Y8L-MN20600-02Wireless transceiver

® • PATIENT PROGRAMMER USER MANUAL • P ATIENT PROGRAMMER GEBRUIKERSHANDLEIDING • PATIENTEN-PROGRAMMIERGERÄT GEBRAUCHSANLEITUNG • PROGRAMMA TEUR PATIENT MANUEL D’UTILISATION • PROGRAMADOR DEL P ACIENTE MANUAL DEL USUARIO PATIENT PROGRAMMER USER MANUAL LP0563-01 Rev A, 2014-02 Copyright © 2014 Spinal Modulation, Inc. All rights reserved. Unauthorized duplication or use is prohibited. AXIUM, SPINAL MODULATION and the Man in Circle Design are trademarks and/or registered trademarks of Spinal Modulation, Inc. Patient Programmer Model MN20600-02 User Manual ® Authorization to affix the CE mark granted in 2011 Contents Explanation of Symbols on Product or Package Labeling .........1 Glossary ....................................................................................2 Introduction ..............................................................................3 Indications for Use .............................................................................................................................3 Description .........................................................................................................................................3 Warnings ............................................................................................................................................3 Precautions – For Your Programmer and Your Stimulator .................................................................4 Precautions – For Your Therapy ........................................................................................................5 Programmer Overview ..............................................................7 Programmer Features .......................................................................................................................7 Charging the Battery ..........................................................................................................................8 Programmer Power Up .....................................................................................................................8 Main Menu ................................................................................9 Stimulator Binding .............................................................................................................................10 Connect .............................................................................................................................................10 Magnet ...............................................................................................................................................10 Connecting with Your Stimulator ..............................................10 Pain Control Screen ..........................................................................................................................11 ID Heading .........................................................................................................................................11 Select Group .....................................................................................................................................11 Back to Main Menu ...........................................................................................................................11 Programmer Status Bar .....................................................................................................................12 Adjusting Your Stimulator Settings ...........................................12 Turn OFF All Stimulation ....................................................................................................................12 Pain Control Tab ................................................................................................................................13 Turn Stimulation On or Off for a Body Region ...................................................................................13 Adjust Stimulation to a Body Region .................................................................................................13 Device, Physician and Clinic Information ...................................14 My Info Tab ........................................................................................................................................14 Device Tab and Physician Tab ...........................................................................................................14 Stimulator Identification Information ..................................................................................................14 Physician Information ........................................................................................................................14 Clinic Tab ...........................................................................................................................................15 To Use with Your TNS Device ....................................................15 To Use with Your INS Device .....................................................16 Cleaning your Programmer .......................................................16 Disposal of your Programmer ...................................................16 Environmental Conditions for Storage and Operation ..............16 Appendix I: Troubleshooting .....................................................20 1 Explanation of Symbols on Product or Package Labeling REF Model Number Serial Number Read the Manual Consult the Manual Contents of Package are Non-Sterile Manufacturing Date Manufacturer 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 m…

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Spinal Modulationhttp://www.spinalmodulation.com/ 1135 O’Brien Dr.Direct: 650 543-6829 Menlo Park, CA 94025Fax: 650 327-2336 Spinal Modulation Programmer Models: Patient Programmer MN20600-02 Fully built programmer (front) note – bottom will be black in production run: Fully built Patient Programmer (back with label) note – bottom will be black in production run:

Spinal Modulation MN20600-02ConfidentialPage 2 of 3 Top of Basestation board(no shields – third item is the battery bucket): Top of Basestation board (with shields): Bottom of Basestation board (with battery): Spinal Modulation MN20600-02ConfidentialPage 3 of 3 Bottom of Basestation board (without battery):

Spinal Modulation http://www.spinalmodulation.com/ 1135 O’Brien Dr. Direct: 650 543-6829 Menlo Park, CA 94025 Fax: 650 327-2336 15March2014 MN20600-02 Tune-Up Procedure Spinal Modulation Patient Programmer Product MN20600-02. The Basestation Board is trimmed at time of manufacturing which remains in effect the entire lifetime of the device. No tune-up procedure exists or is required. April Pixley Senior Director, Hardware/Firmware Engineering Chief Systems Engineer

Nemko Test Report: 10247899RUS1 Applicant: Spinal Modulation, Inc. 1135 O’Brien Drive Menlo Park, CA 94025 USA Equipment Under Test: Patient Programmer MN20600-02 (E.U.T.) FCC ID#: Y8L-MN20600-02 IC ID#: 11060A-20600-02 In Accordance With: FCC Part 95, Subpart E and Industry Canada RSS-243, Issue 3 Medical Devices Operating in the 401-406 MHz Frequency Band Personal Radio Devices. Tested By: Nemko USA Inc. 802 N. Kealy Lewisville, Texas 75057-3136 TESTED BY: DATE: 29 October 2013 David Light, Wireless Engineer APPROVED BY: DATE: 30 October 2013 Tom Tidwell, Technical Manager Total Number of Pages: 19 Nemko USA, Inc. CFR 47, PART 95, Subpart E and Industry Canada RSS-243, Issue 3 Medical Devices Operating in the401-406 MHz Frequency Band EQUIPMENT: 20600-02 PROJECT NO.:10247899RUS1 Page 2 of 19 Table Of Contents SECTION 1. SUMMARY OF TEST RESULTS 3 SECTION 2. GENERAL EQUIPMENT SPECIFICATION 5 SECTION 3. MAXIMUM RF TRANSMIT POWER 7 SECTION 4. OCCUPIED BANDWIDTH 9 SECTION 5. FREQUENCY STABILITY 11 SECTION 6. UNWANTED RADIATION 12 SECTION 7. TEST EQUIPMENT LIST 17 ANNEX A TEST DIAGRAMS 18 Nemko USA, Inc. CFR 47, PART 95, Subpart E and Industry Canada RSS-243, Issue 3 Medical Devices Operating in the401-406 MHz Frequency Band EQUIPMENT: 20600-02 PROJECT NO.:10247899RUS1 Page 3 of 19 Section 1. Summary Of Test Results Manufacturer: Spinal Modulations, Inc. Model No.: 20600-02 Serial No.: SP1023 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 95.627 and Industry Canada RSS-243, Issue 3. All tests were conducted using measurement procedure ANSI C63.4-2003. Radiated Emissions were made on an open area test site. New Submission Production Unit Class II Permissive Change Pre-Production Unit THIS TEST REPORT RELATES ONLY TO THE ITEM(S) TESTED. THE FOLLOWING DEVIATIONS FROM, ADDITIONS TO, OR EXCLUSIONS FROM THE TEST SPECIFICATIONS HAVE BEEN MADE. See “ Summary of Test Data”. This report must not be used to claim product certification, approval, or endorsement by NVLAP, NIST, or any agency of the Federal Government. Nemko USA, Inc. is a NVLAP accredited laboratory. Nemko USA, Inc. authorizes the above named company to reproduce this report provided it is reproduced in its entirety, for use by the company’s employees only. This report must not be used to claim product certification, approval, or endorsement by NVLAP, NIST, or any agency of the Federal Government. Nemko USA, Inc. is a NVLAP accredited laboratory. 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. This report applies only to the items tested. Nemko USA, Inc. CFR 47, PART 95, Subpart E and Industry Canada RSS-243, Issue 3 Medical Devices Operating in the401-406 MHz Frequency Band EQUIPMENT: 20600-02 PROJECT NO.:10247899RUS1 Page 4 of 19 Summary Of Test Data Test/Requirement Description Pass / Fail Applicable Rule Parts Maximum RF Transmitting Power Pass 2.1046, 95.135, 95.639(f)(1), 5.4 Modulation Characteristics Pass 2.1047, 95.631(g), 95.637, 5.2 Occupied Bandwidth Pass 2.1049, 95.627(d), 5.1 Unwanted Radiation Pass 2.1053, 95.635(d), 5.5 Frequency Stability Pass 2.1055, 95.627(d), 5.3 Test Result: The product as presented for testing complied with test requirements as shown above. Nemko USA, Inc. CFR 47, PART 95, Subpart E and Industry Canada RSS-243, Issue 3 Medical Devices Operating in the401-406 MHz Frequency Band EQUIPMENT: 20600-02 PROJECT NO.:10247899RUS1 Page 5 of 19 Section 2. General Equipment Specification Frequency Range: 402 to 405 MHz Operating Frequency(ies) of Sample: 402.15 to 404.85 MHz Number of Channels: 10 User Frequency Adjustment: None Integral Antenna Yes No Nemko USA, Inc. CFR 47, PART 95, Subpart E and Industry Canada RSS-243, Issue 3 Medical Devices Operating in the401-406 MHz Frequency Band EQUIPMENT: 20600-02 PROJECT NO.:10247899RUS1 Page 6 of 19 Description of EUT The EUT is a wireless transceiver used to program medical implants. System Diagram Nemko USA, Inc. CFR 47, PART 95, Subpart E and Industry Canada RSS-243, Issue 3 Medical Devices Operating in the401-406 MHz Frequency Band EQUIPMENT: 20600-02 PROJECT NO.:10247899RUS1 Page 7 of 19 Section 3. Maximum RF Transmit Power NAME OF TEST: Maximum RF Transmit Power PARA. NO.: 95.639 / 5.4 TESTED BY: David Light DATE: 24 October 2013 Minimum Standard: §95.639(f)(1). For transmitters operating in the 401-406 MHz band that are not excepted under § 95.627(b) from the frequency monitoring requirements of § 95.627(a), the maximum radiated power in any 300 kHz bandwidth by MedRadio transmitters operating at 402- 405 MHz, or in any 100 kHz bandwidth by MedRadio transmitters operating at 401-402 MHz or 405-406 MHz shall not exceed 25 microwatts EIRP. For transmitters that are excepted under § 95.627(b) from the frequency monitoring requirements of § 95.627(a), the power radiated by any station operating in 402-405 MHz shall not exceed 100 nanowatts EIRP confined to a maximum total emission bandwidth of 300 kHz centered at 403.65 MHz, the power radiated by any station operating in 401-401.85 MHz or 405- 406 MHz shall not exceed 250 nanowatts EIRP in any 100 kHz bandwidth and the power radiated by any station operating in 401.85-402 MHz shall not exceed 25 microwatts in the 150 kHz bandwidth. Test Results: Complies . . Measurement Data: See attached table. Method of Measurement: The antenna substitution method is used to determine the equivalent radiated power at spurious frequencies. The spurious emissions are measured at a distance of 3 meters. The EUT is then replaced with a reference substitution antenna with a known gain referenced to an isotropic radiator. This antenna is fed with a sig…

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SPINAL MODULATION, INC DOCUMENT TYPE: VERIFICATION REPORT VR#: 167-3 TITLE: LISTEN BEFORE TALK TEST REPORT Rev: B VR167-3 Rev B Confidential Page 1 of 13 REVISION HISTORY Rev Change Description CO Effective Date By A Initial Release. SoMo Programmer AD1634 with SoMo BS PCB AD1621. (Based on VP167 Rev C.) CO3413 11/11/13 Erik Johnson B Correct referenced standards covered by this test report. CO3785 6/9/14 April Pixley SPINAL MODULATION, INC DOCUMENT TYPE: VERIFICATION REPORT VR#: 167-3 TITLE: LISTEN BEFORE TALK TEST REPORT Rev: B VR167-3 Rev B Confidential Page 2 of 13 1. PURPOSE This Report describes the MICS/MedRadio Listen Before Talk testing performed on the SMI Programmer Basestation. This test was 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 noise 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 Trial NeuroStimulator (TNS) respond to the Programmer RF link and are not permitted to initiate an 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) protocol required by applicable parts of MICS standard EN 301 839-1, EN 301 839-2 and MedRadio FCC Part 95.627.a and 95.1209.d. 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. 3. REFERENCE DOCUMENTS 3.1. SMI Reference Documents VP239 Applicable V & V Plan Neurostimulator System (to be filled in report, e.g. VP239 for DP1005) PS1300 Product Requirements Specification Connector Cable HW015 Hardware Requirements Specification Programmer OP033 Design Verification FM130 Report Template ER079 SMI Standard Terminology Definitions and Acronyms VR068 Programmer Emissions Test Report 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#: 167-3 TITLE: LISTEN BEFORE TALK TEST REPORT Rev: B VR167-3 Rev B Confidential Page 3 of 13 EN 301 839-2 Electromagnetic Compatibility and Radio Spectrum Matters (ERM); Radio Equipment in the Frequency Range 402 MHz to 405 MHz for Ultra Low Power Active Medical Implants and Accessories; Part 2: Harmonized EN Covering Essential Requirements of Article 3.2 of the R&TTE Directive EN 301 489-1 Electromagnetic compatibility and Radio spectrum Matters (ERM); ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 1: Common technical requirements EN 301 489-27 Electromagnetic compatibility and Radio spectrum Matters (ERM); ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 27: Specific conditions for Ultra Low Power Active Medical Implants (ULP-AMI) and related peripheral devices (ULP-AMI-P) FCC Part 95 Federal Communications Commission PART 95 MedRadio 4. DEFINITIONS Refer to ER079 for the various definitions, acronyms and terminology used in this document. Abbreviations BS Basestation. PCB in Programmer that has RF and RF MCU control circuitry. BSDiag Basestation API (Patch Code) allows GUI control of BS Product Code CA Clear Channel Assessment GU I Graphical User Interface LBT Listen Before Talk LIC Least Interfered Channel NS PCB Neurostimulator printed circuit board. CW Continuous Wave IF Intermediate Frequency MICS Medical Implant Communication Service RSSI Receive Signal Strength Indicator SMI Spinal Modulation, Inc. 5. SUMMARY OF TEST RESULTS AND CONCLUSIONS 5.1. Test Results Summary All tests in this protocol passed per the applicable test methods and Standards. SPINAL MODULATION, INC DOCUMENT TYPE: VERIFICATION REPORT VR#: 167-3 TITLE: LISTEN BEFORE TALK TEST REPORT Rev: B VR167-3 Rev B Confidential Page 4 of 13 5.2. Protocol Deviations There were no protocol deviations. 5.3. Conclusions Since all the tests in the protocol passed, the Programmer has been determined to meet its Listen-Before-Talk FCC, FDA and CE Mark requirements and is considered suitable for human use according to its Instructions for Use. 5.4. Signatures of Test Personnel Printed Name Function Signature Erik Johnson Firmware Engineer See Raw Data 6. EQUIPMENT AND SUPPLIES Log information in table below. Equipment Mfgr Model Number Serial Number SW/FW Version Date of Next Calibration (if required) BS PCBA SMI AD1616 520066 SW1111 N/A BS PCBA SMI AD1616 520042 SW1111 N/A PC Dell Optiplex GX745 76487-OEM- 0011903-00102 Windows XP SP3 N/A Power Supply Agilent E3640A EQ066 N/A 1/11/14 20 dB Directional coupler Mini-ckts ZFDC-20-4L SF800301017 N/A N/A 3 ft. Coax Cable Johnson 415-033-036 N/A N/A N/A 3 ft. Coax Cable Johnson 415-033-036 N/A N/A N/A Cable USB A-B micro Qualtek 3021003-03 N/A N/A N/A Oscilloscope Agilent DSO8064A EQ0111 N/A 4/11/14 Spectrum Analyzer Agilent EXA N9010A EQ0516 N/A 5/10/14 Signal Generator HP 8656B EQ077 N/A Not Calibrated (cal as part of test procedure) BsDiag software SMI SW1078 N/A 2.0.5.0 N/A SPINAL MODULATION, INC DOCUMENT TYPE: VERIFICATION REPORT VR#: 167-3 TITLE: LISTEN BEFORE TALK TEST REPORT Rev: B VR167-3 Rev B Confidential Page 5 of 13 7. SAMPLE SIZE AND JUSTIFICATION Refer to OP033 for the sample size justification. In general, outside laboratory emissions testing is performed on a sample size of one. Refer to the outside laboratory reports for sample sizes used for particular tests. 8. DEVICE UNDER TEST CONFIGURATION 8.1 Circ…

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