Medtronic 8832 User Manual

You and Your SynchroMed®II Personal Therapy Manager

Model 8832 Personal Therapy Manager for Your SynchroMed®II Implantable Drug Pump

Patient Manual

Rx Only

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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.

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Explanation of Symbols on Product and Packaging

IEC 60601-1, Type BF Equipment

Attention: See accompanying documents

n Serial 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.

Storage Temperature

Relative Humidity

Atmospheric Pressure

XXX kPa XX.X in. Hg

XX kPa XX.X

in. Hg

kPa

XX %

C F

XX XX

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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

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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

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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

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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

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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.

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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.

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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.

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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:

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This manual will describe how to:

• calibrate your Personal Therapy Manager (page 64);

• interrogate your pump (page 58);

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Dose Activation Request

Searching for Pump

Successful Activation

Request Denied

Time Remaining

Communication Failed

Toolkit

Pump Alarm— Status

Interrogate Pump

Refill Date

Write to Diary

Speaker On

Speaker Off

Therapy Information

Patient Dose Information

Dose Lockout Interval

Pump Infustion — Continuous

Patient-Activated Infusion

Return to Patient Option Screen

Attention

• 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.

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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.

Figure 1. Personal Therapy Manager components.

Telemetry Module

PDA

Touchscreen

Telemetry

Light

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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

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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

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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.)

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• 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.

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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).

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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.

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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.

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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.

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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).

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