PQC-MX40SH14INTELLIVUE MX40 1.4 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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PHILIPS Letter Of Agency Date: 1 O-June-201 1 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 aft ention to this matter. Signatory 7jza~ Terrence Sweeney Vice President Global Clinical Affairs

PHILIPS Date: 1 0-June-201 1 Federal Communications Commission Authorization and Evaluation Division Confidentiality Request regarding application for certification of FCC ID: PQC-MX4OSH1 4 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 PQC-MX4OSH14 BlkDia.pdf Schematics PQC-MX4OSH14 Schem.pdf Operational Description PQC-MX4OSH1 4 OpDes.pdf Tuning Procedure PQC-MX4OSH1 4 TunPro.pdf Parts List PQC-MX4OSH1 4 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 Internal Photos PQC-MX4OSH1 4 lntPho.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-MX40SH14 Front Back

Internal Photos, MX40, FCC ID: PQC-MX40SH14 Component side without can: 1.4 GHz radio module Component Side: Component side with Can 1.4 GHz radio module Component side with out can: With Can 1.4 GHz radio module with antenna connected Component side with antenna connected Solder Side with can removed: 1.4 GHz radio module with antenna connected Component side: SpO2 board Solder Side: SpO2 board Main board Main board with SRR and WLAN SRR and WLAN Module

Compliance Worldwide, Inc. - 357 Main Street - Sandown, NH 03873 COMPLIANCE WORLDWIDE INC. TEST REPORT 253-11A In Accordance with the Requirements of MPE Calculation for FCC CFR 47 Part 95, Subpart H FCC Part 15.247, Subpart C Issued to Philips Medical Systems 3000 Minuteman Drive Andover, MA 01810 978-659-2800 for the Philips Telemetry System MX40 Patient Worn Monitor 1.4 GHz CTS Radio FCC ID: PQC-MX40SH14 Report Issued on June 20, 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: 253-11A Issue Date: 06/20/2011 Page 2 of 8 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) Limit (mW/cm2) Result (1) (2) (3) (4) (5) 1.4 GHz 2.5 11.97 -3.0 0.1004688 0.93 Compliant SRR 2.5 0.60 0.3 0.0156591 1.00 Compliant WLAN 2.5 13.64 1.0 0.3707075 1.00 Compliant SUM 2.5 N/A N/A 0.4868355 1.00 Compliant Test Number: 253-11A Issue Date: 06/20/2011 Page 3 of 8 Compliance Worldwide, Inc. - 357 Main Street - Sandown, NH 03873 (603) 887 3903 Fax 887 6445 http://www.cw-inc.com 7. Measurement Data for 1.4 GHz CTS Radio from Test Report #253-11 7.7. RF Safety (Public Exposure to Radio Frequency Energy Levels (95.1125, 1.1307 (b)(1))) Requirement: Portable devices as defined in § 2.1093(b) of this chapter operating in the WMTS are subject to radio frequency radiation exposure requirements as specified in §§ 1.1307(b) and 2.1093 of this chapter. Test Notes: Due to the product configuration, it was not possible to directly connect the device under test to the measurement equipment. The output power of the device was derived from the peak field strength measurements using the following formula: (E x d) 2 P = (30 x G) P = the power in Watts. E = the measured maximum field in V/m G = the numeric gain of the transmitting antenna over an isotropic radiator. d = the distance in meters of the field strength measurement. The calculated output power can be referenced in column 6 of the table below. The calculated peak output power is lower than the 41.93 mW requirement for performing SAR testing using the formula: 60 / F (GHz). Frequency Peak Field Strength Meas. Distance Antenna Gain 1 Output Power Channel (MHz) (dBμV/m) (m) (dBi) (mW) 1 1395.9 104.20 3.0 -3.0 15.7 3 1399.1 104.00 3.0 -3.0 15.0 4 1427.9 102.10 3.0 -3.0 9.7 6 1431.1 101.90 3.0 -3.0 9.3 1 Data provided by the customer Test Number: 253-11A Issue Date: 06/20/2011 Page 4 of 8 7. Measurement Data (continued) 7.7. RF Safety (Public Exposure to Radio Frequency Energy Levels (95.1125, 1.1307 (b)(1)) (continued) The following results are based on the power values derived in the table on the previous page: MPE Distance (cm) DUT Output Power (dBm) DUT Antenna Gain (dBi) Power Density (mW/cm2) Limit (mW/cm2) Channel (1) (2) (3) (4) (5) Result 1 2.5 11.97 -3.0 0.1004688 0.93 Compliant 3 2.5 11.77 -3.0 0.0959470 0.93 Compliant 4 2.5 9.87 -3.0 0.0619486 0.95 Compliant 6 2.5 9.67 -3.0 0.0591604 0.95 Compliant OP + AG (4 x π x d²) PD = PD = Power Density (mW/cm2) 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. Calculated from the peak field strength measurements in section 7.1 of this test report. 3. Data provided by the customer. Antenna manufacturer’s data sheets. 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: 253-11A Issue Date: 06/20/2011 Page 5 of 8 7. Measurement Data for SRR Radio from Test Report #264-11 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 2405 2.5 -5.83 0.3 0.00356 0.03565 1 Compliant 2440 2.5 -4.50 0.3 0.00484 0.04842 1 Compliant 2480 2.5 -2.23 0.3 0.00817 0.08166 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.…

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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-MX40SH14 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: 08/01/2011 Page 3 of 30 C…

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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 304-11R1 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 802.11b/g WLAN FCC ID: PQC-MX40SH14 Report Issued on August 1, 2011 Tested by This test report shall not be reproduced, except in full, without written permission from Compliance Worldwide, Inc. Test Number: 304-11R1 Issue Date: 08/01/2011 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.................................................................................................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......................................................................................................... 9 7.3 99% Bandwidth....................................................................................................................... 13 7.4 Maximum Peak Conducted Output Power ............................................................................. 17 7.5 Operation with directional antenna gains greater than 6 dBi ................................................. 22 7.6 Transmitter Spurious Radiated Emissions ............................................................................. 22 7.7 Receiver Spurious Radiated Emissions ................................................................................. 25 7.8 Band Edge Measurements.....................................................................................................28 7.9 Power Spectral Density .......................................................................................................... 33 7.10 Public Exposure to Radio Frequency Energy Levels ........................................................... 37 8. Test Setup Photographs.............................................................................................................. 40 9. Test Site Description..................................................................................................................... 41 Test Number: 304-11R1 Issue Date: 08…

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Philips 1.4 GHz MX40, Test Set up Photos FCC ID: PQC-MX40SH14 Front Rear Test Number: 264-11 Issue Date: 06/24/2011 8. Test Setup Photographs 8.1. Radiated Emissions Front: Page 27 of 29 Compliance Worldwide, Inc. - 357 Main Street - Sandown, NH 03873 (603) 887 3903 Fax 887 6445 http://www.cw-inc.com Test Number: 264-11 Issue Date: 06/24/2011 8. Test Setup Photographs 8.2. Radiated Emissions Rear: Page 28 of 29 Compliance Worldwide, Inc. - 357 Main Street - Sandown, NH 03873 (603) 887 3903 Fax 887 6445 http://www.cw-inc.com Test Number: 304-11 Issue Date: 07/20/2011 8. Test Setup Photographs 8.1. Radiated Emissions Front: Page 39 of 41 Compliance Worldwide, Inc. - 357 Main Street - Sandown, NH 03873 (603) 887 3903 Fax 887 6445 http://www.cw-inc.com Test Number: 304-11 Issue Date: 07/20/2011 8. Test Setup Photographs 8.2. Radiated Emissions Rear: Page 40 of 41 Compliance Worldwide, Inc. - 357 Main Street - Sandown, NH 03873 (603) 887 3903 Fax 887 6445 http://www.cw-inc.com