Y8L-MN0700Clinical Programmer

Patient Programmer Model MN0600 User Manual Spinal Modulation, Inc. 1135 O’Brien Drive Menlo Park, CA 94025 USA CAUTION – Investigational Device Limited by Federal (US) Law to Investigational Use Copyright © June 2011 by Spinal Modulation, Inc. All Rights Reserved. No portion of this manual may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording, or any information storage and retrieval systems, without the express written permission of Spinal Modulation, Inc. LP0015 Rev E, June 2011 SPINAL MODULATION, INC. P ATIENT PROGRAMMER USER MANUAL 2 T ABLE OF CONTENTS E XPLANATION OF SYMBOLS ON PRODUCT OR PACKAGE LABELING....................................................................... 3 G LOSSARY.............................................................................................................................................. 4 I NTRODUCTION........................................................................................................................................ 5 I NDICATIONS FOR USE...............................................................................................................................5 D ESCRIPTION........................................................................................................................................... 5 W ARNING.............................................................................................................................................. 5 P RECAUTIONS – FOR YOUR PATIENT PROGRAMMER AND YOUR STIMULATOR DEVICE............................................. 6 P RECAUTIONS – FOR YOUR THERAPY............................................................................................................ 7 P ATIENT PROGRAMMER FEATURES............................................................................................................ 10 C HARGING THE BATTERY.......................................................................................................................... 10 P ROGRAMMER POWER UP....................................................................................................................... 10 M AIN MENU......................................................................................................................................... 12 C ONNECTING TO YOUR STIMULATOR DEVICE................................................................................................ 13 P AIN CONTROL SCREEN........................................................................................................................... 15 B ACK TO MAIN MENU........................................................................................................................ 15 S ELECT GROUP.................................................................................................................................. 15 P ROGRAMMER STATUS BAR................................................................................................................. 16 A DJUSTING YOUR STIMULATOR DEVICE SETTINGS......................................................................................... 16 T URNING OFF STIMULATION................................................................................................................. 16 P AIN CONTROL TAB............................................................................................................................ 17 A DJUST STIMULATION LEVEL FOR A BODY REGION.......................................................................................17 I NFO TAB......................................................................................................................................... 18 D EVICE TAB AND PHYSICIAN TAB...............................................................................................................18 C LINIC TAB............................................................................................................................................18 U SING YOUR TNS DEVICE.................................................................................................................... 19 U SING YOUR INS DEVICE......................................................................................................................... 19 A UTHORIZED EUROPEAN REPRESENTATIVE.................................................................................................. 19 C OMPANY CONTACT INFORMATION........................................................................................................... 19 G UIDANCE AND MANUFACTURER’S DECLARATION.......................................................................................... 20 ELECTROMAGNETIC EMISSIONS............................................................................................................... 20 E LECTROMAGNETIC IMMUNITY.............................................................................................................. 21 A PPENDIX I: INS BATTERY LIFE................................................................................................................. 23 A PPENDIX II: TROUBLESHOOTING.............................................................................................................. 32 3 Explanation of Symbols on Product or Package Labeling Model Number Serial Number Read the Manual Consult the Manual Contents of Package are Non‐Sterile Manufacturing Date Manufacturer Warning. Pay attention. Protected against Electric Shock Not waterproof. Applies to the Programmer when it is not in its carrying case. Limited waterproof. Applies to the TNS. Applies to the Programmer in its carrying case. Turns the Programmer ON and OFF. Turns stimulation OFF on the TNS. Keep Dry Store between ‐10°C and 50°C (14°F and 122°F) Store between 0 and 93% humidity The device is a radio transmitter Magnet. Shows the location of the Programmer magnet. Austra…

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Clinical Programmer Model MN0700 User Manual Spinal Modulation, Inc. 1135 O’Brien Drive Menlo Park, CA 94025 USA CAUTION – Investigational Device Limited by Federal (US) Law to Investigational Use Copyright © June 2011 by Spinal Modulation, Inc. All Rights Reserved. No portion of this manual may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording, or any information storage and retrieval systems, without the express written permission of Spinal Modulation, Inc. LP0014 Rev E, June 2011 2 TABLE OF CONTENTS E XPLANATION OF SYMBOLS ON PRODUCT OR PACKAGE LABELING....................................................................... 4 I NTRODUCTION........................................................................................................................................ 5 I NDICATIONS FOR USE...............................................................................................................................5 D ESCRIPTION........................................................................................................................................... 5 W ARNINGS............................................................................................................................................. 6 P RECAUTIONS......................................................................................................................................... 7 C LINICAL PROGRAMMER SYSTEM OVERVIEW................................................................................................. 8 C LINICAL PROGRAMMER FEATURES.............................................................................................................. 8 M AGNET................................................................................................................................................ 9 C HARGING THE CLINICAL PROGRAMMER BATTERY........................................................................................... 9 P ROGRAMMER POWER UP....................................................................................................................... 10 M AIN MENU......................................................................................................................................... 10 D EMO................................................................................................................................................. 10 P ROGRAMMER SETUP............................................................................................................................. 10 C HANGE THE DATE.................................................................................................................................11 C HANGE THE TIME.................................................................................................................................11 S WITCH TO FCE PROGRAMMER...............................................................................................................11 E STABLISHING COMMUNICATION WITH THE NS DEVICE.................................................................................. 11 B ACK TO MAIN MENU............................................................................................................................ 12 N AVIGATION AND SCREEN ELEMENTS.......................................................................................................... 12 N EUROSTIMULATOR DASHBOARD.............................................................................................................. 12 P ROGRAMMER STATUS BAR..................................................................................................................... 13 W ORKSPACE NAVIGATION....................................................................................................................... 13 T EMPORARY AND PERMANENT PROGRAMMING........................................................................................... 14 M ORE ON EDITING TEXT FIELDS................................................................................................................. 14 U SING THE WORKSPACES......................................................................................................................... 15 P ROFILE WORKSPACE.............................................................................................................................. 15 P ATIENT INFORMATION TAB [PROFILE >PATIENT] .......................................................................................15 C LINIC INFORMATION TAB [PROFILE >CLINIC].............................................................................................16 S TIMULATOR INFORMATION TAB [PROFILE >NS] ........................................................................................16 L EADS INFORMATION TAB [PROFILE >LEADS] .............................................................................................17 S YSTEM INFORMATION TAB [PROFILE >SYSTEM].........................................................................................17 S TIM WORKSPACE.................................................................................................................................. 18 S TIM TABS [STIM >TARGET NAME] ..........................................................................................................18 I MPEDANCE TABS [STIM >IMPEDANCE].....................................................................................................21 M AP WORKSPACE.................................................................................................................................. 21 G ROUP WORKSPACE...............................................................................................................................21 L EAD TABS [GROUP >GROUP NAME].....................................................................................................…

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Worldwide Testing and Certification Nemko USA, Inc. Dallas Division 802 N. Kealy, Lewisville, TX USA Tel: +1 972 436-9600 Fax: +1 972 436-2667 Website: www.nemkona.com 21 nd June 2011 To Whom it May Concern: In re.: FCC ID. Y8L-MN0700 EA811549 Please consider the following exhibits associated with the above filing to supercede status. Name Type Date submitted File type Size block diagram Block Diagram 06/01/2011 pdf 11530 use this block diagram Block Diagram 06/01/2011 pdf 16642 Agent letter Cover Letter 06/01/2011 pdf 20527 model diff letter Cover Letter 06/02/2011 pdf 20973 confidentiality letter Cover Letter 06/01/2011 pdf 20189 external photos External Photos 06/01/2011 pdf 214488 label ID Label/Location info. 06/01/2011 pdf 42965 also use this label ID Label/Location info. 06/01/2011 pdf 73130 use this label exhibit ID Label/Location info. 06/01/2011 pdf 97598 internal photos Internal Photos 06/01/2011 pdf 214488 use this oper. desc. Operational Description 06/02/2011 pdf 73475 operational description Operational Description 06/01/2011 pdf 23369 parts list Parts List/Tuneup Info 06/01/2011 pdf 24045 use this parts list Parts List/Tuneup Info 06/02/2011 pdf 22785 use this parts list too Parts List/Tuneup Info 06/02/2011 pdf 24045 rf exposure prediction RF Exposure Info 06/01/2011 pdf 50428 schematic Schematics 06/01/2011 pdf 56663 use this schematic Schematics 06/02/2011 pdf 282184 test report Test Report 06/01/2011 pdf 276361 use this test report Test Report 06/02/2011 pdf 282086 listen before talk test report Test Report 06/02/2011 pdf 1171753 test setup photos Test Setup Photos 06/01/2011 pdf 357848 users manual Users Manual 06/01/2011 pdf 942365 use this manual Users Manual 06/02/2011 pdf 942365 Best regards, Tom Tidwell Nemko USA, Inc.

Spinal Modulation http://www.spinalmodulation.com/ 1135 O’Brien Dr. Direct: 650 543-6800 Menlo Park, CA 94025 Fax: 650 327-2336 FCC OET – Office of Engineering and Technology Equipment Authorization Branch FCC ID: Y8L-MN0700 Model: MN0600 FCC ID: Y8L-MN0700 Model: MN0700 Authority to Act as Agent FCC On our behalf, I appoint Tom Tidwell of Nemko USA, Inc. at 802 N Kealy Avenue, Lewisville TX 75057 to act as our agent in the preparation of this application for equipment certification. I certify that submitted documents properly describe the device or system for which equipment certification is sought. I also certify that each unit manufactured, imported or marketed, as defined in FCC regulations will have affixed to it a label identical to that submitted for approval with this application. In signing this letter, Applicant certifies that neither the applicant nor any party to the application is not subject to a denial of Federal benefits, that include FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. § 862 because of a conviction for possession or distribution of a controlled substance. See 47 CFR 1.2002(b) for the definition of a "party" for these purposes. For instances where our authorized agent signs the application for certification on our behalf, I acknowledge that all responsibility for complying with the terms and conditions for certification still resides Spinal Modulation, 1135 O’Brien Drive, Menlo Park, CA, 94025. Dated this 28 Day of January 20 11 Agency agreement expiration date: October 1, 2011 James G. Judkins Printed Title: Principal Engineer On behalf of : Spinal Modulation, Inc. Telephone: 650 543-6838

Spinal Modulation http://www.spinalmodulation.com/ 1135 O’Brien Dr. Direct: 650 543-6800 Menlo Park, CA 94025 Fax: 650 327-2336 Nemko Canada Inc 303 River Road Ottawa, Ontario, Canada K1V 1H2 Attn: Director of Certification: FCC Model Differences Letter. Spinal Modulation, Inc. products: MN0100 Trial Neurostimulator (TNS) MN0200 Implantable Neurostimulator (INS) MN0600 Patient Programmer (Note: same bill of materials as MN0700) MN0700 Clinical Programmer Three products were tested at Nemko, San Diego; MN0100, MN0200, and MN0700. The MN0600 Patient Programmer is electrically and mechanically identical, using the same bill of materials as the MN0700. The MN0600 difference is the User Interface software with limited neurostimulation control features. FCC Grantee Code: Y8L FCC ID numbers SMI Model Numbers Description Y8L-MN0100 MN0100 Trial Neurostimulator (TNS) Y8L-MN0200 MN0200 Implantable Neurostimulator (INS) Y8L-MN0700 MN0600 Patient Programmer Y8L-MN0700 MN0700 Clinical Programmer Jim Judkins Principal Engineer Spinal Modulation 1135 O’Brien Dr. Menlo Park, CA 94025 http://www.spinalmodulation.com/ Direct: 650 543-6838 Fax: 650 327-2336

Spinal Modulation http://www.spinalmodulation.com/ 1135 O’Brien Dr. Direct: 650 543-6800 Menlo Park, CA 94025 Fax: 650 327-2336 Nemko Canada Inc 303 River Road Ottawa, Ontario, Canada K1V 1H2 Attn: Director of Certification: 1/28/2011 Model: MN0600, MN0700 Re: Request of Confidentiality for FCC ID#: Y8L-MN0700 Pursuant to Sections 0.457(d)(I)(ii) and 0.459 of the Commission’s Rules, the Applicant hereby requests confidential treatment of information accompanying as outlined below: Schematics, Parts List, Operating Description, Block Diagrams The above materials contain trade secrets and proprietary information not customarily released to the public. The public disclosure of these matters might be harmful to the Applicant and provide unjustified benefits to its competitors. The Applicant understands that pursuant to Rule 0.457(d)(I)(ii), disclosure of this Application and all accompanying documentation will not be made before the date of the Grant for this Application. Sincerely, Jim Judkins Principal Engineer Spinal Modulation 1135 O’Brien Dr. Menlo Park, CA 94025 http://www.spinalmodulation.com/ Direct: 650 543-6838 Fax: 650 327-2336

Spinal Modulation http://www.spinalmodulation.com/ 1135 O’Brien Dr. Direct: 650 543-6800 Menlo Park, CA 94025 Fax: 650 327-2336 Spinal Modulation Programmer Models: Clinical Programmer MN0700 and Patient Programmer MN0600

MN0600 Patient Programmer: Draft Label Artwork Actual Size View of Printed Label (Red line will not be visible) Top View LP0288 Rev B, April 2011 Bottom View Label Placement. Note: C linical Programmer label shown, same as Patient Programmer.

MN0700 Clinical Programmer: Draft Label Artwork Actual Size View of Printed Label (Red line will not be visible) Top View Bottom View Label Placement.

Spinal Modulation http://www.spinalmodulation.com/ 1135 O’Brien Dr. Direct: 650 543-6800 Menlo Park, CA 94025 Fax: 650 327-2336 Spinal Modulation Programmer Models: Clinical Programmer MN0700 and Patient Programmer MN0600 Spinal Modulation http://www.spinalmodulation.com/ 1135 O’Brien Dr. Direct: 650 543-6800 Menlo Park, CA 94025 Fax: 650 327-2336 Spinal Modulation Programmer Models: Basestation Printed Circuit Board: Clinical Programmer MN0700 and Patient Programmer MN0600 Top Bottom Top. Shields Removed.

SPINAL MODULATION, INC DOCUMENT TYPE: VERIFICATION REPORT VR#: 167-1 TITLE: LISTEN BEFORE TALK TEST REPORT Rev: B VR167-1 Rev B Page 1 of 27 REVISION HISTORY Rev Change Description CO Effective Date By A Initial Release. CO1395 1/19/11 Jim Judkins B Added measurement uncertainty analysis, appendix. Changed to format FM130. CO1598 3/21/11 Jim Judkins SPINAL MODULATION, INC DOCUMENT TYPE: VERIFICATION REPORT VR#: 167-1 TITLE: LISTEN BEFORE TALK TEST REPORT Rev: B VR167-1 Rev B Page 2 of 27 TABLE OF CONTENTS 1. PURPOSE..............................................................................................................................................3 2. SCOPE...................................................................................................................................................3 3. REFERENCE DOCUMENTS....................................................................................................................3 3.1. SMI Reference Documents..........................................................................................................3 3.2. Regulatory Agency Documents ...................................................................................................3 4. DEFINITIONS........................................................................................................................................4 5. SUMMARY OF TEST RESULTS AND CONCLUSIONS.............................................................................4 5.1. Test Results Summary .................................................................................................................4 5.2. Protocol Deviations .....................................................................................................................4 5.3. Conclusions..................................................................................................................................4 5.4. Signatures of Test Personnel.......................................................................................................4 6. EQUIPMENT AND SUPPLIES.................................................................................................................5 7. SAMPLE SIZE AND JUSTIFICATION.......................................................................................................6 8. TEST PROCEDURE AND RESULTS.........................................................................................................6 8.1 Circuit Description .......................................................................................................................6 9. APPENDIX:...............................................................................................................................................19 10. APPENDIX:.............................................................................................................................................24 MEASUREMENT CALIBRATION AND UNCERTAINTY ANALYSIS.................................................................24 SPINAL MODULATION, INC DOCUMENT TYPE: VERIFICATION REPORT VR#: 167-1 TITLE: LISTEN BEFORE TALK TEST REPORT Rev: B VR167-1 Rev B Page 3 of 27 1. PURPOSE This Report describes the MICS/MedRadio Listen Before Talk testing to be performed on the SMI Programmer Basestation Monitoring system. The Clinical Programmer MN0700 (FD0038) and Patient Programmer MN0600 (FD0039) share an identical BOM. This test will satisfy the Listen Before Talk Monitoring for both systems. This test will be performed by SMI personnel. System Description The Spinal Modulation (SMI) MICS/MedRadio 402 to 405 MHz system is required to scan all of its channels and select the lowest ambient channel prior to initiating an RF link (transmitting). The MICS/MedRadio system uses a master-slave type communication where the handheld Programmer initiates all RF communication. The Implantable NeuroStimulator (INS) or Temporary NeuroStimulator (TNS) respond to the Programmer RF link and are not permitted to initiate a RF link. SMI does not use any of the allowed special emergency transmissions from the INS or TNS. SMI uses the Least Interfered Channel (LIC) method and not the LBT threshold power level. 2. SCOPE This document describes the testing of the Listen Before Talk (LBT) report required by applicable parts of MICS standard EN 301 839-1, EN 301 839-2 Clause 10 and MedRadio FCC Part 95.628.a. The SMI radio system uses the Least-Interfered-Channel (LIC). It does not use pre-scanned alternate channel and this test will not be performed. The tests were conducted using printed circuit board assemblies using coaxial cables for RF connection to the antenna test port connector for RF and a RSSI sample port . 3. REFERENCE DOCUMENTS 3.1. SMI Reference Documents VP074 V & V Plan Neurostimulator System PS1300 Product Requirements Specification Connector Cable HW015 Hardware Requirements Specification Programmer OP033 Design Verification FM130 Report Template ER079 SMI Standard Terminology Definitions and Acronyms 3.2. Regulatory Agency Documents EN 301 839-1 Electromagnetic compatibility and Radio spectrum Matters (ERM); Short Range Devices (SRD); Ultra Low Power Active Medical Implants (ULP-AMI) and Peripherals (ULP-AMI-P) operating in the frequency range 402 MHz to 405 MHz; Part 1: Technical characteristics and test methods SPINAL MODULATION, INC DOCUMENT TYPE: VERIFICATION REPORT VR#: 167-1 TITLE: LISTEN BEFORE TALK TEST REPORT Rev: B VR167-1 Rev B Page 5 of 27 6. EQUIPMENT AND SUPPLIES Refer to table in section 5 of attached VP167 Rev. A LISTEN BEFORE TALK TEST PROTOCOL. Equipment Manuf. Model Number Serial Number SW/FW Version Date of Next Calibration (if required) BS2 PCBA SMI AD1480 Rev.3 201270 SW1021 Rev. 3 N/A BS2 PCBA SMI AD1480 201271 SW1004 Rev. A N/A PC Dell PC 100041 N/A N/A Power Supply HP E3610A KR7531857 9 N/A N/A 20 dB Directional coupler Mini-ckts ZFDC-20-4L N/AN/A N/A 20 dB Directional coupler Mini-ckts ZFDC-20-…

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Nemko USA, Inc. 11696 Sorrento Valley Rd., Suite F San Diego, CA 92121-1024 Phone (858) 755-5525 Fax (858) 452-1810 Page 1 of 20 CERTIFICATION TEST REPORT In Accordance With: FCC Part 95 Subpart I Applicant: Spinal Modulation Inc. 1135 O’Brien Dr. Menlo Park, CA 94025 Equipment Under Test (EUT): Clinical Programmer Model: MN0700, MN0600 FCC ID: Y8L-MN0700 Tested By: Nemko USA Inc. 11696 Sorrento Valley Road, Suite F San Diego, CA 92121 P REPARED ON January 17, 2011 REPORT NUMBER: 2011 01160678 FCC1 PROJECT NUMBER: 53259 NEx Number: 160678 Total Number of Pages: 20 Nemko USA, Inc. 11696 Sorrento Valley Road, Suite F, San Diego, CA 92121 Phone (858) 755-5525 Fax (858) 452-1810 FCC ID: Y8L-MN0700 Report Number: 2011 01160678 FCC1 Page 2 of 20 1. Section1: Summary of Test Results 1.1 General All measurements are traceable to national standards These tests were conducted on a sample of the equipment for the purpose of demonstrating compliance with FCC Part 95 Subpart I. Radiated tests were conducted is accordance with ANSI C63.4-2003. Radiated emissions are made on an open area test site. A description of the test facility is on file with the FCC. The assessment summary is as follows: Apparatus Assessed: Clinical Programmer Model: MN0700 Serial: EB0664 Specifications: FCC Part 95 Subpart I Date Received in Laboratory: January 4, 2011 Compliance Status: Complies Exclusions: None Non-compliances: None Nemko USA, Inc. 11696 Sorrento Valley Road, Suite F, San Diego, CA 92121 Phone (858) 755-5525 Fax (858) 452-1810 FCC ID: Y8L-MN0700 Report Number: 2011 01160678 FCC1 Page 3 of 20 1.2 Document History REVISION DATE COMMENTS - January 17, 2011 Prepared By: Alan Laudani - January 17, 2011 Initial Release: Alan Laudani Note that the results contained in this report relate only to the items tested and were obtained in the period between the date of initial receipt of samples and the date of issue of the report. This test report has been completed in accordance with the requirements of ISO/IEC 17025. Nemko USA Inc. authorizes the applicant to reproduce this report provided it is reproduced in its entirety and for use by the company’s employees only. Any use which a third party makes of this report, or any reliance on or decisions to be made based on it, are the responsibility of such third parties. Nemko USA Inc. accepts no responsibility for damages, if any, suffered by any third party as a result of decisions made or actions based on this report. TESTED BY: _ Date: January 17, 2011 Alan Laudani, RF/EMC Engineer Nemko USA, Inc. 11696 Sorrento Valley Road, Suite F, San Diego, CA 92121 Phone (858) 755-5525 Fax (858) 452-1810 FCC ID: Y8L-MN0700 Report Number: 2011 01160678 FCC1 Page 4 of 20 TABLE OF CONTENTS 1. Section1: Summary of Test Results ..................................................................... 2 1.1 General ................................................................................................................ 2 1.2 Document History ................................................................................................. 3 2. Section 2: Equipment Under Test ........................................................................ 5 1.3 Product Identification ............................................................................................ 5 1.4 Technical Specifications of the EUT ..................................................................... 5 3. Section 3: Test Conditions ................................................................................... 6 3.1 Test Environment ................................................................................................. 6 3.2 Test Equipment .................................................................................................... 6 4. Section 4: Observations ....................................................................................... 7 4.1 Modifications Performed During Assessment ....................................................... 7 4.2 Record Of Technical Judgments .......................................................................... 7 4.3 EUT Parameters Affecting Compliance ................................................................ 7 4.4 Test Deleted ......................................................................................................... 7 4.5 Additional Observations ....................................................................................... 7 5. Section 5: Results Summary ................................................................................ 8 5.1. Test Result summary table ................................................................................... 8 6. Appendix A: Test Results ..................................................................................... 9 A1. Frequency Monitoring .......................................................................................... 9 A2. Frequency vs Temperature ................................................................................ 11 A3. Emission Bandwidth ...............................…

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