Medtronic 8832 Personal Therapy Manager User Manual 221094 a 001

Medtronic, Inc. Personal Therapy Manager 221094 a 001

manual

You and Your SynchroMed®II Personal Therapy ManagerModel 8832 Personal Therapy Manager for Your SynchroMed®II Implantable Drug PumpPatient ManualRx Only221094_a_001.qxd 9/26/2002 4:15 PM Page 1 FCC ID: LF58832FCC ID: LF58832
221094_a_001.qxd 9/26/2002 4:15 PM Page 2 FCC ID: LF58832
A Company Dedicated to PatientsMedtronic was founded in 1949 by Earl Bakken, a graduate student inelectrical engineering, and his brother-in-law, Palmer J. Hermundslie.Today Medtronic is the world leader in medical technology, pioneeringtherapies 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 servescustomers in more than 120 countries. Each year, millions of patientsare treated with Medtronic products and therapies. We invest almost$500 million each year in research and development, working closelywith the world’s leading physicians and scientists to enhance ourcurrent products and therapies, and to develop new ones. Although weare a large company, individual patients and their needs are still thedriving force behind what we do and how we do it.Our goal is to improve the quality of your life. This booklet, whichprovides information about your SynchroMed Personal TherapyManager, is one small way we try to help.Welcome to the Medtronic family. We wish you well. i221094_a_001.qxd 9/26/2002 4:15 PM Page i FCC ID: LF58832
Explanation of Symbols on Product and PackagingIEC 60601-1, Type BF EquipmentAttention: See accompanying documentsnSerial NumberRadio 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 atypical medical setting. However, there is no guarantee that interference will not occur. Refer to thetroubleshooting section of this manual for instructions on what to do if the Personal TherapyManager does not communicate completely with your pump and you suspect interference may bethe cause.FCC ID: LF5 8832This device complies with Part 15 Rules. Operation is subject to the following 2 conditions: (1) thisdevice may not cause harmful interference and (2) this device must accept any interferencereceived, including interference that may cause undesired operation.IMPORTANT: Changes or modifications to this product not authorized by Medtronic, Inc., couldvoid the FCC Certification and negate your authority to operate this product.iiwyStorage TemperatureRelative HumidityAtmospheric PressureXXX kPaXX.X in. HgXX kPaXX.X in. HgkPaXX %XX %CFCFXX XX XX XX L221094_a_001.qxd 9/26/2002 4:15 PM Page ii FCC ID: LF58832
CONTENTSGLOSSARY ................................................................. 1INTRODUCTION.......................................................4Identification of Buttons and Icons .............................5DESCRIPTIVE INFORMATION .............................7Purpose of the Device (Indications)............................8List of Personal Therapy Manager Materials..... 9When the Device Should Not be Used(Contraindications) ......................................................10Risks and Benefits ........................................................10General Warnings and Precautions...........................12Warnings .................................................................12Precautions .............................................................12Electromagnetic Interference (EMI)....................13Care Regimen ...............................................................14iii221094_a_001.qxd 9/26/2002 4:15 PM Page iii FCC ID: LF58832
OPERATING INFORMATION ..............................15Setup Instructions ........................................................15Assembly ................................................................15Install the Batteries ................................................16Turning on Your Personal Therapy Manager ..16Patient Option Screen ...........................................18Synchronization ....................................................21Activating a Dose.........................................................22Position Your Personal TherapyManager (Interrogation) .......................................23Determining the Status of Your Activation Request ...............................................26Toolkit Screen................................................................30Therapy Information Screen ................................31Refill Information Screen......................................33Pump Alarm Status Screen ..................................34Volume Setting Screen ..........................................34iv221094_a_001.qxd 9/26/2002 4:15 PM Page iv FCC ID: LF58832
Caring for Your Personal Therapy Manager ...........35How to Determine if Batteries Needto be Replaced........................................................35Removing the PDA Batteries ...............................38Replacing the PDA Batteries................................39Removing the Telemetry Module Batteries .......41Replacing the Telemetry Module Batteries........42Cleaning and Care .......................................................43Storage ...........................................................................45Disposal .........................................................................47TROUBLESHOOTING............................................48When to Call Your Doctor’s Office............................48Call your doctor’s office if ...................................48How to Get Help..........................................................55v221094_a_001.qxd 9/26/2002 4:15 PM Page v FCC ID: LF58832
ADDITIONAL INFORMATION ...........................56Specifications ................................................................56Special Notice ...............................................................57Travel or International Use.........................................57SPECIAL PROCEDURES ........................................58Interrogation .................................................................58Patient Diary Use .........................................................60Setting the Volume.......................................................62Calibration.....................................................................64Touchscreen Backlight Use .........................................67Resetting Your Personal Therapy Manager .............68vi221094_a_001.qxd 9/26/2002 4:15 PM Page vi FCC ID: LF58832
GLOSSARYButton—A picture on the screen of your Personal TherapyManager that, when pressed, causes a specific action or function.On-screen buttons are presented as dark backgrounds that havelighter-colored pictures inside.Calibration—The process that sets up your Personal TherapyManager the first time batteries are installed or after the devicehas been without power for several minutes.Dose Activation—The initiation of a command from yourPersonal Therapy Manager to your SynchroMed II Pump thattells the pump to activate a prescribed dose of medication.Electromagnetic Interference (EMI)—A field of energy made byequipment found in the home, work, medical, or publicenvironments that is strong enough to interfere with theoperation of your Personal Therapy Manager.1221094_a_001.qxd 9/26/2002 4:15 PM Page 1 FCC ID: LF58832
Icon—A picture on your Personal Therapy Manager that givesyou information or represents a function or action.Incomplete Communication—The failure of your PersonalTherapy Manager to complete delivery of a message to yourpump.Interrogate—The act of using your Personal Therapy Manager toget information from your pump.Interference—Anything that reduces the effectiveness of orinterferes with the communication between your PersonalTherapy Manager and pump.Lockout Interval—A period of time during which you cannotactivate a dose using your Personal Therapy Manager. This timeperiod is determined by your physician.2221094_a_001.qxd 9/26/2002 4:15 PM Page 2 FCC ID: LF58832
PDA (Personal Digital Assistant)—The hand-held component ofthe Personal Therapy Manager that contains the screen.Search Tone—The continuous beeping sound you will hearwhile your Personal Therapy Manager is looking for your pump.Synchronization—The process that updates your PersonalTherapy Manager with information from the pump (such astherapy information). Telemetry—A radio frequency signal that allows the PersonalTherapy Manager to communicate with your implantable pump.Telemetry Module—The component of the Personal TherapyManager that communicates with your pump.3221094_a_001.qxd 9/26/2002 4:15 PM Page 3 FCC ID: LF58832
INTRODUCTIONYou have been supplied with a SynchroMed II Model 8832Personal Therapy Manager that enables you to activate aprogrammed dose of medication prescribed by your doctor fromyour SynchroMed II Implantable Drug Pump. Identification of Buttons and IconsA laminated card provided with your Personal Therapy Managerdefines the icons you may see on the screen. Those icons are alsodefined below:4221094_a_001.qxd 9/26/2002 4:15 PM Page 4 FCC ID: LF58832
This manual will describe how to:• calibrate your Personal Therapy Manager (page 64);• interrogate your pump (page 58);SuccessfulActivationPatient-ActivatedInfusionTimeRemainingRequest DeniedDose ActivationRequestCommunicationFailed AttentionPump Alarm—StatusInterrogatePumpDose Lockout IntervalPatient DoseInformationTherapy InformationPump Infustion —ContinuousRefill DateToolkitWrite to DiaryReturn to Patient Option ScreenwSearchingfor PumpSpeaker OnSpeaker Off5221094_a_001.qxd 9/26/2002 4:15 PM Page 5 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 anyunusual situations or problems arise, consult your doctor. He orshe knows your personal medical history and can give you thedetailed information you may need. In particular, you should askabout the potential complications, risks, and benefits of thistherapy.Important terms appear in bold text and are listed in the glossaryat the front of this manual.6221094_a_001.qxd 9/26/2002 4:15 PM Page 6 FCC ID: LF58832
DESCRIPTIVE INFORMATIONThe Personal Therapy Manager is a hand-held device (Figure 1)that communicates with your implanted pump. The PersonalTherapy Manager has two parts, a personal digital assistant(PDA) and a telemetry module.Figure 1. Personal Therapy Manager components.7TelemetryModulePDATouchscreenTelemetryLight221094_a_001.qxd 9/26/2002 4:15 PM Page 7 FCC ID: LF58832
The PDA part of your Personal Therapy Manager has atouchscreen with buttons and icons on the screen that are used todirect your interaction with the device. Buttons are activatedwhen you press them with your finger.The Personal Therapy Manager uses telemetry (radio waves) tocommunicate with your pump. Purpose of the Device (Indications)The Personal Therapy Manager enables you to activate from yourpump a programmed dose of medication prescribed by yourdoctor. The dose of medication activated by your PersonalTherapy Manager is a supplement to the continuous infusion ofmedication supplied by your implantable pump.Your doctor will program your pump to accept commands fromyour Personal Therapy Manager. You can activate a dose as soonas the lockout interval time ends, if needed. A clock in the pump8221094_a_001.qxd 9/26/2002 4:15 PM Page 8 FCC ID: LF58832
keeps track of your lockout interval periods. You cannot activatemore doses than your doctor prescribes in one day.Be sure to talk with your doctor about the number of doses hehas prescribed for you and the lockout interval period betweendoses so you understand how the Personal Therapy Manager isintended to work. Your doctor may have to adjust yourprescription periodically until a dose schedule is found that isbest for your needs.List of Personal Therapy Manager MaterialsCase material: Injection-molded acrylonitrate butadiene/polycarbonate blend plastic resinLabel: Polycarbonate9221094_a_001.qxd 9/26/2002 4:15 PM Page 9 FCC ID: LF58832
When the Device Should Not be Used (Contraindications)The Personal Therapy Manager should not be used when thepump is implanted more than 1 inch (2.5 cm) from the surface ofthe skin, because the Personal Therapy Manager may not be ableto communicate with the implanted pump.Risks and BenefitsThe possible risks of using the Personal Therapy Managerinclude:• The Personal Therapy Manager features of your pump mightbe programmed incorrectly, which could cause your pump todeliver too little or too much medicine. Delivering too muchmedicine could result in a serious overdose.• The radio signals sent by your Personal Therapy Managercould interfere with other medical devices. Tell your doctor ifyou use any other devices (such as a pacemaker, insulinpump, or pain-relief device.)10221094_a_001.qxd 9/26/2002 4:15 PM Page 10 FCC ID: LF58832
• The Personal Therapy Manager might not work or might beunable to communicate with your pump, and you would beunable to activate a supplemental dose of medication. The possible benefits of using the Personal Therapy Managerinclude: • The Personal Therapy Manager allows you to activate aphysician-prescribed supplemental dose of medication whenyou need it.11221094_a_001.qxd 9/26/2002 4:15 PM Page 11 FCC ID: LF58832
General Warnings and PrecautionsWarningsDo not attempt to use the Personal Therapy Manager on anotherdevice, for example, a pump other than the SynchroMed IIImplantable Pump or a cardiac pacemaker. The Personal TherapyManager will not work on devices other than the SynchroMed IIImplantable Pump. Also, the radio signals (telemetry) from thePersonal Therapy Manager might adversely affect theperformance 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, orclean it with aromatic or chlorinated hydrocarbons or acetone(for example, bleach or nail polish remover).12221094_a_001.qxd 9/26/2002 4:15 PM Page 12 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 interferewith the operation of your Personal Therapy Manager.Electromagnetic interference could prevent your PersonalTherapy Manager from communicating with the implantablepump.If you think that equipment is interfering with your PersonalTherapy 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 toEMI, you should contact your doctor. 13221094_a_001.qxd 9/26/2002 4:15 PM Page 13 FCC ID: LF58832
Care RegimenFollowing are some important guidelines for using your PersonalTherapy Manager.• Use your Personal Therapy Manager only as your doctor hasexplained to you.• Handle your Personal Therapy Manager with care. Do notdrop, throw, or toss your Personal Therapy Manager, orimmerse it in water.• Keep fresh AAA batteries on hand so that you can replace thePersonal Therapy Manager batteries when needed.14221094_a_001.qxd 9/26/2002 4:15 PM Page 14 FCC ID: LF58832
OPERATING INFORMATIONSetup InstructionsAssemblyThe Personal Therapy Manager is shipped unassembled. Youmust place the telemetry module on the PDA before use. Slidethe module into the accessory slot of the PDA (Figure 2).Figure 2. Slide telemetry module onto the PDA. 15221094_a_001.qxd 9/26/2002 4:15 PM Page 15 FCC ID: LF58832
Your doctor can install the batteries in your Personal TherapyManager and calibrate it when you receive the device. You willneed to replace the batteries and calibrate the Personal TherapyManager occasionally. Refer to the Special Procedures section(page 58) of this manual for calibration instructions.Install the BatteriesYour SynchroMed II Personal Therapy Manager runs on fourAAA batteries. If batteries are not installed when you receiveyour Personal Therapy Manager, follow the instructions (page 38)to install the batteries.Turning on Your Personal Therapy ManagerTo turn on your Personal Therapy Manager, use your fingertip todepress the half-moon ON/OFF button on the bottom left ofyour Personal Therapy Manager (Figure 3).16221094_a_001.qxd 9/26/2002 4:15 PM Page 16 FCC ID: LF58832
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.17Personal TherapyManagerON/OFF Button 221094_a_001.qxd 9/26/2002 4:15 PM Page 17 FCC ID: LF58832
If you do not touch the screen for at least 25 seconds, thePersonal Therapy Manager goes into standby mode, and thescreen turns off. To reactivate the screen, press the ON/OFFbutton again.Patient Option ScreenAfter you turn on your Personal Therapy Manager, you will seethe Patient Option Screen (Figure 4).Figure 4. Patient Option Screen.18Speaker ButtonDoseActivationButtonToolkit ScreenButton221094_a_001.qxd 9/26/2002 4:15 PM Page 18 FCC ID: LF58832
The Patient Option Screen displays your name, the PersonalTherapy Manager battery status, and three buttons:Dose activation request button (press this to activate adose; refer to page 22).Toolkit button (press this for information on your therapyand on additional features of the Personal Therapy Manager; refer to page 30).Speaker ON or OFF button. Pressing this button turnsthe sound on or off.19221094_a_001.qxd 9/26/2002 4:15 PM Page 19 FCC ID: LF58832
Figure 5. Turning the volume ON and OFF.When the speaker ON button is on the screen, the sound isON.When the speaker OFF button is on the screen, the sound isOFF.20SpeakerButton221094_a_001.qxd 9/26/2002 4:15 PM Page 20 FCC ID: LF58832
SynchronizationYou should synchronize your Personal Therapy Manager withyour pump as soon as possible after your doctor programs orrefills your pump. You synchronize the two devices byinterrogation. When you interrogate your pump, the informationin your Personal Therapy Manager is updated to match theinformation in your pump. Refer to page 58 for interrogationinstructions.21221094_a_001.qxd 9/26/2002 4:15 PM Page 21 FCC ID: LF58832
Activating a DoseTo activate a dose, press the dose activation request button on thePatient Option Screen.Figure 7. Location of the dose activation request button.Your doctor might have programmed your Personal TherapyManager with a Patient Diary feature. This feature lets yourecord how you are feeling. If the Patient diary screen appears,(Figure 8), make an entry into your Patient Diary (refer topage 60), then press the dose activation request button at thebottom of the screen.22Dose ActivationRequest Button221094_a_001.qxd 9/26/2002 4:15 PM Page 22 FCC ID: LF58832
Figure 8. Patient Diary Screen.Position Your Personal Therapy Manager (Interrogation)The Personal Therapy Manager has a pump search function tohelp you to position it properly over your pump to ensuresuccessful communication. After you press the patient-activateddose button, a graphic on the screen (Figure 9) will direct you toplace the Personal Therapy Manager over your pump. 23221094_a_001.qxd 9/26/2002 4:15 PM Page 23 FCC ID: LF58832
Figure 9. Pump Search Screen.If the speaker is ON, you will hear a search tone (continuousbeeping) while the Personal Therapy Manager is looking for yourpump. The light at the top of the telemetry module will alsoblink.The Personal Therapy Manager must be positioned closely overyour pump for communication to occur. Place the PersonalTherapy Manager over your implant site, and move it aroundslowly in the area of your pump (Figure 10). When the PersonalTherapy Manager finds your pump, the search tone will stop,24221094_a_001.qxd 9/26/2002 4:15 PM Page 24 FCC ID: LF58832
and the telemetry light will quit blinking and remain on. Holdthe Personal Therapy Manager still while it communicates withthe pump. When communication is complete, you will hear ashort series of beeps, and the telemetry light at the top of thePersonal Therapy Manager (refer to Figure 1) will turn off.Figure 10. Position your Personal Therapy Manager over your pump.25221094_a_001.qxd 9/26/2002 4:15 PM Page 25 FCC ID: LF58832
Note: If your Personal Therapy Manager has found yourpump, but loses it (for example, you move it away fromthe pump), the search tone will start again and thetelemetry light will start blinking again. Move thePersonal Therapy Manager back over the pump until thebeeping stops and the light remains on.Determining the Status of Your Activation RequestDuring and after an activation request, your Personal TherapyManager makes sounds that indicate the status of the activationrequest (Table 1).26221094_a_001.qxd 9/26/2002 4:15 PM Page 26 FCC ID: LF58832
Table 1. Personal Therapy Manager SoundsSound MeaningContinuous Beeping Your Personal Therapy Manager is lookingfor your pump.Ascending Tones Your Personal Therapy Manager hassuccessfully communicated with your pump,and a dose has been activated.Descending Tones Your Personal Therapy Manager did notcommunicate with your pump or an activationwas not allowed.After you have completed an activation request, look at thescreen on your therapy manager. One of the following screenswill appear, indicating the status of the activation attempt:27221094_a_001.qxd 9/26/2002 4:15 PM Page 27 FCC ID: LF58832
Successful Dose ActivationThe screen that displays a successful dose activationicon means that you have successfully activated a dose.Communication FailedThe screen with an incomplete telemetry iconmeans that your Personal Therapy Manager andpump did not successfully communicate. Press thepatient-activated dose button in the lower leftcorner of the screen and reposition your PersonalTherapy Manager over your pump (refer toinstructions beginning on page 22).Request DeniedThe screen with request denied andtime remaining icons means that youcannot activate a dose at this time.28TimeRemainingRequestDenied221094_a_001.qxd 9/26/2002 4:15 PM Page 28 FCC ID: LF58832
The time remaining (hh:mm), if shown, is the amount of timeyou must wait before you can successfully activate a dose.Note: The time remaining function might not be available onyour Personal Therapy Manager.If you cannot activate a doseThere are several reasons why you may not be able to activate adose of medication:• You might have tried to activate a dose too soon after yourlast activation• You might have tried to exceed the total number ofactivations 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 TherapyManager.29221094_a_001.qxd 9/26/2002 4:15 PM Page 29 FCC ID: LF58832
Toolkit ScreenTo find information about your pump and its therapy, you canaccess the Toolkit Screen via the toolkit button on the PatientOption Screen. The Toolkit Screen contains four buttons (Figure 11).Figure 11. Toolkit Screen.30TherapyInformationScreenPump AlarmStatus ScreenButtonRefillInformationScreen ButtonVolume SettingScreen ButtonReturn toPatient OptionScreen Button221094_a_001.qxd 9/26/2002 4:15 PM Page 30 FCC ID: LF58832
Therapy Information ScreenWhen you select the therapy information button, your PersonalTherapy Manager screen will change, and three types of therapyinformation become available for you to review.You can access the different types of information by selecting oneof the three tabs at the top of the screen (Figure 12).Figure 12. Therapy Information Screen.31PatientInformationTabPumpInfusion TabPatient-ActivatedDoseInfusion Tab221094_a_001.qxd 9/26/2002 4:15 PM Page 31 FCC ID: LF58832
• The patient information tab tells you how many doses youcan activate in one day and how long your lockout intervalperiod lasts.• The pump infusion tab tells you what prescription drug iscontained in your pump and how much of the prescriptionyour pump is programmed to deliver.• The patient-activated dose infusion tab tells you how muchprescription drug will be delivered during a dose activation.The date your pump was last programmed is displayed at thebottom of the Therapy Information Screen. Press the home buttonto return to the Patient Option Screen.32221094_a_001.qxd 9/26/2002 4:15 PM Page 32 FCC ID: LF58832
Refill Information ScreenThe refill information button on the Toolkit Screen shows yourdoctor information about your refill date. Your doctor will usethe information on this screen to tell you when you should getyour pump refilled (Figure 13). Press the home button to returnto the Patient Option Screen.Figure 13. Refill Information Screen.33221094_a_001.qxd 9/26/2002 4:15 PM Page 33 FCC ID: LF58832
Pump Alarm Status ScreenIf your pump alarm sounds, press the pump alarm button, thenpress the interrogate button and place your Personal TherapyManager over your pump. Your Personal Therapy Manager willinterrogate your pump. If the communication is successful, youwill see a screen telling you a code for the pump alarm(Figure 14). Call your doctor with this information as soon aspossible. Press the home button to return to the Patient OptionScreen.Figure 14. Pump Alarm Status Screen.34221094_a_001.qxd 9/26/2002 4:15 PM Page 34 FCC ID: LF58832
Volume Setting ScreenThe 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 ManagerHow to Determine if Batteries Need to be ReplacedYour Personal Therapy Manager is powered by four AAAbatteries—two batteries power the PDA and two batteries powerthe telemetry module.Battery icons on your Personal Therapy Manager are located onthe Patient Option Screen (Figure 15). These icons show thestatus of the batteries in the PDA and in the telemetry module.35221094_a_001.qxd 9/26/2002 4:15 PM Page 35 FCC ID: LF58832
Figure 15. Location and identification of the battery icons on thePatient Option Screen.To check the status, access the Patient Option Screen, and look atthe battery icons.Batteries are fully charged or near fully charged.Batteries are okay.36PDA battery icon Telemetry modulebattery icon221094_a_001.qxd 9/26/2002 4:15 PM Page 36 FCC ID: LF58832
Batteries are low.Batteries are depleted. Change batteries.Notes:• Alkaline batteries are recommended for use in yourPersonal Therapy Manager.• When not using your therapy manager for more than 4 weeks, remove the AAA batteries from both the PDAand the telemetry module to prevent damage.• Make sure that you always have fresh AAA batterieson hand.37221094_a_001.qxd 9/26/2002 4:15 PM Page 37 FCC ID: LF58832
Removing the PDA Batteries1. 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. AB38221094_a_001.qxd 9/26/2002 4:15 PM Page 38 FCC ID: LF58832
Replacing the PDA Batteries1. Check the battery labels for positive [+] and negative [-]contacts. Match them with the [+] and [-] symbols in thebattery wells.2. Press the batteries down (spring end first) into the batterywells (Figure 17).Note: The spring end is the negative contact.39221094_a_001.qxd 9/26/2002 4:15 PM Page 39 FCC ID: LF58832
Figure 17. Inserting the batteries.3. Replace the battery cover. BA40221094_a_001.qxd 9/26/2002 4:15 PM Page 40 FCC ID: LF58832
Removing the Telemetry Module Batteries1. 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. BA41221094_a_001.qxd 9/26/2002 4:15 PM Page 41 FCC ID: LF58832
Replacing the Telemetry Module Batteries1. Check the battery labels for positive [+] and negative [-]contacts. Match them with the [+] and [-] symbols in thebattery wells.2. Press the batteries down (spring end first) into the batterywells (Figure 19).Note: The spring end is the negative contact.Figure 19. Inserting the batteries.A42221094_a_001.qxd 9/26/2002 4:15 PM Page 42 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; handleit with care.• Do not take apart or tamper with the Personal TherapyManager; this could affect how it works.• Protect the Personal Therapy Manager from sharp blows orphysical shocks.• Clean the outside of the Personal Therapy Manager with aslightly damp cloth. Mild household cleaners will not damagethe case or labels.• Your Personal Therapy Manager is not waterproof. Do notallow moisture to get into the device.43221094_a_001.qxd 9/26/2002 4:15 PM Page 43 FCC ID: LF58832
ECautionDo not immerse the Personal Therapy Manager in liquid. Do not clean itwith bleach, nail polish, or other similar substances.• Clean the battery contacts periodically with a cotton swabdampened with alcohol. Do not use a pencil eraser orsandpaper.• Replace low or depleted batteries to ensure proper operationand to prevent corrosion of the Personal Therapy Manager.• When not using the Personal Therapy Manager for more than4 weeks, remove the batteries to prevent corrosion of thedevice.• To conserve battery power, always turn off your PersonalTherapy Manager when you are done using it.44221094_a_001.qxd 9/26/2002 4:15 PM Page 44 FCC ID: LF58832
StorageYou do not need to remove your Personal Therapy Manager fromits pouch to use it. The pouch helps to protect the PersonalTherapy Manager (Figure 20).Figure 20. Personal Therapy Manager pouch.45221094_a_001.qxd 9/26/2002 4:15 PM Page 45 FCC ID: LF58832
Place the Personal Therapy Manager in the pouch so that thescreen is against the fold-down flap (Figure 21).Figure 21. Storing your Personal Therapy Manager in its pouch.46Fold-downFlapTelemetryModuleScreen221094_a_001.qxd 9/26/2002 4:15 PM Page 46 FCC ID: LF58832
DisposalReturn devices for disposal to the manufacturer. Medtronic officeaddresses are listed at the back of this manual.47221094_a_001.qxd 9/26/2002 4:15 PM Page 47 FCC ID: LF58832
TROUBLESHOOTINGWhen to Call Your Doctor’s OfficeCall your doctor’s office if:• you experience anything unusual, such as new orunexplained 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 callyour doctor. Problems are described in the left column. The textin the middle and right columns lists possible causes of theproblems and describes how to correct the problem. Note: If your problem is not described here, contact your doctor.48221094_a_001.qxd 9/26/2002 4:15 PM Page 48 FCC ID: LF58832
Table 2. TroubleshootingProblem Potential Cause Correction Your Personal Therapy Your Personal Therapy Reset your Personal Therapy Manager is stuck on one Manager has a hardware or Manager (refer to the Specialscreen. software problem. Procedures section of this manual).Call your doctor.Your Personal Therapy No battery, depleted battery, Replace the batteries with Manager does not respond battery is in backward. fresh batteries. to fingertip touch.Software/hardware failure Reset your Personal Therapy Manager (refer to the SpecialProcedures section of thismanual).Your symptom relief is Call your doctor.not adequate.49221094_a_001.qxd 9/26/2002 4:15 PM Page 49 FCC ID: LF58832
Problem Potential Cause Correction Your Personal Therapy Personal Therapy Manager Reset your Personal Therapy Manager does not turn on. failure. Manager (refer to the SpecialProcedures section of thismanual).You cannot activate a dose. Depleted battery. Replace batteriesYou have tried to activate too Wait until activation is many doses in one day allowed.period, or you have tried toactivate a dose too soon sincethe last activation.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. You have turned the volume Turn the volume up (refer to down too low to be able to page 62) or on (refer to hear it, or you have turned pages 19-20).it off.50221094_a_001.qxd 9/26/2002 4:15 PM Page 50 FCC ID: LF58832
Problem Potential Cause Correction Your Personal Therapy You have spilled fluid on Dry it with a towel, and turnManager is on your Personal Therapy the Personal Therapy non-functional. Manager. Manager on to ensure it isworking correctly.Your Personal Therapy 1. Remove the Personal TherapyManager falls into water. Manager from the water. 2. Wipe it with a towel dampened with clean tapwater.3. Open the battery covers andremove the batteries. Shake to remove as much water aspossible.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 TherapyManager. If you see or hearwater inside, repeat steps4 and 5.51221094_a_001.qxd 9/26/2002 4:15 PM Page 51 FCC ID: LF58832
Problem Potential Cause Correction 7. When the Personal Therapy Manager is dry, replace thebatteries and battery covers.8. Turn on the Personal TherapyManager to ensure it isworking correctly.9. If the Personal TherapyManager does not workproperly, call your doctor.Your Personal Therapy Turn on the Personal TherapyManager falls or is Manager to see if the device is dropped. working. If you think theNOTE: The Personal Personal Therapy Manager isTherapy Manager is not working correctly, designed to withstand call your doctor.falls of short distances.52221094_a_001.qxd 9/26/2002 4:15 PM Page 52 FCC ID: LF58832
Problem Potential Cause Correction The telemetry light does not Sunlight may be obscuring Shade the light with your handappear to be functioning. your view. or move into a darker area. The batteries on the PDA are Check the appropriate battery depleted or are very low. 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 Check to see that the batteriesincorrect. are inserted properly. The incomplete telemetry The Personal Therapy Realign the Personal Therapyicon is displayed. Manager was not close Manager and try again. enough to the pump duringthe activation attempt.53221094_a_001.qxd 9/26/2002 4:15 PM Page 53 FCC ID: LF58832
Problem Potential Cause Correction The Personal Therapy Realign the Personal Therapy Manager was moved away Manager with the pump and from the pump too quickly. try again. Excessive electromagnetic Move away from possible EMIinterference (EMI). Inter- sources such as TVs or ference caused by computer computer monitors.monitors or other electronic equipment.After communication with A pump alarm is occurring. Call your doctor. the pump, the PersonalTherapy Manager screencontains an alert iconwith a number.A generic PDA screen The telemetry module Remove and replace theappears instead of the was not inserted correctly. telemetry module, ensuring Patient Option Screen. that none of the buttons onthe bottom of the PDA arepressed during this time.54221094_a_001.qxd 9/26/2002 4:15 PM Page 54 FCC ID: LF58832
How to Get HelpYou can contact Medtronic Patient Services for help at theaddress and phone number listed on the back cover of thismanual. Record other important contacts and phone numbersbelow, in the spaces provided:Contact: Phone:________________________ ________________________________________________ ________________________________________________ ________________________________________________ ________________________________________________ ________________________________________________ ________________________________________________ ________________________55221094_a_001.qxd 9/26/2002 4:15 PM Page 55 FCC ID: LF58832
ADDITIONAL INFORMATIONSpecificationsModel 8832 SynchroMed II Personal Therapy ManagerPower Source: Four commercially available AAA batteries (LR 03)Operating Temperature: 10 °C—40 °C (50 °F—104 °F)Operating Time: ShortStorage Temperature: -20 °C—60 °C (-4 °F—140 °F )Relative Humidity: 90% maximumAtmospheric 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)56221094_a_001.qxd 9/26/2002 4:15 PM Page 56 FCC ID: LF58832
Special NoticeThe Medtronic Model 8832 SynchroMed II Personal TherapyManager is designed for use with the SynchroMed II Pump. Thefunctions of the Personal Therapy Manager are not compatiblewith any other devices. For information regarding difficultieswhich may be encountered using the Personal Therapy Manager,consult the other portions of this manual.Travel or International UseWhen traveling, always carry the ID card that was issued withyour implantable pump. Follow all directions issued by yourdoctor when traveling.You may want to carry extra AAA batteries when travelingoverseas, although they may be readily available, depending onyour destination.57221094_a_001.qxd 9/26/2002 4:15 PM Page 57 FCC ID: LF58832
SPECIAL PROCEDURESThis section describes the following procedures:• Interrogation• Patient Diary Use• Setting the Volume• Calibration• Touchscreen Backlight Use• Reset ProcedureInterrogationWhen you interrogate your pump, the Personal TherapyManager receives updated information from the pump. Thisinformation is a useful tool for your physician.58221094_a_001.qxd 9/26/2002 4:15 PM Page 58 FCC ID: LF58832
To interrogate your pump, press the toolkit button on the PatientOption Screen (Figure 4), then press the pump alarm button ,and finally, the interrogate pump button . The PersonalTherapy Manager will begin to beep, and the light on thetelemetry module will begin to flash. Position your PersonalTherapy Manager over your pump and move it around slowly inthat area until the beeping stops and the light remains on. Youwill hear three ascending tones when successful interrogation iscomplete. If you hear two descending tones, the interrogationfailed, and you should repeat the attempt.59221094_a_001.qxd 9/26/2002 4:15 PM Page 59 FCC ID: LF58832
Patient Diary UseYour Personal Therapy Manager is equipped with a Patient Diary(Figure 22) that allows your doctor to track how well yourtherapy 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 day60221094_a_001.qxd 9/26/2002 4:15 PM Page 60 FCC ID: LF58832
When you make an entry, you will see a ruler on the PatientDiary Screen (Figure 23). Figure 23. Patient Diary Screen.Each small vertical line on the ruler in the middle of the screenrepresents a number, 0 through 10. The pointer on the screenpoints to the number currently selected. You can either drag thepointer left or right on the ruler, or touch a vertical line to bringthe pointer to the number you desire.61221094_a_001.qxd 9/26/2002 4:15 PM Page 61 FCC ID: LF58832
Select a number that represents how you feel. A lower numbermeans your symptoms are less intense. A higher number meansyour symptoms are worse.After you make an entry into the patient diary, press the buttonat the bottom of the screen (the patient-activated dose button orthe write diary button) to continue. After you press the button,your Personal Therapy Manager will either turn off or beginlooking for your pump.Setting the VolumeYour Personal Therapy Manager uses audio signals tocommunicate various messages, such as:• Successful and unsuccessful dose activation;• Request for patient diary entry; and • Searching for pump.62221094_a_001.qxd 9/26/2002 4:15 PM Page 62 FCC ID: LF58832
To set the volume on your Personal Therapy Manager, press theToolkit Screen button on the bottom right of the Patient OptionScreen (Figure 24).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.63ToolkitScreenButton221094_a_001.qxd 9/26/2002 4:15 PM Page 63 FCC ID: LF58832
CalibrationThe Personal Therapy Manager will require periodic calibration(e.g., at initial assembly and after the batteries have completelydepleted). The figures presented below represent the calibrationinstructions that will be presented on the Personal TherapyManager. Follow the instructions on the screen to calibrate thedevice.Note: Use a stylus to touch as closely as possible to the exactcenter of the target symbols.64221094_a_001.qxd 9/26/2002 4:15 PM Page 64 FCC ID: LF58832
12 3Select Center Select Center Select Centerof Target of Target of TargetFigure 25. Calibration Instructions.65221094_a_001.qxd 9/26/2002 4:15 PM Page 65 FCC ID: LF58832
45 67Select OK Select Yes Select Next Select DoneFigure 26. Calibration instructions.w66221094_a_001.qxd 9/26/2002 4:15 PM Page 66 FCC ID: LF58832
Note: The Personal Therapy Manager reads the time of dayfrom the implantable pump. Do not reset the time on thePersonal Therapy Manager Calibration Screens.Touchscreen Backlight UseYour Personal Therapy Manager is equipped with a backlightthat illuminates the touchscreen under dark or limited lightingconditions. To turn on the backlight, press and hold the half-moon shaped ON/OFF button for approximately 2 seconds whenyou turn on your Personal Therapy Manager.67221094_a_001.qxd 9/26/2002 4:15 PM Page 67 FCC ID: LF58832
Resetting Your Personal Therapy ManagerTo reset your Personal Therapy Manager:Remove telemetry module Use a push pin or Replace telemetry moduleother tool to push in the reset buttonStep 1 Step 2 Step 368221094_a_001.qxd 9/26/2002 4:15 PM Page 68 FCC ID: LF58832
INSIDE BACK COVER221094_a_001.qxd 9/26/2002 4:15 PM Page 69 FCC ID: LF58832
© Medtronic, Inc. 2002All Rights Reserved221094001Medtronic, Inc.710 Medtronic ParkwayMinneapolis, MN 55432-5604USAInternet: www.medtronic.comTel. 1-763-505-5000Toll-free 1-800-328-0810Fax 1-763-505-1000221094_a_001.qxd 9/26/2002 4:15 PM Page 70 FCC ID: LF58832

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