Medtronic 3537 3537 User Manual 2

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CONTROLLER3537Patient Programming Manual for TestStimulation! USA Rx only0123Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 01-18-2012M943578A001 Rev X 2013-3

Medtronic® and InterStim® are trademarks of Medtronic,Inc., registered in the U.S. and other countries.! USA FCC InformationThe following is communications regulation informationon the Model 3537 Controller.FCC ID: LF597745This device complies with Part 15 of the FCC Rules.Operation is subject to the following two conditions: (1)this device may not cause harmful interference and (2)this device must accept any interference received,including interference that may cause undesiredoperation.IMPORTANT: Changes or modifications to thisproduct not authorized by Medtronic, Inc., couldvoid the FCC Certification and negate your authorityto 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.Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 01-18-2012M943578A001 Rev X 2013-3

Label symbolsExplanation of symbols on products andpackaging. Refer to the appropriate product tosee symbols that apply.Consult instructions for useManufacturerXXX °FXX °C-XX °F-XX °C Temperature limitationSerial numberConformité Européenne (EuropeanConformity). This symbol means that thedevice fully complies with MDD 93/42/EEC(NB 0123) and R&TTE Directive 1999/5/EC.EC REPAuthorized representative in the Europeancommunity! USAFor USA audiences onlyIEC 60601-1/EN60601-1, Type BFEquipmentNon-ionizing electromagnetic radiation3537 2013-3 EnglishFilename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 01-18-2012M943578A001 Rev X 2013-33Label symbols

Table of contentsLabel Symbols 3Glossary 71 Introduction 10How to use this manual 10Patient guides 112 Using your controller 14How your controller works 14Controller screen and keys 15Unlocking and locking yourcontroller 17Unlocking your controller 17Locking your controller 21Turning your stimulation on or off 22Turning your stimulation on 23Turning your stimulation off 25Adjusting stimulation 27Switching stimulation sides (if your clinicianplaced two leads) 28Changing programs (if applicable) 313537 2013-3 EnglishFilename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 01-18-2012M943578A001 Rev X 2013-35Table of contents

Home screen 34Checking and replacing batteries 38Checking the batteries (externalneurostimulator and controller) 38Replacing the batteries (controlleronly) 45Using the carrying case 46Always carry your controller 473 Troubleshooting 50Controller screens 50Warning screens 51Alert screens 56Notification screens 61Possible problems and solutions 644 Maintenance and assistance 74Cleaning and care 74Safety and technical checks 75Battery and controller disposal 75Declaration of conformity 75Specifications 76Assistance for the controller 76Index 78English 3537Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 01-18-2012M943578A001 Rev X 2013-36Table of contents

GlossaryAmplitude - The strength or intensity of anelectrical pulse.Caution - A statement describing actions thatcould result in damage to or improperfunctioning of a device.Clinician - A healthcare professional such asa doctor or nurse.Controller - A hand-held device that allowsyou to turn your neurostimulator on and offand check your neurostimulator battery. It isalso used to adjust some of the stimulationsettings.External neurostimulator (ENS) - SeeNeurostimulator.Lead - A thin wire with protective coating thathas metal electrodes on one end and aconnector on the other.Neurostimulator - The power source of aneurostimulation system. It contains thebattery and electronics that control thestimulation.3537 2013-3 EnglishFilename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 01-18-2012M943578A001 Rev X 2013-37Glossary

Precaution - See Caution.Program - A specific combination ofstimulation settings assigned to delivertherapy to a specific site.Settings - See Stimulation settings.Stimulation - The delivery of electrical pulsesto a specific site.Stimulation settings - Refers to all thefeatures assembled to define the stimulationyou feel. The clinician programs allstimulation. You can adjust somestimulation settings within clinician-definedlimits.Test stimulation - A postoperative multidaytrial period of a patient’s reaction tostimulation using an externalneurostimulator and implanted leads.Therapy - Treatment of a disease or condition.When neurostimulation therapy isprescribed, a neurostimulation system isused to deliver stimulation to a specificsite.English 3537 2013-3Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 01-18-2012M943578A001 Rev X 2013-38Glossary

1 IntroductionFilename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 01-18-2012M943578A001 Rev X 2013-3

How to use this manualUse this manual during test stimulation. Askyour clinician to explain anything that isunclear.•A glossary is provided at the beginning ofthis manual to describe terms that may beunfamiliar to you.•Chapter 1 "Introduction" describes how touse this manual, a list of patient guides, andinformation on your patient identificationcard.•Chapter 2 "Using your controller" describesthe controller and how to perform specifictasks, including turning your stimulation onand off, adjusting your stimulation,changing stimulation sides (if applicable),changing programs (if applicable), andchecking and replacing batteries. Thischapter also describes how to use thecontroller carrying case, how to label yourcontroller, and an overall description of theHome screen.English 3537 2013-3Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 01-18-2012M943578A001 Rev X 2013-310Introduction 1

•Chapter 3 "Troubleshooting" describescontroller warning and information screens,how to solve possible problems, and whoto contact if your device is lost or broken.•Chapter 4 "Maintenance and assistance"describes how to care for your controller,including how to change the batteries, aswell as device specifications and userassistance.Please read this entire manual before usingyour controller. This manual will help youunderstand and use your InterStim system soyou can adjust your stimulation as your needschange.Patient guidesIn addition to this manual, you should receivethe following documents during teststimulation:•Model 3537 Patient Test Stimulation QuickReference Card•InterStim Patient Therapy Guide3537 2013-3 EnglishFilename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 01-18-2012M943578A001 Rev X 2013-311Introduction 1

Note: For additional warnings,precautions, and adverse events related toInterStim Therapy, refer to the InterStimPatient Therapy Guide provided by yourclinician.If you did not receive these documents, contactyour clinician or Medtronic Patient Services.Refer to the Medtronic contacts at the end ofthis manual.English 3537 2013-3Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 01-18-2012M943578A001 Rev X 2013-312Introduction 1

2 Using yourcontrollerFilename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 01-18-2012M943578A001 Rev X 2013-3

How your controller worksThe controller is used to control and monitoryour external neurostimulator. You will useyour controller to perform the following tasks:•Turn your stimulation on or off.•Check the external neurostimulator andcontroller battery status.•Change stimulation settings.The controller communicates wirelessly withyour external neurostimulator by sendingsignals to and receiving signals from theexternal neurostimulator. Your clinician hasalready set up the controller according to yourspecific test stimulation needs.Note: Make sure to keep your controller withyou at all times in the event that you need toadjust or turn your stimulation off.English 3537 2013-3Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 01-18-2012M943578A001 Rev X 2013-314Using your controller 2

ControllerExternal neurostimulatorFigure 2.1 A patient using her controller.Controller screen and keysYour controller has a touchscreen, a displayscreen that reacts to your touch, that allowsyou to press buttons that are displayed on thescreen. In addition to these on-screen buttons,your controller also has a number of keys(Figure 2.2).Note: There is a cable port on the bottom ofthe controller. This port is not for patient use.3537 2013-3 EnglishFilename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 01-18-2012M943578A001 Rev X 2013-315Using your controller 2

Stimulation On/Off keyTouchscreenIncrease keyDecrease keyFigure 2.2 Controller keys.See Table 2.1 for a list of these keys and theirfunctions.Table 2.1 Controller keys Key FunctionStimulationOn/Off•Turns stimulation on or off.English 3537 2013-3Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 01-18-2012M943578A001 Rev X 2013-316Using your controller 2

Table 2.1 Controller keys (continued)Key FunctionIncrease/Decrease•Increases or decreases stimulationwhen you are on the Home screen.•Press and release the Increase/Decrease key to slowly increase ordecrease the stimulation value (by0.1). Press and hold to quicklyincrease or decrease the stimulationvalue (by 0.5).Unlocking and locking yourcontrollerUnlocking your controllerWhen the Increase/Decrease key is pressed,the Unlock screen appears (Figure 2.3).3537 2013-3 EnglishFilename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 01-18-2012M943578A001 Rev X 2013-317Using your controller 2

Figure 2.3 The Unlock screen.Notes:•If the controller does not display the Unlockscreen, the controller may not have beenproperly initiated. Call your clinician if theUnlock screen does not appear.•When the controller is locked, pressing theStimulation On/Off key will provide theoption to bypass the Unlock screen and toturn stimulation on or off.1. Press and hold the Lock button on theUnlock screen.English 3537 2013-3Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 01-18-2012M943578A001 Rev X 2013-318Using your controller 2

As the Lock button is held, bars appear onthe screen and move toward the Lockbutton (Figure 2.4).Figure 2.4 Unlocking the controller.2. Stop pressing the screen when the screenchanges to a circle of dots (Figure 2.5). Thecontroller is searching for your externalneurostimulator.3537 2013-3 EnglishFilename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 01-18-2012M943578A001 Rev X 2013-319Using your controller 2

Figure 2.5 The controller searching for your external neurostimulator.After unlocking the controller, the firstscreen you see is the Home screen(Figure 2.6).English 3537 2013-3Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 01-18-2012M943578A001 Rev X 2013-320Using your controller 2

Menu buttonStimulationvalue buttonsBattery status button Lock buttonFigure 2.6 The Home screen.If the Home screen does not appear, see"Possible problems and solutions" onpage 64.Locking your controllerYour controller can be locked, so if buttons orkeys are accidentally pressed, there will not bean unexpected change in your stimulation.Note: The controller screen will dim after 15seconds of inactivity, and will automaticallylock itself after 2 minutes of inactivity. You can3537 2013-3 EnglishFilename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 01-18-2012M943578A001 Rev X 2013-321Using your controller 2

also press the Lock button to lock thecontroller immediately.1. From the Home screen, press the Lockbutton to lock the controller (Figure 2.7).Lock buttonFigure 2.7 Pressing the Lock button.Turning your stimulation on oroffYou can turn stimulation on or off at any time.Follow these steps to turn your stimulation onor off.English 3537 2013-3Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 01-18-2012M943578A001 Rev X 2013-322Using your controller 2

Turning your stimulation on1. To turn stimulation on, press theStimulation On/Off key, which is locatedon the top of your controller.Note: Pressing the Stimulation valuebutton on the Home screen also allows youto turn stimulation on.2. Press the On button to turn stimulation on(Figure 2.8).Note: If you do not wish to turn stimulationon or off, but want to access the Homescreen, press the Go To Unlock buttonand unlock your controller.3537 2013-3 EnglishFilename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 01-18-2012M943578A001 Rev X 2013-323Using your controller 2

Figure 2.8 Turning stimulation on.3. A confirmation screen will appear(Figure 2.9). Press the OK button tocontinue to the Home screen.Figure 2.9 Stimulation turned on.English 3537 2013-3Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 01-18-2012M943578A001 Rev X 2013-324Using your controller 2

Turning your stimulation off1. To turn stimulation off, press theStimulation On/Off key, which is locatedon the top of your controller.2. Press the Off button to turn stimulation off(Figure 2.10).Figure 2.10 Turning stimulation off.3. If you do not wish to turn stimulation off, butinstead wish to access the Home screen,press the Go To Unlock button and unlockyour controller.3537 2013-3 EnglishFilename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 01-18-2012M943578A001 Rev X 2013-325Using your controller 2

Note: If your controller was already on, youwill instead have the option to lock thecontroller.Note: If stimulation is uncomfortable andyou need to turn off your stimulationimmediately, but your controller isunavailable or not responding, press andhold the ENS button on the externalneurostimulator for 3 seconds(Figure 2.11).ENS buttonFigure 2.11 The ENS button on the external neurostimulator.English 3537 2013-3Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 01-18-2012M943578A001 Rev X 2013-326Using your controller 2

4. A confirmation screen will appear(Figure 2.12). Press the OK button tocontinue to the Home screen.Figure 2.12 Stimulation turned off.Adjusting stimulationNotes:•Stimulation needs to be turned on beforeadjusting your stimulation. If stimulation isnot on, see "Turning your stimulation on oroff" on page 22.•Every time you turn your stimulation on, thestimulation value starts at zero.3537 2013-3 EnglishFilename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 01-18-2012M943578A001 Rev X 2013-327Using your controller 2

1. From the Home screen, press the Increaseor Decrease key to adjust your stimulationas advised by your clinician.–Press and release the Increase/Decrease key to slowly increase ordecrease stimulation (by 0.1).–Press and hold to quickly increase ordecrease stimulation (by 0.5).Note: When you press and hold theIncrease key, stimulation will continue toquickly increase until you release thebutton.2. When finished adjusting stimulation, pressthe Lock button ( ) to lock the controller.Switching stimulation sides (ifyour clinician placed two leads)Notes:–Instructions on when to switchstimulation sides are provided by yourclinician.English 3537 2013-3Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 01-18-2012M943578A001 Rev X 2013-328Using your controller 2

–If your clinician placed only one lead,switching stimulation sides will not beavailable. Figure 2.13 shows what yourHome screen looks like if you have onelead, and what your Home screen lookslike if you have two leads.One lead Two leadsFigure 2.13 Home screens for one lead and for two leads.Follow these steps to switch stimulationsides:1. Press the Stimulation value button on theinactive side of the Home screen. A screen3537 2013-3 EnglishFilename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 01-18-2012M943578A001 Rev X 2013-329Using your controller 2

will appear asking you to confirm that youwish to change stimulation sides(Figure 2.14).Figure 2.14 Confirming switch of stimulation sides.2. Press the Yes button to confirm switchingstimulation sides.Note: Pressing the No button cancels thechange and continues stimulation on thesame side.3. Your stimulation will switch sides, and theamplitude will be set to zero. Use theIncrease/Decrease key to adjustEnglish 3537 2013-3Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 01-18-2012M943578A001 Rev X 2013-330Using your controller 2

stimulation (see "Adjusting stimulation" onpage 27).Changing programs (ifapplicable)Notes:•Instructions on when to change programs,and which program to select, are providedby your clinician.•Depending on how your clinician set upyour system, you may not be able tochange programs.1. Press the Menu button ( ) in the top rightcorner of the Home screen. A screenappears with two buttons: Programs andClinician Mode (Figure 2.15).3537 2013-3 EnglishFilename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 01-18-2012M943578A001 Rev X 2013-331Using your controller 2

Figure 2.15 The Patient menu.Note: If your screen does not look likeFigure 2.15 but instead asks you to enter acode, then your clinician has set up yoursystem so that changing programs is notavailable. Press the Exit button to go backto the Menu, and then press the Exit buttonagain to go back to the Home screen.2. Press the Programs button. A screenappears with three buttons: Program I,Program II, and Program III (Figure 2.16).The button outlined in green represents theprogram that is currently active.English 3537 2013-3Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 01-18-2012M943578A001 Rev X 2013-332Using your controller 2

Note: If only one program is available, yourclinician set up your system so thatchanging programs is not possible. Pressthe Exit button to return to the Menu. Pressthe Exit button again to return to the Homescreen.Figure 2.16 Selecting a program.Note: Your system may have been set upso that one or more programs is notavailable. Available program buttonsbecome highlighted in green when they arepressed.3. Select an available program as instructedby your clinician.3537 2013-3 EnglishFilename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 01-18-2012M943578A001 Rev X 2013-333Using your controller 2

Note: After switching programs, amplitudeautomatically decreases to zero.4. Press the Exit button ( ) to return to theMenu.5. Press the Exit button ( ) to return to theHome screen.6. Adjust stimulation as advised by yourclinician. See "Adjusting stimulation" onpage 27.Home screenThe Home screen is the first screen to appearafter unlocking your controller. The Homescreen provides an overview of yourstimulation settings (Figure 2.17).Note: Your Home screen may look slightlydifferent than the one shown.English 3537 2013-3Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 01-18-2012M943578A001 Rev X 2013-334Using your controller 2

Menu buttonStimulationvalue buttonsBattery status button Lock buttonFigure 2.17 The Home screen.Information on the Home screen is split intotwo sides: the Left side and the Right side.Note: It is normal for some patients to be ableto adjust only the left side or only the right side.This means you have only one lead placed fortest stimulation instead of two leads.The buttons at the top of the Home screenallow you to perform the following tasks:•Check the battery status of the controller.3537 2013-3 EnglishFilename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 01-18-2012M943578A001 Rev X 2013-335Using your controller 2

•Check the battery status of the externalneurostimulator.•Lock the controller.•Access the Programs screen.Note: Whether you can access thePrograms screen depends on how yourclinician set up your test stimulationsystem. Discuss this with your clinician.Refer to Table 2.2 for more information onthese buttons.Table 2.2 Home screen buttons Icons DescriptionBatterystatus button The left icon on this buttondisplays the controller batterystatus. The right icon on thisbutton displays the externalneurostimulator batterystatus.Press this button to check thebattery status in detail. Formore information on checkingbatteries, see "Checking andreplacing batteries" onpage 38.English 3537 2013-3Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 01-18-2012M943578A001 Rev X 2013-336Using your controller 2

Table 2.2 Home screen buttons (continued)Icons DescriptionLock button Press this button to lock thecontroller.Menu button Press this button to access thePatient menu (if applicable).The body figure at the center of the Homescreen indicates which side is receivingstimulation (if two leads were placed). Thenumber shown in the Stimulation valuebutton is the amplitude of that stimulation(Figure 2.18).3537 2013-3 EnglishFilename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 01-18-2012M943578A001 Rev X 2013-337Using your controller 2

Menu buttonStimulationvalue buttonsBattery status button Lock buttonFigure 2.18 The Home screen.Checking and replacingbatteriesChecking the batteries (externalneurostimulator and controller)Check the status of the batteries in yourexternal neurostimulator and your controllerevery day. You can check the status of thebatteries at any time.English 3537 2013-3Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 01-18-2012M943578A001 Rev X 2013-338Using your controller 2

Note: The battery levels of the controller andthe external neurostimulator are shown on theBattery status button on the Home screen(Figure 2.19). For further detail about batterylevels, follow the steps below.Battery status buttonFigure 2.19 Viewing the battery status on the Home screen.1. From the Home screen, press the Batterystatus button. Two battery figures appear(Figure 2.20).3537 2013-3 EnglishFilename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 01-18-2012M943578A001 Rev X 2013-339Using your controller 2

Controller battery statusExternal neurostimulatorbattery statusFigure 2.20 Example of a Battery status screen.2. Press the Exit button ( ) at the top rightcorner of the touchscreen to exit.Table 2.3 lists several examples of externalneurostimulator battery levels and whetheraction is needed.Table 2.3 Battery level definitions for theexternal neurostimulator External neurostimulator battery icon isgreen. Battery level is full. No action isneeded.English 3537 2013-3Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 01-18-2012M943578A001 Rev X 2013-340Using your controller 2

Table 2.3 Battery level definitions for theexternal neurostimulator (continued)External neurostimulator battery icon isgreen. Battery level is half full. Noaction is needed.External neurostimulator battery icon isorange. Stimulation is still beingprovided, but the externalneurostimulator batteries need to bereplaced soon. Call your clinician.External neurostimulator battery icon isred. Stimulation may no longer beavailable. The external neurostimulatorbatteries need to be replaced. Call yourclinician.Table 2.4 lists several examples of controllerbattery levels and whether action is needed.Table 2.4 Battery level definitions for thecontroller Controller battery icon is green. Batterylevel is full. No action is needed.Controller battery icon is green. Batterylevel is half full. No action is needed.3537 2013-3 EnglishFilename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 01-18-2012M943578A001 Rev X 2013-341Using your controller 2

Table 2.4 Battery level definitions for thecontroller (continued)Controller battery icon is orange. Thecontroller batteries are low. Replacethe controller batteries. See "Replacingthe batteries (controller only)" onpage 45.Controller battery icon is red. Thecontroller batteries are nearly depletedand programming will not be possiblesoon. Replace the controller batteries.See "Replacing the batteries (controlleronly)" on page 45.Table 2.5 lists the warning and alert screensassociated with the batteries for the externalneurostimulator and the controller.English 3537 2013-3Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 01-18-2012M943578A001 Rev X 2013-342Using your controller 2

Table 2.5 Battery message screens for thecontroller and the external neurostimulator The externalneurostimulator batteriesare low and stimulation willnot be available soon.Call your clinician. Pressthe OK button to exit thisscreen.Cause: The externalneurostimulator batteriesare depleted andstimulation is not available.Action: The externalneurostimulator batteriesneed to be replaced. Callyour clinician.Press the OK button toexit this screen.3537 2013-3 EnglishFilename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 01-18-2012M943578A001 Rev X 2013-343Using your controller 2

Table 2.5 Battery message screens for thecontroller and the external neurostimulator (continued)The controller batteries aredepleted. Programming isnot possible.Replace the controllerbatteries now. Refer to"Replacing the batteries(controller only)" onpage 45.The controller batteries arelow. Programming will notbe possible soon.Replace the controllerbatteries now. Refer to"Replacing the batteries(controller only)" onpage 45. Press the OKbutton to exit this screen.English 3537 2013-3Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 01-18-2012M943578A001 Rev X 2013-344Using your controller 2

Replacing the batteries (controlleronly)Note: This section is for replacing thecontroller batteries. Do not attempt to replacethe external neurostimulator batteries unlessdirected by your clinician.1. Open the battery compartment cover(Figure 2.21).Figure 2.21 Opening the battery cover.2. Remove the depleted batteries.3. Insert two new AA alkaline batteries asshown on the battery compartment label(Figure 2.22).3537 2013-3 EnglishFilename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 01-18-2012M943578A001 Rev X 2013-345Using your controller 2

Figure 2.22 Inserting new batteries.4. Close the battery compartment cover.5. Dispose of old batteries according to localregulations.Using the carrying caseThe carrying case has a pouch to hold thecontroller (Figure 2.23).The carrying case also has a clip on the backthat can be attached to a belt.English 3537 2013-3Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 01-18-2012M943578A001 Rev X 2013-346Using your controller 2

Figure 2.23 Insert the controller into the carrying case.Always carry your controllerBecause your controller is the only way toadjust or turn your stimulation on, you shouldalways carry your controller with you. Thecontroller is also the recommended way to turnyour stimulation off.In particular, always bring your controller withyou to follow-up appointments.3537 2013-3 EnglishFilename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 01-18-2012M943578A001 Rev X 2013-347Using your controller 2

In addition, always bring your controller toappointments with other health care providers.During certain procedures, you may need toturn your external neurostimulator off. Youshould also bring your InterStim TherapyPatient Guide. It contains importantinformation about the InterStim system thatyour health care providers should be awareof.English 3537 2013-3Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 01-18-2012M943578A001 Rev X 2013-348Using your controller 2

3TroubleshootingFilename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 01-18-2012M943578A001 Rev X 2013-3

This chapter will help you solve problems withyour controller.Note: If a problem is not solved after severalattempts, or if a problem is not described here,contact your clinician.Controller screensThe controller displays three different types ofscreens: warning screens, alert screens, andnotification screens. These screens provideyou with information about your system, alertyou to a problem with your system, or guideyou during controller use.•Warning screens display a red triangle atthe top with an exclamation point ( ).•Alert screens display an orange triangle atthe top with an exclamation point ( ).•Notification screens display a blue circle atthe top with the letter 'i' ( ).English 3537 2013-3Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 01-18-2012M943578A001 Rev X 2013-350Troubleshooting 3

Warning screensWarning screens indicate a problem with thecontroller or the external neurostimulator.Table 3.1 describes the possible warningscreens and provides instructions (see bluetext) on how to resolve the problem and clearthe screen.3537 2013-3 EnglishFilename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 01-18-2012M943578A001 Rev X 2013-351Troubleshooting 3

Table 3.1 Warning screens Screen Cause and actionSystem ProblemCannot continue.Please call yourclinician.Explanation: The system is notworking correctly. Stimulationmay have stopped.Solution: Write down themessage on the screen andthe screen number in thebottom right corner, thenfollow these steps:1. Remove and reinsert thecontroller batteries, thenretry the action thatcaused the error screen toappear. For instructionson removing andinserting the controllerbatteries, refer to"Replacing the batteries(controller only)" onpage 45.2. If this does not solve theproblem, call yourclinician.English 3537 2013-3Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 01-18-2012M943578A001 Rev X 2013-352Troubleshooting 3

Table 3.1 Warning screens (continued)Screen Cause and actionSoftware ProblemCannot continue.Please call yourclinician.Explanation: The software is notworking correctly. Stimulationmay have stopped.Solution: Write down themessage on the screen andthe screen number in thebottom right corner, thenfollow these steps:1. Remove and reinsert thecontroller batteries, thenretry the action thatcaused the error screen toappear. For instructionson removing andinserting the controllerbatteries, refer to"Replacing the batteries(controller only)" onpage 45.2. If this does not solve theproblem, call yourclinician.3537 2013-3 EnglishFilename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 01-18-2012M943578A001 Rev X 2013-353Troubleshooting 3

Table 3.1 Warning screens (continued)Screen Cause and actionCause: The externalneurostimulator batteries aredepleted and stimulation is notavailable.Action: The externalneurostimulator batteriesneed to be replaced. Writedown the message on thescreen and the screennumber in the bottom rightcorner, and call yourclinician.Press the OK button to clearthe screen.English 3537 2013-3Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 01-18-2012M943578A001 Rev X 2013-354Troubleshooting 3

Table 3.1 Warning screens (continued)Screen Cause and actionCause: The ENS button on theexternal neurostimulator isstuck in the pressed position.Action: Press and release theENS button, then press theOK button to clear thescreen.If this does not solve theproblem, write down themessage on the screen andthe screen number in thebottom right corner, and callyour clinician.Explanation: The controllerbatteries are depleted.Programming is not available.Replace the controllerbatteries now. Refer to"Replacing the batteries(controller only)" on page 45.3537 2013-3 EnglishFilename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 01-18-2012M943578A001 Rev X 2013-355Troubleshooting 3

Table 3.1 Warning screens (continued)Screen Cause and actionCause: The externalneurostimulator has reachedthe end of service. This externalneurostimulator will no longerprovide stimulation.Action: Write down themessage on the screen andthe screen number in thebottom right corner, and callyour clinician.Alert screensAlert screens indicate a pairing or otherconnection problem between the controllerand the external neurostimulator.Table 3.2 describes the possible alert screensand provides instructions (see blue text) onhow to resolve the problem and clear thescreen.English 3537 2013-3Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 01-18-2012M943578A001 Rev X 2013-356Troubleshooting 3

Table 3.2 Alert screens Screen Cause and actionThe external neurostimulatorbatteries are low and stimulationwill not be available soon.Action: Write down themessage on the screen andthe screen number in thebottom right corner, and callyour clinician. Press the OKbutton to exit this screen.The controller batteries are low.Programming will not bepossible soon.Replace the controllerbatteries now. Refer to"Replacing the batteries(controller only)" on page 45.Press the OK button to exitthis screen.3537 2013-3 EnglishFilename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 01-18-2012M943578A001 Rev X 2013-357Troubleshooting 3

Table 3.2 Alert screens (continued)Screen Cause and actionCause: The controller cannotfind the paired externalneurostimulator. The externalneurostimulator may be out ofrange or the externalneurostimulator batteries maybe depleted.Action: Move the controllercloser to the externalneurostimulator and makesure your hand is notcovering the top of thecontroller, then press the TryAgain button.If this does not solve theproblem, the externalneurostimulator batteriesmay need to be replaced.Write down the message onthe screen and the screennumber in the bottom rightcorner, and call yourclinician.Press the Cancel button toclear the screen.English 3537 2013-3Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 01-18-2012M943578A001 Rev X 2013-358Troubleshooting 3

Table 3.2 Alert screens (continued)Screen Cause and actionCause: The externalneurostimulator has less than24 hours of service remaining.This external neurostimulatorwill be unable to providestimulation soon.Write down the message onthe screen and the screennumber in the bottom rightcorner, and call yourclinician.Press the OK button to clearthe screen.Explanation: The externalneurostimulator has detectedthat either a cable or a lead is notconnected.Solution: Ensure all cable andlead connections are secure.Press the OK button to clearthe screen.3537 2013-3 EnglishFilename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 01-18-2012M943578A001 Rev X 2013-359Troubleshooting 3

Table 3.2 Alert screens (continued)Screen Cause and actionCause: The system hasdetected that one or morecomponents in the system is notintended for use with yoursystem.If you replaced the controllerbatteries with new batteriesthat were not given to you byyour clinician, remove thenew batteries and use correctbatteries as instructed byyour clinician.If the issue persists, thecontroller batteries may needto be replaced. Forinstructions on replacing thecontroller batteries, see"Replacing the batteries(controller only)".If this does not solve theproblem, write down themessage on the screen andthe screen number in thebottom right corner, and callyour clinician.Press the OK button to clearthe screen.English 3537 2013-3Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 01-18-2012M943578A001 Rev X 2013-360Troubleshooting 3

Notification screensThe information screens provide informationabout therapy settings, error conditions, andbattery levels.Table 3.3 describes the possible informationscreens and provides instructions on how toproceed (see blue text) when these messagesappear.Table 3.3 Notification screens Screen Description and actionCause: You tried to adjust yourstimulation when stimulationwas off.Action: Press the Turn Onbutton on the controllerscreen to turn stimulationon, then try adjustingstimulation again.To keep stimulation off andnot change settings, pressthe Cancel button to clearthe screen.3537 2013-3 EnglishFilename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 01-18-2012M943578A001 Rev X 2013-361Troubleshooting 3

Table 3.3 Notification screens (continued)Screen Description and actionCause: You tried increasingyour stimulation above thehighest value allowed. You cannot increase your stimulationany higher.Action: Press the OK buttonto clear the screen andreturn to the highest allowedsetting.If not receiving symptomrelief, call your clinician.Cause: You tried decreasingyour stimulation below thelowest value allowed. You cannot decrease your stimulationbelow zero.Press the OK button to clearthe screen and return to thelowest allowed setting.If feeling discomfort, callyour clinician.English 3537 2013-3Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 01-18-2012M943578A001 Rev X 2013-362Troubleshooting 3

Table 3.3 Notification screens (continued)Screen Description and actionCause: Your combinedsettings can not currently bedelivered by the externalneurostimulator.Action: Press the OK buttonto clear the screen.If not receiving symptomrelief, call your clinician.Cause: Controller settings arenot available.Action: Write down themessage on the screen andthe screen number in thebottom right corner, and callyour clinician.Press the OK button to clearthe screen.3537 2013-3 EnglishFilename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 01-18-2012M943578A001 Rev X 2013-363Troubleshooting 3

Possible problems andsolutionsTable 3.4 will help you solve problems oridentify when to call your clinician. Problemsare described in the left column (bold blacktext). The right column lists possible causes ofthe problem (plain text) and how to correct theproblem (bold blue text).Note: If a problem is not solved after severalattempts, or if a problem is not described here,contact your clinician.English 3537 2013-3Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 01-18-2012M943578A001 Rev X 2013-364Troubleshooting 3

Table 3.4 Troubleshooting problems Problems Causes and actionsUncomfortable orIntolerablestimulationYou are experiencingside effects from thestimulation.1. Use your controller toturn stimulation down oroff. See "Adjustingstimulation" on page 27for instructions onadjusting stimulation. See"Turning your stimulationon or off" on page 22 forinstructions on turningstimulation off.2. If your controller isunavailable or notresponding, press andhold the ENS button onthe externalneurostimulator for 3seconds.3. If not receiving symptomrelief, call your clinician.Stimulation areachangesYou notice anunexpected change inwhere you feelstimulation.Call your clinician.3537 2013-3 EnglishFilename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 01-18-2012M943578A001 Rev X 2013-365Troubleshooting 3

Table 3.4 Troubleshooting problems (continued)Problems Causes and actionsStimulation is toostrong 1. Turn stimulation down oroff.See "Adjustingstimulation" on page 27.2. If this does not work, callyour clinician.Not receivingsymptom reliefYou think that yourstimulation may beturned off, or that yourstimulation might not bestrong enough.1. Check that yourstimulation is on, thenincrease stimulation asneeded.2. If this does not solve theproblem, call yourclinician.English 3537 2013-3Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 01-18-2012M943578A001 Rev X 2013-366Troubleshooting 3

Table 3.4 Troubleshooting problems (continued)Problems Causes and actionsController isunresponsive.The display screen isblank when you press akey.1. Make sure to press onlyone button. The controllerdoes not respond whentwo or more buttons arepressed at the sametime.2. If this does not work,check that the batteriesare inserted correctly asshown in the batterycompartment.3. If batteries are insertedcorrectly, the batteriesare depleted. Replace thecontroller batteries. Forinstructions on replacingcontroller batteries, see"Checking and replacingbatteries" on page 38.3537 2013-3 EnglishFilename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 01-18-2012M943578A001 Rev X 2013-367Troubleshooting 3

Table 3.4 Troubleshooting problems (continued)Problems Causes and actionsControllerautomatically resets.Controller screen blinksand returns to theUnlock screen.1. Unlock the controller. Thecontroller screen mayreturn to the screen youwere on when thecontroller reset.2. If the controller continuesto reset and you areunable to program yourstimulation, call yourclinician.Uncomfortabletapping sensationYou feel a tappingsensation that is tooslow or too fast.1. Turn stimulation down oroff.2. If this does not solve theproblem, call yourclinician.English 3537 2013-3Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 01-18-2012M943578A001 Rev X 2013-368Troubleshooting 3

Table 3.4 Troubleshooting problems (continued)Problems Causes and actionsYou will be passingthrough a theftdetector or securitydevice.You will be usingpotentially dangerousequipment.You will be having amedical or dentalprocedure.Before engaging in any ofthese activities, consult theInterStim Patient TherapyGuide for details.WARNING: Failure to followthe recommendations in theInterStim Patient TherapyGuide may injure you ordamage your InterStimsystem.External defibrillationYou received externaldefibrillation.Turn your stimulation off andcall your clinician.Controller settingsController settings (eg,brightness) are makingit difficult to adjust yourstimulation.Call your clinician.3537 2013-3 EnglishFilename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 01-18-2012M943578A001 Rev X 2013-369Troubleshooting 3

Table 3.4 Troubleshooting problems (continued)Problems Causes and actionsDropped controllerYour controller fell orwas dropped.The controller is designed towithstand a short drop to a hardsurface and still operatenormally, even if the case ischipped or nicked.Turn your stimulation off andcall your clinician.English 3537 2013-3Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 01-18-2012M943578A001 Rev X 2013-370Troubleshooting 3

Table 3.4 Troubleshooting problems (continued)Problems Causes and actionsFluid on the controllerFluid was spilled ontothe controller or thecontroller was droppedinto water.The controller is not waterproof,and water can damage thedevice.Immediately remove thecontroller from the water,then dry with a soft towel.Remove the batteries, thenallow the batterycompartment to air dry atroom temperature for 24hours.Clean any spills from thecontroller with a damp towel.If the controller does notwork, or if you need to adjuststimulation while thecontroller is drying, call yourclinician.3537 2013-3 EnglishFilename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 01-18-2012M943578A001 Rev X 2013-371Troubleshooting 3

English 3537 2013-3Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 01-18-2012M943578A001 Rev X 2013-372Troubleshooting 3

4 Maintenanceand assistanceFilename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 01-18-2012M943578A001 Rev X 2013-3

Cleaning and careFollow these guidelines to ensure that thecontroller and accessories function properly.•Keep the device out of the reach of childrenand pets.•Use the device only as explained to you byyour clinician 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.•Clean the outside of the device with a dampcloth when necessary. Mild householdcleaners will not damage the device orlabels.•The device is not waterproof. Do not allowmoisture to get inside the device.•Keep fresh batteries available.•Replace low or depleted batteries.English 3537 2013-3Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 01-18-2012M943578A001 Rev X 2013-374Maintenance and assistance 4

Safety and technical checksPeriodic safety and technical checks orperiodic maintenance of the controller are notrequired. The controller contains no user-serviceable parts. If repair or service isneeded, contact your clinician or a Medtronicsales office. Refer to the Medtronic contacts atthe end of this manual.Battery and controller disposalDispose of depleted batteries and worn outdevices according to local requirements.Return your controller to your clinician.Declaration of conformityMedtronic declares that this product is inconformity with the essential requirements ofDirective 1999/5/EC on Radio andTelecommunications Terminal Equipment,and Directive 93/42/EEC on Medical Devices.For additional information, contact Medtronic.Refer to the list of Medtronic contacts at theend of this manual.3537 2013-3 EnglishFilename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 01-18-2012M943578A001 Rev X 2013-375Maintenance and assistance 4

SpecificationsTable 4.1 Controller specifications Item SpecificationPower source 2 AA alkaline batteries (non-rechargeable, LR03)Operating temperature +9 °C to +43 °C (+49 °F to+110 °F)Temperature limitation -30 °C to +57 °C (-22 °F to+135 °F)Size Approximately 12.0 cm x 6.0 cmx 2.4 cm (4.7 in x 2.4 in x 0.9 in)Weight, includingbatteries Approximately 150 g (5.3 oz.)Battery life 2 months (average) for alkalinebatteriesMode of operation ContinuousAssistance for the controllerThe controller has been designed and testedto provide trouble-free service. If repair orservice is needed, contact your clinician or aMedtronic sales office. Refer to the Medtroniccontacts at the end of this manual.English 3537 2013-3Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 01-18-2012M943578A001 Rev X 2013-376Maintenance and assistance 4

! USA For assistance in the US, call MedtronicPatient Services at: 1-800-510-6735. PatientServices hours are Monday through Friday, 8am to 5 pm Central Time.•If your controller stops working, first try thesteps in Chapter 3 "Troubleshooting" onpage 49.Contact your clinician if indicated by thetroubleshooting information or if you needadditional assistance.•If you lose your controller, contact yourclinician to order a new controller.3537 2013-3 EnglishFilename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 01-18-2012M943578A001 Rev X 2013-377Maintenance and assistance 4

IndexAdjusting stimulation 28Assistance 76Batteriesinserting or replacing 45Batteries (controller)checking 38disposing of 75Batteries (external neurostimulator)checking 38Buttonshome screen 36Carrying case, controller 46Changing programs 31Checking batteriescontroller 38external neurostimulator 38Controllerchecking battery level 38, 41cleaning and care 74disposing of 75English 3537 2013-3Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 01-18-2012M943578A001 Rev X 2013-378Index

how to use 14keys 16locking 22screens 50specifications 76troubleshooting 6768-71unlocking 18use 47Decrease key 17Disposing ofcontroller batteries 75controller 75Errorstroubleshooting 50Home screen buttons 36Home screen 34Increase key 17Information screens 61Keys (controller) 16Locking the controller 22Neurostimulator (external)checking battery level 38, 403537 2013-3 EnglishFilename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 01-18-2012M943578A001 Rev X 2013-379Index

Problemstroubleshooting 50Programschanging 31Repair 75Specifications 76Stimulation On/Off key 16Stimulationadjusting 28changing programs 31switching sides 28troubleshooting 66, 69turning off 22, 25turning on 22, 23uncomfortable 65Switching stimulation sides 28Troubleshooting 50Turning stimulation on or off 22Uncomfortable stimulationtroubleshooting 65Unlocking the controller 18Warning screens 51English 3537 2013-3Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 01-18-2012M943578A001 Rev X 2013-380Index

3537 2013-3 EnglishFilename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 01-18-2012M943578A001 Rev X 2013-381Index

Contacts:Asia: Medtronic International Ltd.Tel. 02919-1362Fax 02907-3998Medtronic 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 1-800-668-6700Austria: 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 210-67-79-399Hungary: 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 02-241381Tel. 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. 067-10-32-00Fax 067-10-32-10Poland: 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 031-868-0199Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 01-18-2012M943578A001 Rev X 2013-3

The Netherlands: Medtronic B.V.Tel. (045)-566-8000Fax (045)-566-8668U.K.: Medtronic U.K. Ltd.Tel. 01923-212213Fax 01923-241004USA: Medtronic, Inc.Tel. (1763)-505-5000Fax (1763)-505-1000Toll-free: (1-800)-328-0810Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 01-18-2012M943578A001 Rev X 2013-3

Manufacturer Medtronic, Inc.710 Medtronic ParkwayMinneapolis, MN 55432-5604USAwww.medtronic.comTel. +1-763-505-5000Fax +1-763-505-1000Authorized Representative EC REPin the European CommunityMedtronic B.V.Earl Bakkenstraat 106422 PJ HeerlenThe NetherlandsTel. +31-45-566-8000Fax +31-45-566-8668Europe/Africa/Middle EastHeadquartersMedtronic International Trading SàrlRoute du Molliau 31Case Postale 84CH-1131 TolochenazSwitzerlandwww.medtronic.euTel. +41-21-802-7000Fax +41-21-802-7900Asia-PacificMedtronic International Ltd.Suite 1106-11 16/F, Tower 1, The Gateway25 Canton Road, TsimshatsuiKowloonHong KongTel. +852-2919-1362Fax +852-2907-3998Contacts for specific countries are listedinside this cover.*M943578A001*© Medtronic, Inc. 2013All Rights ReservedM943578A001Filename Date TimeUC200xxxxxx EN4.625″ x 6.0″ inches (117 mm x 152 mm)Medtronic ConfidentialPPManual.xsl - PatientProgrammerTemplate.fmVersion: 01-18-2012M943578A001 Rev X 2013-3

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