LF597725Pain ENS - Wireless External Neurostimulator

Wireless External Neurostimulator97725 User manual ! USA Rx only Filename Date Time UC200xxxxxx EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential ImplantManual.xsl - IPGTemplate.fm Template version: 05-31-2012 M946491A001 Rev X 2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential ImplantManual.xsl - IPGTemplate.fm Template version: 05-31-2012 M946491A001 Rev X 2013-04 Explanation of symbols on product or package labeling Refer to the appropriate product for symbols that apply. Consult instructions for use Do not reuse Use by STERILE EO Sterilized using ethylene oxide STERILIZE 2 Do not resterilize Manufacturer Date of manufacture XXX °F XX °C -XX °F -XX °C Temperature limitation MR Magnetic Resonance (MR) Unsafe Non-ionizing electromagnetic radiation Serial number Chinese Standard (SJ/T11364-2006) Logo: Electronic Information Products Pollution Control Symbol. (The date in this logo means the environmental protection use period of the product.) System meets the applicable Canadian (CAN/CSA-C22.2 No. 60601-1) and US (UL 60601-1:2003) electrical safety standard requirements. IEC60601-1/EN60601-1, Type BF equipment 2013-04 English 1 2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential ImplantManual.xsl - IPGTemplate.fm Template version: 05-31-2012 M946491A001 Rev X Conformité Européenne (European Conformity). This symbol means that the device fully complies with MDD 93/42/EEC (NB 0123) and R&TTE Directive 1999/5/EC. EC REP Authorized Representative in the European Community For USA audiences only Do not use of the package is damaged. Do not dispose of this product in the unsorted municipal waste stream. Dispose of this product according to local regulations. See http:// recycling.medtronic.com for instructions on proper disposal of this product. 2 English 2013-04 2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential ImplantManual.xsl - IPGTemplate.fm Template version: 05-31-2012 M946491A001 Rev X Medtronic ® and SoftStart/Stop ® are trademarks of Medtronic, Inc., registered in the US and other countries. Bluetooth ® is a registered trademark of Bluetooth SIG, Inc. ! USA FCC Information The following is communications regulation information on the Model 97725 Wireless External Neurostimulator. FCC ID: LF597725 This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. IMPORTANT: Changes or modifications to this product not authorized by Medtronic, Inc., could void the FCC Certification and negate your authority to operate this product. This device complies with Industry Canada license-exempt RSS standard(s). Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device. 2013-04 English 3 2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential ImplantManual.xsl - IPGTemplate.fm Template version: 05-31-2012 M946491A001 Rev X Table of contents Purpose of the device 5 Description 5 Package contents 5 Accessories 5 Device specifications 5 Declaration of Conformity 9 Instructions for use 10 Pairing the wireless external neurostimulator to a programmer or controller 10 Using the wireless external neurostimulator during test stimulation 10 Replacing the wireless external neurostimulator batteries 11 Changing the batteries during test stimulation 11 Changing the batteries before test stimulation 12 Connecting the wireless external neurostimulator to the leads 14 Connecting the wireless external neurostimulator to the 4-contact lead(s) 14 Connecting the wireless external neurostimulator to the 8-contact lead(s) 16 Preparing the wireless external neurostimulator for test stimulation 18 Removing the wireless external neurostimulator after test stimulation 18 Device care and storage 18 Safety and technical checks 19 Refer to the indications sheet for indications and related information. Refer to the appropriate information for prescribers booklet for contraindications, warnings, precautions, adverse events summary, individualization of treatment, patient selection, use in specific populations, resterilization, and component disposal. Refer to System Eligibility, Battery Longevity, Specifications reference manual for neurostimulator selection, battery longevity calculations and specific neurostimulator specifications. ! USA Refer to the clinical summary booklet for information on the clinical study results of the neurostimulation system and individualization of treatment. 4 English 2013-04 2013-04 Filename Date Time UC200xxxxxx EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential ImplantManual.xsl - IPGTemplate.fm Template version: 05-31-2012 M946491A001 Rev X Purpose of the device The Medtronic Model 97725 Wireless External Neurostimulator (ENS) is used to evaluate a Medtronic Neurostimulation System during lead placement or test stimulation. Description The Medtronic Model 97725 Wireless External Neurostimulator is a disposable, sterile, single- use device equipped with Bluetooth wireless technology, and is part of a neurostimulation system. Package contents ▪ Wireless external neurostimulator with batteries inserted ▪ Spare AAA alkaline batteries (2) ▪ Product literature ▪ ! USA Warranty card Accessories ▪ Wireless external neurostimulator boot (packaged separately) Device specifications The Model 97725 Wireless External Neurostimulator (Figure 1 and Figure 2) is a multi- programmable device that delivers stimulation through 1 or more leads. The stimulation settings are stored in programs to target pain areas. A program is a specific c…

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Medtronic, Inc. 7000 Central Ave NE MS RCE 480 Fridley, MN 55432 www.medtronic.com tel (+1-763) 526-9710 fax(+1-763) 526-8363

EXTERNAL PHOTOS Company Name Medtronic Inc Model # 97725 FCC ID # LF597725 IC # 3408D‐MESTIM2 Page 1 of 2 EXTERNAL PHOTOS Company Name Medtronic Inc Model # 97725 FCC ID # LF597725 IC # 3408D‐MESTIM2 Page 2 of 2

INTERNAL PHOTOS Company Name Medtronic Inc Model # 97725 FCC ID # LF597725 IC # 3408D‐MESTIM2 Page 1 of 2 Back side of board INTERNAL PHOTOS Company Name Medtronic Inc Model # 97725 FCC ID # LF597725 IC # 3408D‐MESTIM2 Page 2 of 2 Front side of Board

MPE CALCULATIONS The following MPE calculations are based on a maximum measured conducted RF power of +5.62 dBm as presented to the antenna. The peak gain of this antenna, based on the data sheet is 2.2 dBi. Prediction of MPE limit at a given distance Equation from page 18 of OET Bulletin 65, Edition 97-01 where: S = power densit y P = power input to the antenna G = power gain of the antenna in the direction of interest relative to an isotropic radiator R = distance to the center of radiation of the antenna Maximum peak output power at antenna input terminal:5.62 (dBm) Maximum peak output power at antenna input terminal:3.648 (mW) Antenna gain(typical):2.2 (dBi) Maximum antenna gain:1.660 (numeric) Prediction distance:20 (cm) Prediction frequency:2440 (MHz) MPE limit for uncontrolled exposure at prediction frequency:1 (mW/cm^2) Power density at prediction frequency:0.001204 (mW/cm^2) Maximum allowable antenna gain:31.4 (dBi) 20cm =29.2 dBMargin of Compliance at 2 4R PG S  

W66 N220 Commerce Court ● Cedarburg, WI 53012 Phone: 262.375.4400 ● Fax: 262.375.4248 www.lsr.com TEST REPORT # 312122 A LSR Job #: C-1479 Compliance Testing of: PAIN External NeuroStimulator (ENS) Test Date(s): June 5 th to 19 th , 2012 Prepared For: Medtronic Attn: Mukul Jain 7000 Central Avenue NE MS RCC270 Minneapolis, MN 55432 This Test Report is issued under the Authority of: Khairul Aidi Zainal, Senior EMC Engineer. Signature: Date: 9/11/12 Test Report Reviewed by: Shane Rismeyer, EMC Engineer Signature: Date: 8/7/12 Project Engineer: Khairul Aidi Zainal, Senior EMC Engineer. Signature: Date: 7/17/12 This Test Report may not be reproduced, except in full, without written approval of LS Research, LLC. TABLE OF CONTENTS Prepared For: Medtronic EUT: PAIN ENS LS Research, LLC Report # 312122 A Model #: 97725 Template: 15.247 FHSS template LSR Job #: C-1479 Serial #: NLJ002306N Page 2 of 53 EXHIBIT 1. INTRODUCTION ........................................................................................................... 4 1.1 - Scope ............................................................................................................................... 4 1.2 – Normative References ..................................................................................................... 4 1.3 - LS Research, LLC Test Facility ........................................................................................ 5 1.4 – Location of Testing .......................................................................................................... 5 1.5 – Test Equipment Utilized ................................................................................................... 5 EXHIBIT 2. PERFORMANCE ASSESSMENT ................................................................................. 6 2.1 – Client Information ............................................................................................................ 6 2.2 - Equipment Under Test (EUT) Information ........................................................................ 6 2.3 - Associated Antenna Description ....................................................................................... 6 2.4 - EUT’S Technical Specifications ........................................................................................ 7 2.5 - Product Description .......................................................................................................... 9 EXHIBIT 3. EUT OPERATING CONDITIONS & CONFIGURATIONS DURING TESTS ................ 10 3.1 - Climate Test Conditions ................................................................................................. 10 3.2 - Applicability & Summary Of EMC Emission Test Results ............................................... 10 3.3 - Modifications Incorporated In The EUT For Compliance Purposes ................................. 10 3.4 - Deviations & Exclusions From Test Specifications ......................................................... 10 EXHIBIT 4. DECLARATION OF CONFORMITY ............................................................................ 11 EXHIBIT 5. RADIATED EMISSIONS TEST ................................................................................... 12 5.1 - Test Setup ...................................................................................................................... 12 5.2 - Test Procedure ............................................................................................................... 12 5.3 - Test Equipment Utilized ................................................................................................. 13 5.4 - Test Results ................................................................................................................... 13 5.5 - Calculation of Radiated Emissions Limits and reported data .......................................... 14 5.6 - Radiated Emissions Test Data Chart .............................................................................. 15 5.7 - Test Setup Photo(s) – Radiated Emissions Test ............................................................ 17 5.8 – Screen Captures of Radiated emissions. ....................................................................... 18 EXHIBIT 6. CONDUCTED EMISSIONS TEST, AC POWER LINE ................................................. 21 6.1 Test Setup .................................................................................................................... 21 EXHIBIT 7. OCCUPIED BANDWIDTH ........................................................................................... 22 7.1 - Limits.............................................................................................................................. 22 7.2 - Method of Measurements ............................................................................................... 22 7.3 .......................................................................................................................................... 23 - Test Data ............................................................................................................................. 23 7.4 – Screen Captures ........................................................................................................... 24 EXHIBIT 8. BAND EDGE MEASUREMENTS ................................................................................ 27 Prepared For: Medtronic EUT: PAIN ENS LS Research, LLC Report # 312122 A Model #: 97725 Template: 15.247 FHSS template LSR Job #: C-1479 Serial #: NLJ002306N Page 3 of 53 8.1 - Method of Measurements ............................................................................................... 27 8.2. Band-Edge captures. ....................................................................................................... 28 EXHIBIT 9. POWER OUTPUT (CONDUCTED): 15.247(b) ........................................................... 31 9.1 - Method o…

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LS Research, LLC W66 N220 Commerce Court ● Cedarburg, WI 53012 ● USA Phone: 262.375.4400 ● Fax: 262.375.4248 www.lsr.com ------------------------------------------------------------------------------------------------------------------------- ENGINEERING TEST REPORT # 312122 B LSR Job #: C-1479 Compliance Testing of: Medtronic PAIN External NeuroStimulator (ENS) Test Date(s): June 5 th to 19 th 2012 Prepared For: Medtronic 7000 Central Avenue NE MS RCC270 Minneapolis, MN 55432 In accordance with: RSS-GEN & CFR 47 15.109 This Test Report is issued under the Authority of: Khairul Aidi Zainal, Senior EMC Engineer Signature: Date:9/11/12 Test Report Reviewed by: Peter Feilen, EMC Engineer Signature: Date: 8/7/12 Project Engineer: Khairul Aidi Zainal, Senior EMC Engineer Signature: Date:7/29/12 This Test Report may not be reproduced, except in full, without written approval of LS Research, LLC. Prepared For: Medtronic Model #:97725 LS Research, LLC EUT: PAIN Serial #: NLJ002306N Template: 15.109 Class B Report #:312122 B Customer FCC ID #:N/A Page 2 of 21 TABLE OF CONTENTS (page 1 of 2) EXHIBIT 1. INTRODUCTION 3 1.1 Scope 3 1.2 Normative References 3 1.3 LS Research, LLC Test Facility 4 1.4 Location of Testing 4 1.5 Test Equipment Utilized 4 EXHIBIT 2. PERFORMANCE ASSESSMENT 5 2.1 Client Information 5 2.2 Equipment Under Test (EUT) Information 5 2.3 Associated Antenna Description 5 2.4 EUT’s Technical Specifications 6 2.5 Product Description 7 EXHIBIT 3. EUT OPERATING CONDITIONS & CONFIGURATIONS DURING TESTS 8 3.1 Climate Test Conditions 8 3.2 Applicability & Summary of EMC Emission Test Results 8 3.3 Modifications Incorporated in the EUT for Compliance Purposes 8 3.4 Deviations & Exclusions from Test Specifications 8 EXHIBIT 4. DECLARATION OF CONFORMITY 9 EXHIBIT 5. RADIATED EMISSIONS TEST 10 5.1 Test Setup 10 5.2 Test Setup Photo(s)-Radiated Emissions Test 11 5.3 Test Procedure 12 5.4 Test Equipment Utilized 12 5.5 Test Result 12 5.6 Calculation of Radiated Emission limits 13 5.7 Data Chart- Radiated emissions test 14 5.8 Screen Captures-Radiated Emissions Testing 16 EXHIBIT 6. CONDUCTED EMISSIONS TEST, AC POWER LINE: 15.207 17 APPENDIX A TEST EQUIPMENT LIST 18 APPENDIX B TEST STANDARDS 19 APPENDIX C UNCERTAINTY STATEMENT 20 APPENDIX D PLEXUS INSTRUMENT SHEET 21 Prepared For: Medtronic Model #:97725 LS Research, LLC EUT: PAIN Serial #: NLJ002306N Template: 15.109 Class B Report #:312122 B Customer FCC ID #:N/A Page 3 of 21 EXHIBIT 1. INTRODUCTION 1.1 SCOPE References: RSS-GEN Section 6 CFR 47 15.109 Title: General Requirements and Information for the Certification of Radiocommunication Equipment Purpose of Test: To gain IC and FCC Certification Authorization for a Digital Device operated in Receive Mode Test Procedures: Both conducted and radiated emissions measurements were conducted in accordance with American National Standards Institute ANSI C63.4 – American National Standard for Methods of Measurement of Radio-Noise Emissions from Low-Voltage Electrical and Electronic Equipment in the Range of 9 kHz to 40 GHz. Environmental Classification:  Commercial, Industrial or Business  Residential 1.2 NORMATIVE REFERENCES Publication Title RSS-Gen Issue 3 Spectrum Management and Telecommunications Radio Standards Specification CFR 47 Part 15 Radio Frequency devices ANSI C63.4 American National Standard for Methods of Measurement of Radio-Noise Emissions from Low-Voltage Electrical and Electronic Equipment in the Range of 9 kHz to 40 GHz. Prepared For: Medtronic Model #:97725 LS Research, LLC EUT: PAIN Serial #: NLJ002306N Template: 15.109 Class B Report #:312122 B Customer FCC ID #:N/A Page 4 of 21 1.3 LS Research, LLC TEST FACILITY LS Research, LLC is accredited by A2LA (American Association for Laboratory Accreditation) to conform to ISO/IEC 17025, 2005 “General Requirements for the Competence of Calibration and Testing Laboratories”. LS Research, LLC’s scope of accreditation includes all test methods listed herein, unless otherwise noted. 1.4 LOCATION OF TESTING All testing was performed at LS Research, LLC, W66 N220 Commerce Court, Cedarburg, Wisconsin, 53012 USA, utilizing the facilities listed below, unless otherwise noted. List of Facilities Located at LS Research, LLC:  Compact Chamber  Semi-Anechoic Chamber  Open Area Test Site (OATS) 1.5 TEST EQUIPMENT UTILIZED A complete list of equipment utilized in testing is provided in Appendix A of this test report. Calibration dates are indicated in Appendix A. All test equipment is calibrated in accordance with A2LA standards. Prepared For: Medtronic Model #:97725 LS Research, LLC EUT: PAIN Serial #: NLJ002306N Template: 15.109 Class B Report #:312122 B Customer FCC ID #:N/A Page 5 of 21 EXHIBIT 2. PERFORMANCE ASSESSMENT 2.1 CLIENT INFORMATION 2.2 EQUIPMENT UNDER TEST (EUT) INFORMATION The following information has been supplied by the applicant. Product Name: Medtronic External NeuroStimulator (ENS) Model Number: 97725 Serial Number: NLJ002306N 2.3 ASSOCIATED ANTENNA DESCRIPTION The antenna used in the ENS is a PULSE Bluetooth/WLAN/WiFi Ceramic Chip Antenna part number W3008 with a peak gain of 2.2 dBi. Manufacturer Name: Medtronics Address: 7000 Central Avenue NE MS RCC270, Minneapolis, MN 55432 Contact Name: Mukul Jain ([email protected]) Prepared For: Medtronic Model #:97725 LS Research, LLC EUT: PAIN Serial #: NLJ002306N Template: 15.109 Class B Report #:312122 B Customer FCC ID #:N/A Page 6 of 21 2.4 EUT’S TECHNICAL SPECIFICATIONS Additional Information: Frequency Range (in MHz) 2402MHz to 2480MHz Operating Voltage 3.0 VDC Receiver Sensitivity -74.5 dBm Highest Frequency 9912 MHz Receiver Spurious (worst case at 3m) 27.95dBμV/m at 946MHz (Noise Floor) EUT will be operated under FCC part(s) and IC Rule IC: RSS-GEN FCC: CFR 47 part 15 Portable/Mobile Portable Mobile Modular Filing Yes No Prepared For: Medtronic Model #:97725 LS Research, LLC EUT: PAIN Serial #: NLJ002306N Template: 15.109 Class B Report #:312122 B Customer FCC I…

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TEST SETUP PHOTOS Company Name Medtronic, Inc Model # 97725 FCC ID # LF597725 IC # 3408D‐MESTIM2 Page 1 of 1 EUT setup in Flat Orientation EUT setup in Vertical Orientation EUT setup in Side Orientation EUT setup from the rear