S6W3GECGWireless ECG for Patient Monitoring in MRI Environments

Expression MR400 MRI Patient Monitoring System INSTRUCTIONS FOR USE Revision A English *989803193211* 989803193211 ii Manufacturer Invivo, a division of Philips Medical Systems 12151 Research Parkway Orlando, FL 32826, USA 877‐468‐4861 E‐mail: [email protected] Websites: www.ExpressionMR.com www.invivocorp.com www.philips.com Identification and Publication Details Published by Invivo, a division of Philips Medical Systems. Invivo, a division of Philips Medical 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 N.V. (Royal Philips) 2015 All rights 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. REF 989803193211 Rev. A, March 2015 Invivo, a division of Philips Medical Systems 12151 Research Parkway Orlando, FL 32826 USA Unauthorized copying of this publication may not only infringe copyright, but also reduce the ability of Philips Medical Systems to provide accurate and up‐to‐date information to users. Published in USA iii Regulatory Compliance The Expression MR400 MRI Patient Monitoring System complies with relevant international and national standards and laws. Information on compliance will be supplied on request by your local Royal Philips representative, or by the manufacturer. Explanation of Symbols The symbols in the following table may appear on the Expression MR400 MRI Patient Monitoring System, the accessories, or the packing material. SymbolSymbol Underwriters Laboratories Component Recognition Mark for both the U.S. and Canadian markets Federal Communications Commission radio certification Ministry of Internal Affairs and Communications Japanese Radio Law Certification UL has determined that the product meets requirements Korean Communications Commission radio certification Taiwan National Communications Commission certification Conforms to the European Medical Devices Directive Conforms to the R&TTE Directive (Radio & Telecommunications Terminal Equipment) Authorized representative in the European Community Serial number Catalog, reorder or reference part number Batch code / lot number iv Sterilized using radiationUnique device identifier Sterilized using ethylene oxide In vitro diagnostics compliant MR Conditional: Use in the MR environment is restricted to certain conditions of use to ensure patient and operator safety. MR unsafe: Must not be used in an MRI environment MR safe: Completely safe for use with no potential for interaction with the MR field. Warning! Specific warnings associated with the devices that are not otherwise found on the label; and, on the connector of the wireless ECG patient module, this indicates that only specified ECG lead cables shall be used to ensure safe use in the MR and defibrillation protection. Consult the Instructions for Use Caution! See Instructions for Use for specific warnings or precautions associated with the devices that are not otherwise found on the label The Instructions for Use must be consulted Separate to open then insert Do not adjust without referring to the service manual Single use only, disposable one-time-use product; do not reuse Do not use if container is damaged Defibrillator-proof type CF equipment (IEC 60601- 1) protection against shock SymbolSymbol v Use by date; do not use after the year (YYYY), month (MM) and day (DD) indicated Cable tag marked with use by date; do not use after the year (YYYY) and month (MM) indicated Use by date; do not use after the year (YYYY), month (MM) AC receptacle, below Do not pushCorrect Alternating currentNot sterile SPO2 probe quantity equals Direct current Adult SPO2 clip quantity equals Pediatric SPO2 clip quantity equals Infant SPO2 grip quantity equals Neonatal SPO2 grip quantity equals Adult SPO2 grip quantity equals Pediatric SPO2 grip quantity equals Infant Neonate Toe siteThumb site Finger site Big toe site SymbolSymbol YYYY-MM-DD YYYY-MM vi Prescription onlyFoot site NIBP cuff, correct side outTemperature range Non-pyrogenic fluid pathNIBP cuff, wrong side out Airway adapter quantity equals NIBP cuff circumference range Anesthetic oxygen (O2) sensor location and part number IBP transducer cable quantity equals WeightCannula quantity equals Humidity range Humidity range, non condensing For indoor use only Equipotential (earth) ground FragileKeep dry SymbolSymbol vii Keep away from heat Atmospheric pressure limitation Packages per boxUp Quantity equals Non-invasive blood pressure (NIBP) connection Not manufactured with natural latex rubber Quadtrode electrode Contains or presence of phthalate: bis (2- ethylhexyl) phthalate Quadtrode electrode per package Non-ionizing radiation ECG AAMI ECG CV lead cable connections AAMI ECG lead cable connections AAMI ECG NEO lead cable connections IEC ECG CV lead cable connections IEC ECG lead cable connections IEC ECG NEO lead cable connections SymbolSymbol viii Cardiac gating outputUniversal Serial Bus (USB) Conforms to the RoHS directive Not for general waste Center positive connection: Positive (+) center pin, negative (-) outer ring Pneumatic respiration connection Gas input indicatorGas output indicator Electrical input indicatorElectrical output indicator Temperature connection Electrostatic discharge (ESD) warning Manufacturer name and address YYYY-MM Date of manufacture (year-month) Non-magnetic partBattery Main battery (left side) Main battery (right side) SymbolSymbol ix Do not move the Expression MR400 MRI Patient Monitoring System inside the 5000 gauss field line of the MR magnet or up to the face of a 3T magnet, whichever is greater, as measured from the center line of the bore. Apply wheel locks and do not move …

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tijlnvivo PHILIPS A Philips Company Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Rd. Columbia, MD 21046 Fax: (310) 344-2050 Reference FCC ID: S6WMR400. S6W3GECG, S6W3GSPO2 Organization: Invivo. a division of Philips Medical Systems Subject: Request under 47 CFR 0.457 and 0.459 that materials submitted to the commission be withheld from public inspection. Invivo, a division of Philips Medical Systems hereby requests that the materials attached here to be withheld from public inspection in accordance with 47 CFR 47 0.457 and 0.459. Specifically, Invivo, a division of Philips Medical Systems requests that the following materials be withheld from public inspection under 47 CFR 0.457 and 0.459 because the schematics and designs are considered confidential trade secrets and technical data which customarily would be guarded from competitors: Exhibit Type Block Diagram SchematicOperational description Therefore, in accordance with CFR 47 0.457 and 0.459, Invivo, a division of Philips Medical Systems requests that the above listed materials, copies of which are here, to be withheld from public inspection. Pursuant to DAO4-1705 June 15, 2004 of the Commission’s public notice, we also request temporary confidential treatment of information accompanying this application as outlined below for a period of 180 days: Exhibit Type User’s Manual External Photos Internal Photos Test Setup Photos Authorized Signature: Date: 01-APR-20 15 Krstal Mitchell Quality & Regulatory Engineer Invivo, a division of Philips Medical Systems Page 1 of 1

Qlnvivo PHILIPS A Phihps Company Date: 12-FEB-2015 UL LLC Certification Division 47173 Benicia Street Frernont, CA 94538, USA To whom it may concern: I, the undersigned, hereby authorize UL LLC to act on our behalf in all manners relating to application for equipment authorization, including signing of all documents relating to these matters. Any and all acts carried out by UL LLC on our behalf shall have the same effect as acts of our own. I, the undersigned, hereby certify that we are not subject to a denial of federal benefits, that includes FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 853(a). In authorizing UL LLC as our agent, we still recognize that we are responsible to: a) comply with the relevant provisions of the certification program; b) make all necessary arrangements for the conduct of the evaluation, including provision for examining documentation and access to all areas, records (including internal audit reports) and personnel for the purposes of evaluation (e.g. testing, inspection, assessment, surveillance, reassessment) and resolution of complaints; c) make claims regarding certification only in respect of the scope for which certification has been granted; d) do not use ou product certification in such a manner as to bring the Certification Division into disrepute and not make any statement regarding our product certification which the Certification Division may consider misleading or unauthorized; e) upon suspension or cancellation of certification, discontinue use of all advertising matter that contains any reference thereto and return any certification documents as required by the Certification Division; f) use certification only to indicate the products are certified as being in conformity with specified standards; g) endeavor to ensure that no certificate or report nor any part thereof is used in a misleading manner; Page 1 of2 h) ensure that any reference to our product certification in communication media such as documents, brochures or advertising, complies with the requirements of the Certification Division;i) keep a record of all complaints made known to the us relating to the product’s compliance with requirements of the relevant standard and to make these records available to the Certification Division when requested; j) take appropriate action with respect to such complaints and any deficiencies found in products or services that affect compliance with the requirements for certification; k) document the actions taken. This authorization is valid until further written notice from the applicant. Sincerely Yours, Krystal Mitchell, Quality & Regulatory Engineer Invivo, a division of Philips Medical Systems Page 2 of 2

EXTERNAL PHOTOS FCC ID: S6W3GECG IC: 6331A-3GECG Page 1 of 2 WIRELESS ECG FOR PATIENT MONITORING IN MRI ENVIRONMENTS MODEL NUMBER: wECG (P/N 989803192761 and 989803194341) FCC ID: S6W3GECG IC: 6331A-3GECG wECG - Front wECG - Rear wECG – Side EXTERNAL PHOTOS FCC ID: S6W3GECG IC: 6331A-3GECG Page 2 of 2 wECG - Side wECG – Bottom (Batteries) wECG - Top

LABEL AND LABEL PLACEMENT FCC ID: S6W3GECG IC: 6331A-3GECG Page 1 of 2 WIRELESS ECG FOR PATIENT MONITORING IN MRI ENVIRONMENTS MODEL NUMBER: wECG (P/N 989803192761 and 989803194341) FCC ID: S6W3GECG IC: 6331A-3GECG wECG – Label LABEL AND LABEL PLACEMENT FCC ID: S6W3GECG IC: 6331A-3GECG Page 2 of 2 wECG – Label Placement

INTERNAL PHOTOS FCC ID: S6W3GECG IC: 6331A-3GECG Page 1 of 5 WIRELESS ECG FOR PATIENT MONITORING IN MRI ENVIRONMENTS MODEL NUMBER: wECG (P/N 989803192761 and 989803194341) FCC ID: S6W3GECG IC: 6331A-3GECG wECG – Top INTERNAL PHOTOS FCC ID: S6W3GECG IC: 6331A-3GECG Page 2 of 5 wECG – Bottom INTERNAL PHOTOS FCC ID: S6W3GECG IC: 6331A-3GECG Page 3 of 5 wECG – Top (Metal Cover Removed) INTERNAL PHOTOS FCC ID: S6W3GECG IC: 6331A-3GECG Page 4 of 5 wECG – Bottom (Metal Cover Removed) INTERNAL PHOTOS FCC ID: S6W3GECG IC: 6331A-3GECG Page 5 of 5 wECG – Radio Circuit (Top) wECG - Radio Board (Bottom)

NVLAP LAB CODE 200246-0 FCC 47 CFR PART 15 SUBPART C INDUSTRY CANADA RSS-210 ISSUE 8 CERTIFICATION TEST REPORT FOR WIRELESS ECG FOR PATIENT MONITORING IN MRI ENVIRONMENTS MODEL NUMBER: wECG (REF 989803192761 and REF 989803194341) FCC ID: S6W3GECG IC: 6331A-3GECG REPORT NUMBER: R10608232-RF5 ISSUE DATE: 2015-04-06 Prepared for INVIVO CORP. 12501 RESEARCH PARKWAY ORLANDO FL, 32826, USA Prepared by UL LLC 12 LABORATORY DR. RESEARCH TRIANGLE PARK, NC 27709 USA TEL: (919) 549-1400 REPORT NO: R10608232-RF5 DATE: 2015-04-06 FCC ID: S6W3GECG IC: 6331A-3GECG MODEL: wECG (REF 989803192761 and REF 989803194341) Page 2 of 48 UL LLC FORM NO: CCSUP4701J 12 LABORATORY DR., RESEARCH TRIANGLE PARK, NC 27709 TEL: (919) 549-1400 This report shall not be reproduced except in full, without the written approval of UL LLC Revision History Rev. Issue Date Revisions Revised By -- 2015-03-11 Initial Issue Jeff Moser 1 2015-03-30 Revised Spurious emissions data to include calculated average data per FCC 15.35c. Revised ‘P/N’ to ‘REF’ for the wECG model designations. Jeff Moser 2 2015-04-02 Revised to add 20 dB bandwidth plots and additional Duty Cycle information. Jeff Moser 3 2015-04-06 Revised to include maximum Average Field strength on page 8. Jeff Moser REPORT NO: R10608232-RF5 DATE: 2015-04-06 FCC ID: S6W3GECG IC: 6331A-3GECG MODEL: wECG (REF 989803192761 and REF 989803194341) Page 3 of 48 UL LLC FORM NO: CCSUP4701J 12 LABORATORY DR., RESEARCH TRIANGLE PARK, NC 27709 TEL: (919) 549-1400 This report shall not be reproduced except in full, without the written approval of UL LLC TABLE OF CONTENTS 1. ATTESTATION OF TEST RESULTS ................................................................................. 4 2. TEST METHODOLOGY ..................................................................................................... 5 3. FACILITIES AND ACCREDITATION ................................................................................. 5 4. CALIBRATION AND UNCERTAINTY ................................................................................ 5 4.1. MEASURING INSTRUMENT CALIBRATION .............................................................. 5 4.2. SAMPLE CALCULATION ............................................................................................ 5 4.3. MEASUREMENT UNCERTAINTY ............................................................................... 6 5.6. DESCRIPTION OF TEST SETUP ................................................................................ 9 6. TEST AND MEASUREMENT EQUIPMENT ......................................................................11 7. TEST RESULTS ................................................................................................................13 7.1. 99% BANDWIDTH and 20 dB BANDWIDTH ...............................................................13 7.2. ON TIME AND DUTY CYCLE .....................................................................................20 7.3. RADIATED EMISSIONS .............................................................................................24 7.3.1. FUNDAMENTAL FREQUENCY RADIATED EMISSION ......................................25 7.3.2. TRANSMITTER RESTRICTED BAND EDGES ....................................................31 7.3.3. HARMONICS AND SPURIOUS EMISSIONS ABOVE 1GHz ...............................39 7.3.4. WORST-CASE ABOVE 1 GHz (18-26 GHz) ........................................................45 7.3.5. WORST-CASE BELOW 1 GHz ............................................................................47 REPORT NO: R10608232-RF5 DATE: 2015-04-06 FCC ID: S6W3GECG IC: 6331A-3GECG MODEL: wECG (REF 989803192761 and REF 989803194341) Page 4 of 48 UL LLC FORM NO: CCSUP4701J 12 LABORATORY DR., RESEARCH TRIANGLE PARK, NC 27709 TEL: (919) 549-1400 This report shall not be reproduced except in full, without the written approval of UL LLC 1. ATTESTATION OF TEST RESULTS COMPANY NAME: INVIVO CORP. 12501 RESEARCH PARKWAY ORLANDO, FL, 32826, USA EUT DESCRIPTION: WIRELESS ECG FOR PATIENT MONITORING IN MRI ENVIRONMENTS MODEL: wECG (REF 989803192761 and REF 989803194341) SERIAL NUMBER: SG00000044 and Non-serialized Unit DATE TESTED: 2015-01-14 to 2015-03-04, 2015-04-02 APPLICABLE STANDARDS STANDARD TEST RESULTS CFR 47 Part 15 Subpart C Pass INDUSTRY CANADA RSS-210 Issue 8 Annex 2 Pass INDUSTRY CANADA RSS-GEN Issue 4 Pass UL LLC tested the above equipment in accordance with the requirements set forth in the above standards. All indications of Pass/Fail in this report are opinions expressed by UL LLC based on interpretations and/or observations of test results. Measurement Uncertainties were not taken into account and are published for informational purposes only. The test results show that the equipment tested is capable of demonstrating compliance with the requirements as documented in this report. Note: The results documented in this report apply only to the tested sample, under the conditions and modes of operation as described herein. This document may not be altered or revised in any way unless done so by UL LLC and all revisions are duly noted in the revisions section. Any alteration of this document not carried out by UL LLC will constitute fraud and shall nullify the document. This report must not be used by the client to claim product certification, approval, or endorsement by NVLAP, NIST, any agency of the Federal Government, or any agency of any government. Approved & Released For UL LLC By: Prepared By: Bart Mucha Jeff Moser EMC Staff Engineer EMC Program Manager UL – Consumer Technology Division UL – Consumer Technology Division REPORT NO: R10608232-RF5 DATE: 2015-04-06 FCC ID: S6W3GECG IC: 6331A-3GECG MODEL: wECG (REF 989803192761 and REF 989803194341) Page 5 of 48 UL LLC FORM NO: CCSUP4701J 12 LABORATORY DR., RESEARCH TRIANGLE PARK, NC 27709 TEL: (919) 549-1400 This report shall not be reproduced except in full, without the written approval of UL LLC 2. TEST METHODOLOGY The tests documen…

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SETUP PHOTOS FCC ID: S6W3GECG IC: 6331A-3GECG Page 1 of 6 UL LLC 12 LABORATORY DR., RESEARCH TRIANGLE PARK, NC 27709 TEL: (919) 549-1400 WIRELESS ECG FOR PATIENT MONITORING IN MRI ENVIRONMENTS MODEL NUMBER: wECG (P/N 989803192761 and 989803194341) FCC ID: S6W3GECG IC: 6331A-3GECG 1. SETUP PHOTOS ANTENNA PORT MEASUREMENT SETUP ANTENNA PORT PHOTO SETUP PHOTOS FCC ID: S6W3GECG IC: 6331A-3GECG Page 2 of 6 UL LLC 12 LABORATORY DR., RESEARCH TRIANGLE PARK, NC 27709 TEL: (919) 549-1400 RADIATED RF MEASUREMENT SETUP FOR PORTABLE CONFIGURATION X-AXIS PHOTO SETUP PHOTOS FCC ID: S6W3GECG IC: 6331A-3GECG Page 3 of 6 UL LLC 12 LABORATORY DR., RESEARCH TRIANGLE PARK, NC 27709 TEL: (919) 549-1400 Y-AXIS PHOTO (WORST-CASE) SETUP PHOTOS FCC ID: S6W3GECG IC: 6331A-3GECG Page 4 of 6 UL LLC 12 LABORATORY DR., RESEARCH TRIANGLE PARK, NC 27709 TEL: (919) 549-1400 Z-AXIS PHOTO SETUP PHOTOS FCC ID: S6W3GECG IC: 6331A-3GECG Page 5 of 6 UL LLC 12 LABORATORY DR., RESEARCH TRIANGLE PARK, NC 27709 TEL: (919) 549-1400 RADIATED EMISSIONS (FRONT) SETUP PHOTOS FCC ID: S6W3GECG IC: 6331A-3GECG Page 6 of 6 UL LLC 12 LABORATORY DR., RESEARCH TRIANGLE PARK, NC 27709 TEL: (919) 549-1400 RADIATED EMISSIONS (REAR)