Medtronic MyStim 97740 User manual

PATIENT PROGRAMMER

97740

Pain therapy user manual for neurostimulation

system models 37022, 37701, 37702, 37703,

37704, 37711, 37712, 37713, 37714, 97702,

97712, 97713, 97714

! USA

Rx only

2013

Filename Date Time

UC200xxxxxx EN

4.625″ x 6.0″ inches (117 mm x 152 mm)

Medtronic Confidential

PPManual.xsl - PatientProgrammerTemplate.fm

Template version 6.2: 12-03-2014

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Medtronic

®

, AdaptiveStim

®

, GroupAdjust

®

, Itrel

®

,

PrimeAdvanced

®

, Restore

®

, RestoreAdvanced

®

,

RestorePrime

®

, RestoreSensor

®

, RestoreUltra

®

,

SoftStart/Stop

®

, SureScan

®

, and TargetMyStim

®

are

trademarks of Medtronic, Inc., registered in the U.S.

and other countries.

! USA

FCC Information

The following is communications regulation information

on the Model 97740 Patient Programmer.

FCC ID: LF537741

This device complies with Part 15 Rules. Operation is

subject to the following two conditions: (1) this device

may not cause harmful interference and (2) this device

must accept any interference received, including

interference that may cause undesired operation.

IMPORTANT: Changes or modifications to this

product not authorized by Medtronic, Inc., could

void the FCC Certification and negate your

authority to operate this product.

This device complies with Industry Canada license-

exempt RSS standard(s). Operation is subject to the

following two conditions: (1) this device may not cause

interference, and (2) this device must accept any

interference, including interference that my cause

undesired operation of the device.

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Label Symbols

Explanation of symbols on products and

packaging. Refer to the appropriate product

to see symbols that apply.

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.

Consult instructions for use

Manufacturer

Serial number

EC REP

Authorized Representative in the

European Community

XXX °F

XX °C

-XX °F

-XX °C

Temperature limitation

Non-ionizing electromagnetic radiation

IEC 60601-1/EN60601-1, Type BF

Equipment

Antenna jack

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Label Symbols

PIN No.

PIN number

Keep dry

Ingress protection rating IP22, per

60601-1-11

MR

Magnetic Resonance (MR) Unsafe

System meets the applicable Canadian

(CAN/CSA-C22.2 No. 60601-1) electrical

safety standard requirements.

Chinese Standard (SJ/T11364-2006)

Logo: Electronic Information Products

Pollution Control Symbol. (The date in this

logo means the environmental protection

use period of the product.)

Do not dispose of this product in the

unsorted municipal waste stream.

Dispose of this product according to local

regulations. See http://

recycling.medtronic.com for instructions

on proper disposal of this product.

For USA audiences only

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Label Symbols

Table of contents

Label Symbols 3

Glossary 12

1

Introduction 20

How to use this manual 20

Patient guides 22

Patient identification card 25

2

Important therapy

information 28

Purpose of the device 28

Purpose of the neurostimulation system

(indications) 29

Description of your system 29

Therapies that may not be used with the

neurostimulation system

(contraindications) 34

Risks and benefits 34

Risks of surgery 35

Warnings 35

Precautions 43

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Table of contents

Individualization of Treatment 49

3

Recovery and care after

surgery 52

Recovery from surgery 52

Activities 52

When to call your clinician 54

Care schedule 54

4

Using your patient

programmer 56

How the patient programmer works 56

Patient programmer Therapy screen 58

Status row 59

Group row 61

Parameter row 63

Patient programmer keys 64

Using the Sync key 66

Using the Navigator key 68

Turning your neurostimulator on or

off 70

How to maintain the neurostimulator

batteries 72

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Table of contents

Checking the external neurostimulator

battery 72

Checking the implanted rechargeable

neurostimulator battery 74

Checking the implanted nonrechargeable

neurostimulator battery 79

Changing patient programmer

preferences 81

Using the carrying case and labeling the

patient programmer 89

Using the detachable antenna 91

5

Adjusting your stimulation 96

Introduction 96

Stimulation features 96

Adjusting stimulation settings 99

Increasing or decreasing a parameter

(amplitude, pulse width, or rate) 104

Changing back to clinician settings 108

(Models 37022, 37702, 37712, 37713,

37714, 97702, 97712, 97713,

97714) 108

Viewing and changing a group 111

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Table of contents

(Models 37022, 37701, 37702, 37711,

37712, 37713, 37714, 97702, 97712,

97713, 97714) 111

Displaying group names 114

Using GroupAdjust 116

(Models 37022, 37702, 37712, 37713,

37714, 97702, 97712, 97713,

97714) 116

Viewing Scheduled Therapy 119

(Models 37022, 37701, 37702, 37711,

37712, 37713, 97702, 97712,

97713) 119

Using TargetMyStim 121

(Models 37022, 37702, 37712, 37713,

37714, 97702, 97712, 97713,

97714) 121

Using AdaptiveStim 124

(Models 37714, 97714) 124

AdaptiveStim groups and positions 126

Turning AdaptiveStim on and off 129

Making adjustments to AdaptiveStim 132

6

MRI examinations 136

If you have an MRI appointment 136

Responsibilities of the patient in preparing

for the MRI appointment 136

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Table of contents

At the MRI appointment 137

Placing your neurostimulation system in

MRI mode for the MRI scan 139

Using the Model 97740 patient

programmer to activate MRI mode 140

Activating MRI mode 141

Turning stimulation back on after the MRI

scan 148

For neurostimulators with SureScan MRI

Technology (Models 97702, 97712,

97713, 97714) 152

7

Maintenance 156

Patient programmer batteries 156

Checking the patient programmer

batteries 156

Replacing the patient programmer

batteries 159

Cleaning and care 161

Safety and technical checks 162

Battery and patient programmer

disposal 163

Neurostimulator disposal 163

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Table of contents

Specifications 164

8

Troubleshooting 168

Patient programmer screens 168

Warning screens 168

Information screens 172

Communication screens 181

Possible problems and solutions 181

9

Additional information 190

How stimulation works 190

Controlling your stimulation 195

What your clinician controls 195

What you control 195

Possible adverse effects 196

Changes in therapy 196

Possible system complications 196

10

User assistance 200

Declaration of Conformity 201

11

Appendix A: Electromagnetic

interference (EMI) 204

Contraindication 204

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Table of contents

Warnings 205

Precautions 216

Notes 220

Index 224

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Table of contents

Glossary

Caution - A statement describing actions that

could result in damage to or improper

functioning of a device.

Clinician - A healthcare professional such as

a doctor or nurse.

Clinician programmer - A device used by a

clinician to send instructions to a

neurostimulator.

Contraindication - A condition or

circumstance when a person should not

have a neurostimulation system.

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Glossary

Diathermy - A medical treatment applied to

the outside of the body that delivers

energy into the body. Three types of

energy that can be used are shortwave,

microwave, and ultrasound. Depending on

the power level used, diathermy devices

may or may not produce heat within the

body. This treatment is typically used to

relieve pain, stiffness and muscle spasms,

reduce joint contractures, reduce swelling

and pain after surgery, and promote

wound healing.

Electrode - A metal piece near the tip of the

lead. Electrodes deliver electrical pulses to

the area where your pain signals will be

blocked.

Electromagnetic interference (EMI) - A

strong field of energy near electrical or

magnetic devices that could prevent the

neurostimulator from functioning properly.

EOS (End of service) - The neurostimulator

has reached the scheduled end of service

and no longer delivers the electrical pulses

that block pain signals.

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Glossary

ERI (Elective replacement indicator) - The

neurostimulator is nearing scheduled end

of service.

Group - Combined programs that provide

stimulation to one or more pain sites. Each

group may be defined for a different

activity, symptom, or time of day.

Indication - The purpose of the

neurostimulation system and the medical

condition for which it may be implanted.

Neurostimulation system - The implanted

and external components of the stimulation

system that delivers electrical pulses to

block pain signals as they move to the

brain.

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Glossary

Neurostimulator - The power source of a

neurostimulation system. It contains the

battery and electronics that control the

stimulation you feel. An external

neurostimulator is carried outside the

body. During test stimulation, it is used to

determine whether or not stimulation is

effective. An implanted neurostimulator is

placed inside the body. If stimulation is

effective during test stimulation, the

neurostimulator is implanted.

OOR (Out of regulation) - The

neurostimulator battery is unable to

produce the levels of energy required for

the current stimulation settings.

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.

Parameter - One of three stimulation settings

that adjust the electrical pulse: amplitude,

pulse width, and rate.

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Glossary

POR (Power on reset) - The neurostimulator

battery has caused the electronic circuitry

in the neurostimulator to be reset.

Precaution - See Caution.

Program - Stimulation directed to a specific

pain site.

Recharger - The component of the

neurostimulation system that is used to

recharge your neurostimulator battery.

SoftStart/Stop - This feature, programmed

by your clinician, starts and stops

stimulation gradually by slowly increasing

or decreasing to the programmed

amplitude or OFF.

Spinal cord - This is your body's information

center. Nerve signals from the entire body

travel to your spinal cord, and then to your

brain.

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Glossary

Stimulation - The delivery of electrical

pulses to the area where pain signals are

blocked as they move to the brain.

Stimulation blocks some pain signals from

reaching the brain.

Stimulation settings - Refers to all the

features assembled to define the

stimulation you feel. The clinician

programs all stimulation. You can adjust

some stimulation settings within clinician-

defined limits.

Test stimulation - The period of time when

an external neurostimulator is used to

determine if stimulation blocks the pain

signals effectively.

Therapy - Treatment of a disease or

condition. When neurostimulation therapy

is prescribed, a neurostimulation system is

used to deliver stimulation to one or more

pain sites.

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Glossary

Therapy impedance measurements -

Impedance and stimulation current

measurements taken at the programmed

settings.

Therapy settings - A specific combination of

amplitude, rate, and pulse width

parameters acting on a specific electrode

set that determines the stimulation pulses

that are delivered.

Warning - A statement describing an action

or situation that could harm the patient.

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Glossary

1 Introduction

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How to use this manual

Use this manual during test stimulation and

after receiving an implanted neurostimulator.

Ask your clinician to explain anything that is

unclear.

•A glossary is included at the beginning of

this manual.

•Chapter 1 "Introduction" describes the

patient documents your clinician should

have provided to you.

•Chapter 2 "Important therapy information"

describes when you should and should

not use a neurostimulation system, the

neurostimulation system components, and

the risks, benefits, warnings, precautions,

and patient activities related to your

neurostimulation system.

•Chapter 3 "Recovery and care after

surgery" provides information about

recovering from surgery, activity and care

information, and when to contact your

clinician.

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Introduction 1

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