Medtronic 3537 3537 User Manual 1

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CONTROLLER 3537for InterStim® TherapyClinician Programming Guide! USARx onlyFilename Date TimeUC2001xxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialPTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fmTemplate version: 08-08-2011M943580A002 Rev X 2012-09

Filename Date TimeUC2001xxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialPTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fmTemplate version: 08-08-2011M943580A002 Rev X 2012-09

Medtronic®, and InterStim® are trademarks of Medtronic, Inc., registered in the U.S. and othercountries.! USA FCC InformationThe following is communications regulation information on the Model 3537 Personal TherapyManager.FCC ID: LF53537This device complies with Part 15 Rules. Operation is subject to the following two conditions:(1) this device may not cause harmful interference and (2) this device must accept anyinterference received, including interference that may cause undesired operation.IMPORTANT: Changes or modifications to this product not authorized by Medtronic,Inc., could void the FCC Certification and negate your authority to operate this product.This device complies with Industry Canada license-exempt RSS standard(s). Operation issubject to the following two conditions: (1) this device may not cause interference, and (2) thisdevice must accept any interference, including interference that may cause undesiredoperation of the device.4 English 3537 2012-09Filename Date TimeUC2001xxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialPTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fmTemplate version: 08-08-2011M943580A002 Rev X 2012-09

Table of contentsDescription 7Package contents 7About this manual 7Instructions for use 8Setting up the controller 8Pairing the controller to the external neurostimulator 11Pairing a new controller to an external neurostimulator 11Pairing a previously used controller to an external neurostimulator 14Unlocking and locking the controller 19Unlocking the controller 19Locking the controller 21Turning stimulation on or off 22Turning stimulation on 22Turning stimulation off 23Adjusting stimulation parameters using the Model 3575 Test Stimulation Cable 25Increasing and decreasing amplitude on the Home screen 25Adjusting advanced parameters 27Adjusting stimulation parameters for the Model 3057 Test Stimulation Lead(s) 30Increasing and decreasing amplitude on the Home screen 30Changing the active lead (if two leads were placed) 32Adjusting advanced parameters 33Refer to the indications sheet for indications and related information.Refer to the appropriate information for prescribers booklet for contraindications,warnings, precautions, adverse events summary, individualization of treatment, patientselection, use in specific populations, resterilization, and component disposal.Refer to System Eligibility, Battery Longevity, Specifications reference manual forneurostimulator selection, battery longevity calculations, and specific neurostimulatorspecifications.! USA Refer to the clinical summary booklet for information on the clinical study resultsof the neurostimulation system and individualization of treatment.3537 2012-09 English 5Filename Date TimeUC2001xxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialPTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fmTemplate version: 08-08-2011M943580A002 Rev X 2012-09

Adjusting stimulation parameters for the Model 3093 or Model 3889 Tined Lead 37Adjusting advanced parameters 37Increasing and decreasing amplitude on the Home screen 41Usage Log 42Reset Therapy 44Changing preferences 46Changing the vibration settings 46Changing the brightness of the controller display 48Changing the time 49Changing the date 50Changing the number format 51Changing the language 52Viewing information about the controller and the external neurostimulator 54Checking and replacing batteries 55Checking the external neurostimulator and controller batteries 55Replacing the controller batteries 58Labeling the controller 59Troubleshooting 59Troubleshooting reference guide 60Device specifications 65Device care and storage 656 English 3537 2012-09Filename Date TimeUC2001xxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialPTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fmTemplate version: 08-08-2011M943580A002 Rev X 2012-09

DescriptionThe Medtronic Model 3537 Controller is a hand-held device intended for use with the MedtronicModel 3531 External Neurostimulator. The clinician uses the controller to program settings forthe patient. The patient uses the controller to perform the following tasks as directed by theclinician:▪Adjust amplitude▪Switch between active sides (if two leads were placed)▪Switch programs (if applicable)Package contents▪Model 3537 Controller▪Carrying case▪Batteries (AA)▪Product literature▪! USA Warranty cardAbout this manualThis manual contains the information the physician needs to set up, use, and troubleshoot thecontroller (Figure 1).Stimulation On/Off keyTouchscreenIncrease keyDecrease keyFigure 1. Features of the Model 3537 Controller.3537 2012-09 English 7Filename Date TimeUC2001xxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialPTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fmTemplate version: 08-08-2011M943580A002 Rev X 2012-09

All information and instructions that are available to the patient are included in the Model 3537Controller Patient Test Stimulation Programming Guide and the InterStim Patient TherapyGuide.Instructions for use#Caution: The device is not certified for use in the presence of a flammable anestheticmixture with air or with oxygen or nitrous oxide. The consequences of using the devicenear flammable atmospheres are unknown.#Caution: Do not modify this equipment. Modification of this equipment can result indamage to the device, causing the device to malfunction or become unusable.#Caution: Do not use the device in the proximity of equipment that generateselectromagnetic interference (EMI). EMI may cause a disruption in device function.Examples of common medical sources of EMI are magnetic resonance imaging (MRI) andlithotripsy. Powerful computer monitors, cell phones, x-ray equipment, and othermonitoring equipment may also generate EMI.Setting up the controllerAfter inserting batteries into the controller, a splash screen will appear, followed by a series ofsteps to set up the controller.Note: After completing these setup instructions, you can change the settings at any timeusing the Menu.1. Using the touchscreen, select the desired language from the options available, then pressthe OK button to continue (Figure 2).Slider barFigure 2. Setting the language.Note: Use the slider bar or the Increase and Decrease keys to scroll up or down to seemore languages.2. Using the touchscreen, press the Trial button (Figure 3).8 English 3537 2012-09Filename Date TimeUC2001xxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialPTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fmTemplate version: 08-08-2011M943580A002 Rev X 2012-09

Figure 3. Pressing the Trial button.3. To change the date, the month, or the year, press the touchscreen button with the incorrectvalue, then use the Increase and Decrease keys to change the value. Once the date,month, and year are set correctly, press the OK button to continue (Figure 4).DateMonthYearFigure 4. Setting the date.4. To change the hour, the minute, or the time format, press the touchscreen button with theincorrect value, then use the Increase and Decrease keys to change the value. Once thehour, minute, and time format are set correctly, press the OK button to continue(Figure 5).3537 2012-09 English 9Filename Date TimeUC2001xxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialPTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fmTemplate version: 08-08-2011M943580A002 Rev X 2012-09

AM/PM format 24-hour formatFigure 5. Setting the time.5. Using the touchscreen, press the radio button next to the desired number format for thecontroller, then press the OK button to continue (Figure 6).Figure 6. Selecting the number format.10 English 3537 2012-09Filename Date TimeUC2001xxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialPTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fmTemplate version: 08-08-2011M943580A002 Rev X 2012-09

Pairing the controller to the external neurostimulatorTo ensure correct pairing between the controller and the external neurostimulator, consider thefollowing recommendations:▪Ensure that the controller that you provide to the patient is paired with the patient's externalneurostimulator.▪Ask the patient to bring his or her controller to all follow-up appointments. Use this samecontroller during any clinician programming. This will help to avoid pairing the externalneurostimulator with multiple controllers.▪If the external neurostimulator is paired with a new controller, the connection to the previouscontroller will need to be re-established before the previous controller can be used with theexternal neurostimulator again.Pairing a new controller to an external neurostimulatorNote: Ensure you have the external neurostimulator serial number available. You will need toconfirm this information during the pairing procedure. The serial number is located on the backof the external neurostimulator.1. Press and hold the ENS button for one second to place the external neurostimulator intodiscovery mode (Figure 7). The light on the external neurostimulator will repeatedly blinkfor 90 seconds, or until the external neurostimulator has paired with a controller.Light-emitting diode (LED) ENS buttonOutput jackFigure 7. Turn on the external neurostimulator.2. Press the Continue button on the controller touchscreen (Figure 8). The controller will lookfor the external neurostimulator (Figure 9).3537 2012-09 English 11Filename Date TimeUC2001xxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialPTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fmTemplate version: 08-08-2011M943580A002 Rev X 2012-09

Figure 8. Pressing the Continue button.Figure 9. Controller looking for the external neurostimulator.3. Using the touchscreen, select the radio button next to the correct external neurostimulator,then press the OK button to continue (Figure 10).Note: The number displayed on the controller screen should match the serial numberprinted on the back of the external neurostimulator.12 English 3537 2012-09Filename Date TimeUC2001xxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialPTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fmTemplate version: 08-08-2011M943580A002 Rev X 2012-09

Figure 10. Selecting the device to pair with the controller.Notes:▪If the controller fails to pair with the external neurostimulator, repeat step 1, then pressthe Try Again button to try this step again (Figure 11).▪Pressing the Exit button ( ) will abort the pairing process.Figure 11. Pressing the Try Again button.4. When the pairing is successful, a confirmation screen will appear (Figure 12). Press the OKbutton to continue.3537 2012-09 English 13Filename Date TimeUC2001xxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialPTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fmTemplate version: 08-08-2011M943580A002 Rev X 2012-09

Figure 12. Confirming that the devices are paired.Note: If there is a connection problem, a screen will appear (Figure 13). Check allconnections between the lead and the external neurostimulator, and press the Recheckbutton.Figure 13. Screen prompt to check connections.Pairing a previously used controller to an external neurostimulatorWhen turned on, the previously used controller will automatically attempt to connect to theexternal neurostimulator with which it was previously paired.1. When the controller fails to pair with the previously used external neurostimulator, a screenappears (Figure 14). Press the Menu button in the top right corner of the touchscreen.14 English 3537 2012-09Filename Date TimeUC2001xxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialPTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fmTemplate version: 08-08-2011M943580A002 Rev X 2012-09

Menu buttonFigure 14. Pressing the Menu button.2. Press the Enter Code button (Figure 15).Figure 15. Pressing the Enter Code button.3. Enter the four-digit code by pressing the number buttons on the touchscreen keypad, thenpress the Confirm button to confirm and continue to the Menu (Figure 16).Notes:▪The code is 1155.▪If you make an error while entering the code, press the Undo button to delete the entirecode, then re-enter the correct code.3537 2012-09 English 15Filename Date TimeUC2001xxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialPTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fmTemplate version: 08-08-2011M943580A002 Rev X 2012-09

▪To cancel code entry, press the Exit button ( ) to exit and return to the previous screen.Undo button Exit buttonConfirm buttonKeypadFigure 16. Entering the Menu code.4. From the Menu, select the Pair Device button (Figure 17).Slider barExit buttonFigure 17. Selecting the Pair Device button.16 English 3537 2012-09Filename Date TimeUC2001xxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialPTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fmTemplate version: 08-08-2011M943580A002 Rev X 2012-09

5. Press and hold the ENS button on the external neurostimulator for one second to placethe external neurostimulator into discovery mode. The light on the external neurostimulatorwill repeatedly blink for 90 seconds, or until it has paired with a controller.6. Press the Continue button on the controller touchscreen (Figure 18). The controller willlook for the external neurostimulator (Figure 19).Figure 18. Pressing the Continue button on the touchscreen.Figure 19. Controller looking for the external neurostimulator.7. Using the touchscreen, select the radio button next to the correct external neurostimulator,then press the OK button to continue (Figure 10).Note: The number displayed on the controller screen should match the serial numberprinted on the back of the external neurostimulator.3537 2012-09 English 17Filename Date TimeUC2001xxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialPTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fmTemplate version: 08-08-2011M943580A002 Rev X 2012-09

Figure 20. Selecting the correct device from the list.Notes:▪If the controller fails to pair with the external neurostimulator, repeat step 5 and pressthe Try Again button to continue (Figure 21).▪Pressing the Exit button ( ) will abort the pairing process.Figure 21. No Device Found screen.Note: If there is a connection problem, a screen will appear (Figure 13). Check allconnections between the lead and the external neurostimulator, and press the Recheckbutton.18 English 3537 2012-09Filename Date TimeUC2001xxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialPTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fmTemplate version: 08-08-2011M943580A002 Rev X 2012-09

Figure 22. Screen prompt to check connections.Unlocking and locking the controllerUnlocking the controllerTo unlock the controller, press the Increase/Decrease key.Figure 23. The Unlock screen.Note: When the controller is locked, pressing the Stimulation On/Off key will provide the optionto bypass the Unlock screen and to turn stimulation on or off.1. Press and hold the Lock button on the Unlock screen.3537 2012-09 English 19Filename Date TimeUC2001xxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialPTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fmTemplate version: 08-08-2011M943580A002 Rev X 2012-09

As the Lock button is held, bars appear on the screen and move toward the Lock button(Figure 24).Figure 24. Bars appearing on the Unlock screen.2. Stop pressing the screen when the screen changes to a circle of dots (Figure 25). Thecontroller is looking for the external neurostimulator.Figure 25. The controller looking for the external neurostimulator.The next screen that appears is the Home screen (Figure 26).20 English 3537 2012-09Filename Date TimeUC2001xxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialPTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fmTemplate version: 08-08-2011M943580A002 Rev X 2012-09

Menu buttonStimulation value buttonBattery status button Lock buttonFigure 26. The Home screen.If the Home screen does not appear, see "Troubleshooting" on page 59.Locking the controllerThe controller can be locked so that when buttons or keys are accidentally pressed there willnot be an unexpected change in stimulation.Note: The controller screen will dim after 15 seconds of inactivity, and will automatically lockitself after 2 minutes of inactivity. Pressing the Lock button will lock the controller immediately.From the Home screen, press the Lock button to lock the controller (Figure 27).3537 2012-09 English 21Filename Date TimeUC2001xxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialPTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fmTemplate version: 08-08-2011M943580A002 Rev X 2012-09

Lock buttonFigure 27. Pressing the Lock button.Turning stimulation on or offNote: You can turn stimulation on or off at any time.Turning stimulation on1. To turn stimulation on, press the Stimulation On/Off key on the top of the controller.Note: Pressing the Stimulation value button on the Home screen also allows you to turnstimulation on.2. A screen appears with the option to turn stimulation on. Press the Stimulation On buttonto turn stimulation on (Figure 28).Notes:▪To make no change to stimulation and access the Home screen, press the Go ToUnlock button and unlock the controller.▪To keep stimulation off and continue to the Home screen, press the Stimulation Offbutton.▪Press the Exit button to lock the controller again.22 English 3537 2012-09Filename Date TimeUC2001xxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialPTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fmTemplate version: 08-08-2011M943580A002 Rev X 2012-09

Figure 28. Turning stimulation on.3. A confirmation screen will appear (Figure 29). Press the OK button to continue to the Homescreen.Figure 29. Stimulation turned on.Turning stimulation off1. To turn stimulation off, press the Stimulation On/Off key on the top of the controller.2. A screen appears with the option to turn stimulation off. Press the Stimulation Off buttonto turn stimulation off (Figure 30).3537 2012-09 English 23Filename Date TimeUC2001xxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialPTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fmTemplate version: 08-08-2011M943580A002 Rev X 2012-09

Notes:▪To make no change to stimulation and lock the controller, press the Lock Controllerbutton.▪To keep stimulation on and go to the Home screen, press the Stimulation On button.▪To make no change to stimulation, press the Exit button.Figure 30. Turning stimulation off.Note: If the patient is experiencing discomfort and stimulation must be turned offimmediately, press and hold the ENS button on the external neurostimulator for 3 seconds.3. A confirmation screen will appear (Figure 31). Press the OK button to continue to the Homescreen.Figure 31. Stimulation turned off.24 English 3537 2012-09Filename Date TimeUC2001xxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialPTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fmTemplate version: 08-08-2011M943580A002 Rev X 2012-09

Adjusting stimulation parameters using the Model 3575 Test StimulationCableNotes:▪Before programming, ensure all connections are secure between the externalneurostimulator and the lead(s) or needle.▪For instructions on intraoperative test stimulation, refer to the appropriate lead manual.Increasing and decreasing amplitude on the Home screenWhen using the test stimulation cable, the external neurostimulator uses the following defaultsettings:▪The test stimulation cable is the cathode (-).▪The ground pad is the anode (+).▪Amplitude is set to 0 milliamps.▪Pulse width is set to 210 microseconds.▪Rate is set to 14 Hertz.Note: The cathode and anode configuration does not change. To change amplitude, pulsewidth, and rate, refer to "Adjusting advanced parameters" on page 27.1. Press the Stimulation value button on the Home screen (Figure 32). If stimulation is off,a new screen will appear.Note: If stimulation is already on, the Stimulation value button will be outlined in green.If this happens, proceed to step 3.Stimulation value buttonFigure 32. Pressing the Stimulation value button.2. Press the Turn On button to turn stimulation on and continue (Figure 33).3537 2012-09 English 25Filename Date TimeUC2001xxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialPTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fmTemplate version: 08-08-2011M943580A002 Rev X 2012-09

Note: To cancel and go back to the Home screen, press the OK button.Figure 33. Pressing the Turn On button.3. Use the Increase and Decrease keys to adjust amplitude (Figure 34).Figure 34. Adjusting amplitude.26 English 3537 2012-09Filename Date TimeUC2001xxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialPTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fmTemplate version: 08-08-2011M943580A002 Rev X 2012-09

Note: Press and release the Increase or Decrease key once to change the parametervalue by 0.1 milliamps. Press and hold to change the parameter value in 0.5-milliampincrements.4. To adjust pulse width and rate, refer to "Adjusting advanced parameters".Adjusting advanced parameters1. From the Home screen, press the Menu button in the top right corner of the touchscreen(Figure 35).Menu buttonFigure 35. Pressing the Menu button.2. Press the Enter Code button (Figure 36).3537 2012-09 English 27Filename Date TimeUC2001xxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialPTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fmTemplate version: 08-08-2011M943580A002 Rev X 2012-09

Figure 36. Pressing the Enter Code button.3. Enter the four-digit code by pressing the number buttons on the touchscreen keypad, thenpress the Confirm button to enter the code and continue (Figure 37).Notes:▪The code is 1155.▪If you make an error while entering the code, press the Undo button to delete the entirecode, then re-enter the correct code.▪To cancel code entry, press the Exit button ( ) to exit and return to the previous screen.Undo button Exit buttonConfirm buttonKeypadFigure 37. Entering the Menu code.28 English 3537 2012-09Filename Date TimeUC2001xxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialPTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fmTemplate version: 08-08-2011M943580A002 Rev X 2012-09

4. Select the Therapy button from the Menu (Figure 38).Slider barExit buttonFigure 38. Selecting the Therapy button.5. Adjust the amplitude, pulse width, and rate (Figure 39).Amplitude buttonPulse width buttonRate buttonExit buttonFigure 39. Adjusting amplitude, pulse width, and rate.a. To change the amplitude, press the Amplitude button, then use the Increase andDecrease keys to adjust the amplitude parameter.3537 2012-09 English 29Filename Date TimeUC2001xxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialPTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fmTemplate version: 08-08-2011M943580A002 Rev X 2012-09

Note: Press and release the Increase or Decrease key to change the parameter valueby 0.1 milliamps. Press and hold to change the parameter value in 0.5-milliampincrements.b. To change the pulse width, press the Pulse width button, then use the Increase andDecrease keys to adjust the pulse width parameter.Note: Press and release the Increase or Decrease key to change the parameter valueby 10 microseconds. Press and hold to quickly adjust the parameter.c. To change the rate, press the Rate button, then use the Increase and Decrease keysto adjust the rate parameter.Note: Press the Increase or Decrease key to change the parameter value by 1 Hertz(from 3 to 30 Hertz) or by 5 Hertz (from 30 to 130 Hertz). Press and hold to quicklyadjust the parameter.6. Press the Exit button ( ) at the top right corner of the screen to exit.If using one or more Model 3057 test stimulation lead(s), refer to "Adjusting stimulationparameters for the Model 3057 Test Stimulation Lead(s)" on page 30. If using the Model3093 or Model 3889 Tined Lead, refer to "Adjusting stimulation parameters for the Model3093 or Model 3889 Tined Lead" on page 37.Adjusting stimulation parameters for the Model 3057 Test StimulationLead(s)Notes:▪Before programming, ensure all connections are secure between the externalneurostimulator and the lead(s).▪For instructions on intraoperative test stimulation, refer to the appropriate lead manual.Increasing and decreasing amplitude on the Home screenWhen using the test stimulation lead, the external neurostimulator uses the following defaultsettings:▪The test stimulation lead is the cathode (-).▪If the Model 3676 Cable is used, the ground pad is the anode (+). If the Model 3579 Cableis used, the second test stimulation lead is the anode.▪Amplitude is set to 0 milliamps.▪Pulse width is set to 210 microseconds.▪Rate is set to 14 Hertz.Note: The cathode and anode configuration does not change. To change amplitude, pulsewidth, and rate, refer to "Adjusting advanced parameters" on page 33.1. Press the Stimulation value button on the Home screen (Figure 40). If stimulation is off,a new screen will appear.Notes:▪If two leads were placed, select a side to stimulate by pressing the Stimulation valuebutton on that side.30 English 3537 2012-09Filename Date TimeUC2001xxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialPTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fmTemplate version: 08-08-2011M943580A002 Rev X 2012-09

▪The image below shows the Home screen when two test stimulation leads are placed.If only one test stimulation lead was placed, only one Stimulation value button will beavailable.▪If stimulation is already on, the Stimulation value button will be outlined in green. Ifthis happens, proceed to step 4.Stimulation value buttons Figure 40. Pressing the Stimulation value button on the Home screen.2. Press the Turn On button to turn stimulation on and continue (Figure 41).Note: To cancel and go back to the Home screen, press the OK button.Figure 41. Pressing the Turn On button.3537 2012-09 English 31Filename Date TimeUC2001xxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialPTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fmTemplate version: 08-08-2011M943580A002 Rev X 2012-09

3. A confirmation screen will appear (Figure 42). Press the OK button to continue to the Homescreen.Figure 42. Stimulation turned on.4. Use the Increase and Decrease keys to adjust amplitude.Note: Press and release the Increase or Decrease key once to change the parametervalue by 0.1 milliamps. Press and hold to change the parameter value in 0.5-milliampincrements.5. To adjust pulse width and rate, refer to "Adjusting advanced parameters".Changing the active lead (if two leads were placed)1. Press the Stimulation value button on the side of the Home screen that corresponds tothe inactive lead.2. Press the Yes button to continue (Figure 43).32 English 3537 2012-09Filename Date TimeUC2001xxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialPTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fmTemplate version: 08-08-2011M943580A002 Rev X 2012-09

Figure 43. Confirming change of therapy side.3. Press the Yes button to confirm changing sides.Note: Pressing the No button cancels the change and continues stimulation on the sameside.4. The active lead will change, and stimulation will be set to zero. Use the Increase/Decreasekey to adjust stimulation (see "Increasing and decreasing amplitude on the Home screen"on page 30).Adjusting advanced parameters1. From the Home screen, press the Menu button in the top right corner of the touchscreen(Figure 44).3537 2012-09 English 33Filename Date TimeUC2001xxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialPTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fmTemplate version: 08-08-2011M943580A002 Rev X 2012-09

Menu buttonFigure 44. Pressing Menu button.2. Press the Enter Code button (Figure 36).Figure 45. Pressing the Enter Code button.3. Enter the four-digit code by pressing the number buttons on the touchscreen keypad, thenpress the Confirm button to enter the code and continue (Figure 46).Notes:▪The code is 1155.▪If you make an error while entering the code, press the Undo button to delete the entirecode, then re-enter the correct code.34 English 3537 2012-09Filename Date TimeUC2001xxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialPTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fmTemplate version: 08-08-2011M943580A002 Rev X 2012-09

▪To cancel code entry, press the Exit button ( ) to exit and return to the previous screen.Undo button Exit buttonConfirm buttonKeypadFigure 46. Entering the Menu code.4. Select the Therapy button from the Menu (Figure 47).Slider barExit buttonFigure 47. Selecting the Therapy button.5. Adjust the amplitude, pulse width, and rate (Figure 48).3537 2012-09 English 35Filename Date TimeUC2001xxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialPTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fmTemplate version: 08-08-2011M943580A002 Rev X 2012-09

Amplitude buttonLead II buttonPulse width buttonRate buttonLead I button Exit buttonFigure 48. Adjusting amplitude, pulse width, and rate.a. To change the amplitude, press the Amplitude button, then use the Increase andDecrease keys to adjust the amplitude parameter.Note: Press and release the Increase or Decrease key to change the parameter valueby 0.1 milliamps. Press and hold to change the parameter value in 0.5-milliampincrements.b. To change the pulse width, press the Pulse width button, then use the Increase andDecrease keys to adjust the pulse width parameter.Note: Press and release the Increase or Decrease key to change the parameter valueby 10 microseconds. Press and hold to quickly adjust the parameter.c. To change the rate, press the Rate button, then use the Increase and Decrease keysto adjust the rate parameter.Note: Press the Increase or Decrease key to change the parameter value by 1 Hertz(3 to 30 Hertz) or by 5 Hertz (30 to 130 Hertz). Press and hold to quickly adjust theparameter.6. If using two leads, ensure stimulation parameters are reviewed and adjusted for both leads.a. Press the Lead I or Lead II button at the top of the screen to alternate between lead I(left side) and lead II (right side).b. Repeat step 5 to review and adjust stimulation parameters as desired.7. Press the Exit button ( ) at the top right corner of the touchscreen to exit.8. When programming is finished, press the Lock button to lock the controller before givingthe controller to the patient ("Locking the controller" on page 21).36 English 3537 2012-09Filename Date TimeUC2001xxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialPTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fmTemplate version: 08-08-2011M943580A002 Rev X 2012-09

Adjusting stimulation parameters for the Model 3093 or Model 3889 TinedLeadNotes:▪Before programming, ensure all connections are secure between the externalneurostimulator and the lead.▪For instructions on intraoperative test stimulation, refer to the appropriate lead manual.Adjusting advanced parametersWhen using a Model 3093 or Model 3889 Tined Lead for test stimulation, advanced settingsmust be programmed before adjusting amplitude with the Home screen.1. From the Home screen, press the Menu button in the top right corner of the touchscreen(Figure 49).Menu buttonFigure 49. Pressing the Menu button.2. Press the Clinician Mode button (Figure 50).3537 2012-09 English 37Filename Date TimeUC2001xxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialPTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fmTemplate version: 08-08-2011M943580A002 Rev X 2012-09

Figure 50. Pressing the Clinician Mode button.3. Press the Enter Code button (Figure 51).Figure 51. Pressing the Enter Code button.4. Enter the four-digit code by pressing the number buttons on the touchscreen keypad, thenpress the Confirm button to enter the code and continue (Figure 52).Notes:▪The code is 1155.▪If you make an error while entering the code, press the Undo button to delete the entirecode, then re-enter the correct code.▪To cancel code entry, press the Exit button ( ) to exit and return to the previous screen.38 English 3537 2012-09Filename Date TimeUC2001xxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialPTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fmTemplate version: 08-08-2011M943580A002 Rev X 2012-09

Undo button Exit buttonConfirm buttonKeypadFigure 52. Entering the Menu code.5. Select the Therapy button from the Menu (Figure 53).Slider barExit buttonFigure 53. Selecting the Therapy button.6. Set up electrode configurations as desired (Figure 54).a. Press each individual electrode on the touchscreen to alternate between blank (nopolarity), plus (positive), or minus (negative).3537 2012-09 English 39Filename Date TimeUC2001xxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialPTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fmTemplate version: 08-08-2011M943580A002 Rev X 2012-09

b. To apply stimulation, there must be at least one positive electrode and one negativeelectrode. One can exit the screen if all electrodes are blank, but stimulation will not beturned on.c. Adjusting the electrode configuration automatically sets the amplitude to zero. Adjustthe amplitude parameter again to the desired value.7. Adjust the amplitude, pulse width, and rate (Figure 54).Electrode buttonsProgram I buttonProgram II button Program III buttonAmplitude buttonPulse width buttonRate buttonFigure 54. Adjusting electrode configuration, amplitude, pulse width, and rate.a. To change the amplitude, press the Amplitude button, then use the Increase andDecrease keys to adjust the amplitude parameter.Note: Press and release the Increase or Decrease key to change the parameter valueby 0.1 milliamps. Press and hold to change the parameter value in 0.5-milliampincrements.b. To change the pulse width, press the Pulse width button, then use the Increase andDecrease keys to adjust the pulse width parameter.Note: Press and release the Increase or Decrease key to change the parameter valueby 10 microseconds. Press and hold to quickly adjust the parameter.c. To change the rate, press the Rate button, then use the Increase and Decrease keysto adjust the rate parameter.Note: Press the Increase or Decrease key to change the parameter value by 1 Hertz(3 to 30 Hertz) or by 5 Hertz (30 to 130 Hertz). Press and hold to quickly adjust theparameter.8. If using multiple programs, ensure that stimulation parameters and electrodeconfigurations are reviewed and adjusted for all programs.a. Press the Program I, Program II, or Program III button at the top of the screen toalternate between programs.40 English 3537 2012-09Filename Date TimeUC2001xxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialPTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fmTemplate version: 08-08-2011M943580A002 Rev X 2012-09

b. Repeat step 6 through step 7 to review and adjust electrode configurations as desired.9. When programming is finished, press the Exit button ( ) at the top right corner of thescreen to exit to the Menu.Increasing and decreasing amplitude on the Home screenWhen using a Model 3093 or Model 3889 Tined Lead for test stimulation, advanced settingsmust be programmed before adjusting amplitude with the Home screen.1. Press the Stimulation value button on the Home screen (Figure 55). If stimulation is off,a new screen will appear.Note: If stimulation is already on, the Stimulation value button will be outlined in green.If this happens, proceed to step 3.Stimulation value buttonFigure 55. Pressing the Stimulation value button on the Home screen.2. Press the Turn On button to turn stimulation on and continue (Figure 56).Note: To cancel and go back to the Home screen, press the OK button.3537 2012-09 English 41Filename Date TimeUC2001xxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialPTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fmTemplate version: 08-08-2011M943580A002 Rev X 2012-09

Figure 56. Pressing the Turn On button.3. Use the Increase and Decrease keys to adjust amplitude.Note: Press and release the Increase or Decrease key once to change the parametervalue by 0.1 milliamps. Press and hold to change the parameter value in 0.5-milliampincrements.4. To adjust pulse width, rate, and electrode configuration, refer to "Adjusting advancedparameters".5. When programming is finished, press the Lock button to lock the controller before givingthe controller to the patient ("Locking the controller" on page 21).Usage LogThe Usage Log contains data on the patient test stimulation period, shown as a bar graph. Thegraph displays an approximate timeline of stimulation turned on or off. The graph is shaded insections representing time when stimulation was on, and blank in sections representing timewhen stimulation was off. The Usage Log also displays information related to the following:–When the active side was changed.–When the active program was changed (if applicable).–When stimulation was on or off.1. From the Menu, press the Usage button (Figure 57).42 English 3537 2012-09Filename Date TimeUC2001xxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialPTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fmTemplate version: 08-08-2011M943580A002 Rev X 2012-09

Slider barExit buttonFigure 57. Pressing the Usage button.2. The Usage bar shows when stimulation was on or off. When stimulation was on, the Usagebar is lighter. When stimulation was off, the Usage bar is darker.Day buttonsExit buttonNotification buttonUsage barFigure 58. The Usage Log screen.Note: Scroll down using the touchscreen slider bar to see more days.3537 2012-09 English 43Filename Date TimeUC2001xxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialPTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fmTemplate version: 08-08-2011M943580A002 Rev X 2012-09

3. A blue Notification icon ( ) will appear next to days during which an event occurred.Press the Day button that contains the Notification icon for details on events related tothe patient changing lead sides, changing programs, and turning stimulation on or off(Figure 59).Exit buttonSlider barFigure 59. Example of a Usage log notification.Note: It is possible for the amplitude is set to zero while stimulation is on.Reset TherapyThe Reset Therapy function allows you to set all stimulation settings to their default values forany and all programs.1. From the Menu, press the Reset Therapy button (Figure 60).44 English 3537 2012-09Filename Date TimeUC2001xxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialPTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fmTemplate version: 08-08-2011M943580A002 Rev X 2012-09

Slider barExit buttonFigure 60. Pressing the Reset Therapy button.2. Press the Continue button to confirm resetting all stimulation settings (Figure 61).Note: To cancel the therapy reset, press the Cancel button.Figure 61. Confirming therapy reset.The controller will check the lead and cable connections prior to resetting stimulationsettings.3. If the reset was successful, a confirmation screen will appear (Figure 62). Press the OKbutton to continue to the Home screen.3537 2012-09 English 45Filename Date TimeUC2001xxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialPTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fmTemplate version: 08-08-2011M943580A002 Rev X 2012-09

Figure 62. Therapy Reset successful screen.Note: If the reset was not successful, a warning screen appears (Figure 63). If this screenappears, check all lead and cable connections, press the OK button, and repeat steps 1through 3 to try again.Figure 63. Therapy Reset Failed warning screen.Changing preferencesNote: In the Menu, use the touchscreen slider bar to view all options (Figure 64).Changing the vibration settings1. Select the Vibration button from the Menu (Figure 64).46 English 3537 2012-09Filename Date TimeUC2001xxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialPTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fmTemplate version: 08-08-2011M943580A002 Rev X 2012-09

Slider barExit buttonFigure 64. Selecting the Vibration button.2. To change vibration settings using the touchscreen, press either the No vibration buttonor the Vibration button (Figure 65).No vibration button vibration buttonFigure 65. Changing the vibration settings on the controller.3. Press the OK button to exit.3537 2012-09 English 47Filename Date TimeUC2001xxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialPTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fmTemplate version: 08-08-2011M943580A002 Rev X 2012-09

Changing the brightness of the controller display1. Select the Brightness button from the Menu (Figure 66).Slider barExit buttonFigure 66. Selecting the Brightness button.2. Using the touchscreen, press the radio button below the desired brightness level(Figure 67).Dimmest BrightestFigure 67. Changing the brightness of the controller screen.3. Press the OK button to exit.48 English 3537 2012-09Filename Date TimeUC2001xxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialPTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fmTemplate version: 08-08-2011M943580A002 Rev X 2012-09

Changing the time1. Select the Time button from the Menu (Figure 68).Slider barExit buttonFigure 68. Selecting the Time button.2. To change the hour, the minute, or the time format, press the touchscreen button with theincorrect value, then use the Increase and Decrease keys to change the value. Once thehour, minute, and time format are set correctly, press the OK button to exit (Figure 69).3537 2012-09 English 49Filename Date TimeUC2001xxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialPTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fmTemplate version: 08-08-2011M943580A002 Rev X 2012-09

AM/PM format 24-hour formatFigure 69. Changing the time on the controller.Changing the date1. Select the Date button from the Menu (Figure 70).50 English 3537 2012-09Filename Date TimeUC2001xxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialPTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fmTemplate version: 08-08-2011M943580A002 Rev X 2012-09

Slider barExit buttonFigure 70. Selecting the Date button.2. To change the date, the month, or the year, press the touchscreen button with the incorrectvalue, then use the Increase and Decrease keys to change the value. Once the date,month, and year are set correctly, press the OK button to exit (Figure 71).DateMonthYearFigure 71. Changing the date on the controller.Changing the number format1. Select the Numbers button from the Menu (Figure 72).3537 2012-09 English 51Filename Date TimeUC2001xxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialPTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fmTemplate version: 08-08-2011M943580A002 Rev X 2012-09

Slider barExit buttonFigure 72. Selecting the Numbers button.2. Using the touchscreen, press the radio button next to the desired number format for thecontroller, then press the OK button to exit (Figure 73).Figure 73. Changing the number format of the controller.Changing the language1. Select the Language button from the Menu (Figure 74).52 English 3537 2012-09Filename Date TimeUC2001xxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialPTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fmTemplate version: 08-08-2011M943580A002 Rev X 2012-09

Slider barExit buttonFigure 74. Selecting the Language button.2. Using the touchscreen, select the desired language from the options available, then pressthe OK button to exit (Figure 75).Slider barFigure 75. Changing the language on the controller.Note: Use the slider bar to scroll up or down to see more languages.3537 2012-09 English 53Filename Date TimeUC2001xxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialPTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fmTemplate version: 08-08-2011M943580A002 Rev X 2012-09

Viewing information about the controller and the external neurostimulator1. To view information about the controller or the external neurostimulator, use thetouchscreen to select the About button from the Menu (Figure 76).Slider barExit buttonFigure 76. Selecting the About button.2. When finished reading the information about the controller, press the OK button to exit(Figure 77).Note: To view information about the controller, press the Toggle button (Figure 77).54 English 3537 2012-09Filename Date TimeUC2001xxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialPTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fmTemplate version: 08-08-2011M943580A002 Rev X 2012-09

Toggle buttonFigure 77. The About screen.Checking and replacing batteriesAlways keep 2 new AA alkaline batteries available for replacement.Checking the external neurostimulator and controller batteriesNote: You can see the battery levels of the controller and the external neurostimulator at thetop of the Home screen (Figure 78). For more detailed information on battery levels, follow thesteps below.Table 1 lists several examples of external neurostimulator battery levels and whether action isrequired.Table 1. Battery level definitions for the external neurostimulatorExternal neurostimulator battery icon is green. Batterylevel is full. No action is needed.External neurostimulator battery icon is green. Con-sider replacing the external neurostimulator batteries.External neurostimulator battery icon is orange. Bat-tery level is low. Do not send a patient home with lowbatteries. Replace the external neurostimulator bat-teries.3537 2012-09 English 55Filename Date TimeUC2001xxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialPTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fmTemplate version: 08-08-2011M943580A002 Rev X 2012-09

Table 1. Battery level definitions for the external neurostimulatorExternal neurostimulator battery icon is red. Stimula-tion may no longer be available. Do not send a pa-tient home with low batteries. Replace the externalneurostimulator batteries.Table 2 lists several examples of controller battery levels and whether action is required.Table 2. Battery level definitions for the controllerController battery icon is green. Battery level is full.No action is needed.Controller battery icon is green. Battery level is halffull. No action is needed.Controller battery icon is orange. The controller bat-teries are low. Consider changing controller batteriessoon.Controller battery icon is red. The controller batteriesare nearly depleted and programming will not be pos-sible soon. Replace the controller batteries.You can check the controller batteries at any time. Complete the following steps to check thecontroller batteries.1. From the Therapy Home screen, press the Battery status button (Figure 78).56 English 3537 2012-09Filename Date TimeUC2001xxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialPTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fmTemplate version: 08-08-2011M943580A002 Rev X 2012-09

Battery status buttonFigure 78. Viewing the battery status on the Home screen.Note: Two battery icons are displayed (Figure 79). The upper battery icon shows thebattery status of the controller. The lower battery icon shows the battery status of theexternal neurostimulator.Controller battery statusExternal neurostimulator battery statusFigure 79. Viewing the detailed battery status.2. Press the Exit button ( ) at the top right corner of the touchscreen to exit.3537 2012-09 English 57Filename Date TimeUC2001xxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialPTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fmTemplate version: 08-08-2011M943580A002 Rev X 2012-09

Replacing the controller batteriesNotes:▪For information on replacing the external neurostimulator batteries, refer to the Model 3531External Neurostimulator Technical Manual.▪If not using the controller for an extended period of time, remove the batteries from thecontroller to prevent battery depletion.1. Open the battery compartment cover (Figure 80).Figure 80. Opening the battery cover.2. Remove the depleted batteries.3. Insert the new batteries as shown on the battery compartment label (Figure 81).58 English 3537 2012-09Filename Date TimeUC2001xxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialPTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fmTemplate version: 08-08-2011M943580A002 Rev X 2012-09

Figure 81. Inserting new batteries.4. Close the battery compartment cover.5. Dispose of old batteries according to local requirements.Labeling the controllerWrite your clinic contact information on an identification label and place the label on the backof the controller so the controller can be returned if lost (Figure 82).ID labelFigure 82. Place the adhesive label on the back of the controller.TroubleshootingThis section lists basic troubleshooting for the controller.3537 2012-09 English 59Filename Date TimeUC2001xxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialPTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fmTemplate version: 08-08-2011M943580A002 Rev X 2012-09

The controller displays three different types of screens: warning screens, alert screens, andnotification screens. These screens provide you with information about your system, alert youto a problem with your system, or guide you during controller use.▪Warning screens display a red triangle at the top with an exclamation point ( ).▪Alert screens display an orange triangle at the top with an exclamation point ( ).▪Notification screens display a blue circle at the top with the letter 'i' ( ).If you experience an issue not described in this section, contact your Medtronic representative.Troubleshooting reference guideTable 3. Warning messagesMessage Explanation and SolutionSystem ProblemCannot continue. Please callyour clinician.Explanation: The system is not working correctly. Stimula-tion may have stopped.1. Remove and reinsert the controller batteries, thenretry the action that caused the error screen to ap-pear. For instructions on removing and inserting thecontroller batteries, refer to "Checking and replac-ing batteries" on page 55.2. If the issue persists, remove and reinsert the exter-nal neurostimulator batteries, then retry the actionthat caused the error screen to appear. For instruc-tions on removing and inserting external neurosti-mulator batteries, refer to the manual packaged withthe external neurostimulator.3. If the issue persists and if using the Model 3093/3889Lead, remove all electrode configurations by settingall electrodes to blank for all programs, then repro-gram electrode configurations and retry the actionthat caused the error screen to appear. For instruc-tions on programming electrodes, refer to "Adjust-ing stimulation parameters for the Model 3093 orModel 3889 Tined Lead" on page 37.4. If the steps above do not resolve the issue, the ex-ternal neurostimulator and/or controller need to bereplaced.60 English 3537 2012-09Filename Date TimeUC2001xxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialPTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fmTemplate version: 08-08-2011M943580A002 Rev X 2012-09

Table 3. Warning messagesMessage Explanation and SolutionSoftware ProblemCannot continue. Please callyour clinician.Explanation: The software is not working correctly. Stimu-lation may have stopped.1. Remove and reinsert the controller batteries, thenretry the action that caused the error screen to ap-pear. For instructions on removing and inserting thecontroller batteries, refer to "Checking and replac-ing batteries".2. If the issue persists, replace the controller and referto "Pairing a new controller to an external neurosti-mulator" for instructions on pairing the new control-ler to the external neurostimulator.Button JammedCannot provide stimulation.Release the external devicebutton.Explanation: The ENS button on the external neurostimu-lator is stuck in the pressed position.Solution: Press and release the ENS button, then pressthe OK button. If the problem persists, the externalneurostimulator may need to be replaced.Batteries Empty (externaldevice)External device batteriesneed to be changed. Call yourclinician.Explanation: The external neurostimulator batteries aredepleted and stimulation is not available.Solution: Replace the external neurostimulator batter-ies. For more information on replacing the externalneurostimulator batteries, refer to the Model 3531 Ex-ternal Neurostimulator Technical Manual.Battery Empty (controller)Cannot continue. Replace thecontroller batteries.Explanation: The controller batteries are depleted. Pro-gramming is not available.Solution: Replace the controller batteries. For instruc-tions on replacing the controller batteries, see "Check-ing and replacing batteries" on page 55.Change External DeviceCannot provide stimulation.Call your clinician.Explanation: The external neurostimulator has reached theend of service. This is related to device function, not tobattery level. This external neurostimulator can no longerprovide stimulation.Solution: Replace the external neurostimulator.3537 2012-09 English 61Filename Date TimeUC2001xxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialPTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fmTemplate version: 08-08-2011M943580A002 Rev X 2012-09

Table 4. Alert messagesMessage ExplanationNo Device FoundTry the following: Move thecontroller closer to the exter-nal device.Explanation: The controller cannot find the paired externalneurostimulator. The external neurostimulator may be outof range or the external neurostimulator batteries may bedepleted.Solution: Move the controller closer to the externalneurostimulator and make sure your hand is not cov-ering the top of the controller, then press the Try Againbutton.If the issue persists, the external neurostimulator bat-teries may need to be replaced. For instructions on re-placing the external neurostimulator batteries, see theappropriate technical manual packaged with the exter-nal neurostimulator.Change External DeviceCall your clinician. Stimulationhour(s) remaining: XXExplanation: The external neurostimulator is nearing theend of service. Stimulation will not be available soon.Solution: Replace the external neurostimulator.Batteries Low (external de-vice)External device batteriesneed to be changed. Call yourclinician.Explanation: The external neurostimulator batteries are lowand stimulation will not be available soon.Solution: Replace the external neurostimulator batter-ies. For more information on replacing the externalneurostimulator batteries, refer to the Model 3531 Ex-ternal Neurostimulator Technical Manual.Battery Low (controller)Replace the controller batter-ies soon.Explanation: The controller batteries are low and program-ming will not be available soon.Solution: Replace the controller batteries. For instruc-tions on replacing the controller batteries, see "Check-ing and replacing batteries" on page 55.Incomplete SettingsValid electrodes configura-tion, pulse width, and rate set-tings required.Explanation: One or more stimulation parameters, includ-ing electrode configuration, was left unprogrammed.Solution: Check stimulation parameters. Ensure thatat least one electrode is negative and at least one elec-trode is positive, or that all electrodes are blank.Incompatible DeviceChange external device.Explanation: You are attempting to connect to an incom-patible external neurostimulator.Solution: Replace the external neurostimulator with acompatible model.62 English 3537 2012-09Filename Date TimeUC2001xxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialPTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fmTemplate version: 08-08-2011M943580A002 Rev X 2012-09

Table 4. Alert messagesMessage ExplanationIncompatible System Com-ponentEnsure batteries and othersystem components are com-patible.Explanation: You are attempting to connect to an incom-patible system component.Solution: Verify that all components are compatible.Remove any incompatible system components.If the issue persists, the controller batteries may needto be replaced. For instructions on replacing the con-troller batteries, see "Checking and replacing batter-ies".Connection ChangedCable or lead changed. Ther-apy settings were reset.Explanation: The external neurostimulator has detectedthat a different cable type has been connected.Solution: Press the OK button. Stimulation parametersfor the new connection need to be programmed to de-sired settings.Check ConnectionEnsure all cable and lead con-nections are secure.Explanation: The external neurostimulator has detectedthat either a cable or a lead is not connected.Solution: Ensure all cable and lead connections aresecure. Press the OK button.Table 5. Notification messagesMessage Explanation and solutionStimulation is offSettings cannot be changedwith stimulation off.Explanation: You tried to adjust stimulation/therapy whenstimulation/therapy was off.Solution: Turn stimulation/therapy on, then try adjust-ing stimulation/therapy again.Upper limitSettings cannot be increasedany higher.Explanation: You tried increasing a stimulation parameterabove the highest value allowed. You can not increase thestimulation any higher.Solution: Press the OK button and consider adjustingother stimulation parameters.Lower limitSettings cannot be decreasedany lower.Explanation: You tried decreasing a stimulation parameterbelow the lowest value allowed. You can not decrease theamplitude below zero.Solution: Press the OK button and consider adjustingother stimulation parameters.3537 2012-09 English 63Filename Date TimeUC2001xxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialPTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fmTemplate version: 08-08-2011M943580A002 Rev X 2012-09

Table 5. Notification messagesMessage Explanation and solutionSettings Not AvailableCannot provide your desiredsettings. Call your clinician.Explanation: Your combined settings can not currently bedelivered by the external neurostimulator.Solution: Press the OK button and try the following:1) Consider adjusting other stimulation parameters,including electrode configuration.2) Ensure that lead and cable connections are secure.Retry ENSUnable to find deviceExplanation: The controller cannot find the paired externalneurostimulator. The external neurostimulator may be outof range or the external neurostimulator batteries may bedepleted.Solution: Move the controller closer to the externalneurostimulator and make sure your hand is not cov-ering the top of the controller, then press the Try Againbutton.If this does not work, the external neurostimulator bat-teries may need to be replaced. For instructions on re-placing the external neurostimulator batteries, see theappropriate technical manual packaged with the exter-nal neurostimulator.Note: If you wish to pair the controller to a new exter-nal neurostimulator, see "Pairing the controller to theexternal neurostimulator" on page 11Memory ProblemData has been lost. Repeatset-up process.Explanation: Controller settings are not available, but tele-metry is still available. The controller batteries may havebeen removed or depleted for an extended period of time.Solution: Follow the on-screen prompts to reconfigurecontroller settings, including pairing to the externalneurostimulator.64 English 3537 2012-09Filename Date TimeUC2001xxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialPTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fmTemplate version: 08-08-2011M943580A002 Rev X 2012-09

Table 6. Additional scenariosScenario ExplanationThe controller is unrespon-sive. Explanation: the controller has encountered a problem andmust be reset.1. Solution: Remove and reinsert the batteries. For in-struction on battery removal and placement, see"Replacing the controller batteries" on page 58.2. If batteries are inserted correctly, the batteries aredepleted. Replace the controller batteries. For in-structions on replacing controller batteries, see"Replacing the controller batteries" on page 58.3. If the issue persists, replace the controller.The controller screen goesblank, then returns to the Un-lock screen.Explanation: The controller encountered a problem andhas automatically reset.Solution: Unlock the controller. If necessary, navigateback to the screen that was in use when the controllerwas reset and continue the intended task.Device specificationsTable 7. Model 3537 Controller specificationsaParameter SpecificationPower source Two alkaline AA batteries (nonrechargeable)Operating temperature 9 °C to 43 °C (49 °F to 110 °F)Temperature limitation -30 °C to 57 °C (-22 °F to +135 °F)Controller size 12.0 x 6.0 x 2.4 cm (4.7 x 2.4 x 0.9 in)Controller weight, including batteries 150 g (5.3 oz)Battery life 4–6 weeks average for alkaline batteriesOperating time ShortaAll measurements are approximate.Device care and storage▪Keep new alkaline batteries available.▪Use the controller to check the battery level daily.▪Replace low or depleted batteries.3537 2012-09 English 65Filename Date TimeUC2001xxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialPTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fmTemplate version: 08-08-2011M943580A002 Rev X 2012-09

▪Handle the device with care. Do not drop, strike or step on the device.▪Do not dismantle or tamper with the device.▪Clean the outside of the device with a damp cloth when necessary. Mild household cleanerswill not damage the device or labels.▪The battery contacts may be cleaned periodically with a cotton swab dampened withalcohol. Do not use a pencil eraser or sandpaper.▪Store the device at room temperature. Avoid extreme hot or cold temperatures and directsunlight.▪The device is not waterproof. Do not allow moisture to get inside the device.▪Dispose of depleted batteries and worn out devices according to local requirements.66 English 3537 2012-09Filename Date TimeUC2001xxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialPTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fmTemplate version: 08-08-2011M943580A002 Rev X 2012-09

3537 2012-09 English 67Filename Date TimeUC2001xxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialPTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fmTemplate version: 08-08-2011M943580A002 Rev X 2012-09

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 Czechia s.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) 580-7378SlovakiaMedtronic Slovakia, o.z.Tel. 0268 206 911Fax 0268 206 999Filename Date TimeUC2001xxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialPTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fmTemplate version: 08-08-2011M943580A002 Rev X 2012-09

Spain: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 031-868-0199The 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 TimeUC2001xxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialPTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fmTemplate version: 08-08-2011M943580A002 Rev X 2012-09

Manufacturer Medtronic, Inc.710 Medtronic ParkwayMinneapolis, MN 55432-5604USAwww.medtronic.comTel. +1-763-505-5000Fax +1-763-505-1000Medtronic E.C. Authorized EC REPRepresentative/Distributed byMedtronic 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 listed inside this cover.*M943580A002*© Medtronic, Inc. 2012All Rights ReservedM943580A002Filename Date TimeUC2001xxxx EN4.625 x 6 inches (117 mm x 152 mm)Medtronic ConfidentialPTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fmTemplate version: 08-08-2011M943580A002 Rev X 2012-09

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