Medtronic 37741 Patient Programmer User Manual 7439

Download:
Mirror Download [FCC.gov]
Document ID	535326
Application ID	ZC9LPOlOdhpcr9mVUqXFyg==
Document Description	7439 Users Manual
Short Term Confidential	No
Permanent Confidential	No
Supercede	No
Document Type	User Manual
Display Format	Adobe Acrobat PDF - pdf
Filesize	138.09kB (1726142 bits)
Date Submitted	2005-04-22 00:00:00
Date Available	2005-04-22 00:00:00
Creation Date	2004-10-13 09:25:12
Producing Software	Acrobat Distiller 5.0.5 (Windows)
Document Lastmod	2005-04-20 18:46:12
Document Title	7439.book
Document Creator	FrameMaker 7.0
Document Author:	dahlk1

Neurological
Medtronic Confidential
Title
Model 7439 Patient Programmer User Manual Global
Medtronic Confidential
This Document is the Property of Medtronic, Inc. and must be
accounted for. Information hereon is confidential. DO NOT
reproduce it, reveal it to unauthorized persons or send it
outside Medtronic without proper authorization.
Part No.
Writer
Part No. Rev
221244001
Date
11/03/04
Theresa King-Hunter
Comments
Release for translation
DO NOT PRINT THIS FORM WHEN PRINTING THE LITERATURE PIECE.
DO NOT COUNT THIS FORM IN THE LITERATURE PIECE PAGE COUNT.
REVISION HISTORY: SEE PDM WEBSITE FOR INFORMATION.
1. Materials:
Covers
•
Grade #1, 80 lb. white gloss coated cover stock, minimum brightness level: 89
Text
•
60 lb. white smooth opaque text stock
Labels
•
N/A
2. Colors: To confirm all colors, graphics and text, refer to electronic file
Front Cover
•
4-color cover and solid gloss varnish
Back Cover
•
Black text and graphics; solid gloss varnish
Body
•
2-color text and graphics (PMS 301, black, percentages of PMS 301 or percentages
of black)
Labels
•
N/A
3. Size:
4.6″ ± 0.2 (w) x 6.0″ ± 0.2 (h)
4. Type of Binding:
Clear plastic coil, MWE lay-flat, or perfect bound
5. Other:
•
Cover and text whiteness must match visually.
6. Literature Piece Page Count (Including covers, excluding this form):
136
7. Note to print supplier: Supplier may add up to three blank pages at the end of the
document before the back cover sheet as needed. If more are required, contact the
purchasing agent.
8. Vendor-supplied information may appear at an appropriate location on the literature
piece (eg, part number, bar code, etc.).
9. Graphics Content and Layout to be as shown and per Medtronic electronic file that is
supplied (stored) by Medtronic Neuro.
Page 1
Form MEDN-0043 version 7.0
Medtronic Confidential
NeuroPatntR00
7439_FC.fm 10/13/04 9:26 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
PATIENT PROGRAMMER
Pain therapy user manual
c Rx only
221244001
Rev X
7439
2004
Printing instructions:
7439_FC.fm 10/13/04 9:27 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Medtronic Confidential
NeuroPatntR00
The following are trademarks of Medtronic, Inc.: Medtronic®,
MyStim™, SoftStart™, Synergy Plus+™, Synergy Compact+™,
and Synergy®.
c FCC Information
The following is communications regulation information on
the Model 7439 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.
221244001
Rev X
Printing instructions:
Medtronic Confidential
NeuroPatntR00
7439TOC.fm 10/13/04 9:27 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Contents
Label symbols
1 Introduction
A company dedicated to patients 10
How to use this manual 11
Patient guides 13
Patient identification card 14
2 Important therapy information
15
Purpose of the neurostimulation system
(indications) 16
Therapies that may not be used with the
neurostimulation system
(contraindications) 16
Risks and benefits 17
18
Warnings 19
Precautions 26
System and therapy 26
7439 2004-08 English
221244001
Rev X
Printing instructions:
Contents
Risks of surgery 17
Possible adverse effects 18
Changes in therapy 18
Possible system complications
Medtronic Confidential
NeuroPatntR00
7439TOC.fm 10/13/04 9:27 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Patient activities
29
Individualization of treatment 31
3 Introduction to stimulation
33
How stimulation works 34
Parts of your system 36
Understanding your therapy 38
Controlling your stimulation 40
What your clinician controls 40
What you control 40
Recovery and care 41
Recovering from surgery 41
Activities 41
When to call your clinician 43
Care schedule 44
Contents
4 Using your patient programmer
221244001
45
How the patient programmer works 46
Synchronizing and displaying the THERAPY
screen 48
Guidelines for adjusting your stimulation 53
Turning your neurostimulator ON or
OFF 55
English 7439 2004-08
Rev X
Printing instructions:
Medtronic Confidential
NeuroPatntR00
7439TOC.fm 10/13/04 9:27 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Adjusting stimulation settings 57
Using the NAVIGATOR key 58
Changing a group 59
Increasing or decreasing a parameter
(amplitude, pulse width, or rate) 62
Patient programmer batteries 66
Checking patient programmer
batteries 66
Replacing patient programmer
batteries 68
Summary of keys 69
Preferences: Changing the audio, contrast,
and number format 72
Using the carrying case and labeling the
patient programmer 75
Optional detachable antenna 76
Connecting the antenna
Using the antenna 78
79
Programmer screens 80
Warning screens 80
Communication screen
82
7439 2004-08 English
221244001
Rev X
Printing instructions:
Contents
5 Troubleshooting
76
Medtronic Confidential
NeuroPatntR00
7439TOC.fm 10/13/04 9:27 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Information screens
83
Possible problems and solutions 88
User assistance 95
6 Maintenance
97
Cleaning and care 98
Safety and technical checks 100
Battery and programmer disposal 101
Neurostimulator disposal 101
Declaration of conformity 102
Specifications 103
7 Appendix A: Electromagnetic
interference (EMI) 105
Contraindication 106
Warnings 108
Precautions 116
Notes 120
Contents
Glossary
221244001
Index
123
129
English 7439 2004-08
Rev X
Printing instructions:
Medtronic Confidential
NeuroPatntR00
7439_Sym.fm 10/13/04 9:27 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Label symbols
Explanation of symbols on products and
packaging. Refer to the appropriate product
to see symbols that apply.
CE Conformité Européenne
0123 (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.
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
Label symbols
7439 2004-08 English
221244001
Rev X
Printing instructions:
Medtronic Confidential
NeuroPatntR00
7439_Sym.fm 10/13/04 9:27 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Storage temperature
Relative humidity
Atmospheric pressure
IEC 60601-1/EN60601-1, Type BF
Equipment
Non-ionizing electromagnetic radiation
Screen light
Antenna jack
Label symbols
221244001
For USA audience only
The Medtronic Model 7439 Patient
Programmer is designed to program the
adjustable settings of the Medtronic Model
7479 Synergy Plus+ and Model 7479B
Synergy Compact+ neurostimulators.
English 7439 2004-08
Rev X
Printing instructions:
7439_Ch01.fm 10/13/04 9:27 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Medtronic Confidential
NeuroPatntR00
1 Introduction
221244001
Rev X
Printing instructions:
Medtronic Confidential
NeuroPatntR00
7439_Ch01.fm 10/13/04 9:27 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
A company dedicated
to patients
Introduction 1
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
10
English 7439 2004-08
221244001
Rev X
Printing instructions:
Medtronic Confidential
NeuroPatntR00
7439_Ch01.fm 10/13/04 9:27 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
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 after receiving an implanted
neurostimulator. Ask your clinician to explain
anything that is unclear.
• Chapter 2, “Important therapy
information,” describes when you should
and should not use a neurostimulation
7439 2004-08 English
221244001
Rev X
Printing instructions:
Introduction 1
• Chapter 1, “Introduction,” describes the
patient documents your clinician should
have provided to you.
11
7439_Ch01.fm 10/13/04 9:27 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Medtronic Confidential
NeuroPatntR00
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.
Introduction 1
• Chapter 6, “Maintenance,” describes how
to care for your patient programmer and
system specifications.
12
221244001
• Appendix A provides more information
about electromagnetic interference.
• A glossary is included at the end of this
manual.
English 7439 2004-08
Rev X
Printing instructions:
7439_Ch01.fm 10/13/04 9:27 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Medtronic Confidential
NeuroPatntR00
Patient guides
You should receive the following documents
after a neurostimulator is implanted.
• Medtronic Model 7439 Patient
Programmer Quick Reference Guide:
provides instructions for common patient
programmer tasks.
• The Patient Identification Card: provides
information about you, your
neurostimulator, and your doctor.
Introduction 1
• Medtronic Model 7439 Patient
Programmer Pain Therapy User Manual.
7439 2004-08 English
221244001
Rev X
Printing instructions:
13
Medtronic Confidential
NeuroPatntR00
7439_Ch01.fm 10/13/04 9:27 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
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.
Introduction 1
c 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.
14
221244001
English 7439 2004-08
Rev X
Printing instructions:
7439_Ch02.fm 10/13/04 9:27 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Medtronic Confidential
NeuroPatntR00
2 Important therapy
information
221244001
Rev X
Printing instructions:
Medtronic Confidential
NeuroPatntR00
7439_Ch02.fm 10/13/04 9:27 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Purpose of the
neurostimulation
system (indications)
Important therapy information 2
Refer to the indications sheet
that is packaged with the
patient programmer for the
purpose of the
neurostimulation system and
related information.
16
221244001
Therapies that may
not be used with the
neurostimulation system
(contraindications)
Diathermy – Inform anyone treating you that
you CANNOT have any shortwave diathermy,
microwave diathermy or therapeutic
ultrasound diathermy (all now referred to as
diathermy) anywhere on your body because
you have an implanted neurostimulation
system. Energy from diathermy can be
transferred through your implanted system,
English 7439 2004-08
Rev X
Printing instructions:
Medtronic Confidential
NeuroPatntR00
7439_Ch02.fm 10/13/04 9:27 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
and can cause tissue damage, resulting in
severe injury or death. Refer to “Appendix A:
Electromagnetic interference (EMI)” on
page 105 for more information.
Risks and benefits
Risks of surgery
Implanting a neurostimulation system has
risks similar to spinal procedures, including
spinal fluid leak, headaches, swelling,
bruising, bleeding, infection, or paralysis.
If you are on anticoagulation therapy you
might be at greater risk for postoperative
7439 2004-08 English
221244001
Rev X
Printing instructions:
Important therapy information 2
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.
17
Medtronic Confidential
NeuroPatntR00
7439_Ch02.fm 10/13/04 9:27 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
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.
Important therapy information 2
Changes in therapy
18
221244001
Over time there could be changes in the level
of your symptom control. In most cases your
doctor can correct these changes without
surgery.
Possible system complications
The lead, extension, or neurostimulator could
migrate within the body or erode through the
skin. There could be undesirable changes in
stimulation, possibly related to cellular
changes around the electrode(s), changes in
English 7439 2004-08
Rev X
Printing instructions:
7439_Ch02.fm 10/13/04 9:27 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Medtronic Confidential
NeuroPatntR00
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.
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
affect the operation of a neurostimulator.
7439 2004-08 English
221244001
Rev X
Printing instructions:
Important therapy information 2
Warnings
19
7439_Ch02.fm 10/13/04 9:27 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Medtronic Confidential
NeuroPatntR00
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.
Important therapy information 2
• System damage, resulting in a loss of or
change in symptom control and requiring
additional surgery.
20
221244001
• 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.
• Unexpected changes in stimulation,
causing a momentary increase in
stimulation or intermittent stimulation,
which some patients have described as a
English 7439 2004-08
Rev X
Printing instructions:
7439_Ch02.fm 10/13/04 9:28 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Medtronic Confidential
NeuroPatntR00
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.
Important therapy information 2
Refer to Table 2.1, on page 22, and
“Appendix A: Electromagnetic interference
(EMI)” on page 105 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.
7439 2004-08 English
221244001
Rev X
Printing instructions:
21
22
221244001
Rev X
English 7439 2004-08
Printing instructions:
Household items
High-output ultrasonics
/lithotripsy
Electromagnetic field
devices (eg, arc
welding, power stations)
✓
✓
✓
✓
✓
Electrocautery
Electrolysis
✓
✓
✓
✓
✓
✓
✓
✓
Momentary
increase
in
stimulation
Device
damage
✓
✓
Serious
patient
injury
Diathermy, therapeutic
Dental drills and probes
Defibrillation/
cardioversion
Bone growth stimulators
Device/procedure
✓
✓
Device
turns
OFF or
ON
✓
✓
✓
✓
Intermittent
stimulation
page 120
page 111
page 117
page 116
page 109
page 106
page 116
page 108
page 116
See
guidelines
Table 2.1 Potential effects of EMI from devices or procedures
Important therapy information 2
7439_Ch02.fm 10/13/04 9:28 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Medtronic Confidential
NeuroPatntR00
221244001
Rev X
7439 2004-08 English
Printing instructions:
✓
✓
Serious
patient
injury
✓
✓
✓
✓
✓
✓
Momentary
increase
in
stimulation
✓
✓
Device
damage
Important therapy information 2
Theft detectors/security
devices
Therapeutic magnets
Radiofrequency (RF)/
microwave ablation
Radiation therapy
Psychotherapeutic
procedures
Magnetic resonance
imaging (MRI)
Laser procedures
Device/procedure
✓
✓
✓
✓
Device
turns
OFF or
ON
✓
✓
✓
✓
Intermittent
stimulation
page 114
page 122
page 113
page 119
page 119
page 111
page 118
See
guidelines
Table 2.1 Potential effects of EMI from devices or procedures (continued)
7439_Ch02.fm 10/13/04 9:28 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Medtronic Confidential
NeuroPatntR00
23
24
221244001
Rev X
Transcutaneous
electrical nerve
stimulation (TENS)
Therapeutic ultrasound
Device/procedure
Device
damage
✓
Serious
patient
injury
✓
✓
Momentary
increase
in
stimulation
✓
Device
turns
OFF or
ON
✓
Intermittent
stimulation
page 119
page 106
See
guidelines
Table 2.1 Potential effects of EMI from devices or procedures (continued)
Important therapy information 2
7439_Ch02.fm 10/13/04 9:28 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Medtronic Confidential
NeuroPatntR00
English 7439 2004-08
Printing instructions:
7439_Ch02.fm 10/13/04 9:28 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Medtronic Confidential
NeuroPatntR00
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
7439 2004-08 English
221244001
Rev X
Printing instructions:
Important therapy information 2
Case damage – If the neurostimulator case
is ruptured or pierced due to outside forces,
severe burns could result from exposure to
the battery chemicals.
25
7439_Ch02.fm 10/13/04 9:28 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Medtronic Confidential
NeuroPatntR00
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
Important therapy information 2
System and therapy
26
221244001
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
English 7439 2004-08
Rev X
Printing instructions:
7439_Ch02.fm 10/13/04 9:28 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Medtronic Confidential
NeuroPatntR00
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).
Component compatibility – For proper
therapy, only components that are
compatible with the appropriate indication
(eg, spinal cord stimulation) should be used.
For a list of Medtronic-compatible
components, ask your doctor. No claims of
safety or efficacy are made about the
compatibility of non-Medtronic components
with Medtronic components.
Patient control devices – Do not place
patient control devices (eg, patient
programmer) over another device (eg,
7439 2004-08 English
221244001
Rev X
Printing instructions:
Important therapy information 2
Contact your doctor immediately if you notice
symptoms that could be related to either
device or to the medical condition treated by
that device.
27
7439_Ch02.fm 10/13/04 9:28 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Medtronic Confidential
NeuroPatntR00
pacemaker, defibrillator, another
neurostimulator). The patient control device
could accidently change the operation of
another device.
Important therapy information 2
Patient device handling – To avoid
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.
28
221244001
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.
English 7439 2004-08
Rev X
Printing instructions:
7439_Ch02.fm 10/13/04 9:28 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Medtronic Confidential
NeuroPatntR00
Patient activities
Component manipulation – Do not
manipulate or rub your neurostimulation
system through the skin, sometimes called
“Twiddler’s Syndrome.” Manipulation can
cause damage to your system, skin erosion,
or stimulation at the implant site.
7439 2004-08 English
221244001
Rev X
Printing instructions:
Important therapy information 2
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
bending, twisting, bouncing, or stretching
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.
29
7439_Ch02.fm 10/13/04 9:28 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Medtronic Confidential
NeuroPatntR00
Important therapy information 2
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.
30
221244001
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.
Unexpected changes in stimulation –
Electromagnetic interference, changes in
posture, and other activities can cause a
perceived increase in stimulation, which
English 7439 2004-08
Rev X
Printing instructions:
7439_Ch02.fm 10/13/04 9:28 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Medtronic Confidential
NeuroPatntR00
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.
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.
7439 2004-08 English
221244001
Rev X
Printing instructions:
Important therapy information 2
Individualization of treatment
31
7439_Ch02.fm 10/13/04 9:28 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Medtronic Confidential
NeuroPatntR00
• 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
Important therapy information 2
• Pediatric use (patients under the age
of 18)
32
221244001
English 7439 2004-08
Rev X
Printing instructions:
7439_Ch03.fm 10/13/04 9:28 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Medtronic Confidential
NeuroPatntR00
3 Introduction to
stimulation
221244001
Rev X
Printing instructions:
Medtronic Confidential
NeuroPatntR00
7439_Ch03.fm 10/13/04 9:28 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
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.
Introduction to stimulation 3
Stimulation delivers electrical
pulses to the area where your
pain signals will be blocked as
they move to the brain (Figure 3.1).
34
221244001
Brain
translates
signal as pain
Brain senses
pain and tingling
Neurostimulator
pulses sent to
brain
Signal
from foot
Figure 3.1 Stimulation blocks some of the pain
signals as they move to the brain.
English 7439 2004-08
Rev X
Printing instructions:
7439_Ch03.fm 10/13/04 9:28 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Medtronic Confidential
NeuroPatntR00
Note: Stimulation will not cure your pain, nor
will it block sharp pain caused by a recent
injury.
Area of pain
Area of stimulation
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.
7439 2004-08 English
221244001
Rev X
Printing instructions:
Introduction to stimulation 3
To most patients, the pulses feel like a
steady, tingling sensation in the painful area
(Figure 3.2).
35
Medtronic Confidential
NeuroPatntR00
7439_Ch03.fm 10/13/04 9:28 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
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
Introduction to stimulation 3
Electrodes
36
221244001
Leads
Figure 3.3 Implanted parts of a typical
neurostimulation system.
A typical neurostimulation system also
includes a patient programmer that allows
you to control some stimulation
settings.(Figure 3.4).
English 7439 2004-08
Rev X
Printing instructions:
7439_Ch03.fm 10/13/04 9:28 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Detachable
antenna
(optional)
Medtronic Confidential
NeuroPatntR00
Patient
programmer
Carrying case
Figure 3.4 Patient programmer with accessories.
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
7439 2004-08 English
221244001
Rev X
Printing instructions:
Introduction to stimulation 3
Neurostimulator – The neurostimulator is
the power source for your neurostimulation
system. It contains electronics that generate
the electrical pulses.
37
7439_Ch03.fm 10/13/04 9:28 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Medtronic Confidential
NeuroPatntR00
detachable antenna is also available if you
have difficulty reaching the neurostimulator
implant site.
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.
Introduction to stimulation 3
• Amplitude is the strength of the pulse. It
affects the stimulation strength or
coverage required to manage your pain.
38
221244001
• 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 more
than one pain site.
English 7439 2004-08
Rev X
Printing instructions:
7439_Ch03.fm 10/13/04 9:28 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Medtronic Confidential
NeuroPatntR00
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.
For example, Alex has pain in his low back.
Typically, Alex’s pain doesn’t vary; however,
sometimes Alex has additional pain in his
right thigh. 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 thigh pain (Figure 3.5). Alex
chooses whichever group he requires.
Program 1
Group B
Low back and thigh pain
Program 1
Program 2
Figure 3.5 Example of programs and groups.
7439 2004-08 English
221244001
Rev X
Printing instructions:
Introduction to stimulation 3
Group A
Low back pain
39
Medtronic Confidential
NeuroPatntR00
7439_Ch03.fm 10/13/04 9:28 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
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
Introduction to stimulation 3
Your clinician uses a clinician programmer to
communicate with your neurostimulator and
your patient programmer. 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.
40
221244001
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
English 7439 2004-08
Rev X
Printing instructions:
Medtronic Confidential
NeuroPatntR00
7439_Ch03.fm 10/13/04 9:28 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
group. Talk to your clinician about the
settings that apply to your therapy.
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.
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.
7439 2004-08 English
221244001
Rev X
Printing instructions:
Introduction to stimulation 3
Activities
41
Medtronic Confidential
NeuroPatntR00
7439_Ch03.fm 10/13/04 9:28 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
• 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 2.3 kilograms
(5 pounds).
Introduction to stimulation 3
As you begin to feel better, you should be
able to perform activities such as:
42
221244001
• Bathing or showering
• Sexual activity
• Working at home or at your business
• Hobbies or activities, such as walking,
gardening, cycling, or swimming
• Traveling
English 7439 2004-08
Rev X
Printing instructions:
Medtronic Confidential
NeuroPatntR00
7439_Ch03.fm 10/13/04 9:28 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
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 feel discomfort or pain during
stimulation. Turn your neurostimulator
OFF and call your doctor.
• Your system is not working properly.
• You cannot turn the neurostimulator ON
or OFF.
• You cannot adjust stimulation using your
patient programmer.
7439 2004-08 English
221244001
Rev X
Printing instructions:
Introduction to stimulation 3
• You have pain, redness, or swelling at the
incision(s) later than 6 weeks after
surgery.
43
7439_Ch03.fm 10/13/04 9:28 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Medtronic Confidential
NeuroPatntR00
Care schedule
Your clinician will schedule follow-up visits to
make sure you are receiving the most
appropriate therapy.
Introduction to stimulation 3
Note: Bring your patient programmer to all
appointments with your clinician. When
groups are programmed, some settings are
stored in your neurostimulator and some
settings are stored in your patient
programmer. To most effectively evaluate
your therapy, the clinician needs your patient
programmer.
44
221244001
English 7439 2004-08
Rev X
Printing instructions:
7439_Ch04.fm 10/13/04 9:28 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Medtronic Confidential
NeuroPatntR00
4 Using your patient
programmer
221244001
Rev X
Printing instructions:
7439_Ch04.fm 10/13/04 9:28 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Medtronic Confidential
NeuroPatntR00
How the patient
programmer works
Using your patient programmer 4
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, or the
detachable antenna, must be
placed over the neurostimulator (Figure 4.1).
Notes:
46
English 7439 2004-08
221244001
• The internal antenna is on the back of the
programmer.
• The programmer screen must face
outward.
• The detachable antenna plugs into the
patient programmer.
Rev X
Printing instructions:
Medtronic Confidential
NeuroPatntR00
7439_Ch04.fm 10/13/04 9:28 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
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.
Using your patient programmer 4
• change stimulation settings.
7439 2004-08 English
221244001
Rev X
Printing instructions:
47
7439_Ch04.fm 10/13/04 9:28 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Medtronic Confidential
NeuroPatntR00
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.
Using your patient programmer 4
• 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.
48
221244001
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.
English 7439 2004-08
Rev X
Printing instructions:
Medtronic Confidential
NeuroPatntR00
7439_Ch04.fm 10/13/04 9:28 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
NEUROSTIMULATOR ON
NEUROSTIMULATOR OFF
SYNC
Figure 4.2 Synchronizing your neurostimulator
and patient programmer.
Status row
Group row
Parameter row
3.40
Figure 4.3 THERAPY screen.
Icons on the THERAPY screen indicate your
neurostimulator settings and the patient
programmer battery level (Table 4.1).
7439 2004-08 English
221244001
Rev X
Printing instructions:
Using your patient programmer 4
After synchronizing, the THERAPY screen
appears (Figure 4.3).
49
Medtronic Confidential
NeuroPatntR00
7439_Ch04.fm 10/13/04 9:28 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Table 4.1 THERAPY screen icons
Row
Icons
Status
Description
Neurostimulator is ON
Neurostimulator is OFF
Day Cycling is ON
Neurostimulator battery
level is low
Patient programmer battery
level
Group
Not active
Using your patient programmer 4
50
221244001
Active
Group name
Unknown group
English 7439 2004-08
Rev X
Printing instructions:
Medtronic Confidential
NeuroPatntR00
7439_Ch04.fm 10/13/04 9:28 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Table 4.1 THERAPY screen icons (continued)
Row
Parameter
Icons
Description
Amplitude
Amplitude
Pulse width
Pulse width
Rate
If you cannot change any parameters, this row is
blank.
If your clinician scheduled a time when
stimulation is OFF (eg, when you sleep), the
DAY CYCLING ( ) icon is displayed in the
Status row (Figure 4.4).
Note: Whether DAY CYCLING IS ON or OFF,
you can turn stimulation ON or OFF at any
time.
7439 2004-08 English
221244001
Rev X
Printing instructions:
Using your patient programmer 4
51
Medtronic Confidential
NeuroPatntR00
7439_Ch04.fm 10/13/04 9:28 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
An example of Day Cycling is shown in
Figure 4.4. The screens and timetable show
the following:
• When stimulation is ON, the
NEUROSTIMULATOR ON icon is displayed.
Stimulation is ON for most of the day.
• When stimulation is OFF, the
NEUROSTIMULATOR OFF icon is displayed.
Stimulation is OFF during the time you
would be asleep.
Using your patient programmer 4
Stimulation is ON
52
221244001
Stimulation is
OFF
3.40
3.40
Figure 4.4 Example of Day Cycling.
English 7439 2004-08
Rev X
Printing instructions:
Medtronic Confidential
NeuroPatntR00
7439_Ch04.fm 10/13/04 9:28 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
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 4.2
provides general guidelines for adjusting your
stimulation.
Situation
Action
Stimulation is too
strong
Decrease amplitude(s) or
pulse width(s)
Stimulation is not
strong enough
Increase amplitude(s) or
pulse width(s)
Stimulation covers too
much area
Decrease amplitude(s) or
pulse width(s) or change to
a different group
Stimulation does not
cover painful area
Increase amplitude(s) or
pulse width(s) or change to
a different group
7439 2004-08 English
221244001
Rev X
Printing instructions:
Using your patient programmer 4
Table 4.2 Stimulation adjustment
guidelines
53
Medtronic Confidential
NeuroPatntR00
7439_Ch04.fm 10/13/04 9:29 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Using your patient programmer 4
Table 4.2 Stimulation adjustment
guidelines (continued)
54
221244001
Situation
Action
The pulses
(tapping sensations)
feel too slow
Increase rate
The pulses
(tapping sensations)
feel too fast
Decrease rate
You have unexpected
changes in stimulation
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.
You have tried
adjusting stimulation
but are unable to find
an effective setting.
Contact your clinician.
English 7439 2004-08
Rev X
Printing instructions:
Medtronic Confidential
NeuroPatntR00
7439_Ch04.fm 10/13/04 9:29 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Table 4.2 Stimulation adjustment
guidelines (continued)
Situation
You will be passing
through a theft detector
or security device
You will be using
potentially dangerous
equipment
Action
Before engaging in these
activities, consult
“Appendix A:
Electromagnetic
Interference (EMI),” for
details.
You will be having a
medical procedure
1. Hold the programmer over your
neurostimulator with the programmer
screen facing outward and press the
NEUROSTIMULATOR ON
or
NEUROSTIMULATOR OFF
key
(Figure 4.5). The THERAPY screen
appears.
2. Verify that the appropriate ON or OFF
icon is displayed on the THERAPY screen
(Figure 4.5).
7439 2004-08 English
221244001
Rev X
Printing instructions:
Using your patient programmer 4
Turning your neurostimulator ON
or OFF
55
Medtronic Confidential
NeuroPatntR00
7439_Ch04.fm 10/13/04 9:29 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
ON
OFF
3.40
3.40
Figure 4.5 Turning your neurostimulator ON
or OFF.
Using your patient programmer 4
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.
56
221244001
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 62.
Note: When you turn your neurostimulator
ON or OFF, the patient programmer and
neurostimulator are synchronized.
English 7439 2004-08
Rev X
Printing instructions:
7439_Ch04.fm 10/13/04 9:29 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Medtronic Confidential
NeuroPatntR00
Adjusting stimulation settings
There is often more than one way to change
stimulation settings. These instructions
describe the most common ways.
Notes:
• Ask your clinician to print a report with
your programmed settings.
• When a stimulation setting is changed,
you will see the change on the THERAPY
screen.
– One tone means the stimulation setting
was successfully changed.
– Three rapid tones mean the stimulation
setting change did not occur.
– Up to ten short tones means the patient
programmer is unsuccessfully trying to
establish communication with the
neurostimulator.
7439 2004-08 English
221244001
Rev X
Printing instructions:
Using your patient programmer 4
• If the audio is ON, the following tones
mean:
57
Medtronic Confidential
NeuroPatntR00
7439_Ch04.fm 10/13/04 9:29 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Using the NAVIGATOR key
The NAVIGATOR key arrows move the
selection box on the THERAPY screen
(Figure 4.6).
Using your patient programmer 4
Figure 4.6 NAVIGATOR key.
58
221244001
• 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
your programmer over your
English 7439 2004-08
Rev X
Printing instructions:
Medtronic Confidential
NeuroPatntR00
7439_Ch04.fm 10/13/04 9:29 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
neurostimulator. However, you must hold
your 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 4.7).
Selection box
OPTIONS icon
3.50
Figure 4.7 The OPTIONS icon and selection box.
1. Hold the patient programmer over your
neurostimulator with the screen facing
outward and press the SYNC
key. The
THERAPY screen appears.
Note: Changing a group may take up to
8 seconds.
2. Press the up
arrow on the NAVIGATOR
key to move the selection box to the
Group row (Figure 4.8).
7439 2004-08 English
221244001
Rev X
Printing instructions:
Using your patient programmer 4
Changing a group
59
Medtronic Confidential
NeuroPatntR00
7439_Ch04.fm 10/13/04 9:29 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Group row
Figure 4.8 Group row.
Using your patient programmer 4
3. Press the left
or right
arrows on the
NAVIGATOR key to move the selection box
to the desired group
(Figure 4.9).
60
221244001
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.
Figure 4.9 Move to a new group.
English 7439 2004-08
Rev X
Printing instructions:
Medtronic Confidential
NeuroPatntR00
7439_Ch04.fm 10/13/04 9:29 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
4. Hold the programmer over your
neurostimulator and press the
SYNC
key to send the change to your
neurostimulator (Figure 4.10).
Note: If an UNKNOWN GROUP
icon is
displayed, there is a conflict between the
group settings stored in the programmer
and the group settings stored in the
neurostimulator. Select a different group.
on
Figure 4.10 Active group.
7439 2004-08 English
221244001
Rev X
Printing instructions:
Using your patient programmer 4
5. Verify that the new group is active
the THERAPY screen (Figure 4.10).
61
Medtronic Confidential
NeuroPatntR00
7439_Ch04.fm 10/13/04 9:29 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Increasing or decreasing a parameter
(amplitude, pulse width, or rate)
Notes:
• To increase a parameter, the
neurostimulator must be ON.
Using your patient programmer 4
• To decrease a parameter, the
neurostimulator may be ON or OFF.
62
221244001
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.
English 7439 2004-08
Rev X
Printing instructions:
7439_Ch04.fm 10/13/04 9:29 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Medtronic Confidential
NeuroPatntR00
Notes:
• To change a parameter, it must be in a
group that is active
• Changing a parameter takes one to two
seconds.
2. Use the left
or right
arrow on the
NAVIGATOR key to move the selection box
to the desired parameter (Figure 4.11).
Figure 4.11 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.
7439 2004-08 English
221244001
Rev X
Printing instructions:
Using your patient programmer 4
Parameter row
63
Medtronic Confidential
NeuroPatntR00
7439_Ch04.fm 10/13/04 9:29 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
3. Hold the programmer over your
neurostimulator and press the
INCREASE
or DECREASE
key as
needed (Figure 4.12). The increase or
decrease occurs immediately and is
saved in the neurostimulator.
DECREASE
INCREASE
Using your patient programmer 4
Figure 4.12 DECREASE and INCREASE keys.
64
221244001
Notes:
– Pressing and holding the INCREASE
or DECREASE
key, changes the
value approximately every half-second.
– If one of the information screens in
Table 4.3 appears, you tried to increase
or decrease the value beyond the
available limits programmed by your
clinician.
English 7439 2004-08
Rev X
Printing instructions:
7439_Ch04.fm 10/13/04 9:29 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Medtronic Confidential
NeuroPatntR00
Table 4.3 Parameter limit screens
Lower limit
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.
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.
7439 2004-08 English
221244001
Rev X
Printing instructions:
Using your patient programmer 4
Upper limit
65
7439_Ch04.fm 10/13/04 9:29 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Medtronic Confidential
NeuroPatntR00
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.
Using your patient programmer 4
Checking patient programmer batteries
66
221244001
The patient programmer battery level is
displayed on the THERAPY screen
(Figure 4.13).
• To check the programmer battery level,
hold the patient programmer over your
neurostimulator and press the SYNC
key. The THERAPY screen appears
displaying the programmer battery level
(Figure 4.13).
English 7439 2004-08
Rev X
Printing instructions:
7439_Ch04.fm 10/13/04 9:29 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Medtronic Confidential
NeuroPatntR00
Battery level
3.50
Low:
Replace batteries
New
Figure 4.13 Patient programmer battery level.
If the programmer batteries need immediate
replacement, one of the screens in Table 4.4
appears.
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 patient programmer batteries
are depleted. Programming is not
possible.
Replace the patient programmer
batteries now.
7439 2004-08 English
221244001
Rev X
Printing instructions:
Using your patient programmer 4
Table 4.4 Patient programmer battery replacement
screens
67
7439_Ch04.fm 10/13/04 9:29 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Medtronic Confidential
NeuroPatntR00
Replacing patient programmer
batteries
Using your patient programmer 4
1. Open the battery compartment cover
(Figure 4.14).
68
221244001
Figure 4.14 Opening the battery cover.
2. Remove the depleted batteries. (For
disposal information, see “Battery and
programmer disposal” on page 101.
3. Insert the new batteries as shown on the
battery compartment label.
4. Close the battery compartment cover.
English 7439 2004-08
Rev X
Printing instructions:
7439_Ch04.fm 10/13/04 9:29 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Medtronic Confidential
NeuroPatntR00
Summary of keys
DECREASE
NEUROSTIMULATOR ON
NEUROSTIMULATOR OFF
SYNC
INCREASE
POWER/
BACKLIGHT
NAVIGATOR
Using your patient programmer 4
Figure 4.15 Patient programmer keys.
7439 2004-08 English
221244001
Rev X
Printing instructions:
69
Medtronic Confidential
NeuroPatntR00
7439_Ch04.fm 10/13/04 9:29 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Table 4.5 Summary of keys
Key
Function
Turns the neurostimulator ON
OFF
ON
OFF
or
• The programmer must be held over
the neurostimulator while pressing
the NEUROSTIMULATOR ON
or OFF
key.
• Pressing either of these keys also
automatically synchronizes the
neurostimulator and programmer and
displays the THERAPY screen.
Synchronizes the neurostimulator
and programmer.
Activates a selected group.
Using your patient programmer 4
The programmer must be held over the
neurostimulator while pressing the
SYNC
key.
70
221244001
English 7439 2004-08
Rev X
Printing instructions:
Medtronic Confidential
NeuroPatntR00
7439_Ch04.fm 10/13/04 9:29 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Table 4.5 Summary of keys (continued)
Key
Function
Decreases
parameter.
Decrease
Increase
or increases
• The programmer must be held over
the neurostimulator while pressing
the INCREASE
or DECREASE
key.
• Pressing and holding the INCREASE
or DECREASE
key changes the
parameter approximately every halfsecond.
The OPTION
icon at the end of a row
on the THERAPY 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 light to the display.
7439 2004-08 English
221244001
Rev X
Printing instructions:
Using your patient programmer 4
Moves the selection box on the
THERAPY screen.
71
7439_Ch04.fm 10/13/04 9:29 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Medtronic Confidential
NeuroPatntR00
Preferences: Changing the
audio, contrast, and number
format
Programmer preferences are accessed from
the Status row of the THERAPY screen.
Table 4.6 lists the preference icons.
Table 4.6 Preference icons
Icons
Preference
Audio
Contrast
Using your patient programmer 4
Number format
72
221244001
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
Status row (Figure 4.16).
English 7439 2004-08
Rev X
Printing instructions:
Medtronic Confidential
NeuroPatntR00
7439_Ch04.fm 10/13/04 9:29 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Status row
3.50
Figure 4.16 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 4.17).
Figure 4.17 Move to desired preference.
4. Press the down
arrow to move the
selection box to the Change row
(Figure 4.18).
Change row
Figure 4.18 Move to Change row.
7439 2004-08 English
221244001
Rev X
Printing instructions:
Using your patient programmer 4
Desired preference
73
Medtronic Confidential
NeuroPatntR00
7439_Ch04.fm 10/13/04 9:29 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
5. Follow the steps in Table 4.7 to change
the selected preference.
Table 4.7 Changing preferences
Audio
1. Press the left
or right
arrow on the NAVIGATOR key to
move the selection box to
audio ON
or OFF .
2. Go to step 6.
Contrast
Using your patient programmer 4
1. Press the left
or right
arrow on the NAVIGATOR key to
make the contrast lighter
or
darker .
2. Go to step 6.
74
221244001
Number format
1. Press the left
or right
arrow on the NAVIGATOR key to
change from the comma to the
decimal point format.
2. Go to step 6.
6. When the change is displayed on the
screen, move the selection box to the
Status (top) row and scroll back to the
English 7439 2004-08
Rev X
Printing instructions:
7439_Ch04.fm 10/13/04 9:30 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Medtronic Confidential
NeuroPatntR00
THERAPY screen. Scrolling to the
THERAPY screen 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 case also has a loop on the back that
attaches to a belt.
Figure 4.19 Insert the programmer into the case.
7439 2004-08 English
221244001
Rev X
Printing instructions:
Using your patient programmer 4
The carrying case has a pouch to hold the
patient programmer and the quick reference
guide (Figure 4.19).
75
Medtronic Confidential
NeuroPatntR00
7439_Ch04.fm 10/13/04 9:30 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Place an identification label on the back of
your patient programmer in case the
programmer is lost (Figure 4.20).
ID label
Figure 4.20 Place the adhesive label on the
back of the programmer.
Using your patient programmer 4
Optional detachable antenna
76
221244001
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 4.21).
English 7439 2004-08
Rev X
Printing instructions:
Medtronic Confidential
NeuroPatntR00
7439_Ch04.fm 10/13/04 9:30 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
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 4.22).
Figure 4.22 Pull the fabric through the slit (a)
and wedge in place (b).
7439 2004-08 English
221244001
Rev X
Printing instructions:
Using your patient programmer 4
Figure 4.21 Place the antenna over your
neurostimulator.
77
7439_Ch04.fm 10/13/04 9:30 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Medtronic Confidential
NeuroPatntR00
3. Push the antenna plug firmly into the
antenna jack ( )on the patient
programmer (Figure 4.23).
Using your patient programmer 4
Figure 4.23 Insert the antenna plug into the
antenna jack.
78
221244001
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.
English 7439 2004-08
Rev X
Printing instructions:
7439_Ch05.fm 10/13/04 9:30 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Medtronic Confidential
NeuroPatntR00
5 Troubleshooting
221244001
Rev X
Printing instructions:
Medtronic Confidential
NeuroPatntR00
7439_Ch05.fm 10/13/04 9:30 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
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
Troubleshooting 5
The programmer displays warning ( ),
communication ( ), and information ( )
screens to alert you to a problem with your
system or guide you during programmer use.
If the audio is ON, a series of tones alerts
you to some messages.
Warning screens
80
English 7439 2004-08
221244001
Warning screens indicate a problem with the
programmer, antenna, or neurostimulator.
Table 5.1 describes warning screens and
Rev X
Printing instructions:
Medtronic Confidential
NeuroPatntR00
7439_Ch05.fm 10/13/04 9:30 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
provides instructions (see blue text) on how
to resolve the problem and clear the screen.
Table 5.1 Warning screens
Screen
Cause and action
Synchronize
programmer and
neurostimulator
The programmer and the
neurostimulator are not
synchronized.
Synchronize the
programmer and
neurostimulator.
Replace
programmer
batteries
The programmer batteries are
depleted. Programming is not
possible.
Troubleshooting 5
Replace the programmer
batteries now.
7439 2004-08 English
221244001
Rev X
Printing instructions:
81
Medtronic Confidential
NeuroPatntR00
7439_Ch05.fm 10/13/04 9:30 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Table 5.1 Warning screens (continued)
Screen
Cause and action
Call doctor
EOS: Your neurostimulator
battery is depleted.
Stimulation is not available.
Other code: The system is
not working correctly.
Stimulation might have
stopped.
Write down the code shown
on the screen. Call your
doctor.
Communication screen
Troubleshooting 5
A communication screen shows you that a
process is in progress. Table 5.2 describes
the communication screen for your
neurostimulation system.
82
221244001
The communication screen automatically
clears when the neurostimulation system
finishes the process.
English 7439 2004-08
Rev X
Printing instructions:
Medtronic Confidential
NeuroPatntR00
7439_Ch05.fm 10/13/04 9:30 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Table 5.2 Communication screen
Screen
Description and action
Communication
The programmer is
communicating or attempting
to communicate with the
neurostimulator.
Information screens
The information screens show the
programming status and the battery level for
your programmer and neurostimulator.
Table 5.3 describes information screens and
instructions on how to proceed (see blue
text).
Troubleshooting 5
Note: Press any arrow on the NAVIGATOR key
to clear an information screen.
7439 2004-08 English
221244001
Rev X
Printing instructions:
83
Medtronic Confidential
NeuroPatntR00
7439_Ch05.fm 10/13/04 9:30 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Table 5.3 Information screens
Screen
Description and action
Poor communication The programmer attempted
to communicate with the
neurostimulator, but
communication was
unsuccessful.
Reposition the programmer
over the neurostimulator
with the screen facing
outward and try
communication again.
If using the detachable
antenna, check that the
antenna is connected
properly, reposition the
antenna, and try
communication again.
Press
You tried increasing a
NEUROSTIMULATOR ON parameter value with the
key
neurostimulator OFF.
Troubleshooting 5
Turn your neurostimulator
ON and try communication
again.
84
221244001
English 7439 2004-08
Rev X
Printing instructions:
7439_Ch05.fm 10/13/04 9:30 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Medtronic Confidential
NeuroPatntR00
Table 5.3 Information screens (continued)
Screen
Description and action
Upper limit
(amplitude shown)
You tried increasing a
parameter (amplitude, pulse
width, or rate) above the
highest value allowed.
Lower limit
(amplitude shown)
You tried decreasing a
parameter (amplitude, pulse
width, or rate) below the
lowest value allowed.
Programmer
batteries are low
The patient programmer
batteries are low. You can
finish programming.
Neurostimulator
battery is low
The neurostimulator battery
is low. Stimulation will not be
available soon.
Write down the code
shown on the screen. Call
your clinician.
7439 2004-08 English
221244001
Rev X
Printing instructions:
Troubleshooting 5
Replace the programmer
batteries before the
batteries become depleted.
85
Medtronic Confidential
NeuroPatntR00
7439_Ch05.fm 10/13/04 9:30 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Table 5.3 Information screens (continued)
Screen
Description and action
Sync up
You tried to unsuccessfully
change to a different group,
then tried to turn the
neurostimulator ON.
Synchronize the
programmer and
neurostimulator.
You tried increasing or
decreasing a parameter for
an inactive group.
Synchronize the
programmer and
neurostimulator.
Incorrect patient
programmer
251
Use the correct patient
programmer.
Troubleshooting 5
86
221244001
You have more than one
neurostimulator of the same
type, and you are trying to
use the patient programmer
to communicate with the
wrong neurostimulator.
English 7439 2004-08
Rev X
Printing instructions:
Medtronic Confidential
NeuroPatntR00
7439_Ch05.fm 10/13/04 9:30 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Table 5.3 Information screens (continued)
Screen
Description and action
Patient programmer information
These screens provide information to your clinician
or Medtronic during troubleshooting.
PA
PO
IS
IM
HI
HA
Troubleshooting 5
PM
7439 2004-08 English
221244001
Rev X
Printing instructions:
87
7439_Ch05.fm 10/13/04 9:30 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Medtronic Confidential
NeuroPatntR00
Possible problems and solutions
Table 5.4 will help you solve problems or
identify when to call your clinician. Problems
are described in the left column (bold black
text). The right column lists possible causes
of the problem (plain text) and how to correct
the problem (bold blue text).
Troubleshooting 5
Note: If a problem is not solved after several
attempts, or if a problem is not described
here, contact your clinician.
88
221244001
English 7439 2004-08
Rev X
Printing instructions:
221244001
Rev X
Troubleshooting 5
The selected group or stimulation settings are
not suitable for your current activity or posture.
Uncomfortable stimulation:
You are too uncomfortable
with the current stimulation
to think about how to
change it.
3. Turn the neurostimulator ON.
• Change the group if the active group is
not one that is recommended by your
clinician for your current activity or
posture; or adjust the amplitude, pulse
width, and rate to values that provide
adequate pain relief.
• Reduce the rate for the active group.
• Reduce the amplitude and pulse width for
each program in the active group.
1. Turn the neurostimulator OFF.
2. Change one or more of the following:
Causes and actions
Problems
Table 5.4 Troubleshooting problems
7439_Ch05.fm 10/13/04 9:30 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Medtronic Confidential
NeuroPatntR00
7439 2004-08 English
Printing instructions:
89
90
221244001
Rev X
Intermittent stimulation: You
feel stimulation only some of
the time.
Your clinician programmed SoftStart/Stop so
that stimulation starts and stops gradually:
Delayed stimulation
changes: You do not feel
stimulation right away after
turning ON the
neurostimulator or you feel
stimulation after turning OFF
the neurostimulator.
Your clinician may have programmed your
neurostimulator to turn ON and OFF at regular
intervals. However, if you are not receiving
adequate pain relief, contact your clinician.
You may feel a residual effect after the
neurostimulator is turned OFF.
Allow about 8 seconds for your
neurostimulator to turn ON and OFF.
Causes and actions
Problems
Table 5.4 Troubleshooting problems (continued)
Troubleshooting 5
7439_Ch05.fm 10/13/04 9:30 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Medtronic Confidential
NeuroPatntR00
English 7439 2004-08
Printing instructions:
221244001
Rev X
Troubleshooting 5
Stimulation is OFF.
No stimulation: You do not
feel stimulation but you think
stimulation should be ON.
Use your patient programmer to increase
the amplitude(s).
The amplitudes for each program in the active
group are set too low to feel.
If stimulation is desired, turn stimulation
ON.
Your clinician has programmed Day Cycling and
stimulation is scheduled to be OFF at this time.
Use your patient programmer to turn your
neurostimulator ON.
Causes and actions
Problems
Table 5.4 Troubleshooting problems (continued)
7439_Ch05.fm 10/13/04 9:30 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Medtronic Confidential
NeuroPatntR00
7439 2004-08 English
Printing instructions:
91
92
221244001
Rev X
Dropped programmer:
Your patient programmer
falls off a cabinet or table.
You are pressing two or more patient
programmer keys at the same time.
Patient programmer is
unresponsive: The display
screen is blank when you
press a key.
Try the patient programmer; it should work.
The patient programmer is designed to
withstand a short drop to a hard surface and
still operate normally, even if the case is
chipped or nicked.
Check the battery polarity and reinstall the
patient programmer batteries.
The programmer batteries are in backwards.
Replace the programmer batteries.
The programmer batteries are depleted.
Make sure you are pressing only one key at
a time.
Causes and actions
Problems
Table 5.4 Troubleshooting problems (continued)
Troubleshooting 5
7439_Ch05.fm 10/13/04 9:30 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Medtronic Confidential
NeuroPatntR00
English 7439 2004-08
Printing instructions:
221244001
Rev X
7439 2004-08 English
Printing instructions:
Troubleshooting 5
???
Cannot access or use
group.
The patient programmer is not waterproof, and
water can damage the device.
Fluid on the programmer:
Fluid was spilled onto the
programmer or the
programmer was dropped
into water.
Choose a new group. (See Page 59). Press
the Sync
key.
There is a conflict between the group stored in
the programmer and neurostimulator.
Remove the batteries, then allow the battery
compartment to air dry at room temperature
for 24 hours.
Immediately remove the programmer from
the water, then dry the programmer with a
towel dampened with clean tap water.
Causes and actions
Problems
Table 5.4 Troubleshooting problems (continued)
7439_Ch05.fm 10/13/04 9:30 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Medtronic Confidential
NeuroPatntR00
93
94
221244001
Rev X
No group is selected.
Cannot use group.
Choose a new group. (See Page 59). Press
the Sync
key.
Causes and actions
Problems
Table 5.4 Troubleshooting problems (continued)
Troubleshooting 5
7439_Ch05.fm 10/13/04 9:30 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Medtronic Confidential
NeuroPatntR00
English 7439 2004-08
Printing instructions:
7439_Ch05.fm 10/13/04 9:30 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Medtronic Confidential
NeuroPatntR00
User assistance
The patient programmer has been designed
and tested to provide trouble-free service. If
repair or service is needed, contact your
clinician or a Medtronic sales office. Refer to
the list of Medtronic contacts at the end of
this manual.
The serial number is located in the battery
compartment. This number identifies each
patient programmer. If you contact Medtronic
about your patient programmer, refer to the
serial number.
If your programmer stops working – First
try the steps in Table 5.4. Otherwise, contact
your clinician.
c To register the programmer for service
covered by the warranty, complete and mail
the warranty registration.
7439 2004-08 English
221244001
Rev X
Printing instructions:
Troubleshooting 5
If you lose your programmer – Contact
your clinician to order a new programmer.
95
Medtronic Confidential
NeuroPatntR00
Troubleshooting 5
7439_Ch05.fm 10/13/04 9:30 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
96
221244001
English 7439 2004-08
Rev X
Printing instructions:
7439_Ch06.fm 10/13/04 9:31 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Medtronic Confidential
NeuroPatntR00
6 Maintenance
221244001
Rev X
Printing instructions:
Medtronic Confidential
NeuroPatntR00
7439_Ch06.fm 10/13/04 9:31 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
This section describes how to
care for and dispose of your
patient programmer and
accessories.
Cleaning and care
Follow these guidelines to
ensure that the patient
programmer and accessories
function properly.
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.
Maintenance 6
• Keep the device out of the reach of
children.
98
221244001
• Use the device only as explained to you
by your clinician or as discussed in this
manual.
English 7439 2004-08
Rev X
Printing instructions:
Medtronic Confidential
NeuroPatntR00
7439_Ch06.fm 10/13/04 9:31 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
• Follow all warnings and precautions in
Chapter 2 “Important therapy information”
and “Appendix A: Electromagnetic
interference (EMI)”.
• Handle the device with care. Do not drop,
strike, or step on the device.
• Do not dismantle or tamper with the
device.
• Clean the outside of the device with a
damp cloth when necessary. Mild
household cleaners will not damage the
device or labels.
• The device is not waterproof. Do not allow
moisture to get inside the device.
• Keep fresh batteries available.
Maintenance 6
• Replace low or depleted batteries.
7439 2004-08 English
221244001
Rev X
Printing instructions:
99
Medtronic Confidential
NeuroPatntR00
7439_Ch06.fm 10/13/04 9:31 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Safety and technical checks
Periodic safety and technical checks or
periodic maintenance of the patient
programmer are not required. If the patient
programmer requires repair or is
nonfunctional, send it to the address listed
below. The patient programmer contains no
user-serviceable parts.
Maintenance 6
USA
Medtronic, Inc.
Neurological Division
MSN600
PO Box 1250
Minneapolis, MN 55440-9087
100
221244001
Europe, Africa, Middle East, and Asia-Pacific
countries
Medtronic EOC
Medical Equipment Service Europe
Earl Bakkenstraat 10
6422 PJ Heerlen
The Netherlands
Tel. 31-45566-4880
Fax 31-45566-8028
English 7439 2004-08
Rev X
Printing instructions:
Medtronic Confidential
NeuroPatntR00
7439_Ch06.fm 10/13/04 9:31 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Battery and programmer
disposal
Dispose of depleted batteries and worn out
devices according to local requirements. If
you no longer need your programmer and
would like to donate it, contact your clinician.
Neurostimulator disposal
Maintenance 6
The implanted device should be removed
before burial or cremation. In some countries,
removal of battery-powered implantable
devices is required before burial because of
environmental concerns. Also, the device
should be removed before cremation. The
cremation process causes the battery to
explode. Explanted devices should not be
resterilized or reimplanted.
7439 2004-08 English
221244001
Rev X
Printing instructions:
101
Medtronic Confidential
NeuroPatntR00
7439_Ch06.fm 10/13/04 9:31 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Declaration of conformity
Medtronic declares that this product is in
conformity with the essential requirements of
AIMD Directive 90/385/EEC and R&TTE
Directive 1999/5/EC.
Maintenance 6
For additional information, contact Medtronic
at the telephone numbers and addresses
provided on the back cover.
102
221244001
English 7439 2004-08
Rev X
Printing instructions:
Medtronic Confidential
NeuroPatntR00
7439_Ch06.fm 10/13/04 9:31 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Specifications
Table 6.1 Patient programmer
specifications
Item
Specification
Power source
2 AAA alkaline batteries
(non-rechargeable, LR03)
Operating
temperature
+9 to +43°C (+49 to +110°F)
Storage
temperature
-40 to +65°C (-40 to +150°F)
Operating/storage 30% to 95%
relative humidity
Size
Approximately 9.4 x 5.6 x 2.8 cm
(3.7 x 2.2 x 1.1 inches)
Weight, including
batteries
Approximately 111 g (3.9 oz.)
Battery life
2 months (average) for
alkaline batteries
Mode of operation Continuous
7439 2004-08 English
221244001
Rev X
Printing instructions:
Maintenance 6
Operating/storage 700 hPa to 1060 hPa
atmospheric
(20.7 in. Hg to 31.3 in. Hg)
pressure
103
7439_Ch06.fm 10/13/04 9:31 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Medtronic Confidential
NeuroPatntR00
Table 6.2 Neurostimulation system
specifications
Description
Specifications
Typical materials in contact with human tissuea
Neurostimulator
Case
Connector block
Recharge coil
Grommets, seals
Setscrews
Insulation
Adhesive
Lead
Polyurethane
Platinum iridium
Extension
Polyurethane
For a complete list of materials in contact with
human tissue, contact your clinician.
Maintenance 6
Titanium
Polyurethane
Polysulfone
Silicone rubber
Titanium
Fluoropolymer
Silicone
adhesive
104
221244001
English 7439 2004-08
Rev X
Printing instructions:
7439_Ch07.fm 10/13/04 9:31 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Medtronic Confidential
NeuroPatntR00
7 Appendix A:
Electromagnetic
interference (EMI)
221244001
Rev X
Printing instructions:
Medtronic Confidential
NeuroPatntR00
7439_Ch07.fm 10/13/04 9:31 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Appendix A: Electromagnetic interference
Please review
“Electromagnetic interference
(EMI)” on page 19 and
Table 2.1 on page 22 for
additional information.
106
221244001
Before any medical procedure
is begun, always inform any
health care personnel that you
have an implanted
neurostimulation system. The
potential for the following
effects results from an
interaction of the neurostimulation system
and equipment — even when both are
working properly.
Contraindication
Diathermy – Inform anyone treating you that
you CANNOT have any shortwave
diathermy, microwave diathermy or
therapeutic ultrasound diathermy (all now
referred to as diathermy) anywhere on your
body because you have an implanted
neurostimulation system. Energy from
English 7439 2004-08
Rev X
Printing instructions:
7439_Ch07.fm 10/13/04 9:31 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Medtronic Confidential
NeuroPatntR00
diathermy can be transferred through your
implanted system, can cause tissue
damage, and can result in severe injury or
death.
Personal injury or device damage can occur
during diathermy treatment when:
• the neurostimulation system is turned ON
or OFF.
• diathermy is used anywhere on your body
(not just where your neurostimulation
system is located).
• diathermy is used to deliver heat or no
heat.
• any component of your neurostimulation
system (lead, extension, neurostimulator)
remains in your body.
7439 2004-08 English
221244001
Rev X
Printing instructions:
Appendix A: Electromagnetic interference
Diathermy can also damage parts of your
neurostimulation system. This can result in
loss of therapy from your neurostimulation
system, and can require additional surgery to
remove or replace parts of your implanted
system.
107
7439_Ch07.fm 10/13/04 9:31 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Medtronic Confidential
NeuroPatntR00
Warnings
Appendix A: Electromagnetic interference
EMI from the following medical procedures or
equipment can damage the device, interfere
with device operation, or cause you harm. If
these procedures or equipment are required,
the guidelines below must be followed:
108
221244001
Defibrillation / cardioversion – When you
are in ventricular or atrial fibrillation, the first
consideration is your survival. External
defibrillation or cardioversion can damage a
neurostimulation system and cause induced
electrical currents through the lead and
extension. These induced electrical currents
could injure you. The current flowing through
the neurostimulation system should be
minimized as follows:
• Paddles should be positioned as far from
the neurostimulator as possible.
• Paddles should be positioned
perpendicular to the neurostimulation
system.
English 7439 2004-08
Rev X
Printing instructions:
7439_Ch07.fm 10/13/04 9:31 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Medtronic Confidential
NeuroPatntR00
• The lowest clinically appropriate energy
output (watt seconds) should be used.
After external defibrillation, your doctor
should confirm that the neurostimulation
system is working as intended.
• The insulation on the lead or extension
can be damaged, causing the lead or
extension to fail or causing induced
currents that can damage tissue or
stimulate or shock you.
• The neurostimulator can be damaged,
stimulation can be temporarily decreased
or increased, or the neurostimulator can
be turned OFF because the
neurostimulator was reset to power-onreset values (requiring your health care
provider to reprogram your
neurostimulator).
When electrocautery is necessary, these
precautions must be followed:
7439 2004-08 English
221244001
Rev X
Printing instructions:
Appendix A: Electromagnetic interference
Electrocautery – If electrocautery tools are
used near an implanted device or contacts a
device, the following effects can occur:
109
7439_Ch07.fm 10/13/04 9:31 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Medtronic Confidential
NeuroPatntR00
• The neurostimulator should be turned
OFF before using electrocautery.
• Bipolar cautery should be used.
• If unipolar cautery is necessary:
– only low-voltage modes should be used.
– the lowest possible power setting should
be used.
Appendix A: Electromagnetic interference
– the current path (ground plate) should
be kept as far away as possible from the
neurostimulator, extension, and lead.
110
221244001
– full-length operating-room-table
grounding pads should not be used.
• After electrocautery, your doctor should
confirm that the neurostimulator is
working as intended.
English 7439 2004-08
Rev X
Printing instructions:
7439_Ch07.fm 10/13/04 9:31 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Medtronic Confidential
NeuroPatntR00
Magnetic resonance imaging (MRI) –
Medtronic recommends that an MRI should
not be prescribed for you if you have any
part of an implanted neurostimulation
system. Exposing you to an MRI can
potentially injure you or damage your
neurostimulator. The known potential risks
are as follows:
• Induced electrical currents from the MRI
to the neurostimulation system can cause
heating, especially at the lead electrode
site, resulting in tissue damage. Induced
electrical currents can also stimulate or
shock you.
7439 2004-08 English
221244001
Rev X
Printing instructions:
Appendix A: Electromagnetic interference
High-output ultrasonics / lithotripsy –
Use of high-output ultrasonics or lithotripsy
is not recommended if you have an
implanted neurostimulation system. If
lithotripsy must be used, the beam should
not be focused within 15 cm (6 in) of the
neurostimulator.
111
7439_Ch07.fm 10/13/04 9:31 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Medtronic Confidential
NeuroPatntR00
Note: This warning applies even if only a
lead or an extension is implanted in your
body.
Factors that increase the risks of heating
and injury include, but are not limited to,
the following:
Appendix A: Electromagnetic interference
– High MRI Specific Absorption Rate
(SAR) Radio Frequency (RF) power
levels
112
221244001
– Lower impedance leads or extensions
(Medtronic product names or model
numbers designated with a “Z”, an “LZ”,
or “Low Impedance”)
– MRI RF transmit coil that is near or
extends over the implanted lead
– Implanted leads with small surface area
electrodes
– Short distances between lead
electrodes and tissue that is sensitive to
heat
English 7439 2004-08
Rev X
Printing instructions:
7439_Ch07.fm 10/13/04 9:31 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Medtronic Confidential
NeuroPatntR00
• An MRI can permanently damage the
neurostimulator, requiring it be removed
or replaced.
• The neurostimulator can move within the
implant pocket and align with the MRI
field, resulting in discomfort or reopening
of a recent implant incision.
In addition, the MRI image can be degraded,
distorted, or blocked from view by your
implanted neurostimulation system.
Radiofrequency (RF) / microwave
ablation – Safety has not been established
for radiofrequency (RF) or microwave
ablation in patients with an implanted
neurostimulation system. Induced electrical
currents can cause heating, especially at the
lead electrode site, resulting in tissue
damage.
7439 2004-08 English
221244001
Rev X
Printing instructions:
Appendix A: Electromagnetic interference
• An MRI can affect neurostimulator
operation. The MRI can also reset the
neurostimulator to power-on-reset values
requiring your health care provider to
reprogram your neurostimulator.
113
7439_Ch07.fm 10/13/04 9:31 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Medtronic Confidential
NeuroPatntR00
Appendix A: Electromagnetic interference
Theft detectors and security devices –
Use care when approaching theft detector
and security devices (such as those found in
airports, libraries, and some department
stores). When approaching these devices,
do the following:
114
221244001
1. Show the security personnel your patient
identification card for the neurostimulator
and ask for a manual search. Security
personnel may use a handheld security
wand but ask them not to hold the
security wand near the neurostimulator
any longer than is needed.
2. If you must pass through the theft
detector or security screening device,
turn your neurostimulator OFF, approach
the center of the device and walk through
normally.
a. If two security gates are present, walk
through the middle, keeping as far
away as possible from each gate.
b. If one gate is present, walk as far away
as possible from it.
English 7439 2004-08
Rev X
Printing instructions:
7439_Ch07.fm 10/13/04 9:31 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Double Security
gate
Medtronic Confidential
NeuroPatntR00
Single security gate
(stay as far as possible
from gate)
Note: Some theft detectors might not be
visible.
3. Proceed through the security device. Do
not linger near or lean on the security
device.
4. After you pass through the security
device, turn your neurostimulator ON
again.
7439 2004-08 English
221244001
Rev X
Printing instructions:
Appendix A: Electromagnetic interference
Figure 7.1 Approaching security gates.
115
7439_Ch07.fm 10/13/04 9:31 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Medtronic Confidential
NeuroPatntR00
Precautions
Appendix A: Electromagnetic interference
EMI from the following equipment is unlikely
to affect your neurostimulation system if the
guidelines below are followed:
116
221244001
Bone growth stimulators – The coils of an
external magnetic field bone growth
stimulator should be kept 45 cm (18 in) away
from the neurostimulation system. When a
bone growth stimulator is used, your doctor
should ensure that both the bone growth
stimulator and neurostimulator are working
as intended.
Dental drills and ultrasonic probes – The
neurostimulator should be turned OFF and
the drill or probe should be kept at least
15 cm (6 in) away from the neurostimulator.
Electrolysis – The neurostimulator should
be turned OFF, and the electrolysis wand
should be kept at least 15 cm (6 in) away
from the neurostimulator.
English 7439 2004-08
Rev X
Printing instructions:
Medtronic Confidential
NeuroPatntR00
7439_Ch07.fm 10/13/04 9:31 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Electromagnetic field devices – The
following equipment or environments should
be avoided:
• Antennas of citizen band (CB) or ham
radios
• Electric arc welding equipment
• Electric induction heaters
• Electric steel furnaces
• High-voltage areas (safe if outside the
fenced area)
• Linear power amplifiers
• Magnetic degaussing equipment
• Magnets and other equipment that
generate strong magnetic fields
• Microwave communication transmitters
(safe if outside the fenced area)
• Perfusion systems
• Resistance welders
7439 2004-08 English
221244001
Rev X
Printing instructions:
Appendix A: Electromagnetic interference
• High-power amateur transmitters
117
7439_Ch07.fm 10/13/04 9:31 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Medtronic Confidential
NeuroPatntR00
• Television and radio transmitting towers
(safe if outside the fenced area)
If you suspect that equipment is interfering
with the neurostimulation system, do the
following:
1. Move away from the equipment or object.
Appendix A: Electromagnetic interference
2. If possible, turn off the equipment or
object.
118
221244001
3. Then, if necessary, use the patient
programmer to return the neurostimulator
to the desired ON or OFF state.
4. Inform the equipment owner or operator
about the interference.
If the above actions do not resolve the effects
of the interference, or you suspect that your
therapy is not the same after exposure to
EMI, contact your doctor.
Laser procedures – The neurostimulator
should be turned OFF, and the laser should
be directed away from the neurostimulation
system.
English 7439 2004-08
Rev X
Printing instructions:
7439_Ch07.fm 10/13/04 9:31 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Medtronic Confidential
NeuroPatntR00
Radiation therapy – High radiation sources
such as cobalt 60 or gamma radiation should
not be directed at the neurostimulation
system. If radiation therapy is required near
the neurostimulation system, lead shielding
should be placed over the device to help
prevent damage.
Transcutaneous electrical nerve
stimulation (TENS) – TENS electrodes
should not be placed so that current passes
over any part of the neurostimulation
system. If you feel that the TENS unit might
be interfering with your neurostimulator,
7439 2004-08 English
221244001
Rev X
Printing instructions:
Appendix A: Electromagnetic interference
Psychotherapeutic procedures – Safety
has not been established for
psychotherapeutic procedures using
equipment that generates electromagnetic
interference (eg, electroconvulsive therapy,
transcranial magnetic stimulation) in patients
who have an implanted neurostimulation
system. Induced electrical currents may
cause heating, especially at the lead
electrode site, resulting in tissue damage.
119
7439_Ch07.fm 10/13/04 9:31 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Medtronic Confidential
NeuroPatntR00
discontinue using the TENS until you talk
with your doctor.
Notes
Appendix A: Electromagnetic interference
Household items – Most household
appliances and equipment that work
properly and are properly grounded will not
interfere with the neurostimulation system.
The following equipment is safe if you follow
these guidelines:
120
221244001
• Computer disk drives: Keep the
neurostimulator away from disk drives.
• Induction range: Keep the
neurostimulator away from the burners
while the burners are turned on.
• Freezer, refrigerator, or storm doors: Do
not lean against the magnetic strip that
holds the door closed.
• Power tools: Keep the motor away from
the neurostimulator, lead, and extension.
English 7439 2004-08
Rev X
Printing instructions:
7439_Ch07.fm 10/13/04 9:31 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Medtronic Confidential
NeuroPatntR00
• Radio frequency sources: Keep AM/FM
radios, and cellular, cordless, and
conventional telephones at least
10 cm (4 in) away from the implanted
neurostimulator.
• Stereo speakers and radios for the home
or car: Do not lift or carry them close to or
touching the part of your body where the
neurostimulator is located.
Other medical procedures – EMI from the
following medical procedures is unlikely to
affect your neurostimulation system:
• Computerized axial tomography (CT or
CAT) scans
• Diagnostic ultrasound (eg, carotid scan,
doppler studies)
Note: To minimize potential image
distortion, the neurostimulator should be
turned OFF and the transducer kept
7439 2004-08 English
221244001
Rev X
Printing instructions:
Appendix A: Electromagnetic interference
• Sewing machines or salon hair dryers:
Keep the neurostimulator away from the
motors.
121
Medtronic Confidential
NeuroPatntR00
7439_Ch07.fm 10/13/04 9:31 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
15 cm (6 in) away from the
neurostimulation system.
• Diagnostic X-rays or fluoroscopy
Appendix A: Electromagnetic interference
Note: Tight pressure in the area of your
neurostimulator, such as used during
mammography, can damage the
neurostimulator or disconnect components
of your neurostimulation system. This will
require surgery to replace or repair the
neurostimulation system. X-ray equipment
should be adjusted so it does not squeeze
the neurostimulator too tightly.
122
221244001
• Magnetoencephalography (MEG)
• Positron Emission Tomography (PET)
scans
Therapeutic magnets (eg, magnetic
mattresses, blankets, wrist wraps, elbow
wraps) – Keep the magnet at least 25 cm
(10 in) away from your neurostimulator.
Magnetic fields of 10 gauss or less will
generally not affect the neurostimulator.
English 7439 2004-08
Rev X
Printing instructions:
7439_GLS.fm 10/13/04 9:31 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Medtronic Confidential
NeuroPatntR00
Glossary
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.
Clinician – A healthcare professional such
as a doctor or nurse.
Clinician programmer – A device used by a
clinician to send instructions to the
neurostimulator and the patient programmer.
Diathermy – A medical treatment applied to
the outside of the body that delivers energy
into the body. Three types of energy that can
be used are shortwave, microwave, and
ultrasound. Depending on the power level
used, diathermy devices may or may not
produce heat within the body. This treatment
is typically used to relieve pain, stiffness and
7439 2004-08 English
221244001
Rev X
Printing instructions:
Glossary
Contraindication – A condition or
circumstance when a person should not
have a neurostimulation system.
123
7439_GLS.fm 10/13/04 9:31 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Medtronic Confidential
NeuroPatntR00
muscle spasms, reduce joint contractures,
reduce swelling and pain after surgery, and
promote wound healing.
Electrode – A metal piece near the tip of the
lead. Electrodes deliver electrical pulses to
the area where your pain signals will be
blocked.
Electromagnetic interference (EMI) – A
strong field of energy near electrical or
magnetic devices that could prevent the
neurostimulator from functioning properly.
Extension – A thin wire covered with a
protective coating that connects the
neurostimulator to a lead.
Glossary
Group – Combined programs that provide
stimulation to one or more pain sites. Each
group may be defined for a different activity,
symptom, or time of day.
124
221244001
Group row – The middle row on the
THERAPY screen. This row includes groups
that a patient can change.
English 7439 2004-08
Rev X
Printing instructions:
7439_GLS.fm 10/13/04 9:31 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Medtronic Confidential
NeuroPatntR00
Indication – The purpose of the
neurostimulation system and the medical
condition for which it may be implanted.
Information screen – A screen displayed
on the patient programmer that alerts you to
a problem with the programmer, antenna, or
neurostimulator.
Lead – A thin wire with protective coating
that has metal electrodes on one end and a
connector on the other.
Neurostimulation system – Components
that deliver electrical pulses to block pain
signals as they move to the brain.
Parameter – One of three stimulation
settings that adjust the electrical pulse:
amplitude, pulse width, and rate.
7439 2004-08 English
221244001
Rev X
Printing instructions:
Glossary
Neurostimulator – The power source of a
neurostimulation system. It contains the
battery and electronics that control the
stimulation you feel.
125
Medtronic Confidential
NeuroPatntR00
7439_GLS.fm 10/13/04 9:31 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Parameter row – The bottom row on the
THERAPY screen. Icons indicate the
parameters that a patient can adjust.
Patient programmer – A hand-held device
that allows you to turn your neurostimulator
ON and OFF. It is also used to adjust some
stimulation settings.
Program – Stimulation directed to a specific
pain site.
Programming – Using a clinician or patient
programmer to communicate stimulation
settings to a neurostimulator.
Precaution – See Caution.
Pulse width – The length or duration of an
electrical pulse.
Rate – The number of electrical pulses
delivered each second.
Glossary
Settings – See Stimulation settings.
126
221244001
English 7439 2004-08
Rev X
Printing instructions:
7439_GLS.fm 10/13/04 9:31 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Medtronic Confidential
NeuroPatntR00
SoftStart/Stop – This feature, programmed
by your clinician, starts and stops stimulation
gradually by slowly increasing or decreasing
to the programmed amplitude or OFF.
Spinal cord – This is your body’s
information center. Nerve signals from the
entire body travel to your spinal cord, and
then to your brain.
Status row – The top row on the THERAPY
screen. Icons represent information about
the neurostimulator and the patient
programmer.
Stimulation settings – Refers to all the
features assembled to define the stimulation
you feel. The clinician programs all
stimulation settings. You can adjust some
stimulation settings.
7439 2004-08 English
221244001
Rev X
Printing instructions:
Glossary
Stimulation – The delivery of electrical
pulses to the area where pain signals are
blocked as they move to the brain.
Stimulation blocks some pain signals from
reaching the brain.
127
7439_GLS.fm 10/13/04 9:31 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Medtronic Confidential
NeuroPatntR00
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
sites.
Therapy screen – The main screen
displayed on the patient programmer.
Warning – A statement describing an action
or situation that could harm the patient.
Glossary
Warning screen – A screen displayed on
the patient programmer that alerts you to a
problem with the programmer, antenna, or
neurostimulator.
128
221244001
English 7439 2004-08
Rev X
Printing instructions:
Medtronic Confidential
NeuroPatntR00
7439IX.fm 10/13/04 9:31 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Activities 29, 30, 41
Adjusting stimulation guidelines 53–55
Adjusting stimulation settings 57–65
Adverse effects 18
Amplitude
description 38
increasing or decreasing 62–65
reduce to lowest setting 31
Antenna, detachable 76–78
Antenna, internal (patient programmer) 46
Audio
changing preference 72–75
tones 57, 80
Backlight (Power/Backlight) key 71
Batteries (patient programmer)
about 66
caution 66
checking 66–67
disposing of 101
replacing 68
Bone growth stimulators 116
Cardioversion 108
Carrying case 75
CAT scans 121
Cell phones 121
Change row 73
Changes in stimulation, unexpected 30, 54
Changing a group 59–61
7439 2004-08 English
221244001
Rev X
Printing instructions:
Index
Index
129
Index
7439IX.fm 10/13/04 9:31 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
130
221244001
Medtronic Confidential
NeuroPatntR00
Checking batteries
patient programmer 66–67
Clinician programmer 40
Communication screens 82
Complications, system 18
Computerized axial tomography 121
Contraindications 16
Contrast preference 72–75
Cremation 101
CT scans 121
Day cycling
example 52
icon 51
Decrease key 64, 71
Decreasing a parameter 62–65
Defibrillation 108
Dental drills 116
Diathermy 16
Disposing of
neurostimulator 101
patient programmer 101
patient programmer batteries 101
Driving 31
Electrocautery 109
Electrolysis 116
Electromagnetic field devices 117
Electromagnetic interference (EMI) 19–24, 106–122
Error codes 82
Extensions 37
Fluoroscopy 122
English 7439 2004-08
Rev X
Printing instructions:
7439IX.fm 10/13/04 9:31 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Medtronic Confidential
NeuroPatntR00
Index
Group row 49, 60
Group row icons 50
Group, changing 59–61
Groups 38–39
Hiking 30
Household items 120
Hyperbaric chambers 30
Identification label 76
Increase key 64, 71
Increasing a parameter 62–65
Indications 16
Information screens 83–87
Interference
See Electromagnetic interference (EMI)
Keys (patient programmer) 69–71
Laser procedures 118
Leads 37
Lithotripsy 111
Lower limit screens 65
Magnetic resonance imaging (MRI) 111
Magnetoencephalography (MEG) 122
Magnets, therapeutic 122
Mammography 122
Microwave ablation 113
Navigator key 58, 69
Neurostimulation system parts 36
7439 2004-08 English
221244001
Rev X
Printing instructions:
131
Index
7439IX.fm 10/13/04 9:31 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
132
221244001
Medtronic Confidential
NeuroPatntR00
Neurostimulator
description 37
disposing of 101
low battery screen 85
turning ON or OFF 55
when to turn OFF 31
Neurostimulator OFF key 49, 70
Neurostimulator ON key 49, 70
Number format preference 72–75
Options icon 59
Parameter limit screens 65
Parameter row 49
Parameter row icons 51
Parameter, increasing or decreasing 62–65
Patient identification card 14
Patient programmer
batteries 66–68
cleaning and care 28, 98
description 37, 40, 46, 47
disposing of 101
keys 69–71
preferences 72–75
screens 80
troubleshooting 92–94
Positron Emission Tomography (PET) scans 122
Power tools 31
Power/Backlight key 69, 71
Precautions 26–31
Preference icons 72
Preferences, changing 72–75
English 7439 2004-08
Rev X
Printing instructions:
Medtronic Confidential
NeuroPatntR00
7439IX.fm 10/13/04 9:31 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Index
Pregnancy 32
Programmer
See Patient programmer
Programs
description 38–39
navigating 63
Psychotherapeutic procedures 119
Pulse width
description 38
increasing or decreasing 62–65
Radiation therapy 119
Radiofrequency (RF) ablation 113
Rate
description 38
in programs and group 63
increasing or decreasing 62–65
Scuba diving 30
Security devices 114
Serial number 95
Settings, adjusting stimulation 57–65
Skiing 30
Skydiving 30
SoftStart/Stop 90
Specifications 103
Status row 49, 72
Status row icons 50
7439 2004-08 English
221244001
Rev X
Printing instructions:
133
Index
7439IX.fm 10/13/04 9:31 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
134
221244001
Medtronic Confidential
NeuroPatntR00
Stimulation
adjusting settings 57–65
description 34
guidelines for adjusting 53–55
troubleshooting 89–91
uncomfortable 56, 89
unexpected 56
unexpected changes 30, 54
Sync key 49, 70
Synchronizing 48
Theft detectors 114
Therapy screen 48, 49
Therapy screen icons 49
Tones, audio 57, 80
Transcutaneous electrical nerve stimulation
(TENS) 119
Turning neurostimulator ON or OFF 55
Twiddler’s Syndrome 29
Ultrasonic probes 116
Ultrasonics, high-output 111
Ultrasound 121
Uncomfortable stimulation
preventing 56
troubleshooting 89
Unexpected changes in stimulation 30, 54
Unexpected stimulation, preventing 56
Upper limit screens 65
Warning screens 80–82
Warnings 19–26
X-rays 122
English 7439 2004-08
Rev X
Printing instructions:
7439_bcv.fm 10/13/04 9:31 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Medtronic Confidential
NeuroPatntR00
Contacts:
Asia: Medtronic International Ltd.
Suite 1602 16/F, Manulife Plaza,
The Lee Gardens, 33 Hysan Avenue,
Causeway Bay, Hong Kong
Tel. 852-2891-4068 Fax 852-2591-0313
Medtronic Asia Ltd.
3 Floor Peter Building,
570-6 Shinsa-Dong Kangnam-ku,
Seoul 135-120, South Korea
Tel. 82-2-548-1148 Fax 82-2-518-4786
Australia: Medtronic Australasia Pty. Ltd.
Unit 4/446 Victoria Road, Gladesville NSW 2111
Tel. 02-9879-5999 Fax 02-9879-5100
Austria: Medtronic Österreich G.m.b.H.
Millennium Tower, Handelskai 94-96, 1200 Vienna
Tel. 01-24044 Fax 01-24044-100
Belgium: Medtronic Belgium S.A.
Boechoutlaan 55, 1853 Strombeek-Bever
Tel. 02-456-0900 Fax 02-460-2667
Canada: Medtronic of Canada Ltd.
6733 Kitimat Road, Mississauga,
Ontario L5N 1W3
Tel. 905-826-6020 Fax 905-826-6620
Denmark: Medtronic-ViCare A/S
Birkerød Kongevej 150B, DK-3460 Birkerød
Tel. 45-823366 Fax 45-823365
Finland: Medtronic Finland OY/LTD
Sahaajankatu 24, P.O. Box 230
FIN-00810 Helsinki
Tel. 9-755-2500 Fax 9-755-25018
France: Medtronic France S.A.S.
122, avenue du Général Leclerc,
92514 Boulogne-Billancourt Cedex
Tel. 01-5538-1700 Fax 01-5538-1800
Germany: Medtronic GmbH
Emanuel-Leutze-Straße 20, 40547 Düsseldorf,
P.O. Box 110738
Tel. 0211-52930 Fax 0211-5293100
Greece: Medtronic Hellas S.A.
Agias Varvaras 5, 15231 Halandri, Athens
Tel. +30 2 10-677 90 99 Fax 30 2 10-677 93 99
Italy: Medtronic Italia SpA
P.zza Indro Montanelli 30,20099 Sesto
San Giovanni (MI).
Tel. 02-241371. Fax 02-241381.
Via Lucrezio Caro, 63, 00193 Roma
Tel. 06-328141 Fax 06-3215812
221244001
Rev X
Japan: Medtronic Japan
Solid Square West Tower 6F,
580 Horikawa-cho, Saiwai-ku,
Kawasaki, Kanagawa 210-0913.
Tel. 044-540-6112 Fax 044-540-6200
Latin America Headquarters: Medtronic, Inc.
710 Medtronic Parkway,
Minneapolis, MN 55432-5604 USA
Tel. 763-514-4000 Fax 763-514-4879
The Netherlands: Medtronic B.V.
Earl Bakkenstraat 10, P.O.Box 2542,
6401 DA Heerlen
Tel. 045-5668000 Fax 045-5668668
Norway: Medtronic Vingmed AS
Fjordveien 1, Postboks 366, 1323 Høvik
Tel. 67 58 06 80 Fax 67 10 12 12
Portugal: Medtronic Portugal, Lda.
Rua Tomás da Fonseca,
Torre E 8, andar A,B,
1600 - 209 Lisboa
Tel.21-724-5100 Fax 21-724-5199
Spain: Medtronic Ibérica, S.A.
Centro Empresarial Miniparc III, Edificio K,
Calle Caléndula, 93, El Soto de la Moraleja,
28109 Alcobendas - Madrid
Tel. 91-625-0400 Fax 91-650-7410
Sweden: Medtronic AB
Dackevägen 33, Box 265
S-177 25 Järfälla
Tel. 08-5222-0000 Fax 08-5222-0050
Internet: www.medtronic.se
Switzerland: Medtronic (Schweiz) AG
Route du Molliau 31
Case Postale 84
CH-1131 Tolochenaz
Tel. 021-803-8000 Fax 021-803-8099
U.K. and Ireland: Medtronic U.K. Ltd.
Suite 1, Sherbourne House,
Croxley Business Center, Watford,
Herts WD1 8YE, United Kingdom
Tel. 1923-212213 Fax 1923-241004
USA: Medtronic, Inc.
710 Medtronic Parkway
Minneapolis, MN 55432-5604 USA
Tel. 763-505-0606
Toll-free: 1-800-707-0933
Fax 763-505-0130
Printing instructions:
7439_bcv.fm 10/13/04 9:31 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Medtronic Confidential
NeuroPatntR00
Manufacturer
Medtronic, Inc.
710 Medtronic Parkway
Minneapolis, MN 55432-5604
USA
Internet: www.medtronic.com
Tel. 1-763-505-5000
Fax 1-763-505-1000
Medtronic E.C. Authorized
Representative/Distributed by
Medtronic B.V.
Earl Bakkenstraat 10
6422 PJ Heerlen
The Netherlands
Tel. 31-45-566-8000
Fax 31-45-566-8668
Europe/Africa/Middle East
Headquarters
Medtronic Europe Sàrl
Route du Molliau 31
Case Postale
CH-1131 Tolochenaz
Switzerland
Internet: www.medtronic.co.uk
Tel. 41-21-802-7000
Fax 41-21-802-7900
Asia-Pacific
Medtronic International Ltd.
Suite 1602 16/F, Manulife Plaza
The Lee Gardens, 33 Hysan Avenue
Causeway Bay
Hong Kong
Tel. 852-2891-4068
Fax 852-2591-0313
Contacts for specific countries are listed
inside this cover.
*221244001*
221244001
Rev X
© Medtronic, Inc. 2004
All Rights Reserved
221244001
Printing instructions:

---

Source Exif Data:

File Type                       : PDF
File Type Extension             : pdf
MIME Type                       : application/pdf
PDF Version                     : 1.4
Linearized                      : No
Page Count                      : 137
Page Mode                       : UseOutlines
XMP Toolkit                     : XMP toolkit 2.9.1-13, framework 1.6
About                           : uuid:6d8397ee-7689-4e7f-a616-cee76e0734d9
Producer                        : Acrobat Distiller 5.0.5 (Windows)
Create Date                     : 2004:10:13 09:25:12Z
Modify Date                     : 2005:04:20 18:46:12-05:00
Metadata Date                   : 2005:04:20 18:46:12-05:00
Creator Tool                    : FrameMaker 7.0
Document ID                     : uuid:aa0afb1c-9c28-42e9-85b0-ea6a7613b656
Format                          : application/pdf
Creator                         : dahlk1
Title                           : 7439.book
Author                          : dahlk1

EXIF Metadata provided by EXIF.tools