Medtronic 37021 Users Manual

Neurological
Medtronic Confidential

Title

Model 37021 ENS Test Stimulation Patient Guide

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.

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Part No. Part No. Rev Comments

D
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R

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O NOT PRINT THIS FORM WHEN PRINTING THE LITERATURE PIECE
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EVISION HISTORY

: S

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Writer

Suzanne Dawidowicz

.

.

.

Date

19 August 2004

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Page 1

Form MEDN-0043 version 6.0

37021_FC.fm 8/19/04 8:31 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN

EXTERNAL NEUROSTIMULATOR 37021

Test stimulation patient guide

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Rx only

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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.

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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

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Contents

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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

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Contents

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Label symbols

Explanation of symbols on products and
packaging. Refer to the appropriate product
to see symbols that apply.

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y
w

L

CE

0123

System meets the applicable Canadian
[C22.2-601.1-M90 (R2001)] electrical
safety standard requirements.

IEC 60601-1/EN60601-1, Type BF
Equipment

Caution, consult accompanying
documents

Non-ionizing electromagnetic radiation

For USA audiences only

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.

Label symbols

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Label symbols

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1Introduction

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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.

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Introduction 1

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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.

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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.

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Some doctors may prescribe three to five
days for test stimulation; others may
prescribe more days. Your doctor will

Introduction 1

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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

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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

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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.

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Review these materials and keep them
in a convenient place during test stimulation.

Introduction 1

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2 Using your test

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stimulation

system

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Knowing your system
components

For test stimulation, your
clinician will provide you with
the following components:

• External neurostimulator

– Two AA alkaline

batteries (LR6)

• Snap-lid connector cable
(cable)

• Patient programmer

– Two AAA alkaline batteries (LR03)

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a

a

• External neurostimulator holder with belt
clip

a

Using your test stimulation system 2

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You may need to replace batteries during test
stimulation; have extra batteries available.

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Holder with belt clip

Snap-lid connector cable (cable)

Figure 2.1 Test stimulation system components.

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Patient programmerExternal neurostimulator

Lead or extension

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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

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• Using the T

• 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).

Using your test stimulation system 2

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HERAPY-STOP

key

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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.

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Figure 2.3 Insert the plug into the output jack.

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3. Place the external neurostimulator into
the holder with the red T
facing out (Figure 2.4).

Figure 2.4 Place the external neurostimulator

Checking the external neurostimulator

HERAPY-STOP

into the holder.

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T

HERAPY-STOP

NeuroPatntR00

key

key

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.

Using your test stimulation system 2

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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

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Cautions:

– When replacing batteries during test

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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

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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.

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2. Remove the external neurostimulator

from the holder.

3. Gently pull the cable plug from the output
jack.

Pulling on the cable may break a wire or
dislodge the lead. A broken wire or

Using your test stimulation system 2

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dislodged lead may result in loss of

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Caution: Do not pull on the cable.

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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).

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bac

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).

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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.

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10. Use the patient programmer to turn ON

your external neurostimulator.

11. Dispose of depleted batteries according to
local requirements.

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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

immediately turn stimulation OFF.

HERAPY-STOP

key to

Reconnecting the cable to the external
neurostimulator

If the cable plug is disconnected from the
external neurostimulator, stimulation will
stop.

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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.

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Figure 2.7 Insert the plug into the output jack.

2. Use your patient programmer to turn

stimulation ON.

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Specifications

Table 2.1 External neurostimulator

Item Specification

Power source 2 AA alkaline batteries

Battery life 144 hours minimum (21 days

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specifications

(non-rechargable, LR6)

average) for alkaline batteries

Operating
temperature

Storage
temperature

Relative
humidity

Operating
atmospheric
pressure

Storage
atmospheric
pressure

Size Approximately 8.9 x 5.4 x 2.8 cm

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+10°C to +44°C
(+50°F to +111°F)

–40°C to +65°C (–40°F to +149°F)

30% to 75% (operating)
10% to 95% (storage)

700 hPa to 1060 hPa
(20.7 in. Hg to 31.3 in. Hg)

700 hPa to 1060 hPa
(20.7 in. Hg to 31.3 in. Hg)

(3.5 in. x 2.1 in. x 1.1 in.)

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Tabl e 2.1 External neurostimulator specifications

Item Specification

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(continued)

Weight,

Approximately 100 g (3.5 oz.)
including
batteries

Mode of

Continuous
operation

Case material Polycarbonate/ABS blend plastic

resin

External neurostimulator automatically shuts OFF
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.

a

Using your test stimulation system 2

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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

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3 Your daily

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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.

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Device care

• Keep fresh batteries available.

• Use the patient programmer daily to

check the external neurostimulator
batteries.

• Replace low or depleted batteries.

Your daily activities 3

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• 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.

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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.

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• 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 'log­rolling' 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.

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• Avoid lifting more than 2.3 kilograms

(5 pounds).

• Talk to your doctor about when it is
appropriate for you to resume sexual
activity.

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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

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– Chills
– Pus
– Redness

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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.

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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

Your daily activities 3

movements may cause the lead to move

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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

HERAPY-STOP

red T
neurostimulator to turn OFF the stimulation
immediately.

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key on your external

If you use the red T
must use the patient programmer to turn your
stimulation ON again.

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HERAPY-STOP

37021 2004-08 English

key, you

Printing instructions:

Your daily activities 3

35

37021_IX.fm 8/19/04 8:32 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN

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

Index

Specifications 25

Medtronic Confidential

NeuroPatntR03

36

A01560004 Rev X

English 37021 2004-08

Printing instructions:

37021_IX.fm 8/19/04 8:32 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN

System components 14
Test stimulation

goals 11
overview 10

T

HERAPY-STOP

key 23

Turning stimulation OFF immediately 23

Medtronic Confidential

NeuroPatntR03

A01560004 Rev X

37021 2004-08 English

Printing instructions:

Index

37

37021_IX.fm 8/19/04 8:32 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN

Medtronic Confidential

NeuroPatntR03

A01560004 Rev X

Printing instructions:

37021_bcv.fm 8/19/04 8:32 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. [phone] Fax [phone]

Medtronic Asia Ltd.
3 Floor Peter Building,
570-6 Shinsa-Dong Kangnam-ku,
Seoul 135-120, South Korea
Tel. [phone] Fax [phone]

Austral ia: Medtronic Australasia Pty. Ltd.
Unit 4/446 Victoria Road, Gladesville NSW 2111
Tel. [phone] Fax [phone]

Austria : Medtronic Österreich G.m.b.H.
Millennium Tower, Handelskai 94-96, 1200 Vienna
Tel. [phone] Fax [phone]

Belgium: Medtronic Belgium S.A.
Boechoutlaan 55, 1853 Strombeek-Bever
Tel. [phone] Fax [phone]

Canada: Medtronic of Canada Ltd.
6733 Kitimat Road, Mississauga,
Ontario L5N 1W3
Tel. [phone] Fax [phone]

Denmark: Medtronic-ViCare A/S
Birkerød Kongevej 150B, DK-3460 Birkerød
Tel. [phone] Fax [phone]

Finland: Medtronic Finland OY/LTD
Sahaajankatu 24, P.O. Box 230
FIN-00810 Helsinki
Tel. [phone] Fax [phone]

France: Medtronic France S.A.S.
122, avenue du Général Leclerc,
92514 Boulogne-Billancourt Cedex
Tel. [phone] Fax [phone]

Germany: Medtronic GmbH
Emanuel-Leutze-Straße 20, 40547 Düsseldorf,
P.O. Box 110738
Tel. [phone] Fax [phone]

Greece: Medtronic Hellas S.A.
Agias Varvaras 5, 15231 Halandri, Athens
Tel. [phone] Fax [phone]

Italy: Medtronic Italia SpA
P.zza Indro Montanelli 30,20099 Sesto
San Giovanni (MI).
Tel. [phone]. Fax [phone].
Via Lucrezio Caro, 63, 00193 Roma
Tel. [phone] Fax [phone]

Japan: Medtronic Japan
Solid Square West Tower 6F,
580 Horikawa-cho, Saiwai-ku,
Kawasaki, Kanagawa 210-0913.
Tel. [phone] Fax [phone]

Latin America Headquarters: Medtronic, Inc.
710 Medtronic Parkway,
Minneapolis, MN 55432-5604 USA
Tel. [phone] Fax [phone]

The Netherlands: Medtronic B.V.
Earl Bakkenstraat 10, P.O.Box 2542,
6401 DA Heerlen
Tel. [phone] Fax [phone]

Norway: Medtronic Vingmed AS
Fjordveien 1, Postboks 366, 1323 Høvik
Tel. [phone] Fax [phone]

Portu gal: Medtronic Portugal, Lda.
Rua Tomás da Fonseca,
Torre E 8, andar A,B,
1600 - 209 Lisboa
Tel.[phone] Fax [phone]

Spain: Medtronic Ibérica, S.A.
Centro Empresarial Miniparc III, Edificio K,
Calle Caléndula, 93, El Soto de la Moraleja,
28109 Alcobendas - Madrid
Tel. [phone] Fax [phone]

Sweden: Medtronic AB
Dackevägen 33, Box 265
S-177 25 Järfälla
Tel. [phone] Fax [phone]
Internet: www.medtronic.se

Switzerland: Medtronic (Schweiz) AG
Route du Molliau 31
Case Postale 84
CH-1131 Tolochenaz
Tel. [phone] Fax [phone]

U.K. and Ireland: Medtronic U.K. Ltd.
Suite 1, Sherbourne House,
Croxley Business Center, Watford,
Herts WD1 8YE, United Kingdom
Tel. [phone] Fax [phone]

USA: Medtronic, Inc.

710 Medtronic Parkway
Minneapolis, MN 55432-5604
USA
Tel. [phone]
Toll-free: 1-800-707-0933
Fax [phone]

A01560004 Rev X

Printing instructions:

37021_bcv.fm 8/19/04 8:32 am
Size 4.625" x 6.0" (117 mm x 152 mm)
UC200xxxxxx EN

Manufacturer

Medtronic, Inc.
710 Medtronic Parkway
Minneapolis, MN 55432-5604
USA
Internet: www.medtronic.com
Tel. [phone]
Fax [phone]

Medtronic E.C. Authorized
Representative/Distributed by

Medtronic B.V.
Earl Bakkenstraat 10
6422 PJ Heerlen
The Netherlands
Tel. [phone]
Fax [phone]

Europe/Africa/Middle East
Headquarters

Medtronic Europe Sàrl
Route du Molliau 31
Case Postale
CH-1131 Tolochenaz
Switzerland
Internet: www.medtronic.co.uk
Tel. [phone]
Fax [phone]

Asia-Pacific

Medtronic International Ltd.
Suite 1602 16/F, Manulife Plaza
The Lee Gardens, 33 Hysan Avenue
Causeway Bay
Hong Kong
Tel. [phone]
Fax [phone]

Contacts for specific countrie s are listed
inside this cover.

Medtronic Confidential

NeuroPatntR00

*A01560004*

A01560004 Rev X

© Medtronic, Inc. 2004
All Rights Reserved

A01560004

Printing instructions: