Page 1
Neurological
Medtronic Confidential
Title
Model 37742 Patient programmer: pain therapy
user manual
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accounted for. Information hereon is confidential. DO NOT
reproduce it, reveal it to unauthorized persons or send it
outside Medtronic without proper authorization.
Medtronic Confidential
Part No. Part No. Rev Comments
220907005 B Market release
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Writer
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Date
13 October 2004
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Form MEDN-0043 version 6.0
Page 2
PATIENT PROGRAMMER 37742
Pain therapy user manual
Rx only
2005
Page 3
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.
Page 4
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
Page 5
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
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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
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Contents
5
Page 7
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
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interference (EMI) 121
Contraindication 122
Warnings 124
Precautions 132
Notes 136
Glossary 139
Index 147
37742 2004-08 English
Contents
7
Page 9
Contents
8
English 37742 2004-08
Page 10
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
Page 11
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
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1 Introduction
Page 13
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
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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
Page 15
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
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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
Page 17
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
✓
✓
Page 18
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
Page 19
Introduction 1
18
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2 Important therapy
information
Page 21
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
Page 22
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
Page 23
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
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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
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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,
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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
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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
Page 28
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
Page 29
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)
Page 30
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
Page 31
should reprogram your neurostimulator to
a bipolar configuration and a minimum
rate of 60 Hz. The cardiac device should
be programmed to bipolar sensing.
Precautions
System and therapy
Clinician programmer interaction with a
cochlear implant – If you have a cochlear
implant, the external portion of the cochlear
system should be kept as far away as
possible from the clinician programmer or
the cochlear implant should be turned OFF
during programming to prevent unintended
audible clicks.
Clinician programmer interaction with
other active implanted devices – If you
have a neurostimulator and another active
implanted device, the radio-frequency signal
used to program either device can reset or
reprogram the other device, or the magnet in
a cardiac programmer can activate
magnetically controlled functions in the
Important therapy information 2
30
English 37742 2004-08
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neurostimulator. To verify that inadvertent
programming did not occur, clinicians
familiar with each device should check the
programmed settings before you are sent
home from the hospital and after either
device is programmed (or as soon as
possible after these times).
Contact your doctor immediately if you notice
symptoms that could be related to either
device or to the medical condition treated by
that device.
Component compatibility – For proper
therapy, use only Medtronic Neurological
components that are prescribed by your
physician.
Patient control devices – Do not place
patient control devices (eg, patient
programmer) over another device (eg,
pacemaker, defibrillator, another
neurostimulator). The patient control device
could accidently change the operation of
another device.
37742 2004-08 English
Important therapy information 2
31
Page 33
Patient device handling – To avo i d
damaging the device, do not immerse it in
liquid; do not clean it with bleach, nail polish
remover, mineral oil, or similar substances;
and do not drop it or mishandle it in a way
that may damage it.
Patient device use – When operating an
external neurostimulator, patient
programmer, or charging system, use
special care near flammable or explosive
atmospheres. An interaction between the
flammable or explosive atmospheres and the
battery in the device could occur. The
consequences of using a battery-powered
device near flammable or explosive
atmospheres are unknown.
Patient activities
Activities requiring excessive twisting or
stretching – Avoid activities that put undue
stress on the implanted components of your
neurostimulation system. Activities that
include sudden, excessive, or repetitive
Important therapy information 2
bending, twisting, bouncing, or stretching
32
English 37742 2004-08
Page 34
can cause parts of your neurostimulation
system to fracture or migrate. This can result
in a loss of stimulation, intermittent
stimulation, stimulation at the fracture site,
and additional surgery. Spinal cord
stimulation patients in particular should
avoid excessive bending of the torso.
Component manipulation – Do not
manipulate or rub your neurostimulation
system through the skin; this is sometimes
called “Twiddler’s Syndrome.” Manipulation
can cause damage to your system, lead
dislodgement, skin erosion, or stimulation at
the implant site. Manipulation may also flip
your device so that it can’t be charged.
37742 2004-08 English
Important therapy information 2
33
Page 35
Scuba diving or hyperbaric chambers –
Do not dive below 10 meters (33 feet) of
water or enter hyperbaric chambers above
2.0 atmospheres absolute (ATA). Pressures
below 10 meters (33 feet) of water or above
2.0 ATA can damage the neurostimulation
system. Before diving or using a hyperbaric
chamber, discuss the effects of high
pressure with your doctor.
Skydiving, skiing, or hiking in the
mountains – High altitudes should not affect
the neurostimulator; however, you should
consider the movements involved in any
planned activity and take care to not put
undue stress on your implanted
neurostimulation system. During skydiving,
the sudden jerking that occurs when the
parachute opens can dislodge or fracture the
lead, requiring additional surgery to repair or
replace the lead.
34
Unexpected changes in stimulation –
Electromagnetic interference, changes in
posture, and other activities can cause a
Important therapy information 2
perceived increase in stimulation, which
English 37742 2004-08
Page 36
some patients have described as
uncomfortable stimulation (a jolting or
shocking sensation). You should reduce your
amplitude to the lowest setting and turn OFF
your neurostimulator before engaging in
activities that could become unsafe for you
or others if you received an unexpected jolt
or shock (eg, driving, operating power tools).
Discuss these activities with your doctor.
Individualization of treatment
Patient management – Best results are
achieved when you are fully informed about
the therapy risks and benefits, surgical
procedure, follow-up requirements, and selfcare responsibilities. Maximum benefits from
the neurostimulation system require longterm postsurgical management.
Patient selection – The neurostimulation
system should not be implanted if:
• your symptoms are not of physiological
origin.
37742 2004-08 English
Important therapy information 2
35
Page 37
• you are not an appropriate candidate for
surgery.
• you cannot properly operate the system.
• you do not receive satisfactory results
from test stimulation.
Use in specific populations – The safety
and effectiveness of this therapy has not
been established for the following:
• Pregnancy, unborn fetus, or delivery
• Pediatric use (patients under the age
of 18)
36
Important therapy information 2
English 37742 2004-08
Page 38
3 Introduction to
stimulation
Page 39
How stimulation works
Nerve signals from all over
your body travel to your spinal
cord and then to your brain.
Your brain translates the
signals into sensations such
as pain.
Stimulation delivers electrical
pulses to the area where your
pain signals will be blocked as
they move to the brain (Figure 3.1).
38
Brain
translates
signal as pain
Signal
from foot
Figure 3.1 Stimulation blocks some of the pain
signals as they move to the brain.
Introduction to stimulation 3
English 37742 2004-08
Brain senses
pain and tingling
Neurostimulator
pulses sent to
brain
Page 40
Note: Stimulation will not cure your pain, nor
will it block sharp pain caused by a recent
injury.
To most patients, the pulses feel like a
steady, tingling sensation in the painful area
(Figure 3.2).
Area of stimulation Area of pain
Figure 3.2 Stimulation feels like tingling in the
area of pain.
Generally, people experience a fairly
constant sensation of stimulation. However,
you may feel changes when you suddenly
move or change position.
37742 2004-08 English
Introduction to stimulation 3
39
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Parts of your system
A typical neurostimulation system has
implanted parts that deliver the electrical
pulses to the area where your pain signals
are blocked. Typically the implanted parts
are: a neurostimulator, one or two leads, and
one or two extensions (optional) (Figure 3.3).
Neurostimulator
Extensions
40
Electrodes
Figure 3.3 Implanted parts of a typical
neurostimulation system.
A typical neurostimulation system also
includes external parts for controlling your
system: a patient programmer and a
charging system (Figure 3.4).
Introduction to stimulation 3
English 37742 2004-08
Leads
Page 42
Patient programmer
Detachable
antenna
(optional)
Carrying case
Figure 3.4 External parts of a typical
neurostimulation system.
Charging system
Neurostimulator – The neurostimulator is
the power source for your neurostimulation
system. It contains electronics that generate
the electrical pulses. During test stimulation,
an external neurostimulator is used to
determine whether an implanted
neurostimulator is the right choice for you.
The implanted Restore neurostimulator
contains a rechargeable battery.
Introduction to stimulation 3
37742 2004-08 English
41
Page 43
Lead(s) – A lead is a thin wire covered with
a protective coating. A lead has small metal
electrodes near the tip. The electrodes
transmit electrical pulses to the area where
your pain signals are blocked.
Extension(s) – An extension is a thin wire,
covered with a protective coating, that
connects the neurostimulator to a lead.
Patient programmer – A patient
programmer is a hand-held device that you
use to select and adjust your stimulation. A
detachable antenna is also available if you
have difficulty reaching the neurostimulator
implant site.
Charging system – The charging system is
used to charge the implanted
neurostimulator battery.
42
Introduction to stimulation 3
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Page 44
Understanding your therapy
Stimulation delivers electrical pulses to the
area where your pain signals will be blocked
as they travel to the brain. The electrical
pulses are made up of parameters called
amplitude, pulse width, and rate.
• Amplitude is the strength of the pulse. It
affects the stimulation strength or
coverage required to manage your pain.
• Pulse width is the duration of the pulse. It
affects the stimulation strength or
coverage required to manage your pain.
• Rate is the number of pulses delivered
per second. Rate feels like “tapping.”
A program delivers electrical pulses to a
specified pain site. Programs are combined
into “groups” to provide stimulation to one or
more pain sites.
A menu of groups can be designed to meet a
patient’s specific needs. Typically, each group
is designed for particular activities,
symptoms, or time of day.
37742 2004-08 English
Introduction to stimulation 3
43
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For example, Alex has pain in his low back
and right thigh. Typically, Alex’s pain doesn’t
vary; however, sometimes Alex has
additional pain in his right ankle. Alex’s
clinician designed two groups for Alex to
choose from. Group A is for Alex’s typical
pain; group B is for the additional ankle pain
(Figure 3.5). Alex chooses whichever group
he requires.
44
Group A
Low back and thigh pain
Program 1
Program 2
Figure 3.5 Example of programs and groups.
Introduction to stimulation 3
English 37742 2004-08
Group B
Low back, thigh and ankle pain
Program 1
Program 2
Program 3
Page 46
Controlling your stimulation
Your neurostimulator only accepts
programming from the clinician programmer
or patient programmer; other devices are not
able to program your neurostimulator.
What your clinician controls
Your clinician uses a clinician programmer to
communicate with your neurostimulator. Your
clinician designs programs and groups
according to your needs. Your clinician can
also specify the settings that you will be able
to adjust with your patient programmer.
Discuss this with your clinician.
What you control
As your activities vary throughout the day,
your therapy needs may change. The patient
programmer allows you to turn stimulation
ON and OFF, switch from one group to
another, and adjust the amplitude, pulse
width, or rate for each program in the active
37742 2004-08 English
Introduction to stimulation 3
45
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group. Talk to your clinician about the
settings that apply to your therapy.
Charging
It is critical that you charge your
neurostimulator battery before the battery is
overdischarged. Refer to the manual
packaged with the charging system for more
information.
Caution: Charge the neurostimulator
when you see a low battery ( ) screen on
the patient programmer or recharger; this
prevents the battery from overdischarging
(see glossary). If the neurostimulator battery
is allowed to overdischarge, charging is not
possible; however, the clinician may be able
to restore the battery function.
Allowing the neurostimulator battery to
overdischarge will permanently affect the
neurostimulator in one of the following ways:
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• Battery function is restored; however,
charging sessions may be more frequent
because battery capacity has been
reduced.
• Battery function is not restored and the
neurostimulator must be surgically
replaced. Battery function is not restored
because:
– The neurostimulator battery is
permanently damaged.
– The neurostimulator battery has been
overdischarged and restored twice
before. The third time the battery is
overdischarged, the neurostimulator will
reach end of service. Surgery is
required to replace the neurostimulator.
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Recovery and care
Recovering from surgery
It takes several weeks to heal from surgery. It
is normal to feel some discomfort from the
incision(s) and to have some pain at the
implant site for 2 to 6 weeks.
Your doctor may also prescribe physical
therapy or medication to help manage your
pain. Always follow your doctor’s instructions.
Activities
Some movements can cause changes in
stimulation. For example, leaning back may
cause the lead to move closer to your spinal
cord; this can increase the sensation of
stimulation. Other movements may cause the
lead to move further away from your spinal
cord and decrease the stimulation sensation.
Sudden changes in stimulation are most
common during recovery.
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• Avoid activities where you must bend,
stretch, or twist your body; these
movements can move your leads which
affects your stimulation.
• Avoid lying on your stomach.
• Avoid reaching over your head.
• Avoid turning from side to side.
• Avoid bending forward, backward, or from
side to side.
• Avoid lifting more than 2 kilograms
(5 pounds).
As you begin to feel better, you should be
able to perform activities such as:
• Bathing or showering
• Sexual activity
• Working at home or at your business
• Hobbies or activities, such as walking,
gardening, cycling, or swimming
• Traveling
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Remember, returning to your daily activities
should make you feel better, not worse.
Note: As you adjust to life with better pain
management, you may want to try activities
that you could not perform before your
surgery. Discuss your activity level with your
doctor.
When to call your clinician
Contact your clinician if any of the following
events occur:
• You have pain, redness, or swelling at the
incision(s) later than 6 weeks after
surgery.
• You feel discomfort or pain during
stimulation. Turn your neurostimulator
OFF and call your doctor.
• Your system is not working properly.
50
• You cannot turn the neurostimulator ON
or OFF.
• You cannot adjust stimulation using your
Introduction to stimulation 3
patient programmer.
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Care schedule
Your clinician will schedule follow-up visits to
make sure you are receiving the most
appropriate therapy.
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4 Using your patient
programmer
Page 55
How the patient programmer works
The patient programmer
communicates with your
neurostimulator by sending
signals to and receiving
signals from the
neurostimulator. To send and
receive the signals, the
internal antenna of the
programmer must be placed
over the neurostimulator
(Figure 4.1).
Notes:
• The internal antenna is on the back of the
programmer.
• The programmer screen must face
outward.
54
• A detachable antenna is available for
patients who have difficulty reaching their
neurostimulator (refer to page 91).
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Patient programmer
Neurostimulator
Internal antenna
Figure 4.1 Place the patient programmer over
the neurostimulator.
The patient programmer is used to:
• turn the neurostimulator ON or OFF.
• change stimulation settings.
Synchronizing and displaying the THERAPY screen
Synchronizing sends the settings from your
neurostimulator to the patient programmer.
All communication with the neurostimulator
begins with synchronization.
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• To synchronize your neurostimulator and
the patient programmer, hold the
programmer over your neurostimulator
and press one of the three keys shown in
Figure 4.2.
Note: Using the NEUROSTIMULATOR ON key to
synchronize also turns On the
neurostimulator. Using the NEUROSTIMULATOR
OFF key to synchronize also turns Off the
neurostimulator.
NEUROSTIMULATOR ON
NEUROSTIMULATOR OFF
SYNC
Figure 4.2 Synchronizing your neurostimulator
and patient programmer.
56
After synchronizing, the THERAPY screen
appears (Figure 4.3).
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Status row
Group row
Parameter row
Figure 4.3 T
HERAPY screen.
Icons on the THERAPY screen indicate your
neurostimulator settings and the battery level
of your neurostimulator and patient
programmer (Table 4.1).
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Table 4.1 T
HERAPY screen icons
Row Icons Description
Status Neurostimulator is ON
(Implanted or external
neurostimulator)
Neurostimulator is OFF
(Implanted or external
neurostimulator)
Implanted neurostimulator
battery charge level
External neurostimulator
battery level
Programmer battery level
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a
Group
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Active
Not active
Group name
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Table 4 .1 THERAPY screen icons (continued)
Row Icons Description
Parameter
a
If only one group is available, this row is blank.
b
If you cannot change any parameters, this row is
blank.
b
Amplitude
Pulse width
Rate
If your clinician programmed therapy to occur
at a specific time, the scheduled therapy ( )
icon is shown in the Group row (Figure 4.4).
Your clinician may also schedule a time for
stimulation to be stopped (eg, when you
sleep).
Note: Whether scheduled therapy is active or
stopped, you can turn stimulation ON or OFF.
An example of scheduled therapy is provided
in Figure 4.4 The screens and timetable
display the following:
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• Group B is active most of the day and
stimulation is ON
• Stimulation is stopped during sleep
Stimulation is
stopped
Group B is active
Figure 4.4 Example of scheduled therapy.
Checking the external neurostimulator battery
Check the external neurostimulator battery
level every day.
• To check the external neurostimulator
battery level, hold the patient programmer
over your neurostimulator and press the
SYNC key. The THERAPY screen
appears displaying the external
neurostimulator battery level (Figure 4.5).
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Battery level
Replace
batteries
Figure 4.5 External neurostimulator battery
status on the T
HERAPY screen.
Full
When the batteries are low, replace the
batteries as described in the external
neurostimulator patient guide.
Screens indicating that the external
neurostimulator batteries need immediate
replacement are described in Table 5.1 and
Ta bl e 5 .3 .
Checking the implanted neurostimulator battery
Check the implanted neurostimulator battery
charge level every day.
• To check the implanted neurostimulator
battery charge level, hold the patient
programmer over your neurostimulator
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with the screen facing outward and press
the SYNC key. The THERAPY screen
appears displaying the implanted
neurostimulator battery level (Figure 4.6).
Caution: Charge the neurostimulator
when you see a low battery ( ) screen on
the patient programmer or recharger; this
prevents the battery from overdischarging
(see glossary). If the neurostimulator battery
is allowed to overdischarge, charging is not
possible; however, the clinician may be able
to restore the battery function.
Allowing the neurostimulator battery to
overdischarge will permanently affect the
neurostimulator in one of the following ways:
• Battery function is restored; however,
charging sessions may be more frequent
because battery capacity has been
reduced.
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• Battery function is not restored and the
neurostimulator must be surgically
replaced. Battery function is not restored
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because:
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– The neurostimulator battery is
permanently damaged.
– The neurostimulator battery has been
overdischarged and restored twice
before. The third time the battery is
overdischarged, the neurostimulator will
reach end of service. Surgery is
required to replace the neurostimulator.
Battery charge level
Charge
neurostimulator
Figure 4.6 Implanted neurostimulator charge
level on the T
HERAPY screen.
Full
When the neurostimulator battery charge
level is low, charge the battery as described
in the manual packaged with the charging
system. Your implanted neurostimulator
battery can be charged many times; however,
eventually the neurostimulator will need to be
replaced.
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If the implanted neurostimulator needs
immediate charging, you will see one of the
screens shown on Table 4.2.
Table 4 .2 Neurostimulator battery screens
The implanted neurostimulator
battery charge level is low and
stimulation will not be available
soon.
Charge your implanted
neurostimulator battery. Refer
to the manual packaged with
the charging system.
Press any arrow on the
N
AVIGATOR key to clear this
message from the screen.
The neurostimulator battery
charge level is low and
stimulation has stopped.
Charge the neurostimulator
battery now. Refer to the
manual packaged with the
charging system.
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Table 4 .2 Neurostimulator battery screens
(continued)
Caution: Charge the neurostimulator when you
see a low battery ( ) screen on the patient
programmer or recharger; this prevents the battery
from overdischarging (see glossary). If the
neurostimulator battery is allowed to overdischarge,
charging is not possible; however, the clinician may
be able to restore the battery function.
Allowing the neurostimulator battery to
overdischarge will permanently affect the
neurostimulator in one of the following ways:
• Battery function is restored; however, charging
sessions may be more frequent because battery
capacity has been reduced.
• Battery function is not restored and the
neurostimulator must be surgically replaced.
Battery function is not restored because:
- The neurostimulator battery is permanently
damaged.
- The neurostimulator battery has been
overdischarged and restored twice before. The
third time the battery is overdischarged, the
neurostimulator will reach end of service.
Surgery is required to replace the
neurostimulator.
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Guidelines for adjusting your stimulation
To receive the most effective therapy, some
days you may need to adjust your stimulation
several times; other days you may not need
to adjust it at all. Your clinician will provide
complete guidelines about when you may
want to adjust your stimulation. Table 4.3
provides general guidelines for adjusting your
stimulation.
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Table 4 .3 Stimulation adjustment
guidelines
Situation Action
Stimulation is too
strong
Stimulation is not
strong enough
Stimulation covers too
much area
Stimulation does not
cover painful area
The pulses
(tapping sensations)
feel too slow
The pulses
(tapping sensations)
feel too fast
Decrease amplitude(s) or
pulse width(s)
Increase amplitude(s) or
pulse width(s)
Decrease amplitude(s) or
pulse width(s) or change to
a different group
Increase amplitude(s) or
pulse width(s) or change to
a different group
Increase rate
Decrease rate
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Table 4 .3 Stimulation adjustment
guidelines (continued)
Situation Action
You have unexpected
changes in stimulation
You have tried
adjusting stimulation
but are unable to find
an effective setting.
You will be passing
through a theft detector
or security device
You will be using
potentially dangerous
equipment
You will be having a
medical procedure
Using your patient programmer 4
1. Turn OFF the
neurostimulator.
2. Decrease amplitude(s),
turn ON the
neurostimulator, adjust
parameters, and slowly
increase amplitude(s) to
the desired level.
or
Change to a different
group and turn ON the
neurostimulator.
Contact your clinician.
Before engaging in these
activities, consult
“Appendix A:
Electromagnetic
Interference (EMI),” for
details.
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Turning your neurostimulator ON or OFF
1. Hold the programmer over your
neurostimulator with the programmer
screen facing outward and press the
NEUROSTIMULATOR ON or
NEUROSTIMULATOR OFF key
(Figure 4.7). The THERAPY screen
appears.
2. Verify that the appropriate ON or OFF
icon is displayed on the THERAPY screen
(Figure 4.7).
ON
OFF
Figure 4.7 Turning your neurostimulator ON or
OFF.
Caution: To prevent possible
uncomfortable or unexpected stimulation
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(jolting or shocking sensation) when
stimulation is turned ON, decrease all
amplitudes to the lowest setting before
adjusting the pulse width or rate and after
turning OFF the neurostimulator.
3. If you have turned the neurostimulator
OFF, decrease the program amplitudes to
the lowest setting. For instructions, see
“Increasing or decreasing a parameter
(amplitude, pulse width, or rate)” on
page 75.
Note: When you turn your neurostimulator
ON or OFF, the patient programmer and
neurostimulator are synchronized.
Adjusting stimulation settings
There is often more than one way to change
stimulation settings. These instructions
describe the most common ways.
70
Notes:
• Ask your clinician to print a report with
your programmed settings.
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• When a stimulation setting is changed,
you will see the change on the THERAPY
screen.
• If audio is ON, you will hear one tone that
means the change was effective. Three
rapid tones mean the change did not
occur.
Using the NAVIGATOR key
The NAVIGATOR key arrows move the
selection box on the THERAPY screen
(Figure 4.8).
Figure 4.8 NAVIGATOR key.
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• To move the selection box between rows
press the up and down arrows on
the NAVIGATOR key.
• To move the selection box across a row
that continues, press the left and
right arrows on the NAVIGATOR key.
• When moving the selection box with the
NAVIGATOR key, you do not need to hold
the programmer over your
neurostimulator. However, you must hold
the programmer over your
neurostimulator when pressing all other
keys except the power key.
A row continues when the OPTIONS icon is
displayed at the end of a row (Figure 4.9).
72
Selection box
Figure 4.9 The OPTIONS icon and selection box.
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Options icon
Page 74
Changing a group
1. Hold the patient programmer over your
neurostimulator with the screen facing
outward and press the SYNC key. The
THERAPY screen appears.
2. Press the up arrow on the NAVIGATOR
key to move the selection box to the
Group row (Figure 4.10).
Group row
Figure 4.10 Group row.
3. Press the left or right arrows on the
NAVIGATOR key to move the selection box
to the desired group (Figure 4.11).
Caution: Select the group that your
clinician has recommended for the current
activity or posture. Use of another group
may result in uncomfortable or unexpected
stimulation (jolting or shocking sensation)
when stimulation is turned ON.
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Figure 4.11 Move to a new group.
4. Hold the programmer over your
neurostimulator and press the
SYNC key to send the change to your
neurostimulator (Figure 4.12).
5. Verify that the new group is active on
the THERAPY screen (Figure 4.12).
Figure 4.12 Active group.
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Increasing or decreasing a parameter (amplitude, pulse width, or rate)
Notes:
• To increase a parameter, the
neurostimulator must be ON.
• To decrease a parameter, the
neurostimulator may be ON or OFF.
1. Hold the patient programmer over your
neurostimulator with the screen facing
outward and press the NEUROSTIMULATOR
ON , NEUROSTIMULATOR OFF , or
SYNC key. The THERAPY screen
appears.
Caution: To prevent possible
uncomfortable or unexpected stimulation
(jolting or shocking sensation) when
stimulation is turned ON, decrease all
amplitudes to the lowest setting before
adjusting the pulse width or rate and after
turning OFF the neurostimulator.
Note: To change a parameter, it must be in
a group that is active .
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2. Press the left or right arrow on the
NAVIGATOR key to move the selection box
to the desired parameter (Figure 4.13).
Parameter row
Figure 4.13 Move to parameter row.
Notes:
– If there is more than one program, scroll
to the right to display the amplitude
( ) for each program, followed by
the pulse width ( ) for each
program, and then the rate ( ).
(Scrolling to the left reverses the order.)
– The rate is the same for all programs
within a group.
3. Hold the programmer over your
neurostimulator and press the
NCREASE or DECREASE key as
I
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needed (Figure 4.14). The increase or
decrease occurs immediately and is
saved in the neurostimulator.
DECREASE INCREASE
Figure 4.14 DECREASE and INCREASE keys.
Notes:
– Pressing and holding the INCREASE
or DECREASE key changes the
value every half-second.
– If one of the information screens in
Table 4.4 is displayed, you tried to
increase or decrease the value beyond
the available limits programmed by your
clinician.
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Lower
limit
Table 4 .4 Parameter limit screens
You tried to decrease
a parameter
(amplitude, pulse
width, or rate) below
the lowest value
allowed.
Press any arrow on
the Navigator key
to clear the screen.
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Upper
limit
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You tried to increase
a parameter
(amplitude, pulse
width, or rate) above
the highest value
allowed.
Press any arrow on
the Navigator key
to clear the screen.
Page 80
Patient programmer batteries
Always keep two new AAA alkaline batteries
available for replacement. New batteries
provide about two months use, depending
upon how often the programmer is used.
Caution: If the device will not be used for
several weeks, remove the batteries from the
device. A battery left in the device may
corrode, causing damage to the electronic
components.
Checking patient programmer batteries
The patient programmer battery level is
displayed on the THERAPY screen
(Figure 4.15).
• To check the programmer battery level,
hold the patient programmer over your
neurostimulator and press the SYNC
key. The T
displaying the programmer battery level
(Figure 4.15).
HERAPY screen appears
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Battery level
Replace
batteries
Figure 4.15 Patient programmer battery level.
If the programmer batteries need immediate
replacement, one of the screens shown in
Table 4.5 appears.
Table 4 .5 Patient programmer battery
replacement screens
The patient programmer batteries
are low. You can finish
programming.
Press any arrow on the Navigator
key to clear the screen; then
continue programming. Replace
the programmer batteries before
the batteries become depleted.
The programmer batteries are
depleted. Programming is not
possible.
Replace the programmer batteries
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now.
Full
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Replacing patient programmer batteries
1. Open the battery compartment cover
(Figure 4.16).
Figure 4.16 Opening the battery cover.
2. Remove the depleted batteries.
3. Insert the new batteries as shown on the
battery compartment label.
4. Close the battery compartment cover.
5. Dispose of old batteries according to
local requirements.
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Summary of keys
DECREASE
NEUROSTIMULATOR ON
NEUROSTIMULATOR OFF
SYNC
NAVIGATOR
Figure 4.17 Patient programmer keys.
INCREASE
POWER/
BACKLIGHT
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Table 4 .6 Summary of keys
Key Function
Turns the neurostimulator ON or
OFF .
ON
OFF
• The programmer must be held over
the neurostimulator while pressing
the N
key.
• Pressing either of these keys also
automatically synchronizes the
neurostimulator and programmer
and displays the T
Synchronizes the neurostimulator
and programmer.
Activates a selected group.
The programmer must be held over the
neurostimulator while pressing the
S
YNC key.
EUROSTIMULATOR ON or OFF
HERAPY screen.
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Table 4.6 Summary of keys (continued)
Key Function
Decreases or increases a
parameter.
Decrease
Increase
• The programmer must be held over
the neurostimulator while pressing
the I
NCREASE or DECREASE
key.
• Pressing and holding the I
or D
ECREASE key changes
the parameter every half-second.
• To increase a parameter, the
neurostimulator must be turned ON.
Moves the selection box on the
T
HERAPY screen.
The O
PTIONS icon at the end of a
row on the T
HERAPY screen indicates
that the row continues.
Turns the patient programmer power
ON and OFF.
Pressing and holding this key also
turns the backlight
ON and OFF. The
backlight provides more light to the
display.
NCREASE
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Preferences: Changing the audio, contrast, time, and time/ number format
Programmer preferences are accessed from
the Status row of the THERAPY screen.
Table 4.7 lists the preference icons.
Table 4 .7 Preference icons
Icons Preference
Audio
Contrast
Time
Time and number format
1. Hold the patient programmer over your
neurostimulator with the screen facing
outward and press the SYNC key. The
THERAPY screen appears.
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2. Press the up arrow on the NAVIGATOR
key to move the selection box to the
Status row (Figure 4.18).
Status row
Figure 4.18 Preferences are accessed from the
Status row.
3. Press the left or right arrow on the
NAVIGATOR key to move the selection box
to the desired preference (Figure 4.19).
Desired preference
Figure 4.19 Move to desired preference.
4. Press the down arrow to move the
selection box to the Change row
(Figure 4.20).
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Change row
Figure 4.20 Move to Change row.
5. Follow the steps in Table 4.8 to change
the selected preference.
Table 4.8 Changing preferences
Audio
1. Press the left or right
arrow on the N
move the selection box to
audio ON or OFF .
2. Go to step 6, page 89.
Contrast
1. Press the left or right
arrow on the N
make the contrast lighter or
darker .
2. Go to step 6, page 89.
AVIGATOR key to
AVIGATOR key to
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Table 4 .8 Changing preferences (continued)
Time
1. Press the left or right
arrow on the N
move the selection box to the
hour, minutes, or time of day
(A or P).
2. Press the I
D
ECREASE key to change
the selection.
3. Press the up arrow on the
Navigator key to return the
selection box to the Status
row.
4. Press the left or right
arrow on the N
return to the T
5. Press the S
send the change to your
neurostimulator.
6. To verify the time change,
repeat steps 2 and 3 on
page 86 to return to the time
preference screen.
AVIGATOR key to
NCREASE or
AVIGATOR key to
HERAPY screen.
YNC key to
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Table 4 .8 Changing preferences (continued)
Time and number format
1. Press the left or right
3.50
arrow on the N
move the selection box to a
12-hour clock and numbers
with decimals or with a
24-hour clock and numbers
with commas.
2. Go to step 6, page 89.
AVIGATOR key to
6. When the change is displayed on the
screen, move the selection box to the
Status (top) row. This saves the change
in the patient programmer.
7. Press the left or right arrow on the
NAVIGATOR key to move to another
preference or return to the THERAPY
screen.
Using the carrying case and labeling the patient programmer
The carrying case has a pouch to hold the
patient programmer and the quick reference
guide (Figure 4.21).
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The case also has a loop on the back that
attaches to a belt.
Figure 4.21 Insert the programmer into the case.
Place an identification label on the back of
your patient programmer in case the
programmer is lost (Figure 4.22).
ID label
Figure 4.22 Place the adhesive label on the
back of the programmer.
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Optional detachable antenna
The detachable antenna is available if you
have difficulty reaching the neurostimulator. It
is also useful for viewing the patient
programmer screen while you are adjusting
stimulation.
Connecting the antenna
1. Place the antenna over your
neurostimulator (Figure 4.23).
Figure 4.23 Place the antenna over your
neurostimulator.
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2. Pull the fabric of your clothing through
the large opening in the antenna. Then,
wedge the fabric in the narrow slit to
secure the antenna in place
(Figure 4.24).
b
a
Figure 4.24 Pull the fabric through the slit (a)
and wedge in place (b).
3. Push the antenna plug firmly into the
antenna jack ( ) on the patient
programmer (Figure 4.25).
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Figure 4.25 Insert the antenna plug into the
antenna jack.
Using the antenna
After the antenna is connected, follow the
instructions for using the patient programmer.
When you have finished using the patient
programmer, grasp the antenna plug and pull
it out.
Caution: Do not pull directly on the
antenna cable to disconnect the cable from
the programmer because this may damage
the antenna cable.
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5 Troubleshooting
Page 97
This chapter will help you
solve problems with your
programmer. It also provides
information on when to call
your clinician.
Note: If you cannot solve a
problem or if your problem is
not described here, contact
your clinician.
Programmer screens
The programmer displays
warning ( ), communication ( ), and
information ( ) screens to provide you with
information about your system, alert you to a
problem with your system, or to guide you
during programmer use.
Warning screens
96
Warning screens indicate a problem with the
programmer, the antenna, or the
neurostimulator. If the audio is ON, three
tones alert you to the message. Table 5.1
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describes warning screens and provides
instructions (see blue text) on how to resolve
the problem and clear the screen.
Screen Cause and action
Synchronize
programmer and
neurostimulator
Table 5 .1 Warning screens
The programmer and the
neurostimulator must be
synchronized.
Synchronize the programmer
and neurostimulator.
Replace the
external
neurostimulator
batteries
Replace the
programmer
batteries
The external neurostimulator
batteries are depleted and
stimulation is not available.
Replace the external
neurostimulator batteries now.
Refer to the manual packaged
with the external
neurostimulator.
The programmer batteries are
depleted. Programming is not
possible.
Replace the programmer
batteries now.
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Table 5 .1 Warning screens (continued)
Screen Cause and action
Charge the
implanted
neurostimulator
battery
Caution: Charge the neurostimulator when you
see a low battery ( ) screen on the patient
programmer or recharger; this prevents the battery
from overdischarging (see glossary). If the
neurostimulator battery is allowed to overdischarge,
charging is not possible; however, the clinician may
be able to restore the battery function.
Allowing the neurostimulator battery to
overdischarge will permanently affect the
neurostimulator in one of the following ways:
• Battery function is restored; however, charging
sessions may be more frequent because battery
capacity has been reduced.
• Battery function is not restored and the
neurostimulator must be surgically replaced.
Battery function is not restored because:
The neurostimulator battery
charge level is low and
stimulation has stopped.
Charge the neurostimulator
battery now. Refer to the
manual packaged with the
charging system.
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Table 5 .1 Warning screens (continued)
Screen Cause and action
- The neurostimulator battery is permanently
damaged.
- The neurostimulator battery has been
overdischarged and restored twice before. The
third time the battery is overdischarged, the
neurostimulator will reach end of service.
Surgery is required to replace the
neurostimulator.
Call doctor The system is not working
correctly. Stimulation may have
stopped.
Error codes 0 to 250: Remove
batteries from the patient
programmer, wait several
seconds, then re-insert the
batteries. If the error message
appears again, call your
doctor.
Other codes: Write down the
code shown on the screen.
Call your doctor.
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