LF53531Verify ENS (external neurostimulator)

VERIFY TM EXTERNAL NEUROSTIMULATOR 3531 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: 12-13-2011 M943581A001 Rev X 2013-03 Filename Date Time UC200xxxxxx EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential ImplantManual.xsl - IPGTemplate.fm Template version: 12-13-2011 M943581A001 Rev X 2013-03 Explanation of symbols on product or package labeling Refer to the appropriate product for symbols that apply. 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. System meets the applicable Canadian (CAN/CSA-C22.2 No. 60601-1) electrical safety standard requirements. Do not reuse Consult instructions for use Serial number Manufacturer EC REP Authorized representative in the European community IEC60601-1/EN60601-1, Type BF equipment Non-ionizing electromagnetic radiation XXX °F XX °C -XX °F -XX °C Temperature limitation For USA audiences only 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. 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.) 2013-03 English 1 2013-03 Filename Date Time UC200xxxxxx EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential ImplantManual.xsl - IPGTemplate.fm Template version: 12-13-2011 M943581A001 Rev X Medtronic ® is a trademark of Medtronic, Inc., registered in the U.S. and other countries. Verify TM is a trademark of Medtronic, Inc. Bluetooth ® is a registered trademark of Bluetooth SIG, Inc. ! USA FCC Information The following is communications regulation information on the Model 3531 External Neurostimulator. FCC ID: LF53531 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. 2 English 2013-03 2013-03 Filename Date Time UC200xxxxxx EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential ImplantManual.xsl - IPGTemplate.fm Template version: 12-13-2011 M943581A001 Rev X Table of contents Purpose of the device 5 Description 5 Package contents 5 Device specifications 5 Declaration of Conformity 8 Instructions for use 9 Pairing the external neurostimulator to the controller 9 Using the external neurostimulator during test stimulation 9 Replacing the external neurostimulator batteries 10 Using the external neurostimulator boot 12 Using the external neurostimulator belt 13 Device care and storage 15 Safety and technical checks 15 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 the Test stimulation lead implant manual packaged with the test stimulation lead for test stimulation-specific 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. 2013-03 English 3 2013-03 Filename Date Time UC200xxxxxx EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential ImplantManual.xsl - IPGTemplate.fm Template version: 12-13-2011 M943581A001 Rev X 4 English 2013-03 2013-03 Filename Date Time UC200xxxxxx EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential ImplantManual.xsl - IPGTemplate.fm Template version: 12-13-2011 M943581A001 Rev X Purpose of the device The Medtronic Model 3531 Verify External Neurostimulator (ENS) is used to evaluate a Medtronic Sacral Neuromodulation (SNM) System during lead placement or test stimulation. Description The Medtronic Model 3531 External Neurostimulator is a disposable, single-use device equipped with Bluetooth wireless technology, and is part of a sacral neuromodulation system. Package contents ▪ External neurostimulator ▪ External neurostimulator boot ▪ AAAA alkaline batteries (4) ▪ Product literature ▪ ! USA Warranty card Device specifications The external neurostimulator (Figure 1) is a programmable device that delivers stimulation through one or more leads (delivered through one lead at a time). The stimulation settings are stored in programs. A program is a specific combination of pulse width, rate, and amplitude settings acting on a specific electrode combination. 2013-03 English 5 2013-03 Filename Date Time UC200xxxxxx EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential ImplantManual.xsl - IPGTemplate.fm Template version: 12-13-2011 M943581A001 Rev X Light-emitting diode (LED) ENS button Output jack Figure 1. Model 3531 External Neurostimulator. Table 1. Operating va…

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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 # 3531 FCC ID # LF53531 Page 1 of 2 EXTERNAL PHOTOS Company Name Medtronic Inc Model # 3531 FCC ID # LF53531 Page 2 of 2

FCC ID: LF53531 IC: 3408D-MESTIM3 3531 M943991A001 Rx only

INTERNAL PHOTOS Company Name Medtronic Inc Model # 3531 FCC ID # LF53531 Page 1 of 2 Top and bottom boards connected Front side of top board Back side of top board Close up of antenna INTERNAL PHOTOS Company Name Medtronic Inc Model # 3531 FCC ID # LF53531 Page 2 of 2 Front side of bottom board Back side of bottom board

LS Research, LLC website: www.lsr.com W66 N220 Commerce Court Phone: 262-375-4400 Cedarburg, WI 53012 Exemption from SAR evaluation Medtronic ENS FCC: LF53531 LS Research, LLC website: www.lsr.com W66 N220 Commerce Court Phone: 262-375-4400 Cedarburg, WI 53012 FCC OET KDB 447498 states that unlicensed intentional radiators that meet the output power requirements as stated in section 2(a)(i) may be used in a portable exposure condition with no restrictions on host platform. Output Power Evaluation. Evaluation Frequency = __2480MHz_______ Device Operation separation distance: ≤20cm Maximum Effective Isotropic Radiated Power (dBm) = 6.1 dBm + 2.2dBi = _8.3dBm_ Maximum Effective Isotropic Radiated Power (mW) = log -1 (EIRP(dBm)/10) = _6.76mW_ Section 2(a)(i) general public use limit: Pout ≤ 60/f (GHz) Limit = 60/2.48 = 24.2mW Conclusion: Since the maximum effective isotropic radiated power (EIRP) is less than the applicable limit of 24.2mW, the Product is exempt from SAR Evaluation.

W66 N220 Commerce Court ● Cedarburg, WI 53012 Phone: 262.375.4400 ● Fax: 262.375.4248 www.lsr.com TEST REPORT # 311164-1 TX LSR Job #: C-1264 Compliance Testing of: Medtronic Neuromodulation Interstim External NeuroStimulator (ENS) Test Date(s): October 20 th to November 9 th 2011 Prepared For: Medtronic 7000 Central Avenue NE MS RCC270 Minneapolis, MN 55432 In accordance with: Federal Communications Commission (FCC) Part 15, Subpart C, Section 15.247 Industry Canada (IC) RSS 210 Annex 8 Frequency Hopping Spread Spectrum (FHSS) Operating in the Frequency Band 2400 MHz – 2483.5 MHz This Test Report is issued under the Authority of: Khairul Aidi Zainal, Senior EMC Engineer. Signature: Date: 12/12/2011 Test Report Reviewed by: Ryan Urness, EMC Lab Manager Signature: Date: 12/5/2011 Project Engineer: Khairul Aidi Zainal, Senior EMC Engineer. Signature: Date: 12/12/2011 This Test Report may not be reproduced, except in full, without written approval of LS Research, LLC. Prepared For: Medtronic EUT: Medtronic ENS LS Research, LLC Report # 311164-1 TX Model #: 3531 Template: 15.247 FHSS template LSR Job #: C-1264 Serial #: NLM001545N, NLM001547N NLM001943N, NLM001937N Page 2 of 52 TABLE OF CONTENTS 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 .......................................................................................................... 8 EXHIBIT 3. EUT OPERATING CONDITIONS & CONFIGURATIONS DURING TESTS .................. 9 3.1 - Climate Test Conditions ................................................................................................... 9 3.2 - Applicability & Summary Of EMC Emission Test Results ................................................. 9 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 Prepared For: Medtronic EUT: Medtronic ENS LS Research, LLC Report # 311164-1 TX Model #: 3531 Template: 15.247 FHSS template LSR Job #: C-1264 Serial #: NLM001545N, NLM001547N NLM001943N, NLM001937N Page 3 of 52 7.3 - Test Data ................................................................................................................... 23 7.4 – Screen Captures ........................................................................................................... 24 EXHIBIT 8. BAND EDGE MEASUREMENTS ................................................................................ 27 8.1 - Method of Measurements ............................................................................................... 27 8.2. Band edge captures. .................................…

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TEST SETUP PHOTOS Company Name Medtronic Inc. Model # 3531 FCC ID # LF53531 Page 1 of 1 Test Setup Photo(s) – Radiated Emissions Test EUT Flat orientation EUT Side orientation EUT Vertical orientation EUT on pedestal