Medtronic 8832 Personal Therapy Manager User Manual 221094 a 001
Medtronic, Inc. Personal Therapy Manager 221094 a 001
manual
221094_a_001.qxd 9/26/2002 4:15 PM Page 1 FCC ID: LF58832 FCC ID: LF58832 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 2 FCC ID: LF58832 221094_a_001.qxd 9/26/2002 4:15 PM Page i 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. 221094_a_001.qxd 9/26/2002 4:15 PM Page ii FCC ID: LF58832 Explanation of Symbols on Product and Packaging IEC 60601-1, Type BF Equipment XX C XX F XX C XX F Storage Temperature XX % Attention: See accompanying documents XX % Relative Humidity Serial Number XXX kPa XX.X in. Hg kPa Radio frequency device (IEC-60601-1) XX kPa XX.X in. Hg Atmospheric Pressure 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 221094_a_001.qxd 9/26/2002 4:15 PM Page iii 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 iv 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 v 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 221094_a_001.qxd 9/26/2002 4:15 PM Page vi FCC ID: LF58832 ADDITIONAL INFORMATION ...........................56 Specifications ................................................................56 Special Notice ...............................................................57 Travel or International Use.........................................57 SPECIAL PROCEDURES ........................................58 Interrogation .................................................................58 Patient Diary Use .........................................................60 Setting the Volume.......................................................62 Calibration.....................................................................64 Touchscreen Backlight Use .........................................67 Resetting Your Personal Therapy Manager .............68 vi 221094_a_001.qxd 9/26/2002 4:15 PM Page 1 FCC ID: LF58832 GLOSSARY Button—A picture on the screen of your Personal Therapy Manager that, when pressed, causes a specific action or function. On-screen buttons are presented as dark backgrounds that have lighter-colored pictures inside. Calibration—The process that sets up your Personal Therapy Manager the first time batteries are installed or after the device has been without power for several minutes. Dose Activation—The initiation of a command from your Personal Therapy Manager to your SynchroMed II Pump that tells the pump to activate a prescribed dose of medication. Electromagnetic Interference (EMI)—A field of energy made by equipment found in the home, work, medical, or public environments that is strong enough to interfere with the operation of your Personal Therapy Manager. 221094_a_001.qxd 9/26/2002 4:15 PM Page 2 FCC ID: LF58832 Icon—A picture on your Personal Therapy Manager that gives you information or represents a function or action. Incomplete Communication—The failure of your Personal Therapy Manager to complete delivery of a message to your pump. Interrogate—The act of using your Personal Therapy Manager to get information from your pump. Interference—Anything that reduces the effectiveness of or interferes with the communication between your Personal Therapy Manager and pump. Lockout Interval—A period of time during which you cannot activate a dose using your Personal Therapy Manager. This time period is determined by your physician. 221094_a_001.qxd 9/26/2002 4:15 PM Page 3 FCC ID: LF58832 PDA (Personal Digital Assistant)—The hand-held component of the Personal Therapy Manager that contains the screen. Search Tone—The continuous beeping sound you will hear while your Personal Therapy Manager is looking for your pump. Synchronization—The process that updates your Personal Therapy Manager with information from the pump (such as therapy information). Telemetry—A radio frequency signal that allows the Personal Therapy Manager to communicate with your implantable pump. Telemetry Module—The component of the Personal Therapy Manager that communicates with your pump. 221094_a_001.qxd 9/26/2002 4:15 PM Page 4 FCC ID: LF58832 INTRODUCTION You have been supplied with a SynchroMed II Model 8832 Personal Therapy Manager that enables you to activate a programmed dose of medication prescribed by your doctor from your SynchroMed II Implantable Drug Pump. Identification of Buttons and Icons A laminated card provided with your Personal Therapy Manager defines the icons you may see on the screen. Those icons are also defined below: 221094_a_001.qxd 9/26/2002 4:15 PM Page 5 FCC ID: LF58832 Toolkit Therapy Information Pump Alarm— Status Patient Dose Information Interrogate Pump Dose Lockout Interval Refill Date Pump Infustion — Continuous Write to Diary Patient-Activated Infusion Time Remaining Speaker On Return to Patient Option Screen Communication Failed Speaker Off Dose Activation Request Searching for Pump Successful Activation Request Denied Attention This manual will describe how to: • calibrate your Personal Therapy Manager (page 64); • interrogate your pump (page 58); 221094_a_001.qxd 9/26/2002 4:15 PM Page 6 FCC ID: LF58832 • activate a dose of medication from your pump (page 22); • determine the status of your dose activation request (page 26); and • access additional information about your pump therapy (page 31). 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 bold text and are listed in the glossary at the front of this manual. 221094_a_001.qxd 9/26/2002 4:15 PM Page 7 FCC ID: LF58832 DESCRIPTIVE INFORMATION The Personal Therapy Manager is a hand-held device (Figure 1) that communicates with your implanted pump. The Personal Therapy Manager has two parts, a personal digital assistant (PDA) and a telemetry module. Telemetry Light Telemetry Module Touchscreen PDA Figure 1. Personal Therapy Manager components. 221094_a_001.qxd 9/26/2002 4:15 PM Page 8 FCC ID: LF58832 The PDA part of your Personal Therapy Manager has a touchscreen with buttons and icons on the screen that are used to direct your interaction with the device. Buttons are activated when you press them with your finger. The Personal Therapy Manager uses telemetry (radio waves) to communicate with your pump. Purpose of the Device (Indications) The Personal Therapy Manager enables you to activate from your pump a programmed dose of medication prescribed by your doctor. The dose of medication activated by your Personal Therapy Manager is a supplement to the continuous infusion of medication supplied by your implantable pump. Your doctor will program your pump to accept commands from your Personal Therapy Manager. You can activate a dose as soon as the lockout interval time ends, if needed. A clock in the pump 221094_a_001.qxd 9/26/2002 4:15 PM Page 9 FCC ID: LF58832 keeps track of your lockout interval periods. You cannot activate more doses than your doctor prescribes in one day. Be sure to talk with your doctor about the number of doses he has prescribed for you and the lockout interval period between doses so you understand how the Personal Therapy Manager is intended to work. Your doctor may have to adjust your prescription periodically until a dose schedule is found that is best for your needs. List of Personal Therapy Manager Materials Case material: Injection-molded acrylonitrate butadiene/ polycarbonate blend plastic resin Label: Polycarbonate 221094_a_001.qxd 9/26/2002 4:15 PM Page 10 FCC ID: LF58832 When the Device Should Not be Used (Contraindications) The Personal Therapy Manager should not be used when the pump is implanted more than 1 inch (2.5 cm) from the surface of the skin, because the Personal Therapy Manager may not be able to communicate with the implanted pump. Risks and Benefits The possible risks of using the Personal Therapy Manager include: • The Personal Therapy Manager features of your pump might be programmed incorrectly, which could cause your pump to deliver too little or too much medicine. Delivering too much medicine could result in a serious overdose. • The radio signals sent by your Personal Therapy Manager could interfere with other medical devices. Tell your doctor if you use any other devices (such as a pacemaker, insulin pump, or pain-relief device.) 10 221094_a_001.qxd 9/26/2002 4:15 PM Page 11 FCC ID: LF58832 • The Personal Therapy Manager might not work or might be unable to communicate with your pump, and you would be unable to activate a supplemental dose of medication. The possible benefits of using the Personal Therapy Manager include: • The Personal Therapy Manager allows you to activate a physician-prescribed supplemental dose of medication when you need it. 11 221094_a_001.qxd 9/26/2002 4:15 PM Page 12 FCC ID: LF58832 General Warnings and Precautions Warnings Do not attempt to use the Personal Therapy Manager on another device, for example, a pump other than the SynchroMed II Implantable Pump or a cardiac pacemaker. The Personal Therapy Manager will not work on devices other than the SynchroMed II Implantable Pump. Also, the radio signals (telemetry) from the Personal Therapy Manager might adversely affect the performance of other implantable devices. Precautions • Do not use mercury or zinc-air batteries. • Do not use rechargeable batteries. • Do not immerse the Personal Therapy Manager in liquid, or clean it with aromatic or chlorinated hydrocarbons or acetone (for example, bleach or nail polish remover). 12 221094_a_001.qxd 9/26/2002 4:15 PM Page 13 FCC ID: LF58832 Electromagnetic Interference (EMI) Electromagnetic Interference is a field of energy (electrical, magnetic, or both) made by equipment found in the home, work, medical or public environments that is strong enough to interfere with the operation of your Personal Therapy Manager. Electromagnetic interference could prevent your Personal Therapy Manager from communicating with the implantable pump. If you think that equipment is interfering with your Personal Therapy Manager function, you should do the following: 1. Move away from the equipment or object. 2. If possible, turn off the equipment or object. 3. Inform the equipment owner/operator of what happened. If the above actions do not correct the effects of the interference, or if you think that your therapy is not effective after exposure to EMI, you should contact your doctor. 13 221094_a_001.qxd 9/26/2002 4:15 PM Page 14 FCC ID: LF58832 Care Regimen Following are some important guidelines for using your Personal Therapy Manager. • Use your Personal Therapy Manager only as your doctor has explained to you. • Handle your Personal Therapy Manager with care. Do not drop, throw, or toss your Personal Therapy Manager, or immerse it in water. • Keep fresh AAA batteries on hand so that you can replace the Personal Therapy Manager batteries when needed. 14 221094_a_001.qxd 9/26/2002 4:15 PM Page 15 FCC ID: LF58832 OPERATING INFORMATION Setup Instructions Assembly The Personal Therapy Manager is shipped unassembled. You must place the telemetry module on the PDA before use. Slide the module into the accessory slot of the PDA (Figure 2). Figure 2. Slide telemetry module onto the PDA. 15 221094_a_001.qxd 9/26/2002 4:15 PM Page 16 FCC ID: LF58832 Your doctor can install the batteries in your Personal Therapy Manager and calibrate it when you receive the device. You will need to replace the batteries and calibrate the Personal Therapy Manager occasionally. Refer to the Special Procedures section (page 58) of this manual for calibration instructions. Install the Batteries Your SynchroMed II Personal Therapy Manager runs on four AAA batteries. If batteries are not installed when you receive your Personal Therapy Manager, follow the instructions (page 38) to install the batteries. Turning on Your Personal Therapy Manager To turn on your Personal Therapy Manager, use your fingertip to depress the half-moon ON/OFF button on the bottom left of your Personal Therapy Manager (Figure 3). 16 221094_a_001.qxd 9/26/2002 4:15 PM Page 17 FCC ID: LF58832 Personal Therapy Manager ON/OFF Button Figure 3. Personal Therapy Manager ON/OFF button. Note: DO NOT press any of the buttons below the PDA screen. These buttons are for physician use only. 17 221094_a_001.qxd 9/26/2002 4:15 PM Page 18 FCC ID: LF58832 If you do not touch the screen for at least 25 seconds, the Personal Therapy Manager goes into standby mode, and the screen turns off. To reactivate the screen, press the ON/OFF button again. Patient Option Screen After you turn on your Personal Therapy Manager, you will see the Patient Option Screen (Figure 4). Dose Activation Button Speaker Button Toolkit Screen Button Figure 4. Patient Option Screen. 18 221094_a_001.qxd 9/26/2002 4:15 PM Page 19 FCC ID: LF58832 The Patient Option Screen displays your name, the Personal Therapy Manager battery status, and three buttons: Dose activation request button (press this to activate a dose; refer to page 22). Toolkit button (press this for information on your therapy and on additional features of the Personal Therapy Manager; refer to page 30). Speaker ON or OFF the sound on or off. button. Pressing this button turns 19 221094_a_001.qxd 9/26/2002 4:15 PM Page 20 FCC ID: LF58832 Speaker Button Figure 5. Turning the volume ON and OFF. When the speaker ON button ON. When the speaker OFF button OFF. 20 is on the screen, the sound is is on the screen, the sound is 221094_a_001.qxd 9/26/2002 4:15 PM Page 21 FCC ID: LF58832 Synchronization You should synchronize your Personal Therapy Manager with your pump as soon as possible after your doctor programs or refills your pump. You synchronize the two devices by interrogation. When you interrogate your pump, the information in your Personal Therapy Manager is updated to match the information in your pump. Refer to page 58 for interrogation instructions. 21 221094_a_001.qxd 9/26/2002 4:15 PM Page 22 FCC ID: LF58832 Activating a Dose To activate a dose, press the dose activation request button on the Patient Option Screen. Dose Activation Request Button Figure 7. Location of the dose activation request button. Your doctor might have programmed your Personal Therapy Manager with a Patient Diary feature. This feature lets you record how you are feeling. If the Patient diary screen appears, (Figure 8), make an entry into your Patient Diary (refer to page 60), then press the dose activation request button at the bottom of the screen. 22 221094_a_001.qxd 9/26/2002 4:15 PM Page 23 FCC ID: LF58832 Figure 8. Patient Diary Screen. Position Your Personal Therapy Manager (Interrogation) The Personal Therapy Manager has a pump search function to help you to position it properly over your pump to ensure successful communication. After you press the patient-activated dose button, a graphic on the screen (Figure 9) will direct you to place the Personal Therapy Manager over your pump. 23 221094_a_001.qxd 9/26/2002 4:15 PM Page 24 FCC ID: LF58832 Figure 9. Pump Search Screen. If the speaker is ON, you will hear a search tone (continuous beeping) while the Personal Therapy Manager is looking for your pump. The light at the top of the telemetry module will also blink. The Personal Therapy Manager must be positioned closely over your pump for communication to occur. Place the Personal Therapy Manager over your implant site, and move it around slowly in the area of your pump (Figure 10). When the Personal Therapy Manager finds your pump, the search tone will stop, 24 221094_a_001.qxd 9/26/2002 4:15 PM Page 25 FCC ID: LF58832 and the telemetry light will quit blinking and remain on. Hold the Personal Therapy Manager still while it communicates with the pump. When communication is complete, you will hear a short series of beeps, and the telemetry light at the top of the Personal Therapy Manager (refer to Figure 1) will turn off. Figure 10. Position your Personal Therapy Manager over your pump. 25 221094_a_001.qxd 9/26/2002 4:15 PM Page 26 FCC ID: LF58832 Note: If your Personal Therapy Manager has found your pump, but loses it (for example, you move it away from the pump), the search tone will start again and the telemetry light will start blinking again. Move the Personal Therapy Manager back over the pump until the beeping stops and the light remains on. Determining the Status of Your Activation Request During and after an activation request, your Personal Therapy Manager makes sounds that indicate the status of the activation request (Table 1). 26 221094_a_001.qxd 9/26/2002 4:15 PM Page 27 FCC ID: LF58832 Table 1. Personal Therapy Manager Sounds Sound Meaning Continuous Beeping Your Personal Therapy Manager is looking for your pump. Ascending Tones Your Personal Therapy Manager has successfully communicated with your pump, and a dose has been activated. Descending Tones Your Personal Therapy Manager did not communicate with your pump or an activation was not allowed. After you have completed an activation request, look at the screen on your therapy manager. One of the following screens will appear, indicating the status of the activation attempt: 27 221094_a_001.qxd 9/26/2002 4:15 PM Page 28 FCC ID: LF58832 Successful Dose Activation The screen that displays a successful dose activation icon means that you have successfully activated a dose. Communication Failed The screen with an incomplete telemetry icon means that your Personal Therapy Manager and pump did not successfully communicate. Press the patient-activated dose button in the lower left corner of the screen and reposition your Personal Therapy Manager over your pump (refer to instructions beginning on page 22). Request Denied Time Remaining 28 Request Denied The screen with request denied and time remaining icons means that you cannot activate a dose at this time. 221094_a_001.qxd 9/26/2002 4:15 PM Page 29 FCC ID: LF58832 The time remaining (hh:mm), if shown, is the amount of time you must wait before you can successfully activate a dose. Note: The time remaining function might not be available on your Personal Therapy Manager. If you cannot activate a dose There are several reasons why you may not be able to activate a dose of medication: • You might have tried to activate a dose too soon after your last activation • You might have tried to exceed the total number of activations prescribed by your doctor. Press the home button to return to the Patient Option Screen, or press the ON/OFF button to turn off your Personal Therapy Manager. 29 221094_a_001.qxd 9/26/2002 4:15 PM Page 30 FCC ID: LF58832 Toolkit Screen To find information about your pump and its therapy, you can access the Toolkit Screen via the toolkit button on the Patient Option Screen. The Toolkit Screen contains four buttons (Figure 11). Refill Information Screen Button Therapy Information Screen Volume Setting Screen Button Pump Alarm Status Screen Button Return to Patient Option Screen Button Figure 11. Toolkit Screen. 30 221094_a_001.qxd 9/26/2002 4:15 PM Page 31 FCC ID: LF58832 Therapy Information Screen When you select the therapy information button, your Personal Therapy Manager screen will change, and three types of therapy information become available for you to review. You can access the different types of information by selecting one of the three tabs at the top of the screen (Figure 12). Patient Information Tab PatientActivated Dose Infusion Tab Pump Infusion Tab Figure 12. Therapy Information Screen. 31 221094_a_001.qxd 9/26/2002 4:15 PM Page 32 FCC ID: LF58832 • The patient information tab tells you how many doses you can activate in one day and how long your lockout interval period lasts. • The pump infusion tab tells you what prescription drug is contained in your pump and how much of the prescription your pump is programmed to deliver. • The patient-activated dose infusion tab tells you how much prescription drug will be delivered during a dose activation. The date your pump was last programmed is displayed at the bottom of the Therapy Information Screen. Press the home button to return to the Patient Option Screen. 32 221094_a_001.qxd 9/26/2002 4:15 PM Page 33 FCC ID: LF58832 Refill Information Screen The refill information button on the Toolkit Screen shows your doctor information about your refill date. Your doctor will use the information on this screen to tell you when you should get your pump refilled (Figure 13). Press the home button to return to the Patient Option Screen. Figure 13. Refill Information Screen. 33 221094_a_001.qxd 9/26/2002 4:15 PM Page 34 FCC ID: LF58832 Pump Alarm Status Screen If your pump alarm sounds, press the pump alarm button, then press the interrogate button and place your Personal Therapy Manager over your pump. Your Personal Therapy Manager will interrogate your pump. If the communication is successful, you will see a screen telling you a code for the pump alarm (Figure 14). Call your doctor with this information as soon as possible. Press the home button to return to the Patient Option Screen. 34 Figure 14. Pump Alarm Status Screen. 221094_a_001.qxd 9/26/2002 4:15 PM Page 35 FCC ID: LF58832 Volume Setting Screen The volume setting button allows you to set the volume to low (1), medium (2), or high (3) (refer to page 62). Caring for Your Personal Therapy Manager How to Determine if Batteries Need to be Replaced Your Personal Therapy Manager is powered by four AAA batteries—two batteries power the PDA and two batteries power the telemetry module. Battery icons on your Personal Therapy Manager are located on the Patient Option Screen (Figure 15). These icons show the status of the batteries in the PDA and in the telemetry module. 35 221094_a_001.qxd 9/26/2002 4:15 PM Page 36 FCC ID: LF58832 PDA battery icon Telemetry module battery icon Figure 15. Location and identification of the battery icons on the Patient Option Screen. To check the status, access the Patient Option Screen, and look at the battery icons. Batteries are fully charged or near fully charged. Batteries are okay. 36 221094_a_001.qxd 9/26/2002 4:15 PM Page 37 FCC ID: LF58832 Batteries are low. Batteries are depleted. Change batteries. Notes: • Alkaline batteries are recommended for use in your Personal Therapy Manager. • When not using your therapy manager for more than 4 weeks, remove the AAA batteries from both the PDA and the telemetry module to prevent damage. • Make sure that you always have fresh AAA batteries on hand. 37 221094_a_001.qxd 9/26/2002 4:15 PM Page 38 FCC ID: LF58832 Removing the PDA Batteries 1. Remove the battery cover labeled with the A (Figure 16). Figure 16. Removing the battery cover. 2. Lift the batteries out of the battery wells. 38 221094_a_001.qxd 9/26/2002 4:15 PM Page 39 FCC ID: LF58832 Replacing the PDA Batteries 1. Check the battery labels for positive [+] and negative [-] contacts. Match them with the [+] and [-] symbols in the battery wells. 2. Press the batteries down (spring end first) into the battery wells (Figure 17). Note: The spring end is the negative contact. 39 221094_a_001.qxd 9/26/2002 4:15 PM Page 40 FCC ID: LF58832 Figure 17. Inserting the batteries. 3. Replace the battery cover. 40 221094_a_001.qxd 9/26/2002 4:15 PM Page 41 FCC ID: LF58832 Removing the Telemetry Module Batteries 1. Remove the battery cover labeled with the B (Figure 18). Figure 18. Removing the battery cover. 2. Lift the batteries out of the battery wells. 41 221094_a_001.qxd 9/26/2002 4:15 PM Page 42 FCC ID: LF58832 Replacing the Telemetry Module Batteries 1. Check the battery labels for positive [+] and negative [-] contacts. Match them with the [+] and [-] symbols in the battery wells. 2. Press the batteries down (spring end first) into the battery wells (Figure 19). Note: The spring end is the negative contact. Figure 19. Inserting the batteries. 42 221094_a_001.qxd 9/26/2002 4:15 PM Page 43 FCC ID: LF58832 3. Replace the battery cover. Dispose of depleted batteries according to local regulations. Cleaning and Care • Your Personal Therapy Manager is a precision device; handle it with care. • Do not take apart or tamper with the Personal Therapy Manager; this could affect how it works. • Protect the Personal Therapy Manager from sharp blows or physical shocks. • Clean the outside of the Personal Therapy Manager with a slightly damp cloth. Mild household cleaners will not damage the case or labels. • Your Personal Therapy Manager is not waterproof. Do not allow moisture to get into the device. 43 221094_a_001.qxd 9/26/2002 4:15 PM Page 44 FCC ID: LF58832 E Caution Do not immerse the Personal Therapy Manager in liquid. Do not clean it with bleach, nail polish, or other similar substances. • Clean the battery contacts periodically with a cotton swab dampened with alcohol. Do not use a pencil eraser or sandpaper. • Replace low or depleted batteries to ensure proper operation and to prevent corrosion of the Personal Therapy Manager. • When not using the Personal Therapy Manager for more than 4 weeks, remove the batteries to prevent corrosion of the device. • To conserve battery power, always turn off your Personal Therapy Manager when you are done using it. 44 221094_a_001.qxd 9/26/2002 4:15 PM Page 45 FCC ID: LF58832 Storage You do not need to remove your Personal Therapy Manager from its pouch to use it. The pouch helps to protect the Personal Therapy Manager (Figure 20). Figure 20. Personal Therapy Manager pouch. 45 221094_a_001.qxd 9/26/2002 4:15 PM Page 46 FCC ID: LF58832 Place the Personal Therapy Manager in the pouch so that the screen is against the fold-down flap (Figure 21). Fold-down Flap Telemetry Module Screen Figure 21. Storing your Personal Therapy Manager in its pouch. 46 221094_a_001.qxd 9/26/2002 4:15 PM Page 47 FCC ID: LF58832 Disposal Return devices for disposal to the manufacturer. Medtronic office addresses are listed at the back of this manual. 47 221094_a_001.qxd 9/26/2002 4:15 PM Page 48 FCC ID: LF58832 TROUBLESHOOTING When to Call Your Doctor’s Office Call your doctor’s office if: • you experience anything unusual, such as new or unexplained symptoms; • you notice that you begin to feel differently or worse; • your symptoms do not decrease with activation of a dose; • you are not getting adequate relief from your symptoms; or • your symptoms have dramatically changed. This section will help you solve problems or identify when to call your doctor. Problems are described in the left column. The text in the middle and right columns lists possible causes of the problems and describes how to correct the problem. Note: If your problem is not described here, contact your doctor. 48 221094_a_001.qxd 9/26/2002 4:15 PM Page 49 FCC ID: LF58832 Table 2. Troubleshooting Problem Potential Cause Correction Your Personal Therapy Manager is stuck on one screen. Your Personal Therapy Manager has a hardware or software problem. Reset your Personal Therapy Manager (refer to the Special Procedures section of this manual). Call your doctor. Your Personal Therapy Manager does not respond to fingertip touch. Your symptom relief is not adequate. No battery, depleted battery, battery is in backward. Replace the batteries with fresh batteries. Software/hardware failure Reset your Personal Therapy Manager (refer to the Special Procedures section of this manual). Call your doctor. 49 221094_a_001.qxd 9/26/2002 4:15 PM Page 50 FCC ID: LF58832 Problem Potential Cause Correction Your Personal Therapy Manager does not turn on. Personal Therapy Manager failure. Reset your Personal Therapy Manager (refer to the Special Procedures section of this manual). You cannot activate a dose. Depleted battery. Replace batteries You have tried to activate too many doses in one day period, or you have tried to activate a dose too soon since the last activation. Wait until activation is allowed. Your Personal Therapy Manager Reposition the Personal did not communicate correctly Therapy Manager over your with your pump. pump and try again to activate a dose. The beeper does not sound. 50 You have turned the volume down too low to be able to hear it, or you have turned it off. Turn the volume up (refer to page 62) or on (refer to pages 19-20). 221094_a_001.qxd 9/26/2002 4:15 PM Page 51 FCC ID: LF58832 Problem Potential Cause Correction Your Personal Therapy Manager is non-functional. You have spilled fluid on on your Personal Therapy Manager. Dry it with a towel, and turn the Personal Therapy Manager on to ensure it is working correctly. Your Personal Therapy Manager falls into water. 1. Remove the Personal Therapy Manager from the water. 2. Wipe it with a towel dampened with clean tap water. 3. Open the battery covers and remove the batteries. Shake to remove as much water as possible. 4. Dry battery compartments with a towel. 5. Allow battery compartments to dry at room temperature for as long as possible. 6. Shake the Personal Therapy Manager. If you see or hear water inside, repeat steps 4 and 5. 51 221094_a_001.qxd 9/26/2002 4:15 PM Page 52 FCC ID: LF58832 Problem Potential Cause Correction 7. When the Personal Therapy Manager is dry, replace the batteries and battery covers. 8. Turn on the Personal Therapy Manager to ensure it is working correctly. 9. If the Personal Therapy Manager does not work properly, call your doctor. Your Personal Therapy Manager falls or is dropped. NOTE: The Personal Therapy Manager is designed to withstand falls of short distances. 52 Turn on the Personal Therapy Manager to see if the device is working. If you think the Personal Therapy Manager is not working correctly, call your doctor. 221094_a_001.qxd 9/26/2002 4:15 PM Page 53 FCC ID: LF58832 Problem Potential Cause Correction The telemetry light does not appear to be functioning. Sunlight may be obscuring your view. Shade the light with your hand or move into a darker area. The batteries on the PDA are depleted or are very low. Check the appropriate battery status icon on the Patient Option Screen (refer to page 37). Change the batteries in the PDA (refer to pages 38-40). Battery placement is incorrect. Check to see that the batteries are inserted properly. The incomplete telemetry icon is displayed. The Personal Therapy Manager was not close enough to the pump during the activation attempt. Realign the Personal Therapy Manager and try again. 53 221094_a_001.qxd 9/26/2002 4:15 PM Page 54 FCC ID: LF58832 Problem After communication with the pump, the Personal Therapy Manager screen contains an alert icon with a number. A generic PDA screen appears instead of the Patient Option Screen. 54 Potential Cause Correction The Personal Therapy Manager was moved away from the pump too quickly. Realign the Personal Therapy Manager with the pump and try again. Excessive electromagnetic interference (EMI). Interference caused by computer monitors or other electronic equipment. Move away from possible EMI sources such as TVs or computer monitors. A pump alarm is occurring. Call your doctor. The telemetry module was not inserted correctly. Remove and replace the telemetry module, ensuring that none of the buttons on the bottom of the PDA are pressed during this time. 221094_a_001.qxd 9/26/2002 4:15 PM Page 55 FCC ID: LF58832 How to Get Help You can contact Medtronic Patient Services for help at the address and phone number listed on the back cover of this manual. Record other important contacts and phone numbers below, in the spaces provided: Contact: Phone: ________________________ ________________________ ________________________ ________________________ ________________________ ________________________ ________________________ ________________________ ________________________ ________________________ ________________________ ________________________ ________________________ ________________________ 55 221094_a_001.qxd 9/26/2002 4:15 PM Page 56 FCC ID: LF58832 ADDITIONAL INFORMATION Specifications Model 8832 SynchroMed II Personal Therapy Manager Power Source: Four commercially available AAA batteries (LR 03) Operating Temperature: 10 °C—40 °C (50 °F—104 °F) Operating Time: Short Storage Temperature: -20 °C—60 °C (-4 °F—140 °F ) Relative Humidity: 90% maximum Atmospheric Pressure: 700 hPa to 1060 hPa (20.7 in. Hg to 31.3 in. Hg) Personal Therapy Manager Size: Approximately 16.5x6.1x3.0 cm (6.5x3.5x1.5 inches ) Personal Therapy Manager Weight: Approximately 284 g (10 oz) (including batteries) Battery Life: 6 weeks (typical) 56 221094_a_001.qxd 9/26/2002 4:15 PM Page 57 FCC ID: LF58832 Special Notice The Medtronic Model 8832 SynchroMed II Personal Therapy Manager is designed for use with the SynchroMed II Pump. The functions of the Personal Therapy Manager are not compatible with any other devices. For information regarding difficulties which may be encountered using the Personal Therapy Manager, consult the other portions of this manual. Travel or International Use When traveling, always carry the ID card that was issued with your implantable pump. Follow all directions issued by your doctor when traveling. You may want to carry extra AAA batteries when traveling overseas, although they may be readily available, depending on your destination. 57 221094_a_001.qxd 9/26/2002 4:15 PM Page 58 FCC ID: LF58832 SPECIAL PROCEDURES This section describes the following procedures: • • • • • • Interrogation Patient Diary Use Setting the Volume Calibration Touchscreen Backlight Use Reset Procedure Interrogation When you interrogate your pump, the Personal Therapy Manager receives updated information from the pump. This information is a useful tool for your physician. 58 221094_a_001.qxd 9/26/2002 4:15 PM Page 59 FCC ID: LF58832 To interrogate your pump, press the toolkit button on the Patient Option Screen (Figure 4), then press the pump alarm button and finally, the interrogate pump button . The Personal Therapy Manager will begin to beep, and the light on the telemetry module will begin to flash. Position your Personal Therapy Manager over your pump and move it around slowly in that area until the beeping stops and the light remains on. You will hear three ascending tones when successful interrogation is complete. If you hear two descending tones, the interrogation failed, and you should repeat the attempt. 59 221094_a_001.qxd 9/26/2002 4:15 PM Page 60 FCC ID: LF58832 Patient Diary Use Your Personal Therapy Manager is equipped with a Patient Diary (Figure 22) that allows your doctor to track how well your therapy is providing you relief from your symptoms. Figure 22. Patient Diary Screen. You may be required to make an entry in your patient diary: • prior to dose activation • following dose activation • at specific times of the day 60 221094_a_001.qxd 9/26/2002 4:15 PM Page 61 FCC ID: LF58832 When you make an entry, you will see a ruler on the Patient Diary Screen (Figure 23). Figure 23. Patient Diary Screen. Each small vertical line on the ruler in the middle of the screen represents a number, 0 through 10. The pointer on the screen points to the number currently selected. You can either drag the pointer left or right on the ruler, or touch a vertical line to bring the pointer to the number you desire. 61 221094_a_001.qxd 9/26/2002 4:15 PM Page 62 FCC ID: LF58832 Select a number that represents how you feel. A lower number means your symptoms are less intense. A higher number means your symptoms are worse. After you make an entry into the patient diary, press the button at the bottom of the screen (the patient-activated dose button or the write diary button) to continue. After you press the button, your Personal Therapy Manager will either turn off or begin looking for your pump. Setting the Volume Your Personal Therapy Manager uses audio signals to communicate various messages, such as: • Successful and unsuccessful dose activation; • Request for patient diary entry; and • Searching for pump. 62 221094_a_001.qxd 9/26/2002 4:15 PM Page 63 FCC ID: LF58832 To set the volume on your Personal Therapy Manager, press the Toolkit Screen button on the bottom right of the Patient Option Screen (Figure 24). Toolkit Screen Button Figure 24. Accessing the Toolkit Screen. On the Toolkit Screen, you will see a speaker button: The volume setting changes each time you push this button. 63 221094_a_001.qxd 9/26/2002 4:15 PM Page 64 FCC ID: LF58832 Calibration The Personal Therapy Manager will require periodic calibration (e.g., at initial assembly and after the batteries have completely depleted). The figures presented below represent the calibration instructions that will be presented on the Personal Therapy Manager. Follow the instructions on the screen to calibrate the device. Note: Use a stylus to touch as closely as possible to the exact center of the target symbols. 64 221094_a_001.qxd 9/26/2002 4:15 PM Page 65 FCC ID: LF58832 Select Center of Target Select Center of Target Select Center of Target Figure 25. Calibration Instructions. 65 221094_a_001.qxd 9/26/2002 4:15 PM Page 66 FCC ID: LF58832 Select Yes Select Next Select Done Select OK Figure 26. Calibration instructions. 66 221094_a_001.qxd 9/26/2002 4:15 PM Page 67 FCC ID: LF58832 Note: The Personal Therapy Manager reads the time of day from the implantable pump. Do not reset the time on the Personal Therapy Manager Calibration Screens. Touchscreen Backlight Use Your Personal Therapy Manager is equipped with a backlight that illuminates the touchscreen under dark or limited lighting conditions. To turn on the backlight, press and hold the halfmoon shaped ON/OFF button for approximately 2 seconds when you turn on your Personal Therapy Manager. 67 221094_a_001.qxd 9/26/2002 4:15 PM Page 68 FCC ID: LF58832 Resetting Your Personal Therapy Manager To reset your Personal Therapy Manager: Remove telemetry module Step 1 68 Use a push pin or other tool to push in the reset button Step 2 Replace telemetry module Step 3 221094_a_001.qxd 9/26/2002 4:15 PM Page 69 FCC ID: LF58832 INSIDE BACK COVER 221094_a_001.qxd 9/26/2002 4:15 PM Page 70 FCC ID: LF58832 Medtronic, Inc. 710 Medtronic Parkway Minneapolis, MN 55432-5604 USA Internet: www.medtronic.com Tel. 1-763-505-5000 Toll-free 1-800-328-0810 Fax 1-763-505-1000 © Medtronic, Inc. 2002 All Rights Reserved 221094001
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