Medtronic 37022, 37701, 37702, 37703, 37704 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

Medtronic®, AdaptiveStim®, GroupAdjust®, Itrel®, PrimeAdvanced RestorePrime SoftStart/Stop

, Restore®, RestoreAdvanced®,

, RestoreSensor®, RestoreUltra®,

, 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 licenseexempt 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.

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

-XX °C

-XX °F

REP

XX °C

XXX °F

Authorized Representative in the European Community

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, pe r 60601-1-11

Label Symbols

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 3 Glossary 12

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

Table of contents

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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

Table of contents

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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

Table of contents

for the MRI appointment 136

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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

User assistance 200 Declaration of Conformity 201

11 Appendix A: Electromagnetic

interference (EMI) 204

Table of contents

Contraindication 204

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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.

Glossary

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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.

Glossary

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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.

Glossary

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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 cliniciandefined 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.

Glossary

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1 Introduction

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.

Introduction 1

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Chapter 4 "Using your patient

•

programmer" describes the patient programmer and how to perform specific tasks.

Chapter 5 "Adjusting your stimulation"

•

describes how to adjust your stimulation using your patient programmer.

Chapter 6 "MRI examinations" provides

•

information about what you should do if you have an MRI examination.

Chapter 7 "Maintenance" describes how

•

to care for your patient programmer, including how to change the batteries, and lists the specifications for the patient programmer and the implanted neurostimulation system.

Chapter 8 "Troubleshooting" describes

•

patient programmer warning and information screens and how to solve possible problems.

Chapter 9 "Additional information"

•

describes how stimulation works, possible

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Introduction 1

adverse effects, changes in therapy, and possible system complications.

Chapter 10 "User assistance" describes

•

where to find the patient programmer serial number and who to contact if the patient programmer is lost or broken.

Chapter 11 "Appendix A: Electromagnetic

•

interference (EMI)" provides more information about electromagnetic interference.

Patient guides

Table 1.1 on page 23 describes the documents you should receive after a neurostimulator is implanted.

Notes:

If your implantable neurostimulator (INS)

•

has a rechargeable battery, you should receive documents for the neurostimulator charging system.

If you have an external neurostimulator

•

you will receive the Medtronic Model

Introduction 1

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37022 External Neurostimulator: Test Stimulation Patient Guide. This manual

describes the goals, activities, components, and instructions for test stimulation.

Table 1.1 Patient guides for an implanted

neurostimulator

Patient guide Rechargeable Non-

Medtronic Model 97740 Patient Programmer: Pain Therapy User Manual.

See page 20 for details.

Medtronic Model 97740 Patient Programmer: Quick Reference Guide.

Provides instructions for common patient programmer tasks.

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rechargeable

Introduction 1

Table 1.1 Patient guides for an implanted

neurostimulator (continued)

Patient guide Rechargeable Non-

Medtronic Model 37751 Recharger: Charging System User Manual. Describes the

charging system and how to use it with a rechargeable neurostimulator.

Medtronic Model 37751 Recharger: Charging System Quick Reference Guide. Provides

instructions for common recharging tasks.

Patient Identification Card. Provides

information about you, your implanted neurostimulator, and your doctor.

rechargeable

Introduction 1

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Patient identification card

When you leave the hospital, your doctor will give you a patient identification card. This card supplies information about you, your implanted device, and your doctor. Your identification card may allow you to bypass security devices. Carry this card with you at all times and bring this card with you to all MRI appointments (see Chapter 6 "MRI examinations").

If you move, change doctors, or lose your card, contact Medtronic for a replacement card. Refer to the Medtronic contacts at the end of this manual.

! USA

A temporary identification card will be provided at the hospital. After Medtronic receives your implant registration from the hospital, you will receive a permanent identification card.

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Introduction 1

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2 Important therapy information

Purpose of the device

The Medtronic Model 97740 Patient Programmer is designed to program the following Medtronic neurostimulators:

Rechargeable

Restore Model 37711

•

RestoreUltra Model 37712

•

RestoreUltra with SureScan MRI

•

Technology Model 97712 RestoreAdvanced Model 37713

•

RestoreAdvanced with SureScan MRI

•

Technology Model 97713 RestoreSensor Model 37714

•

RestoreSensor with SureScan MRI

•

Technology Model 97714

Nonrechargeable

Model 37022 External Neurostimulator

•

RestorePrime Model 37701

•

PrimeAdvanced Model 37702

•

Important therapy information 2

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PrimeAdvanced with SureScan MRI

•

Technology Model 97702 Itrel 4 Models 37703 and 37704

•

Refer to your patient identification card to determine the model number of your neurostimulator.

Purpose of the neurostimulation system (indications)

Refer to the indications sheet that is packaged with the patient programmer for the purpose of the neurostimulation system and related information.

Description of your system

A typical neurostimulation system has implanted parts that deliver the electrical pulses to the area where your pain signals are blocked.

Typically the implanted parts of a neurostimulation system include (Figure 2.1):

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Important therapy information 2

a neurostimulator

•

1 or 2 leads

•

1 or 2 extensions (optional)

•

Neurostimulator

Extensions

Electrodes

Figure 2.1 Implanted parts of a typical

neurostimulation system (spinal cord stimulation

shown).

A typical neurostimulation system also includes an external patient programmer for controlling your system. If you have a rechargeable neurostimulator, your system also includes a charging system (Figure 2.2).

Important therapy information 2

Leads

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