S6W2GMODSBWIRELESS ECG MODULE

Expression MR200 MRI Patient Monitoring System INSTRUCTIONS FOR USE Revision B English *989803184961* 989803184961 ii Manufacturer Invivo, a division of Philips Medical Systems 12151 Research Parkway Orlando, FL 32826 USA 877‐468‐4861 +31 (0) 499 378299 www.invivocorp.com Copyright Copyright © 2013, Koninklijke Philips N.V. All rights reserved. REF 989803184961 Rev. B, October 2013 Printed in USA Proprietary Information This document and the information contained in it is proprietary and confidential information of Koninklijke Philips N.V. and may not be reproduced, copied in whole or in part, adapted, modified, disclosed to others, or disseminated without the prior written permission of the Koninklijke Philips N.V. This document is intended to be used by customers and is licensed to them as part of their Koninklijke Philips N.V. equipment purchase. Use of this document by unauthorized persons is strictly prohibited. Koninklijke Philips N.V. provides this document without warranty of any kind, implied or expressed, including, but not limited to, the implied warranties of merchantability and fitness for a particular purpose. Koninklijke Philips N.V. has taken care to ensure the accuracy of this document. However, Koninklijke Philips N.V. assumes no liability for errors or omissions and reserves the right to make changes without further notice to any products herein to improve reliability, function, or design. Koninklijke Philips N.V. may make improvements or changes in the products or programs described in this document at any time. 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 part number and revision indicate the current edition. The printing date changes when a new revision is printed. (Minor corrections and updates which are incorporated at reprint do not cause the date to change.) The document revision letter changes when extensive technical changes are incorporated. Contents Contents 1 Manufacturer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-ii Copyright . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-ii Proprietary Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-ii Chapter 1: Important Information Intended Audience . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1 Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-2 Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2 System Conventions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-2 Document Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-3 Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-3 Cautions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-3 Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-3 Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-4 Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5 Equipment Classification (According to IEC 60601-1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-5 Electromagnetic Compatibility (EMC). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-5 Radios . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-5 Using Batteries Safely . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-9 List of Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-10 Examining the Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-15 Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-16 Disposing of the Packaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-16 Rear Panel Connections. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-16 Replacing Cart Batteries. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-17 Connecting AC Mains Power. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-18 MR200 Battery Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-19 Attaching the SPO2 Sensor to the wSPO2 Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-20 Charging Module Batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-20 Replacing a Module Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-20 Assigning the Network Channel of a Module . . . . .…

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APPLICANT: INVIVO CORPORATION FCC ID: S6W2GMODSB IC: 6331A-2GMODSB EXTERNAL PHOTOS

EC No. Drawn: Dwg No. Title: Date: Sht of Rev: ORLANDO, FLORIDA 32826 This document is confidential and proprietary and is the sole property of Invivo Corporation. It is not to be disclosed to any party, reproduced or used in any other manner without the written consent or said company. Invivo Corporation maintains the right to change specifications at any time without prior notice. Note: 453564381661-M-MART Label, Back Housing, wECG, ROHS ARTWORK; DGK 13NOV13 1 1 D SEE eDMR IC: 6331A-2GMODSB R 201 WW 08215384 FCC ID: S6W2GMODSB REF 989803183661 (ECG) 0979 0413 KCC-CRI-PCE-WirelessECG Assembled for Invivo, a division of Philips Medical Systems 12151 Research Parkway, Orlando, FL 32826 USA Made in USA 50.72 [1.997] NOTES: 4. Refer to mechanical file Scale: 1:1 1. Dimensions are in millimeters [inches]. 2. Text/graphics colors: White. 3. Background color: Pantone Black C. 453564381661for additional requirements. Artwork is incomplete without mechanical file. RoHS COMPLIANT Pantone Black C White Color Key Chart EC No. Drawn: Dwg No. Title: Date: Sht of Rev: ORLANDO, FLORIDA 32826 This document is confidential and proprietary and is the sole property of Invivo Corporation. It is not to be disclosed to any party, reproduced or used in any other manner without the written consent or said company. Invivo Corporation maintains the right to change specifications at any time without prior notice. Note: LABEL, MODEL/SERIAL, REG/SER F 453564357841-M-MART 1 1 SEE eDMR 08NOV13 DGK SN 000000000000 SERVICE # 0000000000 Philips Medizin Systeme Böblingen GmbH Hewlett-Packard-Str.2 71034 Böblingen, Germany EC REP 0889 HSW-2410NF Cirronet CCAI10LP1540T6 IC: 4492A-2410NF IC: 6331A-DR3160 FCC ID: S6WDR3160BAS This device complies with Part 15 of the FCC Rules. Operation is subject to the following conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Rx Only Made in USA Mass: 36.6 kg 0413 0979 0000000000 SN 000000000000 REF Expression Patient Monitor Model MR200 XXXX-XX Assembled for Invivo, a division of Philips Medical Systems 12151 Research Parkway Orlando, FL 32826 USA IPX1 NOTES: 5. Refer to mechanical file Scale: 1:1 1. Dimensions are in millimeters [inches]. 2. Text/graphics colors: Black. 3. Background color: White. 4. Blue perimeter outline represents die-cut and does not print. 453564357841 for additional requirements. Artwork is incomplete without mechanical file.

Philips Healthcare Assembly Instruction, Wireless wECG Module, RoHS Rev. A.2 Document Number A-989803183661-90001 Page 19 of 26 Title: Assembly Instruction, Wireless wECG Module, RoHS Restricted 4. Apply Overlays 1.0 MR200 989803183661 and 453564390601 For Expression 2.0 Remove paper backing, orient, and install 453564381661 Back Housing Label within the ridges of the Back Housing. End Expression 3.0 End Assembly Process 4.0 Perform full final functional and RF Tests of unit per A-989803163121-90001 (Wireless wECG 2 nd Gen Module Functional Test Procedure) and package for shipping or stocking to finished goods

APPLICANT: INVIVO CORPORATION FCC ID: S6W2GMODSB IC: 6331A-2GMODSB INTERNAL PHOTOS

FCC PART 15.249 TEST REPORT UNLICENSED INTENTIONAL RADIATOR Applicant INVIVO CORPORATION Address 12151 RESEARCH PARKWAY SUITE 200 ORLANDO FL 32826 FCC ID S6W2GMODSB Model Number 989803183661 Product Description WIRELESS MODULE Date Sample Received 11/12/2013 Date Tested 11/18/2013 Tested By JOE SCOGLIO Approved By JOE SCOGLIO Report Number 1941AUT13TestReport.docx Test Results PASS FAIL THE ATTACHED REPORT SHALL NOT BE REPRODUCED EXCEPT IN FULL WITHOUT THE WRITTEN APPROVAL OF TIMCO ENGINEERING, INC. Testing Certificate #0955-01 849 NW State Road 45 Newberry, FL 32669 USA Ph: 888.472.2424 or 352.472.5500 Fax: 352.472.2030 Email: [email protected] Website: www.timcoengr.com APPLICANT: INVIVO CORPORATION FCC ID: S6W2GMODSB REPORT #: I\INVIVO\1941AUT13\1941AUT13TestReport.docx Page 2 of 17 Mdea5.11.2012 TABLE OF CONTENT GENERAL REMARKS ..................................................................................................................... 3 GENERAL INFORMATION .............................................................................................................. 4 EMC EQUIPMENT LIST.................................................................................................................. 5 TEST PROCEDURES ...................................................................................................................... 7 RADIATION INTERFERENCE ......................................................................................................... 8 OCCUPIED BANDWIDTH ............................................................................................................... 9 BAND EDGE COMPLIANCE ......................................................................................................... 10 DUTY CYCLE ............................................................................................................................... 16 POWER LINE CONDUCTED INTERFERENCE .............................................................................. 17 APPLICANT: INVIVO CORPORATION FCC ID: S6W2GMODSB REPORT #: I\INVIVO\1941AUT13\1941AUT13TestReport.docx Page 3 of 17 Mdea5.11.2012 GENERAL REMARKS The attached report shall not be reproduced except in full without the written permission of Timco Engineering Inc. Summary The device under test does: fulfill the general approval requirements as identified in this test report not fulfill the general approval requirements as identified in this test report Attestations This equipment has been tested in accordance with the standards identified in this test report. To the best of my knowledge and belief, these tests were performed using the measurement procedures described in this report. All instrumentation and accessories used to test products for compliance to the indicated standards are calibrated regularly in accordance with ISO 17025: 2005 requirements. Certificate # 0955-01 I attest that the necessary measurements were made, under my supervision, at: Timco Engineering Inc. 849 NW State Road 45 Newberry, Fl 32669 Authorized Signatory Name: Joe Scoglio Engineering Project Manager Date: 11/18/2013 APPLICANT: INVIVO CORPORATION FCC ID: S6W2GMODSB REPORT #: I\INVIVO\1941AUT13\1941AUT13TestReport.docx Page 4 of 17 Mdea5.11.2012 GENERAL INFORMATION DUT Specification The test results relate only to the items tested. Applicable Standard Part 15.249 DUT Description WIRELESS MODULE FCC ID S6W2GMODSB Model Number 989803183661 Operating Frequency TX: 2402 MHz to 2482 MHz RX: Same No. of Channels 80 DUT Power Source 110–120Vac/50– 60Hz DC Power Battery Operated Exclusively Test Item Prototype Pre-Production Production Type of Equipment Fixed Mobile Portable Antenna Connector Permanently attached Test Facility Timco Engineering Inc. located at 849 NW State Road 45 Newberry, FL 32669 USA. Test Conditions Temperature: 26ºC Relative humidity: 50% Test Exercise The DUT was placed in continuous transmit mode of operation. Modifications none Test Supporting Equipment Supporting Device Manufacturer Model / FCC ID Serial Number N/A APPLICANT: INVIVO CORPORATION FCC ID: S6W2GMODSB REPORT #: I\INVIVO\1941AUT13\1941AUT13TestReport.docx Page 5 of 17 Mdea5.11.2012 EMC EQUIPMENT LIST Device Manufacturer Model Serial Number Cal/Char Date Due Date 3/10-Meter OATS TEI N/A N/A 12/31/11 12/31/13 3-Meter OATS TEI N/A N/A 12/31/11 12/31/13 Antenna: Passive Loop EMC Test Systems EMCO 6512 9706-1211 06/14/12 06/14/14 Frequency Counter HP 5385A 2730A03025 08/22/13 08/22/15 Frequency Counter HP 5352B 2632A00165 06/26/13 06/26/15 Digital Multimeter Fluke 77 43850817 02/22/12 02/22/14 Digital Multimeter Fluke FLUKE-77-3 79510405 06/20/13 06/20/15 Frequency Counter HP 5385A 3242A07460 06/16/13 06/16/15 Antenna: Active Loop ETS-Lindgren 6502 00062529 10/09/13 10/09/15 Antenna: Double- Ridged Horn Electro- Metrics RGA-180 2319 06/19/12 06/19/14 LISN Electro- Metrics EM-7820 2682 02/26/13 02/26/15 DC Power Supply HP 6264B 05/06/13 05/06/15 3-Meter Semi- Anechoic Chamber Panashield N/A N/A 12/31/11 12/31/13 Temperature Chamber Tenney Engineering TTRC 11717-7 07/03/12 07/03/14 Antenna: Biconnical Electro- Metrics BIA-25 1171 06/13/12 06/13/14 Temperature Chamber Thermotron Corp. S1.2 Mini Max 25-1420-09 07/03/12 07/03/14 Antenna: Log- Periodic Electro- Metrics LPA-25 1122 05/09/13 05/09/15 Digital Multimeter Fluke 77 35053830 08/22/13 08/22/15 Antenna: Biconnical Eaton 94455-1 1096 05/10/13 05/10/15 Antenna: Biconnical Eaton 94455-1 1057 06/14/13 06/14/15 APPLICANT: INVIVO CORPORATION FCC ID: S6W2GMODSB REPORT #: I\INVIVO\1941AUT13\1941AUT13TestReport.docx Page 6 of 17 Mdea5.11.2012 EMC EQUIPMENT LIST Cont Antenna: Log- Periodic Eaton 96005 1243 05/31/13 05/31/15 Analyzer Silver Tower Quasi- Peak Adapter HP 85650A 2811A01175 06/05/13 06/05/15 Analyzer Silver Tower RF Preselector HP 85685A 2926A00983 06/05/13 06/05/15 Analyzer Silver Tower Spectrum Analyzer HP 8566B Opt 462 3552A22064 3638A08608 06/05/13 06/05/15 Antenna: Standard Gain Horn 18.0-26.3 GHz …

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