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

Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)

Medtronic ConfidentialPPManual.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® aretrademarks of Medtronic, Inc., registered in the U.S.and other countries.! USA FCC Information

The following is communications regulation informationon the Model 97740 Patient Programmer.

FCC ID: LF537741

This 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.

Conformité Européenne (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 3

Glossary 12

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

2 Important 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

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

4 Using 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

5 Adjusting 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

6 MRI 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

7 Maintenance 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

8 Troubleshooting 168Patient programmer screens 168

Warning screens 168Information screens 172Communication screens 181

Possible problems and solutions 181

9 Additional 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

10 User assistance 200User assistance 200Declaration of Conformity 201

11 Appendix 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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Diathermy - A medical treatment applied tothe outside of the body that deliversenergy into the body. Three types ofenergy that can be used are shortwave,microwave, and ultrasound. Depending onthe power level used, diathermy devicesmay or may not produce heat within thebody. This treatment is typically used torelieve pain, stiffness and muscle spasms,reduce joint contractures, reduce swellingand pain after surgery, and promotewound healing.

Electrode - A metal piece near the tip of thelead. Electrodes deliver electrical pulses tothe area where your pain signals will beblocked.

Electromagnetic interference (EMI) - Astrong field of energy near electrical ormagnetic devices that could prevent theneurostimulator from functioning properly.

EOS (End of service) - The neurostimulatorhas reached the scheduled end of serviceand no longer delivers the electrical pulsesthat block pain signals.

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ERI (Elective replacement indicator) - Theneurostimulator is nearing scheduled endof service.

Group - Combined programs that providestimulation to one or more pain sites. Eachgroup may be defined for a differentactivity, symptom, or time of day.

Indication - The purpose of theneurostimulation system and the medicalcondition for which it may be implanted.

Neurostimulation system - The implantedand external components of the stimulationsystem that delivers electrical pulses toblock pain signals as they move to thebrain.

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Neurostimulator - The power source of aneurostimulation system. It contains thebattery and electronics that control thestimulation you feel. An externalneurostimulator is carried outside thebody. During test stimulation, it is used todetermine whether or not stimulation iseffective. An implanted neurostimulator isplaced inside the body. If stimulation iseffective during test stimulation, theneurostimulator is implanted.

OOR (Out of regulation) - Theneurostimulator battery is unable toproduce the levels of energy required forthe current stimulation settings.

Overdischarge - The neurostimulator batterycontinues to lose charge even after yousee a low battery screen. Eventually, thebattery loses enough charge topermanently affect the neurostimulator. Ifthis occurs, the battery is overdischarged.

Parameter - One of three stimulation settingsthat adjust the electrical pulse: amplitude,pulse width, and rate.

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POR (Power on reset) - The neurostimulatorbattery has caused the electronic circuitryin the neurostimulator to be reset.

Precaution - See Caution.

Program - Stimulation directed to a specificpain site.

Recharger - The component of theneurostimulation system that is used torecharge your neurostimulator battery.

SoftStart/Stop - This feature, programmedby your clinician, starts and stopsstimulation gradually by slowly increasingor decreasing to the programmedamplitude or OFF.

Spinal cord - This is your body's informationcenter. Nerve signals from the entire bodytravel to your spinal cord, and then to yourbrain.

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Stimulation - The delivery of electricalpulses to the area where pain signals areblocked as they move to the brain.Stimulation blocks some pain signals fromreaching the brain.

Stimulation settings - Refers to all thefeatures assembled to define thestimulation you feel. The clinicianprograms all stimulation. You can adjustsome stimulation settings within clinician-defined limits.

Test stimulation - The period of time whenan external neurostimulator is used todetermine if stimulation blocks the painsignals effectively.

Therapy - Treatment of a disease orcondition. When neurostimulation therapyis prescribed, a neurostimulation system isused to deliver stimulation to one or morepain sites.

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Therapy impedance measurements -Impedance and stimulation currentmeasurements taken at the programmedsettings.

Therapy settings - A specific combination ofamplitude, rate, and pulse widthparameters acting on a specific electrodeset that determines the stimulation pulsesthat are delivered.

Warning - A statement describing an actionor situation that could harm the patient.

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1 Introduction




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How to use this manualUse this manual during test stimulation andafter receiving an implanted neurostimulator.Ask your clinician to explain anything that isunclear.

• A glossary is included at the beginning ofthis manual.

• Chapter 1 "Introduction" describes thepatient documents your clinician shouldhave provided to you.

• Chapter 2 "Important therapy information"describes when you should and shouldnot use a neurostimulation system, theneurostimulation system components, andthe risks, benefits, warnings, precautions,and patient activities related to yourneurostimulation system.

• Chapter 3 "Recovery and care aftersurgery" provides information aboutrecovering from surgery, activity and careinformation, and when to contact yourclinician.

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• Chapter 4 "Using your patientprogrammer" describes the patientprogrammer and how to perform specifictasks.

• Chapter 5 "Adjusting your stimulation"describes how to adjust your stimulationusing your patient programmer.

• Chapter 6 "MRI examinations" providesinformation about what you should do ifyou have an MRI examination.

• Chapter 7 "Maintenance" describes howto care for your patient programmer,including how to change the batteries, andlists the specifications for the patientprogrammer and the implantedneurostimulation system.

• Chapter 8 "Troubleshooting" describespatient programmer warning andinformation screens and how to solvepossible problems.

• Chapter 9 "Additional information"describes how stimulation works, possible

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adverse effects, changes in therapy, andpossible system complications.

• Chapter 10 "User assistance" describeswhere to find the patient programmerserial number and who to contact if thepatient programmer is lost or broken.

• Chapter 11 "Appendix A: Electromagneticinterference (EMI)" provides moreinformation about electromagneticinterference.

Patient guidesTable 1.1 on page 23 describes thedocuments you should receive after aneurostimulator is implanted.

Notes:

• If your implantable neurostimulator (INS)has a rechargeable battery, you shouldreceive documents for the neurostimulatorcharging system.

• If you have an external neurostimulatoryou will receive the Medtronic Model

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37022 External Neurostimulator: TestStimulation Patient Guide. This manualdescribes the goals, activities,components, and instructions for teststimulation.

Table 1.1 Patient guides for an implantedneurostimulator

Patient guide Rechargeable Non-rechargeable

Medtronic Model97740 PatientProgrammer: PainTherapy User Manual.See page 20 fordetails.

X X

Medtronic Model97740 PatientProgrammer: QuickReference Guide.Provides instructionsfor common patientprogrammer tasks.

X X

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Table 1.1 Patient guides for an implantedneurostimulator (continued)

Patient guide Rechargeable Non-rechargeable

Medtronic Model37751 Recharger:Charging System UserManual. Describes thecharging system andhow to use it with arechargeableneurostimulator.

X

Medtronic Model37751 Recharger:Charging SystemQuick ReferenceGuide. Providesinstructions forcommon rechargingtasks.

X

Patient IdentificationCard. Providesinformation about you,your implantedneurostimulator, andyour doctor.

X X

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Patient identification cardWhen you leave the hospital, your doctor willgive you a patient identification card. Thiscard supplies information about you, yourimplanted device, and your doctor. Youridentification card may allow you to bypasssecurity devices. Carry this card with you atall times and bring this card with you to allMRI appointments (see Chapter 6 "MRIexaminations").

If you move, change doctors, or lose yourcard, contact Medtronic for a replacementcard. Refer to the Medtronic contacts at theend of this manual.

! USA A temporary identification card will beprovided at the hospital. After Medtronicreceives your implant registration from thehospital, you will receive a permanentidentification card.

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2 Importanttherapyinformation




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Purpose of the deviceThe Medtronic Model 97740 PatientProgrammer is designed to program thefollowing Medtronic neurostimulators:

Rechargeable

• Restore Model 37711

• RestoreUltra Model 37712

• RestoreUltra with SureScan MRITechnology Model 97712

• RestoreAdvanced Model 37713

• RestoreAdvanced with SureScan MRITechnology Model 97713

• RestoreSensor Model 37714

• RestoreSensor with SureScan MRITechnology Model 97714

Nonrechargeable

• Model 37022 External Neurostimulator

• RestorePrime Model 37701

• PrimeAdvanced Model 37702

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• PrimeAdvanced with SureScan MRITechnology Model 97702

• Itrel 4 Models 37703 and 37704

Refer to your patient identification card todetermine the model number of yourneurostimulator.

Purpose of theneurostimulation system(indications)Refer to the indications sheet that ispackaged with the patient programmer for thepurpose of the neurostimulation system andrelated information.

Description of your systemA typical neurostimulation system hasimplanted parts that deliver the electricalpulses to the area where your pain signalsare blocked.

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

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• a neurostimulator

• 1 or 2 leads

• 1 or 2 extensions (optional)

Neurostimulator

Extensions

Leads

Electrodes

Figure 2.1 Implanted parts of a typical neurostimulation system (spinal cord stimulation

shown).

A typical neurostimulation system alsoincludes an external patient programmer forcontrolling your system. If you have arechargeable neurostimulator, your systemalso includes a charging system (Figure 2.2).

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Charging system (rechargeable

neurostimulator)

Patient programmer

Carrying case

Detachable antenna

(optional)

Figure 2.2 External parts of a typical neurostimulation system.

Neurostimulator – The neurostimulator isthe power source (battery) for yourneurostimulation system. It containselectronics that generate the electricalpulses. During test stimulation, an externalneurostimulator is used to determine whether

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an implanted neurostimulator is the rightchoice for you.

Note: Some implanted neurostimulatormodels include a rechargeable battery.

Rechargeable neurostimulators

• Restore Model 37711

• RestoreUltra Model 37712

• RestoreUltra with SureScan MRITechnology Model 97712

• RestoreAdvanced Model 37713

• RestoreAdvanced with SureScan MRITechnology Model 97713

• RestoreSensor Model 37714

• RestoreSensor with SureScan MRITechnology Model 97714

Non-rechargeable neurostimulators

• RestorePrime Model 37701

• PrimeAdvanced Model 37702

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• PrimeAdvanced with SureScan MRITechnology Model 97702

• Itrel 4 Models 37703 and 37704

Lead(s) – A lead is a set of thin wires,covered with a protective coating. A lead hassmall metal electrodes near the tip. Theelectrodes transmit electrical pulses to thearea where your pain signals are blocked.

Extension(s) – An extension is a set of thinwires, covered with a protective coating, thatconnects the neurostimulator to a lead. Notall neurostimulation systems include anextension.

Patient programmer – A patientprogrammer is a hand-held device that youuse to select and adjust your stimulation. Adetachable antenna is also available if youhave difficulty reaching the neurostimulatorimplant site (refer to "Using the detachableantenna" on page 91).

Charging system used with arechargeable neurostimulator – Thecharging system is used to charge the

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implanted rechargeable neurostimulatorbattery.

Therapies that may not beused with theneurostimulation system(contraindications)Diathermy—Inform anyone treating you thatyou CANNOT have any shortwave diathermy,microwave diathermy or therapeuticultrasound diathermy (all now referred to asdiathermy) anywhere on your body becauseyou have an implanted neurostimulationsystem. Energy from diathermy can betransferred through your implanted system,and can cause tissue damage, resulting insevere injury or death.

Risks and benefitsStimulation has helped thousands of patientsmanage their pain and improve their qualityof life. Your neurostimulation system may beused with other pain treatments. Stimulation

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will not cure your pain. It can, however,reduce your pain to a tolerable level andallow you to resume many of your dailyactivities.

Risks of surgeryImplanting a neurostimulation system hasrisks similar to spinal procedures, includingspinal fluid leak, headaches, swelling,bruising, bleeding, infection, or paralysis.

If you are on anticoagulation therapy youmight be at greater risk for postoperativecomplications such as hematomas that couldresult in paralysis.

WarningsElectromagnetic interference—Electromagnetic interference (EMI) is a fieldof energy generated by equipment found inthe home, work, medical, or publicenvironments that is strong enough tointerfere with neurostimulator function.Neurostimulators include features thatprovide protection from EMI. Most electrical

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devices and magnets encountered in anormal day are unlikely to affect the operationof a neurostimulator. However, sources ofstrong EMI can result in the following:

• Serious patient injury or death,resulting from heating of the implantedcomponents of the neurostimulationsystem and damage to surroundingtissue.

• System damage, resulting in a loss of orchange in symptom control and requiringadditional surgery.

• Operational changes to theneurostimulator, that can cause it to turnon or off (particularly in a neurostimulatorenabled for magnet use) or to reset topower-on-reset (POR) values, resulting inloss of neurostimulation, return ofunderlying symptoms, and in the case ofPOR, requiring your health care providerto reprogram the neurostimulator.

• Unexpected changes in stimulation,causing a momentary increase in

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stimulation or intermittent stimulation,which some patients have described as ajolting or shocking sensation. Although theunexpected change in stimulation mayfeel uncomfortable, it does not damagethe device or injure a patient directly. Inrare cases, as a result of the unexpectedchange in stimulation, patients have fallendown and been injured.

Refer to the following table for informationon the effect of EMI on you and yourneurostimulation system. Additionalinformation and instructions on how toreduce the risk from EMI are located inAppendix A of this manual.

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Tab

le 2

.1 P

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Tab

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dev

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Tab

le 2

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XX

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Tab

le 2

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(TE

NS

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Case damage—If the neurostimulator case isruptured or pierced due to outside forces,severe burns could result from exposure tothe battery chemicals.

Neurostimulator interaction withimplanted cardiac devices—When aneurostimulator and an implanted cardiacdevice (eg, pacemaker, defibrillator) arerequired, the doctors involved with bothdevices (eg, neurologist, neurosurgeon,cardiologist, cardiac surgeon) should discussthe possible interactions between the devicesbefore surgery. To minimize or preventdevice damage or interactions, your doctorsshould place the devices on the opposite sideof the body from one another.

• Defibrillation therapy from an implanteddefibrillator can damage theneurostimulator.

• The electrical pulses from theneurostimulation system could affect thesensing operation from the cardiac deviceand result in inappropriate responses fromthe cardiac device. Your doctor should

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program your neurostimulator to a bipolarconfiguration and a minimum rate of 60Hz. The cardiac device should beprogrammed to bipolar sensing.

Precautions

System and therapyClinician programmer interaction with acochlear implant—If you have a cochlearimplant, the external portion of the cochlearsystem should be kept as far away aspossible from the clinician programmer or thecochlear implant should be turned off duringprogramming to prevent unintended audibleclicks.

Programmer interaction with other activeimplanted devices—If you have aneurostimulator and another active implanteddevice:

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• the radio-frequency (RF) signal used toprogram either device can reset orreprogram the other device

• the magnet in a cardiac programmer canactivate magnetically controlled functionsin the neurostimulator.

To verify that inadvertent programming didnot occur, clinicians familiar with each deviceshould check the programmed settingsbefore you are sent home from the hospitaland after either device is programmed (or assoon as possible after these times).

Contact your doctor immediately if you noticesymptoms that could be related to eitherdevice or to the medical condition treated byeither device.

Component compatibility—For propertherapy, use only Medtronic Neuromodulationcomponents that are prescribed by yourphysician.

Patient control devices may affect otherimplanted devices—Do not place patientcontrol devices (eg, patient programmer) over

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another device (eg, pacemaker, defibrillator,another neurostimulator). The patient controldevice could accidently change the operationof another device.

Patient programmer handling—To avoiddamaging the patient programmer, do notimmerse the device in liquid; do not clean itwith bleach, nail polish remover, mineral oil,or similar substances; and do not drop it orhandle it in a way that might damage it.

Patient device use—When operating anexternal neurostimulator, patientprogrammer, or charging system, use specialcare near flammable or explosiveatmospheres. An interaction between theflammable or explosive atmospheres and thebattery in the device could occur. Theconsequences of using a battery-powereddevice near flammable or explosiveatmospheres are unknown.

Communication interference from EMI—When using your patient programmer tocommunicate with your neurostimulator,move away from equipment that may

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generate electromagnetic interference (EMI)or turn off the likely source of EMI. EMI maydisrupt communication between the patientprogrammer and neurostimulator. Examplesof EMI sources are computer monitors,cellular telephones, and motorizedwheelchairs.

Patient programmer modification—Do notmodify this equipment. Modification of thisequipment can result in damage to theprogrammer, causing the programmer tomalfunction or become unusable.

Patient activitiesPlease read the following importantinformation about activities to avoid.

Activities requiring excessive twisting orstretching—Avoid activities that may putundue stress on the implanted components ofyour neurostimulation system. Activities thatinclude sudden, excessive, or repetitivebending, twisting, bouncing, or stretching cancause parts of your neurostimulation systemto fracture or migrate. This can result in loss

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of stimulation, intermittent stimulation,stimulation at the fracture site, and additionalsurgery. Spinal cord stimulation patients, inparticular, should avoid excessive bending ofthe torso.

Component manipulation (twiddler’ssyndrome)—Do not manipulate or rub yourneurostimulation system through the skin;this is sometimes called “twiddler'ssyndrome.” Manipulation can cause damageto your system, lead dislodgement, skinerosion, or stimulation at the implant site. Ifyou have a rechargeable neurostimulator,manipulation may also flip your device so thatit cannot be charged.

Scuba diving or hyperbaric chambers—Donot dive below 10 meters (33 feet) of water orenter hyperbaric chambers above 2.0atmospheres absolute (ATA). Pressuresbelow 10 meters (33 feet) of water (or above2.0 ATA) can damage the neurostimulationsystem. Before diving or using a hyperbaricchamber, discuss the effects of high pressurewith your doctor.

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Skydiving, skiing, or hiking in themountains—High altitudes should not affectthe neurostimulator; however, you shouldconsider the movements involved in anyplanned activity and take precaution to notput undue stress on your implanted system.During skydiving, the sudden jerking thatoccurs when the parachute opens candislodge or fracture the lead, requiringadditional surgery to repair or replace thelead.

Unexpected changes in stimulation—Electromagnetic interference, changes inposture, and other activities can cause aperceived increase in stimulation, whichsome patients have described asuncomfortable stimulation (a jolting orshocking sensation). You should reduce youramplitude to the lowest setting and turn offyour neurostimulator before engaging inactivities that could be unsafe for you orothers if you received an unexpected jolt orshock (eg, driving, operating power tools).Discuss these activities with your doctor.

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Individualization of TreatmentPatient management—Best results areachieved when you are fully informed aboutthe therapy risks and benefits, surgicalprocedure, follow-up requirements, and self-care responsibilities. Maximum benefits fromthe neurostimulation system require long-term postsurgical management.

Patient selection—The neurostimulationsystem should not be implanted if:

• your symptoms are not of physiologicalorigin,

• you are not an appropriate candidate forsurgery,

• you cannot properly operate the system,or

• you do not receive satisfactory resultsfrom test stimulation.

Use in specific populations—The safetyand effectiveness of this therapy has notbeen established for the following:

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• Pregnancy, unborn fetus, or delivery

• Pediatric use (patients under the age of18)

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3 Recovery andcare after surgery




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Recovery from surgeryIt takes several weeks to heal from surgery. Itis normal to feel some discomfort from theincision(s) and to have some pain at theimplant site for 2 to 6 weeks.

Your doctor may also prescribe physicaltherapy or medication to help manage yourpain. Always follow your doctor’s instructions.

ActivitiesSome movements can cause changes instimulation. For example, leaning back maycause the lead to move closer to your spinalcord; this can increase the sensation ofstimulation. Other movements may cause thelead to move further away from your spinalcord and decrease the stimulation sensation.Sudden changes in stimulation are mostcommon during recovery.

• Avoid activities where you must bend,stretch, or twist your body; thesemovements can move your leads, whichaffects your stimulation.

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• Avoid lying on your stomach.

• Avoid reaching over your head.

• Avoid turning from side to side.

• Avoid bending forward, backward, or fromside to side.

• Avoid lifting more than 2 kilograms(5 pounds).

As you begin to feel better, you should beable to perform activities such as:

• Bathing or showering

• Sexual activity

• Working at home or at your business

• Hobbies or activities, such as walking,gardening, cycling, or swimming

• Traveling

Remember, returning to your daily activitiesshould make you feel better, not worse.

Note: As you adjust to life with better painmanagement, you may want to try activitiesthat you could not perform before your

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surgery. Discuss your activity level with yourdoctor.

When to call your clinicianContact your clinician if any of the followingevents occur:

• You have pain, redness, or swelling at theincision(s) later than 6 weeks aftersurgery.

• You feel discomfort or pain duringstimulation. Turn your neurostimulator offand call your clinician.

• Your system is not working properly.

• You cannot turn the neurostimulator on oroff.

• You cannot adjust stimulation using yourpatient programmer.

Care scheduleYour clinician will schedule follow-up visits tomake sure you are receiving the mostappropriate therapy.

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How the patient programmerworksThe patient programmer communicates withyour neurostimulator by sending signals toand receiving signals from theneurostimulator. Your neurostimulator onlyaccepts communications from the patientprogrammer or clinician programmer.Sending information from the neurostimulatorto the patient programmer is called"synchronizing."

To synchronize the neurostimulator and thepatient programmer, the antenna of thepatient programmer must be placed directlyover the neurostimulator (Figure 4.1).

Notes:

• Keep your patient programmer accessibleat all times.

• The internal antenna is on the back of thepatient programmer.

• The patient programmer screen must faceoutward.

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• An optional detachable external antennais available for patients who have difficultyreaching their neurostimulator (refer topage 91).

Patient programmer with internal antenna

Neurostimulator

Figure 4.1 Placing the patient programmer over the neurostimulator.

Use the patient programmer to:

• turn the neurostimulator on or off.

• check the neurostimulator battery.

• change stimulation settings.

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Notes:

• The patient programmer can be used withall the neurostimulator models referencedin this manual; however, the availablefunctions will be different for each model.Be sure to note when a specificneurostimulator model is referenced todetermine if the information is applicablefor your neurostimulator.

• Figures in this chapter present informationcommon to rechargeable and non-rechargeable neurostimulators. Somefigures may display battery level iconsthat are unique to rechargeableneurostimulators.

Patient programmer TherapyscreenThe Therapy screen displays icons andnumbers that indicate your neurostimulatorand patient programmer status and yourstimulation settings (Figure 4.2).

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Rechargeable Nonrechargeable

Figure 4.2 Therapy screen.

The information that appears on the Therapyscreen may be different for each patient. Theinformation depends on whichneurostimulator you have and how yourclinician has programmed yourneurostimulator.

Information on the Therapy screen isarranged in three rows: the Status row, theGroup row, and the Parameter row.

Status row

The Status row is the top row of the Therapyscreen (Figure 4.3).

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Status row

Figure 4.3 Status row on Therapy screen.

Icons on the Status row indicate theneurostimulator on or off status and thepatient programmer battery level status. Ifyou have a rechargeable neurostimulator, theStatus row also displays the rechargeableneurostimulator battery charge level status.Refer to Table 4.1 for a description of theicons that may appear on the Status row.

Table 4.1 Status row icons

Icon Description

Neurostimulator is off

(Implanted or external neurostimulator)

Neurostimulator is on

(Implanted or external neurostimulator)

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Table 4.1 Status row icons (continued)

Icon Description

Neurostimulator is on and AdaptiveStim isenabled

Implanted rechargeable neurostimulatorbattery charge level

The implanted rechargeableneurostimulator battery charge level is low

The implanted nonrechargeableneurostimulator is near the end of service

External neurostimulator battery level

Patient programmer battery level

Group row

The Group row is the middle row of theTherapy screen (Figure 4.4). The Group rowwill only appear on the Therapy screen ifyour neurostimulator supports the Groupfeature and your clinician has programmedthe Group setting.

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Group row

Figure 4.4 Group row on Therapy screen.

The icons on the Group row indicate thename of the group and whether or not thegroup is active. Refer to Table 4.2 for adescription of the icons that may appear onthe Group row.

Table 4.2 Group row icons

Icon Description

Active

Not active

Group name (can be icons or text)

Scheduled Therapy

AdaptiveStim position (can be this icon ortext)

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Parameter row

The Parameter row is the bottom row of theTherapy screen (Figure 4.5).


Parameter row

Figure 4.5 Parameter row on Therapy screen.

The icons on the Parameter row indicate theparameter settings currently in use for yourstimulation and provide information aboutspecific stimulation settings available for yourneurostimulator. Refer to Table 4.3 for adescription of the icons that may appear onthe Parameter row.

Table 4.3 Parameter row icons

Icon Description

Amplitude

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Table 4.3 Parameter row icons (continued)

Icon Description

Pulse width

Rate

GroupAdjust

1 TargetMyStim

…AdaptiveStim position

Patient programmer keys

Neurostimulator on

Neurostimulator off

Navigator

Sync

IncreaseDecrease

Power / Backlight

Figure 4.6 Patient programmer keys.

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Table 4.4 Patient programmer keys

Key Function

Sync

• Synchronizes the neurostimulatorand patient programmer.

• Activates a selected group.

• The patient programmer must beheld over the neurostimulator whilepressing the Sync key.

Navigator

• Moves the selection box on theTherapy screen.

• Clears the information screens.

On

Off

• Turns the neurostimulator on or off.

• The patient programmer must beheld over the neurostimulator whilepressing the Neurostimulator on key or Neurostimulator off key.

• Pressing either of these keys alsoautomatically synchronizes theneurostimulator and patientprogrammer and displays theTherapy screen.

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Table 4.4 Patient programmer keys (continued)

Key Function

Power /Backlight

• Pressing and releasing this key turnsthe patient programmer on or off.

• Pressing and holding this key turnsthe backlight on or off permanently.Normally, the backlight turns on foreight seconds any time a key ispressed. The backlight providesmore light to the display.

Decrease

Increase

• Decreases or increases a parameter.

• The patient programmer must beheld over the neurostimulator whilepressing the Increase key orDecrease key.

• Pressing and holding the keychanges the parameter every half-second.

• To increase a parameter, theneurostimulator must be turned on.

Using the Sync key

Use the Sync key to synchronize yourneurostimulator and patient programmer(Figure 4.7).

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Sync key

Figure 4.7 Sync key.

Synchronizing sends the settings from yourneurostimulator to the patient programmer.All communication with the neurostimulatorbegins with synchronization. Aftersynchronization, the Therapy screenappears.

To synchronize your neurostimulator and thepatient programmer, hold the patientprogrammer over your neurostimulator andpress the Sync key.

After synchronization, the Therapy screenappears.

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Using the Navigator key

Use the Navigator key (Figure 4.8) tonavigate between and across the rows on theTherapy screen.

Figure 4.8 Navigator key.

The selection box on the Therapy screenacts as a cursor to show which row isselected for programming. If there is moreinformation on the row than can be displayed,the Options icon will appear next to theselection box (Figure 4.9).

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Selection box Options icon

Figure 4.9 Options icon and selection box.

The Navigator key moves the selection box.The arrows on the Navigator key indicate thedirection the selection box will move.

• To move the selection box between rows,press the up and down arrows onthe Navigator key.

• To move the selection box across a rowthat continues, press the left and right arrows on the Navigator key.

• When moving the selection box with theNavigator key, you do not need to holdthe programmer over yourneurostimulator. However, you must holdthe patient programmer over yourneurostimulator when pressing all otherkeys except the Power/Backlight key.

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Turning your neurostimulatoron or offComplete the following steps to turn theneurostimulator on or off.

Note: Turning your neurostimulator on or offalso synchronizes the patient programmerand neurostimulator.

1. Hold the patient programmer over yourneurostimulator with the patientprogrammer screen facing outward andpress the Neurostimulator on orNeurostimulator off key (Figure 4.10).

2. Verify that the appropriate On or Off iconis displayed on the Therapy screen(Figure 4.10).

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On

Off

Figure 4.10 Turning your neurostimulator on or off.

Caution: To prevent possibleuncomfortable or unexpectedstimulation (jolting or shockingsensation) when stimulation is turnedon, decrease all amplitudes to thelowest setting before adjusting thepulse width or rate and after turning offthe neurostimulator.

3. If you have turned the neurostimulator off,decrease the program amplitudes to thelowest setting. For instructions, see"Increasing or decreasing a parameter(amplitude, pulse width, or rate)" onpage 104.

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How to maintain theneurostimulator batteriesIt is very important that you maintain yourneurostimulator batteries, whether you havean external, an implanted rechargeable, or animplanted non-rechargeable neurostimulator.

Though you will not need to recharge theexternal or non-rechargeableneurostimulators, you should check thebattery status regularly and report any lowbattery messages to your clinician.

Checking the externalneurostimulator battery

Check the external neurostimulator batterylevel every day.

Complete the following steps to check theexternal neurostimulator battery.

1. Synchronize the patient programmer andneurostimulator.

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a. Hold the patient programmer directlyover the neurostimulator with thescreen facing outward.

b. Press the Sync key. The Therapyscreen appears.

2. Review the external neurostimulatorbattery level on the Therapy screen(Figure 4.11).

Battery level

FullReplace batteries

Figure 4.11 External neurostimulator battery status.

Table 4.5 lists the message screensassociated with the external neurostimulatorbatteries.

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Table 4.5 External neurostimulator batterymessage screens

The external neurostimulator batteriesare depleted and stimulation is notavailable.

Replace the external neurostimulatorbatteries now. Refer to the manualpackaged with the externalneurostimulator.

The external neurostimulator batteriesare low and stimulation will not beavailable soon.

Replace the external neurostimulatorbatteries. Refer to the manualpackaged with the externalneurostimulator.

Press any arrow on the Navigator keyto clear this information screen.

Checking the implantedrechargeable neurostimulatorbattery

(Models 37711, 37712, 37713, 37714,97712, 97713, 97714)

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Note: This section applies only to aneurostimulator with a rechargeable battery.If your neurostimulator is nonrechargeable,continue with "Checking the implantednonrechargeable neurostimulator battery".Check the implanted rechargeableneurostimulator battery charge level everyday.

It is critical that you charge yourneurostimulator battery before the battery isoverdischarged. Refer to the manualpackaged with the charging system for moreinformation.

Caution: Charge the neurostimulatorwhen you see a Low battery ( ) screendisplayed on the patient programmer orrecharger; this prevents the battery fromoverdischarging (see glossary). If theneurostimulator battery is allowed tooverdischarge, charging is not possible;however, the clinician may be able torestore the battery function.

Allowing the neurostimulator battery tooverdischarge will permanently affect the

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neurostimulator in one of the followingways:

• Battery function is restored; however,charging sessions may be morefrequent because battery capacity hasbeen reduced.

• Battery function is not restored and theneurostimulator must be surgicallyreplaced. Battery function is notrestored because:

– the neurostimulator battery ispermanently damaged.

– the neurostimulator battery hasbeen overdischarged and restoredtwice before. The third time thebattery is overdischarged, theneurostimulator will reach end ofservice. Surgery is required toreplace the neurostimulator.

Complete the following steps to check theimplanted rechargeable neurostimulatorbattery.

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2. Review the implanted rechargeablebattery charge level on the Therapyscreen (Figure 4.12).

Battery charge level

FullCharge

neurostimulator

Figure 4.12 Implanted neurostimulator charge level on the Therapy screen.

Table 4.6 on page 78 lists the messagescreens associated with the implantedrechargeable neurostimulator battery chargelevel.

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When the implanted rechargeableneurostimulator battery charge level is low,charge the battery as described in themanual packaged with the charging system.Your implanted rechargeable neurostimulatorbattery can be charged many times; however,eventually the implanted rechargeableneurostimulator will need to be replaced.

Table 4.6 Implanted rechargeableneurostimulator battery message screens

The implanted rechargeableneurostimulator battery charge level islow and stimulation has stopped.

Charge the neurostimulator batterynow. Refer to the manual packagedwith the charging system.

The implanted rechargeableneurostimulator battery charge level islow and stimulation will not be availablesoon.

Charge the neurostimulator battery.Refer to the manual packaged with thecharging system.


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Checking the implantednonrechargeable neurostimulatorbattery

(Models 37701, 37702, 37703, 37704,97702)

Complete the following steps to check theimplanted nonrechargeable neurostimulatorbattery.




2. Review the battery status on the Therapyscreen.

Table 4.7 lists the message screensassociated with the implantednonrechargeable neurostimulator battery.

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When the battery in an implantednonrechargeable neurostimulator is nearingdepletion, the neurostimulator must bereplaced to continue receiving stimulation.Surgery is required to replace the implantednonrechargeable neurostimulator.

Table 4.7 Implanted nonrechargeableneurostimulator battery message screens

EOSEOS

Error code = EOS: The implantednonrechargeable neurostimulator hasreached its end of service. Stimulation isnot available.

Call your clinician.

Error code = ERI: The implantednonrechargeable neurostimulator isnearing end of service. Stimulation willnot be available soon.

Call your clinician to report thismessage screen.


This screen reappears daily. Afterclearing this screen, a low batterylevel icon appears on the Status rowof the Therapy screen.

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Changing patient programmerpreferencesPatient programmer preferences affect theway information displays on the screen or theway alert tones sound. These patientprogrammer preferences include audio,contrast, time, time/number format, andgroup name. Other features can also beaccessed from preference settings. Table 4.8lists the icons associated with the preferencesettings and where to find information onother features.

Table 4.8 Preference settings icons

Icons Preference

Audio

Contrast

Time

Time and number format

Group name display

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Table 4.8 Preference settings icons (continued)

Icons Preference

Abc… AdaptiveStim name display

Return to clinician settingsa

(see page 108)

AdaptiveStim enableda

(see page 129)a Changing these preferences will change your

stimulation settings.

Complete the following steps to changepatient programmer preferences.




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2. Press the up arrow on the Navigatorkey to move the selection box to theStatus row (Figure 4.13).

Status row

Figure 4.13 Accessing preferences from the Status row.

3. Press the left or right arrow on theNavigator key to move the selection boxto the desired preference (Figure 4.14).

Figure 4.14 Moving to the desired preference.

4. Press the down arrow to move theselection box to the Change row(Figure 4.15).

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Change row

Figure 4.15 Changing the desired preference from the change row.

5. Follow the steps in Table 4.9 to changethe selected preference.

Table 4.9 Changing patient programmerpreferences

Audio

1. Press the left or right arrowon the Navigator key to movethe selection box to audio on or off .

2. Go to step 6, page 88.

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Table 4.9 Changing patient programmerpreferences (continued)

Contrast

1. Press the left or right arrowon the Navigator key to makethe contrast lighter ordarker .


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Time

1. Press the left or right arrowon the Navigator key to movethe selection box to the hour,minutes, or time of day (A or P).

2. Press the Increase orDecrease key to change theselection.

3. Press the up arrow on theNavigator key to return theselection box to the Status row.

4. Press the left or right arrowon the Navigator key to return tothe Therapy screen.

5. Press the Sync key to sendthe change to yourneurostimulator.

6. To verify the time change, repeatsteps 2 and 3 on page 83 toreturn to the Time Preferencescreen.

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Time and number format

1. Press the left or right arrowon the Navigator key to movethe selection box to a 12-hourclock and numbers with decimalsor a 24-hour clock and numberswith commas.


Group name display

(Refer to page 114 for moreinformation about group names.)

1. Press the left or right arrowon the Navigator key to movethe selection box to one of thefollowing:

– icons ( ),

– letters ( ), or

– text ( ).


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Abc…AdaptiveStim name display

(Refer to page 126 for moreinformation about AdaptiveStimnames.)

1. Press the left or right arrowon the Navigator key to movethe selection box to one of thefollowing:

– English,

– French,

– German,

– Italian,

– Spanish, or

– AdaptiveStim icon only.


6. When the change is displayed on thescreen, move the selection box to theStatus row.

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Note: The preference change is sent tothe neurostimulator at the nextsynchronization.

7. Press the left or right arrow on theNavigator key to move to anotherpreference or return to the Therapyscreen.

Using the carrying case andlabeling the patientprogrammerThe carrying case has a pouch to hold thepatient programmer and the quick referenceguide (Figure 4.16).

The case also has a loop on the back thatattaches to a belt.

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Figure 4.16 Insert the patient programmer into the case.

Place an identification label on the back ofyour patient programmer in case the patientprogrammer is lost (Figure 4.17).

ID label

Figure 4.17 Place the adhesive label on the back of the patient programmer.

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Using the detachable antennaA detachable antenna (Model 37092) isavailable if you have difficulty reaching theneurostimulator. It is also useful for viewingthe patient programmer screen while you areadjusting stimulation.

Complete the following steps to use thedetachable antenna.

1. Place the antenna over yourneurostimulator (Figure 4.18).

Figure 4.18 Place the antenna over your neurostimulator.

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2. Pull the fabric of your clothing through thelarge opening in the antenna. Then,wedge the fabric in the narrow slit tosecure the antenna in place (Figure 4.19).

a b

Figure 4.19 Pull the fabric through the slit (a) and wedge in place (b).

3. Push the antenna plug firmly into theantenna jack ( ) on the patientprogrammer (Figure 4.20).

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Figure 4.20 Insert the antenna plug into the antenna jack.

4. After the antenna is connected, follow theinstructions for using the patientprogrammer.

5. When you have finished using the patientprogrammer, grasp the antenna plug andpull it out.

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Caution: Do not pull directly on theantenna cable to disconnect the cablefrom the programmer because thismay damage the antenna cable.

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5 Adjusting yourstimulation




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IntroductionVarious features are available for adjustingyour stimulation. Each type or model ofneurostimulator provides a unique set ofstimulation features.

Stimulation featuresUsing the basic neurostimulation features,you can adjust the rate, amplitude, and pulsewidth settings for your stimulation. Forcomplete information, see "Increasing ordecreasing a parameter (amplitude, pulsewidth, or rate)" on page 104.

For information about other stimulationfeatures and which neurostimulators supportthese features, refer to Table 5.1 onpage 97.

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Tab

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Notes:

• See "Viewing and changing a group" formore information about Groups and"Using GroupAdjust" for more informationabout GroupAdjust.

• See "Using TargetMyStim" for moreinformation about TargetMyStim.

Adjusting stimulation settingsAs your activities vary throughout the day,your therapy needs may change. The patientprogrammer allows you to turn stimulation onand off, switch from one programmedstimulation option to another, and adjust theamplitude, pulse width, or rate of thestimulation. Talk to your clinician about thesettings that apply to your therapy.

Your clinician programs the availablefunctions and specifies the settings you canadjust with your patient programmer. Discussthis with your clinician.

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There is often more than one way to changestimulation settings. These instructionsdescribe the most common ways.

Notes:

• Ask your clinician to print a report withyour programmed settings.

• When a stimulation setting is changed,you will see the change on the Therapyscreen.

• If the patient programmer audio is turnedon, you will hear 1 tone that means thechange was effective. Three rapid tonesmean there was a problemcommunicating with your neurostimulatorand the change may not have occurred.

To receive the most effective therapy, somedays you may need to adjust your stimulationseveral times; other days you may not needto adjust it at all. Your clinician will providecomplete guidelines about when you maywant to adjust your stimulation.

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Table 5.2 provides general guidelines foradjusting your stimulation. For additionaladjustment guidelines refer to the sections onthe specific features associated with yourneurostimulator.

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Table 5.2 General stimulation adjustmentguidelines

Situation Action

Stimulation is too strong Decrease amplitude(s) orpulse width(s)

Stimulation is not strongenough

Increase amplitude(s) orpulse width(s)

Stimulation covers toomuch area

Decrease amplitude(s) orpulse width(s) or change toa different group

Stimulation does not coverpainful area

Increase amplitude(s) orpulse width(s) or change toa different group

The pulses (tappingsensations) feel too slow

Increase rate

The pulses (tappingsensations) feel too fast

Decrease rate

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Table 5.2 General stimulation adjustmentguidelines (continued)

Situation Action

You have unexpectedchanges in stimulation

1. Turn off theneurostimulator.

2. Decrease amplitude(s),turn on theneurostimulator, adjustparameters, and slowlyincrease amplitude(s) tothe desired level.

or

Change to a differentgroup and turn on theneurostimulator.

You have tried adjustingstimulation but are unableto find an effective setting.

Contact your clinician.

You will be passingthrough a theft detector orsecurity device Before engaging in these

activities, consult "AppendixA: Electromagneticinterference (EMI)" fordetails.

You will be usingpotentially dangerousequipment

You will be having amedical procedure

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Increasing or decreasing aparameter (amplitude, pulsewidth, or rate)Complete the following steps to adjust aparameter.

Notes:

• To increase a parameter, theneurostimulator must be on.

• To decrease a parameter, theneurostimulator may be on or off.




Caution: To prevent possibleuncomfortable or unexpectedstimulation (jolting or shockingsensation) when stimulation is turned

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on, decrease all amplitudes to thelowest setting before adjusting thepulse width or rate and after turning offthe neurostimulator.

2. Verify that the group is active ( ) and thatthe selection box is located on theParameter row.

3. Press the left or right arrow on theNavigator key to move the selection boxto the desired parameter and program(Figure 5.1).

Figure 5.1 Moving to the desired parameter.

Notes:

– Only one parameter for one programcan be displayed at a time on theParameter row. Scrolling to the rightdisplays the amplitude ( ) foreach program, followed by the pulse

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width ( ) for each program,and then the rate ( ). (Scrolling tothe left reverses the order.)

– The program is designated by thenumber above the Amplitude or Pulsewidth icon.

– There will not be a number above theRate icon because the rate is thesame for all programs in a group.

4. Hold the patient programmer over yourneurostimulator and press the Increase

or Decrease key as needed. Theincrease or decrease occurs immediatelyand is saved in the neurostimulator.

Notes:

– Pressing and holding the Increase or Decrease key changes thevalue every half-second.

– If one of the information screens inTable 5.3 appears, you tried toincrease or decrease the parameterbeyond the limits programmed by your

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clinician or beyond the capabilities ofyour neurostimulator.

Table 5.3 Parameter limit screens

You tried to decrease a parameter belowthe lowest value allowed (lower limit).

Press any arrow on the Navigator keyto clear the information screen.

You tried to increase a parameter abovethe highest value allowed (upper limit).


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Table 5.3 Parameter limit screens (continued)

You tried to increase a parameter abovewhat your neurostimulator can deliver.


Changing back to cliniciansettings

(Models 37022, 37702, 37712, 37713,37714, 97702, 97712, 97713, 97714)

You can change the stimulation settings backto the original settings programmed by yourclinician.

Complete the following steps to change backto clinician settings.

Note: Clinician settings will be applied to thegroup that is active. If your neurostimulator

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supports the use of groups, verify that thegroup you want to change back to cliniciansettings is active (see "Viewing and changinga group" on page 111 for instructions onselecting a group).





Status row


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3. Press the left or right arrows on theNavigator key to move the selection boxto the Return to Clinician Settingspreference (Figure 5.3).

4. Press the down arrow to move theselection box to the Change row(Figure 5.3).

Change row

Figure 5.3 Change row for selected preference.

5. Press the Sync key to send the changeto your neurostimulator and return to theTherapy screen.

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Viewing and changing a group

(Models 37022, 37701, 37702, 37711,37712, 37713, 37714, 97702, 97712,97713, 97714)

If your clinician programs the Group function,you may be able to change stimulationsettings by selecting a different group. Also, ifthe Group Name function is enabled, you willsee the active group displayed on yourprogrammer screen, see "Displaying groupnames" on page 114 for more information onhow to change how the active group isdisplayed.

Complete the following steps to change to anew group and make the new group active.



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2. If needed, press the up arrow on theNavigator key to move the selection boxto the Group row (Figure 5.4).

Group row

Figure 5.4 Group row on the Therapy screen.

3. Press the left or right arrows on theNavigator key to move the selection boxto the new, inactive group (Figure 5.5).

Caution: Select the group that yourclinician has recommended for thecurrent activity or posture. Use ofanother group may result inuncomfortable or unexpectedstimulation (jolting or shockingsensation) when stimulation is turnedon.

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Figure 5.5 Moving to a new group.

4. Hold the patient programmer over yourneurostimulator and press the Sync key to send the change to yourneurostimulator (Figure 5.6).

5. Verify that the new group is active onthe Therapy screen (Figure 5.6).

Figure 5.6 Making a group active.

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Displaying group names

(Models 37022, 37702, 37712, 37713,97702, 97712, 97713)

Your clinician may enable the Group Namefunction to specify the groups for you to usefor specific areas of coverage, activity, ortimes. The group name displayed on thepatient programmer screen can be a letter(eg, A), an icon (eg, ), or text (eg, Walk).

Use the definitions listed in Table 5.4 tounderstand the icon or text displayed on yourpatient programmer.

Table 5.4 Group name (icons/text)

Icon Texta Definition

Sit Group for sitting

Stand Group for standing

Lie Group for lying

Walk Group for walking

Sleep Group for sleeping

Write Group for writing

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Table 5.4 Group name (icons/text) (continued)

Icon Texta Definition

Day Group for daytime

Night Group for nighttime

Back Group for back pain

L Leg Group for left leg pain

R Leg Group for right leg pain

Legs Group for leg pain

L Arm Group for left arm pain

R Arm Group for right arm pain

Arms Group for arm pain

Hand Group for hand pain

Foot Group for foot pain

a The text listed in this column will be displayed on thepatient programmer exactly as shown in this column(ie, the text will not be translated from English into locallanguages).

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Using GroupAdjust

(Models 37022, 37702, 37712, 37713,37714, 97702, 97712, 97713, 97714)

If your clinician enabled the GroupAdjustfunction, the GroupAdjust icon ( ) willappear in the Parameter row (Figure 5.7).GroupAdjust can be used to adjust all theprogram amplitudes for the active group atthe same time.

Parameter rowA

Figure 5.7 GroupAdjust on the Parameter row.

When the Increase key or Decrease key is selected, the GroupAdjust screen isdisplayed (Figure 5.8).

Figure 5.8 GroupAdjust screen.

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Each bar on the GroupAdjust screenrepresents a program amplitude in the activegroup. The highlighted portion of the barrepresents how much you can adjust theprogram amplitude before reaching the limitsprogrammed by your clinician. Thehighlighted portion of the bar increases ordecreases as you increase or decrease theamplitude.

Complete the following steps to useGroupAdjust to change program amplitudes.

Notes:

• To increase the amplitude, theneurostimulator must be on.

• To decrease the amplitude, theneurostimulator may be on or off.



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2. Verify that the group is active ( ) and theselection box is located on theGroupAdjust icon on the Parameter row(Figure 5.7 on page 116).


or Decrease key. TheGroupAdjust screen appears.


or Decrease key to increase ordecrease the amplitude as needed.

5. Once the desired levels are displayed,release the Increase or Decrease key to save the amplitude adjustment andto return to the Therapy screen.

Notes:

– One program amplitude (representedby one of the bars) may reach its

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upper or lower limit before the otherprogram amplitudes.

– The program that reaches its upper orlower limit will stop increasing ordecreasing while the other programscontinue increasing or decreasing untilthey reach their limits.

– When all programs in the group havereached their upper or lower limits, aninformation screen will indicate that thelimit has been reached (refer toTable 5.3 on page 107).

Viewing Scheduled Therapy

(Models 37022, 37701, 37702, 37711,37712, 37713, 97702, 97712, 97713)

If your clinician programmed ScheduledTherapy, the Scheduled Therapy icon ( )appears in the Group row. ScheduledTherapy allows your clinician to programtherapy for a specific time of day. You canview Scheduled Therapy status from theTherapy screen.

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An example of Scheduled Therapy isprovided in Figure 5.9. The screens andtimetable display the following:

• Group B is active most of the day andstimulation is on

• Stimulation is off during sleep

Group B is active

Stimulation is stopped

Figure 5.9 Example of Scheduled Therapy.

Note: You can still change groups or turnyour neurostimulator on or off whenScheduled Therapy is programmed.

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Using TargetMyStim

(Models 37022, 37702, 37712, 37713,37714, 97702, 97712, 97713, 97714)

If your clinician has programmedTargetMyStim, the TargetMyStim icon ( 1)will appear in the Parameter row(Figure 5.10). TargetMyStim allows you tomake adjustments to your therapy by movingthe lead array (active electrodes) up or downone level.

Parameter row 1 3 / 5

Figure 5.10 TargetMyStim on Parameter row.

Note: If you have a Model 37714 or 97714neurostimulator and are using AdaptiveStim,TargetMyStim is not available forAdaptiveStim groups (refer to page 124 formore information on AdaptiveStim).

The small metal electrodes near the tip of thelead are not all active at the same time. Only

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those electrodes that are active deliver theelectrical pulses. Specific combinations orpositions of active electrodes will deliverstimulation to a very specific pain site.

TargetMyStim allows you to try specificelectrode positions to determine which is bestfor your pain.

The small numbers on the TargetMyStim iconrepresent the electrode position for aprogram in the active group and the numberof adjustments available (Figure 5.10). Forexample, 3/5 means the electrodes are inposition 3 out of a possible 5 positions. Thenumber of available positions will varydepending on how your clinician programmedyour neurostimulator.

When the Increase key or Decrease key is selected, the TargetMyStim screen isdisplayed showing the current position andthe selected position (Figure 5.11).

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3/5 4/53/5 4/51

Figure 5.11 TargetMyStim screen.

Complete the following steps to useTargetMyStim to adjust your stimulation.




2. Verify that the group is active ( ) and theselection box is located on theTargetMyStim icon on the Parameter row(Figure 5.10 on page 121).


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or Decrease key. TheTargetMyStim screen appears.


or Decrease key to change activeelectrode positions as needed.

5. Once the desired levels are displayed,press the Sync key.

The patient programmer changes theelectrode position, then the amplitudeslowly increases until it reaches theprogrammed value. Pressing theIncrease or Decrease key will stopthe amplitude increase before it reachesthe programmed value.

6. Press the left arrow on the Navigatorkey to return to the Therapy screen.

Using AdaptiveStim

(Models 37714, 97714)

If your clinician has programmedAdaptiveStim and AdaptiveStim is turned on,

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the AdaptiveStim icon ( ) will appear next tothe Neurostimulator on icon ( ) in the Statusrow (Figure 5.12).

Note: Your neurostimulator must be turnedon ( ) to view AdaptiveStim settings.

B Lying B

AStatus row

Figure 5.12 AdaptiveStim icon on Status row of Therapy screen.

When your clinician has programmedAdaptiveStim, the neurostimulator recordsyour amplitude adjustments and yourchanges in position. As you make amplitudeadjustments, the new amplitude settings areassigned to the position. The next time youreturn to this position, the stimulation willmatch what you selected the last time youwere in this position.

Note: There may be a short delay before thestimulation changes in response to your

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change in position. This delay keeps theneurostimulator from making unnecessaryadjustments based on temporary changes inyour position. Your clinician can adjust thelength of this delay.

AdaptiveStim groups and positions

Your clinician can program specificamplitudes for each of 6 positions or yourclinician can program AdaptiveStim to adaptthe amplitude settings based on theadjustments you make to your stimulationwhile in one of the positions.

AdaptiveStim recognizes these 6 positions:

• Standing or sitting still

• Lying on your back or face up

• Lying on your front or face down

• Lying on your right side

• Lying on your left side

• Mobile

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AdaptiveStim position names (abbreviatedtext or the AdaptiveStim icon) are displayedon the Group row of the Therapy screen.

AdaptiveStim position icons are displayed onthe Parameter row (Figure 5.13).

Group row

Parameter row

B Lying B

A

Figure 5.13 AdaptiveStim positions.

The AdaptiveStim position displayed on theTherapy screen indicates the position youwere in the last time your patient programmercommunicated with your neurostimulator.This means that the AdaptiveStim positionand stimulation settings displayed on theTherapy screen may not be your currentposition or the settings currently in use byyour neurostimulator.

You must synchronize the patientprogrammer and neurostimulator (refer to"Using the Sync key" on page 66) to display

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your current position and the stimulationsettings currently in use by theneurostimulator.

Note: AdaptiveStim does not recognizereclining positions. The Therapy screen willdisplay your starting position before reclining.For example, when changing to a recliningposition from a standing position, theTherapy screen will reflect Upright or .When changing to a reclining position fromlying on your back, the Therapy screen willreflect Lying B or .

Use the definitions listed in Table 5.5 tounderstand the AdaptiveStim position namesand icons on the Therapy screen.

Table 5.5 AdaptiveStim positions on theTherapy screen

Group rowa Parameterrow

Position description

Upright or Standing or sittingupright

Lying B or Lying on your back

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Table 5.5 AdaptiveStim positions on theTherapy screen (continued)

Group rowa Parameterrow

Position description

Lying F or Lying on your front

Lying R or Lying on your right side

Lying L or Lying on your left side

Mobile or Mobile while upright

Transitioning betweenpositions

a The text listed in this column will be displayed on thepatient programmer in the language selected from theAdaptiveStim name display preference (ie, the text maybe in another language other than English)

Turning AdaptiveStim on and off

If AdaptiveStim is turned on, theAdaptiveStim icon ( ) will appear next to theNeurostimulator on icon ( ) in the Statusrow.

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Note: Your neurostimulator must be turnedon ( ) to view AdaptiveStim settings.

Complete the following steps to turnAdaptiveStim on or off.





Status row


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3. Press the left or right arrows on theNavigator key to move the selection boxto the AdaptiveStim preference(Figure 5.15).

Note: The preference screen displays theAdaptiveStim state that you will changeto. For example, if AdaptiveStim iscurrently turned on, the AdaptiveStim officon (shown in Figure 5.15) will bedisplayed on the preference screen.

AAdaptiveStim off icon showing

Figure 5.15 AdaptiveStim preference screen.

4. Press the Sync key to send the changeto your neurostimulator and return to theTherapy screen.

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Making adjustments toAdaptiveStim

If you make an adjustment to your stimulationand want to have that adjustmentremembered for your current position, youmust make the adjustment and stay in yourcurrent position for at least 3 minutes.

Note: If you change position while increasingor decreasing your stimulation amplitude, theAdaptiveStim icon or text will blink, indicatingthe patient programmer has updated to thecurrent AdaptiveStim position.

Even with AdaptiveStim enabled, you mayneed to make adjustments to yourstimulation. Table 5.6 provides generalguidelines for adjusting your stimulation whenusing AdaptiveStim.

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Table 5.6 AdaptiveStim adjustment guidelines

Situation Action

AdaptiveStim stimulation fora specific position isuncomfortable.

While in the applicableposition, decreaseamplitude(s) and remain inthat position for at least3 minutes.

You are unable to adjustAdaptiveStim stimulationwhile in a specific position.

Make the desiredstimulation adjustment,then get in the desiredposition within 3 minutesand stay there for at leastthree minutes.

Stimulation becomesuncomfortable while ridingin a car or another type oftransportation.

Turn AdaptiveStim off.

Stimulation becomesuncomfortable while movingin an elevator, escalator,etc.

Turn AdaptiveStim off.

You want AdaptiveStim toturn your therapy off whenin a certain position.

Adjust your amplitude to0 V to turn your therapy offinstead of turning theneurostimulator off.

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6 MRIexaminations




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If you have an MRI appointmentDepending on what kind of neurostimulationsystem components that you have implanted,you may be eligible for one of the followingtypes of magnetic resonance imaging (MRI)scans:

• MRI scans of the head only (this isreferred to as head-only eligible).

• MRI scans of any part of your body (this isreferred to as full-body eligible).

Responsibilities of the patientin preparing for the MRIappointment• If you have a patient identification (ID)

card given to you by Medtronic for yourimplanted neurostimulation system, besure to bring your most current card toevery MRI appointment.

The patient ID card shows the MRIclinician that Medtronic is themanufacturer of your implanted

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neurostimulation system. The patient IDcard also identifies your neurostimulatormodel number.

The MRI clinician can use this informationto obtain instructions to determine theeligibility of your implantedneurostimulation system for the MRI scanand the MRI scan safety conditionsrequired by your neurostimulation system.

• Bring the MRI scan eligibility sheet to theMRI appointment if you were given onefrom your clinician managing yourneurostimulation system.

• Bring your patient programmer to everyMRI appointment. However, do not takethe patient programmer into the MRIscanner (magnet) room.

At the MRI appointment• If you have a patient identification (ID)

card given to you by Medtronic for yourimplanted neurostimulation system,

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present your most current card to theMRI clinician.

• Be sure to inform the MRI clinician thatyou have an implanted neurostimulationsystem for chronic pain.

• If you no longer have an implantedneurostimulator, be sure to inform the MRIclinician of any leads or other componentsthat still remain implanted.

• To obtain the MRI guidelines, the MRIclinician can refer to the contactinformation at the back of this manual, orthe MRI clinician can go towww.medtronic.com/mri.

Warning: Inform the MRI clinician beforeyou enter the MRI scanner (magnet) roomthat you have an implantedneurostimulation system. If you do notprovide this important information, youmay be given an inappropriate MRI scan,which could cause you injury or couldcause damage to your implanted medicaldevice. The MRI clinician conducting your

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MRI scan needs to be aware of allmedical implants in order to assess theconditions for safely performing your MRIscan.

Placing your neurostimulationsystem in MRI mode for the MRIscanYour implanted neurostimulation system mustbe placed in MRI mode before your MRIscan. MRI mode turns stimulation off.

MRI mode can be activated with your Model97740 patient programmer or with a clinicianprogrammer (if you have a neurostimulatorwith SureScan MRI Technology). Table 6.1shows where to go in this chapter for moreinformation.

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Table 6.1 Activating MRI mode

With a patientprogrammer

See "Using the Model 97740 patientprogrammer to activate MRI mode"on page 140.

With a clinicianprogrammer

See "For neurostimulators withSureScan MRI Technology (Models97702, 97712, 97713, 97714)" onpage 152.

Using the Model 97740 patientprogrammer to activate MRImodeIf you brought your Model 97740 patientprogrammer to the MRI appointment, you canplace your neurostimulation system in MRImode before your MRI scan and outside ofthe MRI scanner (magnet) room. MRI modeturns stimulation off.

When you activate MRI mode with yourpatient programmer, stimulation is turned offand an MRI scan eligibility screen will appear.Show this screen to the MRI clinician.

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During the MRI scan, keep yourneurostimulation system in MRI mode(stimulation must remain off).

After the MRI scan and outside of the MRIscanner (magnet) room, you can turnstimulation back on using your patientprogrammer or you can return to the clinicianmanaging your neurostimulation system tohave stimulation turned back on.

Activating MRI mode

Complete the following steps to activate MRImode.

1. Synchronize the patient programmer andthe neurostimulator.

a. Hold the patient programmer directlyover your neurostimulator with thescreen facing outward.

b. Press the Sync key (Figure 6.1).

The Therapy screen appears (Figure 6.2on page 143).

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Navigator key

Sync key

Figure 6.1 Location of the Sync key and Navigator key.

Note: If the patient programmer does notsynchronize the first time, try again withthe programmer repositioned over theneurostimulator.

2. If needed, press the up arrow on theNavigator key to move the selection boxto the Status (top) row (Figure 6.2).

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Therapy screen Therapy screen

Status (top) row

Selection box on bottom row

Move selection box totop row

Figure 6.2 Move the selection box to the top row.

3. Press the left or right arrows on theNavigator key to move the selection boxuntil the following screen appears:

MR Conditional symbol

Sync icon

Figure 6.3 The MRI mode activation screen.

4. Hold the patient programmer directly overyour neurostimulator with the screenfacing outward and press the Sync

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key. Do not press any other keyafterwards.

When MRI mode is activated, yourimplanted neurostimulation system hasbeen placed in MRI mode and stimulationis turned off.

Caution: Do not turn stimulation backon before your MRI scan. Leavingstimulation on during the scan couldincrease the potential foruncomfortable, unintended stimulation.

In addition, one of three screens willappear showing the MRI scan eligibility foryour implanted neurostimulation system(Figure 6.4). The display of the MRI scaneligibility screen confirms that yourneurostimulation system has been placedin MRI mode and stimulation has beenturned off.

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Serial number of implanted neurostimulator

Model number of implanted neurostimulator

Information code for MRI clinician to use when contacting Medtronic Technical Support

Figure 6.4 Examples of MRI scan eligibility screens.

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Table 6.2 MRI scan eligibility icons

Icon or iconcombination

Explanation

Full-body scan eligible

The implanted neurostimulationsystem allows the patient to beeligible to have MRI scans of anypart of the body under specificconditions. The MRI clinician mustconsult the MRI guidelines forthose conditions.

Head scan eligible with transmit/receive head coil

The implanted neurostimulationsystem allows the patient to beeligible for MRI scans of the headonly using an RF transmit/receivehead coil and under other specificconditions. The MRI clinician mustconsult the MRI guidelines forthose conditions.

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Table 6.2 MRI scan eligibility icons (continued)

Icon or iconcombination

Explanation

The neurostimulation systemMRI scan eligibility cannot bedetermined.

The MRI clinician must consult theMRI guidelines to determine how toproceed or contact MedtronicTechnical Support.

Information code

The code for the MRI clinician togive when contacting MedtronicTechnical Support to gather furtherinformation about your implantedneurostimulation system.

5. Do not press any other key.

Note: The MRI scan eligibility screen onthe patient programmer will display for20 minutes. The buttons on the front ofthe programmer are disabled when in MRImode to allow the MRI clinician to

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photocopy the MRI scan eligibility screenif needed.

6. Give the patient programmer to the MRIclinician with the MRI scan eligibilityscreen displayed.

Note: Do not take the patientprogrammer into the MRI scanner(magnet) room. If you brought therecharger with you to the MRIappointment, do not take the rechargerinto the MRI scanner (magnet) roomeither.

Turning stimulation back onafter the MRI scanTurn stimulation back on when the MRI scanis complete and you are outside of the MRIscanner (magnet) room.

Turning stimulation back on deactivates MRImode. Stimulation can be turned on with thepatient programmer or the clinicianprogrammer:

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• If you do not have your patientprogrammer with you, go to the clinicianmanaging your neurostimulation systemto turn stimulation on using the clinicianprogrammer.

• If you brought your patient programmer tothe MRI appointment, turn stimulationback on using the patient programmer(see the steps that follow).

Complete the following steps to turn onstimulation using the patient programmer.

1. Hold the patient programmer directly overyour neurostimulator with the screenfacing outward and press the Sync key.

2. Hold the patient programmer over yourneurostimulator with the patientprogrammer screen facing outward andpress the Neurostimulator on key(Figure 6.5).

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Neurostimulator on key

Figure 6.5 Neurostimulator on key.

3. Verify that the Neurostimulator on icon( ) is displayed on the Status row of theTherapy screen.

MRI mode is deactivated when theTherapy screen displays with theNeurostimulator on icon (Figure 6.6).

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Therapy screen

Neurostimulator on icon

Figure 6.6 The Therapy screen displays with the Neurostimulator on icon when MRI mode is

deactivated.

Note: If a power-on-reset (POR) screenappears on the patient programmer, seeTable 6.3.

Table 6.3 POR screens

Screen Cause and action

PORPORCall your clinician

Error code = POR: Stimulationhas stopped.

Call your clinician to restartyour therapy.

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Table 6.3 POR screens (continued)


PORPORReset occurred

The implanted neurostimulatorhas been reset. Stimulation isnot available.

Call your clinician to reportthis message screen.

To clear the informationscreen, press any arrow onthe Navigator key.

For neurostimulators withSureScan MRI Technology(Models 97702, 97712, 97713,97714)Note: The model number for your implantedneurostimulator is on your patient ID card.

If you have a neurostimulator with SureScanMRI Technology, the clinician managing yourneurostimulation system can place yourneurostimulation system in MRI mode foryour MRI examination using the clinicianprogrammer.

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You may need to inform your clinicianmanaging your neurostimulation system thatan MRI examination has been prescribed foryou and that you need MRI mode activated.

MRI mode turns stimulation off. Do not turnstimulation back on before your MRI scan.

Caution: Do not turn stimulation back onbefore your MRI scan. Leaving stimulationon during the scan could increase thepotential for uncomfortable, unintendedstimulation.

The clinician may give you an MRI scaneligibility sheet to bring to your MRIappointment. Give the eligibility sheet to theMRI clinician.

During the MRI scan, keep yourneurostimulation system in MRI mode(stimulation must remain off).

After the MRI scan and outside of the MRIscanner (magnet) room, you can turnstimulation back on using your patientprogrammer or you can return to the clinician

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managing your neurostimulation system tohave stimulation turned back on.

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7 Maintenance




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This section describes how to care for anddispose of your patient programmer andaccessories.

Patient programmer batteriesAlways keep 2 new AAA alkaline batteriesavailable for replacement. New batteriesprovide about 2 months of use, dependingupon how often the programmer is used.

Caution: If the device will not be used forseveral weeks, remove the batteries fromthe device. A battery left in the devicemay corrode, causing damage to theelectronic components.

Keep your programmer out of the reach ofchildren and pets. Keep the batteries awayfrom children. If children or pets swallow thebatteries, contact a doctor at once.

Checking the patient programmerbatteries

You can check the patient programmerbatteries at any time. Complete the following

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steps to check the patient programmerbatteries.




2. Review the patient programmer batterystatus and battery level. The Therapyscreen displays an icon indicating thepatient programmer battery level(Figure 7.1).

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Battery level

FullReplacebatteries

Figure 7.1 Patient programmer battery level on the Therapy screen.

Table 7.1 lists the screens associated withthe patient programmer battery.

Table 7.1 Patient programmer batteryscreens

The patient programmer batteries aredepleted. Programming is not possible.

Replace the patient programmerbatteries now.

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Table 7.1 Patient programmer batteryscreens (continued)

The patient programmer batteries arelow. You can finish programming.

Replace the patient programmerbatteries before the batteriesbecome depleted.

Press any arrow on the Navigatorkey to clear the information screen.

Replacing the patient programmerbatteries

1. Open the battery compartment cover(Figure 7.2).

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Figure 7.2 Opening the battery cover.

2. Remove the depleted batteries.

3. Insert the new batteries as shown on thebattery compartment label.

4. Close the battery compartment cover.

5. Dispose of old batteries according to localrequirements.

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Cleaning and careFollow these guidelines to ensure that thepatient programmer and accessories functionproperly.

Caution: If the device will not be used forseveral weeks, remove the batteries fromthe device. A battery left in the devicemay corrode, causing damage to theelectronic components.

• Keep the device out of the reach ofchildren and pets.

• Use the device only as explained to youby your clinician or as discussed in thismanual.

• Follow all warnings and precautions inChapter 2 "Important therapy information"and Chapter 11 "Appendix A:Electromagnetic interference (EMI)".

• Handle the device with care. Do not drop,strike, or step on the device.

• Do not dismantle or tamper with thedevice.

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• Clean the outside of the device with adamp cloth when necessary. Mildhousehold cleaners will not damage thedevice or labels.

• The device is not waterproof. Do not allowmoisture to get inside the device.

• Keep fresh batteries available.

• Replace low or depleted batteries.

Safety and technical checksPeriodic safety and technical checks orperiodic maintenance of the patientprogrammer are not required. The patientprogrammer contains no user-serviceableparts. If repair or service is needed, contactyour clinician or a Medtronic sales office.Refer to the Medtronic contacts at the end ofthis manual.

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Battery and patientprogrammer disposalDispose of depleted batteries and worn outdevices according to local requirements. Ifyou no longer need your patient programmerand would like to donate it, contact yourclinician.

Neurostimulator disposalThe implanted device should be removedbefore burial or cremation. In some countries,removal of battery-powered implantabledevices is required before burial because ofenvironmental concerns. Also, the deviceshould be removed before cremation. Thecremation process causes the battery toexplode. Explanted devices should not beresterilized or reimplanted.

We suggest you request that your explanteddevice be returned to Medtronic for analysisand disposal. Letting us analyze the conditionof your device will help us improve futuredevices. Refer to the back cover for contact

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information if you or your doctor have anyquestions.

Specifications

Table 7.2 Patient programmer specifications

Item Specification

Power source 2 AAA alkaline batteries

(nonrechargeable, LR03)

Operating temperature 9 °C to 43 °C

(49 °F to 110 °F)

Temperature limitation -34 °C to 57 °C

(-30 °F to 135 °F)

Size

(approximate)

9.4 cm × 5.6 cm × 2.8 cm

(3.7 in × 2.2 in × 1.1 in)

Weight, includingbatteries

(approximate)

111 g (3.9 oz)

Battery lifea 2 months (average) foralkaline batteries

Mode of operation Continuous

Service life Up to 5 years

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Table 7.2 Patient programmer specifications (continued)

Item Specification

Ingress protection IP22 rating for solid objectsgreater than or equal to 12.5mm and for vertically drippingwater when the device istilted 15 degrees

a Batteries should be removed from the device forstorage or transport.

Table 7.3 Implanted neurostimulation systemspecifications

Description Specifications

Typical materials incontact with humantissuea

Neurostimulator Titanium

Polyurethane

Silicone rubber

Silicone medical adhesive

Polysulfone

Lead Polyurethane

Platinum iridium

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Table 7.3 Implanted neurostimulation systemspecifications (continued)

Description Specifications

Extension Polyurethanea For a complete list of materials in contact with human

tissue, contact your clinician.

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8 Troubleshooting




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This chapter will help you solve problemswith your patient programmer. It alsoprovides information on when to call yourclinician.

Note: If you cannot solve a problem or if yourproblem is not described here, contact yourclinician.

Patient programmer screensThe patient programmer displays warning( ), information ( ), and communication ( )screens to provide you with information aboutyour system, alert you to a problem with yoursystem, or to guide you during patientprogrammer use.

Warning screens

Warning screens indicate a problem with thepatient programmer, the antenna, or theneurostimulator. If the patient programmeraudio preference is turned on, 3 tones alertyou when a warning screen is displayed onthe patient programmer.

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Table 8.1 describes the possible warningscreens and provides instructions (see bluetext) on how to resolve the problem and clearthe screen.

Table 8.1 Warning screens


Synchronize patientprogrammer andneurostimulator

The patient programmer and theneurostimulator must besynchronized.

Synchronize the patientprogrammer andneurostimulator.

Replace externalneurostimulatorbatteries

The external neurostimulatorbatteries are depleted andstimulation is not available.

Replace the externalneurostimulator batteries now.Refer to the manual packagedwith the externalneurostimulator.

Replace patientprogrammer batteries

The patient programmerbatteries are depleted.Programming is not possible.

Replace the patientprogrammer batteries now.

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Table 8.1 Warning screens (continued)


Chargeneurostimulatorbattery

The implanted rechargeableneurostimulator battery chargelevel is low and stimulation hasstopped.

Charge the implantedrechargeable neurostimulatorbattery now. Refer to themanual packaged with thecharging system.

See "Checking the implantedrechargeable neurostimulatorbattery" starting on page 74for important information onlow battery level andoverdischarging.

Device not supported

The implanted device that youare attempting to communicatewith is not compatible with thepatient programmer.


EOSEOSCall your clinician

Error code = EOS: Theneurostimulator has reached itsend of service. Stimulation is notavailable.


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Table 8.1 Warning screens (continued)


PORPORCall your clinician

Error code = POR: Stimulationhas stopped.

Call your clinician to restartyour therapy.

Call your clinician

Error codes 0 to 252: Thesystem is not working correctly.Stimulation may have stopped.

Remove batteries from thepatient programmer, waitseveral seconds, then re-insert the batteries. If the errormessage appears again, callyour clinician.

Call your clinician

Other codes: The system is notworking correctly. Stimulationmay have stopped.

Write down the code shownon the screen. Call yourclinician.

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Information screens

The information screens provide informationabout therapy settings, error conditions, andbattery levels.

If the patient programmer audio preference isturned on, 3 tones alert you when aninformation screen is displayed on the patientprogrammer.

Table 8.2 describes the possible informationscreens and provides instructions on how toproceed (see blue text) when thesemessages appear.

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Table 8.2 Information screens

Screen Description and action

Poor communication

Communication between thepatient programmer and theimplanted neurostimulator wasunsuccessful.

Reposition the patientprogrammer over theimplanted neurostimulatorwith the screen facing outwardand try communication again.

If using the detachableantenna, check that theantenna is connectedproperly, reposition theantenna and trycommunication again.


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Table 8.2 Information screens (continued)


Poor communication

Communication between thepatient programmer and theexternal neurostimulator wasunsuccessful.

Reposition the patientprogrammer over the externalneurostimulator with thescreen facing outward and trycommunication again.

If using the detachableantenna, check that theantenna is connectedproperly, reposition theantenna and trycommunication again.


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PORPORReset occurred

The implanted neurostimulatorhas been reset. Stimulation isnot available.



Disconnected cable

The cable to the externalneurostimulator is loose ordisconnected.

Connect the cable to theexternal neurostimulator. Turnthe patient programmer offthen on again.


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Rechargeableneurostimulatorbattery charge levelis low

The implanted rechargeableneurostimulator battery chargelevel is low and stimulation willnot be available soon.

Charge your implantedrechargeable neurostimulatorbattery. Refer to the manualpackaged with the chargingsystem.


Externalneurostimulatorbatteries are low

The external neurostimulatorbatteries are low and stimulationwill not be available soon.

Replace the externalneurostimulator batteries.Refer to the manual packagedwith the externalneurostimulator.


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Patient programmerbatteries are low

The patient programmerbatteries are low. You can finishprogramming.

Replace the patientprogrammer batteries beforethe batteries become depleted.


Neurostimulator isnearing end ofservice

The implanted neurostimulator isnearing end of service.Stimulation will not be availablesoon.

Call your clinician to reportthis message screen. Thisscreen reappears daily. Afterclearing this screen, a lowbattery level icon appears onthe Status row of the Therapyscreen.


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Synchronize

You tried increasing ordecreasing a parameter for aninactive group.

Activate the group bysynchronizing the patientprogrammer andneurostimulator.


Turn neurostimulatoron

You tried increasing a parametervalue with the neurostimulatoroff.

Turn your neurostimulator onand try communication again.


Upper limit reached(amplitude shown)

You tried increasing a parameter(amplitude, pulse width, or rate)above the highest value allowed.


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Lower limit reached(amplitude shown)

You tried decreasing aparameter (amplitude, pulsewidth, or rate) below the lowestvalue allowed.


OOR upper limitreached (amplitudeshown)

You tried increasing a parameter(amplitude, pulse width, or rate)above what your neurostimulatorcan deliver.

Decrease another parameterbefore increasing thisparameter.

Recharge the rechargeableneurostimulator battery (ifapplicable).

Replace the externalneurostimulator batteries (ifapplicable).


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00R

Out of regulationerror

The neurostimulator cannotprovide the programmed therapyor increase the parameter to thevalue that you requested.



Configure ENS error

Your patient programmer cannotcommunicate with the ENS. TheENS will need to be reconfiguredby your clinician.


To clear the informationscreen, turn off your patientprogrammer. Until your ENS isreconfigured by your clinician,this error message will appearwhen you attempt tocommunicate with the ENS.

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Communication screens

Communication screens indicatecommunication between the patientprogrammer and the neurostimulator.

Table 8.3 describes the possiblecommunication screens. Unless there is aproblem with the communication, thecommunication screen automatically clearswhen the process is finished.

Table 8.3 Communication screens


The patient programmer iscommunicating with the externalneurostimulator.

The patient programmer iscommunicating with theimplanted neurostimulator.

Possible problems andsolutionsTable 8.4 will help you solve problemsassociated with the patient programmer or

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identify when to call your clinician. Problemsare described in the left column (see boldblack text). The right column lists possiblecauses of the problem (see plain text) andhow to correct the problem (see bold bluetext).

Note: If a problem is not solved after severalattempts, or if a problem is not describedhere, contact your clinician.

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Ta

ble

8.4 T

rou

ble

sho

oti

ng

pro

ble

ms

Pro

ble

ms

Cau

ses

and

act

ion

s

Un

com

fort

able

sti

mu

lati

on

:Y

ou a

re t

oo u

ncom

fort

able

with

the

curr

ent

stim

ulat

ion

to th

ink

abou

t ho

w t

o ch

ange

it.

The

sel

ecte

d gr

oup

or s

timul

atio

n se

tting

s ar

eno

t su

itabl

e fo

r yo

ur c

urre

nt a

ctiv

ity o

rpo

stur

e.

Tu

rn t

he

neu

rost

imu

lato

r o

ff.

Red

uce

th

e am

plit

ud

e fo

r ea

ch p

rog

ram

in

the

acti

ve g

rou

p.

Ch

ang

e th

e g

rou

p i

f th

e ac

tive

gro

up

is

no

to

ne

that

is

reco

mm

end

ed b

y yo

ur

clin

icia

nfo

r yo

ur

curr

ent

acti

vity

or

po

stu

re;

or

adju

st t

he

amp

litu

de,

pu

lse

wid

th,

and

rat

eto

val

ues

th

at p

rovi

de

adeq

uat

e p

ain

rel

ief.

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Tab

le 8

.4 T

rou

ble

sho

oti

ng

pro

ble

ms

(co

nti

nu

ed)

Pro

ble

ms

Cau

ses

and

act

ion

s

Inte

rmit

ten

t st

imu

lati

on

: Y

oufe

el s

timul

atio

n on

ly s

ome

of t

hetim

e.

You

r cl

inic

ian

may

hav

e pr

ogra

mm

ed y

our

neur

ostim

ulat

or t

o tu

rn o

n an

d of

f at r

egul

arin

terv

als.

If y

ou

are

no

t re

ceiv

ing

ad

equ

ate

pai

nre

lief,

co

nta

ct y

ou

r cl

inic

ian

.

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Tab

le 8

.4 T

rou

ble

sho

oti

ng

pro

ble

ms

(co

nti

nu

ed)

Pro

ble

ms

Cau

ses

and

act

ion

s

No

sti

mu

lati

on

: Y

ou d

o no

t fee

lst

imul

atio

n bu

t you

thi

nkst

imul

atio

n sh

ould

be

on.

Stim

ulat

ion

is o

ff.

Use

yo

ur

pat

ien

t p

rog

ram

mer

to

tu

rn y

ou

rn

euro

stim

ula

tor

on

.

You

r cl

inic

ian

has

prog

ram

med

sch

edul

edth

erap

y an

d st

imul

atio

n is

sch

edul

ed t

o be

stop

ped

at th

is t

ime.

If s

tim

ula

tio

n i

s d

esir

ed,

sele

ct a

no

ther

gro

up

an

d t

urn

sti

mu

lati

on

on

.

The

am

plitu

des

for

each

pro

gram

in t

he a

ctiv

egr

oup

are

set t

oo lo

w to

feel

.

Use

yo

ur

pat

ien

t p

rog

ram

mer

to

in

crea

seth

e am

plit

ud

e(s)

.

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Tab

le 8

.4 T

rou

ble

sho

oti

ng

pro

ble

ms

(co

nti

nu

ed)

Pro

ble

ms

Cau

ses

and

act

ion

s

Del

ayed

sti

mu

lati

on

ch

ang

es:

You

do

not f

eel s

timul

atio

n rig

htaw

ay a

fter

turn

ing

on t

hene

uros

timul

ator

or

you

feel

stim

ulat

ion

afte

r tu

rnin

g of

f th

ene

uros

timul

ator

.

You

r cl

inic

ian

prog

ram

med

Sof

tSta

rt/S

top

soth

at s

timul

atio

n st

arts

and

sto

ps g

radu

ally

.

All

ow

ab

ou

t 8

seco

nd

s fo

r yo

ur

neu

rost

imu

lato

r to

tu

rn o

n a

nd

off

.

Yo

u m

ay f

eel

a re

sid

ual

eff

ect

afte

r th

en

euro

stim

ula

tor

is t

urn

ed o

ff.

Pat

ien

t p

rog

ram

mer

is

un

resp

on

sive

: T

he d

ispl

aysc

reen

is b

lank

whe

n yo

u pr

ess

a ke

y.

The

pat

ient

pro

gram

mer

bat

terie

s ar

ede

plet

ed.

Rep

lace

th

e p

atie

nt

pro

gra

mm

er b

atte

ries

.

The

pat

ient

pro

gram

mer

bat

terie

s ar

e in

back

war

ds.

Ch

eck

the

bat

tery

po

lari

ty a

nd

rei

nst

all

the

pat

ien

t p

rog

ram

mer

bat

teri

es.

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Tab

le 8

.4 T

rou

ble

sho

oti

ng

pro

ble

ms

(co

nti

nu

ed)

Pro

ble

ms

Cau

ses

and

act

ion

s

Dro

pp

ed p

atie

nt

pro

gra

mm

er:

You

r pa

tient

pro

gram

mer

fal

lsof

f a c

abin

et o

r ta

ble.

The

pat

ient

pro

gram

mer

is d

esig

ned

tow

ithst

and

a sh

ort

drop

to a

har

d su

rfac

e an

dst

ill o

pera

te n

orm

ally

, ev

en if

the

case

isch

ippe

d or

nic

ked.

Try

th

e p

atie

nt

pro

gra

mm

er;

it s

ho

uld

wo

rk.

Flu

id o

n t

he

pat

ien

tp

rog

ram

mer

: F

luid

was

spi

lled

onto

the

prog

ram

mer

or

the

patie

nt p

rogr

amm

er w

asdr

oppe

d in

to w

ater

.

The

pat

ient

pro

gram

mer

is n

ot w

ater

proo

f,an

d w

ater

can

dam

age

the

devi

ce.

Imm

edia

tely

rem

ove

th

e p

atie

nt

pro

gra

mm

er f

rom

th

e w

ater

, th

en d

ry t

he

pat

ien

t p

rog

ram

mer

wit

h a

to

wel

dam

pen

ed w

ith

cle

an t

ap w

ater

.

Rem

ove

th

e b

atte

ries

, th

en a

llow

th

eb

atte

ry c

om

par

tmen

t to

air

dry

at

roo

mte

mp

erat

ure

fo

r 24

ho

urs

.

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9 Additionalinformation




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How stimulation worksNerve signals from all over your body travelto your spinal cord and then to your brain.Your brain translates the nerve signals intosensations such as pain.

Stimulation delivers electrical pulses to thearea where pain signals will be blocked asthey move to the brain (Figure 9.1).

Brain senses pain

Pain signal from foot

Brain senses tinglingand reduced pain

Stimulation pulseinhibits pain signal

Pain signal from foot

Figure 9.1 Stimulation blocks pain signals as they move to the brain (spinal cord stimulation

shown).

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Note: Stimulation will not cure your pain, norwill it block sharp pain caused by a recentinjury.

To most patients, the stimulation pulses feellike a steady, tingling sensation in the painfularea (Figure 9.2).

Without stimulation: area of pain

With stimulation: area of tingling

Figure 9.2 Sensations with and without stimulation (spinal cord stimulation shown).

Generally, people experience a fairlyconstant sensation of the electrical pulsesfrom stimulation. However, you may feelchanges when you suddenly move or changeposition.

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The electrical pulses delivered by stimulationare defined by parameters called amplitude,pulse width, and rate.

• Amplitude is the strength of the pulse. Itaffects the stimulation strength orcoverage required to manage your pain.

• Pulse width is the duration of the pulse. Itaffects the stimulation strength orcoverage required to manage your pain.

• Rate is the number of pulses deliveredper second. Rate feels like "tapping."

Your clinician uses a clinician programmer tocommunicate with your neurostimulator. Yourclinician programs stimulation settingsaccording to your needs.

Your clinician designs stimulation optionsusing programs to deliver electrical pulses toa specified pain site. A program defines theamplitude, pulse width, and rate of thestimulation pulse, as well as the specificlocation, pattern, or position in which thepulse will be delivered.

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If your neurostimulator model supports the"groups" feature, your clinician can combineprograms into "groups". A group is acollection of specific programs combined toprovide stimulation to 1 or more pain sites, toprovide different levels of stimulation for useduring specific activities, or to providestimulation that responds to changes in yourposition.

A menu of groups can be designed by theclinician to meet a patient's specific needs.Typically, each group is designed forparticular activities, positions, symptoms, ortime of day.

For example, Alex has received a spinal cordstimulation system. Alex has pain in his lowback and right thigh. Typically, Alex's paindoesn't vary; however, sometimes Alex hasadditional pain in his right ankle.

Alex's clinician used 3 programs (Program 1,Program 2, and Program 3) to design 2groups (Group A and Group B) for Alex.

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• Group A consists of Program 1 (for lowback pain) and Program 2 (for thigh pain).

• Group B consists of Program 1, Program2, and also Program 3 (ankle pain).

Alex chooses whichever group he requires(Figure 9.3).

Group ALow back and thigh

Group BLow back, thigh and ankle

Program 1

Program 2

Program 1

Program 2

Program 3

Figure 9.3 Example of programs and groups.

Your clinician will program specific programsand groups that you will be able to adjust withyour patient programmer. Discuss this withyour clinician.

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Controlling your stimulationYour neurostimulator only acceptsprogramming from the clinician programmeror patient programmer; other devices are notable to program your neurostimulator.

What your clinician controls

Your clinician uses a clinician programmer tocommunicate with your neurostimulator. Yourclinician designs programs and groupsaccording to your needs. Your clinician canalso specify the settings that you will be ableto adjust with your patient programmer.Discuss this with your clinician.

What you control

As your activities vary throughout the day,your therapy needs may change. The patientprogrammer allows you to turn stimulation onand off switch from one group to another, andadjust the amplitude, pulse width, or rate foreach program in the active group. Talk toyour clinician about the settings that apply toyour therapy.

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Possible adverse effectsAdverse effects of stimulation are usuallymild and go away when stimulation is turnedoff. These adverse effects could includeradicular chest wall stimulation,uncomfortable stimulation, a jolting orshocking sensation, or persistent pain at theneurostimulator site.

Changes in therapyOver time there could be changes in the levelof your symptom control. In most cases yourdoctor can correct these changes withoutsurgery.

Possible system complications• The lead, extension, or neurostimulator

could migrate within the body or erodethrough the skin.

• There could be undesirable changes instimulation, possibly related to cellularchanges around the electrode(s), changesin the position of the electrode(s), loose

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electrical connections, or lead orextension fractures.

• The implanted materials could cause anallergic or immune system response.

• Your neurostimulation system mightunexpectedly cease to function due tobattery depletion or other causes. Theseevents, which can include electrical shortsor open circuits, conductor (wire)fractures, and insulation breaches, cannotbe predicted.

• In rare cases, excessive tissue growtharound the electrode(s) may result inspinal cord compression and paralysis.Additional surgery is required to treatthese complications, which can occurweeks to years after lead implantation.

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10 Userassistance




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User assistanceThe patient programmer has been designedand tested to provide trouble-free service. Ifrepair or service is needed, contact yourclinician or a Medtronic sales office. Refer tothe Medtronic contacts at the end of thismanual.

The serial number is located in the batterycompartment. This number identifies eachpatient programmer. If you contact Medtronicabout your patient programmer, refer to theserial number.

If your patient programmer stops working—First try the steps inTable 8.4 on page 183. Otherwise, contactyour clinician.

If you lose your patient programmer—Contact your clinician to order a new patientprogrammer.

! USA To register the patient programmer forservice covered by the warranty, completeand mail the warranty registration.

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Declaration of ConformityMedtronic declares that this product is inconformity with the essential requirements ofDirective 90/385/EEC on Active ImplantableMedical Devices and R&TTE Directive1999/5/EC.

For additional information, contact Medtronic.Refer to the list of Medtronic contacts at theend of this manual.

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11 Appendix A:Electromagneticinterference (EMI)




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Please review "Electromagnetic interference"starting on page 35 for additional information.

Before any medical procedure is begun,always inform any health care personnel thatyou have an implanted neurostimulationsystem. The potential for the following effectsresults from an interaction of theneurostimulation system and equipment—even when both are working properly.

ContraindicationDiathermy—Inform anyone treating you thatyou CANNOT have any shortwave diathermy,microwave diathermy or therapeuticultrasound diathermy (all now referred to asdiathermy) anywhere on your body becauseyou have an implanted neurostimulationsystem. Energy from diathermy can betransferred through your implanted system,and can cause tissue damage, resulting insevere injury or death.

Diathermy can also damage parts of yourneurostimulation system. This can result inloss of therapy from your neurostimulation

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system, and require additional surgery toremove or replace parts of your implantedsystem.

Personal injury or device damage can occurduring diathermy treatment when:

• the neurostimulation system is turned onor off.

• diathermy is used anywhere on your body(not just where your neurostimulationsystem is located).

• diathermy is used to deliver heat or noheat.

• any component of your neurostimulationsystem (lead, extension, neurostimulator)remains in your body.

WarningsEMI from the following medical procedures orequipment can damage the device, interferewith device operation, or cause you harm. Ifthese procedures or equipment are required,the guidelines below must be followed:

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CT scans—Prior to undergoing a CT scan,your neurostimulator should be programmedto 0 V and the neurostimulator turned off.

Defibrillation or cardioversion—When youare in ventricular or atrial fibrillation, the firstconsideration is your survival. Externaldefibrillation or cardioversion can damage aneurostimulation system and cause inducedcurrents through the lead and extension.These induced electrical currents could injureyou.

The current flowing through theneurostimulation system should be minimizedas follows:

• Paddles should be positioned as far fromthe neurostimulator as possible.

• Paddles should be positionedperpendicular to the neurostimulationsystem.

• The lowest clinically appropriate energyoutput (watt seconds) should be used.

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After external defibrillation, your doctorshould confirm that the neurostimulationsystem is working as intended.

Electrocautery—If electrocautery tools areused near an implanted device or contacts adevice or insertion needle, the followingeffects can occur:

• The insulation on the lead or extensioncan be damaged, causing the lead orextension to fail or causing inducedcurrents that can damage tissues orstimulate or shock you.

• The neurostimulator can be damaged,neurostimulation can be temporarilydecreased or increased, or theneurostimulator can be turned off becausethe neurostimulator was reset to power-on-reset values (requiring your healthcare provider to reprogram yourneurostimulator).

When electrocautery is necessary, theseprecautions must be followed:

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• The neurostimulator should be turned offbefore using electrocautery.

• Any cable connecting the lead orextension to a screener or externalneurostimulator should be disconnected.

• Bipolar cautery should be used.

• If unipolar cautery is necessary:

– only low-voltage modes should beused.

– the lowest possible power settingshould be used.

– the current path (ground plate) shouldbe kept as far away as possible fromthe neurostimulator, extension, andlead.

– full-length operating-room-tablegrounding pads should not be used.

• After electrocautery, your doctor shouldconfirm that the neurostimulator isworking as intended.

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High-output ultrasonics or lithotripsy—Use of high-output ultrasonics or lithotripsy isnot recommended if you have an implantedneurostimulation system. If lithotripsy must beused, the beam should not be focused within15 cm (6 in) of the neurostimulator.

Magnetic resonance imaging (MRI)—Depending on the neurostimulation systemcomponents implanted, you may be eligiblefor either an MRI scan of the head only oreligible for an MRI scan on any part of yourbody (this is referred to as full-body eligible).

The MRI clinician will determine the MRI scaneligibility for your implanted neurostimulationsystem before your MRI scan.

For your MRI scan, the MRI clinician mustfollow all conditions given in the MRIguidelines for Medtronic neurostimulationsystems for chronic pain instructions for usemanual.

• Full-body eligible MRI scans

The neurostimulation system that is full-body eligible has been designed to

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minimize the risks associated with an MRIscan.

An MRI scan may be safely performedunder certain specific conditions.1 Notfollowing the specific conditions cancause tissue damage and can result inserious patient injury.

• Head-only eligible MRI scans

An MRI scan of the head only may besafely performed under certain specificconditions.1 However, Medtronicrecommends that an MRI using a radio-frequency (RF) transmit body coil shouldnot be prescribed for you if you have ahead-only eligible implantedneurostimulation system. Exposing you toan MRI using a radio-frequency (RF)transmit body coil or not following the

1 Please have your health care professional contactMedtronic for the latest MRI guidelines for yourneurostimulation system for chronic pain. Contactinformation is found at the back of this manual, orthe health care professional can go towww.medtronic.com/mri.

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specific conditions can cause tissuedamage and can result in serious patientinjury.

The known potential risks for all implantedneurostimulation systems for chronic pain areas follows:

Note: The Medtronic neurostimulationsystems with SureScan MRI Technologyhave been designed to minimize the potentialinteractions described in this section whenthe appropriate conditions are followed asgiven in the MRI guidelines for Medtronicneurostimulation systems for chronic paininstructions for use manual.

• Heating – The RF fields generated by anMRI scanner induce RF energy onto animplanted lead system that may causeheating at the lead electrodes or along thelead body. In addition, the gradientmagnetic and RF fields may causeheating of the neurostimulator.

Note: Heating can occur even if only alead or extension is implanted.

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Factors that increase the risks of heatingand patient injury include, but are notlimited to, the following:

– High MRI specific absorption rate (SAR)RF power levels

– Low impedance leads or extensions(Medtronic product names or modelnumbers designated by a “Z,” an “LZ,”or “low impedance”)

– Implanted lead systems with smallsurface area electrodes

– Short distances between leadelectrodes and heat-sensitive tissue

• Magnetic field interactions – The magneticmaterial of an implanted system mayexert force, vibration, and torque effectsdue to the static magnetic field andgradient magnetic fields produced by anMRI scanner. You may feel a mild tuggingor vibration sensation at the site of thedevice implant. Patients being scannedwith recent implant incisions should be

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monitored for any surgical wounddiscomfort.

• Induced stimulation – The gradientmagnetic and RF fields produced by anMRI scanner induce energies onto animplanted lead system that couldpotentially cause unintended stimulation,which the patient could experience as atingling, shocking, or jolting sensation.

Note: Induced stimulation can occur evenif only a lead or extension is implanted.

• Device damage – The voltages inducedby the MRI fields may damage theneurostimulator electronics requiringreprogramming, explantation, orreplacement.

• Device interactions – MRI may affect theoperation of the neurostimulator andrequire reprogramming of theneurostimulator with the clinicianprogrammer after the MRI scan. The MRImay also reset the parameters to power-on-reset (POR) settings, which may also

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require reprogramming of theneurostimulator after the MRI scan.

In addition, the MRI image can be degraded,distorted, or blocked from view by yourimplanted neurostimulation system.

Radio-frequency or microwave ablation—Safety has not been established forradiofrequency (RF) or microwave ablation inpatients who have an implantedneurostimulation system. Induced electricalcurrents can cause heating, especially at thelead electrode site, resulting in tissuedamage.

Theft detectors and security screeningdevices—Use care when approaching theftdetector and security devices (such as thosefound in airports, libraries, and somedepartment stores).

When approaching these devices, do thefollowing:

1. Show the security personnel your patientidentification card for the neurostimulatorand ask for a manual search. Security

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personnel may use a handheld securitywand but ask them not to hold the securitywand near the neurostimulator any longerthan is needed.

2. If you must pass through the theft detectoror security screening device, turn yourneurostimulator off, approach the centerof the device and walk through normally(Figure 11.1).

a. If two security gates are present, walkthrough the middle, keeping as faraway as possible from each gate.

b. If one gate is present, walk as faraway as possible from it.

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Double security gate Single security gate

Figure 11.1 Approaching security gates.

Note: Some theft detectors might not bevisible.

3. Proceed through the security device. Donot linger near or lean on the securitydevice.

4. After you pass through the securitydevice, turn your neurostimulator onagain.

PrecautionsEMI from the following equipment is unlikelyto affect your neurostimulation system if theguidelines below are followed:

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Bone growth stimulators—The coils of anexternal magnetic field bone growthstimulator should be kept 45 cm (18 in) awayfrom the neurostimulation system. When abone growth stimulator is used, your doctorshould ensure that both the bone growthstimulator and neurostimulator are working asintended.

Dental drills and ultrasonic probes—Theneurostimulator should be turned off and thedrill or probe should be kept at least 15 cm(6 in) away from the neurostimulator.

Electrolysis—The neurostimulator should beturned off, and the electrolysis wand shouldbe kept at least 15 cm (6 in) away from theneurostimulator.

Electromagnetic field devices—Thefollowing equipment or environments shouldbe avoided:

• Antennas of citizen band (CB) or hamradios

• Electric arc welding equipment

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• Electric induction heaters

• Electric steel furnaces

• High-power amateur transmitters

• High-voltage areas (safe if outside thefenced area)

• Linear power amplifiers

• Magnetic degaussing equipment

• Magnets or other equipment that generatestrong magnetic fields

• Microwave communication transmitters(safe if outside the fenced area)

• Perfusion systems

• Resistance welders

• Television and radio transmitting towers(safe if outside the fenced area)

If you suspect that equipment is interferingwith the neurostimulation system do thefollowing:

1. Move away from the equipment or object.

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2. If possible, turn off the equipment orobject.

3. Then, if necessary, use the patientprogrammer to return the neurostimulatorto the desired on and off state.

4. Inform the equipment owner or operatorabout the interference.

If the above actions do not resolve the effectsof the interference, or you suspect that yourtherapy is not the same after exposure toEMI, contact your doctor.

Laser procedures—The neurostimulatorshould be turned off, and the laser should bedirected away from the neurostimulationsystem.

Psychotherapeutic procedures—Safetyhas not been established forpsychotherapeutic procedures usingequipment that generates electromagneticinterference (eg, electroconvulsive therapy,transcranial magnetic stimulation) in patientswho have an implanted neurostimulationsystem. Induced electrical currents may

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cause heating, especially at the leadelectrode site, resulting in tissue damage.

Radiation therapy—High-radiation sourcessuch as cobalt 60 or gamma radiation shouldnot be directed at the neurostimulationsystem. If radiation therapy is required nearthe neurostimulation system, lead shieldingshould be placed over the device to helpprevent radiation damage.

Transcutaneous electrical nervestimulation—Transcutaneous electricalnerve stimulation (TENS) electrodes shouldnot be placed so that the current passes overany part of the neurostimulation system. Ifyou feel that the TENS unit might beinterfering with your neurostimulator,discontinue using the TENS until you talk withyour doctor.

NotesHousehold items—Most householdappliances and equipment that work properlyand are properly grounded will not interferewith the neurostimulation system. The

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following equipment is safe if you follow theseguidelines:

• Computer disk drives: Keep theneurostimulator away from disk drives.

• Freezer, refrigerator, or storm doors:Do not lean against the magnetic strip thatholds the door closed.

• Induction range: Keep theneurostimulator away from the burnerswhile the burners are turned on.

• Power tools: Keep the motor away fromthe neurostimulator, lead, and extension.

• Radio-frequency sources (AM/FMradios, cellular telephones, andcordless and conventionaltelephones): Keep these items at least10 cm (4 in) away from the implantedneurostimulator.

• Sewing machines or salon hair dryer:Keep the neurostimulator away from themotors.

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• Stereo speakers and radios for thehome or car: Do not lift or carry themclose to or touching the part of your bodywhere the neurostimulator is located.

Other medical procedures—EMI from thefollowing medical procedures is unlikely toaffect your neurostimulation system:

• Diagnostic ultrasound (eg, carotid scan,doppler studies)

Note: To minimize potential imagedistortion, the neurostimulator should beturned off and the transducer kept 15 cm(6 in) away from the neurostimulationsystem.

• Diagnostic x-rays or fluoroscopy

Note: Tight pressure in the area of yourneurostimulator, such as used duringmammography, may damage ordisconnect components of yourneurostimulation system. This mayrequire surgery to replace or repair theneurostimulation system. X-ray equipment

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should be adjusted so it does not squeezethe neurostimulator too tightly.

• Magnetoencephalography (MEG)

• Positron emission tomography (PET)scans

Therapeutic magnets—Keep therapeuticmagnets at least 25 cm (10 in) away fromyour neurostimulator. Magnetic fields of 10gauss or less will generally not affect theneurostimulator.

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IndexAblation procedures 214Activities to avoid 46, 52AdaptiveStim

changing name display preference 88description 124-129enabled icon 61guidelines for adjusting 133icon 124making adjustments 132off icon 131positions 126-129turning on and off 129

Adjusting stimulationguidelines for 100-103settings 100-103

Adverse effects 196Amplitude

description 192GroupAdjust 116

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guidelines for adjusting 100-103icon 63increasing or decreasing 104-108

Antennadetachable 91-93internal (in patient programmer) 56

Audiochanging preference 81-89tones 100, 168, 172

Backlight (Power/Backlight) key 66Batteries (external neurostimulator)

checking battery level 72low battery level screen 176replace warning screen 169

Batteries (patient programmer)about 156checking 156disposing of 163replacing 159

Battery charge level (low) screen 176

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Battery (implanted nonrechargeableneurostimulator)

checking battery 79low battery level screen 177

Battery (implanted rechargeableneurostimulator)

charging 74checking battery charge level 75low battery charge level screen 176recharge warning screen 170

Battery level (low) screenexternal neurostimulator 176implanted nonrechargeable

neurostimulator 177patient programmer 177

Bone growth stimulators 217Burial 163Cardiac devices 42, 43, 45Cardioversion 206Carrying case, patient programmer 89CAT scans 206Cell phones 220

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Change row 83Changes in stimulation, unexpected 103Changing a group 111Charging rechargeable neurostimulator 74Charging system 30, 31, 33Checking batteries

external neurostimulator 72implanted nonrechargeable

neurostimulator 79implanted rechargeable


Clinician programmer 195Clinician settings, returning to 108Clinician, when to call 54, 200Communication screens 181Complications, system 196Computer disk drives 220Configure ENS error

error screen 180Contraindications 34Contrast preference 81-89

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Cremation 163CT scans 206Decrease key 66, 106Decreasing a parameter 104-108Defibrillation 206Dental equipment 217Diathermy 34, 204Disposing of

implanted neurostimulator 163patient programmer batteries 163patient programmer 163

Driving 48Electrocautery 207Electrolysis 217Electromagnetic field devices 217Electromagnetic interference (EMI) 36Error codes

0 to 252 171Configure ENS error 180EOS 170ERI 177

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OOR 180other 171POR 151, 152, 171, 175

Extensions 33External neurostimulatorsee Neurostimulator (external)

Fluoroscopy 222Freezer 220GroupAdjust 116Group

changing and making active 111description 193

Group namedisplaying with icon or text 114icon or text definitions 114

Group rowdescription 61icons 62

Hair dryer 220Hiking 48Household items 220Hyperbaric chambers 47

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Identification cardsee Patient identification card

Identification label, patient programmer 90Implanted nonrechargeable neurostimulatorsee Neurostimulator (implantednonrechargeable)

Implanted rechargeable neurostimulatorsee Neurostimulator (implantedrechargeable)

Increase key 66, 106Increasing a parameter 104-108Indications 29Induction range 220Information screens 172-180Interferencesee Electromagnetic interference (EMI)

Itrel 4 neurostimulatorsee Neurostimulator (implantednonrechargeable)

Keys (patient programmer) 64Laser procedures 219Leads 33

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Lithotripsy 209Low battery level screens

external neurostimulator 176implanted nonrechargeable

neurostimulator 177implanted rechargeable


Lower parameter limit screens 107Magnetic resonance imaging (MRI) 136, 209Magnetic strip 220Magnetoencephalography (MEG) 223Magnets, therapeutic 223Mammography 222Medical procedure, what to do 204Microwave ablation 214Model number of implanted

neurostimulator, where to find 29

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MRI examinationsMRI mode, activating with clinician

programmer 152MRI mode, activating with patient

programmer 140, 141MRI scan eligibility sheet 137, 153preparing for MRI appointment 136turning stimulation back on 148

MRI modeactivating with clinician programmer 152activating with patient

programmer 140, 141deactivating 148description 139, 144MRI scan eligibility screens 144-145

MRI scan eligibilityicons 146screens 144-145types of 136

Navigator key 65, 68Neurostimulation system (implanted)

specifications 165

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Neurostimulation system parts 29Neurostimulator (external)

checking battery level 72description 31low battery level screen 176model number 28replace batteries warning screen 169turning on or off 70

Neurostimulator (implanted nonrechargeable)checking battery 79description 31low battery level screen 177model numbers 28turning on or off 70

Neurostimulator (implanted rechargeable)battery charge level warning screen 170charging the battery 74checking battery charge level 75description 31disposing of 163low battery charge level screen 176

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model numbers 28recharge warning screen 170turning on or off 70

Neurostimulator officon 60key 65

Neurostimulator onicon 60key 65

Number format preference 81-89OOR (out of regulation)

error screen 180parameter limit screens 108

Options icon 68Overdischarged neurostimulator battery 75Parameter, increasing or

decreasing 104-108Parameter limit screens 106-108Parameter row

description 63icons 63

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Patient identification cardabout 25MRI appointment 136

Patient programmerbatteries 156-160cleaning and care 161description 33, 56, 195disposing of 163functions 57keys 64low battery level screen 177preferences 81-89purpose 28repair 162, 200replace batteries warning screen 169replacing batteries 159screens 168-181specifications 164troubleshooting 181-187turning on and off 66

Pediatric use 49PET scans 223

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POR screenerror screen 175warning screen 171

Positron emission tomography (PET)scans 223

Power/Backlight key 66Power tools 220Precautions 43Preferences, changing 81-89Preference settings icons 81Pregnancy 49PrimeAdvanced neurostimulatorsee Neurostimulator (implantednonrechargeable)

PrimeAdvanced with SureScan MRITechnology neurostimulatorsee Neurostimulator (implantednonrechargeable)

Programmersee Patient programmer

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Programsdescription 193navigating 105

Psychotherapeutic procedures 220Pulse width

description 192guidelines for adjusting 100-103icon 64increasing or decreasing 104-108

Radiation therapy 220Radio-frequency (RF) ablation 214Radios 220Rate

description 192guidelines for adjusting 100-103icon 64increasing or decreasing 104-108in programs within a group 106

Recovery from surgery 52Refrigerator 220Repair 162

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RestoreAdvanced neurostimulatorsee Neurostimulator (implantedrechargeable)

RestoreAdvanced with SureScan MRITechnology neurostimulatorsee Neurostimulator (implantedrechargeable)

Restore neurostimulatorsee Neurostimulator (implantedrechargeable)

RestorePrime neurostimulatorsee Neurostimulator (implantednonrechargeable)

RestoreSensor neurostimulatorsee Neurostimulator (implantedrechargeable)

RestoreSensor with SureScan MRITechnology neurostimulatorsee Neurostimulator (implantedrechargeable)

RestoreUltra neurostimulatorsee Neurostimulator (implantedrechargeable)

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RestoreUltra with SureScan MRITechnology neurostimulatorsee Neurostimulator (implantedrechargeable)

Scheduled Therapy 119Scuba diving 47Security screening devices 214Selection box 68Serial number, patient programmer 200Settings, adjusting stimulation 100-103Sewing machines 220Skiing 48Skydiving 48SoftStart/Stop 186Specifications

neurostimulation system (implanted) 165patient programmer 164

Status rowdescription 59icons 60

Stereo speakers 220

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Stimulationadjusting settings 100-103description 190guidelines for adjusting 100-103troubleshooting 183-185uncomfortable 183unexpected changes 103

Storm doors 220Surgery

recovery 52risks 35

Synchronize warning screen 169Synchronizing

description 56function 65how to 67

Sync key 65, 66TargetMyStim 121Test stimulation 31Theft detectors 214

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Therapy screendescription 58Group row 61Parameter row 63Status row 59

Time format preference 81-89Time preference 81-89Tones, audio 100, 168, 172Transcutaneous electrical nerve

stimulation (TENS) 220Turning neurostimulator on or off 65, 70Twiddler’s syndrome 47Ultrasonic probes 217Ultrasonics, high-output 209Ultrasound, diagnostic 222Uncomfortable stimulation 71, 104

troubleshooting 183Unexpected changes in stimulation 52, 103Unexpected stimulation 48, 71, 104Upper parameter limit screens 107Warning screens 168-171Warnings 35-43

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X-rays, diagnostic 222

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Contacts: Asia: Medtronic International Ltd.Tel. 02919-1300Fax 02891-6830

Medtronic Asia Ltd.

Tel. (02)-548-1148Fax (02)-518-4786Australia: Medtronic Australasia Pty.Ltd.97 Waterloo RoadNorth Ryde, NSW 2113AustraliaTel. +61-2-9857-9000Fax +61-2-9878-5100Toll-free 1-800-668-670Austria: Medtronic Österreich GmbHTel. 01-240440Fax 01-24044-100Belgium: Medtronic Belgium S.A.Tel. 02-456-0900Fax 02-460-2667Canada: Medtronic of Canada Ltd.Tel. (1-905)-460-3800Fax (1905)-826-6620Czech Republic: Medtronic Czechias.r.o.Tel. 2-965-795-80Fax 2-965-795-89Denmark: Medtronic Danmark A/STel. 45-32-48-18-00Fax 45-32-48-18-01Finland: Medtronic Finland Oy/LTDTel. (09)-755-2500Fax (09)-755-25018France: Medtronic France S.A.S.Tel. 01-5538-1700Fax 01-5538-1800Germany: Medtronic GmbHTel. (02159)-81490Fax (02159)-8149100Greece: Medtronic Hellas S.A.Tel. 210-67-79-099Fax 210-67-79-399

Hungary: Medtronic Hungária Kft.Tel. 1-889-06-00Fax 1-889-06-99Ireland: Medtronic Ireland Ltd.Tel. (01)-890-6522Fax (01)-890-7220Italy: Medtronic Italia SpATel. 02-241371Fax 02-241381

Tel. 06-328141Fax 06-3215812Japan: Medtronic JapanTel. 03-6430-2016Fax 03-6430-7110Latin America: Medtronic, Inc.Tel. (1305)-500-9328Fax (1786)-709-4244Norway: Medtronic Norge ASTel. 67-10-32-00Fax 67-10-32-10Poland: Medtronic Poland Sp. z.o.o.Tel. (022)-465-69-00Fax (022)-465-69-17Portugal: Medtronic Portugal, Lda.Tel. 21-724-5100Fax 21-724-5199Russia: Medtronic RussiaTel. (8495) 580-7377Fax (8495) 580-7378Slovakia: Medtronic Slovakia, o.z.Tel. 0268 206 911Fax 0268 206 999Spain: Medtronic Ibérica, S.A.Tel. 91-625-0400Fax 91-650-7410Sweden: Medtronic ABTel. 08-568-585-00Fax 08-568-585-01Switzerland: Medtronic (Schweiz) AGTel. 031-868-0100Fax 031-868-0199




M940177A012 Rev X 2015-03-01

The Netherlands: Medtronic B.V.Tel. (045)-566-8000Fax (045)-566-8668Turkey: Medtronic TurkeyTel. +90 216 636 1000Fax +90 216 636 1008U.K.: Medtronic U.K. Ltd.Tel. 01923-212213Fax 01923-241004

USA: Medtronic, Inc.Tel. (1-763)-505-5000Fax (1-763)-505-1000Toll-free: (1-800)-328-0810




M940177A012 Rev X 2015-03-01

Manufacturer Medtronic, Inc.710 Medtronic Parkway,Minneapolis, MN 55432-5604,USAwww.medtronic.comTel. +1-763-505-5000Fax +1-763-505-1000

Authorized Representative EC REP

in the European CommunityMedtronic B.V.Earl Bakkenstraat 10,6422 PJ Heerlen,The NetherlandsTel. +31-45-566-8000Fax +31-45-566-8668

Europe/Africa/Middle East HeadquartersMedtronic International Trading SàrlRoute du Molliau 31,Case Postale 84CH - 1131 Tolochenaz,Switzerlandwww.medtronic.euTel. +41-21-802-7000Fax +41-21-802-7900

Asia-PacificMedtronic International Ltd.Suite 1106-11, 11/F, Tower 1, The Gateway,25 Canton Road, Tsimshatsui,Kowloon,Hong KongTel. +852-2919-1300Fax +852-2891-6830

Contacts for specific countries are listed inside this cover.

*M940177A012*© Medtronic, Inc. 2015All Rights Reserved

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Documents

Patient Programmer Manual