators
illuminate, then all turn off.
If 5-wire cable in Standard mode is attached: Red, White,
Black, Green & Brown indicators illuminate, then all turn off.
If 5-wire cable in EASI mode is attached: Red, White, Black,
Green & Brown indicators illuminate, then all turn off. The
EASI indicator also illuminates briefly.
If 6-wire cable is attached: Red, White, Black, Green, Solid
Brown and Brown/White indicators illuminate, then all turn
off.
If all leads are off, the green indicator will be lit.
Unexpected Response:
Any other response indicates a problem with the transceiver or lead
set.
•
•
•
Check the leadset connection. The colored line should not be
visible; otherwise the wrong leadset type may be detected.
If the INOP, INVALID LEADSET, and the corresponding
audible tone occur, the leadset inserted does not match the
transceiver’s configuration . Insert the correct leadset per the
configuration.
Use a new leadset.
If the problem is not corrected, contact your service provider.
6-26
ECG Monitoring
Monitoring during Leads Off
During routine monitoring, the electrode indicators also notify you if one or
more leads are not functioning. When a "Leads Off" condition occurs, the
transceiver automatically illuminates the indicator corresponding to the missing
lead.
Note—Should the lead in the reference lead placement position (standard mode
- RL; EASI mode - green) become disconnected, the ECG signal is lost entirely.
After 10 minutes of this leads off condition, without the SpO2 sensor connected,
the transceiver will enter an RF Auto Shutoff state (if enabled). To correct the
condition, re-attach the lead to the electrode.
Monitoring during Leads Off
ECG Fallback and Extended monitoring states are supported for the transceiver
when the primary and/or secondary leads are in a "Leads Off" INOP condition.
Both of these states are entered into after 10 seconds of "Leads Off" in an
attempt to maintain monitoring and arrhythmia analysis.
ECG
Fallback
Multilead
Analysis
Single Lead
Analysis
ECG Fallback occurs when the primary lead is in "Leads Off" for 10 seconds
and a secondary lead is available.
If there is a "Leads Off" technical alarm in the primary lead for > 10 seconds,
the active secondary lead becomes the primary lead. The arrhythmia algorithm
switches the leads on the display, but relearn does not occur. When the "Leads
Off" condition is corrected, the leads are switched back to their original state.
For single lead analysis, if there are two leads available, the secondary lead is
made the primary lead until the "Leads Off" condition is corrected. The
arrhythmia algorithm performs a relearn using the available lead.
ECG Monitoring
6-27
Monitoring during Leads Off
Fallback for
EASI
Extended
Monitoring
If one of the derived EASI leads is in a technical alarm condition, a flat line is
displayed. After 10 seconds, the directly acquired EASI AI, AS, or ES lead,
depending on which is available, is displayed with the label “ECG”. Arrhythmia
relearn is performed with transition to or from EASI Fallback monitoring using
the available lead(s).
Extended monitoring occurs when both the primary and secondary leads are in
"Leads Off" for 10 seconds and another lead is available. It becomes the
primary lead and the arrhythmia algorithm performs a relearn.
Extended Monitoring applies if:
•
•
Relearning
Telemetry is configured for Extended Monitoring ON by your Service
Provider.
The lead set provides more than two leads (e.g., when using a 5-or 6-wire
leadset ).
Whenever there is a "Leads Off" condition, the arrhythmia algorithm performs a
Relearn, using the available leads.
Warning
Since Relearn happens automatically, if learning takes place during
ventricular rhythm, the ectopics can be incorrectly learned as the normal
QRS complex. This can result in missed detection of subsequent events of
V-Tach and V-Fib. For this reason, you should:
1. Respond promptly to any technical alarm.
2. Ensure that the arrhythmia algorithm is labeling beats correctly.
Using EASI Leads to Troubleshoot
If there is artifact in the ECG waves or a "Cannot Analyze ECG" technical
alarm condition is in effect, you can use the three EASI leads to troubleshoot at
the Information Center:
1. Click 12-Lead ECG on the Patient Window, then on 3 EASI Leads.
6-28
ECG Monitoring
Optimizing ECG Measurement Performance
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.
Optimizing ECG Measurement Performance
Warning
Telemetry should not be used for primary monitoring in applications
where the momentary loss of the ECG is unacceptable.
No matter how good a wireless network design is, a telemetry system will
always experience occasional loss of radio communications, resulting in ECG
waveform dropouts. A telemetry system will never be as reliable as a hardwired
bedside monitor that transmits its signal through a wire. If occasional loss of
ECG monitoring is not acceptable for certain patients, they should be connected
to a hardwired bedside monitor.
Smart Hopping technology alleviates most of the problems associated with
legacy telemetry technologies. Reception problems are less frequent, because
Smart Hopping avoids interference and moves to a different access point if the
signal strength is too low. The level of radio frequency activity is always
fluctuating in the environment. If the level becomes high enough to
significantly interfere with transceiver operation, the system responds by
moving to another “cleaner” area where there is less activity.
The effect of interference on the IntelliVue Telemetry System ranges from a
momentary loss of ECG to complete inoperability, and can be caused by many
sources. The strength, frequency, and proximity of the source of interference to
the transceiver or the access point are factors that determine the degree of
severity. In cases where the source of interference can be identified, corrective
action can be taken. For example, removing or moving away from the source of
interference will increase the equipment's dependability.
ECG Monitoring
6-29
Optimizing ECG Measurement Performance
Clinicians will tend to see more motion related artifact on the ECG of
ambulatory patients than on patients that are restricted to a bed. Proper skin
preparation and electrode application are very important in reducing this
problem.
Problems with the ECG signal stem from two main sources:
1. Frequency-related sources resulting in dropouts from signal disturbances
and loss of signal.
2. Patient-related sources with noise on the waveform caused by clinical
considerations such as poor skin prep, dry electrodes, and poor electrode
adhesion, as well as by patient motion and muscle artifact.
Even in complex situations where problems overlap, most of the time you’ll be
able to greatly enhance performance by taking corrective action.
Monitoring
Considerations
•
•
•
Dropouts
6-30
Patient should be restricted to the designated coverage area. Monitoring
performance will degrade if patients go outside the radius of coverage of
the receiving wireless network.
A patient location strategy is critical to a telemetry system. If a lifethreatening event occurs, the clinician must be able to locate the patient
quickly. The importance of this increases as the coverage area increases.
Frequency management is the responsibility of the hospital. Philips
Medical System has no control over the RF environment in the hospital.
If interference exists at the operating frequencies of the telemetry
equipment, telemetry performance will be affected. Careful selection of
frequencies for all wireless devices used within a facility (transceivers,
other wireless medical devices, etc.) is important to prevent interference
between them.
Because the IntelliVue Telemetry System is a wireless system, under certain
frequency conditions dropouts can occur. Dropouts result from a weak signal or
RF interference, and appear on the waveform when the signal "drops" to the
bottom of the channel for a minimum of 200 ms. If dropouts are frequent
enough to affect the heart rate count, the "Cannot Analyze ECG" or "Cannot
Analyze ST" technical alarm occurs. If there are enough dropouts to cause
ECG Monitoring
Optimizing ECG Measurement Performance
disassociation/reassociation with the Information Center, events in the Clinical
Review application can reflect loss of data for up to 1 minute in the worst case.
Problem
Cause
Dropouts
Signal Strength
Remedy
Low signal strength
See “Signal Strength” below.
RF interference
See “Radio Frequency Interference”
below.
The IntelliVue Telemetry System is custom designed for your site, so reliable
signal reception is only possible where there are receiving access points. When
the signal is too low, the following technical alarms can occur:
•
•
•
•
"Cannot analyze ECG"
"Cannot analyze ST
" Tele Weak signal"
"No signal"
Corrective Action
1. Check the location of the patient. If the patient is out of range, return the
patient to the specified coverage area.
2. If the patient is intentionally out of the coverage area, put telemetry in
Standby Mode. See “Standby Mode” on page 4-4.
3. If the patient is in the coverage area and is stationary, try moving the
transceiver about 15 cm (6 inches).
4. Check for INOP and information signals at the Information Center.
5. Check for interference activity in other sectors at the Information Center
to see if the problem is occurring with other transceivers.
6. If the problem is persistent, call service.
Radio
Frequency
Interference
Radio frequency (RF) interference is caused by monitoring devices from other
manufacturers that intrude into the transmitted electrical signal. You are
probably familiar with electrical interference in our homes and cars when it
causes signal loss or static with cell phones. This same type of interference can
occur with the transmitted telemetry signal even though the IntelliVue
ECG Monitoring
6-31
Optimizing ECG Measurement Performance
Telemetry System is designed to resist these effects and Smart-hopping enables
the system to avoid most instances of interference.
The 2.4 GHz ISM band used by the ITS4850A IntelliVue Telemetry System is
used by many different radio technologies, (e.g. microwave ovens, wireless
phones, Bluetooth devices). Therefore, there is increased potential for
interference. The system has the ability to detect whether the spectrum is too
congested. When detected, a "Wireless Monitoring Loss - Call Service" alert is
issued at the Information Center.
Corrective Action
1. To improve performance, the source of the interference must be identified
and eliminated. Try moving or removing other wireless devices
transmitting in the Wireless Medical Telemetry Service (WMTS - USA
only). Such devices can be identified by the presence of an antenna and/
or the following symbol:
Important—The IntelliVue Telemetry System emits radio frequencies that can
affect the operation of other devices. Contact the manufacturer of other
equipment for possible susceptibility to these frequencies.
Muscle and
Movement
Artifact
Muscle and movement artifact, respiratory variation, as well as poor electrode
contact, inadequate skin preparation, and other patient-related factors can also
affect interference with the ECG signal. Good clinical practice can have a
significant effect on the quality of ECG monitoring.
Corrective Action
Use the following table to help you troubleshoot the most common sources of
physiologically-caused ECG noise.
6-32
ECG Monitoring
Optimizing ECG Measurement Performance
Problem
Cause
Remedy
60-Cycle (AC) Interference Poor electrode placement. Re-apply electrodes, using good skin
preparation (see “Positioning ECG
Possible non-grounded
Electrodes” on page 6-9).
instrument near patient.
Disconnect electrical appliances near
patient (one at a time) by pulling wall
plugs, to determine faulty grounding.
Have engineering check grounding.
Muscle Artifact
Tense, uncomfortable
patient.
Poor electrode placement.
Tremors.
Diaphoresis.
Irregular Baseline
Poor electrical contact.
Respiratory interference.
Faulty electrodes.
Dry electrodes.
Make sure patient is comfortable.
Check that electrodes are applied on
flat non-muscular areas of the torso;
apply fresh electrodes if necessary,
using good skin preparation (see
“Positioning ECG Electrodes” on page
6-9).
Re-apply electrodes, using good skin
preparation (see “Positioning ECG
Electrodes” on page 6-9).
Move electrodes away from areas with
greatest movement during respiration.
ECG Monitoring
6-33
Optimizing ECG Measurement Performance
Problem
Baseline Wander
Cause
Remedy
Movement of patient.
Make sure patient is comfortable.
Improperly applied
electrodes.
Re-apply electrodes, using good skin
preparation (see “Positioning ECG
Electrodes” on page 6-9). Check that
patient cable is not pulling electrodes.
Respiratory interference.
Move electrodes away from areas with
greatest movement during respiration.
Poor Electrode Contact
Loose electrodes.
Defective cables.
Leadset not firmly
connected.
6-34
ECG Monitoring
Change electrodes, using good skin
preparation (see “Positioning ECG
Electrodes” on page 6-9).
Replace cables.
This chapter describes the ST/AR algorithms used for telemetry at the IntelliVue
Information Center. It includes the following sections:
•
•
ST/AR Arrhythmia Algorithm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2
ST/AR ST Segment Algorithm. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-7
ST/AR Arrhythmia & ST Segment Monitoring
7-1
Introduction
ST/AR Arrhythmia & ST Segment
Monitoring
ST/AR Arrhythmia Algorithm
ST/AR Arrhythmia Algorithm
Safety
Information
Warning
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.
Warning
Learning
If you initiate learning during ventricular rhythm, the ectopics can be
incorrectly learned as the normal QRS complex. This can result in missed
detection of subsequent events of V-Tach and V-Fib.
7-2
ST/AR Arrhythmia & ST Segment Monitoring
ST/AR Arrhythmia Algorithm
Warning
Relearning
Arrhythmia relearning is initiated whenever the transceiver is powered
down for one minute or longer or whenever it is directly connected/
disconnected to an IntelliVue MP5 Patient Monitor. Be sure to check your
patient’s arrhythmia annotation for accuracy whenever relearn has
occurred.
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.
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.
For Paced
Patients
Warning
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.
ST/AR Arrhythmia & ST Segment Monitoring
7-3
ST/AR Arrhythmia Algorithm
Warning
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.
Warning
For 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. 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.
Warning
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 algorithm’s failure to detect
pacemaker non-capture or asystole.
Warning
It is possible that pacemaker pulses will not be detected when the ECG
analog output of a defibrillator is plugged into a bedside monitor. This can
result in the arrhythmia algorithm’s failure to detect pacemaker noncapture or asystole.
ST/AR
Arrhythmia
Analysis
For information on arrhythmia detection, refer to the following documentation:
•
•
7-4
ST/AR Algorithm - Arrhythmia Monitoring Application Note,
#452298193051
IntelliVue Information Center Instructions for Use and Online Help
ST/AR Arrhythmia & ST Segment Monitoring
ST/AR Arrhythmia Algorithm
The intended use of the ST/AR basic arrhythmia analysis algorithm is to monitor
the patient’s ECG for heart rate and ventricular arrhythmias and to produce
events/alarms simultaneously for one or more ECG leads. The arrhythmia
algorithm is effective when monitoring both paced and non-paced patients in a
clinical environment.
IntelliVue Telemetry does not have a dedicated cardiotach. Instead, the
arrhythmia cardiotach at the Information Center is used. Therefore, the ST/AR
Arrhythmia algorithm is always on for all IntelliVue Telemetry patients, and
cannot be turned off.
ST/AR provides Heart Rate and PVC Rate numerics and alarm detection for the
conditions listed in the following table. There are two detection levels: Basic and
Enhanced. Enhanced includes the Basic alarms.
Basic & Enhanced Arrhythmia Detection
Basic Arrhythmia Detection
Enhanced Arrhythmia Detection
Asystole
Non-Sustain VT
V-Fib/Tach
Vent Rhythm
V-Tach
Run PVCs
Brady yyy < xxx
Pair PVCs
Tachy yyy > xxx
Pause
HR yyy > xxx
Missed Beat
HR yyy < xxx
SVT
PVCs > xxx/min
R-on-T PVCs
Pacer Not Capturing
Vent Bigeminy
Pacer Not Pacing
Vent Trigeminy
Multiform PVCs
Irregular HR
ST/AR Arrhythmia & ST Segment Monitoring
7-5
ST/AR Arrhythmia Algorithm
Beat classification determined by the ST/AR algorithm is shown on the primary
delayed wave in the Arrhythmia Analysis window at the Information Center. To
access this window, select Arrhythmia Analysis from the Patient Window.
The annotation requires clinical validation of the analyzed heart rhythm. If the
analysis is inaccurate, perform a relearn of the rhythm.
Annotation
Beat Classification
Display
Color
Artifact
Blue
Inoperative
Red
Learning
Red
Missed Beat
Red
Normal
Blue
Paced
Blue
Supraventricular Premature
Blue
Ventricular Premature
Red
Questionable
Red
Pacer Mark
Blue
When monitoring is initiated, when the Wave 1 lead is changed, or if Relearn is
selected, a question mark (?) is displayed next to HR and the annotation “L”
appears on the annotated wave until the HR is calculated and the rhythm is
learned.
7-6
ST/AR Arrhythmia & ST Segment Monitoring
ST/AR ST Segment Algorithm
ST/AR ST Segment Algorithm
Warning
This device provides ST level change information; the clinical significance
of the ST level change information needs to be determined by a physician.
The ST/AR ST algorithm at the Information Center monitors ST segment
elevation or depression for each available telemetry ECG lead and produces
events/alarms simultaneously. ST values update with every measurement period
and enunciate, depending upon the severity of the change, events and alarms as
they are detected.
The ST/AR ST algorithm is approved for use only with non-paced and atriallypaced adult telemetry-monitored patients. With EASI monitoring, ST analysis is
performed on up to 12 leads, and an additional value of ST index is calculated
and displayed (see “EASI ST Analysis” on page 7-9). Assessment of EASIderived 12-lead ST measurement is recommended for adult patients that meet
the following parameters:
•
•
•
•
Ages: 33-82 years
Heights: 147 to 185 cm (58 to 73 in)
Weights: 53 to 118 kg (117 to 261 lbs)
Height to Weight Ratios: 1.41 to 2.99 cm/kg (0.25 to 0.54 in/lb)
All ST analysis and ST alarms for telemetry patients are performed by the
Information Center.
For additional information on ST monitoring, refer to the following
documentation:
•
•
The
Measurement
ST/AR Algorithm - ST Segment Monitoring Application Note,
#452298192851
Information Center Online Instructions for Use and Online Help
The ST measurement for each beat complex is the vertical difference between
two measurement points. The isoelectric point provides the baseline for the
ST/AR Arrhythmia & ST Segment Monitoring
7-7
ST/AR ST Segment Algorithm
measurement and the ST point provides the other measurement point. It is
positioned with reference to the J-point.
R-WAVE PEAK
AT 0 MSEC
J POINT
DIFFERENCE =
ST VALUE
ST
ISO ELECTRIC
POINT
MEASUREMENT
DEFAULT =
POINT
-80 MSEC
DEFAULT =
J+60 MSEC
Algorithm
Processing
ST analysis analyzes ECG signals to classify the heart beats. Only beats
classified as normal or Supraventricular (atrially paced) are used to calculate ST
elevations and depressions.
The ST/AR ST algorithm processing includes special ST filtering, beat selection
and statistical analysis, calculation of ST segment elevations and depressions,
and lead reconstruction and wave generation.
When ST analysis is being performed on two leads, the averaged derived and
reconstructed ST waves and associated ST segment values are given for up to
six leads, depending on the type of patient cable:
•
•
•
•
•
3-wire: one lead
5-wire: up to two leads if monitoring a chest and a limb lead
5-wire: up to six leads if monitoring two limb leads
5-wire: up to 12 leads if monitoring using EASI
6-wire: up to 8 leads if monitoring two limb leads and two chest leads
Note—No ST analysis is done on a patient if an electrode falls off.
7-8
ST/AR Arrhythmia & ST Segment Monitoring
ST/AR ST Segment Algorithm
Displayed
ST Data
ST data displays as values in the Patient Sector and Patient Window. A positive
value indicates ST segment elevation; a negative value indicates ST segment
depression. You can view ST data in ST Review, Trend Review, and Event
Review windows.
EASI ST
Analysis
The Information Center generated ST values presented in the patient sector and
Patient Window for EASI derived leads is STindx (ST Index). STindx is a
summation of three ST segment measurements, using the leads that can indicate
ST segment changes in the different locations of the heart:
•
•
•
anterior lead V2
lateral lead V5
inferior lead aVF
ST Operation
Turning ST
Monitoring On/
Off
The ST Setup Window allows you to turn ST monitoring on or off for all
available ECG leads.
To turn ST monitoring on at the Information Center, perform the following
steps:
Step
Action
From the Patient Window, click the All Controls button.
From the All Controls Window, click the ST Setup button.
From the ST Setup Window, click ST On.
You would turn ST monitoring off if:
•
•
•
•
You are unable to get any lead that is not noisy.
Arrhythmias such as atrial fib/flutter cause irregular baseline.
The patient is continuously ventricularly paced.
The patient has left bundle branch block.
ST/AR Arrhythmia & ST Segment Monitoring
7-9
ST/AR ST Segment Algorithm
Adjusting ST
Measurement
Points
The ST Setup Window enables you to adjust the ST measurement points to
ensure accurate data.
There are three measurement cursors:
•
The ISO measurement cursor positions the isoelectric point in relation to
the R-wave peak.
The J-point cursor positions the J-point in relation to the R-wave peak.
The purpose of the J-point is to correctly position the ST measurement
point.
The ST measurement cursor positions the ST point a fixed distance from
the J point.
•
•
Note—The ST measurement points may need to be re-adjusted if the patient's
heart rate or ECG morphology changes significantly.
Perform the following steps at the Information Center to adjust the ST
measurement points:
Step
Action
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).
ISO
point
7-10
ST/AR Arrhythmia & ST Segment Monitoring
ST/AR ST Segment Algorithm
Step
Action
Adjust the J point, if necessary, by placing the cursor over the Jpoint 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.
J point
Adjust the ST point, if necessary, by using the J point as an
“anchor” and placing the bar at the midpoint of the ST segment.
Choices are J+0, J+20, J+40, J+60, or J+80.
Establishing
ST Reference
Beats
(Baseline)
ST Alarm
Settings
ST point
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.
All IntelliVue Information Center alarm settings (limits and on/off status) have
unit default settings. The IntelliVue 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.
ST/AR Arrhythmia & ST Segment Monitoring
7-11
ST/AR ST Segment Algorithm
•
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 transceiver, an alarm is generated if
two or more ST leads exceed the alarm limits. The default setting is +/-1.0. The
alarm message indicates the two leads that are in greatest violation of the limits,
for example, “**MULTI ST AVR, V6”. If another lead becomes deviant, the
message changes but it is considered the same alarm (no new alarm sounds and
it is not listed as a new event).
See “Physiologic Alarms” on page 5-4 for a list of all ST alarms.
See IntelliVue Information Center Instructions for Use for specifics on alarm
management and behavior.
Adjusting ST
Alarms
Make adjustments to ST alarms on the ST Alarms window at the Information
Center.
Step
7-12
Action
From the Patient Window, select the All Controls button.
ST/AR Arrhythmia & ST Segment Monitoring
ST/AR ST Segment Algorithm
Step
Action
From the All Controls window, select the ST Alarms button under
Alarm Management and Setup.
In the ST Alarms window, adjust alarms as needed. Choices for
setting the ST alarm limits are:
Unit Settings—Click on this button if want to have the specific
limits that are pre-set for your unit.
Smart Limits—Click 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.
Note—Smart 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 limits—Use these to set the high and low alarm limits
based on your assessment of the patient's clinical condition, unit
protocols, or physician orders or medication specified limits. A good
guideline is + 1.0 mm or - 1.0 mm from the patient's ST, or follow
your unit protocol.
ST/AR Arrhythmia & ST Segment Monitoring
7-13
ST/AR ST Segment Algorithm
7-14
ST/AR Arrhythmia & ST Segment Monitoring
This chapter provides an introduction to the SpO2 measurement and its
application. It includes the following sections:
•
•
•
•
•
•
•
•
SpO2 Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2
Pulse Oximetry Measurement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4
Selecting a SpO2 Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-6
Applying the Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-10
Connecting the SpO2 Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-14
Measuring SpO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-15
Understanding SpO2 Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-20
Optimizing SpO2 Measurement Performance . . . . . . . . . . . . . . . . . . 8-20
SpO2 Monitoring
8-1
Introduction
SpO2 Monitoring
SpO2 Safety Information
SpO2 Safety Information
Warning
Always confirm Information Center observations with clinical observation
of the patient before administering interventions.
Warning
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.
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.
Warning
Injected dyes such as methylene blue or intravascular dyshemoglobins such
as methemoglobin and carboxyhemoglobin can lead to inaccurate (overestimated) measurements.
8-2
SpO2 Monitoring
SpO2 Safety Information
Warning
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.
Warning
This equipment is not suitable for use in the presence of a flammable
anesthetic mixture or oxygen concentrations greater than 25% (or partial
pressures greater than 27,5 kPa /206.27 mmHg).
SpO2
Information
for the User
The pulse oximeter is calibrated to indicate functional oxygen saturation
(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 central station is 10 seconds.
Pulse rate is also derived from the pulsatile SpO2 measurement, and displayed
results can range from 30 to 300 bpm. There is no alarm function for pulse rate.
The pleth wave is auto-scaled to maximum display size. It decreases only when
the signal quality becomes marginal. Pleth wave size is NOT directly
proportional to the pulse volume.
SpO2 Monitoring
8-3
Pulse Oximetry Measurement
Pulse Oximetry Measurement
The ECG-SpO2 TRx+ Transceiver supports an SpO2 sensor connection using
Fourier Artifact Suppression Technology (FAST). The FAST algorithm
overcomes many of the issues associated with traditional pulse oximetry such as
sensitivity to patient movement and intense ambient light. The algorithm offers
improved motion artifact rejection as well as performance improvements for
patients with low perfusion. SpO2 can be measured continuously, where a value
is sent to the Information Center every second, or as a single, individual
measurement (Spot Check). The Spot Check measurement will be removed
from the Information Center display after 1 hour. If 1-minute or 5-minute
sampling rate is selected at TeleMon, the transceiver will provide Continuous
SpO2 measurement after disconnection (see “Transceiver Operation when
Connected to TeleMon” on page 9-16).
The SpO2 parameter measures the arterial oxygen saturation, that is, the
percentage of oxygenated hemoglobin in relation to the total hemoglobin.
If, for example, a total of 97% of the hemoglobin molecules in the red blood
cells of the arterial blood combine with oxygen, then the blood has an oxygen
saturation of 97%. The SpO2 numeric that appears on the monitor will read
97%. The SpO2 numeric indicates the percentage of hemoglobin molecules
which have combined with oxygen molecules to form oxyhemoglobin.
•
The oxygen saturation is measured using the pulse oximetry method. This
is a noninvasive method of measuring the arterial hemoglobin oxygen
saturation. It measures how much light, sent from light sources on one
side of the sensor, travels through patient tissue (such as a finger or an
ear), to a receiver on the other side of the sensor.
•
The amount of light passing through depends on many factors, most of
which are constant, such as tissue or venous blood. However one of the
factors, the blood flow in the arterioles, varies with time - because it is
pulsatile.
This measurement principle is used to derive the SpO2 measurement. The
numeric that is displayed at the Information Center is the oxygen
saturation of the arterial blood - the measurement of light absorption
8-4
SpO2 Monitoring
Pulse Oximetry Measurement
during a pulsation. Correct placement of the sensor is essential for
accurate measurements (see “Applying the Sensor” on page 8-10).
Note—Because pulse oximeter equipment measurements are statistically
distributed, only about two-thirds of pulse oximeter equipment measurements
can be expected to fall with ± Arms of the value measured by a CO-oximeter.
Pulse Tone
Indication
During Spot Check measurement initiated at the transceiver, the pulse signal is
detected and communicated to you via an auditory signal at the transceiver. The
indicator is a single low-pitched tone for each pulse detected; it ceases when a
measurement is complete. The tone is controlled by the Volume and Mute
controls at the Information Center.
Since it is possible to have a strong pulse but fail an SpO2 measurement, you
should listen for the successful completion of a measurement (single beep), or a
double beep if the measurement fails.
The pulse indicator is for information only, and should not be used as an
indication for treatment. The indicator is not functional in Continuous
measurement mode, and no tones, for pulse indication or successful/failed
measurement, are generated when Spot Check is initiated remotely from the
Information Center.
Clinical Note: If the transceiver is in Spot Check mode, and the sensor light is
illuminated but you do not hear a low-pitch sound synchronized with the pulse,
readjust the sensor, or move the sensor to another site to provide better
detection. (Adjustable sounds must be on.)
SpO2 Monitoring
8-5
Selecting a SpO2 Sensor
Selecting a SpO2 Sensor
Warning
Use only Philips-approved accessories. Use of product accessories (ECG
leadsets, SpO2 sensors, etc.) other than those specified in this manual may:
- lead to patient injury
- result in increased electromagnetic emissions or decreased immunity of
the product
Warning
Reuse: Never reuse disposable sensors, accessories and so forth that are
intended for single use, or single patient use only.
Packaging: Do not use a sterilized accessory if the packaging is damaged.
Warning
Do not use disposable sensors on patients who exhibit allergic reactions to
the adhesive.
Warning
When the specified Nellcor® sensors are used, the application must be
consistent with the sensor manufacturer's own guidelines.
8-6
SpO2 Monitoring
Selecting a SpO2 Sensor
Philips reusable sensors in adult, pediatric and infant models can be used, as
well as Philips and Nellcor® disposable sensors. If you are using Nellcor®
sensors, see the Directions for Use supplied with these sensors.
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.
SpO2 Monitoring
8-7
Selecting a SpO2 Sensor
The following table and chart will help you in selecting the correct sensor type. .
Sensor Type
When to Use
Reusable
You can use reusable sensors on different
patients after cleaning and disinfecting them.
For care and cleaning instructions, see the
instructions accompanying the sensors. Reusable
sensors should be changed to another site every
2-3 hours or in accordance with your clinical
practice guidelines.
See the Directions for Use supplied by Nellcor®
Incorporated for instructions on preparation and
application of reusable sensors.
Disposable
Use disposable sensors only once and then
discard. However, you can relocate them to a
different patient-site if the first location does not
give the desired results. Do not reuse disposable
sensors on different patients.
See the Directions for Use supplied by Nellcor®
Incorporated for instructions on preparation and
application of disposable sensors.
8-8
SpO2 Monitoring
Selecting a SpO2 Sensor
To use the chart:
Find the patient’s weight on the vertical axes. On the horizontal axis at this
weight, the shaded areas indicate that the sensor is a “best choice” for the
patient. Unshaded areas indicate a “good choice.” For example, the best
reusable sensor for a 50 kg patient is the M1191A, applied to the finger or toe.
Alternatively, you could use M1194A applied to the ear.
Patient
Weight
( lb )
Patient
Weight
( kg )
Adult
Adult
Adult
Adult
Adult
110
50
40
Pedi
Pedi
Pedi
Pedi
Pedi
30
Pedi
88
66
20
44
15
33
M1192A M1191A M1194A M1901B M1903B M1904B
Philips
M1196A
Oxisensor
OxiMax
Reusable
sensor
N-25
D-20
D-25
Disposable
sensor
Preferred sensor types
Alternative sensor types
Selecting an SpO2 Sensor
SpO2 Monitoring
8-9
Applying the Sensor
Applying the Sensor
Sensor
Application
Safety
Information
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, which can severely obstruct circulation and lead to inaccurate
measurements.
Ambient Temperature: Never apply an SpO2 sensor at ambient temperatures
above 37 oC (99 oF) because this can cause severe burns after prolonged
application.
Extremities to Avoid: Avoid sites distal to BP cuff, intra-arterial line, or
intravascular venous infusion line.
Site
Selection
8-10
SpO2 Monitoring
•
Avoid sites with impaired perfusion, skin discoloration, excessive motion
or nail polish.
Applying the Sensor
Sensor
Application
•
Avoid placing the sensor in an environment with bright lights (if
necessary, cover the sensor with opaque material).
•
Avoid use of excessive pressure at the application site (e.g., sensor
applied too tightly, excessive adhesive tape to secure the sensor, clothing
or restraints that are too tight). These result in venous pulsations and
inaccurate measurement, and may severely obstruct circulation.
A minimum pulsatile flow must be present at the application site of your patient
to obtain measurements.
Select an appropriate sensor and apply the sensor properly to avoid incorrect
measurements. Applying a small amount of pressure at the application site can
improve the measurement. Use one of the preferred application sites for your
sensor. Selecting the most suitable sensor and application site will help you to
ensure that:
•
The light emitter and the photo detector are directly opposite each other
and that all the light from the emitter passes through the patient's tissues,
•
The application site is of the correct thickness for light to pass through. If
the application site is too thick or too thin, an SpO2 NON-PULSATILE
technical alarm will occur. You should then select another site as
appropriate.
Light Emitter
Photo Detector
Positioning of the Light 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
8-11
Applying the Sensor
Follow the sensor’s instructions for use, adhering to all warnings and cautions.
To apply the sensor, use the following directions.
Step
Action
Select the site and appropriate sensor (see “Selecting a SpO2
Sensor” on page 8-6).
Apply the sensor to the appropriate part of the patient’s body.
Note—The application site should match the sensor size so that the
sensor can neither fall off nor apply excessive pressure.
Adult Finger
sensor
(M1191A)
8-12
Check that the light emitter and the photo detector are directly
opposite each other. All light from the emitter must pass through the
patient’s tissue.
Push the sensor over the fingertip in such a way that the fingertip touches but
does not protrude from the end of the sensor. The fingertip must be uppermost
and the cable must lie on the back of the hand. This ensures that the light source
cover the base of the fingertip giving the best measurement results. The cable
can be held in place by the accompanying wristband.
SpO2 Monitoring
Applying the Sensor
Small Adult/
Pediatric
Finger sensor
(M1192A)
Push the sensor over the fingertip in such a way that the fingertip touches but
does not protrude from the end of the sensor.
Ear Clip sensor
(M1194A)
Clip the probe onto the fleshy part of the ear lobe as shown in the diagram
below. The plastic fixing mechanism helps to minimize artifact generated by
patient motion. Do not position the probe on cartilage or where it presses
against the head.
The clip sensor can be used as an alternative if the adult finger sensor does not
provide satisfactory results. The preferred application site is the ear lobe,
although other application sites with higher perfusion (such as the nostril) can
be used. Due to the physiologically lower perfusion in the ear lobe, you should
be aware of the reduced accuracy of the measurement and more frequent
technical alarms.
SpO2 Monitoring
8-13
Connecting the SpO2 Cable
Connecting the SpO2 Cable
Step
Action
Connect the sensor cable to IntelliVue TRx+.
• Connect reusable sensors directly into the transceiver.
• Connect disposable sensors into the adapter cable, then
connect the adapter cable to the transceiver. Remove the
protective backing.
Adjust SpO2 alarms in the Patient Window (see “Telemetry
Controls in the Patient Window” on page 9-2).
Make other adjustments in the Telemetry Setup Window (see
“Patient Configurable Settings in Telemetry Setup” on page 9-4).
Caution
Extension cables: The use of extension cables presents a tripping hazard. Use
appropriate care when they are in use.
Electrical Interference: Position the sensor cable and connector away from
power cables, to avoid electrical interference.
8-14
SpO2 Monitoring
Measuring SpO2
Measuring SpO2
Warning
Removal of the SpO2 sensor during Continuous SpO2 monitoring results in
a "No Sensor" technical alarm. There is no technical alarm for a “No
Sensor” condition in Spot Check mode.
Warning
If you measure SpO2 on a limb that has an inflated NBP cuff, a nonpulsatile SpO2 technical alarm can occur. If the monitor is configured to
suppress this alarm, there can be a delay of up to 60 seconds in indicating
critical patient status, such as sudden pulse loss or hypoxia.
SpO2 measurements can be made manually on an as-needed basis in Spot
Check mode, or continuously in Continuous mode, depending on the transceiver
configuration. While operating in Continuous mode, you can also measure
pulse, and display the pleth wave at the Information Center. The SpO2
parameter is turned on by inserting/removing the sensor cable into the
transceiver, or by control from the Information Center. SpO2 monitoring
consumes considerable electrical energy. The battery power must be at least
25% full in order to make SpO2 measurements.
Setting the mode at Spot Check or Continuous is done at the Information Center
(see “Patient Configurable Settings in Telemetry Setup” on page 9-4) or at
TeleMon.
Spot Check
Measurement
When the transceiver is configured for Spot Check measurement, use the
following instructions to take an individual, manual SpO2 reading from the
transceiver.
Note—You can also initiate a Spot Check measurement in the Patient Window
at the Information Center by selecting the STAT SpO2 icon (see “Patient
Configurable Settings in Telemetry Setup” on page 9-4).
SpO2 Monitoring
8-15
Measuring SpO2
Note—Spot Check measurements cannot be made when the transceiver is
connected to TeleMon or the IntelliVue MP5 Patient Monitor, because only
Continuous measurement is available with these devices.
Step
Action
Attach the sensor to the patient.
Connect the SpO2 cable to IntelliVue TRx+, and check that:
• The SpO2 sensor light turns on.
• A low-pitch tone detecting each pulse is audible (unless
sounds are muted).
After approximately 30 seconds, if the measurement was successful,
you’ll hear a single beep from the transceiver. The value, with the
measurement time, will be displayed at the Information Center. The
sensor light will extinguish.
If the measurement was unsuccessful, you’ll hear a double beep.
Remove the sensor cable and reinsert it to retake the measurement.
Note—The SpO2 value and time stamp remain on the Information
Center for 1 hour or until another measurement is taken, with one
exception: If the batteries are removed from the transceiver, the Spot
Check measurement will be erased from the display; however, the
SpO2 measurements will be available in Trend Review.
Continuous
Measurement
When the transceiver is configured for Continuous SpO2 measurement ((see
“Patient Configurable Settings in Telemetry Setup” on page 9-4), use the
following directions to initiate Continuous SpO2 monitoring.
Step
8-16
To repeat a Spot Check measurement at the bedside, disconnect
then reconnect the SpO2 cable to the transceiver.
SpO2 Monitoring
Action
Insert the SpO2 cable into the IntelliVue TRx+, and check that the
sensor light turns on.
Attach the sensor to the patient.
Measuring SpO2
Step
Action
After approximately 15 seconds, the value, with the measurement
time, is displayed at the Information Center.
Note—There are no sounds associated with continuous SpO2
measurement.
To discontinue SpO2 monitoring, uncheck the Enable SpO2 box at
the Information Center.
Note— If the sensor is removed without discontinuing SpO2
monitoring in the Telemetry Setup Window at the Information
Center, an SpO2T NO SENSOR technical alarm will result.
Silencing this technical alarm will turn the SpO2 measurement off.
Displaying
Pulse Rate
When operating in Continuous mode, you can view the Pulse rate at the
Information Center. See “Patient Configurable Settings in Telemetry Setup” on
page 9-4.
Note—If Pulse rate is turned on, the Patient Sector and Patient Window of the
Information Center display the parameter label with “T” (for example,
"PulseT") to indicate that the measurement was made via telemetry.
Displaying
Pleth Wave
When
Connected
to TeleMon
The transceiver can be configured to transmit the Pleth wave for display at the
Information Center. See “Patient Configurable Settings in Telemetry Setup” on
page 9-4.
When the transceiver is connected to TeleMon:
•
The SpO2 measurement mode is always Continuous.
SpO2 Monitoring
8-17
Measuring SpO2
•
You can change the mode. Changes to the mode take effect when the
transceiver is disconnected from TeleMon. The following settings will be
used:
Mode Set at TeleMon
When
Connected
to the MP5
Mode when Transceiver
is Disconnected
Continuous
Continuous
5-minute
Continuous
1-minute
Continuous
Manual
Spot Check
When the transceiver is sourcing the display of patient data on an MP5 bedside
monitor:
•
The SpO2 measurement mode is always Continuous.
Turning SpO2 Monitoring Off
To turn SpO2 monitoring off, disconnect the sensor cable from the transceiver.
SpO2 enters a power-down mode after the cable is disconnected from the
transceiver, thereby conserving battery life.
It is important to disconnect the sensor from the transceiver in order to conserve
battery life. Unplugging the sensor from an adapter cable that is connected to
the transceiver does NOT provide SpO2 power-down mode.
SpO2 should also be turned off at the Information Center. If the transceiver is
configured for Continuous SpO2 measurement and the sensor is removed
without turning SpO2 off, a SpO2T NO SENSOR technical alarm will result.
Silencing this technical alarm will turn the SpO2 measurement off.
8-18
SpO2 Monitoring
Measuring SpO2
SpO2
Enable/
Disable at
Information
Center
You can enable/disable SpO2 monitoring at the Information Center. See
“Patient Configurable Settings in Telemetry Setup” on page 9-4.
When SpO2 is enabled, the Patient Sector and Patient Window of the
Information Center display a “T” next to the SpO2 numeric (for example,
“SpO2T 90%”) to indicate that the measurement was made via telemetry.
When SpO2 monitoring is disabled, setting the sample rate to Spot Check or Off
at the Information Center or at TeleMon will help you conserve the
transceiver’s battery life. See “Patient Configurable Settings in Telemetry
Setup” on page 9-4.
SpO2 Auto
ON at
Information
Center
The SpO2 parameter is automatically enabled at the IntelliVue Information
Center if a manual SpO2 measurement is initiated at the transceiver while in
Spot Check mode or if the SpO2 sensor is inserted into the transceiver while the
transceiver is in Continuous SpO2 mode.
When a patient is discharged and the transceiver is in Continuous mode, the
SpO2 parameter is disabled. To reactivate the SpO2 parameter Auto ON feature
from the transceiver, remember to do one of the following when a patient is
discharged:
– remove the SpO2 cable from the transceiver, wait 15 seconds, then
reinsert the cable
or
– if using TeleMon, reset the transceiver to Manual mode.
Note—The SpO2 parameter Auto ON feature only needs to be reactivated when
the transceiver is in Continuous mode at discharge.
Note— SpO2 can always be enabled/disabled at the IntelliVue Information
Center.
SpO2 Monitoring
8-19
Understanding SpO2 Alarms
Understanding SpO2 Alarms
Physiologic SpO2 alarms are generated and displayed at the Information Center.
SpO2 offers high and low limit alarms, and a high priority (red level) oxygen
desaturation alarm. The SpO2 low limit can be set between 50 and 99%
inclusive, in 1% increments. The desaturation limit is set automatically at 10
below the Low Limit. The SpO2 high alarm limit can be set between 51 and
100% inclusive, in 1% increments.
The delay between the physiologic alarm condition and alarm annunciation at
the Information Center is <16 seconds. This means that the Information Center
will generate an alarm if the averaged numeric value on the display exists
beyond the alarm limit for more than a maximum of 16 seconds.
Setting the high SpO2 alarm limit to 100% is equivalent to switching off the
high alarm. Therefore the upper alarm limit for oxygen saturation must be
carefully selected in accordance with accepted clinical practices.
The default setting for SpO2 yellow alarms is latched. That is, when an SpO2
limit is exceeded, you will need to acknowledge it at the Information Center.
The sound will be silenced but the message will remain on the display until the
condition is resolved.
See Chapter 5, “Alarms” for a list of the SpO2 alarms.
Optimizing SpO2 Measurement Performance
Refer to this section on problem situations if you have difficulty getting a signal
or obtaining accurate measurements.
Distortion
Ambient light, motion, perfusion or incorrect sensor placement can affect the
accuracy of the derived measurements.
8-20
SpO2 Monitoring
Optimizing SpO2 Measurement Performance
Arterial Blood Flow
The measurement depends on the pulsatile nature of blood flow in the arteries
and arterioles; with the following conditions arterial blood flow can be reduced
to a level at which accurate measurements cannot be made:
•
•
•
•
shock
hypothermia
use of vasoconstrictive drugs
anemia
Wavelength Absorption
The measurement also depends on the absorption of particular light wavelengths
by the oxyhemoglobin and reduced hemoglobin. If other substances are present
which absorb the same wavelengths, they will cause a falsely high, or falsely
low SpO2 value to be measured. For example:
• carboxyhemoglobin
• methemoglobin
• methylene blue
• indocyanine green*
• indiocarmine*
*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.
Sensor Wear
Normal wear and tear associated with patient movement and regular sensor
cleaning typically mean that the 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.
To get the best results from your SpO2 reusable sensor:
SpO2 Monitoring
8-21
Optimizing SpO2 Measurement Performance
8-22
SpO2 Monitoring
•
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.
This chapter describes the telemetry functions at the Information Center and
IntelliVue Patient Monitor, as well as the differences in transceiver operation
when connected to TeleMon. It includes the sections listed below. For
additional information, consult the IntelliVue Information Center Instructions
for Use and TeleMon Instructions for Use.
•
•
Telemetry Functions at the Information Center . . . . . . . . . . . . . . . . . . 9-2
•Telemetry Controls in the Patient Window . . . . . . . . . . . . . . . . . . 9-2
•Locating the Transceiver (Find Device). . . . . . . . . . . . . . . . . . . . . 9-3
•Patient Configurable Settings in Telemetry Setup . . . . . . . . . . . . . 9-4
•Unit-Configurable Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-8
Transceiver Operation when Connected to TeleMon . . . . . . . . . . . . . 9-16
Telemetry Functions at the Information Center & TeleMon
9-1
Introduction
Telemetry Functions at the
Information Center & TeleMon
Telemetry Functions at the Information Center
Telemetry Functions at the Information Center1
Telemetry
Controls in
the Patient
Window
The Patient Window at the Information Center (accessed from the Patient
Window control in the Patient Sector) includes controls for a number of
telemetry operations. For detailed instructions on these operations, see the
IntelliVue Information Center Instructions for Use or the Online Help.
To View ECG or SpO2Alarm Limits
Move the cursor over the HR or SpO2 label to display the current high and low
alarm limits.
To Change ECG or SpO2 Alarm Limits
Move the cursor over the High or Low numeric to display up/down arrow
controls for adjusting the limit. After adjusting the limit, move the cursor away
from the area to dismiss the limit controls.
To Change ECG Waveform Size
Move the cursor over the ECG waveform to display the ECG Waveform Size
control. Select the desired size from the list.
To Select Lead
Move the cursor over the ECG waveform to display the Lead Selection control.
Select the desired lead from the list.
Important—Do not set the primary and secondary channels to the same lead.
To Change Va and Vb Default Lead Settings (6-lead only)
Move the cursor over the ECG waveform to display the Lead Selection popup.
Select the label from the label list. For Va or Vb, select Va or Vb, then select the
lead to be assigned. Assignment of the same V lead to both Va and Vb is not
allowed.
Important—Do not set the primary and secondary channels to the same lead.
1. For information on ST functions performed at the Information Center, see “ST/AR ST
Segment Algorithm” on page 7-7.
9-2
Telemetry Functions at the Information Center & TeleMon
Telemetry Functions at the Information Center
To Initiate a Spot Check Measurement
Move the cursor over the SpO2 label. Then click on the Spot Check icon.
Note—There is no audio feedback at the transceiver (pulse tone or successful/
failed measurement) when Spot Check is initiated at the Information Center.
To Initiate Standby
See instructions under “Standby Mode” on page 4-4.
Locating the
Transceiver
(Find
Device)
The Find Device feature enables you to generate an alternating pitch repeated
tone at the transceiver to assist in locating a missing device. This function is
initiated in the Telemetry Setup Window. Find Device requires that the
transceiver has good working batteries and is within the coverage area. The
device will not return from out-of-range until association with the Information
Center is re-established.
To locate a
transceiver
Step
Action
From the Patient Window, select Telemetry Setup.
Select Find Device to generate a repeated tone at the transceiver.
Telemetry Functions at the Information Center & TeleMon
9-3
Telemetry Functions at the Information Center
To silence the
sound
Step
Action
Press and hold the Check button for 6 seconds to turn off the sound.
OR
Remove the batteries.
Viewing
Device
Location in
the Patient
Window
(optional)
You can see the location of a transceiver in the Patient Window. The Device
Location information is identified in the Patient Window by a compass icon
followed by the location name configured by your hospital for your system. If
the location of the transceiver changes, the Patient Window is updated within 5
seconds of the location change.
Viewing
Device
Location
History
(optional)
You can view the location history for a particular transceiver in the Device
Location History field in the Telemetry Setup window. The field displays the
five most recent Device Location descriptions in ascending order and updates
every time there is a change in location for the device. The total timespan of the
log is 60 minutes.
Note—If there is a change in location while viewing the Telemetry Setup
window, you must re-enter Telemetry Setup to see the change, as it does not
update automatically.
Patient
Configurable
Settings in
Telemetry
Setup
9-4
The Telemetry Setup window enables you to configure the transceiver for
patient-specific settings. All patient-specific settings will be reset to the unit
defaults upon patient discharge. To access the window, from the Patient
Window click Telemetry Setup.
The following settings can be adjusted in this window.
Telemetry Functions at the Information Center & TeleMon
Telemetry Functions at the Information Center
Patient-Configurable Settings in Telemetry Setup
Control
Function
Setting Choices
Telemetry
Button
Determine the Information Center
response when Telemetry Button
is pressed.
Nurse Call - generate nurse
call alarm
Factory
Default
Nurse Call
Record - generate a
recording strip
Nurse Call and Record generate nurse call alarm and
recording strip
None
Telemetry
Device:
Volume
Set the volume level for all
adjustable sounds on the
transceiver.
1 (low), 2, 3, 4, 5 (high)
enable (mute)
enable
Note—This control is grayed out
if disabled in Unit Settings.
Telemetry
Device:
Mute
Enable/disable Spot Check and
pulse detection tones on the
transceiver.
disable
Note—This control is grayed out
if disabled in Unit Settings.
Fixed Pacer
Amplitude
Sets the appearance of the pacer
spikes to a fixed size as they
appear in the patient window.
enable
disable
disable
Telemetry Functions at the Information Center & TeleMon
9-5
Telemetry Functions at the Information Center
Patient-Configurable Settings in Telemetry Setup
Control
Function
Setting Choices
Factory
Default
SpO2
Enabled
Enable/disable the SpO2
measurement at the Information
Center or Telemon.
enable
enable
SpO2 Mode
Determine the transceiver SpO2
behavior.
Spot Check - Provides
manual measurements so the
clinician can check as
needed. Measurement
initiated by plugging the
SpO2 cable into the
transceiver or by selecting
the Spot Check SpO2 icon in
the Patient Window. No
pulse or successful/failed
measurement tones are
generated when
measurement is initiated at
Information Center.
Note—Pulse Rate and Pleth Wave
are not available in Spot Check.
disable
Continuous - Sends an SpO2
parameter value to the
Information Center every
second. If selected, Pulse
Rate and Pleth Wave may
also be sent.
9-6
Telemetry Functions at the Information Center & TeleMon
Spot Check
Telemetry Functions at the Information Center
Patient-Configurable Settings in Telemetry Setup
Control
Function
Setting Choices
Factory
Default
Suppress
SpO2 INOPs
with NBP
Enable/disable the SpO2
algorithm to suppress sending
technical alarms from the
transceiver during an NBP
measurement for 60 seconds.
enable
enable
disable
Warning
If you measure SpO2 on a limb
that has an inflated NBP cuff, a
non-pulsatile SpO2 technical
alarm can occur. If the monitor
is configured to suppress this
alarm, there can be a delay of
up to 60 seconds in indicating
critical patient status, such as
sudden pulse loss or hypoxia.
Pleth Wave
Enable/disable the transmission
of the Pleth wave (and its
subsequent display) to the
Information Center. For
Continuous SpO2 mode only.
enable
disable
disable
(Pleth is not
displayed.)
Note—When enabled, the Pleth
wave replaces the Vb wave in the
Patient Window during 6-lead
monitoring.
Pulse
Enable/disable display of the
Pulse rate at the Information
Center. For Continuous SpO2
mode only.
enable
disable
disable
(Pulse rate is
not
displayed.)
Telemetry Functions at the Information Center & TeleMon
9-7
Telemetry Functions at the Information Center
Patient-Configurable Settings in Telemetry Setup
Control
Function
Setting Choices
Factory
Default
SpO2 Alarm
Turn SpO2 alarms on/off at the
Information Center.
enable (on)
enable
Change current settings back to
last saved clinical unit settings.
(none)
Unit Settings
UnitConfigurable
Settings
disable (off)
Unit Settings provide access to clinical configuration items that affect all
patients on an Information Center. Changes in unit settings take effect upon
discharge, except for Standby duration and SpO2 mode, which take effect
immediately.
Access to unit settings requires a password, and the displays are in English.
Telemetry specific settings are accessed through All Controls -> Unit Settings
-> Telemetry Setup. The setting for telemetry non-arrhythmia yellow alarms
is located in All Controls -> Unit Settings -> Alarms Unit Settings. For all
other information on unit settings, see IntelliVue Information Center
Instructions for Use.
Unit Settings - Telemetry Setup
Control
Function
Settings
Factory
Default
Patient Type
Set patient type used for SpO2
and NBP alarm limits.
Adult
Adult
9-8
Pediatric
Telemetry Functions at the Information Center & TeleMon
Telemetry Functions at the Information Center
Unit Settings - Telemetry Setup
Control
Function
Settings
Telemetry
Button
Determine the Information
Center response when Telemetry
Button is pressed.
Nurse Call - generate nurse
call alarm
Factory
Default
Nurse Call
Record - generate a recording
strip
Both - generate nurse call
alarm and recording strip
None
Telemetry
Device:
Volume
Set the volume level for all
adjustable sounds on the
transceiver.
1 (low) to 5 (high)
Telemetry
Device:
Mute
Enable/disable all adjustable
sounds on the transceiver.
enable (unchecked) = sound
mute
Standby
Duration
Sets the standby duration on the
device.
Infinite
10 minutes
20 minutes
30 minutes
1 hour
2 hours
3 hours
4 hours
Infinite
Enable
Remote
Suspend
Enable/disable alarm pause/
suspend at the transceiver.
enable
disable
disable (checked) = mute
disable
Telemetry Functions at the Information Center & TeleMon
9-9
Telemetry Functions at the Information Center
Unit Settings - Telemetry Setup
Control
Function
Settings
Factory
Default
Suspend
Duration
Sets the alarm suspend duration
time for each assigned device on
the Information Center.
1, 2, or 3 minutes
2 minutes
Battery
Gauge on
Information
Center
Display/disable a battery gauge
for each assigned device on the
Information Center.
enable
enable
(battery
gauge is
displayed)
RF Auto
Shutoff
disable
Note—Set to disable if
rechargeable batteries are being
used.
Enable/disable RF operation
during an extended situation of
all leads off for more than 10
minutes and the SpO2 sensor is
not connected.
enable
Fixed Pacer
Amplitude
Sets the appearance of the pacer
spikes to a fixed size as they
appear in the patient window.
enable
Enable
Autopair
Enable/disable the autopairing of
the transceiver and MP5 Patient
Monitor at the Information
Center.
enable
SpO2
Enabled
Enable/disable the SpO2
measurement at the Information
Center or Telemon.
enable
9-10
enable
disable
disable
disable
enable
disable
disable
Telemetry Functions at the Information Center & TeleMon
enable
Telemetry Functions at the Information Center
Unit Settings - Telemetry Setup
Control
Function
Settings
SpO2 Mode
Determine the transceiver SpO2
behavior.
Spot Check - Provides
manual measurements so the
clinician can check as
needed. Measurement
initiated by plugging the
SpO2 cable into the
transceiver or by selecting
Spot Check SpO2 icon in the
Patient Window. No pulse or
successful/failed
measurement tones are
generated when measurement
is initiated at Information
Center.
Note—Pulse Rate and Pleth
Wave are not available in Spot
Check.
Factory
Default
Spot Check
Continuous - Sends an SpO2
parameter value to the
Information Center every
second. If selected, Pulse
Rate and Pleth Wave may
also be sent.
Telemetry Functions at the Information Center & TeleMon
9-11
Telemetry Functions at the Information Center
Unit Settings - Telemetry Setup
Control
Function
Settings
Factory
Default
Suppress
SpO2 Inops
with NBP
Enable/disable the SpO2
algorithm to detect NBP running
and suppress sending technical
alarms from the transceiver for
60 seconds.
enable
enable
disable
Warning
If you measure SpO2 on a limb
that has an inflated NBP cuff,
a non-pulsatile SpO2 technical
alarm can occur. If the
monitor is configured to
suppress this alarm, there can
be a delay of up to 60 seconds
in indicating critical patient
status, such as sudden pulse
loss or hypoxia.
Pleth Wave
Pulse
9-12
Enable/disable the transmission
of the Pleth wave and its
subsequent display to the
Information Center. For
Continuous mode only.
enable
Enable/disable the transmission
of the Pulse rate and its
subsequent display to the
Information Center. For
Continuous mode only.
enable
disable
Note—When enabled, during
disable
(Pleth wave
is not
displayed.)
6-lead monitoring, the Pleth
wave will replace the Vb
wave in the Patient Window.
disable
Telemetry Functions at the Information Center & TeleMon
disable
(Pulse rate is
not
displayed.)
Telemetry Functions at the Information Center
Unit Settings - Telemetry Setup
Control
Function
Settings
Factory
Default
SpO2 Alarm
Turn SpO2 alarms on/off at the
Information Center.
enable (on)
enable
SpO2 Limits
High
Increment/decrement SpO2 high
alarm limit by 1 (in %).
Limit maximum is 100. Limit
minimum is 51 (adult) or 31
(pediatric). High and low
limit must be at least 1%
apart.
100 (adult,
pediatric)
SpO2 Limits
Low
Increment/decrement SpO2 low
alarm limit by 1 (in %).
Limit maximum is 99. Limit
minimum is 50 (adult) or 30
(pediatric). High and low
limit must be at least 1%
apart.
90 (adult,
pediatric)
3-wire
Set the unit default lead.
I, II, III
II
5-wire, ECG1
Set the unit default lead.
I, II, III, MCL, AVR, AVL,
AVF, V
II
5-wire, ECG2
Set the unit default lead.
I, II, III, MCL, AVR, AVL,
AVF, V
5-wire, ECG3
Set the unit default lead.
I, II, III, MCL, AVR, AVL,
AVF, V
III
5-wire EASI,
ECG1
Set the unit default lead.
I, II, III, AVR, AVL, AVF, V1,
V2, V3, V4, V5, V6
II
5-wire EASI,
ECG2
Set the unit default lead.
I, II, III, AVR, AVL, AVF, V1,
V2, V3, V4, V5, V6
V2
disable (off)
Telemetry Functions at the Information Center & TeleMon
9-13
Telemetry Functions at the Information Center
Unit Settings - Telemetry Setup
Factory
Default
Control
Function
Settings
5-wire EASI,
ECG3
Set the unit default lead.
I, II, III, AVR, AVL, AVF, V1,
V2, V3, V4, V5, V6
III
5-wire EASI,
ECG4
Set the unit default lead.
I, II, III, AVR, AVL, AVF, V1,
V2, V3, V4, V5, V6
V5
6-wire, ECG1
Set the unit default lead.
I, II, III, MCL, AVR, AVL,
AVF, V1, V2, V3, V4, V5, V6,
V7, V8, V9, V3R, V4R, V5R
II
6-wire, ECG2
Set the unit default lead.
I, II, III, MCL, AVR, AVL,
AVF, V1, V2, V3, V4, V5, V6,
V7, V8, V9, V3R, V4R, V5R
V2; V lead
choice is
determined
by Va and
Vb settings
6-wire, ECG3
Set the unit default lead.
I, II, III, MCL, AVR, AVL,
AVF, V1, V2, V3, V4, V5, V6,
V7, V8, V9, V3R, V4R, V5R
III
6-wire, ECG4
Set the unit default lead.
I, II, III, MCL, AVR, AVL,
AVF, V1, V2, V3, V4, V5, V6,
V7, V8, V9, V3R, V4R, V5R
V5; V lead
choice is
determined
by Va and
Vb settings
9-14
Telemetry Functions at the Information Center & TeleMon
Telemetry Functions at the Information Center
Unit Settings - Alarms
Control
Function
Settings
Factory
Default
Nonarrhythmia
Yellow
Alarms
Set latched/non-latched status
for SpO2, ST, and other nonarrhythmia yellow alarms.
Latched
Latched
Leads Off
Adjust the severity level of this
technical alarm (INOP).
Low
Non-latched
Low
Medium
High
Replace
Battery
Adjust the severity level of this
technical alarm (INOP).
Low
Low
Medium
High
RF Auto
Shutoff
When RF Auto Shutoff is enabled (default), the transceiver stops broadcasting a
radio signal in order to prevent interference with other transceivers in use. This
condition occurs if there is no ECG signal for 10 minutes and the SpO2 sensor
cable is not inserted in the SpO2 sensor port. The technical alarm, "No Signal",
followed by the "Transmitter Off" INOP will be displayed at the Information
Center. Remove the batteries to conserve battery charge. However, if there is no
ECG signal for 10 minutes but the SpO2 cable is inserted, the transceiver does
not stop broadcasting the signal. This feature can be disabled in Unit Settings.
Telemetry Functions at the Information Center & TeleMon
9-15
Transceiver Operation when Connected to TeleMon
Transceiver Operation when Connected to TeleMon
When connected to TeleMon, the following differences in transceiver operation
will be in effect.
Important—The transceiver must have good batteries installed before being
connected to TeleMon.
Alarms
• Alarm Suspend/Pause and Standby can be initiated only from TeleMon,
not from the transceiver or the Information Center. The alarm suspend
indicator on the transceiver will accurately reflect the current state of
alarm pause.
ECG Operation
• Vb, the second V-lead in 6-wire lead-set, is not supported.
• After a change in leadset, the TeleMon returns to the default ECG
settings, and arrhythmia relearn occurs automatically. Be sure to check the
monitoring leads after you switch leadsets.
SpO2 Operation
• SpO2 is always in continuous mode.
• Changes in SpO2 mode do not take effect until after the transceiver is
disconnected from TeleMon. Mode settings are defined in the following
table:
Mode Selected at TeleMon
•
9-16
Mode at Disconnected Transceiver
Continuous
Continuous
5-min.
Continuous
1-min.
Continuous
Manual
Spot Check
If the sensor is disconnected from the transceiver during SpO2 monitoring
at TeleMon, a No Sensor technical alarm will be displayed at the
Information Center. NO VISUAL OR AUDITORY INDICATORS FOR
THE NO SENSOR ALARM WILL BE ACTIVE AT TELEMON.
Telemetry Functions at the Information Center & TeleMon
Transceiver Operation when Connected to TeleMon
Battery
• The transceiver battery status is not available. When the Check button is
pressed, the battery gauge on the transceiver and at the Information Center
indicates full power, regardless of actual battery strength.
Defibrillation
• In the event of patient defibrillation, it may take several seconds for the
ECG trace to reappear on the screen.
Telemetry Overview
• If NBP is being monitored, NBP values will be displayed at the Overview
window.
Telemetry Functions at the Information Center & TeleMon
9-17
Transceiver Operation when Connected to TeleMon
9-18
Telemetry Functions at the Information Center & TeleMon
You can display measurement data from IntelliVue TRx and TRx+ Transceivers
on IntelliVue Patient Monitors. The transceiver and the monitor must be
assigned to the same patient; this is called "pairing". Once paired, the ECG
source is automatically detected at the Information Center. Should you
subsequently switch the ECG source between the two devices, the change is also
automatically detected at the Information Center.
There are two ways to transmit measurement data to the monitor: either by
directly connecting the transceiver to the monitor using an interface cable
(IntelliVue MP5 Patient Monitor only), or by pairing the transceiver with the
monitor at the Information Center. This chapter describes how to pair the
devices using a direct connection and how the devices operate in paired mode.
It includes the sections listed below. For additional information on monitor
operation, consult the MP5 Patient Monitor Instructions for Use. For additional
information on pairing other IntelliVue Patient Monitors at the Information
Center, consult the IntelliVue Information Center Instructions for Use.
•
•
•
•
Pairing with a Direct Connection to the MP5 Patient Monitor. . . . . . 10-2
Pairing at the Information Center . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-3
Alarm Behavior with Telemetry Overview . . . . . . . . . . . . . . . . . . . . 10-3
Paired Device Synchronized Alarm Settings . . . . . . . . . . . . . . . . . . . 10-7
Note—Pairing of transceivers and IntelliVue Patient Monitors is not available
with IntelliVue Patient Monitors connected to the M3140 Information Center or
with IntelliVue Patient Monitors operating via a 1.4/2.4 GHz wireless
connection.
Pairing with IntelliVue Patient Monitors
10-1
Introduction
10
Pairing with IntelliVue Patient
Monitors
Pairing with a Direct Connection to the MP5 Patient Monitor
Pairing with a Direct Connection to the MP5 Patient Monitor
When the transceiver, assigned to a patient sector at the Information Center, uses
an interface cable to connect to an MP5 Patient Monitor, the Information Center
automatically pairs (if configured to do so) the two devices. Pairing using this
method provides 4 ECG waves at the MP5, along with SpO2 measurements and
a pleth wave. Lead selection and alarm limits may be changed either at the
Information Center or the MP5 Patient Monitor.
To connect the transceiver to the monitor, perform the following steps:
Step
Action
Remove the protective cover from the transceiver’s service port.
Insert the interface cable into the service port.
Attach the interface cable to the monitor using the port labeled with
the
icon.
Warning
When the transceiver is directly connected to the monitor, arrhythmia
relearning is initiated, and again when the transceiver is disconnected from
the monitor.
Controls on the Transceiver, (e.g. Telemetry button to generate a Nurse
Call alarm) will be inactive when directly connected to the monitor.
Important—When transceivers and MP5 Patient Monitors are paired directly via
an interface cable, your ECG source must be connected before connecting or
disconnecting the interface cable to maintain synchronized alarm settings. The
interface cable must be disconnected prior to unpairing the devices at the
Information Center or the monitor.
10-2
Pairing with IntelliVue Patient Monitors
Pairing at the Information Center
Pairing at the Information Center
You can pair an IntelliVue Patient Monitor (Release B.1 or higher) with the
transceiver at the Information Center. The telemetry data automatically displays
as a permanent overview session in the Telemetry Data Window on the
IntelliVue Patient Monitor. At the Information Center, the telemetry data and
any patient monitor data (e.g. NBP) are integrated in the patient sector.
See your IntelliVue Information Center Instructions for Use or IntelliVue Patient
Monitor Instructions for Use for information on how to pair/unpair devices.
Alarm Behavior with Telemetry Overview
Both the IntelliVue Telemetry System and the IntelliVue Patient Monitor source
alarms. The following tables summarize alarm behavior when a telemetry device
is paired with an IntelliVue bedside monitor (wirelessly or directly connected to
the MP5 using the Telemon/Service Port). For detailed information, see the
IntelliVue Patient Monitor Instructions for Use and the IntelliVue Information
Center Instructions for Use.
Pairing with IntelliVue Patient Monitors
10-3
Alarm Behavior with Telemetry Overview
Alarm
Suspend/
Pause
When alarms are suspended/paused, the messages and types of alarms affected
depend on where the suspend/pause was initiated.
If alarms are
suspended/
paused
from....
Information
Center
these alarms are
suspended/
paused
both bedside and
telemetry
measurements
IntelliVue
bedside
Patient Monitor measurements only
Alarm Silence
10-4
and this message appears
Information Center: ALARMS
SUSPENDED or ALARMS
PAUSED
Bedside: ALARMS OFF in
Overview window and ALARMS
OFF or ALARMS PAUSED on the
monitor (depending on
configuration)
Information Center: BED
ALARMS SUSPENDED or BED
ALARMS PAUSED (depending on
configuration)
Bedside: ALARMS OFF or
ALARMS PAUSED
When an active alarm is silenced, the types of alarms that are silenced depend on
the alarm source and where the silence was initiated.
Pairing with IntelliVue Patient Monitors
Alarm Behavior with Telemetry Overview
Warning
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.
Alarm
Source
Where
Silenced
Effect at
Paired
Bedside
Effect at
Information
Center
Bedside alarm
Bedside
Silence button
Alarm is
silenced
Bedside alarm is
silenced. There is
no effect on
telemetry alarms
(if Global
Silence is not
enabled at the
Information
Center)
Telemetry
alarm
Bedside
No effect on
telemetry
alarms
No effect on
telemetry alarms
Bedside and/or Telemetry Data
telemetry alarm Window at
bedside (if
configured)
Bedside and/or Bedside and/or
telemetry alarm telemetry alarm
is silenced (if
is silenced
Silence
Overview
Alarms is
enabled at the
Information
Center)
Pairing with IntelliVue Patient Monitors
10-5
Alarm Behavior with Telemetry Overview
Alarm
Source
Where
Silenced
Effect at
Paired
Bedside
Effect at
Information
Center
Bedside and/or Information
telemetry alarm Center
Bedside and/or Bedside and/or
telemetry alarm telemetry alarm
is silenced
is silenced
Bedside and/or Bedside
telemetry alarm Silence button
Bedside and/or Bedside and/or
telemetry alarm telemetry alarm
is silenced
is silenced (if
Global Silence is
enabled at the
Information
Center)
Note—If the transceiver is connected to TeleMon, silencing an active alarm at
TeleMon silences the alarm at TeleMon only. It has no effect on the alarms at
the Information Center.
Alarm/INOPs
at the
Information
Center
10-6
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 alarms and INOPs
based on ECG source
Displayed, recorded (if
configured), and stored
Bedside non-ECG alarms and
non-ECG INOPs
Displayed, recorded (if
configured), and stored
Pairing with IntelliVue Patient Monitors
Paired Device Synchronized Alarm Settings
Paired Device Synchronized Alarm Settings
If the patient’s ECG is initially being measured with a patient monitor, and then
the patient is connected to the transceiver for monitoring, the Information Center
will use the patient monitor settings for the transceiver. In general, the
following settings will be synchronized:
Heart Rate
HR/Pulse Alarm On/Off, Heart Rate High/Low Limit
ECG
Primary Lead, Secondary Lead, Va Lead, Vb Lead
Arrhythmia
Analysis Mode, Asystole Threshold, Pause
Threshold, VTach HR, VTach Run, PVCs/min, Vent.
Rhythm, SVT HR, SVT Run, PVCs/min On/Off,
Pacer not Capture On/Off, Pacer not Pace On/Off,
Non-sustain On/Off, Vent. Rhythm On/Off, Run
PVCs On/Off, Pair PVCs On/Off, Missed Beat On/
Off, Pause On/Off, R-on-T On/Off, Vent. Bigeminy
On/Off, Vent. Trigeminy On/Off, Multiform PVCs
On/Off, Irregular HR On/Off, SVT On/Off
ST
ST Analysis On/Off, ST Alarm On/Off, ISO point, J
point, ST point, ST Priority List, Single ST Alarm
Limit, Multi ST Alarm Limit
SpO2T
SpO2 Alarms On/Off, SpO2 Alarm Limits
NBP Alarm Suppression On/Off, Pulse (SpO2) On/
Off
Important—When transceivers and MP5 Patient Monitors are paired directly via
an interface cable, your ECG source must be connected before connecting or
disconnecting the interface cable to maintain synchronized alarm settings. The
interface cable must be disconnected prior to unpairing devices at the
Information Center or the monitor.
Pairing with IntelliVue Patient Monitors
10-7
Paired Device Synchronized Alarm Settings
10-8
Pairing with IntelliVue Patient Monitors
All installation tasks are performed by Service personnel and are described in
detail in the service documentation accompanying the system. This chapter
provides procedures for maintaining the equipment after installation including
assigning labels for replacement transceivers, keeping the transceiver clean, and
troubleshooting common problems. It includes the following sections:
•
•
•
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-2
Cleaning and Sterilization. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-4
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-12
Maintenance, Cleaning & Troubleshooting
11-1
Introduction
11
Maintenance, Cleaning &
Troubleshooting
Maintenance
Maintenance
Basic
Monitoring
Before beginning monitoring on a patient:
•
•
•
•
Check for any mechanical damage.
Check all the external leads, plug-ins and accessories.
Check all the functions of the instrument which are needed to monitor the
patient.
Ensure that the instrument is in good, working order.
Do not use the IntelliVue transceiver for any monitoring procedure on a patient
if you identify features which demonstrate impaired functioning of the
instrument. Contact the service provider.
Warning
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.
Testing
Alarms
Visual and auditory alarms appear at the Information Center. One method of
verifying visual and auditory alarms at the Information Center is to connect the
transceiver to an ECG or ECG/SpO2 simulator. By varying the ECG rate and
SpO2 value, alarms can be generated and confirmed for proper operation.
Label Assignment for Replacement Transceiver
During installation, an electronic equipment label is assigned to each transceiver
in a clinical unit so that the device can be identified during operation within the
wireless system. If a transceiver is lost, the Assign Label function at the
Information Center enables you to unassign the label from a lost transceiver, and
re-assign its label to a replacement transceiver. Labels are limited to those
available in an individual clinical unit. The Label Assignment function requires
a password for access, and its controls are available in English only.
11-2
Maintenance, Cleaning & Troubleshooting
Maintenance
Re-assigning
an Equipment
Label
The following instructions enable you to reassign an equipment label from a lost
device to a replacement transceiver.
Note—If the leadset is attached during this procedure, the label assignment will
fail.
Step
Action
At the Information Center, clear the sector that the original
Equipment Label was assigned to. (Patient Window -> Sector
Setup -> Clear Sector -> OK).
Note— Ensure that no patient is being monitored by the original
(lost) device before clearing the sector.
Select All Controls, then Label Assignment.
Enter password.
Note—The remaining screens will be in English only.
Insert batteries into the replacement device, and remove the leadset,
if present.
All transceiver indicators should flash, and you should hear a double
tone repeated every 3 seconds, indicating that the transceiver has no
Equipment Label.
Select Refresh.
Select the MAC address of the replacement device from the “New
Devices” list.
Note—The transceiver MAC address is located inside the battery
compartment.
Select the Equipment Label that was assigned to the unit’s previous
device from “Equipment Labels” list.
Maintenance, Cleaning & Troubleshooting
11-3
Cleaning and Sterilization
Step
Action
Select Assign Label to initiate programming of the Equipment
Label into the replacement telemetry device
- AND within 10 seconds, press the Check button on the telemetry device.
Note—If 10 seconds pass without a button push, then repeat starting
with step 5.
When the label assignment is complete, the assignment will be
verified in the “Status” field.
Go back into Sector Setup, and select the Bed Label and
Equipment Label, followed by OK.
The transceiver goes through the normal startup sequence and starts
monitoring. Verify the signal in the appropriate Patient Sector.
Cleaning and Sterilization
The procedures in this section keep the transceiver clean and provide protection
against infectious agents and bloodborne pathogens. Both the outside of the
transceiver and the inside of the battery compartment must be kept free of dirt,
dust, and debris. The procedures in this section cover the following activities:
•
•
Cleaning: removing surface contaminants from the device.
EO Sterilization: using EO gas treatment to decontaminate cleaned
equipment.
Important—After exposure, the transceiver must be cleaned or cleaned and
EO sterilized as per the instructions contained herein.
11-4
Maintenance, Cleaning & Troubleshooting
Cleaning and Sterilization
Cleaning the Transceiver
Caution
Use of abrasive cleaning materials, or disinfectants or cleaning agents not listed
herein, on any part or component of the IntelliVue TRx or TRx+ transceiver may
damage the components. The use of Sterrad® and Virex® is not supported.
Caution
When cleaning the TeleMon/Service port, do not use any stiff, rigid instruments,
tools, or other devices to clean debris in the port, as such actions will damage the
connector pins. A forceful water stream may be used after soaking for 5 minutes
to flush the port if necessary.
Perform the following steps to clean the transceiver of visible surface
contamination.
Step
Action
Remove the batteries and any cables or accessories.
Soak the transceiver in 70% isopropyl alcohol or 10% sodium
hypochlorite (prepared within 24 hours) for 5 minutes.
Wipe the transceiver clean by using a cloth dampened modestly
with one of the following approved cleaning agents:
•
•
70% isopropyl alcohol
10% sodium hypochlorite (prepared within 24 hours)
If any visible residue remains in the TeleMon/Service Port, flush the
port with a forceful stream of water.
Rinse or wipe the transceiver with distilled water.
Allow to air-dry, or dry with a non-lint producing cloth.
Maintenance, Cleaning & Troubleshooting
11-5
Cleaning and Sterilization
EO Sterilization
The transceiver can be subjected to EO sterilization four times per year for 2
years.
Equipment must first be cleaned (see “Cleaning the Transceiver” on page 11-5)
before this procedure is performed.
Note—If there is concern over cross-contamination due to leadsets or sensors,
new leadsets or sensors should be used.
Equipment and
Materials
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.
11-6
See “References” on page 11-9.
Maintenance, Cleaning & Troubleshooting
Cleaning and Sterilization
Use the following equipment and material to process the transceiver:
1. Ethylene Oxide gas (Allied Signal Oxyfume-2002™ or equivalent).
2. Gas sterilizer manufactured by American Sterilizer Company or other
appropriate manufacturer.
EO
Sterilization
The following generic procedure can be used to supplement the sterilizer
manufacturer’s instructions, although the processing times, temperatures, and
EO concentrations must be equivalent to those given in this procedure in order
to achieve a sterility level of 10E-6.
Step
Action
Remove any obvious contamination from the equipment to be
processed using approved cleaners.
Individually package each transceiver in standard central supply
room (CSR) wrapping material secured with EO color-change indicator tape.
Apply -26 inHg +/- 1 (-12.77 psig +/- .49) vacuum to the empty
sterilizer chamber two times, to remove any residual EO or moisture. Vent the vacuum pump to the outdoors to avoid toxic hazards
to personnel.
Insert the equipment to be processed into the gas sterilizer.
Heat the chamber and its contents to 54.4 +/- 2.8oC (130 +/- 5oF).
Apply -26 inHg +/- 1 (-12.77 psig +/- .49) vacuum to the sterilizer
chamber.
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.
Note—At this pressure, the concentration of sterilant in the chamber
will be 600 +/- 50 mg/liter, regardless of the chamber size.
Maintenance, Cleaning & Troubleshooting
11-7
Cleaning and Sterilization
Step
Action
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
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 environmental regulations. (If the mixture is captured, it can be separated commercially and the component gases re-used.)
See “References” on page 11-9.
a. Pump the gas mixture out of the chamber until you obtain a vacuum of -26 inHg +/- 1 (-12.77 psig +/-.49), returning the mixture to a suitable evacuated container.
b. Return the sterilizer chamber to ambient pressure by introducing air that has been bacterially filtered.
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 residual EO. The vacuum pump must be vented to the outdoors.
b. Return the sterilized chamber to ambient pressure by introducing air that has been bacterially filtered.
12
11-8
Continue with the “Aeration Procedure” (following).
Maintenance, Cleaning & Troubleshooting
Cleaning and Sterilization
Aeration
Procedure
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 11-9.
Aerate the processed equipment by performing the following steps:
Step
Action
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.
Continue with the “Test Procedure” (following).
These values will produce EO and Ethylene Chlorohydrin residual levels in the
transceiver and patient cable plastic that meet ISO 10993-7 in conjunction with
AAMI Technical Information Report 19, that the FDA currently endorses.
References
OSHA: Standard for acceptable levels of personnel exposure to Ethylene Oxide
Gas: 1 ppm on an eight-hour time-weighted average basis.
Reference: U.S.A. Federal Regulations 49 FR 25734/29 CFR Part 1910.1047,
June 22, 1984; final approval 50 FR 9800/2- CFR Part 1910.1047, March 12,
1985.
Maintenance, Cleaning & Troubleshooting
11-9
Cleaning and Sterilization
Test Procedure
Caution
You must perform this test each time you put a transceiver through the EO
sterilization process.
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.
Note—This test assumes that the telemetry system and Information Center are
fully installed, and that you have performed the procedure to learn the
transceiver identity code.
Test the transceiver by performing the following steps. If the test indications do
not appear, refer to your service provider.
Step
11-10
Action
Perform a mechanical inspection of the transceiver (connectors,
battery door opening and closing, Telemetry and Check buttons).
At the Information Center, select the telemetry bedside you are
testing.
Maintenance, Cleaning & Troubleshooting
Cleaning and Sterilization
Step
Action
Test the transceiver:
a. Put fresh batteries in the transceiver (without a leadset
attached) and close the battery door
Result: All six lead lights should flash, and one light
should remain on.
b. Attach a leadset to the ECG port, and attach an SpO2
sensor to the SpO2 port. If an ECG simulator is available, attach the ECG leads to the simulator and the SpO2
sensor to yourself. At TeleMon, set the SpO2 sample
rate to Continuous.
Result: An ECG trace and SpO2 information should be
visible on the Information Center display. All transceiver 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.
Alternate
Cleaning
and
Disinfection
Methods
a. Connect the transceiver to TeleMon and observe the
ECG waveform and SpO2 numerics on the TeleMon display.
Result: The ECG waveform and SpO2 numerics should
be displayed on the TeleMon screen.
The transceiver may be cleaned and disinfected using Metrex Cavi-Wipes, CaviWipes XL, CaviCide, or PDI Sani-Cloth® HB pre-moistened towelettes. Follow
the instructions supplied by the manufacturers of these products.
Maintenance, Cleaning & Troubleshooting
11-11
Troubleshooting
Troubleshooting
Basic Troubleshooting
For problems with...
•
ECG measurement
see...
“Optimizing ECG Measurement Performance”
on page 6-29.
“Using EASI Leads to Troubleshoot” on page 628.
“Technical Alarms (INOPs)” on page 5-9.
•
SpO2 measurement
“Optimizing SpO2 Measurement Performance”
on page 8-20.
“Technical Alarms (INOPs)” on page 5-9.
•
Batteries
“Battery Information” on page 4-13.
“Self Test” on page 4-11.
•
Nurse call
Nurse Call may have been turned off for the
patient. See “Telemetry Button” on page 9-5 for
directions on how to turn it on.
•
Electromagnetic
Interference
“Reducing Electromagnetic Interference” on
page 12-7.
Important—If changes are made to the Group Settings (how telemetry devices,
such as Access Points and Controllers, are grouped in order to provide coverage
for patients throughout the hospital), there will be a break in monitoring of all
transceivers within the Group(s) being modified. Monitoring will resume when
the new Group Settings are in place. Clinical settings will be unaffected by the
reconfiguration.
Information
Signals
11-12
If there is a connection failure within the IntelliVue Clinical Network, an
information signal will be generated. This information signal will be displayed
Maintenance, Cleaning & Troubleshooting
Troubleshooting
in the system message area on the Information Center where the affected
wireless patient monitoring device(s) (transceiver, access point, access point
controller, sync unit, or router) is assigned, as well as on all other Information
Centers connected to a common Database Server. The condition causing the
failure will be described in the Wireless Status Log, which is available in
Service Mode.
Information Signals
Information
Signal
Description
What to Do
Wireless
monitoring loss Contact Service
Problem with wireless
network infrastructure
device(s).
Contact Service.
communication disruption
are available in the
Wireless Status Log.
Note—This
information signal
appears on ALL
Information Centers
connected to a
common Database
Server.
Router failure
Call Service
Note—Details about the
A router used in the
wireless network has
failed.
Contact Service.
Note—This
information signal
appears on ALL
Information Centers
connected to a
common Database
Server.
Maintenance, Cleaning & Troubleshooting
11-13
Troubleshooting
11-14
Maintenance, Cleaning & Troubleshooting
This chapter describes the regulatory standards that the product complies with,
along with product and measurement specifications. It includes the following
sections:
•
•
•
•
•
•
•
Regulatory Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-2
Electromagnetic Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-5
Battery Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-8
Radio Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-9
Physical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-12
Environmental Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-14
Measurement Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-15
Safety Standards & Specifications
12-1
Introduction
12
Safety Standards & Specifications
Regulatory Information
Regulatory Information
Intended Use
The device is intended to provide ambulatory and bedside monitoring of ECG
and SpO2 parameters of adult and pediatric patients in professional healthcare
facilities. It is intended to be used by trained healthcare personnel. It is not
intended for home use.
Indications
for Use
Indicated for use by health care professionals whenever there is a need for
monitoring the physiological parameters of patients. Intended for monitoring,
recording and alarming of multiple physiological parameters of adult and
pediatric patients in transport and hospital environments.
Rx
Federal Law restricts this device to sale by or on the order of a physician.
Patient
Population
This device is not for use with infant or neonatal patients.
Use of the transceiver is restricted to one patient at a time.
The components/accessories which come into contact with the patient’s skin
are in compliance with the relevant requirements of EN ISO 10993-1 for
Biocompatibility. The transceiver is not designed for direct contact with the
patient’s skin. The accompanying pouch is the appropriate means for holding
the transceiver.
12-2
Safety Standards & Specifications
Regulatory Information
Safety
Standards
The device complies with the following safety requirements for medical
electrical equipment:
•
•
•
•
•
•
•
•
IEC 601-1:1988 + A1:1991 + A2:1995 General Requirements for Safety
(with worldwide deviations, including U.S. deviations)
IEC 60601-1-1:2000 System Safety
IEC 60601-1-2:2001 Electromagnetic Compliance
IEC 60601-1-4:1996 Safety for Programmable Electrical Medical Systems
ISO 10993-1:2003 Biocompatibility (for lead wires and pouch)
ISO 9919:2005 Pulse Oximeters
EN 865:1997 Particular Requirements for Pulse Oximeters
AAMI EC 13:2002 Performance Standard, Cardiac Monitors
Essential Performance
The IntelliVue Telemetry System provides Essential Performance (EP) under
normal operating conditions (includes EMC exposure) only as a complete
Medical Electrical System, consisting of the TRx4841A or TRx4851A
Transceivers, the IntelliVue Telemetry Network Infrastructure, the M3150
Information Center, the M2636C TeleMon Companion Monitor (optional), and
the M8105A IntelliVue MP5 Patient Monitor (optional).
The IntelliVue Telemetry System achieves its Essential Performance exclusively
through alarm generation at the M3150 Information Center.
The IntelliVue Telemetry System protects the patient from unacceptable
immediate clinical risk by generating specific Physiological Alarms when
appropriate. If the System cannot generate Physiological Alarms, then relevant
Severe or Hard Technical Alarms (Inoperative Conditions) are created.
Safety Standards & Specifications
12-3
Regulatory Information
System Classification
The TRx4841A and TRx4851A Transceivers are FDA Class II devices. They
have the following characteristics.
Characteristic
Definition
Internally Powered
Equipment
The TRx4841Aand TRx4851A transceivers are
internally powered devices.
Continuous Operation
All equipment is Ordinary Equipment, IPX0, and
provides continuous operation
Type CF
Defibrillation Proof
The TRx4841A and TRx4851A transceivers are
Type CF Defibrillation Proof relative to ECG and
SpO2 patient applied parts.
Water Resistance
IPX0, Non-Protected
When placed inside a Philips-specified carrying
pouch with the flap closed and snaps secured, the
combination of the transceiver and pouch will
withstand showering for up to 10 minutes.
FCC
Compliance
(USA only)
Operation of this equipment requires the prior coordination with a frequency
coordinator designated by the FCC for the Wireless Medical Telemetry Service.
The transceiver and the IntelliVue Telemetry System are subject to radio
frequency interference. In the event of suspected radio frequency interference
with your device, contact your service provider. This device complies with Parts
15 and 95H of the Federal Communications Commission (FCC) Rules.
Operation is subject to the condition that this device does not cause harmful
interference.
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.
12-4
Safety Standards & Specifications
Electromagnetic Compatibility
AC Power
Source
The system is not intended for connection to the public mains as defined in
CISPR11.
Software
Hazard
Prevention
Potential hazards arising from errors in the software program have been
identified. Mitigations applied to reduce the associated risk of such hazards are
included as part of the Risk Management, Clinical Evaluation, and Verification
and Validation phases of the product’s development.
Electromagnetic Compatibility
Medical electrical equipment can either generate or receive electromagnetic
interference. This product has been evaluated for electromagnetic compatibility
(EMC) with the appropriate accessories according to IEC 60601-1-2:2001, the
international standard for EMC for medical electrical equipment. This IEC
standard has been adopted in the European Union as the European Norm, EN
60601-1-2:2001.
Radio frequency (RF) interference from nearby transmitting devices can degrade
performance of the product. Electromagnetic compatibility with surrounding
devices should be assessed prior to using the product.
Fixed, portable, and mobile radio frequency communications equipment can also
affect the performance of medical equipment. See your service provider for
assistance with the minimum recommended separation distance between RF
communications equipment and the product.
The cables, sensors/transducers, and other accessories for which compliance is
claimed are listed in the Service and User documentation accompanying the
product.
Safety Standards & Specifications
12-5
Electromagnetic Compatibility
Warning
The use of accessories, transducers and cables other than those specified in
the product service and user documentation can result in increased
electromagnetic emissions or decreased immunity of the product.
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 on
patients.
12-6
Safety Standards & Specifications
Electromagnetic Compatibility
Reducing Electromagnetic Interference
The transceiver and associated accessories can be susceptible to interference
from other RF energy sources and continuous, repetitive, power line bursts.
Examples of other sources of RF interference are other medical electrical
devices, cellular products, information technology equipment, and radio/
television transmission. If interference is encountered, as demonstrated by
artifact on the ECG or dramatic variations in physiological parameter
measurement values, attempt to locate the source. Assess the following:
•
•
•
•
Is the interference due to misplaced or poorly applied electrodes or
sensors? If so, re-apply electrodes and sensors correctly according to
directions in Chapter 6. ECG Monitoring.
Is the interference intermittent or constant?
Does the interference occur only in certain locations?
Does the interference occur only when in close proximity to certain
medical electrical equipment?
Once the source is located, attempt to attenuate the interference by distancing
the transceiver from the source as much as possible. If assistance is needed,
contact your local service representative.
Restrictions
for Use
Artifact on ECG and other physiological waveforms caused by electromagnetic
interference should be evaluated by a physician or physician authorized
personnel to determine if it will negatively impact patient diagnosis or treatment.
Safety Standards & Specifications
12-7
Battery Specifications
Battery Specifications
Battery Type
Equipment
Battery Type
Battery Life
Specification
2 fresh AA disposable alkaline batteries
Note—The battery life specifications listed below are based on Duracell MN
1500 batteries. Battery life for other brands may differ.
Operating Mode
Battery Life
ECG Only
50 hours
ECG/SpO2 Continuous
18 hours
ECG/SpO2 Spot Check
between 18 hours and 50 hours, depending on
usage rate
Transceiver
Current
Operating Mode
12-8
Nominal Current
ECG Only
51.3 mA @ 2.4V
ECG/SpO2 Continuous
116 mA @ 2.4V
Safety Standards & Specifications
Radio Specifications
Radio Specifications
TRx4841A
Parameter
Frequency Ranges
Specification
Bands: 1395-1400 MHz and 1427-1432 MHz
Channel Spacing: 1.6 MHz
RF Output Power
8 dBm +2/-3 dB (3.2 mW to 10 mW), into
antenna load @ nominal battery voltage
Transceiver Frequency
Accuracy during normal
operation
+/- 15 KHz relative to channel frequency,
includes temperature compensation and aging
effects
Modulation Type
FSK with Root Raised Cosine filtering
(1M60Q7D)
Out of Band Spurious
Emission Levels:
• <= 1394 MHz, >=
1401 MHz
• <= 1428 MHz, >=
1433 MHz
<-41 dBm in 1 MHz bandwidth for FCC limit
Occupied bandwidth as
defined by power in 99%
BW
< +/- 800 KHz
Safety Standards & Specifications
12-9
Radio Specifications
TRx4851A
Parameter
Frequency Range
Specification
ISM Band: 2400 - 2483.5 MHz
Channel Spacing: 1.728 MHz
RF Output Power
FCC: 17 dBm +/- 1 dB (40 mW to 63 mW,
nominal 50 mW), into antenna load @
nominal battery voltage
ETSI: 12 dBm +/- 1 dB (13 mW to 20 mW,
nominal 16 mW), into antenna load @
nominal battery voltage
ARIB: 13.5 dBm +/- 1 dB (18 mW to 28 mW,
nominal 22 mW), into antenna load @
nominal battery voltage
12-10
Transceiver Frequency
Accuracy during normal
operation
<+ 60 /- 100 KHz relative to channel
frequency, includes temperature compensation
and aging effects
Modulation Type
GFSK, Gaussian Frequency Shift keying
(1M40Q7D)
Modulation Bandwidth
Typically 1.4 MHz (20 dB Bandwidth)
Out of Band Spurious
Emission Levels
Meets ETSI, RS210, FCC, ARIB standards
Safety Standards & Specifications
Radio Specifications
WMTS
Channel
Frequencies
1395 to 1400
MHz Band
Parameter
Specification
Lower band edge
1395 MHz
Channel 1
1395.8977 MHz
Channel 2
1397.4970 MHz
Channel 3
1399.0963 MHz
Upper band edge
1400 MHz
Channel spacing
1.6 MHz
Safety Standards & Specifications
12-11
Physical Specifications
1427 to 1432
MHz Band
Parameter
Specification
Lower band edge
1427 MHz
Channel 4
1427.8979 MHz
Channel 4a (*)
1430.2410 MHz
Channel 5 (**)
1429.4972 MHz
Channel 6 (**)
1431.0965 MHz
Upper band edge
1432 MHz
* Available in special geographic area only.
** Not available in special geographic areas.
Physical Specifications
ECG-only
Transceiver
Parameter
12-12
Specification
Height
140 mm (5.6 in)
Width
75 mm (3 in)
Depth
28.5 mm (1.14 in)
Safety Standards & Specifications
Physical Specifications
Parameter
Weight
• without batteries or
leadset
• with batteries only
• with batteries and 3wire leadset
Specification
•
<165 g (5.8 oz.)
•
•
<210 g (7.4 oz)
<284 g (10 oz.)
215 cm3
Volume
ECG/SpO2
Transceiver
Parameter
Specification
Height
140 mm (5.6 in)
Width
88 mm (3.52 in)
Depth
37 mm (1.48 in)
Weight
• without batteries or
leadset
• with batteries only
• with batteries and 5wire leadset
Volume
•
<205 g (7.2 oz.)
•
•
<255 g (9.0 oz)
<324 g (11.5 oz.)
300 cm3
Safety Standards & Specifications
12-13
Environmental Specifications
Environmental Specifications
Parameter
Temperature
• Operating
• Storage
• 0 t 37 oC (32 to 99o F)
• -40o C to 60o C (-40 to 140o F) without batteries
Humidity
• Operating
• Storage
• < 95% RH at 37o C (99o F) non-condensing
• < 90% RH at 60o C (140o F) without batteries
Altitude
• Operating &
Non-operating
12-14
Specification
Safety Standards & Specifications
0 to 3,048 m (10,000 ft)
Measurement Specifications
Measurement Specifications
ECG
Parameter
ECG channel
transmitted Leads
• 3 electrodes
• 5 electrodes
Specification
•
•
•
5 electrodes,
EASI
•
•
6 electrodes
•
Channel #1 = I, II, or III
Channel #1 = II
Channel #2 = III
Channel #3 = MCL
Channel #1 = Va-i
Channel #2 = Va-s
Channel #3 = Ve-s
Channel #1= II
Channel #2 = III
Channel #3 = Va
Channel #4 = Vb
Resolution
5 μV
ECG Input
Differential, defibrillator protected against 360
joules discharge into a 100 ohm load
Input Impedance
> 5 megohms (@ 10 Hz
Input Dynamic Range
+/- 9 mV
DC Offset Range
+/- 320 mV
CMRR
> 90 dB @ 50, 60 Hz
Bandwidth +/- 3 dB
0.05 to 40 Hz
Safety Standards & Specifications
12-15
Measurement Specifications
Parameter
Specification
Gain Accuracy
+/- 5% at 25 oC (77 oF)
Noise Referred to ECG
Input
AAMI: 30 μV
Lead Wires
3, 5 or 6-wire leadset. 5-lead compatible with
IntelliVue Patient Monitor, AAMI/IEC color
codes
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 pacers1
Amplitude
+2 to +700 mV
+2 to +500 mV
+2 to +400 mV
Negative pacers1
Amplitude
-2 to -700 mV
-2 to -500 mV
-2 to -400 mV
Width
0.1, 0.2, 0.5 and 1.0 ms
1.5 ms
2 ms
Width
0.1, 0.2, 0.5 and 1.0 ms
1.5 ms
2 ms
Philips does not claim, verify, or validate
support for all available pacemakers.
EMC Performance
Limits, radiated
immunity
12-16
Safety Standards & Specifications
Meets Essential Performance, but may observe
some waveform disturbance over 181 to 202 MHz
@ >1.8 V/m and 203 to 213 MHz @ > 1.0 V/m
Measurement Specifications
SpO2
Parameter
Specification
SpO2 Measurement
Range (Calibration and
Display)
0 to 100%
SpO2 Accuracy
See table following.
SpO2 Resolution
1%
SpO2 Numerics Averaging
10 seconds
Note—The update rate for the SpO2 pulse
oximetry value and pulse rate is typically 1
second. This can be extended to a max. 60 s
when NIBP is measured on the same limb, with a
corresponding INOP message after a max. of 30
s, indicating that the displayed values are not
current values.
The effect of SpO2 pulse oximetry on data
averaging is internally controllable by the
transmitter, with no user controls.
SpO2 & Pulse Numerics
- Update Rate
Transmitted once per second.
Pleth Wave- Sampling
Rate
125 sps
Technical Alarms
(INOPs)
Triggered if the sensor is disconnected, if a pulse
is not detected, if the signal is noisy, if light
interference is detected, if the sensor is defective,
if the measurement is erratic, or if the module is
malfunctioning
Safety Standards & Specifications
12-17
Measurement Specifications
Parameter
Wavelength Range
Specification
500 to 1000 nm
Note—Information about wavelength range can
be especially useful to clinicians (e.g., clinicians
performing photodynamic therapy).
12-18
Pulse Rate
Measurement
(available only with
Continuous SpO2)
Range: 30 to 300 bpm
Accuracy: +/- 2%
Resolution: 1 bpm
Display of SpO2
numerics
SpO2 values are displayed as xxx % SpO2T to
meet ISO/EN standard EN 865.
Maximum Optical
Output Power
< 15 mW
Safety Standards & Specifications
Measurement Specifications
SpO2
Sensor
Accuracy
Type
Philips
Reusable
Sensors
Description
Model
Number
Accuracy%
Arms (70-100%
Range)
Adult Finger
M1191A
2.0
Adult Finger
M1191AL
2.0
Adult Finger
M1191ANL
2.0
Adult Finger*
M1191T
3.0
Adult Finger
M1196A
3.0
Adult Finger
M1196T
3.0
Pediatric Finger
M1192A
2.0
Pediatric Finger*
M1192T
3.0
Pediatric Finger
M1192AN
2.0
Adult/Pediatric Ear
M1194A
3.0
Adult/Pediatric Ear
M1194AN
3.0
* Requires M1943A or M1943AL adapter cable.
Safety Standards & Specifications
12-19
Measurement Specifications
Type
Philips
Disposable
Sensors
12-20
Description
Model
Number
Accuracy%
Arms (70-100%
Range)
Adult Finger
M1901B
3.0
Pediatric Finger
M1903B
3.0
Adult Finger
M1904B
3.0
Safety Standards & Specifications
Measurement Specifications
Type
Nellcor
Disposable
Sensors
(not
available
from
Philips)
Model
Number
Accuracy%
Arms (70-100%
Range)
OxiCliq A, Adult
N/A
3.0
OxiCliq N, Adult >40 kg
(88 lb)
N/A
3.0
OxiCliq P, Pediatric
N/A
3.0
OxiMax MAX-A, Adult
>30 kg (66 lb)
N/A
3.0
OxiMax MAX-AL,
Adult >30 kg (>66 lb)
N/A
3.0
OxiMax MAX-N, Adult
>40 kg (>88 lb)
N/A
3.0
OxiMax MAX-P,
Pediatric 10-50 kg (22110 lb)
N/A
3.0
Oxisensor II D-20,
Pediatric 10-50 kg (22110 lb)
N/A
3.0
Oxisensor II D-25, Adult
>30 kg (>66 lb)
N/A
3.0
Oxisensor II N-25, Adult
>40 kg (>88 lb)
N/A
3.0
Description
Safety Standards & Specifications
12-21
Measurement Specifications
12-22
Safety Standards & Specifications
This appendix lists the accessories for use with the Transceiver. Accessories are
subject to change. Some accessories are not supplied by Philips.
To order accessories, visit the Philips Medical Supplies website located at the
following web address: http://shop.medical.philips.com, or contact your local
Philips representative.
Accessories
A-1
Introduction
Accessories
Accessory Safety
Accessory Safety
Warning
Use only Philips-approved accessories. Use of product accessories (ECG
leadsets, SpO2 sensors, etc.) other than those specified in this manual may:
- lead to patient injury
- result in increased electromagnetic emissions or decreased immunity of
the product
Warning
Reuse: Never reuse disposable sensors, accessories and so forth that are
intended for single use, or single patient use only.
Packaging: Do not use a sterilized accessory if the packaging is damaged.
Transceiver Accessories
Pouches
Order Number
A-2
Accessories
Description
989803137821
Telemetry Pouch, box of 5
989803137831
Telemetry Pouch, box of 50
989803140371
Telemetry Pouch, case of 200
ECG Accessories
Monitor
Interface
Cable
Order Number
Description
989803140431
Protective Cover for TeleMon/Service Port (ECGonly Transceiver), package of 10
989803140451
Protective Cover for TeleMon/Service Port (ECG/
SpO2Transceiver), package of 10
989803140441
Protective Cover for SpO2 Port (ECG/SpO2
Transceiver), package of 10
Order Number
M1688A
A Sales and Support
Protective
Covers
Description
Monitor Interface Cable for use with IntelliVue
MP5 Patient Monitor
ECG Accessories
Electrodes
Order Number
Description
M2202A
Radio Translucent Foam Electrodes, 60 packages of 5
(300 per box)
40489E
Paper Tape Electrodes, 10 packages of 30 (300 per
box)
40493D
Foam Electrodes, 60 packages of 5 (300 per box)
40493E
Foam Electrodes, 10 packages of 30 (300 per box)
Accessories
A-3
ECG Accessories
Leadsets
Order Number
A-4
Accessories
Description
989803133831
AAMI 3-wire Leadset, Snap, 79 cm (30 ”)
989803133841
AAMI 3-wire Leadset, Grabber ,79 cm (30 ”)
989803133871
AAMI 5-wire Leadset, Snap, 79 cm (30 ”)
989803133881
AAMI 5-wire Leadset, Grabber, 79 cm (30 ”)
989803137241
AAMI 5-wire Color Leadset, Snap, 79 cm (30 ”)
989803137251
AAMI 5-wire Color Leadset, Grabber, 79 cm (30 ”)
989803133911
AAMI 6-wire Leadset, Snap, 79 cm (30 ”)
989803133921
AAMI 6-wire Leadset, Grabber, 79 cm (30 ”)
989803137281
AAMI 6-wire Color Leadset, Snap, 79 cm (30 ”)
989803137291
AAMI 6-wire Color Leadset, Grabber, 79 cm (30 ”)
989803133851
IEC 3-wire Leadset, Snap, 79 cm (30”)
989803133861
IEC 3-wire Leadset, Grabber, 79 cm (30”)
989803133891
IEC 5-wire Leadset, Snap, 79 cm (30”)
989803133901
IEC 5-wire Leadset, Grabber, 79 cm (30”)
989803137261
IEC 5-wire Color Leadset, Snap, 79 cm (30”)
989803137271
IEC 5-wire Color Leadset, Grabber, 79 cm (30”)
989803133931
IEC 6-wire Leadset, Snap, 79 cm (30”)
989803133941
IEC 6-wire Leadset, Grabber, 79 cm
989803137301
IEC 6-wire Color Leadset, Snap, 79 cm
989803137311
IEC 5-wire Color Leadset, Grabber, 79 cm
SpO2 Accessories
Order Number
Description
989803140401
Single ECG Alignment Guide, package of 10
989803140411
Single ECG Alignment Guide, tethered, package of
10
989803140421
Double ECG Alignment Guide, package of 10
Order Number
Description
989803134771
Skin Preparation Sheets, 10 preps/sheet, package of
10 sheets
A Sales and Support
Alignment
Guides
Skin Prep
Paper
SpO2 Accessories
Reusable
Sensors
Order
Number
Description
M1191A
Philips Adult Finger Sensor, 2 m (6.6 feet)
M1191AL
Philips Adult Finger Sensor, 3 m (9.8 feet)
M1191ANL
Philips Adult Finger Sensor, 3 m (9.8 feet)
M1191T
Philips Adult Finger Sensor, 0.45 m (1.5 feet)
M1192A
Philips Pediatric Finger Sensor, 1.5 m (4.9 feet)
M1192AN
Philips Pediatric Finger Sensor, 1.5 m (4.9 feet)
Accessories
A-5
SpO2 Accessories
Order
Number
A-6
Accessories
Description
M1192T
Philips Pediatric Finger Sensor, 0.45 m (1.5 feet)
M1194A
Philips Adult & Pediatric Ear Sensor, 1.5 m (4.9 feet)
M1194AN
Philips Adult & Pediatric Ear Sensor, 1.5 m (4.9 feet)
M1196A
Philips Adult Finger Clip Sensor (8-pin), 3 m (9.8 feet)
M1196T
Philips Adult Finger Clip Sensor (9-pin), 0.90 m (2.9 feet)
SpO2 Accessories
Note—OxiCliq, OxiMax and Oxisensor II sensors are not available from Philips
in the USA or Canada. In those countries, contact Nellcor Incorporated directly.
Order Number
Description
M1901B
Philips Adult >40 kg (>88 lb)
M1903B
Philips Pediatric 10-50 kg (22-110 lb)
M1904B
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
*Nellcor OxiMax MAX-P, Pediatric 10-50 kg (22-110 lb)
N/A from Philips
*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
*Nellcor Oxisensor II N-25, Adult >40 kg (>88 lb)
* Uses reusable OC-3 Sensor Cable.
Adapter
Cables
Note—Adapter cables are not available from Philips in Canada or Japan. In
those countries, contact Nellcor Incorporated directly.
Order Number
Description
M1943A
Adapter cable for Nellcor SpO2 sensor, 2 m (6.6 ft)
M1943AL
Adapter cable for Nellcor SpO2 sensor, 3 m (9.8 ft)
Accessories
A-7
A Sales and Support
Disposable
Sensors Single Use
SpO2 Accessories
Wristband
Order Number
M1627A
A-8
Accessories
Description
Wristband, package of 10
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.
On the web
www.medical.philips.com
Via email
medical@philips.com
By fax
+31 40 27 64 887
By postal service
Philips Medical Systems
Global Information Center
P.O. Box 1168
5602 BD Eindhoven
The Netherlands
Asia
Tel: +852 2821 5888
Europe, Middle East, Africa
Tel: +31 40 27 63005
Latin America
Tel: +55 11 2125 0764
North America
Tel: +1 800 229 6417
Sales and Support Offices
B-1
Introduction
Sales and Support Offices
B-2
Sales and Support Offices
Index
alarms
behavior with paired bedsides,
indicators, 5-2
physiologic, 5-5
SpO2, 8-20
technical, 5-9
testing indicators, 5-2
testing, 11-2
audible tones
definitions, 3-10
start-up, 4-3
turn off, 9-9
auditory information signals
see audible tones, 3-10
battery
inserting, removing,
life, 4-16, 12-8
safety, 2-5, 4-12
storing, 4-15
type, 4-13
4-13
configuration
group settings, 11-12
label assignment, 11-2
Telemetry Setup, 9-4
unit settings, 9-8
controls
buttons, 3-3
indicators, 3-4
labels,back, 3-8
labels,front, 3-5
on/off, 4-2
other marks, 3-8
ports, 3-6
10-3
dropouts (ECG), 6-29
electrodes
placement, 6-9
skin prep, 6-11
electromagnetic interference,
extended monitoring, 6-27
12-5
fallback 6-26
Find Device, 9-3
group settings
11-12
Information Center
transceiver use with, 1-9
information signals, 11-13
INOPs, see technical alarms, 5-9
intended use
ST/AR, 7-4
transceiver, 12-2
interference, 6-28, 12-7
label assignment, 11-2
lead placement, 6-13
noise
eliminating,
Nurse Call 5-6
on/off 9-5
6-31
on/off, 4-2
ordering information
ECG supplies, A-3
SpO2 supplies, A-5
Index-1
transceiver supplies,
A-2
paired bedsides
alarm behavior 10-3
patient window, 9-2
pause alarms, 5-2
pleth wave display on/off, 9-7, 9-12
pouch, 4-7
pulse rate display on/off, 9-7, 9-12
pulse tone on/off, 3-12, 9-5
RF auto shutoff 9-10,
RF interference, 6-30
9-16
safety
battery, 2-5, 4-12
ECG, 2-6
general, 2-2
paced, 2-11, 7-4
SpO2 sensor, 8-10
SpO2, 2-11, 8-2
ST/AR, 2-8, 7-2
symbols, 3-8
transceiver, 4-2
self-test
alarm indicators, 5-2
sensors
applying, 8-10
optimizing use, 8-20
selecting, 8-8
service log, 11-13
shower, transceiver use in, 4-9
signal strength, 6-30
silence alarms, 10-4
skin prep, 6-11
smart hopping 1-5
sounds
see audible tones, 3-10
SpO2
Index-2
audible tones, 8-16, 8-17
auto on/off, 8-19
Continuous, 8-16
measurement, 8-4
mode selection, 9-6, 9-11
NBP inop suppression, 9-7, 9-12
optimizing sensors, 8-20
Spot Check, 8-15
turning measurement on/off, 8-18
turning SpO2 parameter on/off, 8-19
ST 7-11
adjusting measurement points, 7-10
alarm adjustments, 7-12
smart limits, 7-13
turning on/off, 7-9
ST/AR
arrhythmia analysis, 7-4
intended use, 7-4
ST analysis, 7-7
standby mode, 4-4
suspend alarms, 5-2
symbols, 3-6
system messages
see information signals, 11-13
telemetry overview, 10-3
Telemetry Setup, 9-4
TeleMon
NBP measurement with, 1-9
SpO2 measurement modes, 8-17
transceiver use with, 1-9, 9-16
testing
alarm indicators, 5-2
alarms, 4-10
self test, 4-10
status check, 4-11
transceiver
controls, 3-2
models, 1-2
troubleshooting 6-31
TRx (ECG-only)
see transceiver models,
TRx+ (ECG + SpO2)
see transceiver models,
unit settings,
1-2
1-2
9-8
volume, 9-5
Index-3
Index-4

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