PQC-M3813CM3813C STEADY SCALE

Rev. A Document Number: 453564279231 Page 1 of 1 Title: Errata for Philips Telemonitoring Set Instructions for Use, Issue 7 Restricted PHILIPS Errata for: Philips Telemonitoring Set Instructions for Use, Issue 7 This Errata includes additions, deletions, or changes that are associated with the Philips Telemonitoring Set Instructions for Use, Issue 7 published May 2011. The follow statement is an addition to the Instructions for Use. “This device complies with Industry Canada licence-exempt RSS standard(s). Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device.”

Philips Telehealth Solutions Instructions for Use Patient Telemonitoring Set Notice Proprietary Information Published by Philips Lifeline Systems, a division of Philips Electronics North America Corporation. Philips Lifeline Systems reserves the right to make changes to both this Instructions for Use and to the product it describes. Product specifications are subject to change without notice. Nothing contained within this Instructions for Use is intended as any offer, warranty, promise or contractual condition, and must not be taken as such. © Koninklijke Philips Electronics N.V. 2011  All Rights are reserved. Reproduction in whole or in part in any form or by any means, electrical, mechanical or otherwise, is prohibited without the written consent of the copyright holder. Document number: M3810-90096 Issue number 7, May 2011 Philips Lifeline Systems 111 Lawrence Street Framingham, MA 01702 USA Unauthorized copying of this publication is a copyright infringement and will reduce the ability of Philips Lifeline Systems to provide accurate and up-to-date information to users. Non-Philips product names may be trademarks of their respective owners. Published in the United States of America 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. All Editions and Updates of this manual and their publication dates are listed below. First Edition . . . . . . . . . . . . . . . . . . . . . . . . . . . October 2002 Second Edition . . . . . . . . . . . . . . . . . . . . . . . . . . . . July 2006 Third Edition. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . May 2007 Fourth Edition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . May 2008 Fifth Edition . . . . . . . . . . . . . . . . . . . . . . . . . . . October 2008 Sixth Edition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . July 2009 Seventh Edition. . . . . . . . . . . . . . . . . . . . . . . . . . . . May 2011 Personal Health Information Security Telehealth equipment collects personal information in the form of vital sign measurements and survey responses that help your health care organization manage you health care effectively. These data are stored and protected on a secure network and will not be disclosed for purposes other than for the management of your healthcare. Any unintentional disclosure of your personal information will be reported to your health care organization. Trademarks LifeScan OneTouch® Basic® and LifeScan OneTouch Profile® are all registered trademarks of LifeScan, a Johnson&Johnson Company.  Lifeline® is a registered trademark of Philips LifeLine. Bayer Contour® is a registered trademark of BAYER. Contents ContentsI 1. Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Welcome . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 How the System Works . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Keeping the System Working . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Philips Telemonitoring Services System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Safety and Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Follow Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Document Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Bold Typeface. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Display Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 2. Philips Telemonitoring Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Device Description. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 TeleStation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Scale. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Blood Pressure Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Rhythm Strip Recorde . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Pulse Oximeter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 Glucose Meter Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Device Usage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 TeleStation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 Scale. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 Blood Pressure Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . .…

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PHILIPSPhilips Healthcare 22100 Bothell Everett Rwy Letter of Agency &~thelI,wA 98021-8431 June 7, 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 Tel: (800) 285.5585 www.medic2l.philips.com

External Photos – M3813C Scale Front Scale base

Philips Healthcare Label Placement Specification for the Steady Scale Rev. A Document Number: A-989803174191-90003 Title: Label Placement Specification for the Steady Scale Restricted Figure 7: Label at the bottom of the steady scale Figure 8: Label at the bottom of the scale Label to be used

Figure 9: Label at the bottom of the scale Label to be used

Internal Photos – M3813C Control and Transmitter Module Control and Transmitter Module Front Control and Transmitter Module Rear Wetboard Front Wetboard Rear

Compliance Worldwide, Inc. - 357 Main Street - Sandown, NH 03873 (603) 887 3903 Fax 887 6445 http://www.complianceworldwide.com COMPLIANCE WORLDWIDE INC. TEST REPORT 170-11 In Accordance with the Requirements of Federal Communications Commission CFR Title 47 Part 15.249, 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 M3813C Steady Scale FCC ID: PQC-M3813C IC: 3549A-3813C Report Issued on March 11, 2011 Tested by This test report shall not be reproduced, except in full, without written permission from Compliance Worldwide, Inc. Test Number: 170-11 Issue Date: 3/11/2011 Page 2 of 15 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 ......................................................................................................... 4 3.1. Support Equipment .................................................................................................... 4 3.2. Cables ........................................................................................................................ 4 3.3. Operational Characteristics & Software ..................................................................... 4 3.4. Block Diagram ............................................................................................................ 4 4. Measurements Parameters................................................................................................. 5 4.1. Measurement Equipment Used to Perform Test ........................................................ 5 4.2. Measurement & Equipment Setup ............................................................................. 5 4.3. Measurement Procedure............................................................................................ 5 4.4. Choice of Operating Frequencies .............................................................................. 5 5. Measurement Summary...................................................................................................... 6 6. Measurement Data.............................................................................................................. 7 6.1. Antenna Requirement ................................................................................................ 7 6.2. Radiated Field Strength of Fundamental ................................................................... 7 6.3. Radiated Field Strength of Harmonics ....................................................................... 7 6.4. Band Edge Measurements......................................................................................... 8 6.5. Spurious Radiated Emissions .................................................................................. 10 6.6. Occupied Bandwidth (-26 dB) .................................................................................. 12 6.7. 99% Bandwidth ........................................................................................................ 13 6.9. Public Exposure to Radio Frequency Energy Levels ............................................... 14 7. Test Site Description ......................................................................................................... 15 Test Number: 170-11 Issue Date: 3/11/2011 Page 3 of 15 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 M3813C Steady Scale, 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. 2. Product Details 2.1. Manufacturer: Philips 2.2. Model Number: M3813C Steady Scale 2.3. Serial Number: CH51010005 2.4. Description: The Philips M3813C Steady Scale is a redesigned version of the existing M3813B standard scale. It is used in conjunction with the M3810A Telemedicine remote patient monitoring system. The device provides accurate weight measurement data that is wirelessly transmitted to the PTS TeleStation which has been previously qualified. Data from the TeleStation is transferred to a remote patient measurement server via phone line modem. The design and manufacture of the steady scale option for the M3813B Weight Scale is being provided by OEM NCI Technology. 2.5. Power Source: 6 Volts DC (4 AA Alkaline Batteries) 2.6. Hardware Revs.: Rev. A 2.7. Software Rev.: N/A 2.8. EMC Modifications: None Test Number: 170-11 Issue Date: 3/11/2011 Page 4 of 15 Compliance Worldw…

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Philips – Steady Scale, M3813C Test Images: Front Rear