GE Medical Systems Information Technologies 2014748-002 Medical Telemetry Transmitter User Manual

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Document ID	881609
Application ID	maTnhnqxAd0JjwUy/T2xFQ==
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Date Submitted	2007-12-19 00:00:00
Date Available	2007-12-19 00:00:00
Creation Date	2004-04-08 14:43:46
Producing Software	Acrobat Distiller 7.0.5 (Windows)
Document Lastmod	2007-12-13 16:49:29
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GE Healthcare
ApexPro™ Telemetry System
Operator’s Manual
Software Version 4
CARESCAPE® Telemetry T14 Transmitter
ApexPro™
English
2028341-012 (CD)
2028340-030A (paper)
© 2007 General Electric Company.
All rights reserved.
NOTE
Due to continuing product innovation, specifications in this manual are subject to change without notice. The information
in this manual applies to ApexPro software version 4 or later and the CARESCAPE Telemetry T14 transmitter.
NOTE
For technical documentation purposes, the abbreviation GE is used for the legal entity name, GE Medical Systems
Information Technologies.
Listed below are GE Medical Systems Information Technologies trademarks used in this document. All other trademarks
contained herein are the property of their respective owners.
APEX, APEXPRO, DASH, DINAMAP, SOLAR, and TRAM are trademarks of GE Medical Systems Information
Technologies registered in the United States Patent and Trademark Office.
CARESCAPE, CENTRALSCOPE, CD TELEMETRY, CD TELEMETRY-LAN, CIC PRO, EAGLE, IMPACT.wf, PRN 50,
TRAMSCOPE and UNITY NETWORK are trademarks of GE Medical Systems Information Technologies.
T-2
ApexPro™
2001989-301A- draft 2
8 November 2007
Contents
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
Manual information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
Purpose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
Intended audience . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
Related documents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
Conventions used. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
Equipment terms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
Text styles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
Illustrations and names . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
Ordering manuals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
Revision history . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
Equipment overview . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
ra
ft
Equipment information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
Intended use of this equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
Safety statements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
Dangers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-11
Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-14
Equipment symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-14
Equipment compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-15
IEC, UL, and EN 60601-1 device classification. . . . . . . . . . . . . . . . . 1-15
FCC compliance information statement . . . . . . . . . . . . . . . . . . . . . . 1-16
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
ApexPro telemetry system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
Transmitters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
Antenna system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Receiver system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Server . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
CIC Pro center . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Optional components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
Apex oximeter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
Xpod oximeter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
Accutracker DX noninvasive blood pressure (NBP) monitor. . . . . . . . 2-4
Dinamap PRO monitors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
Equipment setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
Transmitter setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
Views . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
Battery installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
2001989-301A- draft 2
ApexPro™
Leadwire installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4
Electrode attachment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5
Verify transmitter/leadwires status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6
Antenna system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6
Optional components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7
Xpod oximeter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7
Apex oximeter. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7
Battery installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8
Transmitter connection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9
Dinamap PRO monitors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9
Interconnection cables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10
Accutracker DX. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10
Battery installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10
Connection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-11
System setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
Bedside monitor setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
ra
ft
CIC Pro center setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
Configuring the CIC Pro center . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Verifying proper operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Customizing the system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Licenses (instituted) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
Defaults (persistent) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6
Service-level defaults . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6
User-level defaults (persistent) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7
Control settings (temporary) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-18
Alarm volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-18
Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
Alarm notification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
Alarm categories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3
Patient status alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3
System status alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4
Managing patient alarms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4
Enable transmitter pause . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5
Pausing alarms at the transmitter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5
Reactivating alarms at the transmitter . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6
Alarm pause breakthrough . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6
Silencing alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-7
Temporarily silencing alarms from the CIC Pro center . . . . . . . . . . . . 5-7
Alarm silence indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-8
Adjusting alarm control settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-8
Monitor alarm control settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-9
Telemetry bed alarm control defaults . . . . . . . . . . . . . . . . . . . . . . . . 5-12
ii
ApexPro™
2001989-301A- draft 2
Alarm unit default settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-12
Telemetry alarm control defaults . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-12
Parameter limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-14
Parameter alarm levels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-15
Arrhythmia alarm levels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-15
System alarm levels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-16
Recalling unit defaults . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-17
Alarm help . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-17
Printing patient alarm graphs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-17
Configure the automatic printing of alarm graphs . . . . . . . . . . . . . . . . . . 5-17
Printing alarm settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-18
Stop printing an alarm graph . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-18
Stop printing to a laser printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-18
Stop printing to a local digital writer. . . . . . . . . . . . . . . . . . . . . . . . . . 5-18
Managing patients . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
ft
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
Skin preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
ra
Electrode placement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
6-leadwire electrode placement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3
5-leadwire electrode placement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4
3-leadwire electrode placement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4
Electrode placement for pediatric patients . . . . . . . . . . . . . . . . . . . . . . . . 6-5
Electrode placement for neonate patients . . . . . . . . . . . . . . . . . . . . . . . . . 6-5
Verify status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-6
Maintaining quality ECG signal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-6
Special considerations for 6-leadwire monitoring . . . . . . . . . . . . . . . . . . . . 6-7
V FAIL message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-7
Relearn . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-7
Admitting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-7
Terminology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-8
Factors guiding the admit process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-9
The source of the ECG data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-10
The source of the patient demographic information . . . . . . . . . . . . . 6-10
The monitor moves (roves) from room to room. . . . . . . . . . . . . . . . . 6-10
The permanent (locked) beds in the multi-patient viewer . . . . . . . . . 6-11
Admitting a patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-11
Changing patient demographic information . . . . . . . . . . . . . . . . . . . . . . . 6-16
Moving a patient to a different bed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-17
Move a patient to a different bed. . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-17
Move a patient to telemetry monitoring . . . . . . . . . . . . . . . . . . . . . . . 6-18
Move a telemetry patient to a different transmitter . . . . . . . . . . . . . . 6-18
Switching transmitters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-18
Discharging an admitted patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-19
Combo and Rover Combo monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-19
Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-19
2001989-301A- draft 2
ApexPro™
iii
Constraints . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-20
ECG setting source . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-21
Viewing real-time patient data . . . . . . . . . . . . . . . . . 7-1
Real-time patient views . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2
Data synchronization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2
Multi-patient viewer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2
Single patient viewer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3
In-unit patient beds . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-5
Viewing in-unit patients experiencing an alarm condition . . . . . . . . . . . . . 7-5
Viewing patient beds from another in-unit CIC Pro center . . . . . . . . . . . . 7-5
Out-of-unit patient beds . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-6
Viewing an out-of-unit patient bed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-6
Removing viewed out-of-unit patient beds . . . . . . . . . . . . . . . . . . . . . . . . 7-6
Configuring the real-time trend window . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-6
ra
ft
Printing real-time data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-8
Printing a continuous ECG strip . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-8
Printing parameter limits or waveforms for all in-unit patient beds . . . . . . 7-9
Stopping a print job. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-10
Stop printing to a laser printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-10
Stop printing to a local digital writer. . . . . . . . . . . . . . . . . . . . . . . . . . 7-10
Monitored parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-11
Adjusting parameter control settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-11
ECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-11
ECG control settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-11
Monitoring pacemaker patients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-13
Multi-vector pace detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-15
Pace help . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-15
Lead analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-16
Multi-Lead analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-16
Single-Lead analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-16
Single-Lead ECG telemetry data. . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-17
Arrhythmia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-17
No arrhythmia detection with 7015 software level patient monitors . 7-18
Full arrhythmia conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-19
Lethal arrhythmia conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-21
AFIB identification. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-21
Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-22
ST analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-22
ST deviation alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-23
Adjusting ST limits. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-23
SpO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-24
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-24
SpO2 in the multi-patient viewer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-24
SpO2 control settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-24
iv
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2001989-301A- draft 2
SpO2 probe safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-25
Infants and pulse oximetry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-26
Signal and data validity. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-27
Signal strength indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-27
Error messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-27
Pressures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-28
Non-invasive blood pressure control settings . . . . . . . . . . . . . . . . . . . . . 7-28
NBP monitoring with telemetry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-29
Patient preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-29
Microphone placement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-30
Placement in the microphone pad. . . . . . . . . . . . . . . . . . . . . . . . . . . 7-31
Placement in the blood pressure cuff . . . . . . . . . . . . . . . . . . . . . . . . 7-31
Safety considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-32
Setting the measurement interval . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-32
Setting test parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-33
Setting limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-34
Software and hardware versions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-34
Viewing stored patient data . . . . . . . . . . . . . . . . . . . 8-1
ft
Stored data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2
ra
Time focus data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2
Events directory. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3
Viewing the Events directory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3
Printing the Events directory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4
Counting how many events occurred . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4
Identifying the most recent occurring event . . . . . . . . . . . . . . . . . . . . . . . . 8-4
Deleting a stored event or data sample . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5
Viewing or printing an Event strip . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5
Full disclosure data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-6
Full disclosure strip. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-7
Viewing or printing a full disclosure strip . . . . . . . . . . . . . . . . . . . . . . . 8-7
Full disclosure page . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-9
Viewing or printing a full disclosure page . . . . . . . . . . . . . . . . . . . . . . 8-9
Graphic trends data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-10
Viewing graphic trends . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-11
Printing graphic trends data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-13
Vital signs data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-14
Viewing vital signs data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-14
Printing vital signs data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-16
Measuring ECG waveform intervals and amplitude . . . . . . . . . . . . . . . . . . 8-16
Viewing or printing a waveform from the Calipers window . . . . . . . . . . . 8-16
Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-18
Patient discharge summary report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-18
Transmitter battery status report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-18
2001989-301A- draft 2
ApexPro™
9
Printing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1
Print devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2
Print output . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2
Telemetry bed parameter data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2
Graph location . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2
Printing real-time data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3
Printing stored patient data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3
Initiating a manual graph . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3
Transmitter initiated graphs (manual graphs) . . . . . . . . . . . . . . . . . . . . . . 9-4
Automatic alarm graphs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-4
Graph messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-4
ft
Graph all patients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-5
Initiating a graph all patients request . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-5
ra
Stopping a print job. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-6
Stop printing to a laser printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-6
Stop printing to a local digital writer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-6
Adjusting print control settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-6
Enable transmitter graph . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-7
Alarm graphs enabled/disabled . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-8
Graph paper out indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-8
Abbreviations and symbols . . . . . . . . . . . . . . . . . . . A-1
Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2
Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-7
Customized defaults worksheet . . . . . . . . . . . . . . . . B-1
Alarms Off selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-2
Telemetry Unit Defaults . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-2
Telemetry parameter limits and alarm levels . . . . . . . . . . . . . . . . . . . . . . . B-3
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-1
Biocompatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-2
vi
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Supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-2
Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-2
Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-3
Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-3
Results of improper cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-4
Cleaning products to avoid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-5
Transmitter/device cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-5
Cleaning/disinfecting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-5
Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-6
ECG cable/leadwire cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-6
Results of improper cleaning. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-6
Cleaning/disinfecting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-6
Sterilizing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-7
Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-7
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-1
ra
ft
ECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-2
Arrhythmia troubleshooting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-2
Problem: Inaccurate heart rate and/or false asystole . . . . . . . . . . . . . D-2
Problem: False ventricular calls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-2
Problem: ARR Suspend . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-3
Pacemaker troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-3
Interface connector ports. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-4
Problem: Inaccurate pacemaker detection . . . . . . . . . . . . . . . . . . . . . D-4
Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-4
ST troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-5
Problem: ST numerics changed to Xs. . . . . . . . . . . . . . . . . . . . . . . . . D-5
SpO2 messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-5
NBP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-6
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-6
NBP status messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-7
Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-7
Alarm messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-7
Graph messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-9
Transmitter-related messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-10
System status messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-10
Patient status messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-10
Technical specifications . . . . . . . . . . . . . . . . . . . . . . E-1
T14 transmitter. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-2
Power requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-2
Alarms and controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-2
Transmission . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-2
ECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-2
2001989-301A- draft 2
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vii
Environmental specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-3
Operating conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-3
Storage conditions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-3
Device specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-3
Physical specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-4
FCC compliance information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-4
Certifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-4
ApexPro telemetry server . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-4
Display specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-4
Power specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-4
Environmental specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-5
Operating conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-5
Storage conditions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-5
Physical specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-5
FCC compliance information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-5
Certifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-5
ra
ft
ApexPro receiver system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-6
Performance specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-6
Network requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-6
Power requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-6
Environmental specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-6
Operating conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-6
Storage conditions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-7
Physical specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-7
FCC compliance information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-7
Certifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-7
viii
ApexPro™
2001989-301A- draft 2
Introduction
ra
ft
2001989-301A- draft 2
ApexPro™
1-1
Introduction
Manual information
Purpose
This manual contains the instructions necessary to operate the ApexPro telemetry
system safely and in accordance with its function and intended use.
It also contains limited instructions necessary to operate the telemetry system when
used with the CIC Pro Clinical Information Center. For more information, refer to
Related documents on page 1-2.
Intended audience
This manual is intended for clinical professionals. Clinical professionals are expected
to have a working knowledge of medical procedures, practices, and terminology, as
required for monitoring of critically ill patients.
Related documents
ra
ft
This manual is intended to be used in conjunction with the CIC Pro Clinical
Information Center Operator’s Manual (PN 2026421-001) and the CIC Pro Clinical
Information Center Bedrock Hardware Platform Service Manual (PN 2026421-002).
This manual assumes that you are familiar with the operating procedures of the CIC
Pro Clinical Information Center. It uses the CIC Pro software version 5 (or later) user
interface for procedures, navigation and illustration purposes.
If your system uses an earlier CIC Pro software version, you may notice minor
discrepancies between what you see on the equipment and the information presented
in this manual. Refer to the documentation provided with your system for the most
accurate operator’s and service instructions.
Conventions used
Equipment terms
This manual uses the following terms to simplify common equipment names.
Term
1-2
Description
ATS
Refers to the ApexPro Telemetry Server.
CIC Pro center
Refers to the CIC Pro Clinical Information Center.
Monitor
Refers to a bedside monitor, transport monitor, blood pressure
monitor, or a wireless monitor on the Unity Network.
Printer
Refers generically to a direct digital writer or a laser printer.
Server
Refers to the ApexPro Telemetry Server (ATS) or a CIC Pro
center with a BCM or Nightshade server.
ApexPro™
2001989-301A- draft 2
Introduction
Term
Description
Transmitter
Refers to the CARESCAPE Telemetry T14 transmitter.
Writer
Refers to the PRN 50-M digital writer.
Text styles
This manual uses the following text styles to identify hardware terms, software terms
and the correct way to enter data.
Style
Definition
Indicates hardware items, such as keys, labels or connectors.
Bold and italicized
Indicates software items, such as menus, menu options or
screen text.
Italics
Emphasizes a word.
Indicates menu options or control settings to select
consecutively.
Indicates keyboard keys to select simultaneously.
ft
Bold
ra
Illustrations and names
In this manual, all illustrations are provided as examples only. They may not
necessarily reflect your monitoring setup or data viewed on your monitoring device.
All names appearing in examples and illustrations are fictitious. The use of any real
person’s name is purely coincidental.
Ordering manuals
A paper copy of this manual will be provided upon request. Contact your local GE
representative and request the part number on the first page of the manual.
Revision history
Each page of the document has the document part number and revision letter at the
bottom of the page. The revision letter changes whenever the document is updated.
Revision
2001989-301A- draft 2
Comments
Initial release.
ApexPro™
1-3
Introduction
Equipment information
Intended use of this equipment
The ApexPro telemetry system is intended for use under the direct supervision of a
licensed healthcare practitioner. The system is designed to acquire and monitor
physiological data for ambulating patients within a defined coverage area. The system
processes this physiological data to detect various ECG arrhythmia events and select
physiological parameter limit violations.
The ApexPro telemetry system is intended to be installed in the hospital or clinical
environment in order to provide clinicians with patient physiological data, while
allowing for patient mobility. These systems are typically deployed in sub acute care
areas in hospitals or clinical sites where patient mobility can enhance the
effectiveness of the medical procedures administered.
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Safety statements
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The physiological parameters monitored include ECG, non-invasive blood pressure
and SpO2. The ApexPro telemetry system is intended to provide ECG data via
Ethernet to the computer platform for processing. The ApexPro is also intended to
provide physiologic data over the Unity network to clinical information systems for
display.
The safety statements presented in this chapter refer to the equipment in general and,
in most cases, apply to all aspects of the device. There are additional safety statements
in other chapters which are specific to that chapter content.
Dangers
The order in which safety statements are presented in no way implies the order of
importance.
Danger statements identify an imminent hazard which, if not avoided, will result in
death or serious injury. No danger statements apply to this system.
Warnings
Warning statements identify a potential hazard or unsafe practice which, if not
avoided, could result in death or serious injury.
The following warning statements apply to this system.
WARNING
Do not monitor patients with a 3-leadwire set when reliable pacer
detection is required. Pacer pulse detection can be erratic when only
a single vector is monitored. Always use a 5- or 6-leadwire set when
reliable pacer detection is required.
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2001989-301A- draft 2
Introduction
WARNING
ACCESSORIES (SUPPLIES) — To ensure patient safety, use only
parts and accessories manufactured or recommended by GE.
Parts and accessories used must meet the requirements of the
applicable IEC 60601 series safety standards and essential
performance standards, and/or the system configuration must meet
the requirements of the IEC 60601-1-1 medical electrical systems
standard.
WARNING
ACCESSORIES (EQUIPMENT) — The use of accessory
equipment not complying with the equivalent safety requirements of
this equipment may lead to a reduced level of safety of the resulting
system. Consideration relating to the choice shall include:
use of the accessory in the patient vicinity; and
„
evidence that the safety certification of the accessory has been
performed in accordance to the appropriate IEC 60601-1 and/or
IEC 60601-1-1 harmonized national standard.
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„
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WARNING
ACCIDENTAL SPILLS — To avoid electric shock or device
malfunction, liquids must not be allowed to enter the device. If
liquids have entered a device, take it out of service and have it
checked by a service technician before it is used again.
WARNING
ACCURACY — If the accuracy of any value displayed on the
monitor, central station, or printed on a graph strip is questionable,
determine the patient's vital signs by alternative means. Verify that
all equipment is working correctly.
WARNING
ADJUSTING SYSTEM ALARM LEVELS — The Leads Fail
alarm indicates that one or more electrodes are not connected to the
patient and, as a result, there is loss of all waveforms and arrhythmia
analysis. The ARR SUSPEND alarm indicates that arrhythmia
conditions are not being detected and therefore alarms associated
with arrhythmias will not occur. The Leads Fail and ARR
SUSPEND alarms should be adjusted to a lower priority level only
by experienced qualified personnel and with great caution.
Adjusting these alarms to a lower priority level may result in
reduced awareness of conditions that indicate the loss of patient
monitoring.
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Introduction
WARNING
ALARMS — Do not rely exclusively on the audible alarm system
for patient monitoring. Adjustment of Alarm Volume to a low level
or off during patient monitoring may result in a hazard to the patient.
Remember that the most reliable method of patient monitoring
combines close personal surveillance with correct operation of
monitoring equipment.
After connecting the monitor to the central station, nurse-call
system, and/or network, verify the function of the alarm system.
The functions of the alarm system for monitoring of the patient must
be verified at regular intervals.
Do not rely exclusively on the Alarm Pause Breakthrough feature
for alarm notification during an alarm pause. This may result in a
hazard to the patient. Only crisis alarms break through an alarm
pause.
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WARNING
BEFORE INSTALLATION — Compatibility is critical to safe and
effective use of this device. Please contact your local sales or service
representative prior to installation to verify equipment compatibility.
WARNING
BEFORE USE — Before putting the system into operation visually
inspect all connecting cables for signs of damage. Damaged cables
and connectors must be replaced immediately.
Before using the system, the operator must verify that it is in correct
working order and operating condition.
Periodically, and whenever the integrity of the product is in doubt,
test all functions.
WARNING
CABLES — Route all cables away from patient's throat to avoid
possible strangulation.
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Introduction
WARNING
CONDUCTIVE CONNECTIONS — Extreme care must be
exercised when applying medical electrical equipment. Many parts
of the human/machine circuit are conductive, such as the patient,
connectors, electrodes, transducers. It is very important that these
conductive parts do not come into contact with other grounded,
conductive parts when connected to the isolated patient input of the
device. Such contact would bridge the patient's isolation and cancel
the protection provided by the isolated input. In particular, there
must be no contact of the neutral electrode and ground.
WARNING
DEFIBRILLATION — Do not come into contact with patients
during defibrillation. Otherwise serious injury or death could result.
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WARNING
DISCONNECTION FROM MAINS — When disconnecting the
system from the power line, remove the plug from the wall outlet
first. Then you may disconnect the power cord from the device. If
you do not observe this sequence, there is a risk of coming into
contact with line voltage by inserting metal objects, such as the pins
of leadwires, into the sockets of the power cord by mistake.
WARNING
DISPOSAL — Dispose of the packaging material, observing the
applicable waste control regulations and keeping it out of children's
reach.
WARNING
DUST COVERS — If the dust covers for the interface connectors
become detached from the transmitter, they may pose a choking
hazard for pediatric patients. Inspect the dust covers before each use
to verify that they are securely attached. If the dust covers become
detached and cannot be reinserted into their retaining slot, do not use
them on the transmitter, and keep them out of pediatric patients’
reach.
WARNING
ELECTRODES — Whenever patient defibrillation is a possibility,
use non-polarizing (silver/silver chloride construction) electrodes
for ECG monitoring. Polarizing electrodes (stainless steel or silver
constructed) may cause the electrodes to retain a residual charge
after defibrillation. A residual charge will block acquisition of the
ECG signal.
2001989-301A- draft 2
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1-7
Introduction
WARNING
ELECTROMAGNETIC INTERFERENCE — Operation of
transmitters outside the designated WMTS frequency band is at
increased risk for electromagnetic interference. WMTS is protected
in the U.S. only. This interference could lead to lapses in patient
monitoring and missed alarm events, putting the patient at risk and
compromising patient safety.
WARNING
EMC— Magnetic and electrical fields are capable of interfering
with the proper performance of the device. For this reason make sure
that all external devices operated in the vicinity of the monitoring
system comply with the relevant EMC requirements. X-ray
equipment or MRI devices are a possible source of interference as
they may emit higher levels of electromagnetic radiation.
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Changes or modifications to this device/system not expressly
approved by GE may cause EMC issues with this or other
equipment. This device/system is designed and tested to comply
with applicable standards and regulations regarding EMC and needs
to be installed and put into service according to the EMC
information stated as follows:
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Use of known RF sources, such as cell/portable phones, or other
radio frequency (RF) emitting equipment near the system may cause
unexpected or adverse operation of this device/system. Consult
qualified personnel regarding device/system configuration.
The device/system should not be used adjacent to, or stacked with,
other equipment. If adjacent or stacked use is necessary, the device/
system should be tested to verify normal operation in the
configuration in which it is being used. Consult qualified personnel
regarding device/system configuration.
The use of accessories, transducers and cables other than those
specified may result in increased emissions or decreased immunity
performance of the device/system.
This device/system is suitable for use in all establishments other
than domestic and those directly connected to the public low-voltage
power supply network that supplies buildings used for domestic
purposes. Mains power should be that of a typical commercial or
hospital environment. Device is compliant to Class A.
WARNING
EXPLOSION HAZARD — Do not use this equipment in the
presence of flammable anesthetics, vapors or liquids.
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2001989-301A- draft 2
Introduction
WARNING
IMPROPER TRANSMITTER/LEADWIRE APPLICATION —
Applying a transmitter and/or leadwire that is not thoroughly dry to
a patient can result in an electrically conductive path being
established and a Leads Fail alarm not being provided if leadwires
come off the patient.
WARNING
INCORRECT ALGORITHMS, ARRHYTHMIA PROCESSING
AND CALCULATIONS BASED ON PATIENT AGE — After
manually updating or automatically retrieving patient demographic
information from a network database, always confirm that the
entered patient’s date of birth matches the patient’s actual date of
birth. Otherwise the appropriate age-related algorithms, arrhythmia
detection, and calculations will not be applied.
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WARNING
INTERFACING OTHER EQUIPMENT — Devices may only be
interconnected with each other or to parts of the system when it has
been determined by qualified biomedical engineering personnel that
there is no danger to the patient, the operator, or the environment as
a result. In those instances where there is any element of doubt
concerning the safety of connected devices, the user must contact
the manufacturers concerned (or other informed experts) for proper
use. In all cases, safe and proper operation should be verified with
the applicable manufacturer's instructions for use, and system
standards IEC 60601-1-1/EN 60601-1-1 must be complied with.
WARNING
LEAKAGE CURRENT TEST — When interfacing with other
equipment, a test for leakage current must be performed by qualified
biomedical engineering personnel before using with patients.
WARNING
LOSS OF DATA — Should the monitor at any time temporarily lose
patient data, the potential exists that active monitoring is not being
done. Close patient observation or alternate monitoring devices
should be used until monitor function is restored.
If the monitor does not automatically resume operation within 60
seconds, power cycle the monitor using the power on/off switch.
Once monitoring is restored, you should verify correct monitoring
state and alarm function.
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Introduction
WARNING
LOSS OF DATA —Caregivers and telemetry patients should be
made aware of antenna coverage areas. Movement outside of the
coverage area may result in loss of patient monitoring.
WARNING
NETWORK INTEGRITY — The ApexPro server resides on the
Unity network. It is possible that inadvertent or malicious network
activity could adversely affect patient monitoring. The integrity of
the Unity network is the responsibility of the hospital.
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WARNING
OPERATOR — Medical technical equipment such as this monitor/
monitoring system must only be used by persons who have received
adequate training in the use of such equipment and who are capable
of applying it properly.
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WARNING
POWER SUPPLY — All devices must be connected to a properly
installed power outlet with protective earth contacts only. If the
installation does not provide for a protective earth conductor,
disconnect the device from the power line and operate it on battery
power, if possible.
All devices of a system must be connected to the same power supply
circuit. Devices which are not connected to the same circuit must be
electrically isolated when operated (electrically isolated EIA232
interface).
WARNING
PROTECTED LEADWIRES — Only use protected leadwires and
patient cables with this device. The use of unprotected leadwires and
patient cables creates the potential for making an electrical
connection to ground or to a high voltage power source which can
cause serious injury or death to the patient.
Unprotected Leadwire
Protected Leadwire
322C
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2001989-301A- draft 2
Introduction
WARNING
RATE METERS — Keep pacemaker patients under close
observation. Rate meters may continue to count the pacemaker rate
during cardiac arrest and some arrhythmias. Therefore, do not rely
entirely on rate meter alarms.
WARNING
SINGLE PATIENT USE —This transmitter is designed for use on
one patient at a time. Using this equipment to monitor different
parameters on different patients at the same time compromises the
accuracy of data acquired.
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WARNING
SITE REQUIREMENTS — For safety reasons, all connectors for
patient cables and sensor leads are designed to prevent inadvertent
disconnection, should someone pull on them. Do not route cables in
a way that they may present a stumbling hazard. For devices
installed above the patient, adequate precautions must be taken to
prevent them from dropping on the patient.
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Cautions
Caution statements identify a potential hazard or unsafe practice which, if not
avoided, could result in minor personal injury or product/property damage.
The following caution statements apply to this system.
CAUTION
DEFIBRILLATOR PRECAUTIONS — Patient signal inputs
labeled with the CF and BF symbols with paddles are protected
against damage resulting from defibrillation voltages. To ensure
proper defibrillator protection, use only the recommended cables
and leadwires.
Proper placement of defibrillator paddles in relation to the electrodes
is required to ensure successful defibrillation.
CAUTION
DISPOSABLES — Disposable devices are intended for single use
only. They should not be reused as performance could degrade or
contamination could occur.
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Introduction
CAUTION
DISPOSAL — At the end of its service life, the product described in
this manual, as well as its accessories, must be disposed of in
compliance with the guidelines regulating the disposal of such
products. If you have questions concerning disposal of the product,
please contact GE or its representatives.
CAUTION
ELECTROCAUTERY PRECAUTIONS — To prevent unwanted
skin burns, apply electrocautery electrodes as far as possible from all
other electrodes, a distance of at least 15 cm/6 in. is recommended.
ft
CAUTION
INSTRUCTIONS FOR USE — For continued safe use of this
equipment, it is necessary that the listed instructions are followed.
However, instructions listed in this manual in no way supersede
established medical practices concerning patient care.
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CAUTION
MAINTENANCE — Regular preventive maintenance should be
carried out annually. You are responsible for any requirements
specific to your country.
CAUTION
MPSO — Do not use a multiple portable socket outlet (MPSO) for a
system because it could result in unacceptable enclosure leakage
currents.
CAUTION
NEGLIGENCE — GE does not assume responsibility for damage to
the equipment caused by improperly vented cabinets, improper or
faulty power, or insufficient wall strength to support equipment
mounted on such walls.
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Introduction
CAUTION
POWER REQUIREMENTS — Before connecting the device to the
power line, check that the voltage and frequency ratings of the
power line are the same as those indicated on the unit's label. If this
is not the case, do not connect the system to the power line until you
adjust the unit to match the power source.
In the U.S.A., if the installation of this equipment will use 240 V
rather than 120V, the source must be a center-tapped, 240V, singlephase circuit.
This equipment is suitable for connection to public mains as defines
in CISPR 11.
CAUTION
RESTRICTED SALE — U.S. federal law restricts this device to sale
by or on the order of a physician.
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CAUTION
SECURITY — The web browser which runs in conjunction with the
ApexPro server is intended for hospital INTRANET use only. If
confidential patient information is made available from the hospital
intranet, the security of the data is the responsibility of the hospital.
CAUTION
SUPERVISED USE — This equipment is intended for use under the
direct supervision of a licensed health care practitioner.
CAUTION
UNINTENTIONAL RADIO FREQUENCY (RF)
INTERFERENCE — Unintentional RF interference could degrade
the reliability and performance of the wireless data link. The facility
must maintain an RF environment free from unintentional
interference. Refer to the service manuals for more information.
CAUTION
VENTILATION REQUIREMENTS — Set up the device in a
location which affords sufficient ventilation. The ventilation
openings of the device must not be obstructed. The ambient
conditions specified in the technical specifications must be ensured
at all times.
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ApexPro™
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Introduction
Notes
Note statements provide application tips or other useful information.
The following note statements apply to this system.
„
Put the CIC Pro center in a location where you can easily see the screen and
access the operating controls.
„
This product is not likely to cause abnormal operation of other patient-connected
equipment such as cardiac pacemakers or other electrical stimulators. Exceptions
are noted in the pacemaker monitoring section, if applicable.
„
This product is protected against the effects of cardiac defibrillator discharges to
ensure proper recovery, as required by test standards.
„
This equipment is suitable for use in the presence of electrosurgery.
Equipment symbols
NOTE
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Some symbols may not appear on all equipment.
ATTENTION: Consult accompanying documents.
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TYPE B APPLIED PART: Non-isolated applied part suitable for intentional external and
internal application to the patient excluding direct cardiac application.
[Medical Standard Definition:] Applied part complying with the specified requirements of IEC/
EN/UL 60601-1 Medical Standards to provide protection against electric shock, particularly
regarding allowable leakage current.
TYPE CF APPLIED PART: Isolated (floating) applied part suitable for intentional external and
internal application to the patient including direct cardiac application. “Paddles” outside the
box indicate the applied part is defibrillator proof.
[Medical Standard Definition:] F-type applied part (floating/isolated) complying with the
specified requirements of IEC/EN/UL 60601-1 Medical Standards to provide a higher degree
of protection against electric shock than that provided by Type BF applied parts.
INTFC.
Interface connector(s)
Complies with IPX3 standards (IEC 60529) for protection against water ingress under test
conditions; water sprayed at an angle up to 60 degrees on either side of the vertical axis shall
have no harmful effects, with device not in actual use.
Complies with IPX7 standards (IEC 60529) for protection against water ingress under test
conditions; immersion in one meter of water for 30 minutes, with device not in actual use.
Operation of this equipment requires the prior coordination with a frequency coordinator
designated by the FCC for the Wireless Medical Telemetry Service.
Non-ionizing electromagnetic radiation: To indicate elevated, potentially dangerous, levels of
non-ionizing radiation. Note - In case of application in a warning sign the rules according to
ISO 3864-1 shall be adhered to.
IEC 60878 note: See safety sign ISO 7010 - W005 "Warning, non-ionizing radiation".
1-14
ApexPro™
2001989-301A- draft 2
Introduction
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.
This symbol indicates the date of manufacture of this device. The first four digits identify the
year and the last two digits identify the month.
2005-08
Medical Equipment
With respect to electric shock, fire and mechanical hazards only in accordance with UL
60601-1, CAN/CSA C22.2 NO. 601.1, IEC 60601-1, IEC 60601-1-1, IEC 60601-2-27 and IEC
60601-2-49.
4P41
Manufacturer name and address.
Equipment compliance
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European authorized representative.
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IEC, UL, and EN 60601-1 device classification
Type of protection against electrical shock
Transmitter — Internally powered
Receiver system — Class I
Degree of protection against electrical
shock
T14 transmitter — Type CF Defibrillation proof applied part
Degree of protection against harmful
ingress of water
T14 transmitter — IPX7 (IEC 60529)1
Receiver system — Ordinary Equipment (enclosed equipment without protection against
ingress of water)
Degree of safety of application in the
presence of a flammable anesthetic
mixture with air or with oxygen or nitrous
oxide
Equipment not suitable for use in the presence of a flammable anesthetic mixture with air
or with oxygen or nitrous oxide
Method(s) of sterilization or disinfection
recommended by the manufacturer
Not applicable
Mode of operation
Continuous operation
The T14 transmitter is designed to be IPX7 compliant, so it can withstand inadvertent submersion. The transmitter should not be exposed to
spray or shower during patient monitoring.
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1-15
Introduction
FCC compliance information statement
The CARESCAPE Telemetry T14 transmitter complies with Part 95 Subpart H of the
FCC rules to be used in wireless medical telemetry service. Operation of this
equipment requires prior coordination with a frequency coordinator designated by the
FCC for the Wireless Medical Telemetry Service.
Installation and maintenance of this transmitter should be performed by a person
certified as technically qualified to perform such operations. Replacement of any
transmitter component or modifications to the transmitter could result in a violation of
the rules. Changes or modifications not expressly approved by the party responsible
for compliance could void the user’s authority to operate the equipment. Use only GE
approved replacement parts, non-approved parts may result in a violation of the FCC
rules.
RF Exposure
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This device complies with FCC radiation exposure limits set forth for an uncontrolled
environment. The RF transmission power from the antenna conforms to the general
public FCC limit of Specific Absorption Rate (SAR) 1.6 W/kg. The maximum SAR
value measured from this device was 0.1200 W/kg. This device must not be co-located
or operating in conjunction with any other antenna or transmitter.
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