Medtronic DBS Therapy 37642 User Manual
PATIENT PROGRAMMER
®
Medtronic
Activa
Activa
Activa
Activa
DBS™ Therapy user manual
®
PC Model 37601
®
RC Model 37612
®
SC Model 37602
®
SC Model 37603
37642
! USA
Rx only
2008
Medtronic®, Activa®, and SoftStart/Stop® are
trademarks of Medtronic, Inc., registered in the U.S.
and other countries.
DBS™ is a trademark of Medtronic, Inc.
! USA
FCC Information
The following is communications regulation information
on the Model 37642 Patient Programmer.
FCC ID: LF537741
This device complies with Part 15 Rules. Operation is
subject to the following two 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.
This device complies with Industry Canada licenseexempt RSS standard(s). Operation is subject to the
following two conditions: (1) this device may not cause
interference, and (2) this device must accept any
interference, including interference that may cause
undesired operation of the device.
Label symbols
Explanation of symbols on products and
packaging. Refer to the appropriate product
to see symbols that apply.
Conformité Européenne (European
Conformity). This symbol means that the
device fully complies with AIMD Directive
90/385/EEC (NB 0123) and R&TTE
Directive 1999/5/EC.
Consult instructions for use
Manufacturer
-XX °C
-XX °F
XX °C
XXX °F
Temperature limitation
Keep dry
Ingress protection rating IP22, per
60601-1-11
Serial number
PIN No.
REP
EC
PIN number
Authorized representative in the
European community
37642 2015-04 English
Label symbols
3
For USA audiences only
IEC 60601-1/EN60601-1, Type BF
Equipment
Non-ionizing electromagnetic radiation
Antenna jack
MR
MR
Magnetic Resonance (MR) Conditional
Magnetic Resonance (MR) Unsafe
System meets the applicable (CAN/CSAC22.2 No. 60601-1) electrical safety
standard requirements.
Do not dispose of this product in the
unsorted municipal waste stream.
Dispose of this product according to local
regulations. See http://
recycling.medtronic.com for instructions
on proper disposal of this product.
Chinese Standard (SJ/T11364-2006)
Logo: Electronic Information Products
Pollution Control Symbol. (The date in this
logo means the environmental protection
use period of the product.)
Label symbols
4
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Table of contents
Label Symbols 3
Glossary 10
1
Introduction 18
How to use this manual 18
For important safety information 20
Purpose of your patient programmer 20
Purpose of the neurostimulation system
(indications) 21
Precautions 21
2 Using your patient
programmer 26
How the patient programmer works 26
Multiple neurostimulators 29
Simple and advanced therapy
modes 29
Summary of keys 32
Using the Navigator key 36
The Therapy screen 38
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Table of contents
5
Synchronizing the patient programmer
and your neurostimulator 41
Turning your therapy on or off 44
The neurostimulator battery 46
About rechargeable batteries 46
Checking the nonrechargeable battery
status 47
Possible nonrechargeable battery status
conditions 48
Customizing your patient
programmer 50
Changing preferences 51
Patient programmer alert 57
Patient programmer accessories 58
Carrying case and patient programmer ID
label 58
Detachable antenna 60
Using the detachable antenna 61
3 Adjusting therapy settings with
Advanced mode 66
Adjusting your therapy settings 66
Therapy settings 68
Changing therapy settings in Advanced
Table of contents
mode 69
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Selecting a new group 73
Returning your therapy to original
settings 77
Understanding therapy parameter
limits 81
4 MRI examinations 84
If you have an MRI appointment 84
Responsibilities of the patient in preparing
for the MRI appointment 84
Preparing your neurostimulation system
for the MRI scan 85
Turning off therapy before the MRI
scan 86
Using the patient programmer to turn off
therapy 87
Using the clinician programmer to turn off
therapy 88
Turning therapy back on after the MRI
scan 89
Activating settings to allow therapy on
during the MRI scan 90
Using the patient programmer to activate
a new group 91
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Table of contents
7
Using the clinician programmer to activate
a new group 92
Returning therapy to your original group
setting after the MRI scan 94
5 Important information about your
rechargeable
neurostimulator 98
The rechargeable neurostimulator
battery 98
Check and charge: make it a habit 100
Checking the rechargeable
neurostimulator battery 102
Low battery status 103
Rechargeable battery overdischarge 105
Charging the neurostimulator battery 106
Patient programmer alert 108
6 Troubleshooting 110
Patient Programmer screens 110
Warning screens 110
Communication screen 113
Information screens 114
Table of contents
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Possible problems and solutions 121
7 Maintenance 128
Patient programmer batteries 128
Checking the patient programmer
batteries 129
Replacing the patient programmer
batteries 132
Cleaning and care 134
Safety and technical checks 135
Battery and patient programmer
disposal 136
Declaration of conformity 136
Specifications 137
8 Assistance for the patient
programmer 140
Index 142
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Table of contents
9
Glossary
Active Group - Available in Advanced mode
only, the active group is the current group
selected for your neurostimulator. See
"Group" for more information.
Amplitude - The strength or intensity of an
electrical pulse.
Caution - A statement describing actions that
could result in damage to or improper
functioning of a device.
Charging system - Equipment used to
charge the battery inside a rechargeable
implanted neurostimulator.
Clinician - A healthcare professional such as
a doctor or nurse.
Clinician programmer - A device used by a
clinician to send instructions to a
neurostimulator.
Contraindication - A condition or
circumstance when a person should not
have a neurostimulation system.
Glossary
10
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Cycling - See Stimulation cycling.
Deep Brain Stimulation (DBS) - The
delivery of electrical pulses to a targeted
area or areas of the brain.
Discharged battery status (rechargeable
battery only) - The rechargeable battery is
depleted and should be charged as soon
as possible. When the battery is in a
discharged state, therapy is not available.
Electrode - A metal piece near the tip of the
lead. Electrodes deliver electrical pulses to
a targeted area or areas of the brain.
Electromagnetic interference (EMI) - A
strong field of energy near electrical or
magnetic devices that could prevent the
neurostimulator from functioning properly.
EOS (End of Service) - A notification that the
neurostimulator has reached its end of
service. At EOS, the neurostimulator no
longer delivers the electrical pulses that
provide therapy.
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Glossary
11
ERI (Elective replacement indicator) - A
notification that the neurostimulator is
nearing its end of service.
Group - A group is a collection of therapy
settings on your patient programmer that
your doctor creates for you. Each group
may be defined for a different activity,
symptom, or time of day. Available in
Advanced mode only, this feature allows
you to adjust your therapy for different
situations or for personal preference.
Group status row - The Parameter row on
the Therapy screen displays the active
group.
Implantable neurostimulat or (INS) - See
Neurostimulator.
Indication - The purpose of the
neurostimulation system and the medical
condition for which it may be implanted.
Lead - The lead is a set of thin wires covered
with a protective coating. It carries the
therapy signal to the electrodes that deliver
Glossary
12
stimulation to the brain tissue.
English 37642 2015-04
Magnetic Resonance Imaging (MRI) - A
type of medical procedure that scans your
body using magnetic fields to provide
detailed pictures of your anatomy.
Neurostimulation system - Components
that deliver, control, and maintain electrical
pulses to provide therapy to the brain.
Neurostimulator - The neurostimulator is the
implanted device that generates and
controls your DBS therapy.
Overdischarge (rechargeable battery only)
- The rechargeable battery cannot be
recharged when it is overdischarged. Once
the battery is in a discharged state, if it is
not recharged it continues to lose charge.
Eventually, the battery loses enough
charge to permanently affect the
neurostimulator. If this occurs, the battery
is overdischarged.
Parameter - One of three therapy settings
that adjust the electrical pulse: amplitude,
pulse width, and rate of the electrical
stimulation.
Glossary
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13
Parameter/Group row - The bottom row on
the Therapy screen showing the
parameter and active group settings (only
available in Advanced mode).
Parameter settings - See Therapy settings.
Patient programmer - A hand-held device
that allows you to turn your therapy on and
off. It may also be used to adjust some
therapy settings.
Precaution - See Caution.
Preferences - Adjustable settings on your
patient programmer including audio,
contrast, and text or icon display format.
Preferences do not affect your therapy.
Pulse width - The length or duration of an
electrical pulse.
Rate - The number of electrical pulses
delivered each second.
Glossary
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SoftStart/Stop - This feature, programmed
by your clinician, starts and stops your
therapy gradually by slowly increasing or
decreasing to the programmed amplitude
or until turned off.
Status row - The top row on the Therapy
screen. This row displays if your therapy is
on or off.
Stimulation - The delivery of electrical
pulses to an appropriate area of the brain.
Your therapy is actually mild electrical
stimulation.
Stimulation cycling - This feature turns your
stimulation on and off at regular intervals
and is programmed by your doctor.
Synchronize - The process of sending and
receiving information between the patient
programmer and neurostimulator.
Therapy - Treatment of a disease or
condition. When neurostimulation therapy
is prescribed, a neurostimulation system is
used to deliver stimulation to one or more
areas of the brain.
Glossary
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15
Therapy screen - The main screen displayed
on the patient programmer.
Therapy settings - Your therapy can be
adjusted by changing the rate, amplitude,
or pulse width of the electrical stimulation.
Your clinician programs all therapy
settings. You may be able to adjust some
therapy settings within clinician-defined
limits. Available in Advanced mode only.
Warning - A statement describing an action
or situation that could harm the patient.
Warning screen - A screen displayed on the
patient programmer that alerts you to a
problem with the programmer, antenna, or
neurostimulator.
Glossary
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1 Introduction
How to use this manual
Refer to this manual after you receive an
implanted neurostimulator. Ask your doctor to
explain anything that is unclear.
A glossary is provided at the beginning of
•
this manual to describe terms that may be
unfamiliar to you.
Chapter 1 "Introduction", on page 17,
•
describes how to use this manual, the
purpose of the patient programmer, and
provides general precautions related to
using your patient programmer.
Chapter 2 "Using your patient
•
programmer", on page 25, describes the
patient programmer and how to perform
specific tasks.
Chapter 3 "Adjusting therapy settings with
•
Advanced mode", on page 65, explains
Introduction 1
18
English 37642 2015-04
how to use your patient programmer to
adjust your therapy settings.
Chapter 4 "MRI examinations", on
•
1
page 83, provides information about
what you should do if you have an MRI
examination.
Chapter 5 "Important information about
•
your rechargeable neurostimulator", on
page 97 emphasizes the importance of
checking and recharging your
neurostimulator battery (for rechargeable
devices only).
Chapter 6 "Troubleshooting", on
•
page 109, describes patient programmer
warning and information screens, how to
solve possible problems, and who to
contact if your device is lost or broken.
Chapter 7 "Maintenance", on page 127
•
describes how to care for your patient
1
Your doctor has programmed your implanted
neurostimulator to provide the correct therapy
settings for your medical condition and will activate
Advanced mode if appropriate.
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Introduction 1
19
programmer, including how to change the
batteries.
For important safety information
Please see your DBS Patient Therapy Guide
and DBS Therapy-specific Patient Booklet for
important safety information, related warnings
and precautions, and additional information
about your therapy.
Purpose of your patient programmer
The Medtronic Model 37642 Patient
Programmer is designed to operate with the
following Medtronic neurostimulators:
Activa PC Model 37601 (nonrechargeable
•
battery)
Activa RC Model 37612 (rechargeable
•
battery)
Activa SC Model 37602 (nonrechargeable
•
battery)
Introduction 1
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Activa SC Model 37603 (nonrechargeable
•
battery)
Purpose of the neurostimulation system (indications)
Refer to the indications sheet that is
packaged with your patient programmer for
the purpose of the neurostimulation system
and related information.
Precautions
Patient control devices may affect other
implanted devices—Do not place the patient
control device (ie, patient programmer) over
another type of active implanted medical
device (eg, pacemaker, defibrillator, another
type of neurostimulator). The patient control
device could unintentionally change the
operation of the other device.
Patient programmer handling—To avoid
damaging the patient programmer, do not
immerse the device in liquid; do not clean it
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Introduction 1
21
with bleach, nail polish remover, mineral oil,
or similar substances; and do not drop it or
handle it in a way that might damage it.
Patient programmer use—The device is not
certified for use in the presence of a
flammable or anesthetic mixture with air or
with oxygen or nitrous oxide. The
consequences of using the device near
flammable atmospheres are unknown.
Patient programmer modification—Do not
modify this equipment. Modification of this
equipment can result in damage to the
programmer, causing the programmer to
malfunction or become unusable.
Communication interference from EMI—
When using your patient programmer to
communicate with your neurostimulator,
move away from equipment that may
generate electromagentic interference (EMI)
or turn off the likely source of EMI. EMI may
disrupt communication between the patient
programmer and neurostimulator. Examples
of EMI sources are computer monitors,
cellular telephones, and motorized
Introduction 1
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wheelchairs. For more information about EMI,
refer to your DBS Therapy-specific patient
booklet.
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Introduction 1
23
Introduction 1
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2 Using your patient programmer
How the patient programmer
works
The patient programmer is used to control
and monitor your implanted neurostimulator
or neurostimulators. For example, you will
use your patient programmer to:
Turn your therapy on or off.
•
Check the neurostimulator and patient
•
programmer battery status.
Alert you when you need to check the
•
status of the neurostimulator battery.
Change therapy settings.
•
Note: Make sure to keep your patient
programmer with you at all times in the event
that you need to adjust your therapy or turn
your therapy off.
1
Your clinician will turn this feature on or off and also
set the time of day that it will alert you.
2
Your clinician will set up the therapy settings you will
be able to adjust depending on your specific therapy
Using your patient programmer 2
requirements. Discuss this with your doctor.
2
1
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The patient programmer communicates with
your neurostimulator by sending signals to
and receiving signals from your implanted
neurostimulator.
When you use the patient programmer, hold
it directly over your implanted neurostimulator
so that the programmer screen is facing out.
The back of the patient programmer should
be as close to the neurostimulator as
possible, as shown in Figure 2.1.
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Using your patient programmer 2
27
Patient programmer
Hold patient programmer
directly over your
implanted
neurostimulator
Figure 2.1 Place the patient programmer
directly over your neurostimulator.
A detachable antenna is available for use
with your neurostimulator system. The
detachable antenna makes it easier to view
the patient programmer screen while
adjusting your therapy settings or checking
the neurostimulator battery status. See
"Using the detachable antenna" on page 61
for more information.
Using your patient programmer 2
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Multiple neurostimulators
Some patients have decided with their
doctors to have two neurostimulators
implanted.
If you have two neurostimulators implanted,
you can use one patient programmer to
communicate with both neurostimulators, but
only with one neurostimulator at a time. The
patient programmer only displays information
about the neurostimulator with which it is
currently synchronized.
The patient programmer must be turned off
prior to sychronizing with the other
neurostimulator or you may not be viewing
the desired information.
Simple and advanced therapy
modes
There are two therapy modes available for
your patient programmer: Simple mode and
Advanced mode. Your doctor will discuss
which mode you will use.
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Using your patient programmer 2
29
Simple mode uses the therapy settings
•
selected by your doctor. Only your doctor
can adjust your therapy settings.
Advanced mode uses therapy settings
•
selected by your doctor and also may
allow you to change certain therapy
settings and/or select preset therapy
groups.
Using your patient programmer 2
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