LF537021External Neurostimulator (ENS)

Neurological Medtronic Confidential Title Model 37021 ENS Test Stimulation Patient Guide Medtronic Confidential This Document is the Property of Medtronic, Inc. and must be accounted for. Information hereon is confidential. DO NOT reproduce it, reveal it to unauthorized persons or send it outside Medtronic without proper authorization. Writer Suzanne Dawidowicz Date 19 August 2004 Part No. Part No. Rev Comments A01560004 A Release for US/OUS Market Release Submissions DO NOT PRINT THIS FORM WHEN PRINTING THE LITERATURE PIECE. D O NOT COUNT THIS FORM IN THE LITERATURE PIECE PAGE COUNT. R EVISION HISTORY: SEE PDM WEBSITE FOR INFORMATION. Page 1 Form MEDN-0043 version 6.0 1. Materials: Covers • Grade #1, 80 lb. white gloss coated cover stock, minimum brightness level: 89 Text • 60 lb. white smooth opaque text stock Labels • N/A 2. Colors: To confirm all colors, graphics and text, refer to electronic file Front Cover • 4-color cover and solid gloss varnish Back Cover • Black text and graphics; solid gloss varnish Body • 2-color text and graphics (PMS 301, black, percentages of PMS 301 or percentages of black) Labels • N/A 3. Size: 4.6′′ ± 0.2 (w) x 6.0′′ ± 0.2 (h) 4. Type of Binding: Clear plastic coil, MWE lay-flat, or perfect bound 5. Other: • Cover and text whiteness must match visually. 6. Literature Piece Page Count (Including covers, excluding this form): 40 7. Note to print supplier: Supplier may add up to three blank pages at the end of the document before the back cover sheet as needed. If more are required, contact the purchasing agent. 8. Vendor-supplied information may appear at an appropriate location on the literature piece (eg, part number, bar code, etc.). 9. Graphics Content and Layout to be as shown and per Medtronic electronic file that is supplied (stored) by Medtronic Neuro. 37021_FC.fm 8/19/04 8:31 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN A01560004Rev X Printing instructions: Medtronic Confidential NeuroPatntR00 EXTERNAL NEUROSTIMULATOR 37021 Test stimulation patient guide Rx only 37021_FC.fm 8/19/04 8:32 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN A01560004Rev X Printing instructions: Medtronic Confidential NeuroPatntR00 Medtronic ® and Restore™ are trademarks of Medtronic, Inc. FCC Information The following is communications regulation information on the Model 37021 external neurostimulator. FCC ID: LF537021 This device complies with Part 15 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. Printing instructions: 37021_TOC.fm 8/19/04 8:32 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN A01560004Rev X 37021 2004-08 English Medtronic Confidential NeuroPatntR00 Contents 3 Contents Label symbols 5 1 Introduction 7 Purpose of the device 8 Precautions 9 How to use this guide 9 Test stimulation overview 10 Test stimulation goals 11 Patient guides 12 2 Using your test stimulation system 13 Knowing your system components 14 Using your external neurostimulator and accessories 16 Using the external neurostimulator holder 16 Checking the external neurostimulator batteries 18 Replacing the external neurostimulator batteries 19 Using the T HERAPY-STOP key 23 A01560004Rev X 37021_TOC.fm 8/19/04 8:32 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Printing instructions: English 37021 2004-08 Medtronic Confidential NeuroPatntR00 Contents 4 Reconnecting the cable to the external neurostimulator 23 Specifications 25 Declaration of Conformity 27 3 Your daily activities 29 What you should know about your activities 30 Device care 30 Physical activities 31 Incision care 33 Sleeping 34 What changes in sensation to expect during test stimulation 34 Index 36 Printing instructions: 37021_Sym.fm 8/19/04 8:32 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN A01560004Rev X 37021 2004-08 English Medtronic Confidential NeuroPatntR00 Label symbols 5 Label symbols Explanation of symbols on products and packaging. Refer to the appropriate product to see symbols that apply. CE 0123 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. The use of this device might be subject to individual country licensing regimes in Europe. System meets the applicable Canadian [C22.2-601.1-M90 (R2001)] electrical safety standard requirements. y IEC 60601-1/EN60601-1, Type BF Equipment w Caution, consult accompanying documents L Non-ionizing electromagnetic radiation For USA audiences only A01560004Rev X 37021_Sym.fm 8/19/04 8:32 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Printing instructions: English 37021 2004-08 Medtronic Confidential NeuroPatntR00 Label symbols 6 37021_Ch01.fm 8/19/04 8:32 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN A01560004Rev X Printing instructions: Medtronic Confidential NeuroPatntR00 1Introduction 37021_Ch01.fm 8/19/04 8:32 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN A01560004Rev X Printing instructions: Medtronic Confidential NeuroPatntR00 English 37021 2004-08 Introduction 1 8 Purpose of the device The Model 37021 external neurostimulator is designed to evaluate the success of Medtronic neurostimulation systems for pain therapy prior to implant. The external neurostimulator provides the same output characteristics as the Medtronic Restore Neurostimulation System for Pain Therapy. The Medtronic neurostimulation system is intended to provide electrical stimulation to relieve severe, intractable pain. The Medtronic neurostimulation system for pain therapy indications, contraindications, risks and benefits, warnings, precautions, and individualization of treatment informatio…

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1.3 Block Diagram Description RESTORE External Neurological Stimulator System Bus Processor Module L284 Stimulation Engine L283 Multi- Function IC ROMSRAMNon Volitile Memory D264 Power Source (Alkaline Batteries) Therapy Off Switch Electrode Connector Telemetry Antenna (Transmit Frequency: 175KHz) TX RX Battery Back-up Crystal 100 kHz

Attn: Director of Certification 19 April 2005 Federal Communications Commission 7435 Oakland Mills Road Columbia, MD 21046 Attn: Reviewing Engineer 19 April 2005 , ENS, FCC ID: LF537021

TÜV America Inc. Phone: (651) 631-2487 1775 Old Highway 8 NW Fax: (651) 638-0285 Suite 104 E-mail: [email protected] New Brighton, MN 55112 www.TUVamerica.com Management Service • Product Service • Industry Service • Automotive • BABT TÜV America Inc. is a subsidiary of TÜV SÜD Group. 27 April 2005 RE: Medtronic Inc FCC ID: LF537021 In response to 21 April 2005 ATCB comments on the above referenced application, Medtronic and/or TÜV America provide the following responses. 1. Additional Photos have been provided and are included in the uploaded Revised Internal Photos document (last 2 pages). 2. The FCC ID has been corrected in the manual and the revised manual uploaded. 3. Additional measurements have been taken to address the peak measurement issue. The report has been revised and Rev B has been uploaded. The modulation type is Continuous Wave Amplitude Burst Modulation. 4. The ENS therapy stimulation does not have any bearing on RF output levels. Even though the programmer can adjust ENS parameters, the RF output isn't affected because it's just commands that are being transmitted from the programmer to the ENS. 5. The Test Report indicates 36 dB/decade and seems to be correct from our Engineer's calculation. Please let us know if you require any further information. Thank you. Jolene Murphy Senior Technical Writer [email protected]

American Telecommunications Certification Body Inc. 6731 Whittier Ave, McLean, VA 22101 April 21, 2005 RE: Medtronic Inc. FCC ID: LF537021 After a review of the submitted information, I have a few comments on the above referenced Application. 1) It is uncertain where the antenna of this device is located. Please provide a photographs or similar diagram that shows the placement of the antenna. 2) The FCC ID given in the manual is incorrect. 3) It appears the fundamental was measured in average mode. Please note that there is also a limit on the peak emissions that is 20 dB above the average limit (15.35). It is also unsure of what type of modulation was present but information in the operational description suggests this will be pulsed emissions. Therefore the FCC expects the device to have been measured in peak mode and corrected mathematically for average. Please provide further information as necessary. For instance, what was the peak to average ratio. What type of modulation was present. Note that the operational description (section 1.4.1) mentions pulse duration and pulse position as possible encoding schemes. This would suggest that peak emissions corrected for worse case average factors should have been applied. 4) The device appears to have pulse width and amplitude adjustments from the programmer. How do these settings affect the RF output (waveform)? Are these sent only as data commands to the stimulation device or is the RF envelope affected? For instance is a programming of the amplitude of the stimulation device accomplished by sending data to the stimulation device, or does the programmer TX waveform actually change amplitude as well. Note it appears from information in the operational description that the duty cycle is affected directly based upon the duty cycle entered in the programmer and that the amplitude may also vary according to programming. The device should have been tested at maximum RF output levels as well as maximum duty cycle. Please explain. 5) It appears that the extrapolation of this device would be 34 dB per decade and not 48 dB per decade. Please review and correct as necessary. Timothy R. Johnson Examining Engineer mailto: [email protected] The items indicated above must be submitted before processing can continue on the above referenced application. Failure to provide the requested information may result in application termination. Correspondence should be considered part of the permanent submission and may be viewed from the Internet after a Grant of Equipment Authorization is issued. Please do not respond to this correspondence using the email reply button. In order for your response to be processed expeditiously, you must submit your documents through the AmericanTCB.com website. Also, please note that partial responses increase processing time and should not be submitted. Any questions about the content of this correspondence should be directed to the sender.

TÜV America Inc. Phone: (651) 631-2487 Product Service Fax: (651) 638-0285 1775 Old Highway 8 NW E-mail: [email protected] Suite 104 www.TUVamerica.com New Brighton, MN 55112 Management Service • Product Service • Industry Service • Automotive • BABT TÜV America Inc. is a subsidiary of Group TÜV Süddeutschland. TÜV AMERICA INC - PRODUCT SERVICE 19333 WILD MOUNTAIN ROAD TAYLORS FALLS, MINNESOTA 55084-1786 ENGINEERING STATEMENT For Certification of Medtronic Inc External Neurostimulator (ENS) Model No: 37021 FCC ID: LF537021 FRN: 0010-0391-05 I am an Electromagnetic Compatibility Engineer for TÜV AMERICA INC - PRODUCT SERVICE, Taylors Falls, Minnesota. My education and experience are a matter of record with the Federal Communications Commission. TÜV AMERICA INC - PRODUCT SERVICE has been authorized by Kevin Kelly, Stim Product Development Director, of Medtronic Inc to make Certification measurements and act as the authorized representative in the preparation of applications for registration of the above mentioned equipment. TÜV AMERICA INC - PRODUCT SERVICE is on file with the FCC under Paragraph 2.948 of the FCC Rules. Test data required by the TCB for Certification is included in this report. It is submitted that the above equipment meets the FCC Part 15 Subpart C requirements and Certification is hereby requested. Joel T. Schneider Senior Engineer Minnesota Wild River Lab TÜV America Product Service Tel: 651 604 4582 Fax: 651 638 0298 [email protected] Dated: 20 April 2005

Medtronic 37021 ENS - Top Medtronic 37021 ENS - Back Medtronic 37021 ENS - Left and Front View Medtronic 37021 ENS - Right and Rear View

37021 LF537021 Because of the small size of the device, the compliance statement is placed in the manual instead of on the device label. Label Placement: Label will be placed here

Medtronic 37021 ENS - Disassembly View 1 Medtronic 37021 ENS - Disassembly View 2 Medtronic 37021 ENS - Disassembly View 3 Medtronic 37021 ENS - Board Top Left Medtronic 37021 ENS - Board Top Right Medtronic 37021 ENS - Board Bottom Left Medtronic 37021 ENS - Board Bottom Right Medtronic 37021 ENS - Antenna Placement - View 1 Medtronic 37021 ENS - Antenna Placement - View 2

PRODUCT SERVICE TEST RESULT SUMMARY FCC PART 15 SUBPART C Section 15.209 MANUFACTURER'S NAME Medtronic Neurological NAME OF EQUIPMENT RX1 ENS TYPE OF EQUIPMENT Battery-powered, temporary external neurostimulator MODEL NUMBER 37021 MANUFACTURER'S ADDRESS 800 53 rd Avenue NE Columbia Heights, MN 55421 TEST REPORT NUMBER WC403136.1 Rev A TEST DATE 06 July 2004 According to testing performed at TÜV Product Service Inc, the above-mentioned unit is in compliance with the electromagnetic compatibility requirements defined in FCC Part 15 Subpart C, Section 15.209. It is the manufacturer's responsibility to assure that additional production units of this model are manufactured with identical electrical and mechanical characteristics. Any modifications necessary for compliance made during testing on the above mentioned date(s) must be implemented in all production units for compliance to be maintained. TÜV Product Service Inc, as an independent testing laboratory, declares that the equipment tested as specified above conforms to the requirements of FCC Part 15 Subpart C, Section 15.209. Date: 20 April 2005 Location: Taylors Falls MN R. M. Johnson T. K. Swanson USA Tested By Reviewed By Not Transferable File No. WC403136.1 Rev A, Page 1 of 13 TÜV PRODUCT SERVICE INC 19333 Wild Mountain Road Taylors Falls MN 55084-1758 Tel: 651 638 0297 Fax: 651 638 0298Rev.No 1.0 PRODUCT SERVICE EMC EMISSION - T E S T R E P O R T Test Report File No. : WC403136.1 Rev A Date of issue: 20 April 2005 Model No. : 37021 Product Name : RX1 ENS Product Type : Battery-powered, temporary external neurostimulator Applicant : Medtronic Neurological Manufacturer : Medtronic Neurological License holder : Medtronic Neurological Address : 800 53 rd Avenue NE : Columbia Heights, MN 55421 Test Result : „ Positive † Negative Test Project Number : Reference(s) WC403136.1 Rev A Total pages including Appendices 26 TÜV Product Service Inc is a subcontractor to TÜV Product Service, GmbH according to the principles outlined in ISO/IEC Guide 25 and EN 45001. TÜV Product Service Inc reports apply only to the specific samples tested under stated test conditions. It is the manufacturer's responsibility to assure that additional production units of this model are manufactured with identical electrical and mechanical components. TÜV Product Service Inc shall have no liability for any deductions, inferences or generalizations drawn by the client or others from TÜV Product Service Inc issued reports. This report is the confidential property of the client. As a mutual protection to our clients, the public and ourselves, extracts from the test report shall not be reproduced except in full without our written approval. This report shall not be used by the client to claim product endorsement by NVLAP or any agency of the US government. TÜV Product Service Inc and its professional staff hold government and professional organization certifications and are members of AAMI, ACIL, AEA, ANSI, IEEE, NVLAP, and VCCI File No. WC403136.1 Rev A, Page 2 of 13 TÜV PRODUCT SERVICE INC 19333 Wild Mountain Road Taylors Falls MN 55084-1758 Tel: 651 638 0297 Fax: 651 638 0298Rev.No 1.0 PRODUCT SERVICE REVISION RECORD REVISION TOTAL NUMBER OF PAGES DATE DESCRIPTION 25 25 July 2004 Initial Release A 26 20 April 2005 Revisions include: ƒ Pg 10, Results for Part 15.209: Corrected dB/decade to 36 dB/decade. File No. WC403136.1 Rev A, Page 3 of 13 TÜV PRODUCT SERVICE INC 19333 Wild Mountain Road Taylors Falls MN 55084-1758 Tel: 651 638 0297 Fax: 651 638 0298Rev.No 1.0 PRODUCT SERVICE D I R E C T O R Y - EMISSIONS Page(s) A) Documentation Test report 1 - 10 Revision Record 2 Directory 3 Test Regulations 4 Deviation from standard / Summary 11 Test-setups (Photos) 12 - 13 Test-setup (drawing) Appendix A B) Test data FCC 15.207 - Conducted emissions 10/150 kHz - 30 MHz 6, 10 FCC 15.209 - Radiated emissions 10 kHz - 30 MHz 6, 10 FCC 15.209 - Radiated emissions 30 MHz - 1000 MHz 7, 10 Interference power 30 MHz - 300 MHz N/A Equivalent Radiated emissions 1 GHz - 18 GHz N/A C) Appendix A Test Data Sheets and Test Setup Drawing(s) A1 – A4 D) Appendix B Constructional Data Form B1 – B7 Product Information Form(s) N/A E) Appendix C Measurement Protocol C1 - C2 File No. WC403136.1 Rev A, Page 4 of 13 TÜV PRODUCT SERVICE INC 19333 Wild Mountain Road Taylors Falls MN 55084-1758 Tel: 651 638 0297 Fax: 651 638 0298Rev.No 1.0 PRODUCT SERVICE EMISSIONS TEST REGULATIONS : The emissions tests were performed according to following regulations: -------------------------------------------------------------------------------- † - EN 50081-1 / 1991 † - EN 55011 / 1991 † - Group 1 † - Group 2 † - Class A † - Class B † - EN 55013 / 1990 † - EN 55014 / 1987 † - Household appliances and similar † - Portable tools † - Semiconductor devices † - EN 55014 / A2:1990 † - EN 55014 / 1993 † - Household appliances and similar † - Portable tools † - Semiconductor devices † - EN 55015 / 1987 † - EN 55015 / A1:1990 † - EN 55015 / 1993 † - EN 55022 / 1987 † - Class A † - Class B † - EN 55022 / 1994 † - Class A † - Class B † - BS † - VCCI † - Class A † - Class B „ - FCC Part 15 Subpart C Section 15.209 † - FCC Part 15 Subpart C Section 15.207 Conducted Emission Requirements † - FCC Part 15 Subpart B † - Class A † - Class B † - CISPR 11 (1990) † - Group 1 † - Group 2 † - Class A † - Class B † - CISPR 22 (1993) † - Class A † - Class B File No. WC403136.1 Rev A, Page 5 of 13 TÜV PRODUCT SERVICE INC 19333 Wild Mountain Road Taylors Falls MN 55084-1758 Tel: 651 638 0297 Fax: 651 638 0298Rev.No 1.0 PRODUCT SERVICE Environmental conditions in the lab: Actual Temperature : 16 °C Relative Humidity : 81 % Atmospheric pressure : 98.0 kPa Power supply system : 3 VDC Battery Sign Explanations: † - not applicable „ - applicable File No. WC403136.1 Rev A, Page 6 of 13 TÜV PRODUCT SERVICE INC 19333 Wild Mountain Road Taylors Falls MN 55084-1758 Tel: 651 638 0297 Fax: 651 638 0298Rev.No 1.0 PRODUCT SERVICE Emissions Test Conditions:…

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TÜV PRODUCT SERVICE INC 19333 Wild Mountain Road Taylors Falls MN 55084-1758 Tel: 651 638 0297 Fax: 651 638 0298Rev.No 1.0 PRODUCT SERVICE Test-setup photo(s): Radiated emission 10 kHz - 1000 MHz TÜV PRODUCT SERVICE INC 19333 Wild Mountain Road Taylors Falls MN 55084-1758 Tel: 651 638 0297 Fax: 651 638 0298Rev.No 1.0 PRODUCT SERVICE TEST SETUP FOR EMISSIONS TESTING WILD RIVER LAB Small Test Site (STS) EUT 180 270 90 0 60 Hz 50 Hz Turntable is 1.2 meters in diameter Enlarged View of Shelter (4 meters square) STS Building Shelter 3 meter antenna 10 meter antenna 30 meter antenna Turntable Control Cable Ground Screen (34 meters long x 12 meters wide) 8 meters