Y8L-MN0100Trial Neurostimulator

Trial Neurostimulator Model MN0100 Draft Physician Manual Spinal Modulation, Inc. 1135 O’Brien Drive Menlo Park, CA 94025 USA Copyright © Month 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 photocopy-ing, recording, or any information storage and retrieval systems, without the express written permission of Spinal Modulation, Inc. Table of Contents Explanation of Symbols on Product or Package Labeling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 TNS Device Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 Stimulation OFF Switch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 3 Explanation of Symbols on Product or Package Labeling Model Number Serial Number Read the Instructions for Use Contents of Package are Non-Sterile Manufacturing Date Manufacturer Warning. Pay attention. Turns all stimulation off on the TNS. Protected against Electric Shock Device is a Radio Transmitter Consult the Instructions for Use Limited Waterproof 4 Symbols, cont. Store between –10°C and 50°C Store between 0 and 93% humidity Keep Dry Diathermy – High energy heat: used to cut or cauterize during surgery, or a type of therapy. Electromagnetic Interference (EMI) – Electrical signals that interfere with the device function. MRI (Magnetic Resonance Imaging) – Medical imaging: produces electronic images of tissues and organs. Paresthesia – Tingling sensation felt during therapy delivery: produced by spinal cord stimulation. Precaution – Situations of which the patient should be aware in order to avoid uncomfortable stimu- lation and possible damage to the TNS device. Program – Instructions or changes to stimulation settings that are programmed into the Programmer and transmitted to the TNS device. Spinal Cord Stimulation – Electrical pulses applied to the spinal cord to block pain signals to the brain. Stimulation – A pain therapy reference to small electrical pulses felt as a tingling sensation that replaces pain signals. Stimulation Level – Measure of stimulation: can be increased or decreased within a range specified by the clinician. Warning – Potentially serious hazard to be aware of to avoid situations that could cause injury or death . 5 Introduction This manual describes the care and use of the Trial Neurostimulator (MN0100). Indications For Use The Spinal Modulation Trial Neurostimulator System is intended as an aid in the management of chronic pain. Contraindications Patients contraindicated for the Spinal Modulation Trial Neurostimulator System are those who: Have an active implantable medical device including but not limited to cardiac pacemakers and cardiac defibrillators Are unable to operate the system Are poor surgical risks Are pregnant Are under the age of 18 Description The Trial Neurostimulator (TNS) attaches to the Connector Cable and delivers energy to the trial leads. The TNS has a female locking connector that attaches to the Connector Cable, a standby button that disables stimulation and a clip for the patient to attach the TNS to their belt or waist-band. 6 The output ranges for the system are: FREQUENCY BAND: The TNS device uses the one frequency band designated specifically for implanted medical devices; the Medical Implant Communications Service (MICS) to communicate with the Programmers. The MICS band operates from 402 MHz to 405 MHz. The Listen Before Talk (LBT) protocol allows mu ltiple pieces of equipment in the location to communicate at the same time without interference. The Clinical and Patient Programmers are used to communicate with the Trial Neurostimulator. The Clinical Programmer is used to program the stimulation parameters in the TNS, as determined by the physician. The TNS device delivers the programmed stimula-tion parameters (energy) to the Leads. The Patient Programmer is easy to use and allows the patient to adjust the stimulation level within limits preset by the physician. It allows the patient to turn stimulation off . The Clinical and Patient Programmers are portable, hand-held devices powered by internal batteries. The batteries are rechargeable using Programmer Charger MN3400 (provided) and a power outlet. Parameter Range Frequency (Hz) 4 – 100 Pulse Width (μs) 40 – 720 Amplitude (μA) 50 – 6000 7 Both Programmers come with a carrying case and should be kept dry. Images depicting the compo-nents of the Spinal Modulation TNS System are shown in Figure 1.  The patient must be trained by their doctor before using the Patient Programmer and the NS device.  The patient must not use their Patient Programmer until their doctor has set up the NS System.  The patient must not undergo any elective magnetic resonance imaging (MRI). If MRI is necessary, the doctor should remove any lead(s) and disconnect t…

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Trial Neurostimulator Model MN0100 Physician Manual Spinal Modulation, Inc. 1135 O’Brien Drive Menlo Park, CA 94025 USA Copyright © June 2011 by Spinal Modulation, Inc. A ll Rights Reserved. No portion of this manual may be reproduced or transmitted in any form or by any means, electronic or mec hanical, including photocopying, re- cording, or any informati on storage and retrieval systems, without the express written permission of Spinal Modula- tion, Inc. LP0010 Draft August 2011 Table of Contents Explanation of Symbols on Product or Package Labeling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 TNS Device Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 Stimulation OFF Switch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 Magnet Activation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 TNS Device Care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 RF Operating Frequencies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . 15 Authorized European Representative . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 Company Contact Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 Appendix I: Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 CAUTION – Investigational Device. Limited by Federal (US) Law to Investigational Use 3 Explanation of Symbols on Product or Package Labeling Model Number Serial Number Read the Instructions for Use Contents of Package are Non-Sterile Manufacturing Date Manufacturer Warning. Pay attention. Turns all stimulation off on the TNS. Protected against Electric Shock Device is a Radio Transmitter Consult the Instructions for Use Limited Waterproof 4 Symbols, cont. Glossary Lead – Surgical wire: takes electrical signals from the neur ostimulator to the stimulation area near the spine. NS – Neurostimulator: stimulator device that creates el ectrical signals to stimulate the neural structures. Refers to either the Trial Neurostimulato r or the Implantable Neurostimulator. TNS – Trial Neurostimulator: external NS that attaches to the connecto r cable which is connected to leads. INS – Implantable Neurostimulator: NS implanted in the back or ab domen and connected to the leads. Connector Cable – Connects the implanted leads to the TNS. Patient Programmer – Portable, hand-held device: allows the patien t to modify the stimulation settings. Clinical Programmer – Portable, hand-held device: used by the clinician to program the NS device. Computer Tomography (CT) Imaging – Computerized X-ray imaging: pro duces electronic images of tissues and organs. Store between –10°C and 50°C Store between 0 and 93% humidity Keep Dry Diathermy – High energy heat: used to cut or cauteriz e during surgery, or a type of therapy. Electromagnetic Interference (EMI) – Electrical signals that interfere with the device function. MRI (Magnetic Resonance Imaging) – Medical imaging: produces electr onic images of tissues and organs. Paresthesia – Tingling sensation felt duri ng therapy delivery: produced by spinal cord stimulation. Precaution – Situations of which the pati ent should be aware in order to av oid uncomfortable stimulation and possible damage to the TNS device. Program – Instructions or changes to stimulation setti ngs that are programmed into the Programmer and transmitted to the TNS device. Spinal Cord Stimulation – Electrical pulses applied to the spinal cord to block pain signals to the brain. Stimulation – A pain therapy reference to sma ll electrical pulses felt as a ti ngling sensation that replaces pain signals. Stimulation Level – Measure of stimulation: can be increased or decreased within a range specified by the clinician. Warning – Potentially serious hazard to be aware of to avoid situations that c ould cause injury or death . 5 Introduction This manual describes the care and use of the Trial Neurostimulator (MN0100). Indications For Use The Spinal Modulation Trial Neurostimulator System is intended as an aid in the management of chronic, intractable, neuropathic pain of the lower limbs-including unilateral or bilateral pain, associated with the following conditions: radicular pain, peripheral neuropathies. Contraindications Patients contraindicated for the Spinal Modulati on Trial Neurostimulator System are those who: Have an active implantable medical dev ice including but not limited to cardiac pacemakers and cardiac defibrillators Are unable to operate the system Are poor surgical risks Are pregnant Are under the age of 18 Description The Trial Neurostimu…

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Spinal Modulation http://www.spinalmodulation.com/ 1135 O’Brien Dr. Direct: 650 543-6800 Menlo Park, CA 94025 Fax: 650 327-2336 August 16, 2011 Federal Communications Commission 7435 Oakland Mills Rd. Columbia, MD 21036 Re: Correspondence Reference Number: 40106; 8/1/2011 731 Conformation Number: EA151513 Subject: Item 2; MPE document filed and application of 95.1221 The medical body-worn transmitter is subject to radio frequency radiation exposure evaluation, as appropriate (95.1221). Implant devices must contain a FDTD computational modeling report (95.1221); “Applications for equipment authorization of implant devices operating under this section must contain a finite difference time domain (FDTD) computational modeling report showing compliance with these provisions for fundamental emissions”. The MN0100 is not an implant, and according to 95.1221 would not require FDTD computational modeling report. The MN0100 is a temporary external MedRadio used to evaluate the efficacy of a more permanent implant device according to 95.628(c) (4). While the device is not categorically excluded according to 1.1307 and 2.1093 radio frequency radiation exposure evaluation, the mitigating technical factors below provide an acceptable radio frequency radiation exposure evaluation. We would also claim that the device:  Required to be worn outside the patients clothing (MN0100 Manual, Page 10, 1 st paragraph).  The antenna is 1cm away from the body; on the opposite side of the belt clip.  Meets the “SUPPLEMENT C Edition 01-01 to OET BULLETIN 65 Edition 97- 01” of < 50 mW; body contact to 2.5 cm away from the body. (Section 3, Page 16, footnote 14),  Required to be less than 200 nW EIRP by 95.628(c) (4) (iii). The MN0100 does comply with IEEE C95.1 1991 and 2005. The MPE document filed for the MN0100 is not applicable. Mitigating Technical Factors: 1. In order to meet the FCC 95.628(c) (4) (iii) requirement of less than 200 nW EIRP, the MN0100 conducted input power to the antenna must be < -21.5 dBm, or 7 uW. The antenna is physically unable to achieve 0.2 mW/cm² IEEE C95.1 1991 limit with a maximum 7 uW antenna input, or SAR Partial Body value of 1.6 W/kg averaged over 1 g of tissue volume in the shape of a cube; that equals approximately 1 cm³. a. SAR limit of 1.6W/kg divided by 1000 = 1.6 mW/g. b. Or in human body tissue; 1.6 mW/cm³ limit. c. The density of human body tissue is similar to that of water; 1g ≈ 1 cm³. Spinal Modulation http://www.spinalmodulation.com/ 1135 O’Brien Dr. Direct: 650 543-6800 Menlo Park, CA 94025 Fax: 650 327-2336 Maximum SAR the MN0100 could possibly develop is 7uW/g if all the power conducted into the antenna was deposited into 1 g (1 cm³) of human tissue. The MN0100 is more than 100 times less than the permissible limit to IEEE C95.1 1991 or 2005 edition. 2. Limited communication. Estimated communication is twice per day for 1 minute each time. Duty cycle for that communication is much less than 25%, or 30 seconds per day. a. Highest possible duty cycle is 50% during communication, typically 1 second burst, every few seconds, for approximately 2 minutes per day. b. The worst case maximum duty cycle is 17% over a 6 minute period for a full firmware download that may occur once over the 3 year estimated lifespan of the device. Sincerely, Jim Judkins Principal Engineer Spinal Modulation 1135 O’Brien Dr. Menlo Park, CA 94025

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 ID: Y8L-MN0100 Model: MN0100 Authority to Act as Agent On our behalf, I appoint Alan Laudani of Nemko USA Inc., 11696 Sorrento Valley Rd, San Diego, CA, USA 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 Federal Communication Commission’s regulations will have affixed to it a label identical to that submitted for approval with this application. 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, as specified by Nemko Canada Inc, still resides with 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 By: James G. Judkins Printed Title: Principal Engineer On behalf of : Spinal Modulation, Inc. Telephone: 650 543-6838

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-MN0100 EA 151513 Please mark 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 11393 use this block diagram Block Diagram 06/01/2011 pdf 16584 agent letter Cover Letter 06/01/2011 pdf 20534 confidentiality letter Cover Letter 06/01/2011 pdf 20180 external photos External Photos 06/01/2011 pdf 140452 label ID Label/Location info. 06/01/2011 pdf 147860 use this label exhibit ID Label/Location info. 06/01/2011 pdf 46955 internal photos Internal Photos 06/01/2011 pdf 140452 oper. desc. Operational Description 06/01/2011 pdf 23131 parts list Parts List/Tuneup Info 06/01/2011 pdf 59236 RF exposure prediction RF Exposure Info 06/01/2011 pdf 50426 schematics Schematics 06/01/2011 pdf 151714 use this schematic Schematics 06/01/2011 pdf 403958 test report Test Report 06/01/2011 pdf 279736 use this one--approved Test Report 06/01/2011 pdf 280287 use this manual Users Manual 06/01/2011 pdf 565402 physicians manual Users Manual 06/01/2011 pdf 630130 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-MN0100 Model: MN0100 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: 1/28/2011 Model: MN0100 Re: Request of Confidentiality for FCC ID#: Y8L-MN0100 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 Trial Neurostimulator (TNS) MN0100

MN0100 TNS Draft Label Artwork Actual Size View of Printed Label (Blue line will not be visible) LP0287 Rev A, April 2011

Spinal Modulation http://www.spinalmodulation.com/ 1135 O’Brien Dr. Direct: 650 543-6800 Menlo Park, CA 94025 Fax: 650 327-2336 Trial Neurostimulator (TNS) MN0100 Spinal Modulation http://www.spinalmodulation.com/ 1135 O’Brien Dr. Direct: 650 543-6800 Menlo Park, CA 94025 Fax: 650 327-2336 Trial Neurostimulator (TNS) MN0100 Top Bottom

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 19 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): Trial Neurostimulator Model: MN0100 FCC ID: Y8L-MN0100 Tested By: Nemko USA Inc. 11696 Sorrento Valley Road, Suite F San Diego, CA 92121 P REPARED ON January 17, 2011 R EPORT NUMBER: 2011 01160678 FCC3 PROJECT NUMBER: 53259 NEx Number: 160678 Total Number of Pages: 19 Nemko USA, Inc. 11696 Sorrento Valley Road, Suite F, San Diego, CA 92121 Phone (858) 755-5525 Fax (858) 452-1810 FCC ID: Y8L-MN0100 Report Number: 2011 01160678 FCC3 Page 2 of 19 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: Trial Neurostimulator Model: MN0100 Serial: See Data Sheets for Specific Serial Numbers 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-MN0100 Report Number: 2011 01160678 FCC3 Page 3 of 19 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-MN0100 Report Number: 2011 01160678 FCC3 Page 4 of 19 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 - Not Required ................................................................. 9 A2. Frequency vs Temperature ................................................................................ 10 A3. Emission Bandwidth ........................................................................................... 12 A4. Unwanted Radiation ........................................................................................... 14 A5. Maximum Transmitter Power ............................................................................. 17 A6. Emission Types .................................................................................................. 19 Nemko USA, Inc. 11696 Sorrento Valley Road, Suite F, San Diego, CA 92121 Phone (858) 755-5525 Fax (858) 452-1810 FCC ID: Y8L-MN0100 Report Number: 2011 01160678 FCC3 Page 5 of 19 2. Section 2: Equipment Under Test 1.3 Product Identification The Equipment Under Test was identified as follows: Description Serial No. Trial Neurostimulator Model: MN0100 See Data Sheets for Specific Serial Numbers 1.4 Technical Specifications of the EUT Manufacturer: Spinal Modulation …

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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 19 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): Trial Neurostimulator Model: MN0100 FCC ID: Y8L-MN0100 Tested By: Nemko USA Inc. 11696 Sorrento Valley Road, Suite F San Diego, CA 92121 P REPARED ON January 17, 2011 R EPORT NUMBER: 2011 01160678 FCC3 PROJECT NUMBER: 53259 NEx Number: 160678 Total Number of Pages: 19 Nemko USA, Inc. 11696 Sorrento Valley Road, Suite F, San Diego, CA 92121 Phone (858) 755-5525 Fax (858) 452-1810 FCC ID: Y8L-MN0100 Report Number: 2011 01160678 FCC3 Page 2 of 19 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: Trial Neurostimulator Model: MN0100 Serial: See Data Sheets for Specific Serial Numbers 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-MN0100 Report Number: 2011 01160678 FCC3 Page 3 of 19 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: _ Dat…

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