Patient Programmer Manual

PATIENT PROGRAMMER 97740Pain therapy user manual for neurostimulationsystem models 37022, 37701, 37702, 37703,37704, 37711, 37712, 37713, 37714, 97702,97712, 97713, 97714

! USA Rx only2013

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Medtronic, AdaptiveStim, GroupAdjust, Itrel,PrimeAdvanced, Restore, RestoreAdvanced,RestorePrime, RestoreSensor, RestoreUltra,SoftStart/Stop, SureScan, and TargetMyStim aretrademarks of Medtronic, Inc., registered in the U.S.and other countries.! USA FCC InformationThe following is communications regulation informationon the Model 97740 Patient Programmer.FCC ID: LF537741This device complies with Part 15 Rules. Operation issubject to the following two conditions: (1) this devicemay not cause harmful interference and (2) this devicemust accept any interference received, includinginterference that may cause undesired operation.IMPORTANT: Changes or modifications to thisproduct not authorized by Medtronic, Inc., couldvoid the FCC Certification and negate yourauthority to operate this product.This device complies with Industry Canada license-exempt RSS standard(s). Operation is subject to thefollowing two conditions: (1) this device may not causeinterference, and (2) this device must accept anyinterference, including interference that my causeundesired operation of the device.

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Label SymbolsExplanation of symbols on products andpackaging. Refer to the appropriate productto see symbols that apply.

Conformit Europenne (EuropeanConformity). This symbol means that thedevice fully complies with AIMD Directive90/385/EEC (NB 0123) and R&TTEDirective 1999/5/EC.

Consult instructions for use

Manufacturer

Serial number

EC REP Authorized Representative in theEuropean Community

XXX FXX C

-XX F-XX C

Temperature limitation

Non-ionizing electromagnetic radiation

IEC 60601-1/EN60601-1, Type BFEquipment

Antenna jack

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PIN No. PIN number

Keep dry

Ingress protection rating IP22, per60601-1-11

MR Magnetic Resonance (MR) Unsafe

System meets the applicable Canadian(CAN/CSA-C22.2 No. 60601-1) electricalsafety standard requirements.

Chinese Standard (SJ/T11364-2006)Logo: Electronic Information ProductsPollution Control Symbol. (The date in thislogo means the environmental protectionuse period of the product.)

Do not dispose of this product in theunsorted municipal waste stream.Dispose of this product according to localregulations. See http://recycling.medtronic.com for instructionson proper disposal of this product.

For USA audiences only

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Table of contentsLabel Symbols 3Glossary 12

1Introduction 20How to use this manual 20Patient guides 22Patient identification card 25

2Important therapyinformation 28Purpose of the device 28Purpose of the neurostimulation system(indications) 29Description of your system 29Therapies that may not be used with theneurostimulation system(contraindications) 34Risks and benefits 34

Risks of surgery 35Warnings 35Precautions 43

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Individualization of Treatment 49

3Recovery and care aftersurgery 52Recovery from surgery 52Activities 52When to call your clinician 54Care schedule 54

4Using your patientprogrammer 56How the patient programmer works 56Patient programmer Therapy screen 58

Status row 59Group row 61Parameter row 63

Patient programmer keys 64Using the Sync key 66Using the Navigator key 68

Turning your neurostimulator on oroff 70How to maintain the neurostimulatorbatteries 72

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Checking the external neurostimulatorbattery 72Checking the implanted rechargeableneurostimulator battery 74Checking the implanted nonrechargeableneurostimulator battery 79

Changing patient programmerpreferences 81Using the carrying case and labeling thepatient programmer 89Using the detachable antenna 91

5Adjusting your stimulation 96Introduction 96Stimulation features 96Adjusting stimulation settings 99Increasing or decreasing a parameter(amplitude, pulse width, or rate) 104Changing 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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(Models 37022, 37701, 37702, 37711,37712, 37713, 37714, 97702, 97712,97713, 97714) 111Displaying 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) 124AdaptiveStim groups and positions 126Turning AdaptiveStim on and off 129Making adjustments to AdaptiveStim 132

6MRI examinations 136If you have an MRI appointment 136Responsibilities of the patient in preparingfor the MRI appointment 136

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At the MRI appointment 137Placing your neurostimulation system inMRI mode for the MRI scan 139Using the Model 97740 patientprogrammer to activate MRI mode 140

Activating MRI mode 141Turning stimulation back on after the MRIscan 148For neurostimulators with SureScan MRITechnology (Models 97702, 97712,97713, 97714) 152

7Maintenance 156Patient programmer batteries 156

Checking the patient programmerbatteries 156Replacing the patient programmerbatteries 159

Cleaning and care 161Safety and technical checks 162Battery and patient programmerdisposal 163Neurostimulator disposal 163

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Specifications 164

8Troubleshooting 168Patient programmer screens 168

Warning screens 168Information screens 172Communication screens 181

Possible problems and solutions 181

9Additional information 190How stimulation works 190Controlling your stimulation 195

What your clinician controls 195What you control 195

Possible adverse effects 196Changes in therapy 196Possible system complications 196

10User assistance 200User assistance 200Declaration of Conformity 201

11Appendix A: Electromagneticinterference (EMI) 204Contraindication 204

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Warnings 205Precautions 216Notes 220

Index 224

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GlossaryCaution - A statement describing actions that

could result in damage to or improperfunctioning of a device.

Clinician - A healthcare professional such asa doctor or nurse.

Clinician programmer - A device used by aclinician to send instructions to aneurostimulator.

Contraindication - A condition orcircumstance when a person should nothave a neurostimulation system.

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