LF52490ACareLink Monitor Model 2490

220548001Rev A Refer to the “Med/Vit_Lds_Cath” category in doc#163256 for Printing Instructions 2490_Fc.fm 1/10/02 9:33 am UC200200183 EN xxx release Draft 2 Medtronic Confidential PtMan_mdvtldct CARELINK ™ MONITOR Model 2490A C A R E L IN K M O N IT O R 2 4 9 0 A W A R N IN G : U S E O N L Y W H E N M O N I T O R I S O N CARELINK Patient manual Caution:Federal law (USA) restricts this device to sale by or on the order of a physician. 220548001Rev A Refer to the “Med/Vit_Lds_Cath” category in doc#163256 for Printing Instructions 2490_Fc.fm 1/10/02 9:33 am UC200200183 EN xxx release Draft 2 Medtronic Confidential PtMan_mdvtldct i 220548001Rev A Refer to the “Med/Vit_Lds_Cath” category in doc#163256 for Printing Instructions 2490TOC.fm 1/10/02 9:33 am UC200200183 EN xxx release Draft 2 Medtronic Confidential PtMan_mdvtldct Table of contents Introduction 3 When to use your CareLink Monitor 3 When not to use your CareLink Monitor 3 Precautions 5 About your CareLink Monitor 6 Choosing a place to set up your CareLink Monitor 7 Setting up your CareLink Monitor 8 Using your CareLink Monitor 12 Green status lights on your CareLink Monitor 16 Orange status lights on your CareLink Monitor 16 Caring for your CareLink Monitor 18 ii 220548001Rev A Refer to the “Med/Vit_Lds_Cath” category in doc#163256 for Printing Instructions 2490TOC.fm 1/10/02 9:33 am UC200200183 EN xxx release Draft 2 Medtronic Confidential PtMan_mdvtldct 3 220548001Rev A Refer to the “Med/Vit_Lds_Cath” category in doc#163256 for Printing Instructions 2490.fm 1/10/02 9:33 am UC200200183 EN xxx release Draft 2 Medtronic Confidential PtMan_mdvtldct Introduction This manual is intended to help you understand and use your Medtronic ® Model 2490A CareLink Monitor. If you have any questions not answered by this manual, or if you have any problems with your CareLink Monitor, talk to your doctor. Your doctor knows your medical history and can give you the help you need. When to use your CareLink Monitor The CareLink Monitor is an electronic device that provides an easy way for your doctor to obtain information about your implanted device. The CareLink Monitor gathers this information to allow your doctor to manage your care. Your CareLink Monitor is intended specifically for your use only. It will not work with other implanted devices and should only be used by you as directed by your doctor. Unauthorized use by others with implanted devices could interrupt the prescribed operation of their device. When not to use your CareLink Monitor Warning:If you are feeling ill and you think you might need to go to the hospital, seek medical attention immediately. If there is an emergency, call 911 or follow other instructions from your doctor. Do not use your 220548001Rev A Refer to the “Med/Vit_Lds_Cath” category in doc#163256 for Printing Instructions 2490.fm 1/10/02 9:33 am UC200200183 EN xxx release Draft 2 Medtronic Confidential PtMan_mdvtldct 4 CareLink Monitor to send your medical information to your doctor unless you have already contacted your doctor and your doctor has requested that you use your CareLink Monitor. Warning:To ensure the safe operation of your implanted device, only use the CareLink Monitor as described in this manual and at the times prescribed by your doctor. If you miss a scheduled time to send data, consult with your doctor. Warning:If you feel ill after positioning the antenna, remove the antenna from over your implanted device and turn "off" your CareLink Monitor. If you still feel ill, contact your doctor. Warning:Your CareLink Monitor’s antenna contains a strong magnet; however, the monitor has been designed for use with your implanted device. To ensure proper function of your implanted device when not using the monitor, avoid other strong magnets, such as those used in some stereo speakers, bingo wands, extractor wands, magnetic badges, and magnetic therapy products. Warning:To ensure proper operation of your implanted device, always turn on the CareLink Monitor before positioning the antenna. Follow the instructions in this manual about positioning the antenna over your implanted device. 5 220548001Rev A Refer to the “Med/Vit_Lds_Cath” category in doc#163256 for Printing Instructions 2490.fm 1/10/02 9:33 am UC200200183 EN xxx release Draft 2 Medtronic Confidential PtMan_mdvtldct Warning:Do not use the antenna if your CareLink Monitor does not operate as described in “Using your CareLink Monitor” on page 12. Check the batteries as described in “Battery status” on page 17. If you need further assistance, contact your clinic. Precautions
Do not use a cellular phone while the antenna is positioned over your implanted device.
If possible, avoid using the telephone while using your CareLink Monitor. Your phone line will be "busy" while your CareLink Monitor is sending data. Note: In the case of an emergency, you can use your phone to call for help. If you have an emergency and the CareLink Monitor is "on" (power status light is lit), press the Power button to turn the CareLink Monitor "off" (power status light is not lit) and to ensure your phone line is available.
You can use your CareLink Monitor away from your home. However, you will need to keep the following requirements in mind: –If you are using a telephone line that requires you to dial a number (usually “9”) to make an outside call, make sure that the telephone line settings are correct. See “Verifying the telephone line settings” on page 10.
Your CareLink Monitor is designed for use in the continental United States, Alaska and Hawaii. 220548001Rev A Refer to the “Med/Vit_Lds_Cath” category in doc#163256 for Printing Instructions 2490.fm 1/10/02 9:33 am UC200200183 EN xxx release Draft 2 Medtronic Confidential PtMan_mdvtldct 6 About your CareLink Monitor Figure 1The CareLink Monitor (front view, approximately 1/4 actual size) The CareLink Monitor (Figure 1) uses an antenna that is permanently attached to the monitor to gather information from your implant…

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The following statement will be added to the instruction manual. This location of the following statement is required due to limitations of space on the label that will be placed on the Monitor. 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.

TRP INC. January 22, 2002 Federal Communications Commission 7435 Oakland Mills Rd Columbia, MD 21036 Re: Application for TCB Grant of Certification for FCC ID: LF52490A Gentlemen: Transmitted herewith is an application for certification of a device called a Carelink Monitor. The Carelink Monitor is a medical device that incorporates a low frequency telemetry link for the purpose of querying and retrieving stored patient data from an implanted device. Once the data is retrieved, it can be sent to the physician via the telephone line through an internal modem. Since the device is used for medical diagnostic test purposes, the digital electronics associated with it are exempt under the provisions of Section 15.103(c). This Monitor uses a unique portable Base Module and a Telemetry Module with the identical RF transmit head that was granted certification under FCC ID:LF58840 on September 9, 2001 to achieve the above functionality. Therefore the RF test data, photos of the telemetry module, printed circuit boards for the telemetry module, and inductive loop coil filed for the above application are applicable to the application for this unit FCC ID:2490A. Sincerely, Phillip Inglis Consultant to Medtronic 14085 Howard Rd Dayton, MD 21036

January 22, 2002 Federal Communications Commission 7435 Oakland Mills Rd Columbia, MD 21036 Re: Request for Confidentiality for FCC ID:LF52490A Pursuant to Sections 0.457(d)(l)(ii) and 0.459 of the Commission’s Rules, Medtronic Incorporated (Applicant) hereby requests post grant confidential treatment of information accompanying their submission for certification as outlined below: - Schematics - 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 would 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 the application and all information contained in the application for grant of certification for the above FCC ID will not be made before the date of the Grant for this Application. Sincerely, Phillip Inglis Consultant to Medtronic Inc. 14085 Howard Rd Dayton, MD 21036

Medtronic 2490A CareLink Monitor 2490A Base Module and Telemetry Module 1/16/2002 D. Diez Medtronic Confidential Page 1 of 5 Medtronic 2490A CareLink Monitor 2490A Telemetry Module 1/16/2002 D. Diez Medtronic Confidential Page 2 of 5

LABEL NAME: SERIAL NUMBER LABEL 2490A LABEL P/N: 220384-003 Medtronic, Inc., Minneapolis, MN USA S/N Rx Only - Medical Equipment Complies With Part 68, FCC Rules Registration No: 3A4 USA-35685-M5-E Ringer Equivalence: 0.3B Input Voltage 6V FCC ID:LF52490A C US CARELINK MONITOR 2490A TM

2490A Main board Top Side 2490A Main Board Bottom Side Radicom Modem Top Side Radicom modem Bottom Side

Medtronic 2490A CareLink Monitor 2490A Telemetry Module Circuit Board, Top Side 1/16/2002 D. Diez Medtronic Confidential Page 3 of 5 Medtronic 2490A CareLink Monitor 2490A Telemetry Module Circuit Board, Bottom Side 1/16/2002 D. Diez Medtronic Confidential Page 4 of 5 Medtronic 2490A CareLink Monitor 2490A Telemetry Module Antenna Coil 1/16/2002 D. Diez Medtronic Confidential Page 5 of 5

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