Medtronic 37021 External Neurostimulator (ENS) User Manual Patient manual

Medtronic, Inc. External Neurostimulator (ENS) Patient manual

Users Manual Revised

Neurological
Medtronic Confidential
Title
Model 37021 ENS Test Stimulation Patient Guide
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.
Writer
Suzanne Dawidowicz
Date
19 August 2004
Part No. Part No. Rev Comments
A01560004 A Release for US/OUS Market Release Submissions
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.
Page 1
Form MEDN-0043 version 6.0
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): 40
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.
37021_FC.fm 8/19/04 8:31 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
A01560004 Rev X Printing instructions:
Medtronic Confidential
NeuroPatntR00
EXTERNAL NEUROSTIMULATOR 37021
Test stimulation patient guide
Rx only
37021_FC.fm 8/19/04 8:32 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
A01560004 Rev X Printing instructions:
Medtronic Confidential
NeuroPatntR00
Medtronic
®
and Restore™ are trademarks of Medtronic, Inc.
FCC Information
The following is communications regulation information on
the Model 37021 external neurostimulator.
FCC ID: LF537021
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.
Printing instructions:
37021_TOC.fm 8/19/04 8:32 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
A01560004 Rev X
37021 2004-08 English
Medtronic Confidential
NeuroPatntR00
Contents
3
Contents
Label symbols 5
1 Introduction 7
Purpose of the device 8
Precautions 9
How to use this guide 9
Test stimulation overview 10
Test stimulation goals 11
Patient guides 12
2 Using your test stimulation
system 13
Knowing your system components 14
Using your external neurostimulator and
accessories 16
Using the external neurostimulator
holder 16
Checking the external neurostimulator
batteries 18
Replacing the external neurostimulator
batteries 19
Using the T
HERAPY
-
STOP
key 23
A01560004 Rev X
37021_TOC.fm 8/19/04 8:32 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Printing instructions:
English 37021 2004-08
Medtronic Confidential
NeuroPatntR00
Contents
4
Reconnecting the cable to the external
neurostimulator 23
Specifications 25
Declaration of Conformity 27
3 Your daily activities 29
What you should know about your
activities 30
Device care 30
Physical activities 31
Incision care 33
Sleeping 34
What changes in sensation to expect during
test stimulation 34
Index 36
Printing instructions:
37021_Sym.fm 8/19/04 8:32 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
A01560004 Rev X
37021 2004-08 English
Medtronic Confidential
NeuroPatntR00
Label symbols
5
Label symbols
Explanation of symbols on products and
packaging. Refer to the appropriate product
to see symbols that apply.
CE
0123
Conformité Européenne
(European Conformity). This
symbol means that the device
fully complies with MDD
93/42/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)] electrical
safety standard requirements.
y
IEC 60601-1/EN60601-1, Type BF
Equipment
w
Caution, consult accompanying
documents
L
Non-ionizing electromagnetic radiation
For USA audiences only
A01560004 Rev X
37021_Sym.fm 8/19/04 8:32 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Printing instructions:
English 37021 2004-08
Medtronic Confidential
NeuroPatntR00
Label symbols
6
37021_Ch01.fm 8/19/04 8:32 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
A01560004 Rev X Printing instructions:
Medtronic Confidential
NeuroPatntR00
1Introduction
37021_Ch01.fm 8/19/04 8:32 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
A01560004 Rev X Printing instructions:
Medtronic Confidential
NeuroPatntR00
English 37021 2004-08
Introduction 1
8
Purpose of the device
The Model 37021 external
neurostimulator is designed to
evaluate the success of
Medtronic neurostimulation
systems for pain therapy prior
to implant. The external
neurostimulator provides the
same output characteristics
as the Medtronic Restore
Neurostimulation System for
Pain Therapy.
The Medtronic neurostimulation system is
intended to provide electrical stimulation to
relieve severe, intractable pain. The
Medtronic neurostimulation system for pain
therapy indications, contraindications, risks
and benefits, warnings, precautions, and
individualization of treatment information are
located in the Model 37742 Patient
Programmer: Pain Therapy User Manual.
Printing instructions:
37021_Ch01.fm 8/19/04 8:32 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
A01560004 Rev X
37021 2004-08 English
Medtronic Confidential
NeuroPatntR00
Introduction 1
9
Precautions
When operating an external neurostimulator,
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.
How to use this guide
For over 30 years, stimulation has helped
thousands of patients manage their pain and
improve their quality of life. Test stimulation
will determine if stimulation is helpful for you.
Stimulation will not cure your pain. It may,
however, reduce your pain to a tolerable
level. As a result, you may be able to resume
your daily activities.
A01560004 Rev X
37021_Ch01.fm 8/19/04 8:32 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Printing instructions:
English 37021 2004-08
Medtronic Confidential
NeuroPatntR00
Introduction 1
10
This guide includes the following information:
•Chapter 1, “Introduction,” provides an
overview and goals of test stimulation.
•Chapter 2, “Using your test stimulation
system,” describes how to use your
external neurostimulator.
•Chapter 3, “Your daily activities,” gives
recommendations regarding your daily
activities during test stimulation.
Ask your doctor to explain anything that
is unclear.
Test stimulation overview
Your pain is unique to you. Because pain
relief can only be evaluated by you, your
doctor has prescribed a test stimulation
period. Test stimulation is designed to help
you and your doctor evaluate the benefits of
stimulation for managing your pain.
Some doctors may prescribe three to five
days for test stimulation; others may
prescribe more days. Your doctor will
Printing instructions:
37021_Ch01.fm 8/19/04 8:32 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
A01560004 Rev X
37021 2004-08 English
Medtronic Confidential
NeuroPatntR00
Introduction 1
11
determine the number of days that is best for
you.
Test stimulation allows you to experience
stimulation during your daily activities. Your
doctor may ask you to keep a log of how you
feel at different times during the day. The log
helps your doctor determine if the stimulation
is effective for managing your pain.
If you experience adequate pain relief during
test stimulation and you are comfortable
using the system, your doctor may decide to
implant a neurostimulation system.
Test stimulation goals
The goals of a test stimulation are to
determine:
•If stimulation covers your body's painful
areas
•If you are comfortable with the sensation
of stimulation
•If you can use the patient programmer to
control your stimulation
A01560004 Rev X
37021_Ch01.fm 8/19/04 8:32 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Printing instructions:
English 37021 2004-08
Medtronic Confidential
NeuroPatntR00
Introduction 1
12
Patient guides
In addition to the information contained in this
guide, your clinician should have provided
you with the following patient materials:
•Medtronic Model 37742 Patient
Programmer: Pain Therapy User Manual.
This manual provides an overview of how
stimulation works, a detailed description
of how to use your patient programmer,
and troubleshooting steps.
•Medtronic Model 37742 Patient
Programmer: Quick Reference Guide.
This guide provides basic, step-by-step
instructions on how to use your patient
programmer.
Review these materials and keep them
in a convenient place during test stimulation.
37021_Ch02.fm 8/19/04 8:32 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
A01560004 Rev X Printing instructions:
Medtronic Confidential
NeuroPatntR00
2 Using your test
stimulation
system
37021_Ch02.fm 8/19/04 8:32 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
A01560004 Rev X Printing instructions:
Medtronic Confidential
NeuroPatntR00
English 37021 2004-08
Using your test stimulation system 2
14
Knowing your system
components
For test stimulation, your
clinician will provide you with
the following components:
•External neurostimulator
–Two AA alkaline
batteries (LR6)
a
•Snap-lid connector cable
(cable)
•Patient programmer
–Two AAA alkaline batteries (LR03)
a
•External neurostimulator holder with belt
clip
a
You may need to replace batteries during test
stimulation; have extra batteries available.
Printing instructions:
37021_Ch02.fm 8/19/04 8:32 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
A01560004 Rev X
37021 2004-08 English
Medtronic Confidential
NeuroPatntR00
Using your test stimulation system 2
15
Figure 2.1 Test stimulation system components.
Patient programmerExternal neurostimulator
Holder with belt clip
Lead or extension
Snap-lid connector cable (cable)
A01560004 Rev X
37021_Ch02.fm 8/19/04 8:32 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Printing instructions:
English 37021 2004-08
Medtronic Confidential
NeuroPatntR00
Using your test stimulation system 2
16
Using your external
neurostimulator and accessories
This section provides you with the
instructions for:
•Using the external neurostimulator holder
•Checking the external neurostimulator
batteries
•Replacing the external neurostimulator
batteries
•Using the T
HERAPY
-
STOP
key
•Reconnecting the cable to the external
neurostimulator
Using the external neurostimulator
holder
Use the external neurostimulator holder to
carry the external neurostimulator on your
belt or garment.
1. Slide the external neurostimulator holder
over your belt or garment (Figure 2.2).
Printing instructions:
37021_Ch02.fm 8/19/04 8:32 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
A01560004 Rev X
37021 2004-08 English
Medtronic Confidential
NeuroPatntR00
Using your test stimulation system 2
17
Note: A belt with device pouches is
available as an option. Refer to the
instructions provided with the belt for
additional information.
Figure 2.2 Slide the external neurostimulator
holder over your belt or garment.
2. With the triangles on the cable plug and
the external neurostimulator pointing
toward each other (Figure 2.3), gently
insert the plug fully into the output jack.
Figure 2.3 Insert the plug into the output jack.
ba
A01560004 Rev X
37021_Ch02.fm 8/19/04 8:32 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Printing instructions:
English 37021 2004-08
Medtronic Confidential
NeuroPatntR00
Using your test stimulation system 2
18
3. Place the external neurostimulator into
the holder with the red T
HERAPY
-
STOP
key
facing out (Figure 2.4).
Figure 2.4 Place the external neurostimulator
into the holder.
Checking the external neurostimulator
batteries
Use your patient programmer to check your
external neurostimulator battery level every
day. For instructions on checking the external
neurostimulator battery level, refer to the
manual packaged with the patient
programmer.
T
HERAPY
-
STOP
key
Printing instructions:
37021_Ch02.fm 8/19/04 8:32 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
A01560004 Rev X
37021 2004-08 English
Medtronic Confidential
NeuroPatntR00
Using your test stimulation system 2
19
If the external neurostimulator batteries need
immediate replacement, the patient
programmer will display an information or
warning screen. Information and warning
screens are described in the Troubleshooting
section of the manual packaged with your
patient programmer.
If test stimulation lasts seven days or less,
you should not need to replace your
batteries. Battery usage depends on your
specific therapy settings and length of test
stimulation.
Replacing the external neurostimulator
batteries
Cautions:
–When replacing batteries during test
stimulation, insert the new batteries
within 15 minutes of removing the old
batteries. If the batteries are not
replaced within 15 minutes, the
neurostimulator may reset. When a
neurostimulator resets, stimulation
A01560004 Rev X
37021_Ch02.fm 8/19/04 8:32 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Printing instructions:
English 37021 2004-08
Medtronic Confidential
NeuroPatntR00
Using your test stimulation system 2
20
history is no longer available, and the
stimulation settings may not reflect
recent programming changes.
–Before installing batteries, always
decrease all amplitudes to the lowest
setting, turn OFF the external
neurostimulator and then disconnect the
cable from the external neurostimulator
to prevent possible uncomfortable or
unexpected stimulation (jolting or
shocking sensation) when stimulation is
turned ON.
1. Use your patient programmer to
decrease all amplitudes and turn OFF the
external neurostimulator.
2. Remove the external neurostimulator
from the holder.
3. Gently pull the cable plug from the output
jack.
Caution: Do not pull on the cable.
Pulling on the cable may break a wire or
dislodge the lead. A broken wire or
dislodged lead may result in loss of
Printing instructions:
37021_Ch02.fm 8/19/04 8:32 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
A01560004 Rev X
37021 2004-08 English
Medtronic Confidential
NeuroPatntR00
Using your test stimulation system 2
21
stimulation and may require surgery to
replace the lead.
4. Press down lightly on the battery
compartment cover (Figure 2.5a).
Figure 2.5 Open the battery compartment cover.
5. Push the cover in the direction of the
arrow, then swing the cover open
(Figure 2.5b, c).
6. Remove the depleted batteries and insert
two new AA alkaline batteries into the
battery compartment (Figure 2.5c).
Note: Match the battery polarity to the
positive (+) and negative (–) markings on
the inside of the battery compartment
cover (Figure 2.5c).
bac
A01560004 Rev X
37021_Ch02.fm 8/19/04 8:32 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Printing instructions:
English 37021 2004-08
Medtronic Confidential
NeuroPatntR00
Using your test stimulation system 2
22
7. Push down the battery compartment
cover until it clicks into position. Then
slide the cover back in the opposite
direction of the arrow until it closes.
8. Reconnect the cable. (For detailed
instructions, see “Reconnecting the cable
to the external neurostimulator” on
page 23.)
9. Place the external neurostimulator into
the holder.
Note: After the batteries are installed and
the battery compartment cover is closed,
stimulation may not be available for up to
60 seconds.
10. Use the patient programmer to turn ON
your external neurostimulator.
11. Dispose of depleted batteries according to
local requirements.
Printing instructions:
37021_Ch02.fm 8/19/04 8:32 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
A01560004 Rev X
37021 2004-08 English
Medtronic Confidential
NeuroPatntR00
Using your test stimulation system 2
23
Using the T
HERAPY
-
STOP
key
Typically, you will use the patient programmer
to turn stimulation OFF. However, if you need
to turn stimulation OFF immediately, press
the red T
HERAPY
-
STOP
key (Figure 2.6). You
must use the patient programmer to turn the
external neurostimulator ON again.
Figure 2.6 Use the T
HERAPY
-
STOP
key to
immediately turn stimulation OFF.
Reconnecting the cable to the external
neurostimulator
If the cable plug is disconnected from the
external neurostimulator, stimulation will
stop.
A01560004 Rev X
37021_Ch02.fm 8/19/04 8:32 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Printing instructions:
English 37021 2004-08
Medtronic Confidential
NeuroPatntR00
Using your test stimulation system 2
24
1. With the triangles on the cable plug and
the external neurostimulator pointing
toward each other, gently insert the plug
fully into the output jack (Figure 2.7).
Caution: Do not pull on the cable.
Pulling on the cable may break a wire or
dislodge the lead. A broken wire or
dislodged lead may result in loss of
stimulation and may require surgery to
replace the lead.
Figure 2.7 Insert the plug into the output jack.
2. Use your patient programmer to turn
stimulation ON.
Printing instructions:
37021_Ch02.fm 8/19/04 8:32 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
A01560004 Rev X
37021 2004-08 English
Medtronic Confidential
NeuroPatntR00
Using your test stimulation system 2
25
Specifications
Table 2.1 External neurostimulator
specifications
Item Specification
Power source 2 AA alkaline batteries
(non-rechargable, LR6)
Battery life 144 hours minimum (21 days
average) for alkaline batteries
Operating
temperature +10°C to +44°C
(+50°F to +111°F)
Storage
temperature –40°C to +65°C (–40°F to +149°F)
Relative
humidity 30% to 75% (operating)
10% to 95% (storage)
Operating
atmospheric
pressure
700 hPa to 1060 hPa
(20.7 in. Hg to 31.3 in. Hg)
Storage
atmospheric
pressure
700 hPa to 1060 hPa
(20.7 in. Hg to 31.3 in. Hg)
Size Approximately 8.9 x 5.4 x 2.8 cm
(3.5 in. x 2.1 in. x 1.1 in.)
A01560004 Rev X
37021_Ch02.fm 8/19/04 8:32 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Printing instructions:
English 37021 2004-08
Medtronic Confidential
NeuroPatntR00
Using your test stimulation system 2
26
Weight,
including
batteries
Approximately 100 g (3.5 oz.)
Mode of
operation Continuous
Case material Polycarbonate/ABS blend plastic
resin
External neurostimulator automatically shuts OFF
a
when:
•Device detects moisture
•Battery door opens
•Snap-lid connector cable is not connected
•Snap-lid connector opens
a
Use the patient programmer to turn the external
neurostimulator ON when the condition is resolved.
Table 2.1 External neurostimulator specifications
(continued)
Item Specification
Printing instructions:
37021_Ch02.fm 8/19/04 8:32 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
A01560004 Rev X
37021 2004-08 English
Medtronic Confidential
NeuroPatntR00
Using your test stimulation system 2
27
Declaration of Conformity
Medtronic declares that this product is in
conformity with the essential requirements of
Directive 1999/5EC on Radio and
Telecommunications Terminal Equipment
and Directive 93/42/EEC on Medical Devices.
For additional information, contact the
appropriate Medtronic representative listed
on the inside back cover of this manual
A01560004 Rev X
37021_Ch02.fm 8/19/04 8:32 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Printing instructions:
English 37021 2004-08
Medtronic Confidential
NeuroPatntR00
Using your test stimulation system 2
28
37021_Ch03.fm 8/19/04 8:32 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
A01560004 Rev X Printing instructions:
Medtronic Confidential
NeuroPatntR00
3 Your daily
activities
37021_Ch03.fm 8/19/04 8:32 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
A01560004 Rev X Printing instructions:
Medtronic Confidential
NeuroPatntR00
English 37021 2004-08
Your daily activities 3
30
What you should
know about your
activities
To reduce the risk of moving
your implanted lead(s) after
surgery, always follow your
clinician’s instructions during
test stimulation.
Read and understand this
patient guide and the other
patient materials about your
system.
Keep a record of your stimulation parameter
settings, daily activities, and pain relief.
Device care
•Keep fresh batteries available.
•Use the patient programmer daily to
check the external neurostimulator
batteries.
•Replace low or depleted batteries.
Printing instructions:
37021_Ch03.fm 8/19/04 8:32 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
A01560004 Rev X
37021 2004-08 English
Medtronic Confidential
NeuroPatntR00
Your daily activities 3
31
•Do not pull on the cable or lead.
•Keep the device out of the reach of
children.
•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.
Physical activities
To reduce the risk of moving your implanted
lead(s), always follow your clinician’s
instructions and these guidelines:
•Limit your physical activities to low or
moderate levels.
•Avoid reaching over your head.
A01560004 Rev X
37021_Ch03.fm 8/19/04 8:32 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Printing instructions:
English 37021 2004-08
Medtronic Confidential
NeuroPatntR00
Your daily activities 3
32
•Avoid turning side to side.
•Avoid climbing too many stairs.
•Avoid sitting in a chair for a long period of
time.
•Avoid sudden, rapid movements such as
twisting, stretching, or bending.
Note: You can move your body in bed
without twisting by moving your shoulders
and hips at the same time with a 'log-
rolling' movement. Ask your clinician to
teach this movement to you while you are
in the hospital.
•Avoid bending forward, backward, or from
side to side.
•Avoid lifting more than 2.3 kilograms
(5 pounds).
•Talk to your doctor about when it is
appropriate for you to resume sexual
activity.
Printing instructions:
37021_Ch03.fm 8/19/04 8:32 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
A01560004 Rev X
37021 2004-08 English
Medtronic Confidential
NeuroPatntR00
Your daily activities 3
33
Incision care
•Keep your incision site(s) dry by taking
sponge baths instead of showers to help
avoid infections.
•Follow your clinician's instructions about
cleaning the incision site(s) or changing
dressings.
•Follow your clinician's advice about
managing your incision pain.
•Call your clinician if you notice any of
these signs of an infection:
–Increased pain in your incision
–Fever
–Chills
–Pus
–Redness
A01560004 Rev X
37021_Ch03.fm 8/19/04 8:32 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Printing instructions:
English 37021 2004-08
Medtronic Confidential
NeuroPatntR00
Your daily activities 3
34
Sleeping
•Do not sleep on your stomach.
•Sleep on your back or on the side
opposite the device.
•Use a firm mattress that supports your
legs and back equally.
What changes in sensation to
expect during test stimulation
The sensation of stimulation is different from
person to person. Most people report a
steady, tingling sensation in the area of their
pain.
Generally, people experience a constant
sensation of stimulation. However you may
feel some normal stimulation changes when
you suddenly move or change position.
Some movements, such as leaning back,
may cause the lead to move closer to your
spinal cord. These movements can increase
your sensation of stimulation. Other
movements may cause the lead to move
Printing instructions:
37021_Ch03.fm 8/19/04 8:32 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
A01560004 Rev X
37021 2004-08 English
Medtronic Confidential
NeuroPatntR00
Your daily activities 3
35
further away from your spinal cord. These
movements may decrease your sensation of
stimulation.
Typically, you will use the patient
programmer to turn stimulation OFF.
However, if you feel a sudden and
unpleasant change in stimulation, press the
red T
HERAPY
-
STOP
key on your external
neurostimulator to turn OFF the stimulation
immediately.
If you use the red T
HERAPY
-
STOP
key, you
must use the patient programmer to turn your
stimulation ON again.
A01560004 Rev X
37021_IX.fm 8/19/04 8:32 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
Printing instructions:
English 37021 2004-08
Medtronic Confidential
NeuroPatntR03
Index
36
Index
Activities 31
Batteries, external neurostimulator
checking 18
precaution 9
replacing 19
Battery level 18
Cable, reconnecting to external neurostimulator 23
Caring for your device 30
Caring for your incision 33
Cleaning device 31
Components 14
External neurostimulator
batteries
checking 18
precaution 9
replacing 19
cable, reconnecting 23
description 8
holder 16
Holder 16
Incision care 33
Patient programmer
checking external neurostimulator battery 18
typical use 23
Precautions 9
Sensation of stimulation 34
Sleeping 34
Specifications 25
Printing instructions:
37021_IX.fm 8/19/04 8:32 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
A01560004 Rev X
37021 2004-08 English
Medtronic Confidential
NeuroPatntR03
Index
37
System components 14
Test stimulation
goals 11
overview 10
T
HERAPY
-
STOP
key 23
Turning stimulation OFF immediately 23
37021_IX.fm 8/19/04 8:32 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
A01560004 Rev X Printing instructions:
Medtronic Confidential
NeuroPatntR03
37021_bcv.fm 8/19/04 8:32 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
A01560004 Rev X Printing instructions:
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
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
37021_bcv.fm 8/19/04 8:32 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN
A01560004 Rev X Printing instructions:
*A01560004*
© Medtronic, Inc. 2004
All Rights Reserved
A01560004
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.

Navigation menu