OU5418500-APROAPEXPRO WIRELESS MEDICAL TELEMETRY TRANSMITTER

ApexPro ™ Telemetry System Operator’s Manual Software Version 1 2001989-002Revision A T-2ApexPro Telemetry SystemRevision A 2001989-0025 June 2000 127(Due to continuing product innovation, specifications in this manual are subject to change without notice. Trademarked names appear throughout this document. Rather than list the names and entities that own the trademarks or insert a trademark symbol with each mention of the trademarked name, the publisher states that it is using the names only for editorial purposes and to the benefit of the trademark owner with no intention of improperly using that trademark. 900 SC, ACCUSKETCH, AccuVision, APEX, AQUA-KNOT, ARCHIVIST, Autoseq, BABY MAC, C Qwik Connect, CardioServ, CardioSmart, CardioSys, CardioWindow, CASE, CD TELEMETRY, CENTRA, CHART GUARD, CINE 35, CORO, COROLAN, COROMETRICS, Corometrics Sensor Tip, CRG PLUS, DASH, Digistore, Digital DATAQ, E for M, EAGLE, Event-Link, FMS 101B, FMS 111, HELLIGE, IMAGE STORE, INTELLIMOTION, IQA, LASER SXP, MAC, MAC-LAB, MACTRODE, MARQUETTE, MARQUETTE MAC, MARQUETTE MEDICAL SYSTEMS, MARQUETTE UNITY NETWORK, MARS, MAX, MEDITEL, MEI, MEI in the circle logo, MEMOPORT, MEMOPORT C, MINISTORE, MINNOWS, Monarch 8000, MULTI-LINK, MULTISCRIPTOR, MUSE, MUSE CV, Neo-Trak, NEUROSCRIPT, OnlineABG, OXYMONITOR, Pres-R-Cuff, PRESSURE-SCRIBE, QMI, QS, Quantitative Medicine, Quantitative Sentinel, RAC RAMS, RSVP, SAM, SEER, SILVERTRACE, SOLAR, SOLARVIEW, Spectra 400, Spectra-Overview, Spectra-Tel, ST GUARD, TRAM, TRAM-NET, TRAM-RAC, TRAMSCOPE, TRIM KNOB, Trimline, UNION STATION, UNITY logo, UNITY NETWORK, Vari-X, Vari-X Cardiomatic, VariCath, VARIDEX, VAS, and Vision Care Filter are trademarks of GE Marquette Medical Systems, Inc. registered in the United States Patent and Trademark Office. 12SL, 15SL, Access, AccuSpeak, ADVANTAGE, BAM, BODYTRODE, Cardiomatic, CardioSpeak, CD TELEMETRY®-LAN, CENTRALSCOPE, Corolation, EDIC, EK-Pro, Event-Link Cirrus, Event-Link Cumulus, Event-Link Nimbus, HI-RES, ICMMS, IMAGE VAULT, IMPACT.wf, INTER-LEAD, IQA, LIFEWATCH, Managed Use, MARQUETTE PRISM, MARQUETTE® RESPONDER, MENTOR, MicroSmart, MMS, MRT, MUSE CardioWindow, NST PRO, NAUTILUS, O 2 SENSOR, Octanet, OMRS, PHi-Res, Premium, Prism, QUIK CONNECT V, QUICK CONNECT, QT Guard, SMART-PAC, SMARTLOOK, Spiral Lok, Sweetheart, UNITY, Universal, Waterfall, and Walkmom are trademarks of GE Marquette Medical Systems, Inc. © GE Marquette Medical Systems, Inc., 2000. All rights reserved. GE Marquette Medical Systems, Inc. 8200 W. Tower Ave. Milwaukee, WI 53223 USA Tel: 414.355.5000 800.558.5120 (USA only) Fax: 414.355.3790 GE Marquette Hellige GmbH Postfach 60 02 65 D-79032 Freiburg Germany Tel: 49.761.45.43.0 Fax: 49.761.45.43.233 Revision AApexPro Telemetry Systemi 2001989-002 Contents 1The Basics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1 About This Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3 Manual Purpose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3 Intended Audience . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3 Revision History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3 Manual Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4 Product References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4 Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4 Illustrations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5 Common Operations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6 “Clicking” the Mouse . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6 Radio Buttons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6 Check Boxes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7 Scroll Bars . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7 Popup Lists . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8 Unit Defaults Worksheet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9 2Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1 For Your Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3 Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3 Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3 System Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3 Dangers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3 Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4 Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7 Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9 Reference Literature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-10 Classification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .…

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The application was filed as indicated in Item 10 for Part 95 authority "FRT - Part 95 Family Radio Body Wire Transmitter" so that this device could be authorized as both Part 95 and Part 15 compliant. Prior to filing this application we cleared through Ray LaForge and Bette Taube how best to reflect this dual status for the device which at the time already had been authorized under Part 15. This request for dual authorization is also reflected in the response to Item 13 which describes the device as a "composite device" previously authorized under Part 15, FCC ID: 0U5418500. The labeling of the proposed device was also coordinated with the FCC staff to reflect the foregoing composite as dual status.

GE Marquette Medical Systems FCC ID OU5418500-APRO Response to FCC Questions in Correspondence Dated March 8 th 2001 Correspondence Reference Number: 18320 731 Confirmation Number: EA99682 1.) Please justify the .0073 power output listed on FCC Form 731. The maximum output power for Part 15.242 and Part 95 (WMTS) is .0073W, as seen on our test report our Maximum output power is 1.2mW at 560.025-613.975MHz. 2.) Please supply and justify a complete emission designator following the prescriptions under Sections 2.201 and 2.202 of the Commission’s R&R. Per section 2.201. Emissions, modulation, and transmission characteristics. The ApexPro Telemetry transmitter utilizes GMSK modulation (Gaussian Minimum Shift Keying). The modulation index, (MSK) Minimum shift keying, which is binary digital FM, has a modulation index of 0.5. The Base Band I & Q signals are Low Pass Filtered, keeping the constant envelope property with a Gaussian filter Bt of 0.3. With this in mind the Emission designator is (G7D). G =Phase modulation: 7 =Two or more channels containing quantized or digital information: D =Data transmission, telemetry, telecommand: 3.) Please supply an occupied bandwidth measurement per Section 2.1049 of the Commission’s R&R. Please see exhibit titled "Occupied Bandwith Measurement" submitted 3/29/2001. Occupied bandwidth measurement = 9500Hz 4.) Please supply frequency stability measurements for temperature and supply voltage variations per section 2.1055 of the Commission’s R&R. Please see exhibit titled "Frequency Stability Measurements" submitted 3/29/2001. Frequency drift over temperature = 698Hz Frequency drift over Voltage range = 10Hz 5.) Please demonstrate compliance with the RF exposure requirements under Section 2.1093 of the Commission’s R&R. Please see exhibit titled "Engineering Analysis of IEEE Standard for Safety Levels" submitted 3/29/2001. Mike Steinike 414.362.2417 [email protected] GE Medical Systems Information Technologies 8200 West Tower Ave. Milwaukee, WI. 53223

GE Marquette Medical Systems FCC ID OU5418500-APRO Confirmation Number: EA99682 Response to FCC Questions in Correspondence Reference Number: 18666 1.) The .0073 W power output value listed on FCC Form 731 has not been justified. The original question #1 from our 3/8/01 request remains unresolved. A field strength of 97.7dBuV/m was measured (reference test report from L.S. Compliance page 15) Converting this to Effective Radiated Power Measurement equals 1.2mW ERP. E = 97.7 dBμV/m = 10 (97.7 dBμ / 20) = 76736 * 10 -6 V/m E (V/m) 2 / 120 *  = (P t * G t ) / 4πR 2 where P = Power Density (in watts/square meter) at a distance R P t = Power radiated by an isotropic radiator (watts) R = Distance of measurement from source G t = Transmit Antenna Gain R = 3m G t = -0.5 dBi = -0.5 + 2.15 = 1.65 dB = 10 (1.65/10) = 1.46 P t = ((E (V/m) 2 * 4πR 2 ) / (G t * 120 * )) P t = (((76736 * 10 -6 ) 2 * 4π (3) 2 ) / (1.466 * 120 * )) = 0.665 / 550.4 = 1.2 * 10 -3 W = 1.2mW 2.) Please indicate the spectrum analyzer settings used for the measurement of occupied bandwidth. HP89440 Vector Signal Analyzer settings for occupied bandwidth. Frequency613.975MHz Span 50KHz Res Bw 1KHz 3.) Section 2.1093 requires the measurement of SAR not MPE. The original question # 5 from our 3/8/01 request remains unresolved. Please see exhibit titled “SAR Evaluation” submitted 5/21/2001. 4.) Page 3-11 of the Users Manual shows an “antenna system”. This does not appear to match the equipment photographs which state that “Green Lead wire acts as the antenna for the transmitter”. The picture on 3-11 is a receive antenna, used to receive the Telemetry signals and then send them to the Receiver System using coax cable.

GE Marquette Medical Systems APEX Pro Transmitter Front of transmitter case showing waterproof button controls

GE Marquette Medical Systems APEX Pro Transmitter Close-up of Battery Compartment area.

GE Marquette Medical Systems APEX Pro Transmitter Patient Monitor System with patient leads attached to cable block. Green Lead wire acts as the antenna for the transmitter.

GE Marquette Medical Systems APEX Pro Transmitter Back of transmitter case showing operational and FCC labeling

GE Marquette Medical Systems APEX Pro Transmitter Close-up of ribbon cable from control board to RF Transmitter board.

I IIIII V(1-6) LA RA LL RL 1 2 3 4 6 5 422196-001 I/N 6 RARLLALLVaVb INTFC. This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Operation of this equipment requires the prior coordination with a frequency coordinator designated by the FCC for the Wireless Medical Telemetry Service. FCC ID: OU5418500-APRO 0459/0123

GE Marquette Medical Systems APEX Pro Transmitter Close-up of RF Transmitter Board.

GE Marquette Medical Systems APEX Pro Transmitter Close-up of flip-side of RF Transmitter board with shield removed from RF section.

GE Marquette Medical Systems APEX Pro Transmitter Transmitter opens for inspection, showing the removal of the single RF Transmitter board.

GE Marquette Medical Systems APEX Pro Transmitter Close-up of RF Transmitter board connected to the cable block.

GE Marquette Medical Systems APEX Pro Transmitter Flip side close-up of RF Transmitter board connected to the cable block.

GE Marquette Medical Systems APEX Pro Transmitter Close-up of back side of cable block showing ribbon connector to RF Transmitter board.

GE Marquette Medical Systems APEX Pro Transmitter Close-up of cable block connections.

© 2001 PCTEST Engineering Lab., Inc. E 6660-B Dobbin Road • Columbia, MD 21045 • U.S.A. TEL (410) 290-6652 • FAX (410) 290-6654 http://www.pctestlab.com CERTIFICATE OF COMPLIANCE (SAR EVALUATION) GE Marquette Medical Systems, Inc. Dates of Tests: May 7, 2001 8200 West Tower avenue Test Report S/N: SAR.210503269.OU5 Milwaukee,WI 53223 Test Site: PCTEST Lab, Columbia, MD USA Attn: Mike Steinike RF Electronics Engineer FCC ID OU5418500-APRO APPLICANT GE Marquette Medical Systems, Inc. EUT Type: Wireless Medical Telemetry Transmitter (GMSK) Tx Frequency: 608.025 - 613.975 MHz Max. RF Output Power: 1.2 mW ERP Trade Name/Model(s): GE Marquette ApexPro FCC Classification: Wireless Medical Telemetry Service (WMTS) Application Type: Certification FCC Rule Part(s): §2.1093; 95(H) Maximum SAR: 0.1421 W/kg Body SAR (GMSK) This wireless portable device has been shown to be compliant for localized specific absorption rate (SAR) for uncontrolled environment/general population exposure limits specified in ANSI/IEEE Std. C95.1-1992 and had been tested in accordance with the measurement procedures specified in ANSI/IEEE Std. C95.3-1992. (See Test Report) I attest to the accuracy of data. All measurements reported herein were performed by me or were made under my supervision and are correct to the best of my knowledge and belief. I assume full responsibility for the completeness of these measurements and vouch for the qualifications of all persons taking them. NVLAP accreditation does not constitute any product endorsement by NVLAP or any agency of the United States Government. PCTEST certifies that no party to this application has been denied the FCC benefits pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 862. 210503269.OU5 Test Report S/N: SAR.210503269.OU5 SAR Measurement Report Test Dates: MAY 7, 2001 FCC Part 95 Certification Table of Contents 1.1 SCOPE........................................................................................................................1 2.1 INTRODUCTION........................................................................................................2 2.2 SAR Definition.......................................................................................................2 3.1 SAR MEASUREMENT SET-UP.............................................................................3 4.1 ISOTROPIC E-FIELD PROBE SYSTEM...............................................................4 5.1 E-FIELD PROBE CALIBRATION PROCESS......................................................5 6.1 TORSO AND EQUIVALENT TISSUES.................................................................7 7.1 SYSTEM SPECIFICATIONS...................................................................................8 8.1 MEASUREMENT PROCESS..................................................................................9 9.1 TEST POSITION OF THE EUT.............................................................................10 10.1 ANSI/IEEE C95.1 - 1992 RF EXPOSURE LIMITS..........................................11 11.1 MEASUREMENT UNCERTAINTIES.................................................................12 12.1 SAR TEST DATA SUMMARY.............................................................................13 13.1 SAR TEST EQUIPMENT.....................................................................................14 14.1 CONCLUSION.......................................................................................................15 Test Report S/N: SAR.210503269.OU5 SAR Measurement Report Test Dates: May 7, 2001 FCC Part 95 Certification FCC ID: OU5418500-APRO (Model: ApexPro) © 2001 PCTEST Lab GE Wireless Medical Telemetry Transmitter (GMSK) 1 SAR MEASUREMENT REPORT 1.1 SCOPE Environmental evaluation measurements of specific absorption rate 1 (SAR) distributions in simulated human tissues exposed to radiofrequency (RF) radiation from wireless portable devices for compliance with the rules and regulations of the U.S. Federal Communications Commission (FCC). 2 Applicant Name: GE Marquette Medical Systems, Inc. Address: 8200 West Tower avenue Milwaukee,WI 53223 Attention: Mike Steinike RF Electronics Engineer • EUT Type: Wireless Medical Telemetry Transmitter (GMSK) • Trade Name: GE Marquette • Model(s): ApexPro • FCC IDENTIFIER: OU5418500-APRO • Tx Frequency: 608.025 - 613.975 MHz (GMSK) • Application Type: Certification • FCC Classification: Wireless Medical Telemetry Service • FCC Rule Part(s): § 2.1093, 95(H) • Modulation(s): GMSK • Max RF. Output Power: 1.2 mW ERP • Date(s) of Tests: May 7, 2001 • Place of Tests: PCTEST Engineering Lab. Columbia, MD, U.S.A. • Report Serial No.: SAR.210503269.OU5 1 Specific Absorption Rate (SAR) is a measure of the rate of energy absorption due to exposure to an RF transmitting source (wireless portable device). 2 IEEE/ANSI Std. C95.1-1992 limits are used to determine compliance with FCC ET-Docket 93-62. Fig. 1 SAR Test Setup Test Report S/N: SAR.210503269.OU5 SAR Measurement Report Test Dates: May 7, 2001 FCC Part 95 Certification FCC ID: OU5418500-APRO (Model: ApexPro) © 2001 PCTEST Lab GE Wireless Medical Telemetry Transmitter (GMSK) 2 2.1 INTRODUCTION The FCC has adopted the guidelines for evaluating the environmental effects of radio frequency radiation in ET Docket 93-62 on Aug. 6, 1996 to protect the public and workers from the potential hazards of RF emissions due to FCC-regulated portable devices.[1] The safety limits used for the environmental evaluation measurements are based on the criteria published by the American National Standards Institute (ANSI) for localized specific absorption rate (SAR) in IEEE/ANSI C95.1-1992 Standard for Safety Levels with Respect to Human Exposure to Radio Frequency Electromagnetic Fields, 3 kHz to 300 GHz. © 1992 by the Institute of Electrical and Electronics Engineers, Inc., New York, New York 10017.[2] The measurement procedure described in IEEE/ANSI C95.3-1992 Recommended Practice for the Measu…

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GE – Marquette Medical Systems FCC ID #: OU5418500 ApexPro Transmitter output Spectrum Board SN:NB1164290 The modulation index, Minimum shift keying ( MSK ), which is binary digital FM, has a modulation index of 0.5. The Base Band I & Q signals are Low Pass Filtered, keeping the constant envelope property with a Gaussian filter with B t of 0.3. The 20db bandwidth is within the 12kHz channel limit.