Medtronic DBS Patient Programmer Patient Manual

PATIENT PROGRAMMER 37642Medtronic® DBS™ Therapy user manualActiva® PC Model 37601Activa® RC Model 37612Activa® SC Model 37602Activa® SC Model 37603

! USA Rx only2008

Medtronic®, Activa®, and SoftStart/Stop® aretrademarks of Medtronic, Inc., registered in the U.S.and other countries.

DBS™ is a trademark of Medtronic, Inc.! USA FCC Information

The following is communications regulation informationon the Model 37642 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 may causeundesired operation of the device.

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

XXX °FXX °C

-XX °F-XX °C

Temperature limitation

Keep dry

Ingress protection rating IP22, per60601-1-11

Serial number

PIN No. PIN number

EC REP Authorized representative in theEuropean community

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For USA audiences only

IEC 60601-1/EN60601-1, Type BFEquipment

Non-ionizing electromagnetic radiation

Antenna jack

MRMagnetic Resonance (MR) Conditional

MR Magnetic Resonance (MR) Unsafe

System meets the applicable (CAN/CSA-C22.2 No. 60601-1) electrical safetystandard requirements.

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.

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

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Table of contentsLabel Symbols 3

Glossary 10

1 Introduction 18How to use this manual 18For important safety information 20Purpose of your patient programmer 20Purpose of the neurostimulation system(indications) 21Precautions 21

2 Using your patientprogrammer 26How the patient programmer works 26

Multiple neurostimulators 29Simple and advanced therapymodes 29

Summary of keys 32Using the Navigator key 36

The Therapy screen 38

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Synchronizing the patient programmerand your neurostimulator 41Turning your therapy on or off 44The neurostimulator battery 46

About rechargeable batteries 46Checking the nonrechargeable batterystatus 47Possible nonrechargeable battery statusconditions 48

Customizing your patientprogrammer 50

Changing preferences 51Patient programmer alert 57Patient programmer accessories 58

Carrying case and patient programmer IDlabel 58Detachable antenna 60Using the detachable antenna 61

3 Adjusting therapy settings withAdvanced mode 66Adjusting your therapy settings 66Therapy settings 68

Changing therapy settings in Advancedmode 69

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Selecting a new group 73Returning your therapy to originalsettings 77Understanding therapy parameterlimits 81

4 MRI examinations 84If you have an MRI appointment 84Responsibilities of the patient in preparingfor the MRI appointment 84Preparing your neurostimulation systemfor the MRI scan 85Turning off therapy before the MRIscan 86

Using the patient programmer to turn offtherapy 87Using the clinician programmer to turn offtherapy 88

Turning therapy back on after the MRIscan 89Activating settings to allow therapy onduring the MRI scan 90

Using the patient programmer to activatea new group 91

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Using the clinician programmer to activatea new group 92

Returning therapy to your original groupsetting after the MRI scan 94

5 Important information about yourrechargeableneurostimulator 98The rechargeable neurostimulatorbattery 98Check and charge: make it a habit 100

Checking the rechargeableneurostimulator battery 102Low battery status 103Rechargeable battery overdischarge 105

Charging the neurostimulator battery 106Patient programmer alert 108

6 Troubleshooting 110Patient Programmer screens 110

Warning screens 110Communication screen 113Information screens 114

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Possible problems and solutions 121

7 Maintenance 128Patient programmer batteries 128

Checking the patient programmerbatteries 129Replacing the patient programmerbatteries 132

Cleaning and care 134Safety and technical checks 135Battery and patient programmerdisposal 136Declaration of conformity 136Specifications 137

8 Assistance for the patientprogrammer 140

Index 142

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GlossaryActive Group - Available in Advanced mode

only, the active group is the current groupselected for your neurostimulator. See"Group" for more information.

Amplitude - The strength or intensity of anelectrical pulse.

Caution - A statement describing actions thatcould result in damage to or improperfunctioning of a device.

Charging system - Equipment used tocharge the battery inside a rechargeableimplanted neurostimulator.

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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Cycling - See Stimulation cycling.

Deep Brain Stimulation (DBS) - Thedelivery of electrical pulses to a targetedarea or areas of the brain.

Discharged battery status (rechargeablebattery only) - The rechargeable battery isdepleted and should be charged as soonas possible. When the battery is in adischarged state, therapy is not available.

Electrode - A metal piece near the tip of thelead. Electrodes deliver electrical pulses toa targeted area or areas of the brain.

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

EOS (End of Service) - A notification that theneurostimulator has reached its end ofservice. At EOS, the neurostimulator nolonger delivers the electrical pulses thatprovide therapy.

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ERI (Elective replacement indicator) - Anotification that the neurostimulator isnearing its end of service.

Group - A group is a collection of therapysettings on your patient programmer thatyour doctor creates for you. Each groupmay be defined for a different activity,symptom, or time of day. Available inAdvanced mode only, this feature allowsyou to adjust your therapy for differentsituations or for personal preference.

Group status row - The Parameter row onthe Therapy screen displays the activegroup.

Implantable neurostimulator (INS) - SeeNeurostimulator.

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

Lead - The lead is a set of thin wires coveredwith a protective coating. It carries thetherapy signal to the electrodes that deliverstimulation to the brain tissue.

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Magnetic Resonance Imaging (MRI) - Atype of medical procedure that scans yourbody using magnetic fields to providedetailed pictures of your anatomy.

Neurostimulation system - Componentsthat deliver, control, and maintain electricalpulses to provide therapy to the brain.

Neurostimulator - The neurostimulator is theimplanted device that generates andcontrols your DBS therapy.

Overdischarge (rechargeable battery only)- The rechargeable battery cannot berecharged when it is overdischarged. Oncethe battery is in a discharged state, if it isnot recharged it continues to lose charge.Eventually, the battery loses enoughcharge to permanently affect theneurostimulator. If this occurs, the batteryis overdischarged.

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

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Parameter/Group row - The bottom row onthe Therapy screen showing theparameter and active group settings (onlyavailable in Advanced mode).

Parameter settings - See Therapy settings.

Patient programmer - A hand-held devicethat allows you to turn your therapy on andoff. It may also be used to adjust sometherapy settings.

Precaution - See Caution.

Preferences - Adjustable settings on yourpatient programmer including audio,contrast, and text or icon display format.Preferences do not affect your therapy.

Pulse width - The length or duration of anelectrical pulse.

Rate - The number of electrical pulsesdelivered each second.

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SoftStart/Stop - This feature, programmedby your clinician, starts and stops yourtherapy gradually by slowly increasing ordecreasing to the programmed amplitudeor until turned off.

Status row - The top row on the Therapyscreen. This row displays if your therapy ison or off.

Stimulation - The delivery of electricalpulses to an appropriate area of the brain.Your therapy is actually mild electricalstimulation.

Stimulation cycling - This feature turns yourstimulation on and off at regular intervalsand is programmed by your doctor.

Synchronize - The process of sending andreceiving information between the patientprogrammer and neurostimulator.

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

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Therapy screen - The main screen displayedon the patient programmer.

Therapy settings - Your therapy can beadjusted by changing the rate, amplitude,or pulse width of the electrical stimulation.Your clinician programs all therapysettings. You may be able to adjust sometherapy settings within clinician-definedlimits. Available in Advanced mode only.

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

Warning screen - A screen displayed on thepatient programmer that alerts you to aproblem with the programmer, antenna, orneurostimulator.

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1 Introduction

How to use this manualRefer to this manual after you receive animplanted neurostimulator. Ask your doctor toexplain anything that is unclear.

• A glossary is provided at the beginning ofthis manual to describe terms that may beunfamiliar to you.

• Chapter 1 "Introduction", on page 17,describes how to use this manual, thepurpose of the patient programmer, andprovides general precautions related tousing your patient programmer.

• Chapter 2 "Using your patientprogrammer", on page 25, describes thepatient programmer and how to performspecific tasks.

• Chapter 3 "Adjusting therapy settings withAdvanced mode", on page 65, explains

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how to use your patient programmer toadjust your therapy settings.1

• Chapter 4 "MRI examinations", onpage 83, provides information aboutwhat you should do if you have an MRIexamination.

• Chapter 5 "Important information aboutyour rechargeable neurostimulator", onpage 97 emphasizes the importance ofchecking and recharging yourneurostimulator battery (for rechargeabledevices only).

• Chapter 6 "Troubleshooting", onpage 109, describes patient programmerwarning and information screens, how tosolve possible problems, and who tocontact if your device is lost or broken.

• Chapter 7 "Maintenance", on page 127describes how to care for your patient

1 Your doctor has programmed your implantedneurostimulator to provide the correct therapysettings for your medical condition and will activateAdvanced mode if appropriate.

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programmer, including how to change thebatteries.

For important safetyinformationPlease see your DBS Patient Therapy Guideand DBS Therapy-specific Patient Booklet forimportant safety information, related warningsand precautions, and additional informationabout your therapy.

Purpose of your patientprogrammerThe Medtronic Model 37642 PatientProgrammer is designed to operate with thefollowing Medtronic neurostimulators:

• Activa PC Model 37601 (nonrechargeablebattery)

• Activa RC Model 37612 (rechargeablebattery)

• Activa SC Model 37602 (nonrechargeablebattery)

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• Activa SC Model 37603 (nonrechargeablebattery)

Purpose of theneurostimulation system(indications)Refer to the indications sheet that ispackaged with your patient programmer forthe purpose of the neurostimulation systemand related information.

PrecautionsPatient control devices may affect otherimplanted devices—Do not place the patientcontrol device (ie, patient programmer) overanother type of active implanted medicaldevice (eg, pacemaker, defibrillator, anothertype of neurostimulator). The patient controldevice could unintentionally change theoperation of the other device.

Patient programmer handling—To avoiddamaging the patient programmer, do notimmerse the device in liquid; do not clean it

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with bleach, nail polish remover, mineral oil,or similar substances; and do not drop it orhandle it in a way that might damage it.

Patient programmer use—The device is notcertified for use in the presence of aflammable or anesthetic mixture with air orwith oxygen or nitrous oxide. Theconsequences of using the device nearflammable atmospheres are unknown.

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

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

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wheelchairs. For more information about EMI,refer to your DBS Therapy-specific patientbooklet.

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2 Using yourpatientprogrammer

How the patient programmerworksThe patient programmer is used to controland monitor your implanted neurostimulatoror neurostimulators. For example, you willuse your patient programmer to:

• Turn your therapy on or off.

• Check the neurostimulator and patientprogrammer battery status.

• Alert you when you need to check thestatus of the neurostimulator battery.1

• Change therapy settings.2

Note: Make sure to keep your patientprogrammer with you at all times in the eventthat you need to adjust your therapy or turnyour therapy off.

1 Your clinician will turn this feature on or off and alsoset the time of day that it will alert you.

2 Your clinician will set up the therapy settings you willbe able to adjust depending on your specific therapyrequirements. Discuss this with your doctor.

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The patient programmer communicates withyour neurostimulator by sending signals toand receiving signals from your implantedneurostimulator.

When you use the patient programmer, holdit directly over your implanted neurostimulatorso that the programmer screen is facing out.The back of the patient programmer shouldbe as close to the neurostimulator aspossible, as shown in Figure 2.1.

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Patient programmer

Hold patient programmerdirectly over yourimplantedneurostimulator

Figure 2.1 Place the patient programmer directly over your neurostimulator.

A detachable antenna is available for usewith your neurostimulator system. Thedetachable antenna makes it easier to viewthe patient programmer screen whileadjusting your therapy settings or checkingthe neurostimulator battery status. See"Using the detachable antenna" on page 61for more information.

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Multiple neurostimulators

Some patients have decided with theirdoctors to have two neurostimulatorsimplanted.

If you have two neurostimulators implanted,you can use one patient programmer tocommunicate with both neurostimulators, butonly with one neurostimulator at a time. Thepatient programmer only displays informationabout the neurostimulator with which it iscurrently synchronized.

The patient programmer must be turned offprior to sychronizing with the otherneurostimulator or you may not be viewingthe desired information.

Simple and advanced therapymodes

There are two therapy modes available foryour patient programmer: Simple mode andAdvanced mode. Your doctor will discusswhich mode you will use.

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• Simple mode uses the therapy settingsselected by your doctor. Only your doctorcan adjust your therapy settings.

• Advanced mode uses therapy settingsselected by your doctor and also mayallow you to change certain therapysettings and/or select preset therapygroups.

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Table 2.1 Tasks available for Simple andAdvanced therapy modes

Tasks Simple Advanced

Check neurostimulator battery Yes Yes

Check patient programmerbattery

Yes Yes

Check status of neurostimulator(on or off)

Yes Yes

Turn audio on or off. This doesnot change the Patient alert.

Yes Yes

Adjust time Yes Yes

Adjust screen contrast Yes Yes

Adjust therapy settings No Yesa

Change active group No Yesa

a This advanced feature is determined by your doctor.

For details about Advanced mode, see"Adjusting therapy settings with Advancedmode" on page 65.

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Summary of keys

Therapy On/Off

Check

Selection

Power/Backlight On/Off

Navigator key

Figure 2.2 Keys used to operate the patient programmer.

Refer to Table 2.2 for a description of thepatient programmer keys.

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Table 2.2 Summary of keys

Key Function

TherapyOn/Off

Turns your therapy on or off.

• The patient programmer (ordetachable antenna) must be helddirectly over the neurostimulatorwhile pressing the Therapy On/Offkey.

• After using the Therapy On/Off key,verify your therapy status by viewingthe displayed Therapy screen.

Press this key to turn your therapy onor off.

Check

Synchronizes the neurostimulator andpatient programmer.

Activates a selected group (Advancedmode only).

Activates the “Return to ClinicianSettings” (Advanced mode only).

The patient programmer (or detachableantenna) must be held directly over theneurostimulator while pressing theCheck key.

Press this key to synchronize thepatient programmer andneurostimulator.

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Table 2.2 Summary of keys (continued)

Key Function

Power/backlightOn/Off

Turns the patient programmer and thebacklight on or off. The backlightprovides more light to the display.

Press and release this key once toturn the patient programmer power onor off.

Press and hold this key to turn thebacklight on or off.

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Key Function

Selection

Selects parameter setting for the left orright side of body (Therapy screen).

Increases or decreases setting values(Parameter screen).

When increasing or decreasing values,hold the patient programmer (ordetachable antenna) directly over theneurostimulator and press theappropriate Selection key.

You have two options to increase ordecrease the settings with the Selectionkey.

• Press and release the Selection keymultiple times to increase ordecrease the settings.

• Press and hold the Selection key toincrease or decrease the settingswhich will change approximatelyevery half-second.

Press the Selection key under anoption displayed on the screen toselect that option.

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Key Function

Navigator

Moves the selection box up or down onthe Therapy screen or to the nextavailable screen.

The Options icon at the end of a rowon the Therapy screen indicates that therow continues on the next screen.

Press the left or right arrows on thiskey to navigate to the next screen.

Press the up or down arrows onthis key to move the selection box to thenext row.

Using the Navigator key

The Navigator key moves the selection boxon the patient programmer screen to the rightor left and up or down (Figure 2.3).

Figure 2.3 Navigator key.

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• To move the selection box across a rowthat continues onto the next screen, pressthe left or right arrows on theNavigator key.

• To move the selection box to a new row,press the up and down arrows onthe Navigator key.

The image below is an example of howthe Options icon is displayed. TheOptions icon is displayed at the end ofa row when that row has additional itemsto view to the right or left (Figure 2.4).

Selectionbox

Optionsicon

Figure 2.4 The Options icon and selection box.

When moving the selection box with theNavigator key, you do not need to hold thepatient programmer over yourneurostimulator.

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The Therapy screenThe Therapy screen displays yourneurostimulator settings and battery status.

• In Simple mode:

The Therapy screen shows whether yourneurostimulator is on or off and the statusof the neurostimulator battery. The Simplemode screen appears the same for ActivaPC, RC, and SC models (Figure 2.5).

Battery row

Status row

Figure 2.5 The Therapy screen in Simple mode for Activa PC, RC, and SC models

• In Advanced mode:

The Therapy screen shows whether yourneurostimulator is on or off, the batterystatus, and the specific parameters set foryour therapy.

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In most cases, the Advanced modescreen appears differently for Activa SCmodels than the Activa PC and Activa RCmodels (Figure 2.6). In most cases, oneActiva PC or RC neurostimulatorstimulates two sides of the brain. Incontrast, one Activa SC neurostimulatorstimulates one side of the brain.

Status row

Advanced mode

Battery row

Parameter/group row

Activa PC and RC Activa SC models

Figure 2.6 The Therapy screen in Advanced modes Activa PC, RC, and SC models.

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Table 2.3 Therapy screen icons

Row Icons Description

Status Therapy is on

Therapy is off

Battery (Activa RC)

Neurostimulator battery chargelevel (rechargeable)a

Needs Charge Full Charge

Battery (Activa PCand SCmodels)

Neurostimulator battery status(nonrechargeable)

Battery OK Battery nearend of service

Parameter/groupb

Active groupc

Amplitude

Pulse width

Ratea For complete rechargeable battery information, see

Chapter 5 "Important information about yourrechargeable neurostimulator".

b The Parameter/group row only appears in Advancedmode.

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Table 2.3 Therapy screen icons

Row Icons Descriptionc If only one group is available, this row displays only

the parameter setting icon.

Synchronizing the patientprogrammer and yourneurostimulatorIn order to check your neurostimulator status,change therapy settings, or turn yourneurostimulator on and off, you must firstsynchronize the patient programmer and theneurostimulator.

Complete the following steps to synchronizethe patient programmer and neurostimulator.

1. Locate the Check key.

2. Hold the patient programmer (or antenna)directly over the neurostimulator with thescreen facing outward.

3. Press the Check key.

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Note: Pressing the Check key alsoturns on the patient programmer(Figure 2.7).

Use theCheck keyto synchronize

Figure 2.7 Press the Check key to synchronize your neurostimulator and patient programmer.

4. After pressing the Check key, theCommunication screen appears briefly.

Figure 2.8 Communication screen.

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a. If synchronization is successful, theTherapy screen appears (Figure 2.9).

Figure 2.9 Therapy screen (Simple mode).

b. If synchronization is not successful,the Position antenna screen or thePoor communication screen appears(Figure 2.10 and Figure 2.11). SeeTable 6.3 on page 115 for informationon how to proceed when thesescreens appear.

Figure 2.10 Position antenna screen

Figure 2.11 Poor communication screen.

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Note: See Chapter 6 "Troubleshooting" formore information about synchronizing thepatient programmer and neurostimulator.

Turning your therapy on or offComplete the following steps to turn yourtherapy on. Be sure to talk to your doctorabout turning your therapy on or off beforefollowing this procedure.

1. Synchronize the patient programmer andneurostimulator.

a. Hold the patient programmer (orantenna) directly over yourneurostimulator with the screen facingoutward.

b. Press the Check key. The Therapyscreen appears.

The Status icon on the Therapy screenindicates whether your therapy is turnedon or off (Figure 2.12).

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Therapy is turned On Therapy is turned Off

Figure 2.12 Therapy status is displayed.

2. Press the Therapy On/Off key .

If your therapy is currently off, pressingthe Therapy On/Off key will turn thetherapy on.

If your therapy is currently on, pressingthe Therapy On/Off key will turn thetherapy off.

The display flashes Off when the therapyis turned off. If the display is set to iconmode, a warning symbol ( ) flasheswhen the therapy is turned off.

Figure 2.13 Therapy off in icon mode.

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Note: See "Changing preferences" onpage 51 for more information about iconmode.

The neurostimulator batteryYour neurostimulator battery may be either arechargeable battery or a nonrechargeablebattery. Check with your doctor if you do notknow what type of neurostimulator batteryyou have.

About rechargeable batteries

The rechargeable neurostimulator batteryneeds to be checked daily to make sure thecharge level is adequate for your therapy.

Note: For complete information about therechargeable neurostimulator battery, seeChapter 5 "Important information about yourrechargeable neurostimulator" on page 97.

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Checking the nonrechargeablebattery status


Note: For information on checking andcharging the rechargeableneurostimulator battery, seeChapter 5 "Important information aboutyour rechargeable neurostimulator".


b. Press the Check key. The Therapyscreen appears (Figure 2.14).

Therapy is turned On Therapy is turned Off

Figure 2.14 Therapy status is displayed.

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2. Check the current status reading for thebattery:

– Simple Mode: Press the left or right arrow on the Navigator key to

display the Battery status screen(Figure 2.15).

– Advanced mode: press the up ordown arrow on the Navigator key toselect the Battery row. Press the left or right arrow on the Navigator keyto display the Battery status screen(Figure 2.15).

Figure 2.15 Battery Status screen.

Possible nonrechargeable batterystatus conditions

The patient programmer displays aninformation screen if the neurostimulatorbattery needs your attention (Table 2.4).

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See Chapter 6 "Troubleshooting" for moreinformation about battery-related screens.

Table 2.4 Nonrechargeable neurostimulatorbattery screens

ERI condition

If the Therapy screen displaysERI, the neurostimulator batteryis close to its end of servicedate.a

You should call your doctorto report.

Nonrecharge-ablebattery status is low

This information screenappears when you synchronizeyour neurostimulator andpatient programmer when thenonrechargeable battery statusis low. This means that yourtherapy will not be availablesoon.

Press any key to clear thismessage. Call your doctor toreport this message.

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Table 2.4 Nonrechargeable neurostimulatorbattery screens (continued)

EOS condition

If the EOS screen displays,then the battery is at end ofservice (EOS), therapy hasstopped, and theneurostimulator needs to bereplaced.

Call your doctor immediately.a If your nonrechargeable neurostimulator battery is

approaching ERI condition, your doctor may set upan alert on the patient programmer to remind you tocheck your neurostimulator battery voltage once aday. For more information see, "Patient programmeralert" on page 57.

Customizing your patientprogrammerYou can adjust the audio and display settingsfor your patient programmer by changing thepreferences. Preferences can be reachedfrom the Status row of the Therapy screen.Changing the preferences for the patientprogrammer do not affect your therapy.

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See Table 2.5 for a list of the availablepreference settings.

Table 2.5 Preference icons

Icons Preference

Audio

Contrast

Timea

Time and number format

Text or icon only display

a The Patient alert feature is based on the time set inyour patient programmer. For more information, see"Patient programmer alert" on page 57.

Changing preferences

Complete the following steps to adjust thepatient programmer preferences.


a. Hold the patient programmer (orantenna) directly over your

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neurostimulator with the screen facingoutward.


Simple mode Advanced mode

Status row

Figure 2.16 Access preferences from the Status row.

2. If in Advanced mode, press the down arrow on the Navigator key to move theselection box to the Status row.

3. Press the left or right arrow on theNavigator key to move the selection boxto the desired preference (Figure 2.17).

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Select preference(audio)

Figure 2.17 Desired preference (audio in this example).

4. Press the down arrow on theNavigator key to move the selection boxto the Change row (Figure 2.18).

Change row

Figure 2.18 Change row (audio in this example).

5. Follow the steps in Table 2.6 to changethe selected preference.

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Table 2.6 Changing programmer preferences

Audio preference

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

b. Continue to step 6 through step 8on page 56.

Note:The Patient alert will playeven if the Audio preference isturned off.

Contrast preference

a. Press the left or right arrowon the Navigator key to movethe selection box to the contrastslider bar.

b. Press the Selection keys to makethe contrast lighter or darker .

c. Continue to step 6 through step 8on page 56.

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Table 2.6 Changing programmer preferences (continued)

Time preference

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

b. Press the Selection keys toincrease or decrease thedisplayed time.

c. Continue to step 6 through step 8on page 56.

Time and number formatpreference

a. Press the left or right arrowon the Navigator key to movethe selection box to a 12-hourclock or to a 24-hour clock.


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Table 2.6 Changing programmer preferences (continued)

Text on

Text off/icononly

Text or icon display format

a. Press the left or right arrowon the Navigator key to movethe selection box to the Text onor Text off/icon only displaysetting.


Note:The text displayed on thepatient programmer will alwaysbe in English.

6. Press the up arrow on the Navigatorkey to return the selection box to theStatus row.

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

8. Hold the patient programmer or antennadirectly over your neurostimulator andpress the Check key to save thepreference change.

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Patient programmer alertYour doctor may set up an alert on thepatient programmer to remind you to checkyour neurostimulator battery once a day(rechargeable neurostimulator batteries only).

Note: For nonrechargeable neurostimulatorbatteries, your doctor may set up this alert foryou when your battery is near its end ofservice.

The default setting for the alarm is 11:00 a.m.However, your doctor may change this to adifferent time of day if appropriate.

The alert time is based on the time set for thepatient programmer. To adjust this time, seeTable 2.6 on page 54.

The patient programmer alert beeps for 30seconds, with a pause every 10 seconds.The Patient alert screen displays while thealarm is beeping (see Figure 2.19). ThePatient alert sounds even if the audiopreference is turned off.

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Figure 2.19 Patient alert screen.

This alert repeats every 15 minutes until theneurostimulator battery status has beenchecked.

To check battery status, see "Checking thenonrechargeable battery status" on page 47or "Checking the rechargeableneurostimulator battery" on page 102.

Patient programmeraccessories

Carrying case and patientprogrammer ID label

A carrying case and identification label areincluded with your patient programmer. TwoAAA alkaline batteries that provide the powerfor your patient programmer are alsoincluded.

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The carrying case has a pouch to hold thepatient programmer and the quick referenceguide.

Figure 2.20 Insert the patient programmer into the case.

You can attach the patient programmer to abelt using the loop on the back of the case.

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Place the provided identification label on theback of your patient programmer just in casethe patient programmer is lost (Figure 2.21).

ID label

Figure 2.21 Place the adhesive label on the back of the patient programmer.

Detachable antenna

A detachable antenna (Model 37092) isuseful for viewing the patient programmerscreen while you are adjusting therapy. Whenthe antenna is connected to the patientprogrammer, hold the antenna or attach it toyour clothing directly over the neurostimulatorto adjust settings or check theneurostimulator battery.

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Using the detachable antenna

1. Place the antenna directly over yourneurostimulator (Figure 2.22).

Figure 2.22 Place the antenna directly over your neurostimulator.

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 2.23).

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a b

Figure 2.23 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 2.24).

Figure 2.24 Insert the antenna plug into the antenna jack.

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After the antenna is connected, follow theinstructions for using the patient programmer.

When you have finished using the patientprogrammer, grasp the antenna plug and pullit out.

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

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3 Adjustingtherapy settingswith Advancedmode

Adjusting your therapy settingsYou may find that on some days, in order toreceive the most effective therapy, you needto adjust your therapy several times. On otherdays you may not need to adjust it at all. Yourdoctor will provide complete guidelines aboutwhen you may want to adjust your therapy.

• Ask your doctor to print a report with yourprogrammed settings.

• When a therapy setting is changed, youwill see the change on the Therapyscreen.

• If your patient programmer audio is turnedon, you will hear one tone that means thechange was effective.

• Three rapid tones means that the changecould not be confirmed or that thesynchronization was not successful.

• Verify the current therapy settings bypressing the Check key and viewingthe Therapy screen.

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Tips for adjusting your therapy:

• Always adjust the therapy settings to thelowest possible setting that providessymptom relief.

– High therapy settings use morerechargeable battery charge which mayforce you to charge the battery morefrequently.

– High therapy settings may shorten theservice life of the nonrechargeablebattery.

• Before changing any therapy settings withyour patient programmer, you need tosynchronize the patient programmer withthe neurostimulator.

Note: If you have two neurostimulatorsimplanted, you can use one patientprogrammer to communicate with bothneurostimulators, but only with oneneurostimulator at a time. Tocommunicate with anotherneurostimulator, turn the patientprogrammer off and then press the Check

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key to synchronize while holding overthe desired neurostimulator.

• If you experience uncomfortable therapyor unwanted side effects when increasingthe amplitude, pulse width, or rate,decrease the setting to a comfortabletherapy setting. You may also use theTherapy On/Off key to stop thetherapy.

Therapy settingsIf your neurostimulator is set to Simple mode,you will not be able to adjust your therapysettings. Your doctor can adjust your settingswhen necessary.

Notes:

• To increase amplitude, pulse width, orrate, your therapy must be turned on.

• To decrease amplitude or pulse width,your therapy may be turned on or off.

• To decrease rate, your therapy must beturned on.

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• For each group, only one parameter canbe changed. For example, group A mayallow you to change only the amplitude ofthe therapy and group B may allow you tochange only the rate of the therapy.

• A group may also be programmed forview only and you will not be able toadjust any settings. Discuss your settingswith your doctor. For more informationabout groups, see "Selecting a newgroup" on page 73.

Changing therapy settings inAdvanced mode

The ability to change therapy settings is onlyavailable in Advanced mode.

You can only change the settings of theactive group. If you want to change settingsavailable for a non-active group, you willneed to make that group active first. See"Selecting a new group" on page 73 forcomplete instructions.

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2. Press the down arrow on theNavigator key to move the selection boxto the Parameter row (Figure 3.1).

Parameter row

Activa PC and RC models Activa SC models

Figure 3.1 Parameter row for Activa PC, RC, and SC models.

3. Press the Selection key directly under thedisplayed setting you want to adjust(Figure 3.2).

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Parameter row for Activa PC and RCTwo sides of the brain

Parameter row for Activa SC ModelsOne side of the brain

Setting forthe left side

of your body

Setting forthe left side

of your body

Setting forthe right sideof your body

Setting forthe right sideof your body

Figure 3.2 Select the appropriate Selection key on Activa PC, RC, and SC models.

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4. Press the Selection keys again toincrease or decrease the selected therapysetting as needed (Figure 3.3).1

Decrease setting

Indicates leftside of body

Increase setting

Figure 3.3 Increasing or decreasing a therapy setting.

Notes:

– Hold the patient programmer ordetachable antenna over yourneurostimulator when increasing ordecreasing your settings. The therapysettings will immediately change asyou press the Selection keys.

1 If you attempt to increase or decrease the therapysetting beyond the available limits, an informationscreen appears, see Table 3.1 on page 81.

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– Press and hold down the Selectionkey to increase or decrease the settingwhich will change approximately everyhalf-second.

5. Press any arrow on the Navigator key toreturn to the Therapy screen.

6. Repeat steps 2-5 for the other side of yourbody if desired.

Note: If you have multipleneurostimulators, the patient programmermust be turned off prior to synchronizingwith the other neurostimulator.

Selecting a new group

The group feature is only available inAdvanced mode.

Caution: Select the group that yourclinician has recommended for yourspecific needs.


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Parameter row


Figure 3.4 Parameter row.

3. Press the right arrow on the Navigatorkey to display the available groups.(Figure 3.5).

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Figure 3.5 Group screen.

4. Press the up or down arrow on theNavigator key to move the selection boxthe desired group (Figure 3.6).

Figure 3.6 Select the desired group.

5. Resynchronize the patient programmerand neurostimulator.


b. Press the Check key to sychronizewith the patient programmer andactivate the selected group.

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6. The Communication screen brieflyappears, followed by the Therapy screen(Figure 3.7).

Figure 3.7 Communication screen.

The Therapy screen will display your newtherapy parameters and group setting(Figure 3.8).

Activa PC and RC models

Activa SC models

Parameter/Group row

Figure 3.8 Therapy screen with new group setting.

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Returning your therapy tooriginal settingsIf you have changed your therapy settingsand want to return to the settings selected byyour doctor, follow these steps:





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Parameter row


Figure 3.9 Parameter row.

3. Press the right arrow on the Navigatorkey to display the available groups. TheGroup settings screen appears(Figure 3.10).

Figure 3.10 Group settings screen.

To change from the current groupsettings back to the doctor defaultsettings:

a. With the selection box highlighting thecurrent group, press the right arrowon the Navigator key. The Groupreset screen appears (Figure 3.11).

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Figure 3.11 Group reset screen.

b. Press the Check key.

To change an inactive group back tothe doctor default settings:

a. Press the up or down arrow onthe Navigator key to move theselection box to the desired inactivegroup (Figure 3.12).

Figure 3.12 Select new group.

b. Press the right arrow on theNavigator key. The Group optionsscreen appears (Figure 3.13).

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Figure 3.13 Group options screen.

c. Press the down arrow on theNavigator key to move the selectionbox to the Clinician setting option(Figure 3.14).

Figure 3.14 Change group to clinician settings.

d. Press the right arrow on theNavigator key to display the Groupreset screen (Figure 3.15).

Figure 3.15 Group reset screen

e. Press the Check key.

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4. The patient programmer beeps when thegroup settings are changed (if the audio isturned on).

Understanding therapyparameter limitsEach therapy parameter will have a defaultlimit set by your doctor. If you attempt tochange a therapy parameter outside theseset limits, you will see one of the screensshown in Table 3.1.

Table 3.1 Parameter limit screens

Lower limit You tried to decrease a parameter(amplitude, pulse width, or rate)below the lowest value allowed.

Press any arrow on the Navigatorkey to clear the screen.

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Table 3.1 Parameter limit screens (continued)

Upper limit You tried to increase a parameter(amplitude, pulse width, or rate)above the highest value allowed.

Press any arrow on the Navigatorkey to clear the screen.

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4 MRIexaminations

If you have an MRI appointmentMR MR Conditional—Depending on what

kind of neurostimulation system componentsthat you have implanted, you may be eligiblefor one of the following types of magneticresonance 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).

Note: You should inform your clinicianmanaging your neurostimulation system thatan MRI examination has been prescribed foryou and that you need him or her todetermine what type of MRI scan you areeligible to receive.

Responsibilities of the patientin preparing for the MRIappointmentBring the following to every MRI appointment:

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• Your patient identification (ID) card foryour neurostimulation system if youreceived one from Medtronic.

Note: If you have two neurostimulationsystems implanted in your body, bringboth ID cards to your MRI appointment.

• Your MRI scan eligibility sheet if you weregiven one from your clinician managingyour neurostimuation system.

• Your patient programmer.

For more information about how MRI canaffect your neurostimulation system and whatyou should do if you have an MRIappointment, refer to the DBS PatientTherapy Guide.

Preparing yourneurostimulation system forthe MRI scanYour implanted neurostimulation system (ie,therapy) may need to be turned off prior toyour MRI scan or reprogrammed to allow the

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system to safely remain on during your MRIscan. This will depend on the neurostimulatormodel implanted in your body, the therapysettings of your neurostimulator, and the typeof MRI scan you are eligible to receive.

Your clinician managing yourneurostimulation system will inform youwhether your system should be on or offduring the MRI scan.

If therapy should be turned off prior to yourMRI scan, refer to "Turning off therapy beforethe MRI scan" on page 86.

If therapy can remain on during your MRIscan, refer to "Activating settings to allowtherapy on during the MRI scan" onpage 90.

Turning off therapy before theMRI scanIf your clinician managing yourneurostimulation system indicates thattherapy should be off during the MRI scan,therapy can be turned off with the patient

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programmer (see page 87) or the clinicianprogrammer (see page 88).

Using the patient programmer toturn off therapy

If you brought your patient programmer to theMRI appointment, you can turn off therapybefore your MRI scan and outside of the MRIscanner (magnet) room.

For instructions on turning off therapy, go to"Turning your therapy on or off" on page 44.

During the MRI scan, keep therapy off.

Caution: Do not turn therapy back onbefore your MRI scan. Leaving therapy onduring the scan could increase thepotential for unintended stimulation.

After the MRI scan and outside of the MRIscanner (magnet) room, you can turn therapyback on using your patient programmer oryou can return to the clinician managing yourneurostimulation system to have therapyturned back on (refer to "Turning therapyback on after the MRI scan" on page 89).

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Note: Do not take the patient programmerinto the MRI scanner (magnet) room. If youbrought the recharger with you to the MRIappointment, do not take the recharger intothe MRI scanner (magnet) room either.

Using the clinician programmer toturn off therapy

Your clinician managing yourneurostimulation system can turn off therapybefore your MRI examination using theclinician programmer.

Do not turn therapy back on before your MRIscan.

Caution: Do not turn therapy back onbefore your MRI scan. Leaving therapy onduring the scan could increase thepotential for unintended stimulation.

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 therapy off.

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After the MRI scan and outside of the MRIscanner (magnet) room, you can turn therapyback on using your patient programmer oryou can return to the clinician managing yourneurostimulation system to have therapyturned back on (refer to "Turning therapyback on after the MRI scan" on page 89).

Turning therapy back on afterthe MRI scanTurn therapy back on when the MRI scan iscomplete and you are outside of the MRIscanner (magnet) room.

Therapy can be turned on with the patientprogrammer or the clinician programmer:

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

• If you brought your patient programmer tothe MRI appointment, turn therapy backon using the patient programmer. For

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instructions on turning on therapy, go to"Turning your therapy on or off" onpage 44.

Note: If a power-on-reset (POR) screenappears on the patient programmer, seeTable 4.1 on page 95.

Activating settings to allowtherapy on during the MRI scanDepending on your therapy settings, yourclinician managing your neurostimulationsystem may create a new group that shouldbe activated prior to your MRI scan. This willallow your system to safely remain on duringthe scan.

If your clinician managing yourneurostimulation system creates a new groupsetting so that therapy can remain on duringyour MRI scan, the new group can beactivated with the patient programmer (seepage 91) or the clinician programmer (seepage 92).

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Using the patient programmer toactivate a new group

If you brought your patient programmer to theMRI appointment, you can activate the newgroup before your MRI scan and outside ofthe MRI scanner (magnet) room. This willallow you to keep therapy on during your MRIscan.

For instructions on activating a new group, goto "Selecting a new group" on page 73.

During the MRI scan, keep therapy on, but donot return therapy to your original groupsetting.

Caution: Do not return therapy to youroriginal group setting before your MRIscan. Returning therapy to your originalgroup setting could increase the potentialfor unintended stimulation during thescan.

After the MRI scan and outside of the MRIscanner (magnet) room, you can returntherapy to your original group setting using

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your patient programmer or you can return tothe clinician managing your neurostimulationsystem to reprogram therapy to your originalgroup setting (refer to "Returning therapy toyour original group setting after the MRIscan" on page 94).

Note: Do not take the patient programmerinto the MRI scanner (magnet) room. If youbrought the recharger with you to the MRIappointment, do not take the recharger intothe MRI scanner (magnet) room either.

Using the clinician programmer toactivate a new group

The clinician managing your neurostimulationsystem can activate the new group beforeyour MRI examination using the clinicianprogrammer. This will allow you to keeptherapy on during your MRI scan.

Do not change therapy to your original groupsetting before the MRI scan.

Caution: Do not return therapy to youroriginal group setting before your MRI

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scan. Returning therapy to your originalgroup setting could increase the potentialfor unintended stimulation during thescan.

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 therapy on, but donot return therapy to your original groupsetting.

After the MRI scan and outside of the MRIscanner (magnet) room, you can returntherapy to your original group setting usingyour patient programmer or you can return tothe clinician managing your neurostimulationsystem to reprogram therapy to your originalgroup setting (refer to "Returning therapy toyour original group setting after the MRIscan" on page 94).

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Returning therapy to youroriginal group setting after theMRI scanReturn therapy to your original group settingwhen the MRI scan is complete and you areoutside of the MRI scanner (magnet) room.

Group settings can be changed with thepatient programmer or the clinicianprogrammer:

• If you do not have your patientprogrammer with you, go to the clinicianmanaging your neurostimulation systemto return therapy to your original groupsetting using the clinician programmer.

• If you brought your patient programmer tothe MRI appointment, return therapy toyour original group setting using thepatient programmer. For instructions onreturning therapy to your original groupsetting, go to "Selecting a new group" onpage 73.

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Note: If a power-on-reset (POR) screenappears on the patient programmer, seeTable 4.1.

Table 4.1 POR screens

Screen Description and action

Warning POR(hazard trianglesymbol in theupper left corner)

Error code POR: Your therapy hasstopped.

Call your clinician to restartyour therapy.

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Table 4.1 POR screens (continued)


InformationalPOR (small "i"icon in the upperleft corner)

The neurostimulator has beenreset. Your therapy has stopped.

1. Press any arrow on theNavigator key to clear thescreen

2. Reset the time, if prompted(for instructions, seeTable 2.6). Before resettingthe time, confirm the patientprogrammer or antenna isdirectly over theneurostimulator.

3. Press the up arrow on thepatient programmer. Thisaction will clear the POR.

4. Press the Therapy on/off key to turn your therapy on.

Call your clinician to report thereset.

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5 Importantinformation aboutyour rechargeableneurostimulator

The rechargeableneurostimulator batteryThe following chapter explains theimportance of maintaining the battery chargelevel of your rechargeable neurostimulator.1

Warning: It is very important to checkyour neurostimulator battery every day. Ifthe therapy provided by yourneurostimulator should stop abruptly thiscould cause your symptoms to return. Insome cases, your symptoms may returnat a greater intensity than before yourimplant. In rare situations, this could resultin a medical emergency.

It is important for you to recharge yourbattery on a regular, frequent basis asrecommended by your doctor to makesure that the neurostimulator batteryremains charged. Depending on yourtherapy settings this may mean chargingyour battery once a day or once a week,

1 This information only applies to implantableneurostimulators that use a rechargeable battery.

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ask your doctor for his recommendation. Ifyou have technical problems whilecharging your battery, contact your doctor,nurse, or Medtronic patient services.

If you notice that your symptoms return,check your battery status first. If itindicates that your battery is not charged,recharge your battery immediately. Pleasefollow your doctor's advice for takingmedications when your neurostimulator isnot working. Medications may help controlyour symptoms while or until your batteryis charged. Please contact your doctorimmediately if your symptoms get worseand do not return to where they werewhen your neurostimulator was working,or if your device battery is not indicating aneed to recharge, please contact yourdoctor immediately. Your doctor cancheck the status of your neurostimulatorsystem and monitor your condition.

Note: For contact information, seeChapter 8 "Assistance for the patientprogrammer" on page 139.

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Check and charge: make it ahabitBecause this is so important, make it apriority to check and charge yourneurostimulator battery on a regularschedule. See Table 5.1 on page 107 forrechargeable battery alert screens thatindicate a low battery charge level.

Recommendations:

• Check your battery charge level at thesame time every day (your doctor can setthe patient programmer alert for this time).

• Combine checking your battery chargelevel with something else you do everyday in order to make it a convenient habit.

• Make sure to bring your neurostimulatorrecharging system with you when youtravel or are hospitalized (even forovernight).

• Allow enough time to fully charge theneurostimulator. Depending on the chargelevel of the battery when you begin

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charging, this could take up to four hours.If the charge level is completely depleted,charging may require more than fourhours.

Note: For more information, see themanual packaged with your rechargingdevice.

• Make sure that the charging antenna isheld securely against the implantedneurostimulator. If the devices are notaligned correctly or if there is open spacebetween the devices, it may take longer tocharge the neurostimulator battery.

• Charge your neurostimulator batterybefore it is depleted. The battery shouldbe charged before it has only 25% powerremaining.

You do not need to wait until the batterycharge level is low. If it’s more convenient,you can charge the battery every day.

Note: Remember that even when yourtherapy is turned off, the neurostimulatorbattery charge will still deplete over time. You

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should continue to check the battery dailyand charge it when necessary.

Consult with your doctor about how often youshould charge your neurostimulator batterybased on your individual therapy settings.

Checking the rechargeableneurostimulator battery



Press the Check key. The Therapyscreen appears displaying theneurostimulator battery charge level(Figure 5.1).

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Needs charge

Battery status

Full charge

Figure 5.1 The neurostimulator battery charge level is displayed on the Therapy screen.

Low battery status

Caution: Charge the neurostimulatorwhen you see a Low battery screendisplayed on the patient programmer orrecharger. If LOW is flashing, the batterycharge level is at 0 and your therapy willstop soon unless you recharge thebattery.

If you see the following screen(Figure 5.2), the neurostimulator battery is

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in a discharged state and your therapyhas stopped.

Figure 5.2 Neurostimulator battery is in a discharged state.

You should charge the battery as soon aspossible. If the battery remains in adischarged state, it continues to losecharge and it will become overdischarged.

If the neurostimulator battery is allowed tooverdischarge, you may not be able torecharge or communicate with theneurostimulator; however, your doctormay be able to restore the batteryfunction.

Allowing the neurostimulator battery tooverdischarge will permanently affect theneurostimulator in one of the followingways:

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• 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.

Rechargeable battery overdischarge

You can avoid the consequences of anoverdischarged battery and the loss oftherapy by keeping the battery charged.

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Charging the neurostimulatorbatteryWhen the neurostimulator battery chargelevel is low, charge the battery as describedin the manual packaged with the chargingsystem.

Note: You can charge your battery moreoften, even daily. You do not need to waituntil the battery charge level is low.

Your neurostimulator battery can be chargedmany times; however, eventually theneurostimulator will need to be replaced.

If the neurostimulator battery needs charging,you will see one of the screens shown inTable 5.1.

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Table 5.1 Rechargeable neurostimulatorbattery screens

Charge batteryscreen

The neurostimulator batterycharge level is low. When the"Low" message is flashing,therapy will not be availablesoon.

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

Press any arrow on theNavigator key to clear thismessage from the screen.

Battery is in adischarged state

The neurostimulator batterycharge level is depleted andneeds immediate charging. Thebattery is in a discharged stateand therapy has stopped whenthe battery is depleted.

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

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Table 5.1 Rechargeable neurostimulatorbattery screens (continued)

EOS condition

If this screen displays, the batteryis at the end of service, therapyhas stopped, and theneurostimulator needs to bereplaced.

If the EOS screen displays, callyour doctor immediately.

a If necessary, you can stop charging the batterybefore it is completely recharged in order to turn thetherapy back on. Finish charging the battery afteryour therapy is turned back on.

Patient programmer alertYour doctor may set up an alert on thepatient programmer to remind you to checkyour neurostimulator battery once a day.

For more information, see "Patientprogrammer alert" on page 57.

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6 Troubleshooting

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

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

Patient Programmer screensAfter you synchronize your patientprogrammer with your implantedneurostimulator, the patient programmer maydisplay a Warning , Communication , orInformation screen to provide you withinformation about your system, alert you to aproblem with your system, or to guide youwhile using the patient programmer.

Warning screens

Warning screens indicate a problem with thepatient programmer, the antenna, or theneurostimulator. If the patient programmeraudio preference is turned on, three tones

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alert you when a warning screen is displayedon the patient programmer.

Table 6.1 describes warning screens andprovides instructions (see blue text) on howto resolve the problem and clear the screen.

Table 6.1 Warning screens

Screen Cause and action

Replace patientprogrammerbatteries

The patient programmerbatteries are depleted.Programming is not possible.

Replace the patientprogrammer batteries now.

Device notsupported

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

Call your doctor.

Synchronize patientprogrammer andneurostimulator

The patient programmer andthe neurostimulator must besynchronized.

Synchronize the patientprogrammer andneurostimulator.

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Table 6.1 Warning screens (continued)


Call your doctorscreens

(compare to theinformation screenson page 114.)

The system is not workingcorrectly. Therapy may havestopped.

Read the error code at thebottom of the screen.

Error codes 0 to 252:

Remove batteries from thepatient programmer, waitseveral seconds, then re-insert the batteries. If theerror message appears again,call your doctor.

Error code EOS: Yourneurostimulator has reached itsend of service. Therapy is notavailable.

Call your doctor.

Error code POR: Your therapyhas stopped.

Call your doctor to restartyour therapy.

Other codes: Write down thecode shown on the screen.

Call your doctor.

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Table 6.1 Warning screens (continued)


Rechargeablebattery only

Rechargeablebattery is in adischarged state

The rechargeableneurostimulator battery is in adischarged state and therapyhas stopped.

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

Warning: If the neurostimulator battery isallowed to overdischarge, you may not beable to recharge it. However, your doctormay be able to restore the batteryfunction.

Refer to "The rechargeable neurostimulatorbattery" on page 98 for more information.

Communication screen

The Communication screen appears whenthe patient programmer is trying tocommunicate with your neurostimulator. Ifthere is a problem, the displayed screen

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provides instructions (see blue text) on howto resolve the problem and clear the screen.

Table 6.2 describes the Communicationscreen. Unless there is a problem with thecommunication, the Communication screenautomatically clears when the process isfinished.

Table 6.2 Communication screens


Communication

The patient programmer iscommunicating with theneurostimulator.

Continue to hold the patientprogrammer over yourneurostimulator.

Information screens

The information screens provide statusinformation about therapy settings, errorconditions, and patient programmer andneurostimulator battery levels.

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If the patient programmer audio setting isturned on, three tones alert you to themessage.

Table 6.3 describes information screens andinstructions on how to proceed (see bluetext) when these messages appear.

Note: Press any arrow on the Navigator keyto clear an information screen.

Table 6.3 Information screens


Turn therapy on

You tried to increase theamplitude, pulse width, or rateparameters with your therapyoff.

Turn your therapy on and trycommunication again.

You tried to decrease rate withyour therapy off.

Turn your therapy on and trydecreasing rate again.

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Table 6.3 Information screens (continued)


Position antennascreen

The patient programmer istrying to communicate with theneurostimulator.

Hold the patient programmeror detachable antenna overyour neurostimulator.

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Poor communication

The patient programmerattempted to communicate withthe neurostimulator, butcommunication wasunsuccessful.

For patients with twoneurostimulators, you may haveattempted to synchronize withanother neurostimulator withoutfirst turning the patientprogrammer off.

Reposition the patientprogrammer over theneurostimulator with thescreen facing outward andtry communication again.

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

Press any arrow on theNavigator key to clear thescreen.

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Upper limit(amplitude shown)

You tried increasing aparameter (amplitude, pulsewidth, or rate) above thehighest value allowed.


Lower limit(amplitude shown)

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


Programmerbatteries are low

The patient programmerbatteries are low. You can finishprogramming.

Replace the patientprogrammer batteries beforethe batteries becomedepleted.

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Power on reset errordetected

The neurostimulator has beenreset. Your therapy hasstopped.

Press any arrow on theNavigator key to clear thescreen, then press theTherapy on/off key to turnyour therapy on.

Call your doctor to report thereset.

Note: This information screenhas a small information icon inthe upper left corner. Comparethis POR screen to the warningscreens explained on page 110.The warning POR screen has ahazard triangle symbol in theupper left corner.

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Out of Regulationerror

The neurostimulator cannotprovide the programmedtherapy or perform therequested parameter increase.

Reduce the requestedparameter increase.

(Rechargeable battery only)Recharge yourneurostimulator.

Call your doctor if thesesteps do not resolve theissue.

Rechargeablebattery only

Rechargeableneurostimulatorbattery charge levelis low

The rechargeableneurostimulator battery chargelevel is low and therapy will notbe available soon.

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

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Nonrechargeablebattery only

Nonrechargeableneurostimulatorbattery status is low

This information screenappears when you synchronizeyour neurostimulator andpatient programmer and thenonrechargeableneurostimulator battery status islow.

This means that your therapywill not be available soon.

Press any arrow on theNavigator key to clear thescreen and call your doctorto report this message.

Possible problems andsolutionsTable 6.4 will help you solve problems oridentify when to call your doctor. Problemsare described in the left column (bold blacktext). The right column lists possible causesof the problem (plain text) and how to correctthe problem (bold blue text).

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

Table 6.4 Troubleshooting problems

Problems Causes and actions

Uncomfortable orIntolerable therapy

You areexperiencing sideeffects from thetherapy.

The selected therapy settingsare not suitable for your currentactivity.

1. Turn your therapy off(see page 44).

2. Call your doctor.

If your patient programmer isusing Advanced mode, you cantry the following before callingyour doctor.

• Reduce the amplitude orpulse width setting forboth sides of your body(see page 66).

• If necessary, select adifferent group (seepage 73).

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Table 6.4 Troubleshooting problems (continued)


Delayed therapychanges

You do not noticethe therapy rightaway after turningyour therapy on oryou notice therapy-like sensations afterturning your therapyoff.

Your doctor may haveprogrammed SoftStart/Stopwhich gradually starts andstops your therapy.

Your doctor can advise you asto how long it takes to feel theeffects of the therapy. This timecan be different from patient topatient. It also depends uponyour medical condition.

In general, allow about 8seconds for yourneurostimulator to turn onand off.

You may also notice a residualeffect after the neurostimulatoris turned off.

Intermittenttherapy

You only notice yourtherapy some of thetime.

Your doctor may haveprogrammed your therapy toturn on and off at regularintervals.

However, if you are notreceiving adequate symptomrelief, contact your doctor.

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No therapy

You cannot noticeyour therapy but youthink that therapyshould be on.

Therapy is off.

Use your patient programmerto turn your therapy on (seepage 44).

The amplitude setting for theactive group is set too low tofeel. (The effect of theamplitude setting may take upto 10 minutes or more tonotice.)

If you do not feel the desiredeffect from a change inamplitude, call your doctor.

If your patient programmer isusing Advanced mode, you cantry the following before callingyour doctor.

Use your patient programmerto increase the amplitude forone or both sides of yourbody (see page 69).

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Patientprogrammer isunresponsive

The display screenis blank when youpress a key.

The patient programmerbatteries are depleted.

Replace the patientprogrammer batteries (seepage 128).

The patient programmerbatteries are in backwards.

Check the battery polarityand reinstall the patientprogrammer batteries (seepage 128).

Dropped patientprogrammer

Your patientprogrammer falls offa cabinet or table.

The patient programmer isdesigned to withstand a shortdrop to a hard surface and stilloperate normally, even if thecase is chipped or nicked.

Try the patient programmer;it should work.

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Fluid on the patientprogrammer

Fluid was spilledonto the patientprogrammer or thepatient programmerwas dropped intowater.

The patient programmer is notwaterproof, and water candamage the device.

Immediately remove thepatient programmer from thewater, then dry with a softtowel.

Remove the batteries, thenallow the batterycompartment to air dry atroom temperature for 24hours.

Note: If you need to check yourrechargeable neurostimulatorbattery while your patientprogrammer is drying, you canuse the recharger device.

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7 Maintenance

This chapter descibes how to care for yourpatient programmer and accessories.

Patient programmer batteriesAlways keep two new AAA alkaline batteriesavailable for replacement. New batteriesprovide about two months of use, dependingupon how often the patient programmer isused.

You can check your patient programmerbatteries at any time. The patientprogrammer also monitors its own batterycharge and will display the following screenswhen the batteries are low or depleted(Figure 7.1).

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.

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Patient programmerbatteries are low

Patient programmerbatteries are depleted

Figure 7.1 Patient programmer battery screens.

Checking the patient programmerbatteries

The images in this procedure are an exampleand show how to check the patientprogrammer batteries:




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Figure 7.2 Therapy screen.

2. To display the current patient programmerbattery status:

– Simple mode: Press the right arrowon the Navigator key once to displaythe patient programmer battery status(Figure 7.3).

– Advanced mode: Press the up arrow on the Navigator key once tohighlight the Status row, then pressthe right arrow (Figure 7.3).

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Status row

Figure 7.3 Status row and Therapy screen.

3. Review the status of the patientprogrammer battery (Figure 7.4).

Replace batteries Full charge

Figure 7.4 Patient programmer battery level.

If the batteries are low, see "Replacingthe patient programmer batteries" onpage 132 for replacement instructions.

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Table 7.1 Patient programmer batteryreplacement screens

Patient programmerbatteries are low

The patient programmerbatteries are low. You can finishprogramming.

Press any arrow on theNavigator key to clear thescreen; then continueprogramming.

Replace the patientprogrammer batteries beforethe batteries becomedepleted.

See page 132.

Replace patientprogrammerbatteries

The patient programmerbatteries are depleted.Programming is not possible.

Replace the patientprogrammer batteries now.

See page 132.

Replacing the patient programmerbatteries

1. Open the battery compartment cover bysliding the cover down and pulling it up.

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Slide cover down

Lift cover up

Figure 7.5 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. Keep the batteriesaway from children. If children or petsswallow the batteries, contact a doctor atonce.

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

• 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 doctor or a Medtronic sales office. Referto the Medtronic contacts at the end of thismanual.

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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 yourdoctor.

Declaration of conformityMedtronic declares that this product is inconformity with the essential requirements ofDirective 1999/5/EC on Radio andTelecommunications Terminal Equipment,and Directive 90/385/EEC on ActiveImplantable Medical Devices.

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

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Specifications

Table 7.2 Patient programmer specifications

Item Specification

Power source 2 AAA alkaline batteries (non-rechargeable, LR03)

Operatingtemperature

9 °C to 43 °C

(49 °F to 110 °F)

Temperaturelimitationa

-34 °C to 57 °C

(-30 °F to 135 °F)

Ingress protection IP22 rating for solid objectsgreater than or equal to12.5 mm, and for verticallydripping water when the deviceis tilted 15 degrees, per60601-1-11.

Size Approximately

9.4 cm x 5.6 cm x 2.8 cm

(3.7 in x 2.2 in x 1.1 in)

Weight, includingbatteries

Approximately 111 g (3.9 oz.)

Battery life 2 months (average) for alkalinebatteries

Service life Up to 5 years

Mode of operation Continuous

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Table 7.2 Patient programmer specifications

Item Specificationa Batteries should be removed from the device for

storage or transport.

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8 Assistance forthe patientprogrammer

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

For assistance in the US, call Medtronicpatient services at 1-800-510-6735.

If you contact Medtronic about your patientprogrammer, refer to the serial number. Theserial number is located in the batterycompartment. This number identifies eachpatient programmer.

• If your patient programmer stops working,first try the steps inChapter 6 "Troubleshooting" on page 109.

Contact your doctor if indicated by thetroubleshooting information. If the problempersists, contact your doctor.

• If you lose your patient programmer,contact your doctor to order a new patientprogrammer.

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Note: To register the patientprogrammer for service covered by thewarranty, complete and mail the warrantyregistration.

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IndexAbout rechargeable batteries 46Adjusting therapy

adjustment limits 81guidelines for 81settings 66-82

Adjustment stimulationsee Adjusting therapy

Alertspatient programmer 57, 108

Amplitudeincreasing or decreasing 81, 82

Audiotones 66, 111, 115

Backlight (Power/Backlight On/Off) key 34Batteries (patient programmer)

battery charge level (low) screen 118checking 128disposing of 136replacing 132

Battery icons 40

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Battery neurostimulatorsee Neurostimulator battery

Button descriptions 32Changing a group 73Charging the Neurostimulator battery

(rechargeable) 106Checking batteries

patient programmer 128Checking the nonrechargeable battery 47Communication screen 114Decreasing therapy settings 69

limits 81Disposing of

patient programmer batteries 136patient programmer 136

EOS (end of service) error code 112Error codes 112Group, changing 73Icons

battery 40Parameter/Group 40Status 40

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Identification label 60Increasing therapy settings

limits 82Indications 21Information screen 114Keys (patient programmer) 32Low battery level screen

neurostimulator 102patient programmer 118

Lower limit screens 81Magnetic resonance imaging (MRI) 84MRI examinations

activating a new group 86, 91, 92MRI scan eligibility sheet 85, 88, 93preparing for an MRI appointment 85returning therapy to your original group

settings 94turning off therapy 86, 87, 88turning therapy back on 89

MRI scan eligibilitytypes of 84

Navigator key 36

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Neurostimulator battery 46Neurostimulator battery (rechargeable)

automatic alert 57, 108charging the battery 106checking battery level (charge level) 98low battery charge level

screen 49, 120, 121overdischarge 105rechargeable battery screens 106recharge warning screen 113warning 98when to check and charge 100

Nonrechargeable neurostimulator battery 47Options icon 37Overdischarge 105Parameter/Group row icons 40Parameter

increasing or decreasing limits 81limit screens 81

Parameter row 38Patient programmer alert 57, 108

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Patient programmerbatteries 128-133buttons 32cleaning and care 134description 26disposing of 136keys 32low battery level screen 118purpose 20replacing batteries 132screens 110troubleshooting 110-126turning on and off 34

POR 96Possible battery status conditions

(nonrechargeable) 48Power/Backlight On/Off key 34Precautions 21Preference icons 51Pulse Width

increasing or decreasing 81, 82

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Rateincreasing or decreasing 81, 82

Rebound effect 98Recharge warning screen 113Repair 135Serial number 140Settings

adjusting therapy 66-82limits 81

SoftStart/Stop 123Specifications 137Status row icons 40Stimulation

limits when adjusting settings 81stops suddenly 98troubleshooting 124uncomfortable 122

SynchronizePatient programmer and implanted

neurostimulator 41warning screen 111

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Therapy settings 37decreasing 69increasing 69turning therapy on or off 33

Therapyadjusting settings 66-82guidelines for adjusting 81On/Off key 33

Tones, audio 66, 111, 115Turning neurostimulator on or offsee Turning your therapy on or off

Turning patient programmer on and off 34Turning your therapy on or off 33Uncomfortable stimulation

troubleshooting 122Upper limit screens 82Warning screens 111-112When to check your rechargeable

neurostimulator battery 100

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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

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

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.

*M929532A026*© Medtronic, Inc. 2015All Rights Reserved

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Medtronic DBS Patient Programmer Patient Manual