Medtronic 37751 Patient Recharge System (INSR) User Manual Patient manual

Medtronic, Inc. Patient Recharge System (INSR) Patient manual

Users Manual

Neurological
Medtronic Confidential
Title
Model 37751 INSR patient manual
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
Theresa King-Hunter Date
24 August 2004
Part No. Part No. Rev Comments
A08366001 A Global market release
Page 1
Form MEDN-0043 version 6.0
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
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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): 86
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.
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RECHARGER 37751
Charging System user manual
c Rx Only
2005
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Medtronic®, Restore™, and SoftStart™ are trademarks of
Medtronic, Inc.
c FCC Information
The following is communications regulation information on
the Model 37751 Patient Programmer.
FCC ID: LF537751
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.
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Contents
3
Contents
Label symbols 6
1Introduction9
Purpose of the device 10
Warnings 10
Precautions 11
How to use this manual 13
Parts of your charging system 15
How your charging system works 17
Recharger keys and screens 19
Recharger keys 19
Recharger screens 21
2 Using your charging system 25
Battery and charging information 26
Recharger and Neurostimulator 26
Recharger 27
Neurostimulator 28
Neurostimulator battery status 29
Charging your neurostimulator battery 32
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4
Turning the neurostimulator ON and OFF
while charging 39
Accessories 41
Using the recharger pouch 41
Using the charging system carrying
case 41
Identification label 41
3 Troubleshooting 43
Recharger screens 44
Warning screens 44
Information screens 49
Possible problems and solutions 56
User assistance 63
4 Maintenance 65
Recharger maintenance tasks 66
Checking the recharger battery 67
Charging your recharger battery 69
Cleaning and care 72
Safety and technical checks 73
Battery and device disposal 75
Declaration of conformity 75
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Specifications 76
Glossary 78
Index 80
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Label symbols
6
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 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.
wCaution: consult accompanying
documents
nSerial number
Storage temperature
Relative humidity
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Atmospheric pressure
yIEC 60601-1/EN60601-1, Type BF
equipment
LNon-ionizing electromagnetic radiation
Class II equipment
System meets the applicable Canadian
[C22.2-601.1-M90 (R2001)] and US
(UL 60601-1:2003) electrical safety
standard requirements.
cFor USA audiences only
kPa
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8
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1 Introduction
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Introduction 1
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Purpose of the device
The Medtronic Model 37751
Charging System is designed
to charge the Medtronic
Model 37711 Restore
Neurostimulator. The Restore
Neurostimulation System is
intended to provide electrical
stimulation to relieve severe,
intractable pain. Restore
Neurostimulation System
indications, contraindications,
risks and benefits, warnings, precautions,
and individualization of treatment information
is located in the Model 37742 Patient
Programmer: Pain Therapy User Manual.
Warnings
•DO NOT use the recharger on an
unhealed wound. The recharger, antenna,
and belt are not sterile, and contact with
the wound can cause an infection.
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•Do not use the AC power supply near
water or during a lightning storm. Electric
shock, serious injury, or death may result.
Precautions
•Charge the neurostimulator when you see
a low battery ( ) screen on the patient
programmer or recharger; this prevents
the battery from overdischarging (see
glossary). If the neurostimulator battery is
allowed to overdischarge, charging is not
possible; however, the clinician may be
able to restore the battery function.
Allowing the neurostimulator battery to
overdischarge will permanently affect the
neurostimulator in one of the following
ways:
–Battery function is restored; however,
charging sessions may be more
frequent because battery capacity has
been reduced.
–Battery function is not restored, and the
neurostimulator must be surgically
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replaced. Battery function is not
restored because:
•The neurostimulator battery is
permanently damaged.
•The neurostimulator battery has
been overdischarged and restored
twice before. The third time the
battery is overdischarged, the
neurostimulator will reach end of
service. Surgery is required to
replace the neurostimulator.
•Do not expose the recharger or antenna
to extremely hot [eg, hot cars, saunas, or
direct sunlight; +40°C (104°F)] or cold
[eg, walk-in freezers; –20°C (–4°F)]
environments. The recharger and
antenna are sensitive to temperature
extremes and can become damaged.
•Use only the Medtronic neurological
charging system components to charge
your recharger. Use of non-Medtronic
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charging equipment to charge the
recharger can damage your charging
system components.
•When operating a 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.
How to use this manual
This manual is designed to help you
understand your charging system. Ask your
clinician to explain anything that is unclear.
•Chapter 1, “Introduction,” describes the
recharger keys and screens and how the
system works.
•Chapter 2, “Using your charging system,”
describes the recharger and how to
perform specific tasks.
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•Chapter 3, “Troubleshooting,” describes
recharger warning and information
screens, how to solve possible charging
system problems, and who to contact if
your recharger is lost or broken.
•Chapter 4, “Maintenance,” describes how
to care for your recharger and contains
system specifications and battery
information.
•A glossary is provided at the end of this
manual.
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Parts of your charging system
Figure 1.1 Parts of your charging system.
Recharger: The recharger is a hand-held
device for charging the battery in your
neurostimulator. It can also turn your
neurostimulator ON or OFF. The display on
the recharger provides information on your
charging system.
AC power supply and power cord: This
device is used to charge the recharger using
AC power. If you need to charge your
Recharger
AC power
supply
Power cord
Antenna
Belt
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neurostimulator but your recharger battery is
low, connect your recharger to the AC power
supply to conduct a charging session. The
power cord plugs into an electrical outlet and
connects the AC power supply to the
recharger. The power supply is a universal
component.
Note: Use only the power supply provided by
Medtronic with your charging system.
Antenna: The antenna connects to the
recharger to establish communication with
your neurostimulator. You can adjust a dial on
the antenna to improve the charging
efficiency between the recharger and the
neurostimulator.
Belt: The belt allows you to keep the antenna
directly over your neurostimulator during a
charging session.
Pouch: The recharger fits into a pouch that
can be attached to the belt so you can
maintain your normal activities during a
charging session.
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System carrying case: The carrying case is
used to store the recharger, the charging
system components, and your patient
programmer.
How your charging system
works
The charging system is used to charge your
implanted neurostimulator battery. The
battery in your recharger is similar to the
rechargeable batteries commonly found in
electronic devices. The battery typically lasts
for approximately 5 years, depending upon
your therapy needs and how often you use
your recharger.
Rechargeable batteries lose some of their
power every day, even when not used.
Charging sessions restore power to the
recharger battery.
Caution:
•Charge the neurostimulator when you see
a low battery ( ) screen on the patient
programmer or recharger; this prevents
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the battery from overdischarging (see
glossary). If the neurostimulator battery is
allowed to overdischarge, charging is not
possible; however, the clinician may be
able to restore the battery function.
Allowing the neurostimulator battery to
overdischarge will permanently affect the
neurostimulator in one of the following
ways:
–Battery function is restored; however,
charging sessions may be more
frequent because battery capacity has
been reduced.
–Battery function is not restored, and the
neurostimulator must be surgically
replaced. Battery function is not
restored because:
•The neurostimulator battery is
permanently damaged.
•The neurostimulator battery has
been overdischarged and restored
twice before. The third time the
battery is overdischarged, the
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neurostimulator will reach end of
service. Surgery is required to
replace the neurostimulator.
Recharger keys and screens
Recharger keys
Five keys on the recharger allow you to
control the recharger and turn your
neurostimulator ON and OFF.
Figure 1.2 Recharger keys.
STOP CHARGE AUDIO CONTROL
START CHARGE/TEST
NEUROSTIMULATOR ON
NEUROSTIMULATOR OFF
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•NEUROSTIMULATOR ON : Tur ns your
neurostimulator ON.
•NEUROSTIMULATOR OFF : Turns your
neurostimulator OFF.
•START CHARGE/TEST : Begins charging
the neurostimulator.
•STOP CHARGE : Ends or interrupts
charging the neurostimulator.
•AUDIO CONTROL : Turns your recharger
ON.
Note: When your recharger is ON, pressing
the AUDIO CONTROL key turns audible status
tones ON and OFF. The AUDIO CONTROL key
is also used to display the recharger battery
status.
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Recharger screens
Figure 1.3 shows the recharger screens.
Figure 1.3 Recharger screens.
The screens are separated into either two or
three rows of icons.
Status row – Displays icon information for
the recharger or neurostimulator.
During a neurostimulator charging session,
on the status row you will see:
•Neurostimulator is ON ( ) or OFF ( )
•Audio (sound) is ON ( ) or OFF ( )
•Battery charge status of the recharger
( , needs recharging to full,
respectively)
Charge
progress row
Status row
Charge
efficiency row
Neurostimulator
charging session
screen.
Recharger
charging session
screen.
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•The recharger is plugged into the AC
power supply ( ). If the recharger is not
plugged into a power supply, this area of
the screen will be blank.
During a recharger charging session, the
status row displays:
•Audio (sound) is ON ( ) or OFF ( )
Charge progress row – Indicates the
progress of the charging session.
During a neurostimulator charging session,
you will see:
•Current charge status of the
neurostimulator battery. A flashing battery
icon ( ) indicates the neurostimulator is
charging. When charging is complete, the
NEUROSTIMULATOR CHARGING COMPLETE
screen will display.
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During a recharger charging session, you will
see:
•Current charge status of the recharger
battery. A flashing battery icon ( )
indicates the recharger is charging. When
charging is complete, the RECHARGER
CHARGING COMPLETE screen will display.
•The connection icon ( ), indicating that
the power supply is connected to an
operational electrical outlet.
Charge efficiency row – Displays a series
of boxes indicating the efficiency of the
charging signal between the neurostimulator
and recharger. More solid black boxes (a
maximum of eight) indicate a more efficient
charging signal and a shorter charging
session ( ). The least efficient
charge is indicated by empty boxes
( ). If you see six empty boxes,
adjust the antenna to continue charging.
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2 Using your
charging system
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This chapter includes
information on:
•the recharger battery and
the charging procedure.
•neurostimulator battery
status icons.
•charging your
neurostimulator.
•how to turn your
neurostimulator ON or
OFF during a charging
session.
•the charging system accessories.
Battery and charging information
Recharger and Neurostimulator
•Charge the recharger or neurostimulator
even if you are not using them for an
extended period of time.
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•You can charge the neurostimulator and
recharger at the same time. Follow the
instructions for both procedures
(“Charging your neurostimulator battery”
on page 32 and “Charging your recharger
battery” on page 69) at the same time.
•Ensure you charge the batteries in your
recharger and neurostimulator before
they are low.
Recharger
•As your recharger ages, you will need to
charge the battery more often.
•The recharger battery might have run low
since it was manufactured and shipped.
You might need to charge it before you
use it the first time.
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Neurostimulator
•Your ability to locate your neurostimulator
and the depth of the neurostimulator
determine the efficiency of the charging
session. With practice, you will find the
best location on your skin for placing your
recharger and antenna.
•If your neurostimulator is on while you are
charging the battery, your charging
session might last longer.
•Depending on your therapy needs,
charging your neurostimulator could take
from one hour to more than 12 hours per
week.
•You can partially charge your
neurostimulator if you do not have enough
time for a complete charging session.
•You can charge your neurostimulator at
any time; you do not have to wait for a low
battery message.
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Neurostimulator battery status
Use your patient programmer to check your
neurostimulator battery charge level every
day. Refer to the manual supplied with the
patient programmer.
If either message in Table 2.1 is displayed,
you must recharge the neurostimulator
battery.
Table 2.1 When to charge the neurostimulator.
When you see this It means
The neurostimulator battery
charge level is low, and soon
your therapy will not be
available.
Charge the neurostimulator
battery. Press the gray
AUDIO key on the recharger
to clear the message.
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The neurostimulator battery
charge level is low.
Stimulation has stopped.
Charge the neurostimulator
battery now. Press the
green Start charge/test key
to clear the screen.
Caution: Charge the neurostimulator when you
see a low battery ( ) screen on the patient
programmer or recharger; this prevents the battery
from overdischarging (see glossary). If the
neurostimulator battery is allowed to overdischarge,
charging is not possible; however, the clinician may
be able to restore the battery function.
Allowing the neurostimulator battery to
overdischarge will permanently affect the
neurostimulator in one of the following ways:
•Battery function is restored; however, charging
sessions may be more frequent because battery
capacity has been reduced.
•Battery function is not restored, and the
neurostimulator must be surgically replaced.
Battery function is not restored because:
Table 2.1 When to charge the neurostimulator.
(continued)
When you see this It means
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The neurostimulator battery is permanently
damaged.
The neurostimulator battery has been
overdischarged and restored twice before.
The third time the battery is overdischarged,
the neurostimulator will reach end of service.
Surgery is required to replace the
neurostimulator.
Table 2.1 When to charge the neurostimulator.
(continued)
When you see this It means
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Charging your neurostimulator
battery
Check with your clinician prior to using your
recharger for the first time. When your
neurostimulator needs to be charged, follow
the steps below.
Notes:
•You might need to charge the recharger
battery before you charge your
neurostimulator battery. Refer to
“Recharger maintenance tasks” on
page 66.
•Based on the configuration of your
implanted neurostimulator, you might
need to use more than one template
(Figure 2.1) to ensure the antenna
remains positioned correctly over your
neurostimulator.
1. Press your bare skin where your
neurostimulator is located to determine
the best place for the belt and antenna.
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Notes:
•Do not place the antenna or belt over
bulky clothing or bandages.
•The antenna may be placed directly on
your skin. However, if the antenna irritates
your skin, you might want to wear a thin
undergarment to protect your skin.
2. Put on your belt, with the template
centered over your neurostimulator
(Figure 2.1) and secure the belt.
Reposition your template, if necessary.
Figure 2.1 Place the belt over your
neurostimulator.
3. Place the antenna in the template, and
press it into the belt until it snaps into the
openings on the template (Figure 2.2).
Belt
Implanted
neurostimulator Te m p l a t e
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Figure 2.2 Attach the antenna to the belt.
4. Press the green START CHARGE/TEST
key. The recharger wait screen will
appear on the recharger display
(Figure 2.3). The RECHARGER WAIT
screen indicates that the neurostimulator
and recharger are trying to communicate.
Figure 2.3 RECHARGER WAIT screen.
When charging begins, the recharger
displays a new screen indicating the
Antenna
Clips to lock antenna
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neurostimulator battery charge level and
efficiency of the charging session
(Figure 2.4).
Figure 2.4 Neurostimulator battery charge level
and charging efficiency.
The battery charge level updates throughout
the charging session. Charging sessions can
take a few minutes to more than 12 hours,
depending on the charging efficiency, how
often you charge, and your therapy needs.
Notes:
•If you need to interrupt your charging
session, press the STOP CHARGE key.
•You might hear periodic clicking noises
during recharging, and you might see the
screen refresh.
Neurostimulator battery charge level
Charge
neurostimulator
Full
charge
Efficiency
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5. If the recharger screen shows a less
efficient session, use the dial on the
antenna to try to make the session more
efficient. Turn the dial on the antenna one
quarter turn in either direction
(Figure 2.5). Press the green START
CHARGE/TEST key. The recharger will
display an updated efficiency status.
Note: The efficiency status screen will not be
updated unless the START CHARGE/TEST key is
pressed.
Figure 2.5 Adjusting the antenna dial.
Note: Repeat step 5 until the recharger
screen indicates a more efficient charging
session. Charging efficiency is affected by
factors such as implant depth, and
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efficiency will vary between patients. You
and your clinician can work together to
identify the best efficiency for you.
6. Periodically check the progress of the
charging session by reviewing the icons
on your recharger screen. If you see 6
empty boxes ( ) adjust the
antenna to continue charging.
7. When your neurostimulator has a charge
sufficient for use, you will see the
following screen:
Figure 2.6 NEUROSTIMULATOR CHARGE
SUFFICIENT FOR USE screen.
8. You can press the STOP CHARGE key to
quit your charging session, if desired.
You will hear three tones if the audio is
ON. If you wait for the system to fully
charge your neurostimulator, the
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NEUROSTIMULATOR CHARGING COMPLETE
screen will be displayed on the recharger
display, and you will hear one tone, if the
audio is ON (Figure 2.7).
Figure 2.7 NEUROSTIMULATOR CHARGING
COMPLETE screen.
9. Carefully expand the clips to unlock the
antenna and remove it from the belt
(Figure 2.8).
Figure 2.8 Removing the antenna.
10. Remove the belt and store the belt,
antenna, and recharger in the charging
system carrying case.
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Turning the neurostimulator ON
and OFF while charging
You can turn your neurostimulator ON or OFF
during a charging session.
To turn the neurostimulator ON while charging:
1. Press the NEUROSTIMULATOR ON key.
2. If audio is enabled, listen for the
confirmation tone.
3. Verify that the NEUROSTIMULATOR ON icon
( ) is displayed on the recharger
screen.
To turn the neurostimulator OFF while charging:
1. Press the NEUROSTIMULATOR OFF
key.
2. If audio is enabled, listen for the
confirmation tone.
3. Verify that the NEUROSTIMULATOR OFF
icon ( ) is displayed on the recharger
screen.
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Note: If you want to adjust stimulation using
your patient programmer before your
neurostimulator is completely charged, press
the STOP CHARGE key on the recharger.
You might need to remove the antenna so
your patient programmer can communicate
with your neurostimulator. Adjust stimulation
with your patient programmer. Resume the
charging session by pressing the START
CHARGE/TEST key.
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Accessories
Using the recharger pouch
The recharger comes with a small pouch that
you can wear on a belt during a charging
session. Using this allows you to remain
active during a charging session.
Using the charging system carrying
case
The recharger comes with a carrying case to
store the recharger and accessories. Using
the case keeps the components clean and
free from damage.
Identification label
Place an identification label on the back of
your recharger in case the recharger is lost.
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This section will help you
solve problems with your
charging system. It also
provides information on when
to call your clinician or
Medtronic.
Note: If you cannot solve a
problem, or if a problem is not
described here, contact your
clinician.
Recharger screens
The recharger displays warning () and
information ( ) screens to provide you with
information about your system, alert you to a
problem with your system, or to guide you
during recharger use.
Warning screens
Warning screens ( ) indicate a problem
with the recharger, the antenna, or the
neurostimulator. If the audio is ON, three
tones alert you to the screen. Table 3.1
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describes warning screens and provides
instructions (see blue text) on how to resolve
the problem and clear the screen.
Table 3.1 Recharger warning screens
s
Warning screen Cause and action
Reposition
antenna
You tried to turn your
neurostimulator ON or OFF
during a charging session, but
the recharger did not
communicate successfully with
the neurostimulator.
Reposition your antenna over
your neurostimulator. Try
again to turn your
neurostimulator ON or OFF.
The communication between
your recharger and your
neurostimulator was interrupted
or could not be established.
Reposition your antenna over
your neurostimulator, and
press the green START
CHARGE/TEST key.
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Charge your
neurostimulator
battery
The neurostimulator battery
charge level is low. Stimulation
has stopped.
Press the green START
CHARGE/TEST key to clear the
screen.
Charge the neurostimulator
battery now.
Caution: Charge the neurostimulator when you
see a low battery ( ) screen on the patient
programmer or recharger; this prevents the battery
from overdischarging (see glossary). If the
neurostimulator battery is allowed to overdischarge,
charging is not possible; however, the clinician may
be able to restore the battery function.
Allowing the neurostimulator battery to
overdischarge will permanently affect the
neurostimulator in one of the following ways:
•Battery function is restored; however, charging
sessions may be more frequent because battery
capacity has been reduced.
•Battery function is not restored, and the
neurostimulator must be surgically replaced.
Battery function is not restored because:
Table 3.1 Recharger warning screens (continued)
s
Warning screen Cause and action
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The neurostimulator battery is permanently
damaged.
The neurostimulator battery has been
overdischarged and restored twice before. The
third time the battery is overdischarged, the
neurostimulator will reach end of service.
Surgery is required to replace the
neurostimulator.
Charge your
recharger battery
Your recharger battery charge is
insufficient to charge your
neurostimulator.
Charge your recharger with
the AC power supply.
Call doctor Your neurostimulator has
reached end of service.
Stimulation has stopped.
Call your doctor immediately.
Table 3.1 Recharger warning screens (continued)
s
Warning screen Cause and action
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Call clinician Your system is not working
correctly. Stimulation might
have stopped.
Call your clinician and
provide the specific error
code shown on the recharger
display.
Table 3.1 Recharger warning screens (continued)
s
Warning screen Cause and action
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Information screens
Information screens ( ) provide information
and instructions on how to proceed. If the
audio is ON, three tones alert you to the
message. Press the AUDIO key on the
recharger to clear the screen. Table 3.2
describes information screens.
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Table 3.2 Recharger information screens
.
Information
screen Description and action
Check antenna The antenna connection to the
recharger is loose or your
antenna is not connected.
Check that the antenna and
recharger are making full
contact. Connect or tighten
the connection and retry.
The antenna or recharger might
require service.
Call Medtronic. Refer to the
addresses and phone
numbers on the inside back
cover of this manual.
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Move to a cooler
environment;
ensure your
system is not too
hot
Your antenna is too hot to work
properly.
Allow the antenna to cool and
retry. Store the charging
system components in a cool,
dry place.
Your skin temperature is too
warm for a successful charging
session.
Move to a cool location,
remove any excess clothing,
allow your skin temperature
to cool, and retry.
The antenna may require
service.
Contact Medtronic. Refer to
the addresses and phone
numbers on the inside back
cover of this manual.
Table 3.2 Recharger information screens
(continued)
Information
screen Description and action
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Note: This screen might
appear during a recharging
session, even if the antenna
surface does not feel warm to
you. Recharging will stop
when this screen is displayed
because the antenna is too
warm for the system to work
properly. Recharging will
begin again once the surface
temperature of the recharger
antenna is within the
operating range of the
system.
Recharger
system
information
The AUDIO CONTROL and
STOP CHARGE keys were
pressed at the same time.
Press the STOP CHARGE key to
clear this message.
Table 3.2 Recharger information screens
(continued)
Information
screen Description and action
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Charge your
neurostimulator
battery
The neurostimulator battery
charge level is low and
stimulation will stop soon.
Charge your neurostimulator
battery using the recharger.
Charge your
recharger
The recharger battery charge
level is low.
Charge your recharger
battery using the AC power
supply.
Finish
neurostimulator
charging session
The neurostimulator battery is
only partially charged.
You did not completely
charge the neurostimulator
battery. Finish charging your
neurostimulator battery using
the recharger, if desired.
Table 3.2 Recharger information screens
(continued)
Information
screen Description and action
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Finish recharger
charging session
The recharger battery is only
partially charged.
You did not completely
charge the recharger battery.
Finish charging your
recharger battery using the
AC power supply, if desired.
Neurostimulator
charging
complete
The neurostimulator battery
contains sufficient charge for
use.
Press the AUDIO key to clear
the message.
Recharger
charging
complete
The recharger battery is fully
charged.
Press the AUDIO key to clear
the message.
Table 3.2 Recharger information screens
(continued)
Information
screen Description and action
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Call clinician There is a problem with a
component of your system.
Call your clinician and
provide the specific error
code shown on the recharger
display.
Call clinician Your neurostimulator needs to
be replaced, because
stimulation will stop soon.
Call your clinician and
provide the message shown
on the recharger display.
Table 3.2 Recharger information screens
(continued)
Information
screen Description and action
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Possible problems and solutions
The following table 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).
Note: If a problem is not resolved after
several attempts or if a problem is not
described in the following table, contact your
clinician.
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Table 3.3 Troubleshooting
Problems Causes and actions
Your recharger screen
does not turn on when
you try to charge your
neurostimulator
The recharger battery is low.
Attach the AC power supply to the recharger.
The recharger is broken.
Contact your doctor.
You cannot turn ON your
neurostimulator with the
recharger
Electronic devices might be interfering with the
recharger communication signal.
Move away from all electronic devices (eg,
TVs, computer monitors, or microwaves), and
retry.
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Your AC power supply will
not turn ON (the light on
the supply does not turn
green when you plug it in)
The power cord might not be plugged into the AC
power supply or electrical outlet.
Connect the power cord to the electrical
outlet.
The connection to the power cord might be loose.
Reseat the electrical cord on the AC power
supply.
The power cord connected to the AC power
supply might be incompatible with the electrical
outlet.
Obtain an adapter for the type of electrical
outlet you are using.
Table 3.3 Troubleshooting (continued)
Problems Causes and actions
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You spill fluid on your
recharger, antenna, or AC
power supply
1. If the AC power supply is plugged into an
electrical outlet, interrupt the flow of
electricity to the outlet. Unplug the power
supply.
2. Dry the component with a towel.
Table 3.3 Troubleshooting (continued)
Problems Causes and actions
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Your recharger or antenna
falls into water
1. If the AC power supply is plugged into an
electrical outlet, interrupt the flow of
electricity to the outlet. Unplug the power
supply.
2. Remove the recharger or antenna from the
water.
3. If the recharger or antenna is dirty, wipe it
with a towel dampened with clean water.
4. Shake the recharger or antenna.
5. If you see or hear water inside, wipe it dry
with a clean towel. Repeat steps 4 and 5.
6. When the recharger or antenna is dry, try to
use it.
Table 3.3 Troubleshooting (continued)
Problems Causes and actions
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Your AC power supply
falls into water
1. Turn off the power, preferably at the
breaker fuse box, if the AC power cord is
plugged into an electrical outlet. Unplug
the power supply.
2. Remove the AC power supply from water.
3. If it is dirty, wipe it with a towel dampened
with clean water.
4. Leave the AC power supply on a dry towel
for a few hours.
5. Shake the AC power supply. If you see or
hear water inside, repeat steps 4 and 5 until
the power supply is thoroughly dry.
6. Plug the power cord into a GROUNDED
electrical outlet. A green light on the top of
the power supply will come on if it is
working properly.
Table 3.3 Troubleshooting (continued)
Problems Causes and actions
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Your recharger, antenna,
or AC power supply falls
off a cabinet or table
The recharger, antenna, and AC power supply are
designed to withstand falls of short distances.
Try the recharger, antenna, or AC power
supply; they should work.
Your recharger is beeping You cannot resolve the problem or you see a
screen other than those described in this section.
Contact your clinician to resolve the problem.
Your recharger screen is
blank
The recharger wait screen did not appear when
you pressed the START CHARGE/TEST key.
Connect your recharger to the AC power
supply and follow the directions for charging
your recharger on page 69.
Note: If the Recharger charging screen does
not appear after you connect the recharger to
the AC power supply, contact your clinician.
Table 3.3 Troubleshooting (continued)
Problems Causes and actions
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User assistance
Your recharger 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 on the back of
the recharger. This number identifies each
recharger. If you contact Medtronic about
your recharger, refer to the serial number.
If your recharger stops working – First try
the steps in Table 3.3. Otherwise, contact
Medtronic.
If you lose your recharger – Contact your
clinician to order a new recharger.
c To register the recharger for service
covered by the warranty, complete and mail
the warranty registration.
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66
This section describes how to
care for and dispose of your
recharger and accessories.
Recharger
maintenance tasks
Maintaining the battery in your
recharger ensures that you
can charge your
neurostimulator battery when
needed. For information on
charging and the batteries
within the recharger, see “Battery and
charging information” on page 26.
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Checking the recharger battery
Press the gray AUDIO key on the recharger to
turn ON your recharger and check the
recharger battery charge level. The
RECHARGER BATTERY CHARGE LEVEL screen
displays the current battery charge level
(Figure 4.1).
Figure 4.1 RECHARGER BATTERY CHARGE LEVEL
screen and icons.
Charge your recharger with the AC power
supply when you see either of the screens in
Tabl e 4.1.
Charge
recharger
Full
charge
Battery charge level
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Table 4.1 When to charge the recharger
When you see this It means
The recharger battery charge
level is low and will lose
power soon. Charge the
recharger battery.
Press the AUDIO key to
clear the message, and
charge the recharger
battery.
The recharger battery lost or
is about to lose power.
Charge the recharger
battery immediately.
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69
Charging your recharger battery
Follow the steps below to charge the
recharger battery using the AC power supply.
1. Plug the AC power supply into your AC
outlet (Figure 4.2). A green light indicates
it has power.
Warning: Do not use the AC power
supply near water or during a lightning
storm. Electric shock, serious injury, or
death may result.
Figure 4.2 Plug in the AC power supply.
2. Connect the recharger to the AC power
supply (Figure 4.3). The recharger will
automatically start to charge when
connected to the AC power supply, and
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the RECHARGER CHARGING SESSION
screen will be displayed. (Figure 4.4).
The charging session could take several
hours, depending on the charge level of
the batteries.
Note: To interrupt a recharger charging
session, disconnect the recharger from the
AC power supply.
Figure 4.3 Connect the recharger to the AC
power supply.
Figure 4.4 illustrates a RECHARGER CHARGING
SESSION screen.
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Figure 4.4 RECHARGER CHARGING SESSION
screen.
3. When the charging session is complete,
the recharger will show a RECHARGER
CHARGING COMPLETE screen (Figure 4.5.)
Figure 4.5 RECHARGER CHARGING COMPLETE
screen.
4. Unplug the AC power supply from the
electrical outlet.
5. Disconnect the AC power supply from the
recharger.
6. Return the recharger, power cord, and
AC power supply to the system carrying
case.
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Cleaning and care
Follow these guidelines to ensure that the
recharger system and accessories function
properly:
•Keep the recharger, antenna, and AC
power supply out of the reach of children.
•Use the recharger, antenna, and AC
power supply only as instructed by your
clinician and this manual.
•Handle the recharger, antenna, and AC
power supply with care. Do not drop,
strike or step on the components.
•Do not dismantle or tamper with the
recharger, antenna, or AC power supply.
•Clean the outside of the recharger,
antenna, and AC power supply with a
damp cloth when necessary. Mild
household cleaners will not damage the
components.
•The recharger, antenna, and AC power
supply are not waterproof. Do not allow
moisture to get inside the components.
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•The belt, with the antenna removed, can
be washed with a mild laundry detergent
in a washing machine and dried in a dryer
on a low heat setting.
Safety and technical checks
Periodic safety and technical checks or
periodic maintenance of the recharger are
not required.
The recharger contains no user-serviceable
parts. If the recharger requires repair or is
nonfunctional, send it to the appropriate
address listed below.
USA
Medtronic, Inc.
Neurological Division
MSN600
PO Box 1250
Minneapolis, MN 55440-9087
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Europe, Africa, Middle East, and Asia-Pacific
countries
Medtronic EOC
Medical Equipment Service Europe
Earl Bakkenstraat 10
6422 PJ Heerlen
The Netherlands
Tel. 31-455664880
Fax 31-455668028
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Battery and device disposal
Dispose of worn out devices according to
local regulations. Do not incinerate. If you no
longer need your recharger and would like to
donate it, contact your clinician.
Declaration of conformity
Medtronic declares that this product is in
conformity with the essential requirements of
Directive 1999/5/EC on Radio and
Telecommunications Terminal Equipment
and Directive 90/385/EEC on Active
Implantable Medical Devices.
For additional information, contact Medtronic.
Refer to the list of Medtronic contacts at the
end of this manual.
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Specifications
The following table lists the specifications for
your recharger.
Table 4.2 Recharger specifications
Parameter Specification
Power source 2 non-removable lithium-ion
batteries (rechargeable)
Operating
temperature +10 to +35°C (+50 to +95°F)
Storage
temperature –20 to +40°C (–4 to +104°F)
Operating/storage
relative humidity 30% to 95%
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)
Recharger size Approximately 13 x 8 x 3.18 cm
(5 x 3 x 1.25 inches)
Recharger weight,
including battery Approximately 227 g (8 oz.)
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a The longevity of your recharger battery is dependent
upon how often you use your recharger.
Battery life 5 years (life of device)a
Power supply
voltage 100–240V voltage (auto-ranging)
Rated frequency 50/60 Hz
Input current 0.35 A
Outputs 0.85 A, 8.4 V dc (V charge)
0.5 A, 10 V dc (V base)
Mode of operation Continuous
Table 4.2 Recharger specifications (continued)
Parameter Specification
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Glossary
78
Glossary
Caution – A statement describing actions
that could result in damage to or improper
functioning of a device.
Clinician – A health care professional such
as a doctor or nurse.
Contraindication – A condition or
circumstance when a person should not
have a neurostimulation system.
Indication – The purpose of the
neurostimulation system and the medical
condition for which it may be implanted.
Neurostimulator – The power source of a
neurostimulation system. It contains the
battery and electronics that control the
stimulation you feel.
Overdischarge – The neurostimulator
battery continues to lose charge even after
you see a low battery ( ) screen.
Eventually, the battery loses enough charge
to permanently affect the neurostimulator. If
this occurs, the battery is overdischarged.
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79
Patient programmer – A hand-held device
that allows you to turn your neurostimulator
ON and OFF. It is also used to adjust some
of the stimulation settings.
Precaution – See “Caution”.
Recharger – The component of the Restore
Neurostimulation System that is used to
charge your neurostimulator battery.
Stimulation – The delivery of electrical
pulses to the area where pain signals are
blocked. Stimulation blocks some pain
signals from reaching the brain.
Template – The cut-out area in the plastic
part of the charging system belt.
Warning – A statement describing an action
or situation that could harm the patient.
Warning screen – A screen displayed on
the recharger that alerts you to a problem
with the charging system.
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Index
80
Index
AC power supply
description 15
troubleshooting 58, 59, 61, 62
Accessories 41
Antenna
description 16
troubleshooting 59, 60, 62
Antenna dial
about 16
adjusting 36–37
Audio control key 19, 20
Audio tones 38, 44
Battery (neurostimulator)
See Neurostimulator battery
Battery (recharger)
See Recharger battery
Belt 16
Care 72
Carrying case 17, 41
Charge efficiency row 23
Charge progress row 22
Charging efficiency 23, 36–37
Charging neurostimulator and recharger at same
time 27
Charging session
neurostimulator battery 34–38
recharger battery 70–71
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Index
Charging system
cleaning and care 72
how it works 17
parts 15–17
Charging the neurostimulator battery
procedure 32–38
turning neurostimulator ON and OFF while
charging 39–40
Charging the recharger battery 69–71
Checking recharger battery 67–68
Cleaning 72
Dial (antenna)
about 16
adjusting 36–37
Disposing of devices 75
Identification label 41
Information screens 49–55
Interrupting
neurostimulator battery charging session 35
recharger battery charging session 70
Keys, recharger 19
Maintenance 66–71
Neurostimulation system 10
Neurostimulator
charging information 26–27, 28
turning ON and OFF while charging 39–40
See also Neurostimulator battery
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Neurostimulator battery
battery level messages 29–30, 46
charging 32–38
checking status 29
interrupting charging session 35
See also Neurostimulator
Neurostimulator OFF key 19, 20
Neurostimulator ON key 19, 20
Patient programmer 29
Pouch 16, 41
Power cord 15
Power supply
See AC power supply
Precautions 11–13
Recharger
charging information 26–27
description 15
troubleshooting 57, 59, 60, 62
See also Recharger battery
Recharger battery
about 17
charging 69–71
checking charge level 67–68
interrupting charging session 70
maintaining 66–71
See also Recharger
Recharger keys 19
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Index
Recharger screens
about 21–23
information screens 49–55
Neurostimulator charging session screen 21
Recharger charging session screen 21
warning screens 44–48
Recharger system
See Charging system
Repair address 73
Screens
See Recharger screens
Serial number 63
Specifications 76
Start charge/Test key 19, 20
Status row 21
Stop charge key 19, 20, 35
Template 33
Test (Start charge/Test) key 19, 20
Tones, audio 38, 44
Troubleshooting 44–62
Turning neurostimulator ON and OFF while
charging 39–40
Warning screens 44–48
Warnings 10–11
Warranty registration 63
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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
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*A08366001* © Medtronic, Inc. 2005
All Rights Reserved
A08366001
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.

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