PQC-TRX4841AINTELLIVUE TRANSCEIVER IS A PATIENT WORN DEVICE FOR MONITORING ECG AND SPO2

Instructions for Use IntelliVue TRx/TRx + Transceivers for the ITS4840A/ITS4850A IntelliVue Telemetry System Part Number: 4535 640 87761 Printed in the U.S.A. September 2008 First Edition Notice (ITS4842A, TRx4841A) These devices comply with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) these devices may not cause harmful interference, and (2) these devices must accept any interference received, including interference that may cause undesired operation. Notice (ITS4852A, TRx4851A) These devices comply with part 15 of the FCC Rules, ETSI, RSS-210, and other international radio standards that govern operation in the ISM band. Operation is not subject to WMTS rules. ii NoticeDocument number: 453564087761, First Edition Printed in the USA. © Copyright 2008 Koninklijke Philips Electronics N.V. All Rights Reserved. Reproduction in whole or in part is prohibited without the prior written consent of the copyright holder. Philips Medical Systems Nederland B.V. reserves the right to make changes in specifications and/or to discontinue any product at any time without notice or obligation and will not be liable for any consequences resulting from the use of this publication. Equipment specifications are subject to alteration without notice. All changes will be in compliance with regulations governing manufacture of medical equipment. OxiCliq ® and OxiMax ® are registered trademarks of Nellcor Incorporated. Duracell ® is a registered trademark of Duracell International Incorporated. ManufacturerPhilips Medical Systems 3000 Minuteman Road Andover, MA 01810-1099 (978) 687-1501 Printing History iii Printing History New editions of this document will incorporate all material updated since the previous edition. Update packages can be issued between editions and contain replacement and additional pages to be merged by a revision date at the bottom of the page. Note that pages which are rearranged due to changes on a previous page are not considered revised. The documentation printing date and part number indicate its current edition. The printing date changes when a new edition is printed. (Minor corrections and updates which are incorporated at reprint do not cause the date to change.) The document part number changes when extensive technical changes are incorporated. First Edition...............................................................................September 2008 IntelliVue TRx4841A C.00 Transceivers are compatible with: IntelliVue Telemetry System, Revision A.00 and B.00 IntelliVue Information Center, Software Revision L.00 M2636C TeleMon Companion Monitor, Revision C.00 IntelliVue MP5 Patient Monitor, Revision G.00 IntelliVue TRx4851A C.00 Transceivers are compatible with: IntelliVue Telemetry System, Revision B.00 IntelliVue Information Center, Software Revision L.00 M2636C TeleMon Companion Monitor, Revision C.00 IntelliVue MP5 Patient Monitor, Revision G.00 About this Book iv About this Book This book contains operating instructions for use of the IntelliVue TRx and TRx + Transceivers as used with the IntelliVue Telemetry System with Smart- Hopping Technology. It also includes operational information for the telemetry functions of the IntelliVue Information Center. The intended audience is the clinician who uses and/or teaches others to use this equipment in a healthcare environment. Additional resources for Philips products used in conjunction with the IntelliVue TRx and TRx + Transceivers include: •IntelliVue Information Center Instructions for Use •IntelliVue Information Center Online Help •M2636C TeleMon Companion Monitor Instructions for Use •IntelliVue Telemetry System Training Program •IntelliVue MP5 Patient Monitor Instructions for Use •IntelliVue MP2 Patient Monitor Instructions for Use •IntelliVue X2 Patient Monitor Instructions for Use For preventive maintenance, repair, and test methods for verification of device performance, refer to the IntelliVue Telemetry System Service Kit. About this Book v Document Conventions The following document conventions are used throughout this manual to identify specific safety and operational information. Warnings WarningWarning Warnings are information you must know to avoid injuring patients and personnel. Cautions Caution Cautions are information you must know to avoid damaging your equipment and software. Notes Note—Notes contain additional information on use of the IntelliVue Telemetry System. Procedures Procedures are indicated in the following table: Step Action 1 2 3 About this Book vi Contents Contents-1 1. Introducing IntelliVue Telemetry. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1 The IntelliVue Transceiver. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2 Transceiver Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2 Transceiver Models . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2 IntelliVue Telemetry System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4 Bi-directional Capability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4 Smart-hopping Technology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5 Spectrum Sharing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8 IntelliVue Clinical Network . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8 Transceiver Use with Other Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9 2. Product Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-…

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Philips Medical Systems PH I LI PS Letter Of Agency Date: 12-April-20 10 To Whom It May Concern: Please be advised that Terrence Sweeney of Philips Medical Systems authorizes Larry Stillings of Compliance Worldwide, Inc. to act on our behalf, until otherwise notified, for applications submitted for the purpose of obtaining an FCC Grant of Equipment Authorization.We certify that we are not subject to denial of federal benefits, that includes FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse ACT of 1988, U.S.C. 862. Further, no party, as defined in 47 CAR 1.2002(b), to the application is subject to denial of federal benefits, that includes FCC benefits. Thank you for your attention to this matter. Sincerely Terrence J. Sweeney Vice President — Global Clinical Affairs

Philips Medical Systems P11 I LI PS Date: 5-May-201 0 Federal Communications Commission Authorization and Evaluation Division Confidentiality Request regarding application for certification of FCC ID: POC TRX4841 A Pursuant to Sections 0.457 and 0.459 of the Commission’s Rules, we hereby request confidential treatment of information accompanying this application as outlined below: Exhibit Type File Name Block Diagram TRX4841A BlkDia.pdf Schematics TRX4841 A Schem.pdf Operational Description TRX4841 A OpDes.pdf Parts List TRX4841A PartsLst.pdf The above materials contain trade secrets and proprietary information not customarily released to the public. The public disclosure of these materials may be harmful to the applicant and provide unjustified benefits to its competitors. The applicant understands that pursuant to Section 0.457 of the Rules, disclosure of this application and all accompanying documentation will not be made before the date of the Grant for this application. Pursuant to DAO4-1 705 June 15, 2004 of the Commission’s public notice, we also require temporary confidential treatment of information accompanying this application as outlined below: Exhibit Type File Name External Photos TRX4841A ExtPho.pdf Internal Photos TRX4841A lntPho.pdf Confidentiality Request regarding application for certification of FCC ID: PQC-TRX4841 A Page 1 of 2 Temporary confidentiality from public disclosure is important for Philips Medical Systems from a commercial perspective. It enables the company to complete its development and regulatory efforts prior to introducing the product to the marketplace. Releasing information on the product via the FCC website prior to formal market introduction can be confusing to our customers and the medical community, and places the company at a competitive disadvantage. Sincerely, C Terrence Sweeney Vice President-Global Clinical Affairs Confidentiality Request regarding application for certification of FCC ID: PQC-TRX4841A Page 2 of 2

External Photos – Philips TRx4841A, FCC ID: PQC-TRX4841A Front Rear

Label Location – FCC ID: PQC-TRX4841A

Internal Photos – Philips TRx4841A, FCC ID: PQC-TRX4841A

Compliance Worldwide, Inc. - 357 Main Street - Sandown, NH 03873 COMPLIANCE WORLDWIDE INC. TEST REPORT 154-10 In Accordance with the Requirements of Federal Communications Commission CFR 47 Part 95, Subpart H Low Power Licensed Radio Communication Devices Wireless Medical Telemetry Service Transceiver In the bands 1395-1400 and 1427-1432 MHz Issued to Philips Medical Systems 3000 Minuteman Drive Andover, MA 01810 978-659-2800 for TRx4841A 1.4 GHz Patient Worn Device With Cost Reduced LP1 Radio Board, P/N 453564193531 FCC ID: PQC-TRX4841A Report Issued on March 12, 2010 Tested by This test report shall not be reproduced, except in full, without written permission from Compliance Worldwide, Inc. (603) 887 3903 Fax 887 6445 http://www.complianceworldwide.com Test Number: 154-10 Issue Date: 03/12/2010 Page 2 of 21 Compliance Worldwide, Inc. - 357 Main Street - Sandown, NH 03873 (603) 887 3903 Fax 887 6445 http://www.cw-inc.com Table of Contents 1. Scope........................................................................................................................................ 3 2. Product Details.......................................................................................................................... 3 2.1. Manufacturer ..................................................................................................................... 3 2.2. Model Number ................................................................................................................... 3 2.3. Serial Number.................................................................................................................... 3 2.4. Description......................................................................................................................... 3 2.5. Power Source .................................................................................................................... 3 2.6. EMC Modifications............................................................................................................. 3 3. Product Configuration ............................................................................................................... 3 3.1. Operational Characteristics & Software............................................................................. 3 3.2. EUT Hardware................................................................................................................... 3 3.3. EUT Hardware/Software/Firmware Revision Level ........................................................... 3 3.4. EUT Cables/Transducers .................................................................................................. 4 3.5. Support Equipment............................................................................................................ 4 3.6. Support Equipment Cables/Transducers........................................................................... 4 3.7. Block Diagram ................................................................................................................... 5 4. Measurements Parameters....................................................................................................... 5 4.1. Measurement Equipment Used to Perform Test ............................................................... 5 4.2. Measurement & Equipment Setup..................................................................................... 6 4.3. Test Procedure .................................................................................................................. 6 4.4. Measurement Uncertainty ................................................................................................. 6 5. Choice of Equipment for Test Suits ..........................................................................................7 5.1. Choice of Model................................................................................................................. 7 5.2. Presentation ...................................................................................................................... 7 5.3. Choice of Operating Frequencies ..................................................................................... 7 6. Measurement Summary............................................................................................................ 7 7. Measurement Data ................................................................................................................... 8 7.1. Occupied Bandwidth.......................................................................................................... 8 7.2. Radiated Field Strength of Fundamental ......................................................................... 10 7.3. Radiated Field Strength of Harmonics............................................................................. 13 7.4. Band Edge....................................................................................................................... 14 7.5. Spurious Radiated Emissions.......................................................................................... 17 7.6. RF Safety......................................................................................................................... 20 Test Number: 154-10 Issue Date: 03/12/2010 Page 3 of 21 Compliance Worldwide, Inc. - 357 Main Street - Sandown, NH 03873 (603) 887 3903 Fax 887 6445 http://www.cw-inc.com 1. Scope This test report certifies that the Philips cost reduced LP1 radio board from RTX, P/N 453564193531, for the TRx4841A 1.4 GHz Patient Worn Device, using 1.9 GHz DECT technology, as tested, meets the Federal Communications Commission CFR 47, PART 95 requirement. The scope of this test report is limited to the test sample provided by the client, only in as much as that sample represents other production units. If any significant changes are made to the unit, the changes shall be evaluated and a retest may be r…

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Test Set Up Photos – Philips TRx4841A , FCC ID: PQC-TRX4841A Radiated, Front Radiated, Rear Frequency Stability Frequency Stability