PQC-4852AINTELLIVUE 2.4GHz ACCESS POINT

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 Healthcare 281 Hillmo unt Ro ad Mar kham , O n t ar i o C anada L6C 2S3 A Division of Philips Electronics Ltd. Te l epho ne: (905) 201-4100 / To ll Free: 1- 877-744-5633 Facsimile: (905) 201-4323 / To ll Free: 1- 800-418-4285 www.healthcare.philips.com CANADIAN REPRESENTATIVE LETTER OF ATTESTATION Canadian Representative Contact Name: Althea Lawrence Company Name: Philips Electronics Ltd . Address: 281 Hillmount Road Markham, Ontario Canada L6C 2S3 Telephone No.: 905-201-4494 Fax No.: 905-201-4323 Email: [email protected] To: Industry Canada 3701 Carling Avenue, Bldg. 94, Ottawa, ON K2H 8S2 ATTENTION: Certification and Engineering Bureau This letter is to confirm that we have accepted the responsibility to act as Canadian Representative on behalf of the Applicant noted below. As Canadian Representative, we are aware of the requirements involved as outlined in Industry Canada applicable document, RSP- 100, Section 3.4. Applicant Company Name: Philips Medical Systems Company No.: 3549B Address: 3000 Minuteman Road Andover, MA 01810 Telephone No.: 978-659-4348 Fax No.: 978-685-5624 Email: [email protected] Certification Number: 3549B-4852 Model Number: ITS4852A Signature: Date: April 6, 2011 Signed by: Althea Lawrence Director, Regulatory Affairs

Date:21-April-2011 Federal Communications Commission Authorization and Evaluation Division Confidentiality Request regarding application for certification of FCC ID: PQC-4852A 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 Schematics Operational Description Tuning Procedure Parts List PQC-4852A BlkDia.pdf PQC-4852A Schem.pdf PQC-4852A OpDes.pdf PQC-4852A TunPro.pdf PQC-4852A 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 DA04-1705 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 Internal Photos PQC-4852A ExtPho.pdf PQC-4852A IntPho.pdf 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, Terrence Sweeney Vice President Global Clinical Affairs

Letter Of Agency Date: 21-April-2011 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 CFR 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. Signatory Terrence Sweeney Vice President Global Clinical Affairs

Date:21-April-2011 Federal Communications Commission Authorization and Evaluation Division Confidentiality Request regarding application for certification of FCC ID: PQC-4852A 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 Schematics Operational Description Tuning Procedure Parts List PQC-4852A BlkDia.pdf PQC-4852A Schem.pdf PQC-4852A OpDes.pdf PQC-4852A TunPro.pdf PQC-4852A 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 DA04-1705 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 Internal Photos PQC-4852A ExtPho.pdf PQC-4852A IntPho.pdf 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, Terrence Sweeney Vice President Global Clinical Affairs

External Photos – Philips ITS 4852A Front Rear

Philips Medical – FCC ID: PQC-ITS4852A Label Location and Label

Internal Photos – Philips ITS4852A EUT with cover off Main Board Front Main Board Rear Transmitter Board – Front Transmitter Board – Front covers Off Transmitter Board – Rear

Test Number: 438-10R2 Issue Date: 04/29/2011 Page 29 of 34 Compliance Worldwide, Inc. - 357 Main Street - Sandown, NH 03873 (603) 887 3903 Fax 887 6445 http://www.cw-inc.com 6. Measurement Data (continued) 6.11. Public Exposure to Radio Frequency Energy Levels (15.247(i) (1.1307 (b)(1)) RSS-GEN 5.5, RSS 102 Power Density MPE Distance (cm) DUT Output Power (dBm) DUT Antenna Gain (dBi) (mW/cm2) (W/m2) Limit (mW/cm2) Channel Frequency (1) (2) (3) (4) (5) Result 2401.060 20.0 0.04498 3.2 0.0004200 0.0041998 1 Compliant 2442.320 20.0 0.04677 3.2 0.0004202 0.0042015 1 Compliant 2482.252 20.0 0.04721 3.2 0.0004202 0.0042019 1 Compliant • PD = Power Density (mW/cm 2 ) • OP = DUT Output Power (dBm) • AG = DUT Antenna Gain (dBi) • d = MPE Distance (cm) 1. Reference CFR 2.1093(b): For purposes of this section, a portable device is defined as a transmitting device designed to be used so that the radiating structure(s) of the device is/are within 20 centimeters of the body of the user. 2. Section 6.2 of this test report. 3. Data supplied by the client. Antenna specification data of worst case antenna used by the DUT. 4. Power density is calculated from field strength measurement and antenna gain. 5. Reference CFR 1.1310, Table 1: Limits for Maximum Permissible Exposure (MPE), Section (B): Limits for General Population/Uncontrolled Exposure. RSS-102 Section 2.5, 2.5.1 & 2.5.2 Requirements: 2.5 - All transmitters are exempt from routine SAR and RF exposure evaluations provided that output power complies with the power levels of sections 2.5.1 or 2.5.2. If the equipment under test (EUT) meets the requirements of sections 2.5.1 or 2.5.2, applicants are only required to submit a properly signed declaration of compliance (see Annex C). 2.5.1 - SAR evaluation is required if the separation distance between the user and the radiating element of the device is less than or equal to 20 cm, except when the device operates as follows: • above 2.2 GHz and up to 3 GHz inclusively, and with output power (i.e. the higher of the conducted or radiated (e.i.r.p.) source-based, time-averaged output power) that is less than or equal to 20 mW for general public use and 100 mW for controlled use 2.5.2 - RF exposure evaluation is required if the separation distance between the user and the device’s radiating element is greater than 20 cm, except when the device operates as follows: • at or above 1.5 GHz and the maximum e.i.r.p. of the device is equal to or less than 5 W. OP + AG (4 x π x d²) PD =

Compliance Worldwide, Inc. - 357 Main Street - Sandown, NH 03873 (603) 887 3903 Fax 887 6445 http://www.complianceworldwide.com COMPLIANCE WORLDWIDE INC. TEST REPORT 438-10R3 In Accordance with the Requirements of FCC PART 15.247, SUBPART C INDUSTRY CANADA RSS 210, ISSUE 8 Low Power License-Exempt Radio Communication Devices Intentional Radiators Issued to Philips Medical Systems 3000 Minuteman Drive Andover, MA 01810 978-659-2800 for the Philips Telemetry System ITS4852A 2.4 GHz Access Point (RadioHead) FCC ID: PQC-4852A IC: 3549B-4852A Original Report Issued on February 18, 2011 R2 report issued on April 29, 2011 R3 report issued on May 25, 2011 Tested by This test report shall not be reproduced, except in full, without written permission from Compliance Worldwide, Inc. Test Number: 438-10R3 Issue Date: 05/25/2011 Page 2 of 34 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 EUT Hardware.......................................................................................................................... 4 3.3 Support Equipment................................................................................................................... 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 Antenna Requirement .............................................................................................................. 8 6.2 Minimum 6 dB Bandwidth......................................................................................................... 8 6.3 99% Bandwidth....................................................................................................................... 10 6.4 Maximum Peak Conducted Output Power ............................................................................. 13 6.5 Operation with directional antenna gains greater than 6 dBi ................................................. 15 6.6 Transmitter Spurious Radiated Emissions ............................................................................. 15 6.7 Receiver Spurious Radiated Emissions ................................................................................. 19 6.8 Band Edge Measurements.....................................................................................................21 6.9 Power Spectral Density .......................................................................................................... 24 6.10 Power Line Conducted Emissions........................................................................................ 26 6.11 Public Exposure to Radio Frequency Energy Levels ........................................................... 29 7 Test Setup Photographs.................................................................................................................... 30 8 Test Site Description ......................................................................................................................... 34 Test Number: 438-10R3 Issue Date: 05/25/2011 Page 3 of 34 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 Medical Telemetry System ITS4852A 2.4 GHz Access Point, as tested, meets the FCC Part 15, Subpart C and Industry Canada RSS 210, Issue 8 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. R1 report issued to correct serial number and test dates. Revision - R2 added IC RS-…

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Test Number: 438-10R1 Issue Date: 03/10/2011 Page 30 of 34 Compliance Worldwide, Inc. - 357 Main Street - Sandown, NH 03873 (603) 887 3903 Fax 887 6445 http://www.cw-inc.com 7. Test Setup Photographs 7.1. Radiated Emissions Front: Test Number: 438-10R1 Issue Date: 03/10/2011 Page 31 of 34 Compliance Worldwide, Inc. - 357 Main Street - Sandown, NH 03873 (603) 887 3903 Fax 887 6445 http://www.cw-inc.com 7. Test Setup Photographs 7.2. Radiated Emissions Rear: Test Number: 438-10R1 Issue Date: 03/10/2011 Page 32 of 34 Compliance Worldwide, Inc. - 357 Main Street - Sandown, NH 03873 (603) 887 3903 Fax 887 6445 http://www.cw-inc.com 7. Test Setup Photographs 7.3. Conducted Emissions Front: Test Number: 438-10R1 Issue Date: 03/10/2011 Page 33 of 34 Compliance Worldwide, Inc. - 357 Main Street - Sandown, NH 03873 (603) 887 3903 Fax 887 6445 http://www.cw-inc.com 7. Test Setup Photographs 7.4. Conducted Emissions Rear: