LF58831SynchroMed Activator, Model 8831

You and Your SynchroMed ® Activator Model 8831 Activator for Your SynchroMed ® or SynchroMed ® EL Implantable Drug Pump Patient Manual Caution:Investigational Device. Limited by federal law (U.S.A.) to investigational use. Rx Only 200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 1 FCC ID: LF58831FCC ID: LF58831FCC ID: LF58831FCC ID: LF58831FCC ID: LF58831FCC ID: LF58831 File No. NC1GXXXX01, Page AX of AXX FCC ID: LF58831 200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 2 A Company Dedicated to Patients Medtronic was founded in 1949 by Earl Bakken, a graduate student in electrical engineering, and his brother-in-law, Palmer J. Hermundslie. Today Medtronic is the world leader in medical technology, pioneering therapies that restore health, extend life and alleviate pain. From its modest beginnings in a 55-square-meter Minneapolis garage, we have transformed Medtronic into a worldwide company that serves customers in more than 120 countries. Each year, millions of patients are treated with Medtronic products and therapies. We invest almost $500 million each year in research and development, working closely with the world’s leading physicians and scientists to enhance our current products and therapies, and to develop new ones. Although we are a large company, individual patients and their needs are still the driving force behind what we do and how we do it. Our goal is to improve the quality of your life. This booklet, which provides information about your SynchroMed Activator, is one small way we try to help. Welcome to the Medtronic family. We wish you well. 200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 3 Explanation of Symbols Status Light Symbols Successful Dose ActivationIncomplete Communication Interval LockoutActivator Battery Status Miscellaneous Symbols IEC 60601-1, Type BF Equipment Attention: See accompanying documents Caution: This device contains a strong magnet. Proximity to recording tape and disks should be avoided. Medtronic ® , SynchroMed ® , and SynchroMed ® EL, are registered trademarks of Medtronic, Inc. Refer to the instructional label on the SynchroMed Activator for all applicable approvals. 9V w y w 200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 4 CONTENTS FCC INFORMATION........................................................ 1 INTRODUCTION.............................................................. 2 SYNCHROMED ACTIVATOR DESCRIPTION.......... 4 SYNCHROMED ACTIVATOR COMPONENTS AND FEATURES ................................................................ 7 Battery.............................................................................9 Replacing the 9-Volt Battery.....................................10 To remove the battery..........................................13 To install the battery.............................................14 STORING YOUR ACTIVATOR IN ITS POUCH .......15 ACTIVATION BUTTON..................................................18 POSITIONING AND USING YOUR SYNCHROMED ACTIVATOR..........................20 How to use the SynchroMed Activator with your pump....................................................21 200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 5 INITIALIZATION.............................................................23 UNDERSTANDING THE SYNCHROMED ACTIVATOR LIGHTS AND SOUNDS........................25 TROUBLESHOOTING....................................................29 WHEN TO CALL YOUR DOCTOR’S OFFICE.........................................................34 Call your doctor’s office if.........................................34 CLEANING AND CARE.................................................35 SPECIFICATIONS.............................................................37 Model 8831 SynchroMed Activator Specifications...............................................................37 GLOSSARY.........................................................................38 LIMITED WARRANTY....................................................41 SERVICE..............................................................................45 WARRANTY REGISTRATION CARD.........................47 200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 6 FCC INFORMATION The following is communications regulation information on the Model 8831 SynchroMed ® Activator. FCC ID: LF58831 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. 1 200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 1 INTRODUCTION You have been supplied with a Model 8831 SynchroMed ® Activator that enables you to activate a programmed dose of medication prescribed by your doctor from your SynchroMed ® or SynchroMed ® EL Implantable Drug Pump. The SynchroMed Activator is one part of the system that was prescribed for you and should be used only according to the instructions given in this manual and those provided by your doctor. 2 200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 2 This manual will describe how to: • activate a dose of medication from your pump; • determine if an activation was successful; • determine if enough time has elapsed since your previous dose to allow you to activate another; and • understand the meaning of the lights on the back of your SynchroMed Activator and of the audio signals from the device. If you have questions unanswered by this manual, or if any unusual situations or problems arise, consult your doctor. He or she knows your personal medical history and can give you the detailed information you may need. In particular, you should ask about the potential complications, risks, and benefits of this therapy. Important terms appear in boldtext and are listed in the glossary at …

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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 SynchroMed Activator Model No: 8831 FCC ID: LF58831 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 Steve LaPorte, Vice President and General Manager, of Medtronic Incorporated – Neurological Division, to make Certification measurements on the 8831 SynchroMed Activator. 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: 07 September 2001

Page 1 of 4 Front of EUTFCC ID: LF58831 Page 2 of 4 Back of EUT Page 3 of 4 Top and Right of EUT Page 4 of 4 Bottom and Left of EUT

LF58831 FCC ID: LF58831 Rx on Label refers to Prescription SynchroMed ® Activator PN 220333-001 UC200101213 EN Label Placement - Back 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: LF58831), 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

Page 1 of 11 Disassembly – Front cover offFCC ID: LF58831 Page 2 of 11 Disassembly – Front cover off, battery out Page 3 of 11 Disassembly – inside view from front Page 4 of 11 Disassembly – inside view from back Page 5 of 11 Board Top – Full view Page 6 of 11 Board Top – Upper Left

Page 7 of 11 Board Top – Upper Right Page 8 of 11 Board Top – Lower Right Page 9 of 11 Board Top – Lower Left Page 10 of 11 Board Back – w label Page 11 of 11 Board Back – w/o Label

FCC ID: LF58831 TCB BABT Product Service 4855 Patrick Henry Drive, Building 6 Santa Clara CA 95054 Declaration of Compliance to RF Exposure Limits for Humans The 8831 SynchroMed Activator 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 of 175 kHz, and output power of 642 nanowatts based on TP = (FS x D) 2 / 30 x 1.64, (562 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 NAME OF EQUIPMENTSynchroMed Activator MODEL NUMBER8831 MANUFACTURER'S ADDRESS710 Medtronic Parkway NE Minneapolis MN 55432-5604 TEST REPORT NUMBERW0566.1 TEST DATE20 October 2000 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, 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 electromagnetic compatibility requirements of FCC Part 15, section 15.209. Date:28 November 2000 Location:Taylors Falls MNT. K. SwansonJ. T. Schneider USATest TechnicianLead Engineer Not Transferable FCC ID: LF58831FCC ID: LF58831 FCC ID: LF58831 File No. WC1G056601.1, 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.: WC1G056601.1 Date of issue:28 November 2000 Model / Serial No.: 8831 / Product Type: SynchroMed Activator Applicant: Medtronic Manufacturer: Medtronic License holder: Medtronic Address: 710 Medtronic Parkway NE : Minneapolis MN 55432-5604 Test Result: nn Positiveoo Negative Test Project Number: Reference(s) W0566.1 Total pages including Appendices27 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. WC1G056601.1, 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 – A4 D)Appendix B Constructional Data Form B2 – B10 E)Appendix C Measurement ProtocolC1 – C2 File No. WC1G056601.1, 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. WC1G056601.1, 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: 21 °C Relative Humidity: 41 % Atmospheric pressure: 98.7 kPa Power supply system: 9.0 VDC Battery Sign Explanations: o - not applicable n - applicable File No. WC1G056601.1, 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 frequency ran…

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Page 1 of 4 FCC ID: LF58831 – Medtronic 8831 Test Setup Up Photos - Radiated Emissions Page 2 of 4 Page 3 of 4 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 Page 4 of 4