LF537741Patient Programmer

Neurological Medtronic Confidential Title Model 7439 Patient Programmer User Manual - Global 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 Theresa King-Hunter Date 11/03/04 Part No. Part No. Rev Comments 221244001 D Release for translation 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 7.0 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): 136 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. 7439_FC.fm 10/13/04 9:26 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN 221244001Rev X Printing instructions: Medtronic Confidential NeuroPatntR00 PATIENT PROGRAMMER 7439 Pain therapy user manual c Rx only 2004 7439_FC.fm 10/13/04 9:27 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN 221244001Rev X Printing instructions: Medtronic Confidential NeuroPatntR00 The following are trademarks of Medtronic, Inc.: Medtronic ® , MyStim™, SoftStart™, Synergy Plus + ™, Synergy Compact + ™, and Synergy ® . c FCC Information The following is communications regulation information on the Model 7439 Patient Programmer. FCC ID: LF537741 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: 7439TOC.fm 10/13/04 9:27 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN 221244001Rev X 7439 2004-08 English Medtronic Confidential NeuroPatntR00 Contents 3 Contents Label symbols 7 1Introduction9 A company dedicated to patients 10 How to use this manual 11 Patient guides 13 Patient identification card 14 2 Important therapy information 15 Purpose of the neurostimulation system (indications) 16 Therapies that may not be used with the neurostimulation system (contraindications) 16 Risks and benefits 17 Risks of surgery 17 Possible adverse effects 18 Changes in therapy 18 Possible system complications 18 Warnings 19 Precautions 26 System and therapy 26 221244001Rev X 7439TOC.fm 10/13/04 9:27 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Printing instructions: English 7439 2004-08 Medtronic Confidential NeuroPatntR00 Contents 4 Patient activities 29 Individualization of treatment 31 3 Introduction to stimulation 33 How stimulation works 34 Parts of your system 36 Understanding your therapy 38 Controlling your stimulation 40 What your clinician controls 40 What you control 40 Recovery and care 41 Recovering from surgery 41 Activities 41 When to call your clinician 43 Care schedule 44 4 Using your patient programmer 45 How the patient programmer works 46 Synchronizing and displaying the T HERAPY screen 48 Guidelines for adjusting your stimulation 53 Turning your neurostimulator ON or OFF 55 Printing instructions: 7439TOC.fm 10/13/04 9:27 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN 221244001Rev X 7439 2004-08 English Medtronic Confidential NeuroPatntR00 Contents 5 Adjusting stimulation settings 57 Using the NAVIGATOR key 58 Changing a group 59 Increasing or decreasing a parameter (amplitude, pulse width, or rate) 62 Patient programmer batteries 66 Checking patient programmer batteries 66 Replacing patient programmer batteries 68 Summary of keys 69 Preferences: Changing the audio, contrast, and number format 72 Using the carrying case and labeling the patient programmer 75 Optional detachable antenna 76 Connecting the antenna 76 Using the antenna 78 5 Troubleshooting 79 Programmer screens 80 Warning screens 80 Communication screen 82 221244001Rev X 7439TOC.fm 10/13/04 9:27 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Printing instructions: English 7439 2004-08 Medtronic Confidential NeuroPatntR00 Contents 6 Information screens 83 Possible problems and solutions 88 User assistance 95 6 Maintenance 97 Cleaning and care 98 Safety and technical checks 100 Battery and programmer disposal 101 Neurostimulator disposal 101 Declaration of conformity 102 Specifications 103 7 Appendix A: Electromagnetic interference (EMI) 105 Contraindication 106 Warnings 108 Precautions 116 Notes 120 Glossary 123 Index 129 Printing instructions: 7439_Sym.fm 10/13/04 9:27 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN 221244001Rev X 7439 2004-08 English Medtronic Confidential NeuroPatntR00 Label symbols 7 Label symbols Explanation of symbols on products and packaging. Refer to the appropriate product to see symbols that apply. CE 0123…

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Neurological Medtronic Confidential Title Model 37742 Patient programmer: pain therapy user manual 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 Theresa King-Hunter Date 13 October 2004 Part No. Part No. Rev Comments 220907005 B Market release 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): 156 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. 37742_FC.fm 10/13/04 10:16 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN 220907005Rev X Printing instructions: Medtronic Confidential NeuroPatntR00 PATIENT PROGRAMMER 37742 Pain therapy user manual Rx only 2005 37742_FC.fm 10/13/04 10:17 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN 220907005Rev X Printing instructions: Medtronic Confidential NeuroPatntR00 Medtronic ® , Restore™, and SoftStart™ are trademarks of Medtronic, Inc. c FCC Information The following is communications regulation information on the Model 37741 Patient Programmer. FCC ID: LF537741 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: 37742TOC.fm 10/13/04 10:17 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN 220907005Rev X 37742 2004-08 English Medtronic Confidential NeuroPatntR00 3 Contents Label symbols 9 1Introduction11 A company dedicated to patients 12 How to use this manual 13 Patient guides 15 Patient identification card 17 2 Important therapy information 19 Purpose of the device 20 Purpose of the neurostimulation system (indications) 20 Therapies that may not be used with the neurostimulation system (contraindications) 20 Risks and benefits 21 Risks of surgery 21 Possible adverse effects 22 Changes in therapy 22 Possible system complications 22 220907005Rev X 37742TOC.fm 10/13/04 10:17 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Printing instructions: English 37742 2004-08 Medtronic Confidential NeuroPatntR00 Contents 4 Warnings 23 Precautions 30 System and therapy 30 Patient activities 32 Individualization of treatment 35 3 Introduction to stimulation 37 How stimulation works 38 Parts of your system 40 Understanding your therapy 43 Controlling your stimulation 45 What your clinician controls 45 What you control 45 Charging 46 Recovery and care 48 Recovering from surgery 48 Activities 48 When to call your clinician 50 Care schedule 51 4 Using your patient programmer 53 How the patient programmer works 54 Printing instructions: 37742TOC.fm 10/13/04 10:17 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN 220907005Rev X 37742 2004-08 English Medtronic Confidential NeuroPatntR00 Contents 5 Synchronizing and displaying the THERAPY screen 55 Checking the external neurostimulator battery 60 Checking the implanted neurostimulator battery 61 Guidelines for adjusting your stimulation 66 Turning your neurostimulator ON or OFF 69 Adjusting stimulation settings 70 Using the NAVIGATOR key 71 Changing a group 73 Increasing or decreasing a parameter (amplitude, pulse width, or rate) 75 Patient programmer batteries 79 Checking patient programmer batteries 79 Replacing patient programmer batteries 81 Summary of keys 82 Preferences: Changing the audio, contrast, time, and time/number format 85 220907005Rev X 37742TOC.fm 10/13/04 10:17 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Printing instructions: English 37742 2004-08 Medtronic Confidential NeuroPatntR00 Contents 6 Using the carrying case and labeling the patient programmer 89 Optional detachable antenna 91 Connecting the antenna 91 Using the antenna 93 5 Troubleshooting 95 Programmer screens 96 Warning screens 96 Communication screens 100 Information screens 100 Possible problems and solutions 106 User assistance 112 6 Maintenance 113 Cleaning and care 114 Safety and technical checks 116 Battery and programmer disposal 117 Neurostimulator disposal 117 Declaration of conformity 118 Specifications 119 7 Appendix A: Electromagnetic Printing instructions: 37742TOC.fm 10/13/04 10:17 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN 220907005Rev X 37742 2004-08 English Medtronic Confidential NeuroPatntR00 Contents 7 interference (EMI) 121 Contraindication 122 Warnings 124 Precautions 132 Notes 136 Glossary 139 Index 147 220907005Rev X 37742TOC.fm 10/13/04…

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1.3 Block Diagram Description uP Power Management Alkaline Batteries LCD Lighting Transmit Receive Power to Circuits System Memory/ I/O Crystal 9.8304MHz Audio Transducer Push Button Matrix LCD Module RTC Crystal 32.768 kHz Backup Power IRDA External Antenna Internal Antenna Software Loading Port RESTORE Patient Programmer Transmit frequency: 175kHz

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. 21 April 2005 RE: Medtronic Inc FCC ID: LF537741 In response to ATCB comments on the above referenced application. 1. Page C2 of C2 describes the EUT was examined in 3 orthogonal axes. Test setup photographs indicate the worst case configuration. 2. The device was tested with internal antenna and external antenna. External antenna is worst case configuration, and thus the configuration for which data is reported. 3. This is an omission in the test report. Peak measurements were made, and were 8 dB higher than the average measurements. Reports will be corrected and resent. 4. ANSI C63.4 procedures are followed - page C2 of C2 describes procedure used. Both Test Reports have been revised, including photos, and are being uploaded at the same time as this correspondence. In addition, a revised Test Setup Photos exhibit is also being uploaded. Please let us know if the above responses are satisfactory, as some of your same comments were also issued on one of the other submittals. 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: LF537741 After a review of the submitted information, I have a few comments on the above referenced Application. 1) According to ANSI C63.4 (13.1.4.1), Portable devices are required to be positioned in each of 3 axis and measured to obtain worse case. This does not appear to have been done. Please review? 2) There appears to be an internal and external antenna option associated with this. However test configuration photographs only appear to show the external antenna version. Was the internal antenna version also tested? If so are photographs available? If not, why not? 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. If the device contains pulsed emissions, 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. 4) Please explain how the loop antenna (measurement antenna) was positioned and maximized during test. Loop antennas should be checked positioned in Vertical and Horizontal polarities according to ANSI C63.4 at a 1 meter height. Additionally, Vertical polarity should have been rotated about the Vertical axis to obtain worse case (ANSI C63.4 8.2.1). Antenna positioning can dramatically affect the results. No mention of antenna positioning appears in the report. Please explain. 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.

Attn: Director of Certification 19 April 2005 Federal Communications Commission 7435 Oakland Mills Road Columbia, MD 21046 Attn: Reviewing Engineer 19 April 2005 , Patient Programmer, FCC ID: LF537741

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 Patient Programmer Platform Model No: 37741 Platform (consisting of Pacemaker Programmer Models 7439 and 37742) FCC ID: LF537741 FRN: 0010-0391-05 The patient programmer platform hardware design is model 37741. This hardware platform does not have application software. The platform will never be sold to a patient because it needs software to talk to an implantable device. So, this platform was used and an application was added that enables the device to talk to a rechargeable implantable neurostimulator - this complete device was then branded for market release as model number 37742 (Restore). This platform was also used with another application applied that enables the device to talk to a different implantable neurostimulator (different therapy) - this complete device was then branded for market release as model number 7439 (Synergy +). Because each released device contains the same hardware platform (model 37741), we used this as the FCC id number. Both device were tested because they communicate differently (to different implantables). 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

Patient Programmer - Top View Patient Programmer - Bottom View Patient Programmer with external antenna Patient Programmer - Side 1 view Patient Programmer - Side 2 View Patient Programmer - Side 3 View Patient Programmer - Side 4 View

Due to the small size of the device, the compliance statement will be placed in the user manual. Label Placement (prototype label is shown in photo. Refer to above for final label):

Patient Programmer - Disassembly Patient Programmer - Top of Board 1 Patient Programmer - Bottom of Board 1 Patient Programmer - Top of Board 2 Patient Programmer - Top of Board 2 (without shield) Patient Programmer - Bottom of Board 2 Patient Programmer - LCD Front Patient Programmer - LCD Back Patient Programmer - internal antenna Patient Programmer - external antenna

PRODUCT SERVICE TEST RESULT SUMMARY FCC PART 15 SUBPART C Section 15.209 MANUFACTURER'S NAME Medtronic Neurological NAME OF EQUIPMENT Trilogy Patient Programmer TYPE OF EQUIPMENT Battery-powered, hand-held programmer MODEL NUMBER 7439 MANUFACTURER'S ADDRESS 800 53 rd Avenue NE Columbia Heights, MN 55421 TEST REPORT NUMBER WC402657.1 Rev B TEST DATE 15 June 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: 21 April 2005 Location: Taylors Falls MN R. M. Johnson T. K. Swanson USA Tested By Reviewed By Not Transferable File No. WC402657.1 Rev B, 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. : WC402657.1 Rev B Date of issue: 21 April 2005 Model No. : 7439 Product Name : Trilogy Patient Programmer Product Type : Battery-powered, hand-held programmer 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) WC402657.1 Rev B Total pages including Appendices 29 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. WC402657.1 Rev B, 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 28 20 July 2004 Initial Release A 29 18 April 2005 Revisions include: ƒ Changed Minimum limit margin for fundamental on page 10 to 85 dB. Also changed falloff to 60 dB/decade. B 29 21 April 2005 Revisions include: ƒ Added peak measurement data to page A3 and added comment regarding peak measurements to page 10. ƒ Replaced photo on page 13. File No. WC402657.1 Rev B, 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 - 11 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) A2 – A7 D) Appendix B Constructional Data Form B2 – B7 Product Information Form(s) N/A E) Appendix C Measurement Protocol C1 - C2 File No. WC402657.1 Rev B, 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. WC402657.1 Rev B, 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 : 20 °C Relative Humidity : 40 % Atmospheric pressure : 97.0 kPa Power supply system : 3 VDC Battery Sign Explanations: † - not applicable „ - applica…

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PRODUCT SERVICE TEST RESULT SUMMARY FCC PART 15 SUBPART C Section 15.209 MANUFACTURER'S NAME Medtronic Neurological NAME OF EQUIPMENT RX1 Patient Programmer TYPE OF EQUIPMENT Battery-powered, hand-held programmer MODEL NUMBER 37742 MANUFACTURER'S ADDRESS 800 53 rd Avenue NE Columbia Heights, MN 55421 TEST REPORT NUMBER WC402657.4 Rev B TEST DATE 15 June 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: 21 April 2005 Location: Taylors Falls MN R. M. Johnson T. K. Swanson USA Tested By Reviewed By Not Transferable File No. WC402657.4 Rev B, 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. : WC402657.4 Rev B Date of issue: 21 April 2005 Model No. : 37742 Product Name : RX1 Patient Programmer Product Type : Battery-powered, hand-held programmer 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) WC402657.4 Rev B Total pages including Appendices 30 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. WC402657.4 Rev B, 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 29 20 July 2004 Initial Release A 30 18 April 2005 Revisions include: ƒ Changed Minimum limit margin for fundamental on page 10 to 41 dB. Also changed falloff to 52 dB/decade. B 30 21 April 2005 Revisions include: ƒ Added peak measurement data to page A3 and added comment regarding peak measurements to page 10. ƒ Replaced photo on page 13. File No. WC402657.4 Rev B, 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 - 11 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) A2 – A8 D) Appendix B Construct…

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