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 Manager
Model 8832 Personal Therapy Manager for Your SynchroMed®II
Implantable Drug Pump
Patient Manual
Rx Only
221094_a_001.qxd 9/26/2002 4:15 PM Page 1 FCC ID: LF58832
FCC ID: LF58832
221094_a_001.qxd 9/26/2002 4:15 PM Page 2 FCC ID: LF58832
A Company Dedicated to Patients
Medtronic was founded in 1949 by Earl Bakken, a graduate student in
electrical engineering, and his brother-in-law, Palmer J. Hermundslie.
Today Medtronic is the world leader in medical technology, pioneering
therapies that restore health, extend life and alleviate pain.
From its modest beginnings in a 55-square-meter Minneapolis garage,
we have transformed Medtronic into a worldwide company that serves
customers in more than 120 countries. Each year, millions of patients
are treated with Medtronic products and therapies. We invest almost
$500 million each year in research and development, working closely
with the world’s leading physicians and scientists to enhance our
current products and therapies, and to develop new ones. Although we
are a large company, individual patients and their needs are still the
driving force behind what we do and how we do it.
Our goal is to improve the quality of your life. This booklet, which
provides information about your SynchroMed Personal Therapy
Manager, is one small way we try to help.
Welcome to the Medtronic family. We wish you well. i
221094_a_001.qxd 9/26/2002 4:15 PM Page i FCC ID: LF58832
Explanation of Symbols on Product and Packaging
IEC 60601-1, Type BF Equipment
Attention: See accompanying documents
nSerial Number
Radio frequency device (IEC-60601-1)
Medtronic®and SynchroMed®are registered trademarks of Medtronic, Inc.
This equipment has been tested and complies with the limits for medical devices as outlined in
IEC 60601-1-2:1997. The device provides reasonable protection against harmful interference in a
typical medical setting. However, there is no guarantee that interference will not occur. Refer to the
troubleshooting section of this manual for instructions on what to do if the Personal Therapy
Manager does not communicate completely with your pump and you suspect interference may be
the cause.
FCC ID: LF5 8832
This device complies with Part 15 Rules. Operation is subject to the following 2 conditions: (1) this
device may not cause harmful interference and (2) this device must accept any interference
received, including interference that may cause undesired operation.
IMPORTANT: Changes or modifications to this product not authorized by Medtronic, Inc., could
void the FCC Certification and negate your authority to operate this product.
ii
w
yStorage Temperature
Relative Humidity
Atmospheric Pressure
XXX kPa
XX.X in. Hg
XX kPa
XX.X
in. Hg
kPa
XX %
XX %
C
F
C
F
XX
XX
XX
XX
L
221094_a_001.qxd 9/26/2002 4:15 PM Page ii FCC ID: LF58832
CONTENTS
GLOSSARY ................................................................. 1
INTRODUCTION.......................................................4
Identification of Buttons and Icons .............................5
DESCRIPTIVE INFORMATION .............................7
Purpose of the Device (Indications)............................8
List of Personal Therapy Manager Materials..... 9
When the Device Should Not be Used
(Contraindications) ......................................................10
Risks and Benefits ........................................................10
General Warnings and Precautions...........................12
Warnings .................................................................12
Precautions .............................................................12
Electromagnetic Interference (EMI)....................13
Care Regimen ...............................................................14
iii
221094_a_001.qxd 9/26/2002 4:15 PM Page iii FCC ID: LF58832
OPERATING INFORMATION ..............................15
Setup Instructions ........................................................15
Assembly ................................................................15
Install the Batteries ................................................16
Turning on Your Personal Therapy Manager ..16
Patient Option Screen ...........................................18
Synchronization ....................................................21
Activating a Dose.........................................................22
Position Your Personal Therapy
Manager (Interrogation) .......................................23
Determining the Status of Your
Activation Request ...............................................26
Toolkit Screen................................................................30
Therapy Information Screen ................................31
Refill Information Screen......................................33
Pump Alarm Status Screen ..................................34
Volume Setting Screen ..........................................34
iv
221094_a_001.qxd 9/26/2002 4:15 PM Page iv FCC ID: LF58832
Caring for Your Personal Therapy Manager ...........35
How to Determine if Batteries Need
to be Replaced........................................................35
Removing the PDA Batteries ...............................38
Replacing the PDA Batteries................................39
Removing the Telemetry Module Batteries .......41
Replacing the Telemetry Module Batteries........42
Cleaning and Care .......................................................43
Storage ...........................................................................45
Disposal .........................................................................47
TROUBLESHOOTING............................................48
When to Call Your Doctor’s Office............................48
Call your doctor’s office if ...................................48
How to Get Help..........................................................55
v
221094_a_001.qxd 9/26/2002 4:15 PM Page v FCC ID: LF58832
ADDITIONAL INFORMATION ...........................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 vi 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.
1
221094_a_001.qxd 9/26/2002 4:15 PM Page 1 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.
2
221094_a_001.qxd 9/26/2002 4:15 PM Page 2 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.
3
221094_a_001.qxd 9/26/2002 4:15 PM Page 3 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:
4
221094_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);
Successful
Activation
Patient-Activated
Infusion
Time
Remaining
Request Denied
Dose Activation
Request
Communication
Failed Attention
Pump Alarm—
Status
Interrogate
Pump
Dose
Lockout Interval
Patient Dose
Information
Therapy
Information
Pump Infustion —
Continuous
Refill Date
Toolkit
Write to Diary
Return to Patient
Option Screen
w
Searching
for Pump
Speaker On
Speaker Off
5
221094_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 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.
6
221094_a_001.qxd 9/26/2002 4:15 PM Page 6 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.
Figure 1. Personal Therapy Manager components.
7
Telemetry
Module
PDA
Touchscreen
Telemetry
Light
221094_a_001.qxd 9/26/2002 4:15 PM Page 7 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
8
221094_a_001.qxd 9/26/2002 4:15 PM Page 8 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
9
221094_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 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 10 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 11 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 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 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 13 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 14 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 15 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 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.
17
Personal Therapy
Manager
ON/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, 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).
Figure 4. Patient Option Screen.
18
Speaker Button
Dose
Activation
Button
Toolkit Screen
Button
221094_a_001.qxd 9/26/2002 4:15 PM Page 18 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 button. Pressing this button turns
the sound on or off.
19
221094_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 is
ON.
When the speaker OFF button is on the screen, the sound is
OFF.
20
Speaker
Button
221094_a_001.qxd 9/26/2002 4:15 PM Page 20 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 21 FCC ID: LF58832
Activating a Dose
To activate a dose, press the dose activation request button on the
Patient Option Screen.
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
Dose Activation
Request Button
221094_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 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 23 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 24 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 25 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 26 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 27 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
The screen with request denied and
time remaining icons means that you
cannot activate a dose at this time.
28
Time
Remaining
Request
Denied
221094_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 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 29 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).
Figure 11. Toolkit Screen.
30
Therapy
Information
Screen
Pump Alarm
Status Screen
Button
Refill
Information
Screen Button
Volume Setting
Screen Button
Return to
Patient Option
Screen Button
221094_a_001.qxd 9/26/2002 4:15 PM Page 30 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).
Figure 12. Therapy Information Screen.
31
Patient
Information
Tab
Pump
Infusion Tab
Patient-
Activated
Dose
Infusion Tab
221094_a_001.qxd 9/26/2002 4:15 PM Page 31 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 32 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 33 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.
Figure 14. Pump Alarm Status Screen.
34
221094_a_001.qxd 9/26/2002 4:15 PM Page 34 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 35 FCC ID: LF58832
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
PDA battery icon Telemetry module
battery icon
221094_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 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 37 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.
A
B
38
221094_a_001.qxd 9/26/2002 4:15 PM Page 38 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 39 FCC ID: LF58832
Figure 17. Inserting the batteries.
3. Replace the battery cover.
B
A
40
221094_a_001.qxd 9/26/2002 4:15 PM Page 40 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.
B
A
41
221094_a_001.qxd 9/26/2002 4:15 PM Page 41 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.
A
42
221094_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; 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 43 FCC ID: LF58832
ECaution
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 44 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 45 FCC ID: LF58832
Place the Personal Therapy Manager in the pouch so that the
screen is against the fold-down flap (Figure 21).
Figure 21. Storing your Personal Therapy Manager in its pouch.
46
Fold-down
Flap
Telemetry
Module
Screen
221094_a_001.qxd 9/26/2002 4:15 PM Page 46 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 47 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 48 FCC ID: LF58832
Table 2. Troubleshooting
Problem 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 Special
screen. 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 Special
Procedures section of this
manual).
Your symptom relief is Call your doctor.
not adequate.
49
221094_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 Special
Procedures section of this
manual).
You cannot activate a dose. Depleted battery. Replace batteries
You have tried to activate too Wait until activation is
many doses in one day allowed.
period, or you have tried to
activate a dose too soon since
the 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.
50
221094_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 turn
Manager is on your Personal Therapy the Personal Therapy
non-functional. Manager. Manager on to ensure it is
working correctly.
Your Personal Therapy 1. Remove the Personal Therapy
Manager falls into water. 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 51 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 Turn on the Personal Therapy
Manager falls or is Manager to see if the device is
dropped. working. If you think the
NOTE: The Personal Personal Therapy Manager is
Therapy Manager is not working correctly,
designed to withstand call your doctor.
falls of short distances.
52
221094_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 hand
appear 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 batteries
incorrect. are inserted properly.
The incomplete telemetry The Personal Therapy Realign the Personal Therapy
icon is displayed. Manager was not close Manager and try again.
enough to the pump during
the activation attempt.
53
221094_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 EMI
interference (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 Personal
Therapy Manager screen
contains an alert icon
with a number.
A generic PDA screen The telemetry module Remove and replace the
appears instead of the was not inserted correctly. telemetry module, ensuring
Patient Option Screen. that none of the buttons on
the bottom of the PDA are
pressed during this time.
54
221094_a_001.qxd 9/26/2002 4:15 PM Page 54 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 55 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 56 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 57 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 58 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 59 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 60 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 61 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 62 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).
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
Toolkit
Screen
Button
221094_a_001.qxd 9/26/2002 4:15 PM Page 63 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 64 FCC ID: LF58832
12 3
Select Center Select Center Select Center
of Target of Target of Target
Figure 25. Calibration Instructions.
65
221094_a_001.qxd 9/26/2002 4:15 PM Page 65 FCC ID: LF58832
45 67
Select OK Select Yes Select Next Select Done
Figure 26. Calibration instructions.
w
66
221094_a_001.qxd 9/26/2002 4:15 PM Page 66 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 half-
moon 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 67 FCC ID: LF58832
Resetting Your Personal Therapy Manager
To reset your Personal Therapy Manager:
Remove telemetry module Use a push pin or Replace telemetry module
other tool to push in
the reset button
Step 1 Step 2 Step 3
68
221094_a_001.qxd 9/26/2002 4:15 PM Page 68 FCC ID: LF58832
INSIDE BACK COVER
221094_a_001.qxd 9/26/2002 4:15 PM Page 69 FCC ID: LF58832
© Medtronic, Inc. 2002
All Rights Reserved
221094001
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
221094_a_001.qxd 9/26/2002 4:15 PM Page 70 FCC ID: LF58832