Spacelabs Healthcare WT12 010-1927-00 User Manual 070 2407 00 Rev A

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Telemetry Transmitter
96281-A, 96281-B, 96281-C
Operations Manual
070-2407-00 Rev. A
©2012Spacelabs Healthcare
All rights reserved. Contents of this publication may not be reproduced in any form without the written permission of
Spacelabs Healthcare. Products of Spacelabs Healthcare are covered by U.S. and foreign patents and/or pending
patents. Printed in U.S.A. Specifications and price change privileges are reserved.
Spacelabs Healthcare considers itself responsible for the effects on safety, reliability and performance of the
equipment only if:
•
assembly operations, re-adjustments, modifications or repairs are carried out by persons authorized by
Spacelabs Healthcare, and
•
the electrical installation of the relevant room complies with the requirements of the standard in force, and
•
the equipment is used in accordance with the operations manual.
Spacelabs Healthcare will make available, on request, such circuit diagrams, component part lists, descriptions,
calibration instructions or other information which will assist appropriately qualified technical personnel to repair those
parts of the equipment which are classified by Spacelabs Healthcare as field repairable.
Spacelabs Healthcare is committed to providing comprehensive customer support beginning with your initial inquiry
through purchase, training, and service for the life of your Spacelabs Healthcare equipment.
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CORPORATE OFFICES
U.S.A.
Spacelabs Healthcare, LLC
5150 220th Ave SE
Issaquah, WA 98029
Telephone: 425-657-7200
Telephone: 800-522-7025
Fax: 425-657-7212
Authorized EC Representative UNITED KINGDOM
Spacelabs Healthcare, Ltd.
1 Harforde Court
John Tate Road
Hertford, SG13 7NW
Hertfordshire, UK
Telephone: 44 (0) 1992 507730
Fax: 44 (0) 1992 501213
BirthNet, Clinical Browser, Data Shuttle, Flexport, Intesys, Mermaid, MOM, Multiview, PCMS, Quicknet, Sensorwatch,
TruLink, Ultraview, Ultraview Care Network, Ultraview Digital Telemetry, Ultraview SL, Uni-Pouch, UCW, Varitrend,
Dynamic Network Access, DNA, XPREZZON, qube, Xhibit, and AriaTele are trademarks of Spacelabs Healthcare.
Other brands and product names are trademarks of their respective owners.
Caution:
Rx Only
US Federal law restricts the devices documented herein to sale by, or on the order of, a
physician.
Before use, carefully read the instructions, including all warnings and cautions.
Table of Contents
Introduction
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About This Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Conventions Used in This Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Overview of the Telemetry Transmitter (96281-A/96281-B/96281-C) . . . . . . . . . . . . . . . . . . . .
Manufacturer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Relationship to Other Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Warnings, Cautions, and Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Potential Users . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Nurses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Monitor Technicians . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Biomedical Engineers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Physicians . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Patients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Environmental Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Sources of Interference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Potential Sources of Damage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Repairs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
About the Transmitters
Telemetry Transmitters (96281-A, 96281-B, 96281-C) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Lead Fault Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Optional Leadwire Grouper . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Labeling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Leadwire Color Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Telemetry Channel Label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Lead Availability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1-1
1-1
1-2
1-2
1-3
1-3
1-3
1-4
1-7
1-7
1-7
1-7
1-7
1-7
1-8
1-8
1-8
1-8
1-9
2-1
2-2
2-3
2-4
2-4
2-5
2-6
ECG and SpO2
ECG Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Patient Preparation and Electrode Application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
To Set Up ECG Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
To prepare the patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
To apply ECG electrodes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Adult Electrode Placement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
ECG Problem Solving . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Lead Fault Indication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Noise Detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
False Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
SpO2 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Traditional Pulse Oximetry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Warnings and Cautions for SpO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Electrodes, Leadwires, Sensors, and Sensor Cables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
TE L E M E T R Y T R A N S M I T T E R ( 9 6 2 8 1 ) O P E R A T I O N S M A N U A L
3-1
3-1
3-2
3-2
3-2
3-3
3-4
3-4
3-4
3-5
3-5
3-5
3-6
3-7
4
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Electrodes, Leadwires, Sensors and Sensor Cables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8
Setting Up SpO2 Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8
Ensuring Accurate SpO2 Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9
SpO2 and Pulse Rate Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-11
Using the Sensorwatch Feature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-12
Enabling and Adjusting Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-13
Spacelabs Healthcare Technology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-13
To enable and adjust SpO2 alarms (telemetry). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-13
Additional Information for Telemetry Products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-13
Data Averaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-13
Telemetry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-13
Heart Rate Averaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-13
Display Details at the Host Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-15
Printing SpO2 Waveforms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-16
SpO2 Messages at the Host Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-16
Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-18
Spacelabs Healthcare SpO2 Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-18
Additional Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-18
SpO2 Alarm Delays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-19
SpO2 Troubleshooting Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-20
Basic Operations
Getting Started . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
Transmitter Batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
Host Monitors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
Telemetry Receiver Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
Assigning a Telemetry Channel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
Basic Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
Top, Front and Bottom View (96281-C) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Rear View (96281-C) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
Front View (96281-A) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6
Battery Compartment (96281-A, 96281-B, 96281-C) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7
Selecting Options for Leads . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8
Basic User Actions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-9
To send a recording to the central monitor or station . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10
To unlock the user interface on the 96281 telemetry transmitter . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10
Basic Modes of Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11
View Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12
ECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12
SpO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-14
Status Messages at the Host Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-15
Telemetry Transmitter with ECG Only Troubleshooting Guide . . . . . . . . . . . . . . . . . . . . . . . . 4-16
Telemetry Transmitter with Display Troubleshooting Guide . . . . . . . . . . . . . . . . . . . . . . . . . . 4-16
Telemetry Transmitter with Display and SpO2 Troubleshooting Guide . . . . . . . . . . . . . . . . . . 4-17
Cleaning, Disinfecting, and Sterilization
Cleaning Products Not Recommended for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
Cleaning the Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
Transmitter, Leadwires, Cables, and Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
Cleaning/Disinfecting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
Recommended Cleaning Solutions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
TE L E M E T R Y T R A N S M I T T E R ( 9 6 2 8 1 ) O P E R A T I O N S M A N U A L
ii
Cleaning and Disinfecting the 96281Telemetry Transmitters and Cables . . . . . . . . . . . . . . . . .
Basic Cleaning and Low-level Disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Cleaning ECG Leadwires . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Cleaning Buttons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Cleaning the Battery Cover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Appendix A — Guidance and Manufacturer’s Declaration
Electromagnetic Environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Electromagnetic Emmissions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Table 1—Electromagnetic Emmissions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Electromagnetic Immunity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Table 2—Electromagnetic Immunity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Table 2—Electromagnetic Immunity (continued) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Separation Distances . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Table 3—Separation Distances . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
A-1
A-1
A-1
A-2
A-2
A-3
A-4
A-4
Appendix B — Symbols
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5-2
5-3
5-3
5-3
5-3
TE L E M E T R Y T R A N S M I T T E R ( 9 6 2 8 1 ) O P E R A T I O N S M A N U A L
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Introduction
Spacelabs Healthcare patient monitoring systems demonstrate an ongoing commitment to
innovation that supports decision-making and enhances patient care.
Spacelabs Healthcare networking features support seamless data acquisition and data exchange
across the medical enterprise, addressing the need for continuous information management.
These powerful tools help you care for patients more efficiently by providing both local and remote
access to patient data.
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About This Manual
This manual provides instruction for specific features of the Spacelabs Healthcare AriaTele™
Telemetry Transmitter (96281). It does not address system issues such as antenna infrastructure,
receivers, central monitor or central station. Refer to the customer documentation for your specific
telemetry receiver for information on antenna infrastructure. Refer to the customer documentation
for your central monitor for information on the central monitor or station in use with the telemetry
transmitter.
Conventions Used in This Manual
Some of the formatting conventions used in this manual are included in the list that follows.
•
For manuals viewed in PDF format, reference links are blue and italicized. Blue italicized
typeface is a link to additional information in the manual. Hover the mouse over the blue text
and click to show the topic. Reference links are located throughout the manual, including the
Table of Contents.
•
Non-blue italicized typeface are references to information outside this manual. They may
indicate references to other manuals or information which is available in another form, as
identified by a title and/or a part number. Non-blue italicized typeface may also refer to error or
status messages that show on the host monitor.
•
Bold typeface indicates text labels, phrases, or titles that show on an LCD or display which are
part of a Spacelabs Healthcare software application.
•
Bold typeface may also indicate the formal name of graphical user interface, such as an icon
or control, but which does not include a text label or title.
•
Terms that are ALL CAPITALIZED may represent user interface such as a key label or menu,
or a status or error message on a host monitor.
•
Numbered steps are presented to accomplish a task. Some steps may conclude in a step
result—unnumbered, indented text. Step results are shown in gray typeface. For an example
of task steps, click the cross-reference To send a recording to the central monitor or station on
page 4-10.
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•
Warnings, cautions, and notes are listed in the priority of the information and formatted specifically
as shown below. Warnings are of the highest priority and notes are not as serious as the warnings
and cautions.
Warnings:
Warnings indicate potentially harmful conditions that may lead to injury or death.
Cautions:
Cautions indicate conditions that may lead to damage to or malfunction of the device.
Notes:
Notes alert the user to relevant facts and conditions.
Overview of the Telemetry Transmitter
(96281-A/96281-B/96281-C)
Note:
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When worn by a patient, the 96281 telemetry transmitter acquires ECG data through electrodes
attached directly to the patient’s body. Additionally, the 96281-C telemetry transmitter can acquire
SpO2 data through sensors attached to the patient’s body. It transmits acquired data to the
telemetry antenna infrastructure for processing by a telemetry receiver. This transmitted data may
then show on a central station or bedside monitor. Refer to About the Transmitters on page 2-1 for
more detailed information about each telemetry transmitter model. The 96281 telemetry transmitter
does not indicate any alarm conditions. Alarms are configured, generated, and activated within the
receiver-side components of the Ultraview System only.
SpO2 functionality is only available on the 96281-C telemetry transmitter.
Manufacturer
The 96281 telemetry transmitter is manufactured by:
Spacelabs Medical, Inc.
5150 220th Avenue, S.E.
Issaquah, Washington 98027
U.S.A.
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Relationship to Other Systems
The 96281 telemetry transmitter is related only to Spacelabs Healthcare monitoring systems. Data
collected by the transmitter may be interfaced from the monitoring system to a hospital clinical
information system.
The telemetry transmitter is compatible with the list of receivers that follow:
•
Digital Telemetry System Receiver (90478) and Receiver Housing (90479-A, 90479-B,
90479-C)
Refer to Patient Monitoring Operations Documents (P/N 084-1101-xx) and to the Spacelabs
Healthcare Service CD (P/N 070-0700-xx) for information relating to the 90478 and 90479 digital
telemetry systems.
The 90478 receiver interacts with the Ultraview SL 91387-38 or 91387-39 central monitor, and with
Ultraview SL patient monitors.
Note:
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Not all products are available in all locales. Check with your local Spacelabs Healthcare
representative.
Intended Use
The Spacelabs Healthcare AriaTele Telemetry Transmitter (96281), when used in conjunction with
a Spacelabs Healthcare Ultraview patient monitor and telemetry receiver, provides a means for the
continuous collection and monitoring of electrocardiographic (ECG) signals in order to detect
abnormal cardiac rhythms, including life-threatening events such as high and low heart rates,
asystole and ventricular fibrillati
on. Optionally, on adult patients, additional abnormal cardiac rhythms such as ventricular runs,
tachycardia and ST-segment deviations are detected.
The 96281 also provides a means for continuous collection and monitoring of SpO2.
The 96281 provides an optional display intended to allow clinicians a means to view the SpO2 and
pulse rate at the patient’s side. The display also provides a snapshot view of the ECG to allow the
clinician to view the patient’s ECG rhythm and quality of signal.
The 96281 is intended for use with either adult, pediatric or neonate populations in a healthcare
facility by, or on the order of, a physician. It is not intended for home use.
Indications for Use
The 96281-A and 96281-B telemetry transmitters are indicated for ECG monitoring of adult,
pediatric and neonatal patients. The 96281-C telemetry transmitter is indicated for ECG and SpO2
monitoring of adult, pediatric and neonate patient populations.
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Warnings, Cautions, and Notes
This chapter includes warnings, cautions, and notes specifically related to digital telemetry. Refer
to the ECG chapter in the Clinical Parameters Operations Manual, P/N 070-2113-xx, for warnings
and cautions and cautionary disclosures related to ECG. Refer to the product specifications
chapter for warnings and cautions and cautionary disclosures that apply to electrodes and
leadwires, defibrillators (including automatic implantable cardiac defibrillators), pacemakers,
electrosurgical activity, several physiological parameters, or to the monitoring system itself.
Obey these warnings and cautions to avoid injury or death to individuals or damage to equipment.
Warnings:
Review the device prior to each and every procedure. If it shows signs of abuse then
either make sure the device is repaired in an appropriate manner, serviced, or retired
from use.
•
Medical telemetry spectrum allocations may be assigned to frequencies already
allotted to other priority users. Radio frequency interference from other products
may disrupt or impede telemetry patient monitoring during the life of this equipment.
You are urged to regularly consult with applicable local and federal regulatory
agencies (e.g., FCC, FDA) regarding the locations and frequencies of other spectrum
users in your geographic area. A Spacelabs Healthcare field service engineer may be
able to assist you in reconfiguring your equipment frequencies to reduce the risk of
interference. Spacelabs Healthcare cannot, and does not, guarantee interference-free
telemetry operation.
•
Telemetry systems may be more susceptible to interference than hardwired systems;
this may impact signal quality.
•
The transmitters do not currently support inhibition of their pacer detection
functionality. Since Left Ventricular Assist Devices (LVADs) can generate
electromagnetic noise having similar characteristics to pacemaker artifact, users
should pay particular attention to ECG traces acquired using these transmitters
when an LVAD is in use.
•
Do not use the 96281 telemetry transmitter during magnetic resonance imaging (MRI)
procedures. MRI operations will cause damage to the transmitter.
•
Remove the 96281 telemetry transmitter from any patient before beginning an MRI
procedure.
•
Operation of hand-held, wireless telephone equipment (cordless telephones,
cellular telephones) near telemetry systems may cause interference and should be
discouraged. While personal communication devices are turned on, a separation of
>2 meters (>6.5 feet) should be maintained between personal communication
devices and interior walls, the patient cables, and any electronic medical device to
which the patient may be connected. Patients should not use any type of electronic
communication equipment while connected to any electronic medical device without
an on-site evaluation by the biomedical staff. Two-way radio equipment and other
personal communication devices must be evaluated on site to determine if additional
space limitations are needed.
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•
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INTRODUCTION
•
The Spacelabs Healthcare digital telemetry transmitters are contra indicated for use
with other medical instrumentation (e.g., respiration monitors using impedance
pneumography, electrocautery) that source electrical current through the patient.
Further, telemetry monitoring is contra indicated for the operating room
environment.
•
The device should only ever be used for one patient at a time.
•
Opening the battery door and removing one or more of the batteries will result in the
patient NOT being monitored and the ECG signal NOT being processed.
•
SpO2 alarms are inhibited by ECG lead-off conditions.
Cautions:
This telemetry transmitter has a limited bandwidth range of 0.05 to 40 Hz, which may
adversely affect the recording of high frequency components in the ECG signal,
especially when the morphology of the ECG changes rapidly.
•
This telemetry transmitter has a limited dynamic range of +/- 4 mV, which may render
the device vulnerable to saturation by ECG signals with amplitudes higher than 4 mV.
•
Patients should not use any type of electronic equipment (for example, portable
radios, cellular telephones, pagers, personal computers) while connected to any
medical electronic device without prior evaluation of that electronic equipment by
the biomedical engineering staff.
Notes:
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•
•
Continuous monitoring of blood oxygen saturation values are only supported in conjunction
with ECG monitoring. SpO2 alarms are inhibited by ECG leads-off condition.
•
Operation of this equipment may be subject to licensing requirements by your local
telecommunications authority. Please check with your Spacelabs Healthcare field service
engineer.
•
Spacelabs Healthcare’s telemetry equipment complies with Part 95H of the FCC Rules and
with RSS-210 of Industry Canada and with requirements of other national spectrum
management authorities.
Repeated here are operational cautions for biomedical telemetry from the FCC Rules
(47CFR15.242(f)): “Biomedical telemetry devices must not cause harmful interference to
licensed TV broadcast stations or to other authorized radio services, such as operations on
the broadcast frequencies under subpart G and H of part 74 of this chapter, land mobile
stations operating under part 90 of this chapter in the 470-512 MHz band, and radio
astronomy operation in the 608-614 MHz band. (See section 15.5). If harmful interference
occurs, the interference must either be corrected or the device must immediately cease
operation on the occupied frequency. Further, the operator of the biomedical telemetry
device must accept whatever level of interference is received from other radio operations.
The operator, i.e., the health care facility, is responsible for resolving any interference that
occurs subsequent to the installation of these devices.”
Installation of this telemetry device is permitted in hospitals and health care facilities only.
This device shall not be operated in mobile vehicles (including ambulances and other
vehicles associated with health care facilities).
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INTRODUCTION
The installer/user of a transmitter operating in the band of 608-614 MHz shall ensure that it
is at least 80 km from the Dominion Radio Astrophysical Observatory (DRAO) near
Pentiction, British Columbia. The coordinates of DRAO are: latitude N 49° 19’ 15”, longitude
W 119°37’ 12”. For medical telemetry systems not meeting this 80 km separation (e.g. the
Okanagan Valley, British Columbia) the installer/user must coordinate with, and obtain
written the concurrence of, the Director of DRAO before the equipment can be installed or
operated. The Director of DRAO may be contacted at 250-497-2300 (telephone) or 250497-2355 (fax). (Alternatively, the Manager, Regulatory Standards, Industry Canada, may
be contacted.)
Transmitters operating in the bands 1395-1400 MHz or 1429-1432 MHz shall not be
operated in the areas of Sydney, Nova Scotia, or Gander, Newfoundland and Labrador.
Please contact the local Industry Canada Office for further information.
Transmitters operating in the bands 608-614 MHz, 1395-1400 MHz or 1429-1432 MHz
comply with Industry Canada licence-exempt RSS standard(s). Operation is subject to the
following two conditions: (1) this device may not cause interference, and (2) this device
must accept any interference, including interference that may cause undesired operation of
the device.
The user of this equipment is not authorized to make any changes or alterations that could
compromise the national certifications.
•
Operation of hand-held, wireless telephone equipment (cordless telephones, cellular
telephones) near telemetry systems may cause interference and should be discouraged.
While personal communication devices are turned on, a separation of >6.5 feet (>2 meters)
should be maintained between personal communication devices and interior walls, the
patient cables, and any electronic medical device to which the patient may be connected.
Patients should not use any type of electronic communication equipment while connected to
any electronic medical device without an on-site evaluation by the biomedical staff. Twoway radio equipment and other personal communication devices must be evaluated on site
to determine if additional space limitations are needed.
•
Telemetry equipment is authorized to operate license exempt in the European Union’s (EU)
Harmonized 433 to 434 MHz Short Range Device (SRD) band. Telemetry equipment
operating in this band may not cause interference and must accept interference from other
devices found in the band. Many countries outside the EU also permit access to this band
for qualifying devices.
•
Operation of telemetry equipment in the 608 to 614 MHz bands (part of the Wireless
Medical Telemetry Service (WMTS)) and in authorized spectrum of each country may be
geographically restricted by government regulation. Operation of this equipment in all U.S.
WMTS bands requires coordination and registration with the FCC-designated frequency
coordinator.
•
Operation of telemetry equipment in the 1395 to 1400 MHz and 1429 to 1432 MHz bands
(part of the Wireless Medical Telemetry Service (WMTS)) and in authorized spectrum of
each country may be geographically restricted by government regulation. Operation of this
equipment in all U.S. WMTS bands requires coordination and registration with the
FCC-designated frequency coordinator.
•
Operation of this equipment may be subject to liscensing requirements by your local
telecommunications authority. Check with your Spacelabs Healthcare field service
engineer.
•
Users of medical telemetry equipment are cautioned that the operation of the equipment
could result in harmful interference to other nearby medical devices.
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•
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INTRODUCTION
Potential Users
The potential users of the 96281 telemetry transmitter are classified into the groups that follow.
Nurses
Nurses attach the transmitter to the patient, maintain the ECG electrodes, SpO2 sensor, and
generally care for the patient. They may also admit the patient to the monitoring system and
monitor the patient.
Monitor Technicians
Monitor technicians may surveil patients at a central station or monitoring room configuration.
Technicians may also admit patients to the system and prepare the transmitter with fresh batteries
and electrodes.
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Biomedical Engineers
A biomedical engineer, or biomed, may install, support, and repair monitoring systems, including
telemetry. Biomeds may work directly for the hospital, for a third-party contract organization, or be
a Spacelabs Healthcare Field Service Engineer (FSE).
Physicians
Physicians may be common reviewers of the physiological data that is collected and subsequently
presented on a monitor or at a full disclosure review station. Physicians may be responsible to treat
telemetry patients, including the use of defibrillation.
Patients
A telemetry patient may carry a transmitter in a gown pocket or in a pouch (the transmitter is
connected to the patient by way of electrodes attached directly to the patient’s body). The patient
can initiate a recording by pressing the Action button on the front of the transmitter if it is
configured for this at the central station or bedside monitor.
Note:
The central monitor or station may be configured to ignore messages from individual telemetry
transmitter units if a patient is likely to misuse this capability. Refer to the user manuals for your
central monitor or station for more information.
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INTRODUCTION
Environmental Considerations
The hospital environment where this product is used could contain environmental conditions that
may affect the product.
Since this is a wireless radio frequency (RF) device, outside interference can come from multiple
sources. Even while operating within the WMTS band in North America, interference and
coexistence issues may occur with other products.
The device shall be sent to a separate collection facility for recovery and recycling.
Refer to the data sheet for the AriaTele Transmitter (96281), P/N 061-2553-xx, for operating and
storage details.
Sources of Interference
Some potential sources of interference are included in the list that follows:
•
Monitoring patients in elevators during transport to other units, or outside of the primary unit.
•
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Poor transmission of signals may occur. Use a monitor with a display if elevator transport is
required.
Monitoring patients off the ward (radiology areas, for example) may result in poor reception due
to antenna placement and wall construction.
If monitoring is necessary, the augmentation of the antenna system may be required.
•
Defibrillation of a patient who is wearing the product.
•
Implanted or external pacemakers associated with a patient who is wearing the product.
Potential Sources of Damage
•
Exposure to bodily fluids or other liquids.
•
The product accidentally drops onto hard surfaces, such as flooring or walls, or into sinks
or toilets.
•
Exposure to disinfectant and various types of cleaner.
Refer to Cleaning, Disinfecting, and Sterilization on page 5-1 for more detailed information.
Accessories
For optimum performance, only use the device with recommended accessories. Refer to the data
sheet AriaTele Transmitter (96281), P/N 061-2553-xx, for transmitter accessories and to the
Spacelabs Healthcare Supplies and Accessories Catalog for a list of suitable electrodes and
supplies from Spacelabs Healthcare.
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INTRODUCTION
Repairs
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Transmitters that are damaged and need repair should be sent to an authorized Spacelabs
Healthcare repair depot for recovery or recycling. Check with your Spacelabs Healthcare
representative for locations.
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About the Transmitters
Telemetry Transmitters (96281-A, 96281-B, 96281-C)
The telemetry transmitters function as part of a digital telemetry system. This system consists of
transmitters, diversity antennas, receiver modules, and either a receiver housing and/or a monitor.
Typically a request comes from a central host monitor to obtain data from electrodes and/or remote
sensors attached to a patient which are connected to the transmitter. The central or bedside
monitor tells a receiver what channel to begin listening on—one that matches the transmitter on
the patient.
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Refer to the data sheet AriaTele Transmitter (96281), P/N 061-2553-xx, for the options available
with the 96281 telemetry transmitter. Contact your Spacelabs Healthcare representative for the
complete compatibility list.
96281-A
96281-B
96281-C
The patient-worn transmitters are small battery-powered devices that monitor ECG activity and
SpO2 data (96281-C only) and transmit this information to the telemetry receiver module.
Each transmitter only uses one channel. The wideband units transmit four leads; the narrowband
units transmit two leads. The transmitters with a display show four leads.
A label is affixed to each transmitter with its channel number representing a unique radio
frequency. Telemetry receivers are tuned from the Spacelabs Healthcare monitor touchscreen
to receive the available transmitter frequencies.
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All transmitters are assigned a channel number at the factory. When using telemetry, the receiver
must be assigned the appropriate channel for a patient at the bedside or central monitor.
Admission of the patient is done at the monitor.
Lead Fault Indicators
The 96281 transmitter has amber indicators on the front of the transmitter case. Each indicator
provides the status of its respective leadwire and flashes if the leadwire is disconnected from the
skin electrode or if the skin electrode makes poor electrical contact with the patient. It is possible
for all lead fault indicators to flash simultaneously if all electrodes are disconnected. In addition, all
indicators may flash if the transmitter is unable to determine an ECG waveform.
Up to five standard, disposable, silver/silver chloride chest electrodes may be connected to the
patient. The ECG leadwires are attached to these electrodes and connected to the transmitter.
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The 96281 telemetry transmitter is designed to operate with five patient leadwires. If you choose to
use only three or four patient leadwires, patient information is still processed, but a lead fault
message will show on the host monitor. An optional leadwire grouper is available for use with the
ECG leadwires (refer to Figure 2-2 on page 2-3).
Figure 2-1: ECG leadwire connectors and lead fault indicators (96281-C)
Leadwire connectors
Lead fault indicators
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Optional Leadwire Grouper
Figure 2-2: Leadwire grouper (front view including ECG connectors and color codes label)
Figure 2-3: Leadwire grouper (rear view including clip and ECG connectors)
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Labeling
Leadwire Color Codes
Both AHA/AAMI or IEC color codes are used on the leadwires and the transmitter labeling. The
color codes for your transmitter and leadwires are based on the preference in your locale. These
color variations are shown on the back label of the transmitter, front of the leadwire grouper, and
on the individual ECG connectors and leadwires. This is to assist in connecting the leadwires to the
correct input.
Match the color of the ECG leadwire to the color label on the leadwires grouper
Match the color label on the leadwires grouper to the color label on the transmitter
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AHA/AAMI Leadwire Labels
Figure 2-4: 5-lead AHA/AAMI color codes label on rear of transmitter
Figure 2-5: 5-way AHA/AAMI label on front of grouper
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IEC Leadwire Labels
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Figure 2-6: 5-lead IEC color codes label on rear of transmitter
Figure 2-7: 5-way IEC color codes label on front of grouper
Telemetry Channel Label
Note:
“Ch.” refers to the channel. The label includes a barcode on the 96281 devices.
Table 1: Labels for Radio Frequency Channels
Radio Frequency (RF)
Channel Label Border Color
608-614 MHz
433-434 MHz
1395-1431.5 MHz
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Lead Availability
ECG lead availability depends on which electrodes are connected to a transmitter, and whether the
transmitter is a Narrowband device (option N), or a Wideband device (option W).
Table 2 and Table 3 detail lead availability for narrowband and wideband transmitters, respectively,
based on which electrodes are connected.
Note:
Augmented leads aVR, aVL and aVF are only available at the monitor when leads I, II, and
III are all available.
•
For optimum performance, the right leg electrode should always be connected.
•
If an electrode is not connected, its lead fault indicators will flash on and off at the
transmitter.
•
If there are no leads available, all lead fault indicators will flash on and off at the transmitter.
•
The headings for each electrode list the AAMI and IEC lead designations (the IEC
designations are in parentheses).
•
If a lead is not available, the monitor will either show a blank or switch to an alternate
available lead.
•
Leads are only shown on a transmitter if the transmitter includes an optional display.
•
If a lead is not available, the transmitter will show a baseline trace.
•
Other combinations of disconnected electrodes yield no useful data, resulting in no lead
availability at either the monitor or the transmitter.
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•
Table 2: Lead Availability with Narrowband transmitters (96281-xxxNx)
Connected Electrodes (X)
Available leads at the
monitor
Shown
leads at the
transmitter
RA
(R)
LA
(L)
LL
(F)
RL
(N)
(C)
II, V
I, II, III, V
II, V
I, II, III, V
I, II, III, aVR, aVF, aVL
I, II, III
I, II, III, aVR, aVF, aVL
I, II, III
III
III
III
III
III
III
III
III
II
II
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Table 2: Lead Availability with Narrowband transmitters (96281-xxxNx)
Connected Electrodes (X)
RA
(R)
LA
(L)
LL
(F)
RL
(N)
(C)
Shown
leads at the
transmitter
II
II
II
II
II
II
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Available leads at the
monitor
Table 3: Lead Availability with Wideband transmitters (96281-xxxWx)
Connected Electrodes (X)
Available leads at the
monitor
Shown
leads at the
transmitter
I,II,III,V, aVF, aVL, aVR
I, II, III, V
I,II,III, aVF, aVL, aVR
I, II, III
I,II,III, aVF, aVL, aVR
I, II, III
III
III
III
III
III
III
II
II
II
II
II
II
II
II
RA
(R)
LA
(L)
LL
(F)
RL
(N)
(C)
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ECG and SpO 2
ECG Overview
ECG monitoring begins when the system detects a signal through the connection of ECG electrodes or
by installation of a battery into a telemetry transmitter. Please refer to the operations manual for your
patient monitor for complete information on ECG and SpO2 setup.
Telemetry ECG monitoring requires the minimum conditions from the list that follows:
ECG electrodes must be properly attached to the leadwires.
•
The leadwires must be properly attached to the telemetry transmitter.
•
The telemetry transmitter must have functional batteries.
•
The telemetry receiver module must be:
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•
Inserted in the receiver housing that is connected to a central station, or
Connected to a monitor that is powered ON.
Configured to the same channel number as its corresponding telemetry transmitter.
Connected to a Spacelabs Healthcare diversity antenna.
Patient Preparation and Electrode Application
Use silver/silver-chloride electrodes or their equivalent, and always connect all electrodes required for
a particular lead. Missing electrodes may result in the loss of the ECG waveform.
Note:
Use only Spacelabs Healthcare-recommended electrodes. Some electrodes may polarize and
create large offset potentials. This can compromise recovery time after application of defibrillator
pulses. Squeeze-bulb electrodes, commonly used for diagnostic ECG recordings, may be
particularly vulnerable to this effect.
Noise on ECG signals, especially noise that resembles actual cardiac waveforms, is a frequent cause
of false alarms. Some of this noise may be because of electrode positioning, patient movement or
intermittent signal connections (either of electrode to skin or of leadwires to electrodes). You can
eliminate some of this noise (and many of these false alarms) by paying careful attention to skin
preparation and electrode application.
The telemetry transmitter is color-coded to match the color of the leadwires. Table 1 on page 3-3 lists
leadwire color and identifier codes.
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E C G AND SPO 2
To Set Up ECG Monitoring
When attaching leadwires to the telemetry transmitter, use the color coding and/or leadwire identifier
code to ensure that the correct connections are made.
ECG electrodes have a column of conductive gel that is surrounded by an adhesive surface. The
condition of the electrode’s gel column directly affects the quality of the ECG signal. For example, more
noise appears on the ECG signal if gel is displaced (or air is trapped) when you apply an electrode to
the patient. Key points to remember include:
Before using electrodes, verify that they have not expired and that the conductive gel is not
dry. Replace the electrodes if necessary.
•
Always attach the electrode to its leadwire before applying the electrode to the patient (refer to
Figure 3-1). Do not apply pressure directly over the electrode’s gel column.
•
Press firmly around the outer edge of the electrode’s adhesive surface to ensure that the
electrode is securely attached to the patient.
•
To minimize muscle artifact, place electrodes over flat, non-muscular areas of the body (refer
to Figure 3-2). This is important for telemetry patients who are usually ambulatory.
•
After electrodes and leadwires are attached, add a stress loop (a loop of leadwire taped close
to its electrode) to minimize stress or pulling on the electrode itself. This will improve ECG
signal quality, particularly for ambulatory patients.
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•
Note:
Spacelabs Healthcare recommends that electrodes be replaced after 24 to 48 hours of use.
To prepare the patient
To apply ECG electrodes
•
Wash the area with soap and water.
•
Attach an electrode to a leadwire.
•
If necessary, shave the area where you
plan to position the electrodes.
•
Apply the electrode to the patient’s skin.
•
Clean the skin with alcohol.
•
Dry the skin thoroughly.
•
Abrade the skin.
Figure 3-1: Electrode application
Attach the electrode to the leadwire.
Apply the electrode to the skin.
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Table 1: Leadwire Color and Identifier Codes
AAMI
Electrode
Identifier
AAMI Color Code
Electrode Placement
IEC
Electrode
Identifier
IEC Color Code
RA
White
Right Arm
Red
LA
Black
Left Arm
Yellow
LL
Red
Left Leg
Green
RL
Green
Right Leg
Black
Brown
Chest
White
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Adult Electrode Placement
5 Electrodes
I, II, III, aVR, aVL, aVF,
V1 - V6
With 5-electrodes, one precordial lead
is selected by appropriate placement
of the chest (V) electrode.
Figure 3-2: Adult electrode placement
RL
RA
LA
LL
5-9
V1 through V6
Note:
For best ECG performance, the right leg electrode should always be connected.
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ECG Problem Solving
If ECG signal quality is poor (indicated by wandering baseline, excessive noise, or muscle or
respiration artifact), try the solutions from the list that follows:
•
Make sure that silver/silver-chloride electrodes are being used.
•
Make sure that the patient's skin is properly prepared.
•
Make sure that all electrodes are firmly attached and in good condition.
•
Make sure that the electrodes are positioned on a flat, non-muscular area.
•
Make sure that leadwires are properly fastened and in good condition.
•
If these actions fail to resolve the problem, select a different lead.
Lead Fault Indication
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The lead fault indication messages listed here are on the central monitor/station and not the transmitter
display.
The message CHECK XX (where XX identifies the failed or missing electrode) appears in the ECG
waveform zone if a lead fault occurs.
If automatic lead switching is enabled, another lead is automatically selected so that monitoring is
uninterrupted.
A LEADS OFF message appears if automatic lead switching is disabled.
Noise Detection
A NOISY SIGNAL message appears in the ECG waveform zone of the central monitor/station if noise
is detected. If both the first and second lead are noisy, the module suspends processing temporarily. If
the noise persists for 10 seconds, the system initiates an alarm. The message and alarm cease when
the noise disappears.
Notes:
•
If monitoring is interrupted because of overload or saturation of the input amplifiers,
including overload caused by a defibrillator discharge, the ECG waveform is shown as an
out-of-range signal accompanied by a NOISY SIGNAL or HR UNAVAILABLE message.
If the overload or saturation condition persists, the ECG waveform is shown as a flat-line
signal accompanied by an ASYSTOLE ALARM message.
•
If the waveform shown does not appear noisy, but the NOISY SIGNAL message persists,
check all leads for noise before calling a qualified field service engineer.
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False Alarms
Careful attention to skin preparation and electrode application, especially during setup, will reduce
false alarms.
If false alarms occur, check for the issues from the list that follows:
•
Excessive noise on the signal (the most common cause of false alarms). Electrodes that are
placed incorrectly over muscles, or a poor lead connection, can cause significant noise when
the patient moves.
•
Heart rate limits set too close to patient's heart rate. Adjust the limits as necessary.
SpO 2 Overview
Note:
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Pulse oximetry is used to continuously and noninvasively measure functional oxygen saturation in the
blood. Pulse oximetry is measured by using changes in light absorption, as the light passes over a
pulsating arteriolar bed. Pulse oximetry is also used to continuously and noninvasively measure pulse
rate, using an SpO2 sensor.
SpO2 functionality is only available on the 96281-C telemetry transmitter.
The pulse oximetry sensor contains two light-emitting diodes (LEDs). These LEDs emit specific
wavelengths of red and infrared light, which are measured by a photo detector. The monitor shows this
functional oxygen saturation as percent SpO2.
The amount of light absorbed by the arteriolar bed varies during pulsations. During systole, a pulse of
arterial blood enters the vascular bed, increasing the blood volume and light absorption. During
diastole, blood volume and light absorption reach their lowest point. The pulse oximeter’s SpO2
measurement depends on the difference between the maximum and minimum absorption (systole and
diastole, respectively).
Traditional Pulse Oximetry
Traditional pulse oximetry is based on two principles:
•
Oxyhemoglobin and deoxyhemoglobin differ in their absorption of red and infrared light
(spectrophotometry).
•
The volume of arterial blood in tissue and the light absorbed by the blood changes during the pulse
(plethysmography).
Traditional pulse oximetry assumes that all of the pulsations in the light absorbance signal are due to
oscillations in the arterial blood volume. Therefore, the blood flow in the region of the sensor passes
entirely through the capillary bed. Concentrating on the light absorption of pulsatile arterial blood
eliminates the effects of non-pulsatile absorbers (such as bone, tissue, pigmentation, and venous
blood), which normally absorb a constant amount of light over time.
Oxyhemoglobin and deoxyhemoglobin differ in light absorption. The amount of red and infrared light
absorbed by blood can be used to calculate the ratio of oxygenated hemoglobin to total hemoglobin in
arterial blood, at each of two wavelengths (such as 660 nm and 940 nm). This ratio is translated into
the functional oxygen saturation (SpO2) measurement that the monitor shows.
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Note:
• Because SpO2 measurements depend upon light from a sensor, excessive ambient light can
interfere with the pulse oximeter’s measurements.
•
This pulse oximeter measures functional saturation, which is essentially the percentage of
hemoglobin that can transport oxygen (oxyhemoglobin). Pulse oximeters do not detect
significant amounts of dysfunctional hemoglobins, such as carboxyhemoglobin or
methemoglobin, which cannot carry oxygen. Saturation measurements from pulse oximeters
cannot be directly compared to measurements from a laboratory co-oximeter. Co-oximeters
provide a fractional saturation (SaO2) value by measuring each type of hemoglobin individually.
This fractional value is the ratio of oxygenated hemoglobin to all measured (oxygenated and
dysfunctional) hemoglobins.
•
A pulse oximeter SpO2 measurement may not match the saturation calculated from a blood gas
partial pressure of oxygen (PO2). The most likely reason is that the calculated saturation value
was not corrected to reflect the effects of variables that alter the relationship of PO2 and pH.
Such variables can include temperature, the partial pressure of carbon dioxide (PCO2),
2,3-DPG, and fetal hemoglobin.
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Refer to your hospital’s protocols for specific instructions.
Warnings and Cautions for SpO2
This section includes warnings and cautions specifically related to SpO2. Also included are cautionary
disclosures that apply to electrodes and leadwires, defibrillators (including automatic implantable
cardiac defibrillators), pacemakers, electrosurgical activity, several physiological parameters, or to the
monitoring system itself.
Warning:
•
A pulse oximeter should be considered an early warning device and should NOT be
used as an apnea monitor. If a trend toward patient deoxygenation is indicated, blood
samples should be analyzed by a laboratory co-oximeter to completely understand
the patient's condition.
•
Pulse rate measurement is based on the optical detection of a peripheral flow pulse
and therefore may not detect certain arrhythmias. The pulse oximeter should not be
used as a replacement or substitute for ECG-based arrhythmia analysis.
•
Carboxyhemoglobin may erroneously increase readings. The level of increase is
approximately equal to the amount of carboxyhemoglobin present. Dyes or any
substance containing dyes that change usual arterial pigmentation may cause
erroneous readings.
•
Inaccurate measurements may be caused by:
Significant levels of dysfunctional hemoglobins (e.g., carboxyhemoglobin or
methmoglobin).
Intravascular dyes such as indocyanine green or methylene blue.
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Exposure to excessive illumination, such as surgical lamps (especially ones with a
xenon light source), bilirubin lamps, fluorescent lights, infrared heating lamps, or
direct sunlight (exposure to excessive illumination can be corrected by covering the
sensor with a dark or opaque material).
Venous pulsations.
Placement of a sensor on an extremity with a blood pressure cuff, arterial catheter, or
intravascular line.
Do not use the oximetry sensors during MRI scanning. Induced current could
potentially cause burns.
•
Tissue damage can be caused by incorrect application or by wrapping the sensor too
tightly for example. Inspect the sensor site as directed in the sensor directions for
use to ensure skin integrity and to ensure correct positioning and adhesion of the
sensor.
•
Applying an oximetry sensor incorrectly or leaving the sensor in place for too long
may cause tissue damage, especially when monitoring neonates.
•
Check the sensor site frequently, and do not allow the sensor to remain on one site
for too long. Refer to the instructions from the sensor manufacturer for more
information.
•
Do not use a sensor with exposed optical components.
•
SpO2 functional test fixtures can not be used to assess accuracy of a pulse oximeter
sensor or monitor.
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•
Electrodes, Leadwires, Sensors, and Sensor Cables
Warnings:
•
Carefully route all cables between the patient and the monitor to reduce the
possibility of patient entanglement or strangulation.
•
Signals resulting from devices such as Implantable Cardiac Defibrillators (ICD) may
momentarily blank the ECG waveform rather than show an out-of-range signal. In
such cases it may not be apparent that the ICD has triggered and the condition of the
patient should be checked. In all instances of the ICD being triggered, the monitor
will reshow the ECG waveform within five seconds.
•
ECG alarms for ventricular fibrillation and asystole remain active while the patient’s
rate and morphology are being learned (for example, following a lead switch or use
of the RELEARN feature). ECG alarms for high rate, low rate, ventricular run, couplet,
VE/minute, atrial fibrillation, pause, and PSVT are not reactivated until the learning
process ends.
•
To ensure against any possibility of electric shock, do not touch lead electrodes or
the monitor during defibrillation.
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Electrodes, Leadwires, Sensors and Sensor Cables
Cautions:
Visually inspect each leadwire for obvious damage and replace as needed.
•
Use only patient cables and leadwires specified by Spacelabs Healthcare. Other cables
and leadwires may damage the monitor during defibrillation and may also change the
required input impedance and DC offset voltage, affecting performance.
•
Do not use stainless steel electrodes.
•
Do not allow conductive parts of electrode leads or connectors, including the neutral
electrode, to contact other conductive parts, including the ground.
•
Use only patient sensors specified by Spacelabs Healthcare. If you use sensors other
than those specified, it may degrade SpO2 performance and could damage the monitor
during defibrillation.
•
Spacelabs Healthcare recommends the use of sensors repaired or remanufactured by
the original manufacturer only.
•
Never attach an SpO2 sensor to a limb being monitored with a blood pressure cuff or a
limb with restricted blood flow.
•
A poorly applied sensor may give incorrect saturation values. The Sensorwatch
signal-strength indicator is used to identify a poorly applied sensor or a poorly chosen
site. Refer to Using the Sensorwatch Feature on page 3-12 for additional information.
•
Choose a site with sufficient perfusion to ensure accurate oximetry values.
•
An adapter cable is required between the sensor and the transmitter. Do not discard the
adapter cable when you have finished using a disposable oximetry sensor. Disconnect
the sensor cable from the adapter cable before discarding the sensor.
Note:
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•
For cleaning and disinfecting procedures, refer to the Cleaning, Disinfecting, and Sterilization
chapter of this manual.
Setting Up SpO2 Monitoring
1 Connect the SpO2 adapter cable to the patient-worn telemetry transmitter.
2 Attach the sensor to the patient and connect the sensor cable to the SpO2 adapter cable.
3 Initiate ECG monitoring on the patient monitor.
4 Touch ECG.
5 Touch CHANNEL FORMAT.
6 Touch SpO2/ON.
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Ensuring Accurate SpO2 Monitoring
Each sensor requires site-specific application procedures. The quality of the patient’s pulse oximetry
measurements and pulse signals may be adversely affected by certain environmental factors, by
oximetry sensor application errors, and by patient conditions. Any of these factors can interfere with
the monitor’s ability to detect and show measurements and may result in a loss-of-pulse condition.
If the SpO2 measurement does not seem reasonable, first check the patient’s vital signs by alternate
means and then check the pulse oximeter for proper operation.
Patients with anemia and/or significant concentrations of dysfunctional hemoglobins (such as
carboxyhemoglobin, methemoglobin, and sulphemoglobin) may appear to have normal saturation
values while actually being hypoxic. Further assessment, using means other than pulse oximetry, is
recommended for such patients.
For anemic patients, this condition occurs because patients have decreased arterial oxygen
contents.
•
For patients with dysfunctional hemoglobins (that are unable to carry oxygen), this condition
occurs because less functional hemoglobin is available to carry oxygen.
Caution:
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•
Hemoglobin levels below 5 g/dl may prevent the monitor from providing SpO2 values.
Other patient conditions that may result in inaccurate measurements or a loss-of-signal
condition during operation include:
•
Low perfusion
•
Dark pigment
•
Prolonged and/or excessive patient movement
•
An arterial occlusion (blocked artery) proximal to the sensor
•
Venous pulsations
•
Wrapping the sensor too tightly around the patient’s digit or other extremity
•
Placing the sensor on an extremity with a blood pressure cuff, arterial catheter, or intravascular line
•
Inflating a blood pressure cuff on the limb to which the sensor is attached
External factors that may adversely affect the accuracy of oximetry readings include:
•
High ambient lighting
•
High-frequency electrical noise, such as electrosurgical units and defibrillators
•
The presence of intravascular dyes, such as indocyanine green or methylene blue, or externally
applied coloring, such as nail polish or pigmented creams
•
The patient has hypotension, severe vasoconstriction, severe anemia, or hypothermia
•
The patient is in cardiac arrest or is in shock
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Caution:
Sources of high ambient light such as direct sunlight, surgical lights (especially those with
a xenon light source), bilirubin lamps, fluorescent lights, and infrared heating lamps can
interfere with an SpO2 sensor’s performance and result in inaccurate measurements. When
using SpO2 under such conditions, this interference can be reduced by covering the
application site with an opaque material and by ensuring that the sensor is properly
applied.
Taking the actions that follow may improve SpO2 performance:
Select an application site with unrestricted blood flow.
•
Do not select a site near potential electrical interference (e.g., electronic equipment,
electrosurgical units, other power cords). If possible, remove these electrical noise sources from
the area.
•
If artificial nails or externally applied coloring agents such as nail polish are present, select another
site or remove the polish/artificial nails.
•
If necessary, wipe the sensor site for 20 to 30 seconds with a 70% isopropyl alcohol pad to
improve performance.
•
Apply the sensor correctly, ensuring that the LEDs and the photo detector are properly aligned
directly opposite each other, preferably on a site that minimizes the distance between the emitter
and photodetector. Periodically check to ensure that the sensor remains properly positioned on the
patient.
•
Do not restrict blood flow when securing a sensor with tape.
•
If high ambient light is affecting measurements, ensure that the sensor is properly applied and then
cover the application site with an opaque material such as a blanket or towel. Failure to do this
may result in inaccurate measurements.
•
Maintain a minimum signal level above the Sensorwatch bar.
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•
If patient movement presents a problem, one or more of the actions that follow may correct it:
•
Verify that the sensor is properly and securely applied.
•
Move the sensor to a less active site; to reduce or eliminate motion artifact, the application site
should remain as immobile as possible.
•
Use an adhesive sensor that tolerates some patient motion.
•
Use a new sensor with fresh adhesive backing.
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SpO 2 and Pulse Rate Specifications
Displayed Range
SpO2 (functional) 0% - 100%
Pulse Rate (bpm) 30- 240 bpm
Resolution
SpO2 (functional) 1%
Pulse Rate (bpm) 1 bpm
Table 2: Pediatric or Adult SpO2 and Pulse Rate Accuracy
Patient Type
Signal Condition
Range
SpO2
(functional)
Pediatric or Adult
No motion and normal
perfusion
70-100
0-69
+/- 2%
unspecified
Pulse Rate
(bpm)
Pediatric or Adult
No motion and normal
perfusion
30-240
+/- 3 bpm
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Parameter
Accuracy
Table 3: Neonate SpO2 and Pulse Rate Accuracy
Parameter
Patient Type
Signal Condition
Range
Accuracy
SpO2
(functional)
Neonate
No motion and normal
perfusion
70-100
0-69
+/- 3.25%
unspecified
Neonate
No motion and normal
perfusion
30-240
+/- 3 bpm
Pulse Rate
(bpm)
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Using the Sensorwatch Feature
The Sensorwatch feature provides a graphical presentation of the amplitude of the signal received
from the sensor. It can be used to determine the best sensor site and application.
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Figure 3-3: SpO2 Sensorwatch bar on the 91387-38 central monitor
Figure 3-4: SpO2 Sensorwatch symbol on the 96281-C telemetry transmitter.
Changes in the bar’s shaded level signify changes in the patient’s perfusion or changes in the
application of the sensor. The horizontal line in the bottom fourth of the bar is used in Spacelabs
Healthcare SpO2 technology only and represents the minimum signal level that results in accurate
saturation values.
When the shading is just below this line, the message LOW SIGNAL STRENGTH - Reposition or
replace sensor appears.
•
Reposition the sensor to a different site to provide better perfusion.
•
Reposition the sensor to provide better contact with the skin. Make sure the LEDs and photo
detector are properly aligned.
•
Replace a defective sensor.
•
Wait for the patient to warm up and for the patient’s perfusion to increase.
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Enabling and Adjusting Alarms
Spacelabs Healthcare Technology
Pulse oximetry alarm limits and delays are set internally based upon defined default values. Refer to
the user manuals for your patient monitor for details on operating system alarms.
To enable and adjust SpO2 alarms (telemetry)
1 Touch ECG.
2 Touch ALARM LIMITS.
3 Touch SPO2 ALARM LIMITS.
4 Select SPO2 ALM / ON.
5 Select HI=, LO=, ALM DELAY, or MSG ALARM DELAY (if present).
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6 Use the arrow keys to adjust.
Additional Information for Telemetry Products
When SpO2 alarms are enabled, a bell symbol appears immediately after the measured
SpO2 saturation percentage (%).
Data Averaging
Data averaging is performed internally on the telemetry transmitter. The data averaging feature
smooths the oximetry saturation value by averaging patient input values over several seconds.
Telemetry
For telemetry monitoring, the heart rate for the display is obtained directly from the acquired ECG
leads. In addition, the pulse rate is obtained from the SpO2 parameter. SpO2 pulse rate is viewable in
the patient’s trends and on the 96281-C telemetry transmitter.
Heart Rate Averaging
On-Transmitter Heart Rate Display Performance
The 96281-B and 96281-C transmitters can show the patient’s heart rate when the transmitter is in
view mode. The heart rate shown on the transmitter is to aid patient hook up and is indicative only; it is
not for diagnostic use. The heart rate shown on the transmitter is not related to the heart rate shown on
any central monitor/station. The heart rate is calculated using the QRS complexes detected within the
last five seconds on ECG data. Averaging is performed within the five second window. The heart rate
shown on the screen is updated approximately every 1.8 seconds.
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The on-transmitter heart rate display has been tested according to IEC 60601-2-27:2011 for:
•
Tall T-wave rejection: It rejects T-waves up to 150% of the QRS complex amplitude,
•
Maximum response times, to the nearest second, to step changes in heart rates:
•
5 seconds when the heart rate changes from 80 beats per minute to 120 beats per minute.
5 seconds when the heart rate changes from 80 beats per minute to 40 beats per minute.
Heart rate accuracy and response to irregular rhythms:
The heart rates that show on the display for the four irregular rhythm test waveforms within the
standard are listed in Table 4.
Table 4: Heart Rates for Four Irregular Rhythm Test Waveforms
Heart Rate Shown
on Monitor
A1
80
A2
63
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Warning:
Test Waveform
A3
119
A4
86
The on-transmitter heart rate display accuracy may be affected by cardiac arrhythmias
and pacemaker pulses. The heart rate shown on a central station or bedside monitor
may similarly be affected. Refer to their manuals for appropriate details.
Note:
The on-transmitter heart rate is calculated using ECG Lead II only, consequently if either RA or
LL electrode is not present, then heart rate cannot be calculated and ??? will be shown on the
transmitter display.
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Display Details at the Host Monitor
Signal detection is indicated on your monitor when an ECG signal appears next to the ECG parameter
key in the zone assigned to receive the transmitted telemetry channel. The transmitter's channel
number is always identified above the waveform, to the left of the ECG key.
HR=70
A=3
II
98%
2241
BED 01
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10
Figure 3-5: Central monitor — split view (SpO2 turned ON)
Notes:
•
SpO2 does not show if it is turned OFF.
•
A bell symbol follows the percent (%) symbol if the SpO2 alarm is enabled.
Current heart rate
Abnormal beats per minute counter
ECG lead designator
SpO2 reading
Telemetry channel number
ECG rate alarm limits. Split-view central monitors show a bell symbol when alarms are enabled.
Sensorwatch signal strength indicator
Shaded area (waveform index, WFI) expands up proportionally to signal strength; horizontal line
indicates minimum signal level.
No shading (lowest waveform index) corresponds to no detected signal strength or a faulty
sensor.
ECG key for first lead
Bed/patient ID
10 ECG waveform for first lead
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Printing SpO2 Waveforms
This feature is not supported in telemetry products.
SpO 2 Messages at the Host Monitor
Caution:
Status messages indicate problems or conditions that may affect accurate monitoring
values. Do not ignore these messages. Correct any fault before continuing.
When a status message appears, the saturation value and pulse rate immediately change to ???.
An alarm may occur if your module is configured to do so. Depending on the configuration and
option purchased, this alarm may not occur until after the message alarm delay time has elapsed.
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Telemetry products use different text for SpO2 status messages than non-telemetry products.
Telemetry products also show status messages within the ECG display zone, therefore, the ECG
alarm messages that follow take priority over other SpO2 messages.
•
LEADS OFF
•
NOISY SIGNAL
•
ECG ALARMS SUSPENDED
Refer to the customer documentation for your monitor for complete information on potential status
messages which may appear at a host monitor that is configured with a 96281-A, 96281-B, 96281-C
telemetry transmitter.
When a status message appears, the saturation value and pulse rate immediately change to ???.
An alarm may occur if your module is configured to do so. Depending on the configuration and
option purchased, this alarm may not occur until after the message alarm delay time has elapsed.
Telemetry products use different text for SpO2 status messages than non-telemetry products. Refer to
Table 5 for interpretations of the telemetry messages.
Telemetry products also show status messages within the ECG display zone, therefore, the
ECG alarm messages that follow take priority over other SpO2 messages.
•
LEADS OFF
•
NOISY SIGNAL
•
ECG ALARMS SUSPENDED
Table 5: Telemetry Message Equivalents
Telemetry SpO2 Message
SPO2 SENSOR DISCONNECTED
SPO2 FAULTY SENSOR
SPO2 SENSOR DISCONNECTED
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Table 5: Telemetry Message Equivalents (continued)
Telemetry SpO2 Message
SPO2 SENSOR OFF PATIENT
SPO2 INSUFFICIENT SIGNAL
SPO2 AMBIENT LIGHT INTF.
SPO2 NOISY SIGNAL
SPO2 INSUFFICIENT SIGNAL
SENSOR DISCONNECTED — Check connection at adapter cable
This message and alarm indicate that the sensor is either disconnected or the wiring is faulty.
•
Check for proper sensor connection to the adapter cable.
•
If the message persists, replace the sensor and/or the adapter cable.
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SENSOR OFF PATIENT — Check connection at patient
•
The telemetry transmitter does not detect a valid sensor input signal. Check the patient for proper
sensor placement.
•
The tissue between the LED and photodiode is too transmissive. If the sensor placement seems
correct and the message persists, try a sensor site with a thicker tissue bed.
Note:
This message is not available with all SpO2 sensors.
INSUFFICIENT SIGNAL — Reposition or replace sensor
•
Insufficient signal for proper operation, indicated by a low deflection on the Sensorwatch signal
strength bar.
•
Poor sensor application or site. Correctly reapply or reposition to a better perfused site, or
massage the site.
•
If the message persists, then replace the sensor.
LOW SIGNAL STRENGTH — Reposition or replace sensor
When this message appears, the saturation and pulse rate continue to show. However, the
Sensorwatch bar flashes as an indication of a possible error condition.
•
Insufficient blood flow between the sensor light emitter and detector. Move the sensor to an area of
higher perfusion.
•
Poor sensor application. Reposition to place active components closer to the skin or locate to a
better perfused site.
•
The sensor site is below the blood pressure cuff. Move to another site.
•
If the message persists, then replace the sensor.
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AMBIENT LIGHT INTERFERENCE — Cover sensor area
•
The sensor is receiving external light interference from a bright light source near the sensor. Shield
the sensor from the external light source.
•
The sensor photodiode and LED are misaligned on flexible sensors, allowing light to enter. Realign
the sensor photodiode with the LED.
•
If the message persists, then replace the sensor.
NOISY SIGNAL
•
The sensor signal is disturbed by motion or other interference. Eliminate sensor movement.
•
Power cords or other electrically noisy devices are too close to the sensor. Move the noisy device
or move the sensor to another site.
•
If the message persists, then replace the sensor.
FAULTY SENSOR — Replace sensor
The LED or photodiode (or both) may have failed.
•
Ensure the sensor is properly connected, disconnect and then reconnect the sensor.
•
If the error occurs again, replace the sensor and/or sensor adapter cable.
•
If replacing the sensor and/or cable does not correct the problem, contact your Spacelabs
Healthcare Field Service Engineer.
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•
HARDWARE INCOMPATIBILITY — Contact service
The hardware configuration in your module is not compatible with the programmed software options.
•
Contact your Spacelabs Healthcare Field Service Engineer.
Sensors
For SpO2 sensor compatibility, refer to the information that follows.
Spacelabs Healthcare SpO 2 Sensors
Please refer to the the accessories in Telemetry Transmitter (96281) Data Sheet for compatible
sensors (for the 96281-C) and adapter cables.
Additional Information
For additional information about biocompatibility or sensor disposal, refer to the manufacturer's
instructions enclosed with each sensor.
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E C G AND SPO 2
SpO2 Alarm Delays
Table 6: SpO2 Alarms
Alarm Setting
Range
Alarm Delay
Spacelabs Healthcare
50 to 99%
• Less than (15 seconds + user selected alarm delay)
• Alarm delay is user selected from 0 to 30 seconds in
5 second increments.
Sat High
51 to 100%
• Less than (20 seconds + user selected alarm delay)
• Alarm delay is user selected from 0 to 30 seconds in
5 second increments.
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Sat Low
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E C G AND SPO 2
SpO 2 Troubleshooting Guide
Clinical Situation
Possible Cause
Solution
•
SpO2 is not enabled at the
90478 receiver.
•
Enable multiparameter
telemetry in the Module
Configuration Manager or
enable the SpO2 display in the
Channel Format menu.
SpO2 value shows
as ???
•
Sensor is not connected to the
patient.
•
Reattach the sensor.
•
There is excessive patient
motion.
•
Request patient to remain still
while reading is in progress.
•
Module is in the initialization
phase (the first 15 seconds
after sensor application).
•
Wait until the initialization is
complete.
•
Adapter cable is improperly
connected to the telemetry
transmitter.
•
Correctly connect the adapter
cable.
•
Sensor is not connected to the
adapter cable.
•
Correctly connect the sensor.
•
Telemetry low battery indicator
is constantly illuminated.
•
Contact your biomed or a
qualified field service engineer.
•
Sensor placement is not
optimum.
•
Move the sensor to a site which
has better perfusion.
•
Align the LED with the sensor
photo detector.
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No SpO2 parameter key
in Channel Format
menu
Low signal strength
-ORInsufficient Signal
Intermittent or
complete failure to
operate
•
Sensor is placed below the
blood pressure cuff.
•
Move the sensor to an
alternate limb.
•
Receiver or transmitter error.
•
Contact your biomed or a
qualified field service engineer.
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E C G AND SPO 2
Clinical Situation
No SpO2 alarms are
shown
FAULTY SENSOR
Replace Sensor
Solution
•
Presence of dysfunctional
hemoglobins (COHb, MetHb).
•
Follow hospital procedure for
determining oxygenation in
these patients.
•
Presence of intravascular dyes
(indocyamine green,
methylene blue) in the blood
stream.
•
Follow hospital procedure for
determining oxygenation in
these patients.
•
High ambient light level.
•
Reduce light levels near the
patient.
•
Electrosurgical interference.
•
Follow hospital procedure for
determining oxygenation in
these patients.
•
Patient is significantly anemic
(Hb less than 5 g/dl) or has
received large amounts of IV
solutions.
•
Follow hospital procedure for
determining oxygenation in
these patients.
•
ECG “Leads Off” condition
exists.
•
Re-attach ECG leadwires to the
patient and resume ECG
monitoring.
•
Higher priority alarm condition
is present.
•
Clear the current alarm
condition and/or re-prioritize
SpO2 alarms in the Module
Configuration Manager.
•
When SpO2 alarms are ON, all
SpO2 alarm conditions cause
the parameter value to blink
according to the alarm priority
set using the Module
Configuration Manager.
•
To clear the message, connect
a known good sensor to the
adapter cable.
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Factors causing
significant variances in
sensor accuracy
Possible Cause
•
A faulty or incompatible sensor
is connected to the adapter
cable.
•
Sensor has failed.
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Basic Operations
Getting Started
Device setup must be performed before patient application and, on appropriate units, the LCD should
be visually verified to function before use on a patient.
Transmitter Batteries
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When batteries are installed, the transmitter is continuously ON. If no batteries are installed, the
transmitter is OFF. To extend battery life, insert batteries only to use the transmitter with a patient.
Remove the batteries when the transmitter is not in use.
Spacelabs Healthcare recommends two AA 1.5-volt alkaline batteries for standard use in the digital
telemetry transmitter for a battery source of 3 volts. Alternatively, you may use two AA-equivalent 2400
mAH NiMH rechargeable batteries.
Check the battery position and polarity, as shown at the bottom of the battery compartment on the
device. After battery installation, close and latch the compartment cover. Transmission of telemetry
signals begin as soon as the battery is in place.
Refer to Battery Compartment (96281-A, 96281-B, 96281-C) on page 4-7 for details on battery
compartment labels and components.
Warnings:
•
Batteries exposed to short circuit, high temperature, or fire may leak, vent, or explode.
•
Do not use any transmitter that has been compromised by liquid ingress.
•
Do not allow any liquid to enter the case. An open battery compartment is not fluid
resistant.
•
Users should inspect batteries before using them within the transmitter- do not use
any batteries that appear to be damaged or have been subject to misuse.
•
Do not attempt to use depleted batteries or mix different types of batteries. Doing so
may result in the telemetry transmitter being unable to accurately determine the
battery condition and prevent the transmitter from working properly. If the battery
low indicator flashes as soon as batteries are inserted, then they are too depleted to
be used and the transmitter will not work properly. Replace with new or fully-charged
batteries immediately.
Cautions:
•
Obey the battery manufacturer’s recommended handling procedure.
•
Collect and transport batteries in a manner that prevents short circuit, compacting,
mutilation, or any other abuse that would compromise the physical integrity.
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B ASIC O PERATIONS
•
Clean the transmitter case with the battery door closed.
•
Inspect and check the transmitter for damage prior to every procedure.
•
Use either new alkaline batteries or fully-charged 2400 mAH NiMH rechargeable batteries
for each and every new procedure.
•
Clean the transmitter after each use. Refer to the Telemetry Transmitter (96281-A,
96281-B, 96281-C) Service Manual (P/N 070-2408-xx), located on the Telemetry
Service (9628X) CD (P/N 084-2202-xx) for preventive maintenance instructions.
•
Make sure that service on the transmitter is performed by authorized Spacelabs
Healthcare service personnel when repairs are necessary or at suitable intervals.
Notes:
The description that follows of transmitter operation is valid only for two AA 1.5-volt alkaline or
two AA-equivalent 2400 mAH NiMH rechargeable batteries and does not apply to any other
type of battery.
When a low battery condition is detected, the orange battery status indicator illuminates on
the front cover of all three transmitter models: 96281-A, 96281-B, 96281-C. In addition, a
red battery symbol appears in the display of the 96281-B and 96281-C transmitters.
•
Used batteries must be properly disposed of or recycled according to national and/or local
regulation.
•
Refer to the product service manual for more details.
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•
Host Monitors
The 96281 telemetry transmitter is compatible with the Ultraview SL 3800-38/-39 central monitor and
the Ultraview and Ultraview SL line of bedside monitors. For information on configuring battery alarm
status, enabling and adjusting alarms, assigning telemetry channels, status or interference messages,
refer to the operations and service manuals for the specific monitor in use with the telemetry
transmitter devices.
If you use Ultraview SL 3800-38 or 3800-39 central monitor,
•
refer to the Ultraview SL Operations Manual (P/N 070-1150-xx), 91387 Service Manual (P/N
070-1159-xx), and to the Clinical Parameters Operations Manual (P/N 070-2113-xx) for more
information.
Telemetry Receiver Module
The telemetry transmitters are compatible with the 90478 Digital Telemetry System Receiver and
Receiver Housing (90479-A, 90479-B, 90479-C). The receiver housing is related to the central
monitor. The receiver module can go in the housing or in a bedside monitor.
Refer to Clinical Parameters Operations Manual (P/N 070-2113-xx) located on the Patient Monitoring
Operations Documents CD (P/N 084-1101-xx) and to the Spacelabs Healthcare Service CD (P/N
070-0700-xx) for detailed information relating to the 90478 and 90479 digital telemetry systems.
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B ASIC O PERATIONS
Warning:
All system connections (except for those related to moving receivers from one monitor
or housing to another) must be made by trained or qualified personnel only. Changes or
modifications not expressly approved by Spacelabs Healthcare may void the user’s
authority to operate the equipment.
Cautions:
•
Telemetry transmitters have preassigned channel numbers (frequencies) that cannot be
changed. The channel number is identified on the back cover of the transmitter.
•
Only qualified personnel should tune telemetry receiver modules to receive data from a
telemetry transmitter. Telemetry receiver modules must be used with a transmitter on
the same frequency.
•
Qualified service personnel should set the telemetry receiver’s frequency band via the
Module Configuration Manager feature.
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Assigning a Telemetry Channel
When connecting a new patient to a transmitter, make sure the prior patient’s information has been
purged at the host monitor.
Your central station can only show a telemetry channel after that channel has been assigned a specific
bed or room number. Refer to the user manuals for your central monitor or station for information to
assign a specific bed name to a telemetry channel and to assign the bed to a specific display zone.
Your central monitor can be configured to remember the bed name assigned to individual telemetry
channels. These beds are permanently assigned until you unassign or reassign them. Refer to the
Ultraview SL Module Configuration Manager System Administration Guide (P/N 070-1245-xx) for more
information.
Basic Components
The 96281-B telemetry transmitter is essentially the same as the 96281-C model, except for the
SpO2 capability. Thus the components described in the illustrations of the 96281-C are also applicable
to the 96281-B model except for the SpO2 connector cap.
The 96281-A model is similar to the 96281-B and 96281-C but it does not include a display or an SpO2
connector cap or functionality (refer to Figure 4-3 on page 4-6).
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Top, Front and Bottom View (96281-C)
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Figure 4-1: Top, front, and bottom views (96281-C)
Top view showing lead inputs and SPO2 connector cap (SPO2 cap on 96281-C only)
Front view of SPO2 connector cap (96281-C only)
Location on display where lead fault indicators show (96281-B, 96281-C)
Action button
Note:
The nurse may instruct the patient to press the Action button if he or she experiences any
discomfort.
Low battery indicator
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B ASIC O PERATIONS
Bottom view of the battery compartment latch
Up/down buttons for LCD configuration (96281-B and 96281-C only)
Rear View (96281-C)
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Figure 4-2: Rear view (96281-C)
Grouper (includes a clip)
“Do not modify” symbol (repairs and modifications must be done by Spacelabs Healthcare,
or the warranty is void)
ECG label (includes lead legend and leads placement diagram)
Channel identifier
Manufacturing technical label
Battery compartment cover
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B ASIC O PERATIONS
Front View (96281-A)
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Figure 4-3: 96281-A Telemetry Transmitter
Lead fault indicators on 96281-A
(up to five triangular shapes may illuminate when activated by a lead off condition)
Action button
Low battery indicator
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B ASIC O PERATIONS
Battery Compartment (96281-A, 96281-B, 96281-C)
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Figure 4-4: Details of battery compartment (cover open)
Battery type label affixed to underside of open battery compartment cover
Battery polarity label
Battery compartment latch (on bottomside)
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B ASIC O PERATIONS
Selecting Options for Leads
Up to five standard, disposable, silver/silver chloride chest electrodes are connected to the patient. The
ECG leadwires are attached to these electrodes and connected to the transmitter.
Refer to Figure 4-5 on page 4-8 for leads placement and SpO2 connections.
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Figure 4-5: ECG leads placement and SpO2 connections
RA
LA
LL
RL
96281-C telemetry transmitter
SpO2 sensor
SpO2 cable
Monitors and transmitters may be placed in pouches and attached to the patient’s belt.
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B ASIC O PERATIONS
Notes:
•
If one of the leads fails, a lead fault message shows on the host monitor.
•
If there is no valid lead vector, the message CHAN 1 & 2 - LEADS OFF shows and an alarm
tone sounds only at the host monitor.
Basic User Actions
The up and down arrow buttons (refer to 6 in Figure 4-1 on page 4-4) provide navigational control,
such as moving through ECG and SpO2 displays. These up/down buttons are only included on the
96281-B and 96281-C models.
Warnings:
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All 96281 devices include the Action button, refer to item 4 in Figure 4-1 on page 4-4. If a patient or
user presses this button, and keeps the button pressed for approximately one and a half seconds, the
transmitter sends an “event” to the host monitor. The transmitter provides visual indication of such
“events” by flashing all its LEAD OFF indicators on-off, on-off, twice in quick succession. The
corresponding action at the host monitor, depends on the configuration settings of the host monitor, so
please refer to the Monitor Operations Manual, but typically events are used to generate strip
recordings.
•
Do not use any transmitter that has been compromised by liquid ingress.
•
Do not allow liquid to enter the battery compartment.
•
Readings for SpO2 should not be taken from the same arm that has an NIBP cuff
attached.
Cautions:
•
Clean the transmitter case with the battery door closed. Fluids, including cleaning
solutions, may damage the electrical components inside and cause the transmitter to
malfunction.
•
Clean the transmitter after every procedure (refer to Cleaning, Disinfecting,
and Sterilization on page 5-1 for more information).
Notes:
•
Should all of the lead fault indicators illuminate and stay illuminated during operation, then
the AriaTele transmitter has detected an internal fault condition. If this occurs, the device
will stop transmitting and will not show any ECG or SpO2 information. To clear this
condition, install new batteries.
•
If all of the lead fault indicators remain permanently illuminated, please contact your
Spacelabs Healthcare service representative for assistance.
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B ASIC O PERATIONS
To send a recording to the central
monitor or station
To unlock the user interface on the 96281
telemetry transmitter
•
•
From either the view or non-view mode,
firmly push the action button for
2 seconds. Refer to Basic Modes of
Operation on page 4-11 for more
Push and hold the up and down buttons
simultaneously for at least three seconds.
Note:
When the user interface is locked, the LCD
appears blank, even though the transmitter
is in a non-view mode and still transmitting.
information.
Note:
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The record function must be enabled at the
central station to send a recording. Refer to
the operations manual for your central
station for more information.
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B ASIC O PERATIONS
Basic Modes of Operation
There are three basic operating modes to the telemetry transmitter.
Off
View
Non-View
Table 1: Basic Modes of Operation
Operating Mode
Off
Description
The device is off and is not in use if there are no batteries installed.
96281-B, 96281-C
View
User can view patient vital signs on the host monitor or
transmitter LCD.
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User can initiate printing.
Patient vital signs are transmitted to the central station.
After 60 seconds of inactivity, the unit moves to the non-view mode.
96281-A, 96281-B, 96281-C
Note:
Since the 96281-A does not have an LCD, it is either
continuously in non-view mode or is OFF.
Non-View
The LCD is off on the 96281-B or 96281-C.
User can initiate printing.
Patient vital signs are transmitted to the central station.
User can return to the view mode by unlocking the user
interface (96281-B or 96281-C only).
To unlock the interface, push and hold
the up and down buttons
simultaneously for at least three
seconds.
Note:
The 96281-C automatically detects a sensor connection and activates or deactivates the SpO2
option accordingly.
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B ASIC O PERATIONS
View Mode
View Mode is available only with transmitters that include a display (96281-B or 96281-C), so it is not
applicable to the 96281-A telemetry transmitter.
ECG
ECG data is obtained directly from the patient connection and shows on the transmitter LCD as shown
in Figure 4-6, depending on configuration of leads and available parameters.
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Figure 4-6: Paced ECG and SpO2 display on the 96281-C
SpO2 saturation percentage (available on 96281-C only)
ECG waveform
Battery charge indicator (shows the battery state)
Pacing marker
Shown lead indicator
Heart rate derived from ECG (indicated by solid heart icon)
Note:
The AriaTele acquires and transmits ECG data in samples. In addition, it may show the ECG
waveform on its optional display. When the AriaTele acquires an ECG sample that it detects as
possessing a pacing pulse, it does two things:
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B ASIC O PERATIONS
•
It sends a notification to the receiving system, indicating that the ECG sample contained a
pacing pulse.
•
It marks the location of the pacing pulse, on its optional display, using purple pacing
markers as shown.
The receiver system uses the information it receives to mark corresponding purple pacing
pulses on the ECG waveform that it receives.
Note:
•
ECG leads show in the order that follows: Lead II, V, Lead I, Lead III.
•
If a lead is not available due to electrode configuration, that lead shows as a straight line on
the display.
•
Pacing marker (shows only if detected) is shown as a vertical purple line.
The symbols that follow show on the 96281-B and 96281-C telemetry transmitter LCD when numerics
are not available or are out of the designated range for a parameter.
???
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Not available
Under range
---
Over range
+++
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B ASIC O PERATIONS
SpO 2
SpO2 is only available with the 96281-C. SpO2 data is obtained directly from the patient and may show
as in Figure 4-7, depending on configuration of leads and available parameters.
The 96281-C auto-detects a sensor connection and activates or deactivates the SpO2 option
accordingly.
Note:
SpO2 view does not show if a SpO2 adapter cable is not connected.
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Figure 4-7: Typical SpO2 display on 96281-C (shows a low battery state)
SpO2 saturation percentage (96281-C only)
SpO2 pulse waveform (96281-C only)
Battery charge indicator (defined by quartiles)
Signal quality/strength indicator (at least one color bar in the indicator is recommended for a
reliable SpO2 value)
Pulse rate derived from SpO2 (indicated by an asterisk)
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B ASIC O PERATIONS
Status Messages at the Host Monitor
Various status messages related to the telemetry transmitter may show at the host monitor when there
is a problem with the signal or when the battery is low. The host monitor may be either the central
station or bedside monitor.
Caution:
•
Do not ignore status messages.
•
SpO2 data may not show when the INTERMITTENT SIGNAL LOSS message appears.
•
Status messages indicate a problem or condition which may affect accurate monitoring
values.
•
Correct any fault before continuing.
The status messages that follow may appear at the host monitor. Refer to SpO2 Messages at the
Host Monitor on page 3-16, for status messages related to SpO2.
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• INTERMITTENT SIGNAL LOSS
Indicates that the patient may be out of antenna range or the battery is depleted. Return the patient
into antenna range. Check that the battery is functioning properly. A low-priority alarm occurs after
10 seconds in this condition.
• LOW BATTERY
Indicates the battery is weak. After this message appears, the battery has approximately one hour
of useful life left (depending on the type of battery used). Install a new battery. A low-priority alarm
occurs if the setup menu’s LOW BAT ON/OFF key is set to ON.
• SIGNAL INTERFERENCE
Indicates, through the triangle-shaped squelch waveform, that an interfering signal has been
detected. The patient’s signal can no longer be detected because of interference from a stronger
signal source lasting more than 0.5 seconds. A low priority alarm occurs whenever this message
appears in the waveform zone.
•
IS SIGNAL LOSS PERMANENT?
Indicates no radio frequency (RF) signal is detected.
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Telemetry Transmitter with ECG Only
Troubleshooting Guide
Clinical Situation
Possible Cause
Solution
•
The batteries are low.
•
Replace batteries.
All leads off LEDs lit
•
Self test failure.
•
Contact Spacelabs Healthcare.
Any or all leads off
LEDs flashing
•
Check ECG leads.
ECG is not shown at
Central Station
•
Check if batteries are low.
•
Replace batteries.
ECG is not shown at
Central Station
•
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Low battery LED
flashing
Unit malfunction.
•
Contact Spacelabs Healthcare.
Telemetry Transmitter with Display
Troubleshooting Guide
Clinical Situation
Possible Cause
Solution
•
The batteries are low.
•
Replace batteries.
All leads off LEDs lit
•
Self test failure.
•
Contact Spacelabs Healthcare.
Any or all leads off
LEDs flashing
•
Check ECG leads.
ECG is not shown at
Central Station
•
Check if batteries are low.
•
Replace batteries.
ECG is not shown on
transmitter display
•
Unit malfunction.
•
Contact Spacelabs Healthcare.
Low battery LED
flashing
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Telemetry Transmitter with Display and SpO 2
Troubleshooting Guide
Clinical Situation
Possible Cause
Solution
•
The batteries are low.
•
Replace batteries.
All leads off LEDs lit
•
Self test failure.
•
Contact Spacelabs Healthcare.
Any or all leads off
LEDs flashing
•
Check ECG leads.
ECG is not shown at
Central Station
•
Check if batteries are low.
•
Replace batteries.
SpO2 data is not
shown on transmitter
display
•
SpO2 cable and/or sensor is
faulty.
•
Unit malfunction.
•
Unit malfunction.
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Low battery LED
flashing
SpO2 is not shown at
Central Station
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•
Check SpO2 cable and sensor.
•
Contact Spacelabs Healthcare.
•
Contact Spacelabs Healthcare.
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Cleaning, Disinfecting,
and Sterilization
Cleaning Products Not Recommended for Use
Warnings:
Do not use Accelerated Hydrogen Peroxide (AHP) and quaternary ammonia-based
products to clean the transmitter, leadwires, cables, or sensors. Common quaternary
ammonia germicidal products include Cavicide, Virex, Virex 256, SaniCloth, and
Sanicloth Plus.
•
These chemicals attack the plastics used in patient monitors and cables, and will
cause serious safety hazards as the electrical insulating properties and structural
integrity of the equipment break down.
•
These germicidal products are safe for use ONLY on hard, non-porous surfaces,
such as linoleum floors, formica countertops, and stainless steel.
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•
Cleaning the Display
Clean the display with a soft cloth moistened with either 70% isopropyl alcohol solution or
soapy water.
Notes:
Obey your hospital protocol for the handling of blood and body fluids.
Transmitter, Leadwires, Cables, and Sensors
Cleaning/Disinfecting
Warnings:
•
Use only recommended cleaning solutions, or you may void the manufacturer’s
warranty.
•
Harsh chemical agents degrade plastics and compromise the safety of the device.
Some germicidal and other harsh cleaning compounds are known to damage some
plastics by weakening the structural integrity and compromising the electrical
insulating properties.
•
Disconnect the equipment from the patient before cleaning.
TE L E M E T R Y T R A N S M I T T E R ( 9 6 2 8 1 ) O P E R A T I O N S M A N U A L
5-1
C LEANING, D ISINFECTING, AND STERILIZATION
•
Do not immerse the equipment or cables in water or cleaning solutions.
•
Do not autoclave.
Recommended Cleaning Solutions
Use only the recommended cleaning solutions that follow:
•
Mild soap and water solution
•
U.S. Pharmacopoeia (USP) green soap
•
Sodium hypochlorite solution (1:10 dilution of household chlorine bleach in water)
•
Phenolic germicidal detergent (1% aqueous solution)
•
Isopropyl alcohol (70% solution)
Caution:
Note:
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Questions and concerns about cleaning issues should be directed to Spacelabs
Healthcare Technical Support.
•
Repeated use of a chlorine bleach solution may cause some colors to fade.
•
Tape adhesive can be removed with Spacelabs Healthcare adhesive tape remover pads
(P/N 392196-001).
Accessories
•
Where provided, obey the manufacturers' instructions concerning disposable and reusable
supplies.
•
As applicable, obey your hospital protocol concerning cleaning, disinfection, and/or
sterilization of reusable supplies.
•
Obey hospital protocols to dispose of used and contaminated single-use accessories.
Cleaning and Disinfecting the 96281Telemetry
Transmitters and Cables
In normal use the product is worn by one hospital patient for a few days. Clean and disinfect the
transmitter after every procedure and/or before it is worn by another patient. There is a risk that the
product may carry dangerous levels of infectious agents to the next patient if it is not adequately
cleaned and/or disinfected.
Refer to Recommended Cleaning Solutions on page 5-2 for a list of acceptable cleaning solutions.
TE L E M E T R Y T R A N S M I T T E R ( 9 6 2 8 1 ) O P E R A T I O N S M A N U A L
5-2
C LEANING, D ISINFECTING, AND STERILIZATION
Basic Cleaning and Low-level Disinfection
1 Remove the batteries and close the battery
cover.
7 Wet a clean cloth with the selected cleaning
solution.
2 Remove the ECG leadwires, grouper, and
SPO2 cable (if fitted).
8 Remove excess liquid from the cloth and
squeeze dry.
3 Inspect the transmitter for contamination. If
required and carry out steps 4 and 5 to clean
the transmitter.
9 Wipe all exposed surfaces of the equipment
and cables.
4 Rub the transmitter with a cloth wetted in a
mild detergent solution.
5 Dry the transmitter thoroughly.
6 Prepare the cleaning solution chosen from
the list of recommended cleaning solutions
according to the manufacturer’s instructions.
10 Leave the transmitter for the required contact
time, during which it should remain wet.
11 Remove any soap residue by gently wiping
with a clean damp cloth.
12 Wipe dry with a clean dry cloth.
13 Take steps to remove disinfectant residues in
accordance with the disinfectant labelling.
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Cleaning ECG Leadwires
Inspect the leadwire sockets for contamination. If necessary, flush using a syringe and clean
using a toothpick. Once clean, Spacelabs Healthcare recommends wetting the sockets with 70%
isopropyl alcohol to provide low level disinfection. This agent can be left to dry naturally and does
not require any rinse procedures.
Note:
After cleaning ECG leadwires, remove the ECG leadwires from the lead block and thoroughly
dry them at the lead block ends and at the lead connector ends. Thorough drying will prevent
residual moisture from providing a low-current path between leads, which can interfere with
lead off detection and cause false asystoles.
Cleaning Buttons
Clean the buttons by wetting a small brush with a mild detergent solution and gently scrubbing
around and across the buttons. Dry the buttons with a rubbing action.
Disinfect the buttons by using the same method. Spacelabs Healthcare recommends using
70% isopropyl alcohol which can be left to dry naturally and does not require any rinse procedures.
Cleaning the Battery Cover
Clean around the battery cover release with a small brush using a mild detergent solution. Disinfect
using the same method with 70% isopropyl alcohol to provide low level disinfection.
Open the battery cover and inspect the hinges and catch for contamination. If necessary, flush
using a syringe and clean using a small brush, taking care not to deform the cover spring. Once
clean, we recommend wetting with 70% isopropyl alcohol to provide low level disinfection. This
agent can be left to dry naturally and does not require any rinse procedures.
TE L E M E T R Y T R A N S M I T T E R ( 9 6 2 8 1 ) O P E R A T I O N S M A N U A L
5-3
D
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Appendix A — Guidance and
Manufacturer’s Declaration
Electromagnetic Environment
The 96281 telemetry transmitter is intended for use in the electromagnetic environment specified
in the reference tables in this chapter. The customer or user of the 96281 should make sure that it
is used in such an environment.
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Electromagnetic Emmissions
Table 1—Electromagnetic Emmissions
Emission Test
Compliance
Electromagnetic Environment
RF emissions
CISPR 11
Group 1
The 96281 emits electromagnetic energy in
order to perform its intended function. Nearby
electronic equipment may be affected.
RF emissions
CISPR 11
Class B
The 96281 is suitable for use in all
establishments, including those directly
connected to the public low-voltage power
supply network that supplies public buildings.
Harmonic emissions
IEC 61000-3-2
N/A
N/A
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
N/A
N/A
TE L E M E T R Y T R A N S M I T T E R ( 9 6 2 8 1 ) O P E R A T I O N S M A N U A L
A-1
APPENDIX A — GUIDANCE AND MANUFACTURER ’S DECLARATION
Electromagnetic Immunity
Table 2—Electromagnetic Immunity
Immunity Test
Electrostatic
discharge (ESD)
IEC 61000-4-2
IEC 60601 Test Level
Compliance
Level
Electromagnetic
Environment
Floors should be wood,
concrete, or ceramic tile.
If floors are covered with
synthetic material, the
relative humidity should
be at least 30%.
±6 kV contact
±8 kV air
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV for power supply lines
±1 kV for input/output lines
N/A
N/A
Surge
IEC 61000-4-5
±1 kV line(s) to line(s)
±2 kV line(s) to earth
N/A
N/A
<5% UT
(>95% dip in UT for 0.5 cycle)
40% UT
(60% dip in UT for 5 cycles)
70% UT
(30% dip in UT for 25 cycles)
<5% UT
(>95% dip in UT for 5 seconds)
N/A
N/A
3 A/m
Power frequency
magnetic fields should be
at levels characteristic of
a typical location in a
commercial or hospital
environment.
Voltage dips, short
interruptions, and
voltage variations
on power supply
input lines
IEC 61000-4-11
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
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±6 kV contact
±8 kV air
3 A/m
Note: UT is the AC mains voltage prior to application of the test level.
TE L E M E T R Y T R A N S M I T T E R ( 9 6 2 8 1 ) O P E R A T I O N S M A N U A L
A-2
APPENDIX A — GUIDANCE AND MANUFACTURER ’S DECLARATION
Table 2—Electromagnetic Immunity (continued)
Immunity
Test
IEC 60601
Test Level
Compliance
Level
Conducted RF
IEC 61000-4-6
N/A
N/A
Electromagnetic Environment
Portable and mobile RF communications
equipment should be used no closer to any part of
the monitoring device, including cables, than the
recommended separation distance calculated from
the equation applicable to the frequency of the
transmitter.
Recommended separation distance:
d = 1.17
80 MHz to 800 MHz
d = 2.34
3 V/m
80 MHz to
2.5 GHz
800 MHz to 2.5 GHz
3 V/m
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Radiated RF
IEC 61000-4-3
Where P is the maximum output power rating of
the transmitter in watts (W), according to the
transmitter manufacturer, and d is the
recommended separation distance in meters (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey (a),
should be less than the compliance level in each
frequency range.
Interference may occur in the vicinity of
equipment marked with the following
symbol.
(a) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast, and TV
broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the location in which the monitoring device are
used exceeds the applicable RF compliance level above, the 96281 telemetry device should
be observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as reorienting or relocating the 96281 telemetry device.
Notes:
•
At 800 MHz, the higher frequency range applies.
•
These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reflection from structures, objects, and people.
TE L E M E T R Y T R A N S M I T T E R ( 9 6 2 8 1 ) O P E R A T I O N S M A N U A L
A-3
APPENDIX A — GUIDANCE AND MANUFACTURER ’S DECLARATION
Separation Distances
The 96281 is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or user of the 96281 telemetry transmitter can help
prevent electromagnetic interference by maintaining a minimum distance between portable and
mobile RF communications equipment (transmitters) and the 96281 as recommended below,
according to the maximum output power of the communications equipment.
Table 3—Separation Distances
Recommended separation distances between portable and
mobile RF communications and the 96281 telemetry transmitter
Rated maximum output
power of Transmitter (W)
Separation distance according to
the frequency of transmitter (m)
800 MHz to 2.5 GHz
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80 MHz to 800 MHz
d = 1.17
d = 2.34
0.01
0.117
0.234
0.1
0.37
0.738
1.17
2.34
10
3.69
7.37
100
11.7
23.4
For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in meters (m) can be estimated using the equation applicable to the
frequency of the transmitter, where P is the maximum output power rating of the transmitter in
watts (W) according to the transmitter manufacturer.
Notes:
•
At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
•
These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reflection from structures, objects, and people.
TE L E M E T R Y T R A N S M I T T E R ( 9 6 2 8 1 ) O P E R A T I O N S M A N U A L
A-4
Appendix B — Symbols
The following list of international and safety symbols describes all symbols used on Spacelabs Healthcare
products. No one product contains every symbol.
Note: Graphic elements of certain keys and symbols may vary between product lines.
HELP Key
HELP (Explain Prior Screen) Key
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MONITOR SETUP Key
REMOTE Key
TRENDS Key
RECORD Key
Dynamic Network Access (DNA) Key
SPECIAL FUNCTIONS Key
NORMAL SCREEN Key
SAVE Key
Telemetry Transmitter (96281) Operations Manual
B-1
Appendix B — Symbols
No Network Connection
Network Connection
Do Not Connect to Network
No Connection to Intesys® Clinical Suite (ICS)
Compression
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Magnifying Glass
File Cabinet
List of Rooms
Printer
Service Message
PREVIOUS MENU Key
HOME Key
Arrows
On Direction
ON — Power Connection to Mains
Telemetry Transmitter (96281) Operations Manual
B-2
Appendix B — Symbols
ON — Part of the Instrument Only
ON Position for Push Button Power Switch
OFF — Power Disconnection from Mains
OFF Position for Push Button Power Switch
OFF — Part of the Instrument Only
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Partial ON/OFF
ON/OFF
Standby
STANDBY Key
Power ON/OFF Key
Keyboard Connection
Mouse Connection
PAUSE or INTERRUPT
START/STOP Key
START/STOP
STOP or CANCEL Key
CONTINUE Key
ENTER Key
Telemetry Transmitter (96281) Operations Manual
B-3
Appendix B — Symbols
Delete
Nurse Alert Interface
ALARM SUSPEND/TONE RESET Key
ALARMS Key
Alarm, General
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Alarm Reset
Alarm Audio ON
Alarm Audio OFF
Alarm Audio Paused
Low Priority Alarm
Medium Priority Alarm
High Priority Alarm
Alarms Paused
Alarm OFF
---
Parameter below measurement range
+++
Parameter above measurement range
Telemetry Transmitter (96281) Operations Manual
B-4
Appendix B — Symbols
???
Parameter measurement indeterminate
Indicator — Remote Control
PRINT REPORT Key
Normal Screen
Clock/Time Setting Key
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Slow Run
Activate Recorder for Graphics
Reset
START (NIBP) Key
Power Indicator LED
Activate Telemetry Recorder
Output (Non-terminated)
Data Input/Output
Input
No Output (Terminated)
Indicator — Local Control
Telemetry Transmitter (96281) Operations Manual
B-5
Appendix B — Symbols
Indicator — Out of Paper
Recorder Paper
Menu Keys
Waveform/Parameter Keys
Return to Prior Menu
Monitor Setup
Select Program Options
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Set Initial Conditions Menu
Access Special Function Menu
Return Unit to Monitor Mode
Keypad
Serial Port 1
Serial Port 2
Serial Port
Auto Mode (NIBP)
External Marker Push Button Connection
Telemetry Transmitter (96281) Operations Manual
B-6
Appendix B — Symbols
Arterial Pulse
Gas Exhaust
Video Output
Television; Video Display
Video Output, Primary
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Video Output, Secondary
Enlarge, Zoom
Input/Output
PCMCIA Card
Touchscreen, External
Universal Serial Bus
SDLC
SDLC Port
Hard Drive
Antenna
Electrocardiograph or
Defibrillator Synchronization
Telemetry Transmitter (96281) Operations Manual
B-7
Appendix B — Symbols
Microphone
Foot Switch
Audio Output, Speaker
Event
Gas Sampling Port
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Gas Return Port
Battery
Replace only with the appropriate battery.
Battery Status
Battery
Replace only with the appropriate battery.
Low Battery
Replace only with the appropriate battery.
(+ / - signs may be reversed)
All batteries should be disposed of properly to protect the environment. Lithium batteries
should be fully discharged before disposal. Batteries such as lead-acid (Pb) and nickelcadmium (Ni-Cd) must be recycled. Please follow your internal procedures and or local
(provincial) laws regarding disposal or recycling.
This symbol indicates that the waste of electrical and electronic equipment must not be
disposed as unsorted municipal waste and must be collected separately. Please contact
an authorized representative of the manufacturer for information concerning the
decommissioning of your equipment.
Caution - hazardous voltages. To reduce risk of electric shock, do not remove the cover or
back. Refer servicing to a qualified field service engineer (U.S.A.).
DANGER - High Voltage (International)
Protective Earth Ground
Telemetry Transmitter (96281) Operations Manual
B-8
Appendix B — Symbols
Replace Fuse Only as Marked
Power supply jack polarity.
(+ / - signs may be reversed)
Alternating Current
Both Direct and Alternating Current
Functional Earth Ground
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Fuse
Equipotentiality Terminal
Direct Current
Input Power. Use only Spacelabs Power Supply (P/N 119-0527-xx).
AC/DC Input
Loop Filter
Audio Output, Speaker
IEC 60601-1 Type B equipment. The unit displaying this symbol contains an adequate
degree of protection against electric shock.
IEC 60601-1 Type BF equipment which is defibrillator-proof. The unit displaying this
symbol is an F-type isolated (floating) patient-applied part which contains an adequate
degree of protection against electric shock, and is defibrillator-proof.
IEC 60601-1 Type BF equipment. The unit displaying this symbol is an F-type isolated
(floating) patient-applied part providing an adequate degree of protection against electric
shock.
Telemetry Transmitter (96281) Operations Manual
B-9
Appendix B — Symbols
IEC 60601-1 Type CF equipment. The unit displaying this symbol is an F-type isolated
(floating) patient-applied part providing a high degree of protection against electric shock,
and is defibrillator-proof.
IEC 60601-1 Type CF equipment. The unit displaying this symbol is an F-type isolated
(floating) patient-applied part providing a high degree of protection against electric shock.
IEC 60601-1 Class II equipment, double-isolated. The unit displaying this symbol does not
require a grounded outlet.
Warning: Do not modify this equipment without authorization of the manufacturer.
Operates on Non-Harmonized Radio Frequencies in Europe
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Adult Noninvasive Blood Pressure (NIBP)
Fetal Monitor Connection (Analog)
Fetal Monitor Connection
RS-232 (Digital)
Physiological Monitor Connection RS-232 (Digital)
Noninvasive Blood Pressure (NIBP),
Symbol Set, Adult/Pediatric Cuff Sizes
Symbol Set, Neonatal Cuff Sizes
NIBP Cuff, Neonatal 1
NIBP Cuff, Neonatal 2
NIBP Cuff, Neonatal 3
Telemetry Transmitter (96281) Operations Manual
B-10
Appendix B — Symbols
NIBP Cuff, Neonatal 4
NIBP Cuff, Neonatal 5
NIBP Cuff, Single Hose
NIBP Cuff, Dual Hose
CHILD
CHILD, LONG
SMALL ADULT, LONG
SMALL ADULT
ADULT, LONG
LARGE ADULT, LONG
LARGE ADULT
NIBP Cuff, Surface Applied to Patient
NIBP Cuff, Child Size
(12 to 19 cm)
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THIS SIDE TO PATIENT
NIBP Cuff, Child Size, Long
(12 to 19 cm)
NIBP Cuff, Small Adult Size, Long
(17 to 25 cm)
NIBP Cuff, Small Adult Size
(17 to 25 cm)
NIBP Cuff, Adult Size, Long
(23 to 33 cm)
NIBP Cuff, Large Adult Size, Long
(31 to 40 cm)
NIBP Cuff, Large Adult Size
(31 to 40 cm)
ADULT
NIBP Cuff, Adult Size
(23 to 33 cm)
INFANT
NIBP Cuff, Infant Size
(8 to 13 cm)
NEONATAL 1
NIBP Cuff, Neonatal 1 Size
(3 to 6 cm)
Telemetry Transmitter (96281) Operations Manual
B-11
Appendix B — Symbols
NEONATAL 2
NIBP Cuff, Neonatal 2 Size
(4 to 8 cm)
NEONATAL 3
NIBP Cuff, Neonatal 3 Size
(6 to 11 cm)
NEONATAL 4
NIBP Cuff, Neonatal 4 Size
(7 to 13 cm)
NEONATAL 5
NIBP Cuff, Neonatal 5 Size
(8 to 15 cm)
NIBP Cuff, Thigh Size (38-50 cm)
NYLON
NIBP Cuff, Nylon Material
SOFT
VINYL
QTY
ARTERY
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THIGH
NIBP Cuff, Soft Material
NIBP Cuff, Vinyl Material
Quantity
Place Artery Symbol and Arrow over Brachial or Femoral Artery
Follow Instructions For Use
Warning
Warning About Potential Danger to Human Beings (Consult Accompanying Documents)
Caution
Note
Caution About Potential Danger to a Device (Consult Accompanying Documents)
Note
Keep Dry
Telemetry Transmitter (96281) Operations Manual
B-12
Appendix B — Symbols
Indoor Use Only
12,200 m
Environmental Shipping/Storage Altitude Limitations
Environmental Shipping/Storage Temperature Limitations
Fragile; Handle with Care
This Way Up
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Up Arrow
Down Arrow
Environmental Shipping/Storage Humidity Limitations
Open Padlock
Closed Padlock
Happy Face
Sad Face
PVC
PVC-Free (Polyvinyl Chloride)
Do Not Reuse; Single Use Only
Reusable
Telemetry Transmitter (96281) Operations Manual
B-13
Appendix B — Symbols
Drip-Proof
IPX7
REF
Unit can withstand accidental immersion in one meter of water for up to 30 minutes
Reference Number or Order Number
Use by date [YYYY-MM-DD]
Recycle
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Non Sterile
Latex-Free
Date of Manufacture
Manufacturer
Radio transmitting device; elevated levels of non-ionizing radiation
A CE mark certifies that a product has met EU health, safety, and environmental
requirements, which ensure consumer safety.
XXXX
XXXX is the European Notified Body number. 0123 is the number for TÜV SÜD Product
Service GmbH, München, Germany.
®
Canadian Standards Association Approved
LOT
NE
Batch Code
Nellcor Oxisensor II Compatible
Telemetry Transmitter (96281) Operations Manual
B-14
Appendix B — Symbols
NV
Novametrix Compatible
Spacelabs TruLink Compatible
Nellcor OxiMax Compatible
Spacelabs Compatible
UL recognized component in Canada and United States
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Nellcor OxiMax Compatible
Masimo SET Compatible
Abbreviations used as symbols are shown below.
1 - 32
AIR
ANT 1
ANT 2
Arr1
ArrNet2
avDO2
CaO2
CH
ch
cmH2O
Access Codes 1 Through 32
Air
Amperes
Diversity Antenna System 1
Diversity Antenna System 2
Arrhythmia Net 1
Arrhythmia Net 2
Arterial/Venous Oxygen Difference
Arterial Oxygen
EEG, EMG, or ECG Channel
EEG Channels - CH1, CH2, CH3, CH4
EMG Channel - CH5
Centimeters of Water
C.O.
CO
Cardiac Output
CvO2
Venous Oxygen
CO2
CO2
Carbon Dioxide
Telemetry Transmitter (96281) Operations Manual
B-15
Appendix B — Symbols
DIA
dia
Diastolic
ECG
ecg
Electrocardiogram
EEG
eeg
Electroencephalogram
EMG
emg
Electromyogram
ESIS
Electrosurgical Interference Suppression
EXT
External
Fetal Electrocardiogram
FHR1
FHR2
Fetal Heart Rate, Channel 1
Fetal Heart Rate, Channel 2
GND
gnd
Hz
Hgb
HLO
hlo
Multiview
N 2O
NIBP
nibp
O2AV
O2
PaO2
PRESS
press
PRS
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FECG
Ground
Hertz
Hemoglobin
High-Level Output
Multi-Lead Electrocardiogram
Nitrous Oxide
Noninvasive Blood Pressure
Oxygen Availability
Oxygen
Partial Pressure of Arterial Oxygen
Pressure
PvO2
Partial Pressure of Mixed Venous Oxygen
Ref.
Oxygen reference gas port
RESP
resp
Respiration
SDLC
Synchronous Data Link Control
Telemetry Transmitter (96281) Operations Manual
B-16
Appendix B — Symbols
SPO2
SpO2
SpO2
SaO2
Arterial Oxygen Saturation
as Measured by Pulse Oximetry
SVO2
SvO2
SvO2
Mixed Venous Oxygen Saturation
T1
T2
T3
T4
TEMP
temp
UA
UV
VAC
VO2
Systolic
Temperature 1
Temperature 2
Temperature 3
Temperature 4
Temperature
Uterine Activity or Umbilical Artery
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SYS
sys
Umbilical Venous
Vacuum Connection
Oxygen Consumption
Volts
Watts
Telemetry Transmitter (96281) Operations Manual
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