PQC-4851Medical telemetry patient worn device

Instructions for Use IntelliVue TRx/TRx + Transceivers for the ITS4840A/ITS4850A IntelliVue Telemetry System Part Number: M4841-9001J Printed in the U.S.A. December 2006 First Edition Notice (ITS4840A) This system complies with part 15 of the FCC Rules. Operation is subject to the condition that this device does not cause harmful interference. Operation of this equipment in the United States requires the prior coordination with a frequency coordinator designated by the Federal Communications Commission (FCC) for the Wireless Medical Telemetry Service (WMTS). Notice (ITS4850A) This system complies with part 15 of the FCC Rules, ETSI, RS-210, and other international radio standards that govern operation in the ISM band. Operation is not subject to WMTS rules. Printing History ii NoticeDocument number: M4841-9001J, First Edition Printed in the USA. © Copyright 2004, 2005, 2006 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 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.) About this Book iii The document part number changes when extensive technical changes are incorporated. First Edition...............................................................................December 2006 IntelliVue TRx4841A Transceivers are compatible with: IntelliVue Telemetry System, Revision A.00 IntelliVue Information Center, Software Revisions F.00, G.00, H.00 and J.00 M2636C TeleMon Companion Monitor, Revision A.00, B.00 and C.00 IntelliVue MP5 Patient Monitor, Revision E.00 IntelliVue TRx4851A Transceivers are compatible with: IntelliVue Telemetry System, Revision B.00 IntelliVue Information Center, Software Revision J.00 M2636C TeleMon Companion Monitor, Revision C.00 IntelliVue MP5 Patient Monitor, Revision E.00 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 About this Book iv •IntelliVue MP5 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 (USA Only) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6 IntelliVue Clinical Network . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8 Transceiver Use with Other Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9 2. Product Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . …

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RF Exposure Statement Philips Medical Systems hereby declares that the Wireless Medical Telemetry Device, TRx4851A (FCC ID: PQC-4851) is compliant to 47 CFR Part 15B and 15C, §1.1310 and §2.1093 of the FCC rules. As per the FCC/TCB training of October 15, 2004, this statement of compliance is sufficient for devices with sourced based time average power of less than 1 mW. This applies to both TCB and FCC filings. The output power for this device based on sourced based time average power is less than 1 mW. The duty cycle is 1.6 %. Zety Billard, Regulatory Engineer Submitted 21-November-2006 Philips Medical Systems

Compliance Worldwide, Inc. - 357 Main Street - Sandown, NH 03873 (603) 887 3903 Fax 887 6445 http://www.complianceworldwide.com COMPLIANCE WORLDWIDE INC. TEST REPORT 257-06R1 In Accordance with the Requirements of FCC PART 15, SUBPART C INDUSTRY CANADA RSS 210, ISSUE 6 Low Power License-Exempt Radio Communication Devices Intentional Radiators Issued to Philips Medical Systems 3000 Minuteman Drive Andover, MA 01810 978-659-2800 for TRx4851A = M4851A Telemetry II Patient Worn Device / ROW Report Issued on October 25, 2006 Tested by This test report shall not be reproduced, except in full, without written permission from Compliance Worldwide, Inc. Test Number: 257-06R1 Issue Date: 10/25/2006 Page 2 of 18 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 2.3 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 Support Equipment ........................................................................................................................... 4 3.3 Additional Support Equipment (Directly connected to the DUT) ..................................................... 4 3.4 Cables............................................................................................................................................... 4 3.5 Block Diagram .................................................................................................................................. 5 4 Measurements Parameters ................................................................................................................. 6 4.1 Measurement Equipment Used to Perform Test .............................................................................. 6 4.2 Measurement & Equipment Setup ................................................................................................... 6 4.3 Test Procedure ................................................................................................................................. 6 5 Measurement Summary ...................................................................................................................... 7 6 Measurement Data .............................................................................................................................. 8 6.1 Radiated Field Strength of Fundamental.......................................................................................... 8 6.2 Radiated Field Strength of Harmonics ............................................................................................. 8 6.3 Spurious Radiated Emissions......................................................................................................... 10 6.4 Spurious Radiated Emissions >1 GHz ........................................................................................... 12 6.5 Band Edge Measurements ............................................................................................................. 13 6.6 99% Occupied Bandwidth ...................................................................................................... 15 7 Test Site Description ......................................................................................................................... 16 8 Test Setup Photos ............................................................................................................................. 17 Test Number: 257-06R1 Issue Date: 10/25/2006 Page 3 of 18 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 Trx4851A = M4851A Telemetry II Patient Worn Device (PWD)/ROW with Integral Antenna, as tested, meets the FCC Part 15, Subpart C and Industry Canada RSS 210, Issue 6 requirements. 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 required. This report replaces test report #257-06. 2 Product Details 2.1 Manufacturer: Philips Medical Systems 2.2 Model Number: TRx4851A = M4851A Telemetry II Patient Worn Device/ ROW PP2 2.3 Serial Number: US42300566 2.4 Description: The TRx4851A = M4851A PWD is leveraged from the existing M4841A CTS PWD with a 2.4 GHz radio module and can operate in a Frequency hopping mode or a non-Frequency hopping mode. All other components are the same as the M4841A. The M4851A PWD will communicate with the Network Infrastructure via an M4852A 2.4 GHz ROW Access Point. Patient data is displayed on the IntelliVu…

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Compliance Worldwide, Inc. - 357 Main Street - Sandown, NH 03873 (603) 887 3903 Fax 887 6445 http://www.complianceworldwide.com COMPLIANCE WORLDWIDE INC. TEST REPORT 257-06R1 In Accordance with the Requirements of FCC PART 15, SUBPART C INDUSTRY CANADA RSS 210, ISSUE 6 Low Power License-Exempt Radio Communication Devices Intentional Radiators Issued to Philips Medical Systems 3000 Minuteman Drive Andover, MA 01810 978-659-2800 for TRx4851A = M4851A Telemetry II Patient Worn Device / ROW Report Issued on October 25, 2006 Tested by This test report shall not be reproduced, except in full, without written permission from Compliance Worldwide, Inc. Test Number: 257-06R1 Issue Date: 10/25/2006 Page 2 of 18 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 2.3 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 Support Equipment ........................................................................................................................... 4 3.3 Additional Support Equipment (Directly connected to the DUT) ..................................................... 4 3.4 Cables............................................................................................................................................... 4 3.5 Block Diagram .................................................................................................................................. 5 4 Measurements Parameters ................................................................................................................. 6 4.1 Measurement Equipment Used to Perform Test .............................................................................. 6 4.2 Measurement & Equipment Setup ................................................................................................... 6 4.3 Test Procedure ................................................................................................................................. 6 5 Measurement Summary ...................................................................................................................... 7 6 Measurement Data .............................................................................................................................. 8 6.1 Radiated Field Strength of Fundamental.......................................................................................... 8 6.2 Radiated Field Strength of Harmonics ............................................................................................. 8 6.3 Spurious Radiated Emissions......................................................................................................... 10 6.4 Spurious Radiated Emissions >1 GHz ........................................................................................... 12 6.5 Band Edge Measurements ............................................................................................................. 13 6.6 99% Occupied Bandwidth ...................................................................................................... 15 7 Test Site Description ......................................................................................................................... 16 8 Test Setup Photos ............................................................................................................................. 17 Test Number: 257-06R1 Issue Date: 10/25/2006 Page 3 of 18 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 Trx4851A = M4851A Telemetry II Patient Worn Device (PWD)/ROW with Integral Antenna, as tested, meets the FCC Part 15, Subpart C and Industry Canada RSS 210, Issue 6 requirements. 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 required. This report replaces test report #257-06. 2 Product Details 2.1 Manufacturer: Philips Medical Systems 2.2 Model Number: TRx4851A = M4851A Telemetry II Patient Worn Device/ ROW PP2 2.3 Serial Number: US42300566 2.4 Description: The TRx4851A = M4851A PWD is leveraged from the existing M4841A CTS PWD with a 2.4 GHz radio module and can operate in a Frequency hopping mode or a non-Frequency hopping mode. All other components are the same as the M4841A. The M4851A PWD will communicate with the Network Infrastructure via an M4852A 2.4 GHz ROW Access Point. Patient data is displayed on the IntelliVu…

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