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 D R

A01560004 A Release for US/OUS Market Release Submissions

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

: S

PDM

WEBSITE FOR INFORMATION

1. Materials:

Covers

• Grade #1, 80 lb. white gloss coated cover stock, minimum brightness level: 89

Text

• 60 lb. white smooth opaque text stock

Labels

• N/A

2. Colors: To confirm all colors, graphics and text, refer to electronic file

Writer

Suzanne Dawidowicz

Date

19 August 2004

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.

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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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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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

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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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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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

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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.

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