Y8L-MN0200Implantable Neurostimulator

Axium ™ Neurostimulator System Physician Implant Manual Spinal Modulation, Inc. 1135 O’Brien Drive Menlo Park, CA 94025 USA Copyright © September 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. LP0275 Rev B, September 2011 TM Spinal Modulation, Inc. Physician Implant Manual i Contents Explanation of Symbols on Product or Package Labeling................................................. 4 INTRODUCTION............................................................................................................................ 5 System Overview ............................................................................................................ 6 Indications for Use.......................................................................................................... 7 Contraindications............................................................................................................ 7 SYSTEM DESCRIPTION.................................................................................................................... 7 Trial Neurostimulator (TNS) ............................................................................................ 9 Implantable Neurostimulator (INS)................................................................................. 9 Implant Leads / Trial Leads / Lead Extension..................................................................10 Connector Cable Kit .......................................................................................................10 Lead Accessories ............................................................................................................10 Implantation Tools.........................................................................................................11 Additional Accessories ...................................................................................................11 Clinical Programmer and Patient Programmer...............................................................11 Sterilization Information................................................................................................12 Storage Conditions.........................................................................................................12 Product Materials ..........................................................................................................12 S AFETY INFORMATION..................................................................................................................13 • General Warnings .................................................................................................13 • Warnings – For Use in Home or Work Environments.............................................15 • Precautions...........................................................................................................16 Adverse Events ..............................................................................................................17 I MPLANTING THE NEUROSTIMULATOR SYSTEM...................................................................................18 • Precautions for the Implant Procedure .................................................................18 Selection of Neurostimulator Trial Approach .................................................................19 Preparing the Patient and Devices for Use .....................................................................20 Placing the Lead.............................................................................................................20 Intraoperative Testing....................................................................................................25 Removing the Delivery System Components – Percutaneous Lead Trial.........................26 Lead Anchoring – Percutaneous Lead Trial.....................................................................28 Neurostimulation Trial –Percutaneous Lead Trial...........................................................28 Removing Trial Lead –Percutaneous Lead Trial..............................................................29 Removing the Delivery System Components – Implant Lead Trial Only..........................29 Lead Anchoring ..............................................................................................................31 Spinal Modulation, Inc. Physician Implant Manual ii Percutaneous Extension Tunneling – Implant Lead Trial Only........................................32 Removing Lead Extension – Implant Lead Trial Only......................................................33 Creating the INS Pocket – Implant..................................................................................34 Lead or Extension Tunneling ..........................................................................................35 Connecting Lead to Extension ........................................................................................35 Connecting the INS.........................................................................................................36 Implanting the INS .........................................................................................................37 Checking System Integrity..............................................................................................38 Completing the Procedure .............................................................................................38 REPLACING AN INS......................................................................................................................38 Disposing of an Explanted Device...................................................................................39 A PPENDIX…

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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 September 1, 2011 Federal Communications Commission 7435 Oakland Mills Rd. Columbia, MD 21036 Re: Correspondence Reference Number: 40144; 8/4/2011 731 Conformation Number: EA439873 Subject: Item 4; Medical Implant EIRP Measurements. 4.) Section 95.628(g)(3)(i). The FCC will accept radiated measurements performed without a body simulator for this specific application filing. However, confirmation that operation of the device at the authorized power level has been validated in situ, in the form of an attestation or test results, is requested. Please be reminded that any post-grant transmit power increase would require a new FCC ID. The Spinal Modulation medical implant MN0200 EIRP has been verified in-situ. We have determined that testing in air is the worst case and the MN0200 EIRP is approximately 10 dB higher in air than in human body simulator. The testing at Nemko further verified the MN0200 will be in FCC compliance when operated in air on some special occasions.  Functional checks prior to shipping.  Pre-surgical functional checks prior to patient preparation.  Functional checks during patient surgery prior to final implant and surgical closing. The compliance testing at Nemko was in air and maximum possible power. Therefore, there will be no post-grant request for transmit power increase. Sincerely, Jim Judkins Principal Engineer Spinal Modulation 1135 O’Brien Dr. Menlo Park, CA 94025

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-MN0200 EA439873 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 agent letter Cover Letter 06/01/2011 pdf 122095 confidentiality letter Cover Letter 06/01/2011 pdf 20517 external photos External Photos 06/01/2011 pdf 122095 label ID Label/Location info. 06/01/2011 pdf 112762 use this label ID Label/Location info. 06/01/2011 pdf 140752 use this label exhibit ID Label/Location info. 06/01/2011 pdf 144675 internal photos Internal Photos 06/01/2011 pdf 122095 oper. desc. Operational Description 06/01/2011 pdf 23131 Use this oper. desc. Operational Description 06/01/2011 pdf 74988 parts list Parts List/Tuneup Info 06/01/2011 pdf 61449 RF exposure prediction RF Exposure Info 06/01/2011 pdf 50427 schematics Schematics 06/01/2011 pdf 151714 test reportm Test Report 06/01/2011 pdf 263020 SAR test report Test Report 06/01/2011 pdf 901470 use this test report Test Report 06/01/2011 pdf 263146 test setup photos Test Setup Photos 06/01/2011 pdf 170813 use this manual Users Manual 06/01/2011 pdf 1291336 physicians manual Users Manual 06/01/2011 pdf 3192203 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-MN0200 Model: MN0200 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. Pursuant to section 95.1217, the MN0200 Implantable device FCC ID number and the information required in Section 2.925 will be placed in the User manual and on the shipping box label in lieu of being placed directly on the implantable device. 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: MN0200 Re: Request of Confidentiality for FCC ID#: Y8L-MN0200 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 Implantable Neurostimulator (INS) MN0200

MN0200 Shipping Box: Draft Label Artwork Actual Size View of Printed Label (Red line will not be visible) LP0146 Rev A, October 2010

Spinal Modulation http://www.spinalmodulation.com/ 1135 O’Brien Dr. Direct: 650 543-6800 Menlo Park, CA 94025 Fax: 650 327-2336 Implantable Neurostimulator (INS) MN0200 Top Bottom

Spinal Modulation http://www.spinalmodulation.com/ 1135 O’Brien Dr. Direct: 650 543-6800 Menlo Park, CA 94025 Fax: 650 327-2336 October 26, 2011 Federal Communications Commission 7435 Oakland Mills Rd. Columbia, MD 21036 Re: Correspondence Reference Number: 40144; 8/4/2011 731 Conformation Number: EA439873 Y8L-MN0200 Subject: Response and clarification to Item 5 for updated SAR report. 5) The FCC will consider the FIT computational method for evaluation of RF exposure provided that the following are addressed: a.i) The general recommendations in Supplement C 01-01 for FDTD and the reporting requirements (Appendix B) are followed to validate the numerical codes used by the FIT simulation package used for the calculations. The FIT package developer should provide documentation, in the form of applicable computational standards protocols, or other acceptable requirements specific to the simulation package, demonstrating that the underlying numerical codes and algorithm implementations are accurate and acceptable for the SAR modeling required for this MedRadio device. A detailed summary, including benchmark setup and results, should be included in the SAR report to verify code and:  Numerical accuracy: Appendix 2.  Numerical dispersion: Section 4, paragraph 3.  Absorbing boundary conditions: Appendix 4.  Voxel resolution requirements: Section 4.2  SAR averaging algorithm accuracy: Appendix 2, 3. a.ii) The results of at least two benchmarks should be included; both simple and complex configurations for free-space and multiple tissue dielectric media should be considered and compared to established benchmark results. You may use the benchmark models specified in the latest draft of IEEE P1528.1 (May 2011) or equivalent models.  Free-space: Appendix 2.  Multiple tissue dielectrics: Appendix 6. a.iii) The SAR benchmark tests of a standard dipole source described in Annex D of IEEE Std 1597.2-2010 may be considered for the simple benchmark configuration case. Appendix 5. b.i) The numerical model of the test device must be verified against specific operating parameters of the actual device to confirm that it is an accurate representation for performing the SAR simulation. For example, S parameters and resonance frequency may be calculated from the model and the results compared against actual measured parameters. Spinal Modulation http://www.spinalmodulation.com/ 1135 O’Brien Dr. Direct: 650 543-6800 Menlo Park, CA 94025 Fax: 650 327-2336 Figures 7 and 8. b.ii) An explanation of any discrepancies between the modeled and measured results should be provided, along with the methodology used resolve the discrepancy. Section 5.2, paragraph 3, 4. b.iii) Methods such as scaling are generally preferred to modifying or adding components to the model, as that may result in a model that is no longer representative of the actual device. Also, the calculated field strength values at specific locations may be compared against measured values, if available. Since the computed SAR may be scaled to the device maximum output power level, reliable maximum conducted output measurement results, or an alternate means of accurately establishing output power, are necessary to support the SAR scaling. Figure 7, point [1], is a 50 point in the circuit and power is measured at an Antenna-Test- Port connector with a system measurement uncertainty of +/- 0.5 dB. c) A description of the procedures and locations used to determine sinusoidal steady- state conditions and source modeling considerations should be described in the SAR report. Section 4, paragraph 3, figure 2. d) The recommendations in draft IEEE P1528.1 and general considerations in Supplement C 01-01 to estimate the computational uncertainty should be followed and addressed in the SAR report. Appendix 2, 3. e) Please provide further explanation of why the electrode leads, modeled at 20 times the actual radius, should have insignificant impact to the SAR distributions resulting from the antenna and other radiating structures of the test device. It should be noted that the numerical modeling considerations acceptable for this device may not apply to other circumstances without further consideration of the individual situations; for example, output power and SAR levels, applicability of simplifications to both device and tissue (phantom) models and other technical considerations. The left SAR plot in Figure 11 clearly shows the exit point of the electrode leads are one- order of magnitude below the peak SAR on the opposite side of the header. The continuation of the electrode leads show they are not in any appreciable field to affect the antenna radiation pattern or input impedance. The electrode leads in the actual and simulated implant device are electrically isolated from the implant ‘can’. Sincerely, Jim Judkins Principal Engineer Spinal Modulation 1135 O’Brien Dr. Menlo Park, CA 94025

CST of America, Inc. 492 Old Connecticut Path, Suite 505 Framingham, MA 01701 USA Phone | +1 (508)-665-4400 Fax | +1 (508)-665-4401 [email protected] www.cst.com SAR ANALYSIS OF SPINAL MODULATION IMPLANTABLE DEVICE Model MN0200 FCC ID: Y8L-MN0200 October 21, 2011 Submitted to: Jim Judkins Spinal Modulation 1135 O'Brien Dr. Menlo Park, CA 94025 Submitted by: Ian Wood and David Johns CST of America 492 Old Connecticut Path, Suite 505 Framingham, MA 01701 1 CST of America, Inc. 492 Old Connecticut Path, Suite 505 Framingham, MA 01701 USA Phone | +1 (508)-665-4400 Fax | +1 (508)-665-4401 [email protected] www.cst.com SAR ANALYSIS OF SPINAL MODULATION IMPLANTABLE DEVICE Model MN0200 October 21, 2011 Signed by: Ian Wood Application Engineer CST of America 492 Old Connecticut Path, Suite 505 Framingham, MA 01701 Signed by: David Johns VP of Engineering and Support CST of America 492 Old Connecticut Path, Suite 505 Framingham, MA 01701 2 CST of America, Inc. 492 Old Connecticut Path, Suite 505 Framingham, MA 01701 USA Phone | +1 (508)-665-4400 Fax | +1 (508)-665-4401 [email protected] www.cst.com 1 Introduction The Spinal Modulation MN0200 Implantable Neurostimulator is designed for patient pain relief by electrical stimulation of nerve bundles located in the spinal area. It communicates to an external Programmer thru a RF link using the MICS/MedRadio standard at 403 MHz. The RF communication is used initially by the clinician to program stimulation during implant and again during routine visits by the patient. The patient has their own Programmer that can be used to adjust stimulation levels daily. The radio antenna is located at the top of the implant device, referred to as the ‘header’, along with the stimulation lead ports and encapsulated in a clear plastic epoxy. The antenna is a wire coil in a cuboid shape with an approximate volume of 1 cubic centimeter. The electronics are housed inside a sealed titanium can. The entire assembly is implanted away from the spinal area in a location determined by the physician and typically near the iliac crest. The stimulation leads are routed from the header lead ports to the specific spinal nerve bundles. A photograph of the implanted device, alongside the model used for simulation is shown below in Figure 1. Figure 1: Image of physical device and imported model for simulation 3 CST of America, Inc. 492 Old Connecticut Path, Suite 505 Framingham, MA 01701 USA Phone | +1 (508)-665-4400 Fax | +1 (508)-665-4401 [email protected] www.cst.com The requirements for use of this band of frequencies are described in 47 CFR Part 95 [1]. In part 95.603(f) there is a requirement for certification. Part of that process includes the evaluation of the specific absorption rate (SAR) of body tissue exposed to the radiation from the implant. The limits for this device are described in 47 CFR Part 1 in section 1.1307 and in 47 CFR Part 2, Section 2.1093 [2]. The usage of the equipment is uncontrolled and therefore the limits are for a Partial Body value of 1.6 W/kg averaged over any 1 g of tissue volume and in the shape of a cube. The Whole Body limit for average SAR is at 0.08 W/kg. The numerical method used to determine the SAR values is time domain simulation based on The Finite Integration Technique (FIT) [3-6]. FIT can be considered an extension of the Finite Difference time Domain (FDTD) technique as mentioned in the draft IEEE P1528.1 standard [7]. Details on the FIT method relevant to SAR calculation are provided in Appendix 1. 2 Scope The purpose of this report is to show compliance of the Spinal Modulation implanted device SMI Model # MN0200, FCC ID# Y8L-MN0200, with 47 CFR Part 1 section 1.1307 and 47 CFR Part 2 section 2.1093 SAR values using the FIT calculation technique. 3 Results The maximum computed SAR levels are below the limits as specified in 47 CFR Part 1, secti on 1.1307 and in 47 CRF Part2, section 2.1093. Whole Body average SAR at 403 MHz 0.1585 mW/Body Weight (80kg) = 0.001981mW/kg dB below 0.08 W/kg limit46.06 dB Maximum 1g SAR at 403 MHz 10.32 mW/kg dB below 1.6 W/kg limit21.90 dB 4 CST of America, Inc. 492 Old Connecticut Path, Suite 505 Framingham, MA 01701 USA Phone | +1 (508)-665-4400 Fax | +1 (508)-665-4401 [email protected] www.cst.com 4 Calculation Technique The CST Microwave Studio simulation program was used. Microwave Studio uses the Finite Integration Technique (FIT) which in the time domain can be considered an extension of the FDTD method [3]. Details about FIT are provided in Appendix 1. FIT has been validated through numerous publications, for example Reference 6. Examples of validation specific to SAR analysis include References 8 and 9. Additionally, a series of benchmarks from the current draft of IEEE Std. 1528.1 were also conducted to show the validity of FIT for SAR calculations, and can be found in Appendix 2-6. A SuperMicro workstation with 2Quad Core X5550 2.53 Ghz processors and 72 GB RAM was used during the simulations. Portions of the field analysis were run on an nVIDIA S1070 GPU for acceleration. The operating system used was Microsoft Windows Server 2008 R2, standard x64 Edition Service Pack 2. During computation 26,946,432 mesh cells were used which gave a solver memory requirement of 14,273 MB. The total simulation took 2 hours 5 minutes with 8 threads parallelized. The simulation halted when the energy dropped to -60dB below the peak (Figure 2). At this level, truncation error introduced by terminating the transient signals is negligible, as shown by the absence of any ringing artifacts in the resulting frequency domain results. As such, results obtained through the transient simulation accurately reflect the steady state behavior of the device. Figure 2: Energy decay plot. The Y axis units are dB with 0dB set as a reference at the peak energy. 5 CST of America, Inc. 492 Old Connecticut Path, Suite 505 Framingham, MA 01701 USA Phone | +1 (508)-665-4400 Fax | +1 (508)-665-4401 [email protected] w…

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CST of America, Inc. 492 Old Connecticut Path, Suite 505 Framingham, MA 01701 USA Phone | +1 (508)-665-4400 Fax | +1 (508)-665-4401 [email protected] www.cst.com SAR ANALYSIS OF SPINAL MODULATION IMPLANTABLE DEVICE Model MN0200 FCC ID: Y8L-MN0200 January 6, 2012 Submitted to: Jim Judkins Spinal Modulation 1135 O'Brien Dr. Menlo Park, CA 94025 Submitted by: Ian Wood and David Johns CST of America 492 Old Connecticut Path, Suite 505 Framingham, MA 01701 1 CST of America, Inc. 492 Old Connecticut Path, Suite 505 Framingham, MA 01701 USA Phone | +1 (508)-665-4400 Fax | +1 (508)-665-4401 [email protected] www.cst.com SAR ANALYSIS OF SPINAL MODULATION IMPLANTABLE DEVICE Model MN0200 January 6, 2012 Signed by: Ian Wood Application Engineer CST of America 492 Old Connecticut Path, Suite 505 Framingham, MA 01701 Signed by: David Johns VP of Engineering and Support CST of America 492 Old Connecticut Path, Suite 505 Framingham, MA 01701 2 CST of America, Inc. 492 Old Connecticut Path, Suite 505 Framingham, MA 01701 USA Phone | +1 (508)-665-4400 Fax | +1 (508)-665-4401 [email protected] www.cst.com 1 Introduction The Spinal Modulation MN0200 Implantable Neurostimulator is designed for patient pain relief by electrical stimulation of nerve bundles located in the spinal area. It communicates to an external Programmer thru a RF link using the MICS/MedRadio standard at 403 MHz. The RF communication is used initially by the clinician to program stimulation during implant and again during routine visits by the patient. The patient has their own Programmer that can be used to adjust stimulation levels daily. The radio antenna is located at the top of the implant device, referred to as the ‘header’, along with the stimulation lead ports and encapsulated in a clear plastic epoxy. The antenna is a wire coil in a cuboid shape with an approximate volume of 1 cubic centimeter. The electronics are housed inside a sealed titanium can. The entire assembly is implanted away from the spinal area in a location determined by the physician and typically near the iliac crest. The stimulation leads are routed from the header lead ports to the specific spinal nerve bundles. A photograph of the implanted device, alongside the model used for simulation is shown below in Figure 1. 3 CST of America, Inc. 492 Old Connecticut Path, Suite 505 Framingham, MA 01701 USA Phone | +1 (508)-665-4400 Fax | +1 (508)-665-4401 [email protected] www.cst.com Figure 1: Image of physical device and imported model for simulation The requirements for use of this band of frequencies are described in 47 CFR Part 95 [1]. In part 95.603(f) there is a requirement for certification. Part of that process includes the evaluation of the specific absorption rate (SAR) of body tissue exposed to the radiation from the implant. The limits for this device are described in 47 CFR Part 1 in section 1.1307 and in 47 CFR Part 2, Section 2.1093 [2]. The usage of the equipment is uncontrolled and therefore the limits are for a Partial Body value of 1.6 W/kg averaged over any 1 g of tissue volume and in the shape of a cube. The Whole Body limit for average SAR is at 0.08 W/kg. The numerical method used to determine the SAR values is time domain simulation based on The Finite Integration Technique (FIT) [3-6]. FIT can be considered an extension of the Finite Difference time Domain (FDTD) technique as mentioned in the draft IEEE P1528.1 standard [7]. Details on the FIT method relevant to SAR calculation are provided in Appendix 1. 2 Scope The purpose of this report is to show compliance of the Spinal Modulation implanted device SMI Model # MN0200, FCC ID# Y8L-MN0200, with 47 CFR Part 1 section 1.1307 and 47 CFR Part 2 section 2.1093 SAR values using the FIT calculation technique. 3 Results The maximum computed SAR levels are below the limits as specified in 47 CFR Part 1, secti on 1.1307 and in 47 CRF Part2, section 2.1093. Whole Body average SAR at 403 MHz 0.1585 mW/Body Weight (80kg) = 0.001981mW/kg dB below 0.08 W/kg limit46.06 dB Maximum 1g SAR at 403 MHz 10.32 mW/kg dB below 1.6 W/kg limit21.90 dB 4 Calculation Technique 4 CST of America, Inc. 492 Old Connecticut Path, Suite 505 Framingham, MA 01701 USA Phone | +1 (508)-665-4400 Fax | +1 (508)-665-4401 [email protected] www.cst.com The CST Microwave Studio simulation program was used. Microwave Studio uses the Finite Integration Technique (FIT) which in the time domain can be considered an extension of the FDTD method [3]. Details about FIT are provided in Appendix 1. FIT has been validated through numerous publications, for example Reference 6. Examples of validation specific to SAR analysis include References 8 and 9. Additi onally, a series of benchmarks from the current draft of IEEE Std. 1528.1 were also conducted to show the validity of FIT for SAR calculations, and can be found in Appendix 2-6. A SuperMicro workstation with 2Quad Core X5550 2.53 GHz processors and 72 GB RAM was used during the simulations. Portions of the field analysis were run on an nVIDIA S1070 GPU for acceleration. The operating system used was Microsoft Windows Server 2008 R2, standard x64 Edition Service Pack 2. During computation 26,946,432 mesh cells were used which gave a solver memory requirement of 14,273 MB. The total simulation took 2 hours 5 minutes with 8 threads parallelized. The simulation halted when the energy dropped to -60dB below the peak (Figure 2). The energy leaving the simulatoin volume was monitored at the port, open boundaries and internally within the material losses. At -60 dB decay level, truncation error introduced by terminating the transient signals is negligible, as shown by the absence of any ringing artifacts in the resulting frequency domain results. When the fourier transformation is applied to transient signal results to optain frequency domain results, such as the s-parameters, truncation manifests as a characteristic ringing or ripple in the amplitude; this behavior is absent within t…

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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): Implantable Neurostimulator Model: MN0200 FCC ID: Y8L-MN0200 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 FCC P ROJECT NUMBER: 53259 NEx Number: 160678 Total Number of Pages: 19 Nemko U…

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