OU5418500Medical Telemetry TX

ApexPro ™ Telemetry System Operator’s Manual Software Version 1 2001989-002Revision A Preliminary T-2ApexPro Telemetry SystemRevision A 2001989-00218 January 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 Marquette Hellige GmbH Postfach 60 02 65 D-79032 Freiburg Germany Tel: 49.761.45.43.0 Fax: 49.761.45.43.233 Preliminary

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 2Equipment Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3 ApexPro Telemetry System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4 ApexPro Transmitter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4 ApexPro Transmitter Keys and LEDs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5 ApexPro Transmitters and MCL Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7 Apex Oximeter SpO2 Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7 Apex Oximeter Keys and LEDs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7 Accutracker DX Noninvasive Blood Pressure Monitor . . . . . . . . . . . . . . . . . . . . . . 2-8 Accutracker DX Buttons and Switches . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9 Antenna System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-10 Receiver Subsystem . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-10 Unity Network . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-10 Clinical Information Center . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11 Preliminary iiApexPro Telemetry SystemRevision A 2001989-002 3Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1 For Your Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3 Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3 Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3 System Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3 Dangers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3 Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4 Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7 Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9 Reference Literature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10 Classification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10 Underwriters Laboratories, Inc. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10 Equipment Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-11 4Connection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1 ApexPro Transmitter Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3 ApexPro Transmitter Battery Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3 Battery Functional Life . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3 ApexPro Transmitter Leadwire Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4 Multi-Link Leadwire Sets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4 ApexPro Transmitter Leadwire Attachment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5 ApexPro Transmitter Leadwire Removal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5 Apex Oximeter Setup . . . . . . . . . . . . . . . . .…

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14-10ApexPro Telemetry SystemRevision A 2001989-002 Appendices: Appendix C — Technical Specifications FCC Compliance This device complies with Part 15 of the FCC Rules and with RSS-210 of Industry Canada. 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. :$51,1* Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment. Preliminary

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

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

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 ribbon cable from control board to RF Transmitter board.

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.

I IIIII V(1-6) LARA LL RL 1 2 3 4 6 5 422196-001 I/N 3 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. 0459 FCC ID: OU5418500

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

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.

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.

LSC- . . . . . . . . . . . . . . . . . . . L. S. Compliance, Inc. Compliance Testing of: GE Marquette Medical Systems Apex Pro Telemetry Unit Model 001 Prepared for: Michael Steinike Test Report Number: 300112 Date(s) of Testing: January 24 and 26, 2000 All results of this report relate only to the items that were tested. L. S . C o mp lia nc e , Inc . W66 N220 Commerce Court Cedarburg, Wisconsin 53012 Phone: 414 - 375 - 4400 Fax: 414 - 375 - 4248 L. S. COMPLIANCE, Inc. FCC ID: OU5418500 LSC-GE/MARQUETTE 300112pageof 25 1 This report may not be reproduced, except in full, without written approval of L. S. Compliance, Inc. L. S. COMPLIANCE, Inc. FCC ID: OU5418500 LSC-GE/MARQUETTE 300112pageof 25 0 Table of Contents SectionDescriptionPage # Index0 Description of Measurement Facilities1 1.2Signature Page2 1.3Summary of Test Report3 1.4Introduction4 1.5Purpose4 1.6Radiated Emission Test Setup4 1.7Radiated Emission Test Procedure5 1.8Radiated Emission Test Equipment Utilized6 1.9Conducted Emission Measurements6 1.10Restricted Bands (Frequencies and Limits)7 1.11Photos taken during testing8 1.12Summary of Results and Conclusions9 1.13Test Equipment List10 Appendic es ASample Calculations:11 i.Calculation of Radiated Emissions Limits12 BData Charts13 CGraphs16 L. S. COMPLIANCE, Inc. FCC ID: OU5418500 LSC-GE/MARQUETTE 300112pageof 25 1 D ESCRIPTION OF M EASUREMENT F ACILITIES Site on File with the FCC ID Number: 31040/SIT 1300F2 Site on file with Industry Canada: ID Number: IC 3088 “ The site referenced above has been found to comply with the test site criteria found in ANSI C63.4-1992 and 47CFR Section 2.948.” L. S. COMPLIANCE, Inc. FCC ID: OU5418500 LSC-GE/MARQUETTE 300112pageof 25 2 L. S. COMPLIANCE, Inc. FCC ID: OU5418500 LSC-GE/MARQUETTE 300112pageof 25 3 SIGNATURE PAGE Tests performed by:February 28. 2000 Prepared By: Approved By: February 28, 2000 Kenneth L. Boston, EMC Lab ManagerDate PE #31926 Registered Professional Engineer (State of Wisconsin) L. S. COMPLIANCE, Inc. FCC ID: OU5418500 LSC-GE/MARQUETTE 300112pageof 25 4 1.3 S UMMARY OF T EST R EPORT MANUFACTURER:General Electric / Marquette Medical MODEL:001 SERIAL:AOTT0017GP DESCRIPTION:Medical Telemetry Transmitter FREQUENCY RANGE:560-614 MHz The Apex Pro transmitter was found to “meet” the radiated emission specification of Title 47 CFR FCC, Part 15, subpart C. for an intentional radiator L. S. COMPLIANCE, Inc. FCC ID: OU5418500 LSC-GE/MARQUETTE 300112pageof 25 5 1.4 I NTRODUCTION On January 24 and 26 of 2000, a series of Radiated Emissions tests were performed on one sample model of the GE Marquette Medical Systems Apex Pro transmitter, a medical telemetry device designed to send patient care parameters to a centralized receiver, while located in a hospital or clinic. The device is a GMSK (FM) transmitter, designed to send NiBP, SPO2 and ECG over a narrow channel of spectrum, assigned to 12.5 kHz spaced channels located within the UHF television channels allowed for this type of device. These tests were performed using the test procedures outlined in ANSI C63.4-1992 for intentional radiators, and in accordance with the limits set forth in FCC Part 15.242 for a medical telemetry transmitter. These tests were performed by Thomas T lee, of L. S. Compliance, Inc. and witnessed by Mike Steinike of Marquette Medical, Inc. 1.5 P URPOSE The above mentioned tests were performed in order to determine the compliance of the Apex Pro with limits contained in various provisions of Title 47 CFR, FCC Part 15, including: 15.209 15.242 All radiated emissions tests were performed to measure the emissions in the frequency bands described by the above sections, and to determine whether said emissions are below the limits established by the above sections. These tests were performed in accordance with the procedure described in the American National Standard for methods of measurement of Radio-Noise Emissions from Low-Voltage Electrical and Electronic Equipment in the Range of 9 kHz to 40 GHz (ANSI C63.4-1992). Another document used as reference for the EMI receiver specification was the International Special Committee on Radio Interference (CISPR) number 16-1 (1993). 1.6 R ADIATED E MISSIONS T EST S ETUP The test sample was operated within the 3 meter Semi-Anechoic, FCC listed chamber located at L.S. Compliance in Cedarburg, WI. The sample was placed on an 80cm high wooden table, which was centered on the flush-mounted 2m diameter metal turntable. The test sample was operated on its own [new] internal battery. The battery voltage at the beginning of the tests was measured to be 3.3 volts. The test sample contained modified software, allowing it to transmit a continuous data stream, representative of the data signal that would normally be transmitted. Please refer to Section 1.11 for pictures of the test setup. L. S. COMPLIANCE, Inc. FCC ID: OU5418500 LSC-GE/MARQUETTE 300112pageof 25 6 1.7 R ADIATED E MISSION T EST P ROCEDURE The fundamental and spurious (harmonic) emissions of the transmitter were tested for compliance to Title 47 CFR, FCC Part 15.242 and 15.209b, limits for a medical telemetry device. For the calculations used to determine the limits applicable for the test sample (at the respective operating frequency) refer to Appendix A. These limits are expressed in decibels (dB) above 1 microvolt per meter (μV/m). The samples were tested from the lowest frequency generated by the transmitter (without going below 9 kHz, and for this design; 1.84 MHz) to the 10th harmonic of the fundamental frequency generated by the device. (6.2 GHz) The appropriate limits were also observed when the fundamental or spurious signals were located within any of the restricted bands as described in Part 15.205a. These frequencies, and their associated limits, are referenced in Section 1.10. The samples were placed on a nonconductive (wooden) table in the 3 Meter chamber and the antenna mast was placed such that the antenna was 3m from the test object. A loop antenna w…

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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.