S6WESSENTIALMRI PATIENT MONITOR

*989803173791* 989803173791 Essential MRI Patient Monitor (Model 865353) Instructions for Use 989803173791 Rev 0.6 English 2 989803173791 Rev 0.6 989803173791 Rev 0.6 3 Manufacturer Invivo Corporation Orlando, Florida 32826 U.S.A. (407) 275‐3220 (800) 331‐3220 www.invivocorp.com Copyright Copyright © 2010, Invivo. All rights reserved. Printed in the United States. REF 989803173791 Rev. A, October 2010 Equipment Classification NOTE Laws in the United States restrict this device to sale by or on the order of a physician. EQUIPMENT CLASSIFICATION (according to IEC 60601‐1) According to the type of protection against electrical shock Class I equipment According to the degree of protection against electrical shock: Type CF (defibrillator‐proof) equipment According to the degree of protection against harmful ingress of water: IPX2 (enclosed equipment tilted 15 degrees with protection against dripping liquid). According to the methods of sterilization or disinfection: Non‐sterilizable. Use of liquid surface disinfectants only. According to the mode of operation:Continuous operation Equipment not suitable for use in the presence of flammable anesthetic mixture with air or with oxygen or nitrous oxide. 4 989803173791 Rev 0.6 Proprietary Information This document and the information contained in it is proprietary and confidential information of Invivo and may not be reproduced, copied in whole or in part, adapted, modified, disclosed to others, or disseminated without the prior written permission of Invivo. This document is intended to be used by customers and is licensed to them as part of their Invivo equipment purchase. Use of this document by unauthorized persons is strictly prohibited. Invivo 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. Invivo has taken care to ensure the accuracy of this document. However, Invivo 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. Invivo 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. 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 989803173791 Rev 0.6 Contents i Chapter 1: Important Information Intended Audience . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 System Conventions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Document Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Cautions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 SpO 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Power. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Miscellaneous . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Electromagnetic Compatibility (EMC). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Radios . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 EMC Emissions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 EMC Immunity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Recommended Separation Distances . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Battery Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Disposing of Batteries in Europe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Disposing of Batteries in the United States . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 List of Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Unpacking the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .…

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External Photos – FCC: S6WESSENTIAL IC: 6331A-ESSENTIAL Philips Medical Front Rear

Location of FCC Label Page 1 of 1 The FCC Label will be located as indicated on the following photograph, on the rear of the device beneath the battery: Although the photograph shows a label that does not bear the FCC identification number, the production devices will bear the FCC identification number on this label as indicated in the following drawing:

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: 453564198541-M-MART ARTWORK; SERVICE LABEL CT 11JAN10 1 1 B See Edmr 58mm 50mm This device complies with Part 15 of the FCC Rules. Operation is subject to the following two 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. IC: 6331A-ESSENTIAL FCC ID: S6WESSENTIAL *0000000000* 0000000000 *453564198611* 453564198611 SERVICE # R3.0 x 4 NOTES: 1. ALL CHARACTERS & LEGENDS TO BE LOCATED APPROXIMATELY AS SHOWN. 2. REF AND SN BARCODE TO BE ENTERED INTO JETFORM AT TIME OF PRINTING 3. BARCODE GRAPHIC SHOWN IS FOR ILLUSTRATIVE PURPOSES ONLY, ACTUAL BARCODE AND HUMAN READABLE BARCODE FIGURES WILL VARY FROM SHOWN. 4. FOUR (4) DIGIT DATE WILL CHANGE AS NEEDED TO REFLECT CURRENT YEAR. DATE CODE TO BE 9 PT. HIGH CHARACTERS 5. (2) DIGIT MONTH OF MANUFACTURE TO BE 9PT. HIGH CHARACTERS. 6. LABEL TO CONFORM TO UL969 AND UL60601-1 CLAUSE 6.8 STANDARDS. 7. GRAPHICS AND TEXT TO BE BLACK 8. MATERIAL: 8.1. BASE: 2 MIL THICK METALLIZED SILVER POLYESTER WITH MATTE TOPCOAT. 8.2. ADHESIVE: 1 MIL THICK (UL APPROVED) PRESSURE SENSITIVE ADHESIVE. 8.3. LABEL COLOR: SILVER 8.4. RELEASE LINER: SEMI-BLEACHED TRANSLUCENT KRAFT DRY RELEASE (FOR OPTICAL DETECTION OF LABEL EDGES). 8.5. LABELS ARE TO BE KISS-CUT TO DIMENSIONS SHOWN FOR EASY REMOVAL. WASTE MATERIAL AROUND LABELS IS TO BE REMOVED. 8.6. LABELS TO BE PRODUCED IN ROLL FORM. EACH ROLL TO BE ONE LABEL IN WIDTH. SEE DRAWING FOR DIMENSIONS 8.7. MAXIMUM QUANTITY OF 250 LABELS PER ROLL. 9. PACKAGING: 9.1. EACH ROLL OF LABELS TO BE LABELLED ON THE INSIDE SURFACE OF THE ROLL’S CORE WITH THE FOLLOWING INFO; INVIVO PART NUMBER, REVISION LEVEL QUANTITY, DATE OF MANUFACTURE, FORMAT = YYMM, ADHESIVE EXPIRATION DATE, FORMAT = YYMM, MANUFACTURER’S NAME AND COUNTRY OF ORIGIN. 9.2. EACH ROLL TO BE INDIVIDUALLY SEALED INSIDE AN AMINE-FREE ANTI-STATIC BAG. 9.3. EACH BAG TO BE LABELLED WITH THE SAME INFO SPECIFIED IN 9.1. 9.4. PACKAGING FOR SHIPPING: 9.4.1. MULTIPLE ROLLS OF LABELS MAY BE BULK PACKAGED INTO A SINGLE CONTAINER. CONTAINER WEIGHT MUST NOT EXCEED 30LBS. 9.4.2. PRODUCT TO BE ADEQUATELY PROTECTED BY THE VENDOR TO PREVENT DAMAGE DURING SHIPPING AND HANDLING. 9.4.3. OUTER CONTAINERS TO BE MARKED WITH THE FOLLOWING INFORMATION: PER A-Q2920-40552, DATE OF MANUFACTURE, FORMAT = YYMM, ADHESIVE EXPIRATION DATE, FORMAT = YYMM 10. OTHER: 10.1. DATE OF MANUFACTURE IS DEFINED AS THE DATE THE LABEL IS MANUFACTURED BY THE LABEL SUPPLIER. 10.2. THE CONTRACT MANUFACTURER PURCHASING THIS LABEL ON THE BEHALF OF PHILIPS/INVIVO SHALL BE RESPONSIBLE FOR INCORPORATING SHELF LIFE CONTROLS AND STORAGE CONDITIONS. SERIAL NUMBER CONFIGURATION: SG XX XX XXXX COUNTRY OF ORIGIN YEAR NUMBER WEEK NUMBER SERIAL NUMBER STARTING WITH 1000

Internal Photos FCC: 6331A-ESSENTIAL IC: S6WESSENTIAL Philips Medical Inside EUT Component Side Solder Side

Compliance Worldwide, Inc. - 357 Main Street - Sandown, NH 03873 (603) 887 3903 Fax 887 6445 http://www.complianceworldwide.com COMPLIANCE WORLDWIDE INC. TEST REPORT 354-10 In Accordance with the Requirements of Federal Communications Commission CFR Title 47 Part 15.249, Subpart C Industry Canada RSS 210, Issue 7 Low Power License-Exempt Radio Communication Devices Intentional Radiators Invivo a division of Philips Medical Systems 3000 Minuteman Drive Andover, MA 01810 978-659-2800 for the Invivo N-Vue SP02 ECG Monitor FCC ID: S6WESSENTIAL IC: 6331A-ESSENTIAL Report Issued on September 10, 2010 Tested by This test report shall not be reproduced, except in full, without written permission from Compliance Worldwide, Inc. Test Number: 354-10 Issue Date: 9/10/2010 Page 2 of 22 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. EUT Hardware ........................................................................................................... 3 3.2. Support Equipment .................................................................................................... 3 3.3. Cables ........................................................................................................................ 3 3.4. Operational Characteristics & Software ..................................................................... 4 3.5. Block Diagram ............................................................................................................ 5 4. Measurements Parameters................................................................................................. 5 4.1. Measurement Equipment Used to Perform Test ........................................................ 5 4.2. Measurement & Equipment Setup ............................................................................. 5 4.3. Measurement Procedure............................................................................................ 6 4.4. Choice of Operating Frequencies .............................................................................. 6 5. Measurement Summary...................................................................................................... 7 6. Measurement Data.............................................................................................................. 8 6.1. Antenna Requirement ................................................................................................ 8 6.2. Radiated Field Strength of Fundamental ................................................................... 8 6.3. Radiated Field Strength of Harmonics ..................................................................... 10 6.4. Band Edge Measurements....................................................................................... 11 6.5. Spurious Radiated Emissions .................................................................................. 13 6.6. Occupied Bandwidth (-26 dB) .................................................................................. 17 6.7. 99% Bandwidth ........................................................................................................ 17 6.8. Occupied (-26 dB) Bandwidth / 99% Bandwidth Plots ............................................. 18 6.9. Public Exposure to Radio Frequency Energy Levels ............................................... 19 6.10. Spurious Emissions of License Exempt Receivers ................................................ 21 7. Test Site Description ......................................................................................................... 22 Test Number: 354-10 Issue Date: 9/10/2010 Page 3 of 22 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 Invivo a division of Philips Medical Systems Invivo N-Vue SP02 ECG Monitor, as tested, meets the FCC Part 15, Subpart C and Industry Canada RSS 210, Issue 7 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: Invivo a division of Philips Medical Systems 2.2. Model Number: N-Vue SP02 ECG Monitor 2.3. Serial Number: USA10171015 2.4. Description: The N-Vue is a wireless patient monitor intended to provide multi-vital sign patient monitoring capability in the MRI environment, i.e. within the magnet room and in close proximity to an MRI scanner magnet. The N-Vue is intended to be used either as a standalone SpO2 MRI monitor or a basic companion monito…

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Invivo/Philips Test Set up photos - N-Vue monitor Front: Rear