
Text extracted from the exhibit documents filed with the FCC. Open a document above to read the original.
GE Healthcare ApexPro™ English 2028341-012 (CD) 2028340-030A (paper) © 2007 General Electric Company. All rights reserved. ApexPro™ Telemetry System Operator’s Manual Software Version 4 CARESCAPE ® Telemetry T14 Transmitter T-2ApexPro™2001989-301A- draft 2 8 November 2007 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. Draft 2001989-301A- draft 2ApexPro™i Contents 1Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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 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 2Equipment overview . . . . . . . . . . . . . . . . . . . . . . . . . 2-1 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 3Equipment setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1 Transmitter setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2 Views . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2 Battery installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3 Draft iiApexPro™2001989-301A- draft 2 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. . . . . . . . . . . .…
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T-2ApexPro™2001989-301A- draft 1 8 October 2007 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, CARESCAPE, DASH, DINAMAP, SOLAR, and TRAM are trademarks of GE Medical Systems Information Technologies registered in the United States Patent and Trademark Office. 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. 2001989-301A- draft 1ApexPro™CE-1 CE marking information Compliance The ApexPro telemetry system bears CE mark CE-0459 indicating conformity with the provisions of the Council Directive 93/42/EEC concerning medical devices, and fulfills the essential requirements of Annex I of this directive. The product is radio- interference protection class A in accordance with EN 55011. The country of manufacture can be found on the equipment labeling. The product complies with the requirements of standard EN 60601-1-2 “Electromagnetic Compatibility-Medical Electrical Equipment.” The safety and effectiveness of this device has been verified against previously distributed devices. Although all standards applicable to presently marketed devices may not be appropriate for prior devices (i.e. electromagnetic compatibility standards), this device will not impair the safe and effective use of those previously distributed devices. Exceptions The CIC Pro Clinical Information Center and ApexPro Telemetry Server are suitable for use in the specified electromagnetic environment. For more information, refer to the appropriate service manual. R&TTE directive The ApexPro 420-460 MHz transmitters and receiver bear the CE mark CE 0123 indicating conformity to R&TTE Directive 1999/5/EC. The product complies with the requirements of standard EN 300 220-1 [ETSI 300 220-1 v1.2.1]: “Electromagnetic Compatibility and Radio Spectrum Matters (ERM); Short Range Devices (SRD); Part 1: Technical Characteristics and Test Methods”. For more information, refer to the appropriate service manual. General information „This manual is an integral part of the product and describes its intended use. It should always be kept close to the equipment. Observance of the manual is a prerequisite for proper product performance and correct operation and ensures patient and operator safety. „The symbol means ATTENTION: Consult accompanying documents. „Information which refers only to certain versions of the product is accompanied by the model number(s) of the product(s) concerned. The model number is given on the nameplate of the product. CE-2ApexPro™2001989-301A- draft 1 CE marking information „The warranty does not cover damages resulting from the use of accessories and consumables from other manufacturers. „GE is responsible for the effects on safety, reliability, and performance of the product, only if: ‹assembly operations, extensions, readjustments, modifications, or repairs are carried out by persons authorized by GE; ‹the electrical installation of the relevant room complies with the requirements of the appropriate regulations; and, ‹the device is used in accordance with the instructions for use. „All publications conform with the product specifications and applicable IEC publications on safety and essential performance of electromedical equipment as well as with applicable UL and CSA requirements and AHA recommendations valid at the time of printing. „The quality management system complies with the international standards ISO 9001 and ISO 13485, and the Council Directive on Medical Devices 93/42/EEC Annex II. 2001989-301A- draft 1ApexPro™i Contents 1Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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 information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4 Intended use of this equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4 Safety statements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4 Dangers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4 Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4 Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-11 Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . …
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iiApexPro™2001989-301A- draft 1 Battery installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3 Leadwire installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5 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 4System setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1 Bedside monitor setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2 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 5Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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 2001989-301A- draft 1ApexPro™iii Telemetry bed alarm control defaults . . . . . . . . . . . . . . . . . . . . . . . . 5-12 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 6Manag…
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viiiApexPro™2001989-301A- draft 1 ETechnical specifications . . . . . . . . . . . . . . . . . . . . . . E-1 ApexPro and ApexPro CH transmitters . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-2 Power requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-2 Alarms and controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-2 Transmission . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-2 ECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-2 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-5 Display specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-5 Power specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-5 Environmental specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-5 Operating conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-5 Storage conditions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-5 Physical specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-5 FCC compliance information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-5 Certifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-6 ApexPro receiver system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-6 Performance specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-6 Network requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-6 Power requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-6 Environmental specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-7 Operating conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-7 Storage conditions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-7 Physical specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-7 FCC compliance information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-7 Certifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-7 2001989-301A- draft 1ApexPro™1-1 1Introduction 1-2ApexPro™2001989-301A- draft 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 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. TermDescription ATSRefers to the ApexPro Telemetry Server. CIC Pro centerRefers to the CIC Pro Clinical Information Center. MonitorRefers to a bedside monitor, transport monitor, blood pressure monitor, or a wireless monitor on the Unity Network. PrinterRefers generically to a direct digital writer or a laser printer. ServerRefers to the ApexPro Telemetry Server (ATS) or a CIC Pro center with a BCM or Nightshade server. Introduction 2001989-301A- draft 1ApexPro™1-3 Text styles This manual uses the following text styles to identify hardware terms, software terms and the correct way to enter data. 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 p…
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Introduction 2001989-301A- draft 1ApexPro™1-13 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, single- phase 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. 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. 1-14ApexPro™2001989-301A- draft 1 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 Some 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. Introduction 2001989-301A- draft 1ApexPro™1-15 Equipment compliance IEC, UL, and EN 60601-1 device classification 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. 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. Manufacturer name and address. European authorized representative. 2005-08 4P41 Type of protection against electrical shockTransmitter — 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 operationContinuous operation 1 The T14 transmitter is designed to be IPX7 compliant, so it can withstand inadvertent submersion.…
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| # | Rule Parts | Frequency Range | Power Output | Emission | Tolerance |
|---|---|---|---|---|---|
| 1 | 95H | 1.40 GHz - 1.40 GHz | 5.00 mW | 11K9F7D | 0.5000000000 ppm |

URP Detector UWB Radio PWA and Antenna Module
Equipment Class
UWB - Ultra Wideband Transmitter
Wireless Access Point (AP) for Medical Monitoring
Equipment Class
TNB - Licensed Non-Broadcast Station Transmitter
EA-WMTS-SHU-4
Equipment Class
TNB - Licensed Non-Broadcast Station Transmitter
Medical Telemetry Transmitter worn on body
Equipment Class
TNT - Licensed Non-Broadcast Transmitter Worn on Body
WMTS Transmitter
Equipment Class
TNT - Licensed Non-Broadcast Transmitter Worn on Body