PQC-MX40SH24INTELLIVUE MX40 2.4 GHz PATIENT WORN DEVICE

IntelliVue MX40 Instructions for Use Draft Copy ii Notice Proprietary Information This document contains proprietary information, which is protected by copyright. Copyright Copyright © 2011 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 products at any time without notice or obligation and will not be liable for any consequences resulting from the use of this publication. OxiCliq ® and OxiMax ® are registered trademarks of Nellcor Incorporated. Duracell ® is a registered trademark of Procter & Gamble Incorporated. STERRAD ® is a registered trademark of Advanced Sterilization Products. GORE-TEX ® is a registered trademark of W.L. Gore & Assoc.Incorporated Tone modulation is licensed under US patent 4,653,498 from Nellcor Puritan Bennett Incorporated. Manufacturer Philips Medical Systems 3000 Minuteman Road Andover, MA 01810-1099 (978) 687-1501 Printed in USA Document number 453 564 242 441 Warranty The information contained in this document is subject to change without notice. Philips Medical Systems makes no warranty of any kind with regard to this material, including, but not limited to, the implied warranties or merchantability and fitness for a particular purpose. Philips Medical Systems shall not be liable for errors contained herein or for incidental or consequential damages in connection with the furnishing, performance, or use of this material. Draft Copy iii FCC This device complies with Part 15 and/or Part 95 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. Changes and modifications not expressly approved by Philips Medical Systems can void your authority to operate this equipment under Federal Communications Commissions rules Printing History New editions of this document will incorporate all material updated since the previous edition. Update packages may 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 June 2011 Document Conventions In this guide: Warnings Warning A Warning alerts you to a potential serious outcome, adverse event or safety hazard. Failure to observe a warning may result in death or serious injury to the user or patient. Draft Copy iv Cautions Caution A Caution alerts you to where special care is necessary for the safe and effective use of the product. Failure to observe a caution may result in minor or moderate personal injury or damage to the product or other property, and possibly in a remote risk of more serious injury. Notes A Note contains additional information on the product's usage. Draft Copy Contents - 1 Contents 1. Introducing the IntelliVue MX40 1-1 MX40 Features -------------------------------------------------------------------------- 1-2 MX40 Models ---------------------------------------------------------------------------- 1-3 MX40 Compatibility -------------------------------------------------------------------- 1-4 2. Product Safety 2-1 General Safety -------------------------------------------------------------------------- 2-2 Safety Symbols & Other Marks ----------------------------------------------------- 2-4 3. Basic Operation 3-1 Controls, Indicators and Connectors ---------------------------------------------- 3-2 MX40 Controls and Indicators -------------------------------------------------- 3-2 Operating and Navigating ------------------------------------------------------------ 3-7 Power-On Self Test --------------------------------------------------------------- 3-7 Navigating --------------------------------------------------------------------------- 3-7 Selecting Display Elements ----------------------------------------------------- 3-8 Locking the Display---------------------------------------------------------------- 3-8 Measurement Area ---------------------------------------------------------------- 3-8 Measurement Area Display Configurations --------------------------------- 3-8 Connecting/Disconnecting the Patient Cable ------------------------------ 3-9 Understanding Settings -------------------------------------------------------------- 3- 10 Changing Measurement Settings --------------------------------------------- 3- 10 ECG Settings at the MX40 ----------------------------------------------------- 3- 10 Waveform Settings at the MX40 ---------------------------------------------- 3- 11 Battery Information -------------------------------------------------------------------- 3- 12 Battery Safety Information ------------------------------------------------------ 3- 12 Lithium-ion Rechargeable Battery Care ------------------------------------ 3- 13 Inserting/Removing Batteries -------------------------------------------------- 3- 14 Inserting Batteries ---------------------------------------------------------------- 3- 15 Removing the Batteries --------------------------------------------------------- 3- 16 Battery Charge Status ----------------------------------------------------------- 3- 17 Pouch Use------------------------------------------------------------------------------- 3- 19 Securing the Pouch -------------------------------------------------------------- 3- 19 Showering -----------…

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Letter Of Agency Date: 19-July-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: 19- July-2011 Federal Communications Commission Authorization and Evaluation Division Confidentiality Request regarding application for certification of FCC ID: PQC-MX40SH24 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-MX40SH24 BlkDia.pdf PQC-MX40SH24 Schem.pdf PQC-MX40SH24 OpDes.pdf PQC-MX40SH24 TunPro.pdf PQC-MX40SH24 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 Internal Photos PQC-MX40SH24 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, MX40, FCC ID: PQC-MX40SH24 Front Back

Internal Photos, MX40, FCC ID: PQC-MX40SH24 2.4 GHz radio module 2.4 GHz radio module without can Component side: SpO2 board Solder Side: SpO2 board Main board Main board with 2.4 SH and WLAN 2.4 SH and WLAN Module

Compliance Worldwide, Inc. - 357 Main Street - Sandown, NH 03873 COMPLIANCE WORLDWIDE INC. TEST REPORT 278-11AR2 In Accordance with the Requirements of MPE Calculation for FCC PART 15.247, SUBPART C INDUSTRY CANADA RSS 210, ISSUE 8 Issued to Philips Medical Systems 3000 Minuteman Drive Andover, MA 01810 978-659-2800 for the Philips Telemetry System MX40 Patient Worn Monitor 2.4 GHz CTS Radio FCC ID: PQC-MX40SH24 IC: 3549B-MX40SH24 Report Issued on August 5, 2011 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: 278-11AR2 Issue Date: 08/5/2011 Page 2 of 9 Compliance Worldwide, Inc. - 357 Main Street - Sandown, NH 03873 (603) 887 3903 Fax 887 6445 http://www.cw-inc.com RF Exposure Requirements: 1.1307(b)(1) and 1.1.307(b)(2): Systems operating under the provision of this section shall be operated in a manner that ensures that the public is not exposed to radio frequency energy levels in excess of the Commission’s guidelines. RF Radiation Exposure Limit: 1.1310: As specified in this section, the Maximum Permissible Exposure (MPE) limit shall be used to evaluate the environmental impact of human exposure to radio frequency (RF) radiation as specified in Section 1.1307(b), except in the case of portable devices which shall be evaluated according to the provisions of Sec 2.1093 of this chapter. Test Results: Compliant. A summation of the power densities of each of the individual radios shows that the combination of all three radios are in compliance with the limit. Channel MPE Distance (cm) DUT Output Power (dBm) DUT Antenna Gain (dBi) Power Density (mW/cm2) Power Density (W/m2) Limit (mW/cm2) Result (1) (2) (3) (4) (4) (5) 2.4 GHz 2.5 15.40 -3.0 0.2212637 2.2126367 1.00 Compliant SRR 2.5 0.60 0.3 0.0156591 0.1565914 1.00 Compliant WLAN 2.5 13.64 1.0 0.3707075 3.7070750 1.00 Compliant SUM 2.5 N/A N/A 0.6076303 6.0763032 1.00 Compliant Test Number: 278-11AR2 Issue Date: 08/5/2011 Page 3 of 9 7. Measurement Data for 2.4 GHz CTS Radio from Test Report #278-11R1 7.10. 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 2.5 15.40 -3.0 0.22126 2.21264 1 Compliant 2442.320 2.5 15.00 -3.0 0.20179 2.01795 1 Compliant 2482.252 2.5 13.70 -3.0 0.14959 1.49593 1 Compliant OP + AG (4 x π x d²) PD = • 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 2.5 centimeters of the body of the user. 2. Section 7.4 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. Compliance Worldwide, Inc. - 357 Main Street - Sandown, NH 03873 (603) 887 3903 Fax 887 6445 http://www.cw-inc.com Test Number: 278-11AR2 Issue Date: 08/5/2011 Page 4 of 9 Compliance Worldwide, Inc. - 357 Main Street - Sandown, NH 03873 (603) 887 3903 Fax 887 6445 http://www.cw-inc.com 7. Measurement Data (continued) 7.10. Public Exposure to Radio Frequency Energy Levels (15.247(i) (1.1307 (b)(1)) RSS- GEN 5.5, RSS 102 The calculated output power can be referenced in column 6 of the table below. The calculated peak output power is greater than the 24.17 mW requirement for performing SAR testing using the formula: 60 / F (GHz). Frequency Peak Field Strength Distance Antenna Gain 1 Measured Output Power Time Averaged Power Channel (MHz) (dBμV/m) (m) (dBi) (mW) (mW) Low 2401.1 107.60 3.0 -3.0 34.44 0.0086 Middle 2442.3 107.20 3.0 -3.0 31.41 0.0079 High 2482.3 105.90 3.0 -3.0 23.29 0.0058 However the time averaged power is significantly lower then the 24.17 mW requirement for 47CFR 1.1307 and 20 mW requirement for RSS-102 Power Density Channel Frequency (MHz) Output Power (mW) Time Averaging Duty Cycle Correction (mW/cm2) (W/m2) Limit (mW/cm2) Result 2401.060 34.44 0.01575 0.01051 0.10509 1 Compliant 2442.320 31.41 0.01575 0.00958 0.09584 1 Compliant 2482.252 23.29 0.01575 0.00710 0.07105 1 Compliant 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. Test Number: 278-11AR2 Issue Date: 08/5/2011 7. Measurement Data (continued) 7.10. Public Exposure to Radio Frequency Energy Levels (15.247(i) (1.1307 (b)(1)) RSS- GEN 5.5, RSS 102 (continued) Time Average Reduction = 20 log (1.575 mS / 100 mS) = -36.05 dB 7.10…

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Compliance Worldwide, Inc. - 357 Main Street - Sandown, NH 03873 COMPLIANCE WORLDWIDE INC. TEST REPORT 278-11R1 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 MX40 Patient Worn Monitor 2.4 GHz CTS Radio FCC ID: PQC-MX40SH24 IC: 3549B-MX40SH24 Original Report Issued on August 2, 2011 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: 278-11R1 Issue Date: 08/02/2011 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 ......................................................................................................... 4 3.1 Operational Characteristics & Software ................................................................................... 4 3.2 EUT Hardware.......................................................................................................................... 4 3.3 EUT Hardware/Software/Firmware Revision Level.................................................................. 4 3.4 EUT Cables/Transducers ......................................................................................................... 4 3.5 Support Equipment................................................................................................................... 4 3.6 Support Equipment Cables/Transducers ................................................................................. 5 3.7 Miscellaneous........................................................................................................................... 5 3.8 Block Diagram .......................................................................................................................... 5 4. Measurements Parameters.................................................................................................6 4.1 Measurement Equipment Used to Perform Test...................................................................... 6 4.2 Measurement & Equipment Setup ........................................................................................... 6 4.3 Measurement Procedure .......................................................................................................... 6 4.4 Measurement Uncertainty ........................................................................................................ 7 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......................................................................................................8 7. Measurement Data.............................................................................................................. 9 7.1 Antenna Requirement .............................................................................................................. 9 7.2 Minimum 6 dB Bandwidth......................................................................................................... 9 7.3 99% Bandwidth....................................................................................................................... 11 7.4 Maximum Peak Conducted Output Power ............................................................................. 14 7.5 Operation with directional antenna gains greater than 6 dBi ................................................. 17 7.6 Transmitter Spurious Radiated Emissions ............................................................................. 19 7.7 Receiver Spurious Radiated Emissions ................................................................................. 20 7.8 Band Edge Measurements.....................................................................................................23 7.9 Power Spectral Density .......................................................................................................... 27 7.10 Public Exposure to Radio Frequency Energy Levels ........................................................... 29 8. Test Setup Photographs.............................................................................................................. 31 9. Test Site Descriptio…

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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 264-11R1 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 MX40 Patient Worn Monitor 2.4 GHz Short Range Radio (SRR) FCC ID: PQC-MX40SH24 IC: 3549B-MX40SH24 Tested by This test report shall not be reproduced, except in full, without written permission from Compliance Worldwide, Inc. Test Number: 264-11R1 Issue Date: 08/01/2011 Page 2 of 30 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 . EUT Hardware/Software/Firmware Revision Level................................................................ 4 3.4 EUT Cables/Transducers ......................................................................................................... 4 3.5 Support Equipment................................................................................................................... 4 3.6 Support Equipment Cables/Transducers ................................................................................. 4 3.7 Miscellaneous........................................................................................................................... 4 3.7 Block Diagram .......................................................................................................................... 5 4. Measurements Parameters.................................................................................................6 4.1 Measurement Equipment Used to Perform Test...................................................................... 6 4.2 Measurement & Equipment Setup ........................................................................................... 6 4.3 Measurement Procedure .......................................................................................................... 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......................................................................................................8 7. Measurement Data.............................................................................................................. 8 7.1 Antenna Requirement .............................................................................................................. 8 7.2 Minimum 6 dB Bandwidth......................................................................................................... 8 7.3 99% Bandwidth....................................................................................................................... 11 7.4 Maximum Peak Conducted Output Power ............................................................................. 13 7.5 Operation with directional antenna gains greater than 6 dBi ................................................. 16 7.6 Transmitter Spurious Radiated Emissions ............................................................................. 16 7.7 Receiver Spurious Radiated Emissions ................................................................................. 19 7.8 Band Edge Measurements.....................................................................................................22 7.9 Power Spectral Density .......................................................................................................... 25 7.10 Public Exposure to Radio Frequency Energy Levels ........................................................... 27 8. Test Setup Photographs.............................................................................................................. 28 9. Test Site Description..................................................................................................................... 30 Test Number: 264-11R1 Issue Date: 08/01/…

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Compliance Worldwide, Inc. - 357 Main Street - Sandown, NH 03873 COMPLIANCE WORLDWIDE INC. TEST REPORT 304-11R2 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 MX40 Patient Worn Monitor 2.4 GHz 802.11b/g WLAN FCC ID: PQC-MX40SH24 IC: 3549B-MX40SH24 Report Issued on August 5, 2011 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: 304-11R2 Issue Date: 08/05/2011 Page 2 of 42 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 . EUT Hardware/Software/Firmware Revision Level................................................................ 4 3.4 EUT Cables/Transducers ......................................................................................................... 4 3.5 Support Equipment................................................................................................................... 4 3.6 Support Equipment Cables/Transducers ................................................................................. 4 3.7 Miscellaneous........................................................................................................................... 5 3.8 Block Diagram .......................................................................................................................... 5 4. Measurements Parameters.........................................................................…

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