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

GE Medical Systems Information Technologies Inc. Medical Telemetry Transmitter

Manual Draft2 Excerpt

GE HealthcareApexPro™English2028341-012 (CD)2028340-030A (paper)© 2007 General Electric Company.All rights reserved.ApexPro™ Telemetry SystemOperator’s ManualSoftware Version 4CARESCAPE® Telemetry T14 Transmitter
T-2 ApexPro™ 2001989-301A- draft 28 November 2007NOTEDue 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. NOTEFor 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.
Draft2001989-301A- draft 2 ApexPro™ iContents1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1Manual information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2Purpose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2Intended audience . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2Related documents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2Conventions used. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2Equipment terms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2Text styles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3Illustrations and names . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3Ordering manuals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3Revision history . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3Equipment information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4Intended use of this equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4Safety statements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4Dangers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-11Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-14Equipment symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-14Equipment compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-15IEC, UL, and EN 60601-1 device classification. . . . . . . . . . . . . . . . . 1-15FCC compliance information statement . . . . . . . . . . . . . . . . . . . . . . 1-162 Equipment overview . . . . . . . . . . . . . . . . . . . . . . . . . 2-1Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2ApexPro telemetry system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2Transmitters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2Antenna system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3Receiver system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3Server . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3CIC Pro center . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3Optional components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4Apex oximeter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4Xpod oximeter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4Accutracker DX noninvasive blood pressure (NBP) monitor. . . . . . . . 2-4Dinamap PRO monitors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-43 Equipment setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1Transmitter setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2Views . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2Battery installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
Draftii ApexPro™ 2001989-301A- draft 2Leadwire installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4Electrode attachment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5Verify transmitter/leadwires status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6Antenna system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6Optional components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7Xpod oximeter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7Apex oximeter. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7Battery installation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8Transmitter connection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9Dinamap PRO monitors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9Interconnection cables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10Accutracker DX. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10Battery installation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10Connection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-114 System setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1Bedside monitor setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2CIC Pro center setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3Configuring the CIC Pro center . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4Verifying proper operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4Customizing the system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4Licenses (instituted) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5Defaults (persistent) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6Service-level defaults . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6User-level defaults (persistent) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7Control settings (temporary) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-18Alarm volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-185 Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1Alarm notification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2Alarm categories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3Patient status alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3System status alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4Managing patient alarms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4Enable transmitter pause . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5Pausing alarms at the transmitter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5Reactivating alarms at the transmitter . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6Alarm pause breakthrough . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6Silencing alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-7Temporarily silencing alarms from the CIC Pro center . . . . . . . . . . . . 5-7Alarm silence indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-8Adjusting alarm control settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-8Monitor alarm control settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-9Telemetry bed alarm control defaults . . . . . . . . . . . . . . . . . . . . . . . . 5-12
Draft2001989-301A- draft 2 ApexPro™ iiiAlarm unit default settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-12Telemetry alarm control defaults . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-12Parameter limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-14Parameter alarm levels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-15Arrhythmia alarm levels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-15System alarm levels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-16Recalling unit defaults . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-17Alarm help . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-17Printing patient alarm graphs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-17Configure the automatic printing of alarm graphs . . . . . . . . . . . . . . . . . . 5-17Printing alarm settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-18Stop printing an alarm graph . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-18Stop printing to a laser printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-18Stop printing to a local digital writer. . . . . . . . . . . . . . . . . . . . . . . . . . 5-186 Managing patients . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2Skin preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2Electrode placement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-26-leadwire electrode placement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-35-leadwire electrode placement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-43-leadwire electrode placement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4Electrode placement for pediatric patients . . . . . . . . . . . . . . . . . . . . . . . . 6-5Electrode placement for neonate patients . . . . . . . . . . . . . . . . . . . . . . . . . 6-5Verify status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-6Maintaining quality ECG signal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-6Special considerations for 6-leadwire monitoring. . . . . . . . . . . . . . . . . . . . 6-7V FAIL message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-7Relearn . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-7Admitting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-7Terminology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-8Factors guiding the admit process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-9The source of the ECG data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-10The source of the patient demographic information . . . . . . . . . . . . . 6-10The monitor moves (roves) from room to room. . . . . . . . . . . . . . . . . 6-10The permanent (locked) beds in the multi-patient viewer . . . . . . . . . 6-11Admitting a patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-11Changing patient demographic information . . . . . . . . . . . . . . . . . . . . . . . 6-16Moving a patient to a different bed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-17Move a patient to a different bed. . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-17Move a patient to telemetry monitoring . . . . . . . . . . . . . . . . . . . . . . . 6-18Move a telemetry patient to a different transmitter . . . . . . . . . . . . . . 6-18Switching transmitters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-18Discharging an admitted patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-19Combo and Rover Combo monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-19Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-19
Draftiv ApexPro™ 2001989-301A- draft 2Constraints . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-20ECG setting source . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-217 Viewing real-time patient data . . . . . . . . . . . . . . . . . 7-1Real-time patient views. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2Data synchronization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2Multi-patient viewer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2Single patient viewer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3In-unit patient beds . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-5Viewing in-unit patients experiencing an alarm condition . . . . . . . . . . . . . 7-5Viewing patient beds from another in-unit CIC Pro center . . . . . . . . . . . . 7-5Out-of-unit patient beds . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-6Viewing an out-of-unit patient bed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-6Removing viewed out-of-unit patient beds . . . . . . . . . . . . . . . . . . . . . . . . 7-6Configuring the real-time trend window . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-6Printing real-time data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-8Printing a continuous ECG strip . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-8Printing parameter limits or waveforms for all in-unit patient beds . . . . . . 7-9Stopping a print job. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-10Stop printing to a laser printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-10Stop printing to a local digital writer. . . . . . . . . . . . . . . . . . . . . . . . . . 7-10Monitored parameters. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-11Adjusting parameter control settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-11ECG. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-11ECG control settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-11Monitoring pacemaker patients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-13Multi-vector pace detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-15Pace help . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-15Lead analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-16Multi-Lead analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-16Single-Lead analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-16Single-Lead ECG telemetry data. . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-17Arrhythmia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-17No arrhythmia detection with 7015 software level patient monitors . 7-18Full arrhythmia conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-19Lethal arrhythmia conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-21AFIB identification. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-21Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-22ST analysis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-22ST deviation alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-23Adjusting ST limits. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-23SpO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-24Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-24SpO2 in the multi-patient viewer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-24SpO2 control settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-24
Draft2001989-301A- draft 2 ApexPro™ vSpO2 probe safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-25Infants and pulse oximetry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-26Signal and data validity. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-27Signal strength indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-27Error messages. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-27Pressures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-28Non-invasive blood pressure control settings . . . . . . . . . . . . . . . . . . . . . 7-28NBP monitoring with telemetry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-29Patient preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-29Microphone placement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-30Placement in the microphone pad. . . . . . . . . . . . . . . . . . . . . . . . . . . 7-31Placement in the blood pressure cuff . . . . . . . . . . . . . . . . . . . . . . . . 7-31Safety considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-32Setting the measurement interval . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-32Setting test parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-33Setting limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-34Software and hardware versions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-348 Viewing stored patient data . . . . . . . . . . . . . . . . . . . 8-1Stored data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2Time focus data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2Events directory. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3Viewing the Events directory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3Printing the Events directory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4Counting how many events occurred . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4Identifying the most recent occurring event . . . . . . . . . . . . . . . . . . . . . . . . 8-4Deleting a stored event or data sample . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5Viewing or printing an Event strip . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5Full disclosure data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-6Full disclosure strip. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-7Viewing or printing a full disclosure strip . . . . . . . . . . . . . . . . . . . . . . . 8-7Full disclosure page . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-9Viewing or printing a full disclosure page . . . . . . . . . . . . . . . . . . . . . . 8-9Graphic trends data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-10Viewing graphic trends . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-11Printing graphic trends data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-13Vital signs data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-14Viewing vital signs data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-14Printing vital signs data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-16Measuring ECG waveform intervals and amplitude. . . . . . . . . . . . . . . . . . 8-16Viewing or printing a waveform from the Calipers window . . . . . . . . . . . 8-16Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-18Patient discharge summary report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-18Transmitter battery status report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-18
Draftvi ApexPro™ 2001989-301A- draft 29 Printing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1Print devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2Print output . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2Telemetry bed parameter data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2Graph location . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2Printing real-time data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3Printing stored patient data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3Initiating a manual graph . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3Transmitter initiated graphs (manual graphs) . . . . . . . . . . . . . . . . . . . . . . 9-4Automatic alarm graphs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-4Graph messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-4Graph all patients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-5Initiating a graph all patients request . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-5Stopping a print job. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-6Stop printing to a laser printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-6Stop printing to a local digital writer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-6Adjusting print control settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-6Enable transmitter graph . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-7Alarm graphs enabled/disabled . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-8Graph paper out indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-8A Abbreviations and symbols . . . . . . . . . . . . . . . . . . . A-1Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-7B Customized defaults worksheet . . . . . . . . . . . . . . . . B-1Alarms Off selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-2Telemetry Unit Defaults . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-2Telemetry parameter limits and alarm levels . . . . . . . . . . . . . . . . . . . . . . . B-3C Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-1Biocompatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-2
Draft2001989-301A- draft 2 ApexPro™ viiSupplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-2Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-2Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-3Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-3Results of improper cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .C-4Cleaning products to avoid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .C-5Transmitter/device cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-5Cleaning/disinfecting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .C-5Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .C-6ECG cable/leadwire cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-6Results of improper cleaning. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .C-6Cleaning/disinfecting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .C-6Sterilizing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .C-7Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .C-7D Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-1ECG. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-2Arrhythmia troubleshooting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-2Problem: Inaccurate heart rate and/or false asystole . . . . . . . . . . . . .D-2Problem: False ventricular calls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-2Problem: ARR Suspend . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-3Pacemaker troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-3Interface connector ports. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .D-4Problem: Inaccurate pacemaker detection . . . . . . . . . . . . . . . . . . . . .D-4Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .D-4ST troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-5Problem: ST numerics changed to Xs. . . . . . . . . . . . . . . . . . . . . . . . .D-5SpO2 messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-5NBP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-6Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .D-6NBP status messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .D-7Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-7Alarm messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .D-7Graph messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .D-9Transmitter-related messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .D-10System status messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-10Patient status messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .D-10E Technical specifications . . . . . . . . . . . . . . . . . . . . . . E-1T14 transmitter. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-2Power requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-2Alarms and controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-2Transmission . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-2ECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-2
Draftviii ApexPro™ 2001989-301A- draft 2Environmental specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-3Operating conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-3Storage conditions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-3Device specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-3Physical specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-4FCC compliance information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-4Certifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-4ApexPro telemetry server . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-4Display specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-4Power specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-4Environmental specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-5Operating conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-5Storage conditions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-5Physical specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-5FCC compliance information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-5Certifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-5ApexPro receiver system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-6Performance specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-6Network requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-6Power requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-6Environmental specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-6Operating conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-6Storage conditions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-7Physical specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-7FCC compliance information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-7Certifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-7
Draft2001989-301A- draft 2 ApexPro™ 1-11Introduction
Draft1-2 ApexPro™ 2001989-301A- draft 2IntroductionManual informationPurposeThis 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 audienceThis 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 documentsThis 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 usedEquipment termsThis manual uses the following terms to simplify common equipment names.Term DescriptionATS 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.
DraftIntroduction2001989-301A- draft 2 ApexPro™ 1-3Text stylesThis manual uses the following text styles to identify hardware terms, software terms and the correct way to enter data.Illustrations and namesIn 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 manualsA 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 historyEach 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.Transmitter Refers to the CARESCAPE Telemetry T14 transmitter. Writer Refers to the PRN 50-M digital writer.Term DescriptionStyle DefinitionBold 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.Revision CommentsA Initial release.
Draft1-4 ApexPro™ 2001989-301A- draft 2IntroductionEquipment informationIntended use of this equipmentThe 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.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.Safety statementsThe 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. The order in which safety statements are presented in no way implies the order of importance. DangersDanger statements identify an imminent hazard which, if not avoided, will result in death or serious injury. No danger statements apply to this system.WarningsWarning 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. WARNINGDo 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.
DraftIntroduction2001989-301A- draft 2 ApexPro™ 1-5WARNINGACCESSORIES (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.WARNINGACCESSORIES (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.WARNINGACCIDENTAL 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.WARNINGACCURACY — 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.WARNINGADJUSTING 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.
Draft1-6 ApexPro™ 2001989-301A- draft 2IntroductionWARNINGALARMS — 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.WARNINGBEFORE 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.WARNINGBEFORE 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.WARNINGCABLES — Route all cables away from patient's throat to avoid possible strangulation.
DraftIntroduction2001989-301A- draft 2 ApexPro™ 1-7WARNINGCONDUCTIVE 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.WARNINGDEFIBRILLATION — Do not come into contact with patients during defibrillation. Otherwise serious injury or death could result.WARNINGDISCONNECTION 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.WARNINGDISPOSAL — Dispose of the packaging material, observing the applicable waste control regulations and keeping it out of children's reach.WARNINGDUST 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.WARNINGELECTRODES — 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.
Draft1-8 ApexPro™ 2001989-301A- draft 2IntroductionWARNINGELECTROMAGNETIC 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. WARNINGEMC— 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.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: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.WARNINGEXPLOSION HAZARD — Do not use this equipment in the presence of flammable anesthetics, vapors or liquids.
DraftIntroduction2001989-301A- draft 2 ApexPro™ 1-9WARNINGIMPROPER 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.WARNINGINCORRECT 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.WARNINGINTERFACING 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.WARNINGLEAKAGE CURRENT TEST — When interfacing with other equipment, a test for leakage current must be performed by qualified biomedical engineering personnel before using with patients.WARNINGLOSS 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.
Draft1-10 ApexPro™ 2001989-301A- draft 2IntroductionWARNINGLOSS 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.WARNINGNETWORK 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.WARNINGOPERATOR — 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.WARNINGPOWER 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).WARNINGPROTECTED 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.322CUnprotected Leadwire Protected Leadwire
DraftIntroduction2001989-301A- draft 2 ApexPro™ 1-11WARNINGRATE 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.WARNINGSINGLE 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.WARNINGSITE 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.CautionsCaution 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. CAUTIONDEFIBRILLATOR 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.CAUTIONDISPOSABLES — Disposable devices are intended for single use only. They should not be reused as performance could degrade or contamination could occur.
Draft1-12 ApexPro™ 2001989-301A- draft 2IntroductionCAUTIONDISPOSAL — 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.CAUTIONELECTROCAUTERY 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.CAUTIONINSTRUCTIONS 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.CAUTIONMAINTENANCE — Regular preventive maintenance should be carried out annually. You are responsible for any requirements specific to your country.CAUTIONMPSO — Do not use a multiple portable socket outlet (MPSO) for a system because it could result in unacceptable enclosure leakage currents. CAUTIONNEGLIGENCE — 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.
DraftIntroduction2001989-301A- draft 2 ApexPro™ 1-13CAUTIONPOWER 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, single-phase circuit. This equipment is suitable for connection to public mains as defines in CISPR 11. CAUTIONRESTRICTED SALE — U.S. federal law restricts this device to sale by or on the order of a physician.CAUTIONSECURITY — 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.CAUTIONSUPERVISED USE — This equipment is intended for use under the direct supervision of a licensed health care practitioner.CAUTIONUNINTENTIONAL 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.CAUTIONVENTILATION 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.
Draft1-14 ApexPro™ 2001989-301A- draft 2IntroductionNotesNote 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 symbolsNOTESome symbols may not appear on all equipment.ATTENTION: Consult accompanying documents.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.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".INTFC.
DraftIntroduction2001989-301A- draft 2 ApexPro™ 1-15Equipment complianceIEC, UL, and EN 60601-1 device classificationThis 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.Medical EquipmentWith 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.Manufacturer name and address.European authorized representative.2005-084P41Type of protection against electrical shock Transmitter — Internally poweredReceiver system — Class IDegree of protection against electrical shockT14 transmitter — Type CF Defibrillation proof applied part Degree of protection against harmful ingress of water T14 transmitter — IPX7 (IEC 60529)1Receiver 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 oxideEquipment not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxideMethod(s) of sterilization or disinfection recommended by the manufacturerNot applicableMode of operation Continuous operation1The 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.
Draft1-16 ApexPro™ 2001989-301A- draft 2IntroductionFCC compliance information statementThe 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 ExposureThis 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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