Neurological
Medtronic Confidential
Title
Model 37742 Patient programmer: pain therapy
user manual
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outside Medtronic without proper authorization.
Medtronic Confidential
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220907005 B Market release
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Writer
Theresa King-Hunter
Date
13 October 2004
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Page 1
Form MEDN-0043 version 6.0
PATIENT PROGRAMMER 37742
Pain therapy user manual
Rx only
2005
Medtronic®, Restore™, and SoftStart™ are trademarks of
Medtronic, Inc.
c FCC Information
The following is communications regulation information on
the Model 37741 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.
Contents
Label symbols 9
1Introduction11
A company dedicated to patients 12
How to use this manual 13
Patient guides 15
Patient identification card 17
2 Important therapy information 19
Purpose of the device 20
Purpose of the neurostimulation system
(indications) 20
Therapies that may not be used with the
neurostimulation system
(contraindications) 20
Risks and benefits 21
Risks of surgery 21
Possible adverse effects 22
Changes in therapy 22
Possible system complications 22
37742 2004-08 English
3
Warnings 23
Precautions 30
System and therapy 30
Patient activities 32
Individualization of treatment 35
3 Introduction to stimulation 37
How stimulation works 38
Parts of your system 40
Understanding your therapy 43
Controlling your stimulation 45
What your clinician controls 45
What you control 45
Charging 46
Recovery and care 48
Recovering from surgery 48
Activities 48
When to call your clinician 50
Care schedule 51
4
4 Using your patient programmer 53
How the patient programmer works 54
Contents
English 37742 2004-08
Synchronizing and displaying the THERAPY
screen 55
Checking the external neurostimulator
battery 60
Checking the implanted neurostimulator
battery 61
Guidelines for adjusting your stimulation 66
Turning your neurostimulator ON or
OFF 69
Adjusting stimulation settings 70
Using the NAVIGATOR key 71
Changing a group 73
Increasing or decreasing a parameter
(amplitude, pulse width, or rate) 75
Patient programmer batteries 79
Checking patient programmer
batteries 79
Replacing patient programmer
batteries 81
Summary of keys 82
Preferences: Changing the audio, contrast,
time, and time/number format 85
37742 2004-08 English
Contents
5
Using the carrying case and labeling the
patient programmer 89
Optional detachable antenna 91
Connecting the antenna 91
Using the antenna 93
5 Troubleshooting 95
Programmer screens 96
Warning screens 96
Communication screens 100
Information screens 100
Possible problems and solutions 106
User assistance 112
6 Maintenance 113
Cleaning and care 114
Safety and technical checks 116
Battery and programmer disposal 117
Neurostimulator disposal 117
Declaration of conformity 118
6
Specifications 119
7 Appendix A: Electromagnetic
Contents
English 37742 2004-08
interference (EMI) 121
Contraindication 122
Warnings 124
Precautions 132
Notes 136
Glossary 139
Index 147
37742 2004-08 English
Contents
7
Contents
8
English 37742 2004-08
Label symbols
Explanation of symbols on products and
packaging. Refer to the appropriate product
to see symbols that apply.
CE
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.
The use of this device might be
subject to individual country
licensing regimes in Europe.
w
0123
System meets the applicable Canadian
[C22.2-601.1-M90 (R2001)] and US
(UL 60601-1:2003) electrical safety
standard requirements.
Caution, consult accompanying
documents
Serial number
n
Storage temperature
37742 2004-08 English
Label symbols
9
y
L
Relative humidity
Atmospheric pressure
IEC 60601-1/EN60601-1, Type BF
Equipment
Non-ionizing electromagnetic radiation
Screen light
Antenna jack
For USA audiences only
10
Label symbols
English 37742 2004-08
1 Introduction
A company dedicated to patients
Medtronic was founded in
1949 by Earl Bakken, a
graduate student in electrical
engineering, and his brotherin-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 (600-square-foot) 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
Introduction 1
12
English 37742 2004-08
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 neurostimulation system, is one
small way we try to help.
Welcome to the Medtronic family. We wish
you well.
How to use this manual
Use this manual during test stimulation and
after receiving an implanted neurostimulator.
Ask your clinician to explain anything that is
unclear.
• Chapter 1, “Introduction,” describes the
patient documents your clinician should
have provided to you.
• Chapter 2, “Important therapy
information,” describes when you should
and should not use a neurostimulation
37742 2004-08 English
Introduction 1
13
system, and the risks, benefits, warnings,
precautions, and patient activities related
to your neurostimulation system.
• Chapter 3, “Introduction to stimulation,”
describes the therapy, neurostimulation
system components, and recovery and
care information.
• Chapter 4, “Using your patient
programmer,” describes the patient
programmer and how to perform specific
tasks.
• Chapter 5, “Troubleshooting,” describes
patient programmer warning and
information screens, how to solve
possible problems, and who to contact if
your device is lost or broken.
• Chapter 6, “Maintenance,” describes how
to care for your patient programmer and
system specifications.
14
• Appendix A provides more information
about electromagnetic interference.
• A glossary is included at the end of this
Introduction 1
manual.
English 37742 2004-08
Patient guides
Table 1.1 describes the documents you
should receive during test stimulation and
after a neurostimulator is implanted.
Table 1 .1 Patient guides for test stimulation and
implant
Document
Medtronic Model 37021 External
Neurostimulator: Test
Stimulation Patient Guide.
Describes the goals, activities,
components and instructions for
test stimulation.
Test
(ENS
✓
a
)
Implant
(INS
b
)
Medtronic Model 37742 Patient
Programmer: Pain Therapy User
Manual. See page 13 for
chapter details.
Medtronic Model 37742 Patient
Programmer: Quick Reference
Guide. Provides instructions for
common patient programmer
tasks.
37742 2004-08 English
✓✓
✓✓
Introduction 1
15
Table 1 .1 Patient guides for test stimulation and
implant (continued)
Document
Medtronic Model 37751
Recharger: Charging System
User Manual. Describes the
charging system and how to use
it with an implanted
neurostimulator.
Test
(ENS
a
)
Implant
b
(INS
)
✓
16
Medtronic Model 37751
Recharger: Charging System
Quick Reference Guide.
Provides instructions for
common charging system tasks.
Patient Identification Card.
Provides information about you,
your implanted neurostimulator,
and your doctor.
a
External neurostimulator
b
Implanted neurostimulator
Introduction 1
English 37742 2004-08
✓
✓
Patient identification card
When you leave the hospital, your doctor will
give you a patient identification card. This
card supplies information about you, your
implanted device, and your doctor. Your
identification card may allow you to bypass
security devices. Carry this card with you at
all times. If you move, change doctors, or
lose your card, contact Medtronic for a
replacement card. Refer to the Medtronic
contacts at the end of this manual.
A temporary identification card will be
provided at the hospital. After Medtronic
receives your implant registration from the
hospital, you will receive a permanent
identification card.
37742 2004-08 English
Introduction 1
17
Introduction 1
18
English 37742 2004-08
2 Important therapy
information
Purpose of the device
The Medtronic Model 37742
Patient Programmer is
designed to program the
Medtronic Model 37711
Restore Neurostimulator.
Purpose of the neurostimulation system (indications)
Refer to the indications sheet
that is packaged with the patient programmer
for the purpose of the neurostimulation
system and related information.
Therapies that may not be used with the neurostimulation system (contraindications)
20
Diathermy – Inform anyone treating you that
you CANNOT have any shortwave diathermy,
microwave diathermy or therapeutic
Important therapy information 2
ultrasound diathermy (all now referred to as
English 37742 2004-08
diathermy) anywhere on your body because
you have an implanted neurostimulation
system. Energy from diathermy can be
transferred through your implanted system,
and can cause tissue damage, resulting in
severe injury or death. Refer to “Appendix A:
Electromagnetic interference (EMI)” on
page 121 for more information.
Risks and benefits
Stimulation has helped thousands of patients
manage their pain and improve their quality
of life. Your neurostimulation system may be
used with other pain treatments. Stimulation
will not cure your pain. It can, however,
reduce your pain to a tolerable level and
allow you to resume many of your daily
activities.
Risks of surgery
Implanting a neurostimulation system has
risks similar to spinal procedures, including
spinal fluid leak, headaches, swelling,
bruising, bleeding, infection, or paralysis.
37742 2004-08 English
Important therapy information 2
21
If you are on anticoagulation therapy you
might be at greater risk for postoperative
complications such as hematomas that could
result in paralysis.
Possible adverse effects
Adverse effects of stimulation are usually
mild and go away when stimulation is turned
OFF. These adverse effects could include
radicular chest wall stimulation,
uncomfortable stimulation, a jolting or
shocking sensation, or persistent pain at the
neurostimulator site.
Changes in therapy
Over time there could be changes in the level
of your symptom control. In most cases your
doctor can correct these changes without
surgery.
22
Possible system complications
The lead, extension, or neurostimulator could
migrate within the body or erode through the
Important therapy information 2
skin. There could be undesirable changes in
English 37742 2004-08
stimulation, possibly related to cellular
changes around the electrode(s), changes in
the position of the electrode(s), loose
electrical connections, or lead or extension
fractures. It is also possible that the
implanted materials could cause an allergic
or immune system response.
Your neurostimulation system might
unexpectedly cease to function due to battery
depletion or other causes. These events,
which can include electrical shorts or open
circuits, conductor (wire) fractures, and
insulation breaches, cannot be predicted.
Warnings
Electromagnetic interference (EMI) –
Electromagnetic interference is a field of
energy generated by equipment found in the
home, work, medical or public environments
that is strong enough to interfere with
neurostimulator function. Neurostimulators
include features that provide protection from
EMI. Most electrical devices and magnets
encountered in a normal day are unlikely to
Important therapy information 2
37742 2004-08 English
23
affect the operation of a neurostimulator.
However, strong sources of EMI can result in
the following:
• Serious patient injury or death, resulting
from heating of the implanted
components of the neurostimulation
system and damage to surrounding
tissue.
• System damage, resulting in a loss of or
change in symptom control and requiring
additional surgery.
• Operational changes to the
neurostimulator that can cause it to turn
ON or OFF (particularly in a
neurostimulator enabled for magnet use)
or to reset to the power-on-reset (POR)
values, resulting in loss of stimulation,
return of underlying symptoms, and in the
case of POR, requiring your health care
provider to reprogram your
neurostimulator.
24
• Unexpected changes in stimulation,
causing a momentary increase in
Important therapy information 2
stimulation or intermittent stimulation,
English 37742 2004-08
which some patients have described as a
jolting or shocking sensation. Although
the unexpected change in stimulation
could feel uncomfortable, it does not
damage the device or injure a patient
directly. In rare cases, as a result of the
unexpected changes in stimulation,
patients have fallen down and been
injured.
Refer to Table 2.1, on page 26, and
“Appendix A: Electromagnetic interference
(EMI)” on page 121 for information on the
sources of EMI, the effect of EMI on you and
your neurostimulation system, and
instructions on how to reduce the risk from
EMI.
37742 2004-08 English
Important therapy information 2
25
Device
See
guidelines
stimulation
Intermittent
turns
OFF or
ON
26
in
increase
stimulation
Momentary
Device
damage
injury
patient
Serious
Table 2 .1 Potential effects of EMI from devices or procedures
Important therapy information 2
English 37742 2004-08
Device/procedure
✓✓ ✓page 132
Bone growth stimulators
✓✓ ✓ ✓page 124
Defibrillation/
cardioversion
✓ page 132
Dental drills and probes
✓✓ ✓page 133
✓✓ ✓page 122
✓✓ page 125
✓✓ page 132
Diathermy, therapeutic
Electrocautery
Electrolysis
Electromagnetic field
devices (eg, arc
welding, power stations)
✓ page 127
High-output ultrasonics
/lithotripsy
✓✓ page 136
Household items
See
guidelines
stimulation
Intermittent
Table 2 .1 Potential effects of EMI from devices or procedures (continued)
turns
Device
OFF or
in
increase
Momentary
Device
damage
patient
Serious
Device/procedure
ON
stimulation
✓ page 134
injury
Laser procedures
✓✓ ✓ ✓ ✓page 127
Magnetic resonance
✓✓✓✓page 135
✓ page 135
imaging (MRI)
Psychotherapeutic
procedures
Radiation therapy
37742 2004-08 English
✓ page 138
✓✓ ✓page 130
✓✓ ✓page 129
Radiofrequency (RF)/
microwave ablation
Therapeutic magnets
Theft detectors/security
devices
Important therapy information 2
27
Device
See
guidelines
stimulation
Intermittent
turns
OFF or
ON
28
in
increase
stimulation
Momentary
Device
damage
injury
patient
Serious
Important therapy information 2
Table 2 .1 Potential effects of EMI from devices or procedures (continued)
Device/procedure
English 37742 2004-08
✓✓ page 135
✓✓ ✓page 122
Therapeutic ultrasound
Transcutaneous
electrical nerve
stimulation (TENS)
Case damage – If the neurostimulator case
is ruptured or pierced due to outside forces,
severe burns could result from exposure to
the battery chemicals.
Neurostimulator interaction with cardiac
implantable devices – When a
neurostimulator and an implanted cardiac
device (eg, pacemaker, defibrillator) are
required, the doctors involved with both
devices (neurologist, neurosurgeon,
cardiologist, cardiac surgeon) should
discuss the possible interaction between the
devices before surgery. To minimize or
prevent device damage or interactions, your
doctors should place the devices on the
opposite side of the body from one another.
• Defibrillation therapy from the implanted
defibrillator can damage the
neurostimulator.
• The electrical pulses from the
neurostimulation system could affect the
sensing operation of the cardiac device
and result in inappropriate responses
from the cardiac device. Your doctor
37742 2004-08 English
Important therapy information 2
29
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