TVF-STRP-PP-V00Patient Programmer

Clinician’s Guide DRAFT Worldwide Corporate Office Bioness Inc 25103 Rye Canyon Loop Valencia, CA 91355 USA Telephone: 800.211.9136 Email: [email protected] Website: www.bioness.com Manufactured by Bioness Neuromodulation Ltd. 19 Ha’Haroshet Street PO Box 2500 Industrial Zone Ra’Anana 43654, Israel European Authorized Representative NESS Europe B.V. Stationsweg 41 3331 LR Zwijndrecht, The Netherlands Telephone: +31.78.625.6088 Email: [email protected] Website: www.bioness.com Rx Only StimRouter ™ , Bioness, the Bioness Logo ® and LiveOn ® are trademarks of Bioness Inc. in the United States or other countries. | www.bioness.com 612-00578-001 Rev. A Neuromodulation System Clinician’s Guide DRAFT Rx Only Copyright ©2012 by Bioness Inc. All Rights Reserved. No part of this publication may be reproduced, transmitted, transcribed, stored in a retrieval system or translated into any language or any computer language, in any form or by any third party, without the prior written permission of Bioness Inc. Guarantees Bioness Inc reserves the right to modify, without prior notice, information relating to its products to improve their reliability or operating capacity. Registered Trademarks StimRouter ™ , Bioness, the Bioness Logo ® and LiveOn ® are trademarks of Bioness Inc. in the United States or other countries.| www.bioness.com Patents Pending This device is protected under one or more of the following U.S. Patents: U.S. Pat. No. 7,502,652. U.S. and foreign patents pending. Disclaimer Bioness Inc shall not be liable for any injury or damage suffered by any person, either directly or indirectly, as a result of the unauthorized use or repair of Bioness Inc products. Bioness does not accept any responsibility for any damage caused to its products, either directly or indirectly, as a result of use and/or repair by unauthorized personnel. Environmental Policy Service personnel are advised that when changing any part of the StimRouter system, care should be taken to dispose of those parts in the correct manner; where applicable, parts should be recycled. When the life cycle of a StimRouter component has been completed, the product should be discarded according to the laws and regulations of the local authority. For more information regarding these recommended procedures, please contact Bioness Inc. Bioness is committed to continuously seeking and implementing the best possible manufacturing procedures and servicing routines. European Authorized Representative NESS Europe B.V. Stationsweg 41 3331 LR Zwijndrecht, The Netherlands Telephone: +31.78.625.6088 Email: [email protected] Website: www.bioness.com Worldwide Corporate Office Bioness Inc 25103 Rye Canyon Loop Valencia, CA 91355 USA Telephone: 800.211.9136 Email: [email protected] Website: www.bioness.com Manufactured by Bioness Neuromodulation Ltd. 19 Ha’Haroshet Street PO Box 2500 Industrial Zone Ra’Anana 43654, Israel Conformity Certification ii List of Symbols iii Caution or Warning Double Insulated (Equivalent to Class II of IEC 536) Type BF Applied Part(s) Non-Ionizing Radiation Date of Manufacture Manufacturer This Product Must Not Be Disposed of with Other Household Waste Consult Instructions for Use Re-Order Number Lot Number Serial Number Complies with United States and Canadian Product Safety Standards Single Patient Use Storage Temperature Complies with the European Union Medical Device Directive Quantity iv Clinician’s Guide Table of Contents List of Symbols ........................................................................................................................ iii Chapter 1: Introduction........................................................................................................1 Chapter 2: Warnings and Cautions .................................................................................. 3 Indications for Use .....................................................................................................................3 Contraindications ...................................................................................................................... 3 Implantation Setting .................................................................................................................. 4 Patient Screening .......................................................................................................................5 Warnings ................................................................................................................................... 5 Magnetic Resonance Imaging ............................................................................................. 5 Pregnancy ............................................................................................................................ 8 Long-Term Effectiveness of Neurostimulation...................................................................... 8 Programming ...................................................................................................................... 8 Device Components ........................................................................................................... 9 Flammable Fuel or Chemicals ............................................................................................. 9 Driving and Operating Machinery........................................................................................... 9 Electromagnetic Compatibility Warnings .................................................................................. 9 Medical Devices/Therapies ................................................................................................. 9 Electrosurgery Devices........................................................................................................ 10 High-Frequency Surgical Equipment ...................................................................................10 Body-Worn Device..................................…

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June 26, 2012 To: Telefication B.V. Attn: Dept. FCC TCB Edisonstraat 12A 6902 PK ZEVENAAR The Netherlands Subject: Application for certification of Patient Programmer, FCC ID:TVF-STRP-PP-V00 Dear Gentlemen, Please find attached our application for certification of Patient Programmer, FCC ID:TVF-STRP-PP-V00, prepared in accordance with FCC Rules, part 2 and part 15 subpart C, section 15.249. The product testing and this application for certification were performed by Hermon Laboratories, which is listed by FCC, Registration Numbers 90623, 90624. The FCC Designation Number is US1003. Hermon Labs responsible person is Mr. Michael Nikishin, tel: 011 972 4626 8440, fax:011 972 4628 8277, e-mail: [email protected]. Please send an invoice to Hermon Labs. Eyal Kayton HW/SW manager Bioness Neuromodulation Ltd.

Bioness Neuromodulation Ltd. - A Bioness Inc Company FCC ID:TVF-STRP-PP-V00 Page 1 of 3 EXTERNAL PHOTOGRAPHS This document contains 2 photographs Bioness Neuromodulation Ltd. - A Bioness Inc Company FCC ID:TVF-STRP-PP-V00 Page 2 of 3 Photograph No.1 Patient programmer front view Bioness Neuromodulation Ltd. - A Bioness Inc Company FCC ID:TVF-STRP-PP-V00 Page 3 of 3 Photograph No.2 Patient programmer rear side view

Bioness Neuromodulation Ltd. - A Bioness Inc Company FCC ID:TVF-STRP-PP-V00 Page 1 of 1 LABEL The label shown below is affixed on the rear panel of the Patient Programmer. Label location on the unit rear panel The label with FCC ID:TVF-STRP-PP-V00, will be located here. The part 15 statement required by FCC rules, paragraph 15.19 (a)(3), is inserted into the Clinician’s_guide_23171, paragraph “Conformity Certification”, page 16, provided to the user together with each unit.

Bioness Neuromodulation Ltd. - A Bioness Inc Company FCC ID:TVF-STRP-PP-V00 Page 1 of 8 INTERNAL PHOTOGRAPHS This document contains 7 photographs Bioness Neuromodulation Ltd. - A Bioness Inc Company FCC ID:TVF-STRP-PP-V00 Page 2 of 8 Photograph No.1 Patient programmer internal view Bioness Neuromodulation Ltd. - A Bioness Inc Company FCC ID:TVF-STRP-PP-V00 Page 3 of 8 Photograph No.2 Patient programmer two PCBs front view Bioness Neuromodulation Ltd. - A Bioness Inc Company FCC ID:TVF-STRP-PP-V00 Page 4 of 8 Photograph No.3 Patient programmer RF PCB front view Bioness Neuromodulation Ltd. - A Bioness Inc Company FCC ID:TVF-STRP-PP-V00 Page 5 of 8 Photograph No.4 Patient programmer RF PCB second side view Bioness Neuromodulation Ltd. - A Bioness Inc Company FCC ID:TVF-STRP-PP-V00 Page 6 of 8 Photograph No.5 Patient programmer CMC display PCB front view Bioness Neuromodulation Ltd. - A Bioness Inc Company FCC ID:TVF-STRP-PP-V00 Page 7 of 8 Photograph No.6 Patient programmer display PCB second side view Bioness Neuromodulation Ltd. - A Bioness Inc Company FCC ID:TVF-STRP-PP-V00 Page 8 of 8 Photograph No.7 Patient programmer antenna

Hermon Laboratories Ltd. Harakevet Industrial Zone, Binyamina 30500, Israel Tel. +972-4-6288001 Fax. +972-4-6288277 E-mail: [email protected] Page 1 of 54 Report ID: BIORAD_FCC.23171_PP_rev1.docx Date of Issue: 14-May-12 ELECTRICAL TESTING 0839.01 TEST REPORT ACCORDING TO: FCC 47 CFR PART 15 subpart C, section 15.249 and subpart B FOR: Bioness Neuromodulation Ltd. - A Bioness Inc Company Patient Programmer of StimRouter Peripheral Nerve Stimulator Model number: ST2-5110 FCC ID:TVF-STRP-PP-V00 This report is in conformity with ISO/ IEC 17025. The "A2LA Accredited" symbol endorsement applies only to the tests and calibrations that are listed in the scope of Hermon Laboratories accreditation. The test results relate only to the items tested. This test report shall not be reproduced in any form except in full with the written approval of Hermon Laboratories Ltd. Report ID: BIORAD_FCC.23171_PP_rev1.docx Date of Issue: 14-May-12 Page 2 of 54 Table of contents 1 Applicant information ..................................................................................................................................................... 3 2 Equipment under test attributes .................................................................................................................................... 3 3 Manufacturer information .............................................................................................................................................. 3 4 Test details .................................................................................................................................................................... 3 5 Tests summary .............................................................................................................................................................. 4 6 EUT description ............................................................................................................................................................. 5 6.1 General information ....................................................................................................................................................... 5 6.2 Changes made in the EUT ............................................................................................................................................ 5 6.3 Test configuration .......................................................................................................................................................... 5 6.4 Transmitter characteristics ............................................................................................................................................ 6 7 Transmitter tests according to 47CFR part 15 subpart C requirements ........................................................................ 7 7.1 Field strength of emissions ............................................................................................................................................ 7 7.2 Band edge emission .................................................................................................................................................... 25 7.3 Antenna requirements ................................................................................................................................................. 29 7.4 Occupied bandwidth test ............................................................................................................................................. 30 8 Emission tests according to 47CFR part 15 subpart B requirements .......................................................................... 34 8.1 Radiated emission measurements .............................................................................................................................. 34 9 APPENDIX A Test equipment and ancillaries used for tests ....................................................................................... 39 10 APPENDIX B Measurement uncertainties ................................................................................................................... 41 11 APPENDIX C Test laboratory description ................................................................................................................... 42 12 APPENDIX D Specification references ....................................................................................................................... 42 13 APPENDIX E Test equipment correction factors ......................................................................................................... 43 14 APPENDIX F Abbreviations and acronyms ................................................................................................................. 54 Report ID: BIORAD_FCC.23171_PP_rev1.docx Date of Issue: 14-May-12 Page 3 of 54 1 Applicant information Client name: Bioness Neuromodulation Ltd. - A Bioness Inc Company Address: P.O.Box 2500, 19 Ha’haroshet street, Ra’anana 43654, Israel Telephone: +972 9790 7100 Fax: +972 9748 5740 E-mail: [email protected] Contact name: Mr. Eyal Kayton 2 Equipment under test attributes Product name: Patient programmer of StimRouter Peripheral Nerve Stimulator Product type: Transceiver Model number: ST2-5110 Serial number: 5001101 Hardware version: 2.6 Software release: 2.0.1.7 Receipt date 4/17/2012 3 Manufacturer information Manufacturer name: Bioness Neuromodulation Ltd. - A Bioness Inc Company Address: P.O.Box 2500, 19 Ha’haroshet street, Ra’anana 43654, Israel Telephone: +972 9790 7100 Fax: +972 9748 5740 E-Mail: [email protected] Contact name: Mr. Eyal Kayton 4 Test details Project ID: 23171 Location: Hermon Laboratories Ltd. Harakevet Industrial Zone, Binyamina 30500, Israel Test started: 4/17/2012 Test completed: 5/13/2012 Test specification(s): FCC 47 CFR Part 15, subpart C, §15.249; subpart B §15.109 Report ID: BIORAD_FCC.23171_PP_rev1.docx Date…

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Bioness Neuromodulation Ltd. - A Bioness Inc Company FCC ID:TVF-STRP-PP-V00 Page 1 of 5 SETUP PHOTOGRAPHS This document contains 4 photographs Bioness Neuromodulation Ltd. - A Bioness Inc Company FCC ID:TVF-STRP-PP-V00 Page 2 of 5 Photograph No.1 Setup for spurious emission field strength measurements below 30 MHz in the anechoic chamber Bioness Neuromodulation Ltd. - A Bioness Inc Company FCC ID:TVF-STRP-PP-V00 Page 3 of 5 Photograph No.2 Setup for spurious emission field strength measurements from 30 MHz to 1000 MHz in the anechoic chamber Bioness Neuromodulation Ltd. - A Bioness Inc Company FCC ID:TVF-STRP-PP-V00 Page 4 of 5 Photograph No.3 Setup for carrier, spurious emission field strength and occupied bandwidth measurements from 1 to 18 GHz in the anechoic chamber Bioness Neuromodulation Ltd. - A Bioness Inc Company FCC ID:TVF-STRP-PP-V00 Page 5 of 5 Photograph No.4 Setup for field strength emission measurements at the OATS from 18 to 25 GHz