PQC-MX40SH1C4Intellivue MX40 1.4 GHz Patient Worn Device

IntelliVue MX40 Instructions for Use Release B.0 Notice Proprietary Information This document contains proprietary information, which is protected by copyright. First Edition 2012 4535 643 15721 Copyright Copyright © 2012 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. This product contains software licensed under an open source license. For acknowledgments, license texts and source code, please refer to the IntelliVue Information Center iX M3290B Software\References\README.pdf. Windows ® is a registered trademark of Microsoft Corporation in the United States and other countries. EASI is a trademark of Zymed Inc. 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 4535 643 15721 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. 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 Commission's rules Protecting Personal Information It is recommended that customers have policies and procedures for the proper handling of personal or sensitive information, ePHI (electronic protected health information) and PHI (protected health information), which will maintain the confidentiality, integrity, and the availability of these types of data. Any organization using this product should implement the required protective means necessary to safeguard personal information consistent with each applicable country law, code and regulation; and consistent with their developed and maintained internal policies and procedures. While handling personal information is outside the scope of this document; in general, each organization is responsible for identifying:  Who has access to personal data and under what conditions an individual has authorization to use that data.  What security controls are in place to protect personal and sensitive data.  How the data is stored and the conditions by which it is stored.  How the data is transmitted and the conditions under which that data is transmitted. Protecting personal health information is a primary component of a security strategy. Personal and sensitive information should be protected according to the applicable laws, regulations and directives, such as HIPAA, PIPEDA and/or Council of the European Union security and privacy rules. Compliance Uses of the system for purposes other than those intended and expressly stated by the manufacturer, as well as incorrect use, incorrect operation, or modifications made to the system without explicit approval from Philips, may relieve the manufacturer (or his agent) from all or some responsibilities for resultant noncompliance, damage or injury. 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 February 2012 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. 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. Contents 1 Contents 1. Introducing the IntelliVue MX40 1-1 MX40 Features -------------------------------------------------------------------------- 1-2 MX40 Models ---------------------------------------------------------------------------- 1-3 MX40 Release B.0 Compatibility --------------------------------------------------- 1-4 2. What's New? 2-1 New Features and Enhancements------------------------------------------------- 2-2 3. Product Safety 3-1 General Safety ---------------…

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Philips Medical Systems IH I LI PS Patient Monitoring 3000 Minuteman Road Andover, MA 01810 Tel: (978) 659-3382 Letter Of Agency Date: 12 February 2014 To Whom It May Concern: Please be advised that Delroy Smith 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 Del roy Smith Principal Scientist

Philips Medical Systems P1.1 I LI PS Patient Monitoring Quality & Regulatory Group 3000 Minuteman Road Mailstop 0480 Andover, MA 01810 Tel: (978) 659-4348 Fax: (978) 659-4481 21 March 2014 Reference: PQC-MX4OSH1C4 Subject: Attestation statement that NIl and DTS transmitters are the same. To Whom It May Concern; The NIl and DTS transmitters of the MX4O, proposed FCC ID are the same as the previously submitted PQC-MX4OSH1B4. The entire device PQC-MX4OSH1C4 is electricity identical to the old device PQC MX4OSH1B4. The only difference between FCC ID: PQC-MX4OSH1B4 and the new device FCC ID: PQC MX4OSH1C4 is an increase in the rf output power. The old test reports for the other radios remains relevant because there have been no changes to these radios. Only maximum of 3 radios exist in the device at any one time. The configurations are as follows: WMTS 1.4GHz Radio, SRR, and WLAN 2.4GHz & 5GHz Radio. 2.4 GHz Radio, SRR 2.4GHz Radio, WLAN 2.4GHz & 5GHz Radio. (has separate FCC ID) SRR 2.4GHz Radio, and WLAN 2.4GHz & 5GHz Radio (has separate FCC ID) Best regards, Claire Arakaki Regulatory Affairs Specialist Connected Care Solutions, Philips Healthcare

Philips Medical Systems PH I LI PS Patient Monitoring 3000 Minuteman Road Andover, MA 01810 Tel: (978) 659-3382 Date: 12 February 2014 Federal Communications Commission Authorization and Evaluation Division Confidentiality Request regarding application for certification of FCC ID: PQC-MX4OSH1C4 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-MX4OSH 1 C4 BIkDia.pdf Schematics PQC-MX4OSH1 C4 Schem.pdf Operational Description PQC-MX4OSH1C4 OpDes.pdf Tuning Procedure PQC-MX4OSH 1 C4 TunPro.pdf Parts List PQC-MX4OSH1C4 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-MX4OSH 1 C4 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, * Delroy Smith Principal Scientist Philips Medical Systems IH I LI PS Patient Monitoring 3000 Minuteman Road Andover, MA 01810 Tel: (978) 659-3382 Letter Of Agency Date: 12 February 2014 To Whom It May Concern: Please be advised that Delroy Smith 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 Del roy Smith Principal Scientist

Philips Medical Systems PH I LI PS Patient Monitoring Quality & Regulatory Group 3000 Minuteman Road Mailstop 0480 Andover, MA 01810 Tel: (978) 659-4348 Fax: (978) 685-5624 Feb 28, 2014 Subject: Use of FCC Notice on the Device MX4O To Whom It May Concern; Due to the size and dimensions of the MX4O, the FCC Notice cannot fit into the allocated space for the label. The area for the entire label as shown in the label placement picture is recessed into the plastic housing. The plastic material surrounding the label will be textured to enable better handling of the device by the end user. Label materials will not be able to adhere to the textured surface. As required the regulation, the following notice is will be placed in the User Manual: This device complies with Part 15 of the FCC Rules: Operation is subject to the following conditions: 1. This device many not cause harmful interference, and 2. This device 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. Best Regards, Claire Arakaki Regulatory Affairs Specialist

External photos – PQC-MX40SH1C4 Front Back Left Side Right side

Internal Photos, MX40, FCC ID: PQC-MX40SH2B4 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

Test Number: 504-11R3 Issue Date: 03/24/2014 Page 64 of 67 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 Requirement: (15.407(f)) U-NII devices are subject to the radio frequency radiation exposure requirements specified in 47CFR 1.1307(b), FCC 47 CFR 2.1091 and 47 CFR 2.1093, as appropriate. All equipment shall be considered to operate in a ‘‘general population/uncontrolled’’ environment. Applications for equipment authorization of devices operating under this section must contain a statement confirming compliance with these requirements for both fundamental emissions and unwanted emissions. Technical information showing the basis for this statement must be submitted to the Commission upon request Procedure: The power density is calculated from the peak field strength and device antenna gain. PD Power Density mW/cm 2 OP DUT Output Power dBm AG DUT Antenna Gain dBi d MPE Distance cm Conclusion: The device under test is meets radio frequency radiation exposure requirements specified in 47CFR 1.1307(b), § 2.1091 and § 2.1093. Power Calculated from Peak Field Strength Frequency Field Strength Distance Antenna Gain 1 Measured Output Power Time Averaged Power Channel (MHz) (dBμV/m) (m) (dBi) (mW) (dBm) (mW) 36 5180 108.53 3.0 1.0 16.99 12.30 0.0002718 40 5200 108.82 3.0 1.0 18.16 12.59 0.0002906 48 5240 109.29 3.0 1.0 20.24 13.06 0.0003238 52 5260 109.42 3.0 1.0 20.85 13.19 0.0003336 64 5320 107.00 3.0 1.0 11.94 10.77 0.0001911 100 5500 112.57 3.0 1.0 43.06 16.34 0.0006890 116 5580 112.86 3.0 1.0 46.04 16.63 0.0007366 140 5700 113.01 3.0 1.0 47.66 16.78 0.0007625 149 5745 114.22 3.0 1.0 62.97 17.99 0.0010075 153 5765 113.96 3.0 1.0 59.31 17.73 0.0009489 161 5805 114.46 3.0 1.0 66.55 18.23 0.0010647 1 Taken from the antenna manufacture's data guide. OP + AG (4 x π x d²) PD = Test Number: 504-11R3 Issue Date: 03/24/2014 Page 65 of 67 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 (continued) Power Density MPE Distance (cm) DUT Output Power (dBm) Time Averaged Power DUT Antenna Gain (dBi) (mW/cm2) (W/m2) Limit (mW/cm2) Channel Frequency (1) (2) dBm (3) (4) (5) Result 5180 2.5 12.30 -35.66 1.0 0.000004 0.00004 1 Compliant 5200 2.5 12.59 -35.37 1.0 0.000005 0.00005 1 Compliant 5240 2.5 13.06 -34.90 1.0 0.000005 0.00005 1 Compliant 5260 2.5 13.19 -34.77 1.0 0.000005 0.00005 1 Compliant 5320 2.5 10.77 -37.19 1.0 0.000003 0.00003 1 Compliant 5500 2.5 16.34 -31.62 1.0 0.000011 0.00011 1 Compliant 5580 2.5 16.63 -31.33 1.0 0.000012 0.00012 1 Compliant 5700 2.5 16.78 -31.18 1.0 0.000012 0.00012 1 Compliant 5745 2.5 17.99 -29.97 1.0 0.000016 0.00016 1 Compliant 5765 2.5 17.73 -30.23 1.0 0.000015 0.00015 1 Compliant 5805 2.5 18.23 -29.73 1.0 0.000017 0.00017 1 Compliant 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. Peak field strength values derived from measurements taken for Section 6.1 of this test report. 3. Data supplied by the client. 4. Power density is calculated from field strength measurement and antenna gain. Reference the procedure outlined above. 5. Reference FCC 47CFR 1.1310, Table 1: Limits for Maximum Permissible Exposure (MPE), Section (B): Limits for General Population/Uncontrolled Exposure. The transmitter covered in this test report can be operated with other transmitters within the device. A separate Public Exposure Exhibit will be generated for its co-location.

Compliance Worldwide, Inc. - 357 Main Street - Sandown, NH 03873 (603) 887 3903 Fax 887 6445 http://www.complianceworldwide.com COMPLIANCE WORLDWIDE INC. TEST REPORT 504-11R3 In Accordance with the Requirements of FCC PART 15.407, Subpart E INDUSTRY CANADA RSS 210, ISSUE 8, ANNEX 9 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 WLAN Radio FCC ID: PQC-MX40SH1C4 Report Issued on March 24, 2014 Original Report Issued on April 23, 2012 Tested by This test report shall not be reproduced, except in full, without written permission from Compliance Worldwide, Inc. Test Number: 504-11R3 Issue Date: 03/24/2014 Page 2 of 67 Compliance Worldwide, Inc. - 357 Main Street - Sandown, NH 03873 (603) 887 3903 Fax 887 6445 http://www.cw-inc.com Table of Contents 1 Scope................................................................................................................................................... 3 2 Product Details .................................................................................................................................... 3 2.1. Manufacturer ............................................................................................................................. 3 2.2. Model Number........................................................................................................................... 3 2.3. Serial Number ........................................................................................................................... 3 2.4. Description ................................................................................................................................ 3 2.5. Power Source............................................................................................................................ 3 2.6. EMC Modifications .................................................................................................................... 3 3. Product Configuration ......................................................................................................................... 3 3.1. Operational Characteristics & Software ....................................................................................3 3.2. EUT Hardware .......................................................................................................................... 4 3.3. EUT Hardware/Software/Firmware Revision Level .................................................................. 4 3.4. EUT Cables/Transducers.......................................................................................................... 4 3.5. Support Equipment ................................................................................................................... 5 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 Procedures......................................................................................................... 6 4.4. Measurement Uncertainty ......................................................................................................... 7 5. Choice of Equipment for Test Suits .................................................................................................... 8 5.1. Choice of Model ........................................................................................................................ 7 5.2. Presentation .............................................................................................................................. 7 5.3. Choice of Operating Frequencies ............................................................................................. 7 6. Measurement Summary ..................................................................................................................... 8 7. Measurement Data ........................................................................................................................... 10 7.1. Justification for Test Methodology .......................................................................................... 10 7.2. Maximum Conducted Output Power ....................................................................................... 11 7.3. Peak Power Spectral Density ................................................................................................. 19 7.4. 26 dB Emission Bandwidth ..................................................................................................... 26 7.5. 99% Power Bandwidth ............................................................................................................ 33 7.6. Peak Excursion of the Modulation Envelope .......................................................................... 40 7.7. Transmitter Spurious Radiated Emissions (32 kHz to 40 GHz ............................................... 47 7.8. Band Edge Measurements ..................................................................................................... 55 7.9. Frequency Stability.............................................................................…

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Test set up photos – PQC-MX40SH1C4 Spurious Loop – Front Spurious Loop – Back Spurious MW – Front Spurious MW – Back Spurious Bilog – Front Spurious Bilog – Back Frequency Stability – Front