LF58832Personal Therapy Manager

You and Your SynchroMed ® II Personal Therapy Manager Model 8832 Personal Therapy Manager for Your SynchroMed ® II Implantable Drug Pump Patient Manual Rx Only 221094_a_001.qxd 9/26/2002 4:15 PM Page 1 FCC ID: LF58832 FCC ID: LF58832 221094_a_001.qxd 9/26/2002 4:15 PM Page 2 FCC ID: LF58832 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 Personal Therapy Manager, is one small way we try to help. Welcome to the Medtronic family. We wish you well. i 221094_a_001.qxd 9/26/2002 4:15 PM Page i FCC ID: LF58832 Explanation of Symbols on Product and Packaging IEC 60601-1, Type BF Equipment Attention: See accompanying documents nSerial Number Radio frequency device (IEC-60601-1) Medtronic ® and SynchroMed ® are registered trademarks of Medtronic, Inc. This equipment has been tested and complies with the limits for medical devices as outlined in IEC 60601-1-2:1997. The device provides reasonable protection against harmful interference in a typical medical setting. However, there is no guarantee that interference will not occur. Refer to the troubleshooting section of this manual for instructions on what to do if the Personal Therapy Manager does not communicate completely with your pump and you suspect interference may be the cause. FCC ID: LF5 8832 This device complies with Part 15 Rules. Operation is subject to the following 2 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. ii w y Storage Temperature Relative Humidity Atmospheric Pressure XXX kPa XX.X in. Hg XX kPa XX.X in. Hg kPa XX % XX % C F C F XX XX XX XX L 221094_a_001.qxd 9/26/2002 4:15 PM Page ii FCC ID: LF58832 CONTENTS GLOSSARY................................................................. 1 INTRODUCTION.......................................................4 Identification of Buttons and Icons .............................5 DESCRIPTIVE INFORMATION.............................7 Purpose of the Device (Indications) ............................8 List of Personal Therapy Manager Materials..... 9 When the Device Should Not be Used (Contraindications) ......................................................10 Risks and Benefits ........................................................10 General Warnings and Precautions ...........................12 Warnings .................................................................12 Precautions .............................................................12 Electromagnetic Interference (EMI) ....................13 Care Regimen ...............................................................14 iii 221094_a_001.qxd 9/26/2002 4:15 PM Page iii FCC ID: LF58832 OPERATING INFORMATION ..............................15 Setup Instructions ........................................................15 Assembly ................................................................15 Install the Batteries ................................................16 Turning on Your Personal Therapy Manager ..16 Patient Option Screen ...........................................18 Synchronization ....................................................21 Activating a Dose .........................................................22 Position Your Personal Therapy Manager (Interrogation) .......................................23 Determining the Status of Your Activation Request ...............................................26 Toolkit Screen................................................................30 Therapy Information Screen ................................31 Refill Information Screen......................................33 Pump Alarm Status Screen ..................................34 Volume Setting Screen ..........................................34 iv 221094_a_001.qxd 9/26/2002 4:15 PM Page iv FCC ID: LF58832 Caring for Your Personal Therapy Manager ...........35 How to Determine if Batteries Need to be Replaced ........................................................35 Removing the PDA Batteries ...............................38 Replacing the PDA Batteries ................................39 Removing the Telemetry Module Batteries .......41 Replacing the Telemetry Module Batteries........42 Cleaning and Care .......................................................43 Storage ...........................................................................45 Disposal .........................................................................47 TROUBLESHOOTING ............................................48 When to Call Your Doctor’s Office............................48 Call your doctor’s office if ...................................48 How to Get Help ..........................................................55 v 221094_a_001.qxd 9/26/2002 4:15 PM Page v FCC ID: LF58832 ADDITIONAL INFORMATION ............…

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FCC ID: LF58832 FCC ID: LF58832

Front, Left, Bottom Back Right, Top FCC ID: LF58832 Back Front Bottom Top Left Right Separated Back Front

Part number: 220712-002 L Medtronic ® SynchroMed ® II 8832 Personal Therapy Manager IEC-60601 Medtronic, Inc. Distributed by Medtronic Neurological Minneapolis, MN 55432-5604 USA Rx only FCC ID: LF58832 L Label placed here FCC ID: LF58832

PTM Seperated1 FCC ID: LF58832 FCC ID: LF58832 FCC ID: LF58832 Head PCB Top Head PCB Bottom VIB in Case VIB Assembly Angle 2 VIB Top VIB Bottom

PRODUCT SERVICE TEST RESULT SUMMARY FCC PART 15 SUBPART C Section 15.209 MANUFACTURER'S NAME Medtronic Inc. NAME OF EQUIPMENT Personal Therapy Manager MODEL NUMBER 8832 MANUFACTURER'S ADDRESS 710 Medtronic Parkway Minneapolis, MN 55432 TEST REPORT NUMBER NC203909.1 TEST DATE 26 July 2002 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 requirements of FCC Part 15. Date: 12 August 2002 Location: Taylors Falls MN R. M. Johnson T. K. Swanson USA Tested By EMC Technical Writer Not Transferable FCC ID: LF58832 File No. NC203909.1, Page 1 of 11 TÜV PRODUCT SERVICE INC 19333 Wild Mountain Road Taylors Falls MN 55084-1758 Tel: 651 638 0297 Fax: 651 638 0298 Rev.No 1.0 PRODUCT SERVICE EMC EMISSION - T E S T R E P O R T Test Report File No. : NC203909.1 Date of issue: 12 August 2002 Model No. : 8832 Product Type : Personal Therapy Manager Applicant : Medtronic Inc. Manufacturer : Medtronic Inc. License holder : Medtronic Inc. Address : 710 Medtronic Parkway : Minneapolis, MN 55432 Test Result : nn Positive oo Negative Test Project Number : Reference(s) NC203909.1 Total pages including Appendices 21 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. NC203909.1, Page 2 of 11 TÜV PRODUCT SERVICE INC 19333 Wild Mountain Road Taylors Falls MN 55084-1758 Tel: 651 638 0297 Fax: 651 638 0298 Rev.No 1.0 PRODUCT SERVICE D I R E C T O R Y - EMISSIONS Page(s) A) Documentation Test report 1 – 11 Directory 2 Test Regulations 3 Deviation from standard / Summary 9 Test-setups (Photos) 10 – 11 B) Test data Conducted emissions 10/150 kHz - 30 MHz 5 Radiated emissions 10 kHz - 30 MHz 6 Radiated emissions 30 MHz - 1000 MHz 7 C) Appendix A Constructional Data Form A2 – A8 Product Information Form(s) N/A D) Appendix B Measurement Protocol B1 – B2 File No. NC203909.1, Page 3 of 11 TÜV PRODUCT SERVICE INC 19333 Wild Mountain Road Taylors Falls MN 55084-1758 Tel: 651 638 0297 Fax: 651 638 0298 Rev.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 / 1991 o - Group 1 o - Group 2 o - Class A o - Class B o - EN 55013 / 1990 o - EN 55014 / 1987 o - Household appliances and similar o - Portable tools o - Semiconductor devices o - EN 55014 / A2:1990 o - EN 55014 / 1993 o - Household appliances and similar o - Portable tools o - Semiconductor devices o - EN 55015 / 1987 o - EN 55015 / A1:1990 o - EN 55015 / 1993 o - EN 55022 / 1987 o - Class A o - Class B o - EN 55022 / 1994 o - Class A o - Class B o - BS o - VCCI o - Class A o - Class B n - FCC Part 15 Subpart C Section 15.209 o - FCC Part 15 Subpart B o - Class A o - Class B o - CISPR 11 (1990) o - Group 1 o - Group 2 o - Class A o - Class B o - CISPR 22 (1993) o - Class A o - Class B File No. NC203909.1, Page 4 of 11 TÜV PRODUCT SERVICE INC 19333 Wild Mountain Road Taylors Falls MN 55084-1758 Tel: 651 638 0297 Fax: 651 638 0298 Rev.No 1.0 PRODUCT SERVICE Environmental conditions in the lab: Actual Temperature : 22 °C Relative Humidity : 57 % Atmospheric pressure : 99 kPa Power supply system : 3 VDC - Battery Sign Explanations: o - not applicable n - applicable File No. NC203909.1, Page 5 of 11 TÜV PRODUCT SERVICE INC 19333 Wild Mountain Road Taylors Falls MN 55084-1758 Tel: 651 638 0297 Fax: 651 638 0298 Rev.No 1.0 PRODUCT SERVICE CONDUCTED EMISSIONS (15.207) Conducted emissions 450 kHz - 30 MHz n - Test not applicable Conducted emissions on the 60 Hz power interface of the EUT are measured in the frequency range of 450 kHz to 30 MHz. The measurements are performed using a receiver, which has CISPR characteristic bandwidth and quasi-peak detection, and a Line Impedance Stabilization Network (LISN), with 50 Ω/50 μH (CISPR 16) characteristics. In some cases, a pre-scan using a spectrum analyzer is initially performed on the units comprising the system under test to locate the highest emissions. If the minimum passing margin appears to be less than 20 dB with a peak mode measurement, the emissions are re-measured using a tuned receiver or spectrum analyzer with quasi-peak and average detection and recorded on the data sheets. The final measurement is taken off of the receiver, which has the LISN insertion loss, cable loss, and 10 dB attenuator factors stored in me…

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Test-setup photo(s): Radiated emission 10 kHz - 1000 MHz FCC ID: LF58832 TEST SETUP FOR EMISSIONS TESTING WILD RIVER LAB Large Test Site Notes: 1. Items shown in dotted lines are located on the floor below the test area. It is 5 meters vertically from the ground floor to the test area. 2. 50 Hz, 60 Hz, and 400 Hz are power panels for alternating current. 3. The antenna may be positioned horizontally 3, 10 or 30 meters from the center of the turntable. 4. The circle is a 6.7 meter diameter turntable. 5. A ground plane is in the plane of this sheet. 6. The test sample is shown in the azimuthal position representing zero degrees. EUT 0 90270 180 60 Hz 50 Hz 400 Hz Shielded Enclosure ANTENNA