LF58840N'Vision Clinician Programmer, Model 8840

TÜV MANAGEMENT SERVICEPhone: (651) 631 2487 TÜV PRODUCT SERVICE INC.Fax: (651) 638 0285 1775 Old Highway 8 NW, Suite 104email [email protected] New Brighton MN 55112-1891http:://www.tuvglobal.com Divisions of TÜV America Inc., a subsidiary of TÜV Süddeutschland TÜV PRODUCT SERVICE INC 19333 WILD MOUNTAIN ROAD TAYLORS FALLS, MINNESOTA 55084-1786 ENGINEERING STATEMENT For Certification of Medtronic Incorporated – Neurological Division 710 Medtronic Parkway Minneapolis MN 55432-5604 N’VISION Hand Held Clinical Programmer Model No: 8840 FCC ID: LF58840 I am an Electromagnetic Compatibility Engineer for TÜV PRODUCT SERVICE INC, Taylors Falls, Minnesota. My education and experience are a matter of record with the Federal Communications Commission. TÜV PRODUCT SERVICE INC has been authorized by Clifton W Owens, Vice President and General Manager, of Medtronic Incorporated – Neurological Division, to make Certification measurements on the 8840 Hand Held Clinical Programmer. These tests were made by me or under my supervision at our Wild River Laboratory which is on file with the FCC under Paragraph 2.948 of the FCC Rules. Test data required by the TCB is included in this report. It is submitted that the above equipment meets the FCC Part 15, Subpart C (15.209) Requirements and Certification is hereby requested. Joel T. Schneider Chief Engineer Minnesota Wild River Lab TÜV Product Service [email protected] Dated: 13 September 2001

FCC ID: LF58840 Medtronic Neurological 710 Medtronic Parkway Minneapolis MN 55432-5604 USA Telephone: (763) 505-5000 Toll Free: l-800-328-081 0 Fax: (763) 505-l 000 Internet: w.medtronic.com August 7,200l TCB BABT Product Service 4855 Patrick Henry Drive, Building 6 Santa Clara, CA 95054 Re: Request of Confidentiality Pursuant to Sections 0.457(d)(l)(ii) and 0.459 of the Commission’s Rules, the Applicant hereby requests confidential treatment of information accompanying as outlined below: - Schematics - Parts list - Block Diagram - Technical Circuit Description The above materials contain trade secrets and proprietary information not customarily released to the public. The public disclosure of these matters might be harmful to the Applicant and provide unjustified benefits to its competitors. The Applicant understands that pursuant to Rule 0.457(d)(1)(ii), disclosure of this Application and all accompanying documentation will not be made before the date of the Grant for this Application. Sincerely, William J. Hozper Vice President , MDD Operations Phone: 763-505-0330 Fax: 763-505-0335

8840 Programmer – Exterior– Front Page 1 of 6 FCC ID: LF58840 8840 Base Module – Exterior – Front (With Telemetry Module Extended) Page 2 of 6 8840 Programmer – Exterior – Back Page 3 of 6 8840 Base Module – Exterior – Back (With optional magnet on extended Telemetry Module) Page 4 of 6 8840 Programmer – Exterior – Bottom and Left Edges Page 5 of 6 8840 Programmer – Top and Right Edges Page 6 of 6

FCC ID: LF58840 8840 Programmer – Label Placement The following documentation includes a letter from the FCC accepting that the compliance statement for a product similar to this product (FCC ID: LF57435) was not on the label, but in the User’s Manual. If this is not acceptable by the TCB for the unit we are currently submitting application for (FCC ID: LF58840), please request a ruling from the FCC. Page 1 of 9 Page 2 of 9 Page 3 of 9 Page 4 of 9 Page 5 of 9 Page 6 of 9 Page 7 of 9 Page 8 of 9 Page 9 of 9

8840 Programmer – Interior – Inside Battery Compartment Page 1 of 14 FCC ID: LF58840 8840 – Interior – Inside Empty Battery Compartment Page 2 of 14 8840 Base Module – Interior – Disassembly (from front) Page 3 of 14 8840 Base Module – Interior – Disassembly (from back) Page 4 of 14 8840 Telemetry Module – Interior – Disassembly (from front) With Reel Assembly Page 5 of 14 8840 Telemetry Module – Interior – Disassembly (from back) With Reel Assembly Page 6 of 14 8840 Base Module PCB Assembly (front) Page 7 of 14 8840 Base Module PCB Assembly (back) Page 8 of 14 FCC ID: LF58840 Receptical for Compact Flash Card 8840 Base Module PCB Assembly (back) Right Half Page 9 of 14 8840 Base Module PCB Assembly (back) Left Half Page 10 of 14 8840 Base Module PCB Assembly (Front) Right Half Page 11 of 14 8840 Base Module PCB Assembly (Front) Left Half Page 12 of 14 8840 Telemetry Module PCB Assembly (Front) Page 13 of 14 8840 Telemetry Module PCB Assembly (Back) Page 14 of 14

FCC ID: LF58840 TCB BABT Product Service 4855 Patrick Henry Drive, Building 6 Santa Clara CA 95054 Declaration of Compliance to RF Exposure Limits for Humans The 8840 Hand-Held Clinical Programmer complies with the RF exposure limits for humans as called out in CFR 47, Part 2.1093. The transmitters are used to transmit data relating to Implantable Device Programming. It is exempt from RF evaluation based on its operating frequency range of 166 – 185 kHz (center frequency of 175 kHz), and output power of 2.6 microwatts based on TP = (FS x D) 2 / 30 x 1.64, (1122 uV/m x 10) 2 / 30 x 1.64. This would be less than the 200 milliwatt requirement for a portable device. Joel T Schneider TUV Product Service

PRODUCT SERVICE TEST RESULT SUMMARY FCC PART 15 SUBPART C, Section 15.209 Radiated Emissions MANUFACTURER'S NAMEMedtronic, Inc. NAME OF EQUIPMENTN’VISION Hand Held Clinical Programmer MODEL NUMBER8840 MANUFACTURER'S ADDRESS710 Medtronic Parkway NE Minneapolis MN 55432-5604 TEST REPORT NUMBERNC104316.3 TEST DATE17 May 2001 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. 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 electromagnetic compatibility requirements of FCC Part 15 Date:13 September 2001 Location:Taylors Falls MNT. K. SwansonJ. C. Sausen USATest TechnicianTest Engineer Not Transferable FCC ID: LF58840 File No. NC104316.3, Page 1 of 11 TÜV PRODUCT SERVICE INC19333 Wild Mountain RoadTaylors Falls MN 55084-1758Tel: 651 638 0297Fax: 651 638 0298Rev.No 1.0 PRODUCT SERVICE EMC EMISSION - T E S T R E P O R T Test Report File No.: NC104316.3 Date of issue: 13 September 2001 Model / Serial No.: 8840 / NHF000050, NHF000055 Product Type: N’VISION Hand Held Clinical Programmer Applicant: Medtronic, Inc. Manufacturer: Medtronic, Inc. License holder: Medtronic, Inc. Address: 710 Medtronic Parkway NE : Minneapolis MN 55432-5604 Test Result: nn Positiveoo Negative Test Project Number: Reference(s) NC104316.3 Total pages including Appendices23 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. NC104316.3, Page 2 of 11 TÜV PRODUCT SERVICE INC19333 Wild Mountain RoadTaylors Falls MN 55084-1758Tel: 651 638 0297Fax: 651 638 0298Rev.No 1.0 PRODUCT SERVICE D I R E C T O R Y - EMISSIONS Page(s) A)Documentation Test report1 – 9 Directory2 Test Regulations3 Deviations from standard / Summary9 Test-setups (Photos)10 – 11 Test-setup (drawing)Appendix A B)Test data FCC Conducted Emissions150 kHz - 30 MHz5, 8 FCC Radiated Emissions30 MHz – 1000 MHz5, 8 FCC Radiated Emissions1 GHz – 100 GHz5, 8 FCC Radiated Emissions9 kHz - 30 MHz6, 8 FCC Interference Power30 MHz – 300 MHz6, 8 C)Appendix A Test Data Sheets and Test Setup Drawing(s) A2 – A3 D)Appendix B Constructional Data Form B2 – B7 E)Appendix C Measurement ProtocolC1 – C2 File No. NC104316.3, Page 3 of 11 TÜV PRODUCT SERVICE INC19333 Wild Mountain RoadTaylors Falls MN 55084-1758Tel: 651 638 0297Fax: 651 638 0298Rev.No 1.0 PRODUCT SERVICE EMISSIONS TEST REGULATIONS : The emissions tests were performed according to following regulations: -------------------------------------------------------------------------------- o - EN 50081-1 / 1991 o - EN 55011 / 1991o - Group 1o - Group 2 o - Class Ao - Class B o - EN 55013 / 1990 o - EN 55014 / 1987o - Household appliances and similar o - Portable tools o - Semiconductor devices o - EN 55014 / A2:1990 o - EN 55014 / 1993o - Household appliances and similar o - Portable tools o - Semiconductor devices o - EN 55015 / 1987 o - ETS 300 683 / 1997, Emission Requirements o - EN 300 330 / 1999, Sections 7.2, 7.3, 7.4, 8.1 Class 1 o - EN 55022 / 1987o - Class Ao - Class B o - EN 55022 / 1994, Amendment A1: 1995 &o - Class Ao - Class B Amendment A2: 1997 o - EN 60601-1-2 / 1993, Emission Requirements o - VCCIo - Class Ao - Class B o - FCCo - Class Ao - Class B n - FCC Part 15 Subpart C Section 15.209 - Radiated o - AS 3548 (1992)o - Class Ao - Class B o - CISPR 11 (1990) o - Group 1o - Group 2 o - Class Ao - Class B o - CISPR 22 (1993) o - Class Ao - Class B File No. NC104316.3, Page 4 of 11 TÜV PRODUCT SERVICE INC19333 Wild Mountain RoadTaylors Falls MN 55084-1758Tel: 651 638 0297Fax: 651 638 0298Rev.No 1.0 PRODUCT SERVICE Environmental conditions in the lab: Actual Temperature: 24 °C Relative Humidity: 35 % Atmospheric pressure: 97.9 kPa Power supply system: 6.0 VDC Battery Sign Explanations: o - not applicable n - applicable File No. NC104316.3, Page 5 of 11 TÜV PRODUCT SERVICE INC19333 Wild Mountain RoadTaylors Falls MN 55084-1758Tel: 651 638 0297Fax: 651 638 0298Rev.No 1.0 PRODUCT SERVICE FCC Emissions Test Conditions: CONDUCTED EMISSIONS (Interference Voltage) The CONDUCTED EMISSIONS (INTERFERENCE VOLTAGE) measurements were performed at the following test location: n - Test not applicable o - Wild River Lab Large Test Site (Open Area Test Site) o - Wild River Lab Small Test Site (Open Area Test Site) o - Oakwood Lab (Open Area Test Site) o - Wild River Lab Screen Room o - New Brighton Lab Shielded Room FCC Emissions Test Conditions: RADIATED EMISSIONS (Electric Field) The RADIATED EMISSIONS (ELECTRIC FIELD) measurements, in the frequen…

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Page 1 of 3 Test Setup Photo – Radiated Emissions FCC ID: LF58840 Page 2 of 3 Test Setup Photo – Radiated Emissions TEST SETUP FOR EMISSIONS TESTING WILD RIVER LAB Small Test Site (STS) EUT 180 27090 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