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User Manual 1 | Users Manual | 2.11 MiB | July 06 2012 / April 12 2012 | |||
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User Manual 3 | Users Manual | 87.82 KiB | July 06 2012 / April 12 2012 | |||
1 | Cover Letter(s) | July 06 2012 | ||||||
1 | Operational Description | July 06 2012 | ||||||
1 | Cover Letter(s) | July 06 2012 | ||||||
1 | Cover Letter(s) | July 06 2012 | ||||||
1 | External Photos | July 06 2012 / April 12 2012 | ||||||
1 | ID Label/Location Info | July 06 2012 | ||||||
1 | Internal Photos | July 06 2012 / April 12 2012 | ||||||
1 | RF Exposure Info | July 06 2012 | ||||||
1 | Cover Letter(s) | July 06 2012 | ||||||
1 | Test Report | July 06 2012 | ||||||
1 | Test Setup Photos | July 06 2012 / April 12 2012 |
1 | User Manual 1 | Users Manual | 2.11 MiB | July 06 2012 / April 12 2012 |
Filename Date Time UC2001xxxx EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential PTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fm Template version: 08-08-2011 CONTROLLER for InterStim Therapy 3537 Clinician Programming Guide
! USA Rx only M943580A002 Rev X 2012-09 Filename Date Time UC2001xxxx EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential PTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fm Template version: 08-08-2011 M943580A002 Rev X 2012-09 Filename Date Time UC2001xxxx EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential PTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fm Template version: 08-08-2011 Explanation of symbols on product or package labeling Refer to the appropriate product for symbols that apply. Consult instructions for use Manufacturer XX C XXX F Temperature limitation
-XX C
-XX F Serial number Conformit Europenne (European Conformity). This symbol means that the device fully complies with MDD 93/42//EEC (NB 0123) and R&TTE Directive 1999/5/EC. EC REP Authorized representative in the European community
! USA For USA audiences only IEC 60601-1/EN60601-1, Type BF equipment Non-ionizing electromagnetic radiation System meets the applicable Canadian (CAN/CSAC22.2 No. 60601-1) electrical safety standard requirements. Do not dispose of this product in the unsorted municipal waste stream. Dispose of this product according to local regulations. See http://recycling.medtronic.com for instructions on proper disposal of this product. Chinese Standard (SJ/T11364-2006) Logo: Electronic Information Products Pollution Control Symbol. (The date in this logo means the environmental protection use period of the product.) 3537 2012-09 English 3 M943580A002 Rev X 2012-09 Filename Date Time UC2001xxxx EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential PTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fm Template version: 08-08-2011 Medtronic, and InterStim are trademarks of Medtronic, Inc., registered in the U.S. and other countries.
! USA FCC Information The following is communications regulation information on the Model 3537 Personal Therapy Manager. FCC ID: LF53537 This 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 any interference 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 is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device. 4 English 3537 2012-09 M943580A002 Rev X 2012-09 Filename Date Time UC2001xxxx EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential PTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fm Template version: 08-08-2011 Table of contents Description 7 Package contents 7 About this manual 7 Instructions for use 8 Setting up the controller 8 Pairing the controller to the external neurostimulator 11 Pairing a new controller to an external neurostimulator 11 Pairing a previously used controller to an external neurostimulator 14 Unlocking and locking the controller 19 Unlocking the controller 19 Locking the controller 21 Turning stimulation on or off 22 Turning stimulation on 22 Turning stimulation off 23 Adjusting stimulation parameters using the Model 3575 Test Stimulation Cable 25 Increasing and decreasing amplitude on the Home screen 25 Adjusting advanced parameters 27 Adjusting stimulation parameters for the Model 3057 Test Stimulation Lead(s) 30 Increasing and decreasing amplitude on the Home screen 30 Changing the active lead (if two leads were placed) 32 Adjusting advanced parameters 33 Refer 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, patient selection, use in specific populations, resterilization, and component disposal. Refer to System Eligibility, Battery Longevity, Specifications reference manual for neurostimulator selection, battery longevity calculations, and specific neurostimulator specifications.
! USA Refer to the clinical summary booklet for information on the clinical study results of the neurostimulation system and individualization of treatment. 3537 2012-09 English 5 M943580A002 Rev X 2012-09 Filename Date Time UC2001xxxx EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential PTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fm Template version: 08-08-2011 Adjusting stimulation parameters for the Model 3093 or Model 3889 Tined Lead 37 Adjusting advanced parameters 37 Increasing and decreasing amplitude on the Home screen 41 Usage Log 42 Reset Therapy 44 Changing preferences 46 Changing the vibration settings 46 Changing the brightness of the controller display 48 Changing the time 49 Changing the date 50 Changing the number format 51 Changing the language 52 Viewing information about the controller and the external neurostimulator 54 Checking and replacing batteries 55 Checking the external neurostimulator and controller batteries 55 Replacing the controller batteries 58 Labeling the controller 59 Troubleshooting 59 Troubleshooting reference guide 60 Device specifications 65 Device care and storage 65 6 English 3537 2012-09 M943580A002 Rev X 2012-09 Filename Date Time UC2001xxxx EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential PTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fm Template version: 08-08-2011 Description The Medtronic Model 3537 Controller is a hand-held device intended for use with the Medtronic Model 3531 External Neurostimulator. The clinician uses the controller to program settings for the patient. The patient uses the controller to perform the following tasks as directed by the clinician:
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 About this manual This manual contains the information the physician needs to set up, use, and troubleshoot the controller (Figure 1).
! USA Warranty card Stimulation On/Off key Touchscreen Increase key Decrease key Figure 1. Features of the Model 3537 Controller. 3537 2012-09 English 7 M943580A002 Rev X 2012-09 Filename Date Time UC2001xxxx EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential PTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fm Template version: 08-08-2011 All information and instructions that are available to the patient are included in the Model 3537 Controller Patient Test Stimulation Programming Guide and the InterStim Patient Therapy Guide. Instructions for use
# Caution: The device is not certified for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide. The consequences of using the device near flammable atmospheres are unknown.
# Caution: Do not modify this equipment. Modification of this equipment can result in damage to the device, causing the device to malfunction or become unusable.
# Caution: Do not use the device in the proximity of equipment that generates electromagnetic interference (EMI). EMI may cause a disruption in device function. Examples of common medical sources of EMI are magnetic resonance imaging (MRI) and lithotripsy. Powerful computer monitors, cell phones, x-ray equipment, and other monitoring equipment may also generate EMI. Setting up the controller After inserting batteries into the controller, a splash screen will appear, followed by a series of steps to set up the controller. Note: After completing these setup instructions, you can change the settings at any time using the Menu. 1. Using the touchscreen, select the desired language from the options available, then press the OK button to continue (Figure 2). Slider bar Figure 2. Setting the language. Note: Use the slider bar or the Increase and Decrease keys to scroll up or down to see more languages. 2. Using the touchscreen, press the Trial button (Figure 3). 8 English 3537 2012-09 M943580A002 Rev X 2012-09 Filename Date Time UC2001xxxx EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential PTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fm Template version: 08-08-2011 Figure 3. Pressing the Trial button. 3. To change the date, the month, or the year, press the touchscreen button with the incorrect value, 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). Date Month Year Figure 4. Setting the date. 4. To change the hour, the minute, or the time format, press the touchscreen button with the incorrect value, then use the Increase and Decrease keys to change the value. Once the hour, minute, and time format are set correctly, press the OK button to continue
(Figure 5). 3537 2012-09 English 9 M943580A002 Rev X 2012-09 Filename Date Time UC2001xxxx EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential PTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fm Template version: 08-08-2011 AM/PM format 24-hour format 5. Using the touchscreen, press the radio button next to the desired number format for the controller, then press the OK button to continue (Figure 6). Figure 5. Setting the time. Figure 6. Selecting the number format. 10 English 3537 2012-09 M943580A002 Rev X 2012-09 Filename Date Time UC2001xxxx EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential PTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fm Template version: 08-08-2011 Pairing the controller to the external neurostimulator To ensure correct pairing between the controller and the external neurostimulator, consider the following recommendations:
Ensure that the controller that you provide to the patient is paired with the patient's external neurostimulator. Ask the patient to bring his or her controller to all follow-up appointments. Use this same controller during any clinician programming. This will help to avoid pairing the external neurostimulator with multiple controllers. If the external neurostimulator is paired with a new controller, the connection to the previous controller will need to be re-established before the previous controller can be used with the external neurostimulator again. Pairing a new controller to an external neurostimulator Note: Ensure you have the external neurostimulator serial number available. You will need to confirm this information during the pairing procedure. The serial number is located on the back of the external neurostimulator. 1. Press and hold the ENS button for one second to place the external neurostimulator into discovery mode (Figure 7). The light on the external neurostimulator will repeatedly blink for 90 seconds, or until the external neurostimulator has paired with a controller. Light-emitting diode (LED) ENS button Output jack Figure 7. Turn on the external neurostimulator. 2. Press the Continue button on the controller touchscreen (Figure 8). The controller will look for the external neurostimulator (Figure 9). 3537 2012-09 English 11 M943580A002 Rev X 2012-09 Filename Date Time UC2001xxxx EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential PTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fm Template version: 08-08-2011 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 number printed on the back of the external neurostimulator. 12 English 3537 2012-09 M943580A002 Rev X 2012-09 Filename Date Time UC2001xxxx EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential PTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fm Template version: 08-08-2011 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 press the 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 OK button to continue. 3537 2012-09 English 13 M943580A002 Rev X 2012-09 Filename Date Time UC2001xxxx EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential PTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fm Template version: 08-08-2011 Figure 12. Confirming that the devices are paired. Note: If there is a connection problem, a screen will appear (Figure 13). Check all connections between the lead and the external neurostimulator, and press the Recheck button. Figure 13. Screen prompt to check connections. Pairing a previously used controller to an external neurostimulator When turned on, the previously used controller will automatically attempt to connect to the external neurostimulator with which it was previously paired. 1. When the controller fails to pair with the previously used external neurostimulator, a screen appears (Figure 14). Press the Menu button in the top right corner of the touchscreen. 14 English 3537 2012-09 M943580A002 Rev X 2012-09 Filename Date Time UC2001xxxx EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential PTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fm Template version: 08-08-2011 Menu button 2. Press the Enter Code button (Figure 15). Figure 14. Pressing the Menu button. Figure 15. Pressing the Enter Code button. 3. Enter the four-digit code by pressing the number buttons on the touchscreen keypad, then press 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 entire code, then re-enter the correct code. 3537 2012-09 English 15 M943580A002 Rev X 2012-09 Filename Date Time UC2001xxxx EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential PTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fm Template version: 08-08-2011 To cancel code entry, press the Exit button (
) to exit and return to the previous screen. Confirm button Undo button Exit button Keypad 4. From the Menu, select the Pair Device button (Figure 17). Figure 16. Entering the Menu code. Exit button Slider bar Figure 17. Selecting the Pair Device button. 16 English 3537 2012-09 M943580A002 Rev X 2012-09 Filename Date Time UC2001xxxx EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential PTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fm Template version: 08-08-2011 5. Press and hold the ENS button on the external neurostimulator for one second to place the external neurostimulator into discovery mode. The light on the external neurostimulator will 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 will look 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 number printed on the back of the external neurostimulator. 3537 2012-09 English 17 M943580A002 Rev X 2012-09 Filename Date Time UC2001xxxx EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential PTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fm Template version: 08-08-2011 Figure 20. Selecting the correct device from the list. Notes:
If the controller fails to pair with the external neurostimulator, repeat step 5 and press the 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 all connections between the lead and the external neurostimulator, and press the Recheck button. 18 English 3537 2012-09 M943580A002 Rev X 2012-09 Filename Date Time UC2001xxxx EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential PTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fm Template version: 08-08-2011 Figure 22. Screen prompt to check connections. Unlocking and locking the controller Unlocking the controller To 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 option to 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 19 M943580A002 Rev X 2012-09 Filename Date Time UC2001xxxx EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential PTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fm Template version: 08-08-2011 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). The controller 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 2012-09 M943580A002 Rev X 2012-09 Filename Date Time UC2001xxxx EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential PTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fm Template version: 08-08-2011 Battery status button Lock button Menu button Stimulation value button If the Home screen does not appear, see "Troubleshooting" on page 59. Figure 26. The Home screen. Locking the controller The controller can be locked so that when buttons or keys are accidentally pressed there will not be an unexpected change in stimulation. Note: The controller screen will dim after 15 seconds of inactivity, and will automatically lock itself 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 21 M943580A002 Rev X 2012-09 Filename Date Time UC2001xxxx EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential PTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fm Template version: 08-08-2011 Lock button Figure 27. Pressing the Lock button. Turning stimulation on or off Note: You can turn stimulation on or off at any time. Turning stimulation on 1. 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 turn stimulation on. 2. A screen appears with the option to turn stimulation on. Press the Stimulation On button to turn stimulation on (Figure 28). Notes:
To make no change to stimulation and access the Home screen, press the Go To Unlock button and unlock the controller. To keep stimulation off and continue to the Home screen, press the Stimulation Off button. Press the Exit button to lock the controller again. 22 English 3537 2012-09 M943580A002 Rev X 2012-09 Filename Date Time UC2001xxxx EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential PTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fm Template version: 08-08-2011 3. A confirmation screen will appear (Figure 29). Press the OK button to continue to the Home screen. Figure 28. Turning stimulation on. Figure 29. Stimulation turned on. Turning stimulation off 1. 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 button to turn stimulation off (Figure 30). 3537 2012-09 English 23 M943580A002 Rev X 2012-09 Filename Date Time UC2001xxxx EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential PTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fm Template version: 08-08-2011 Notes:
To make no change to stimulation and lock the controller, press the Lock Controller button. 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 off immediately, 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 Home screen. Figure 31. Stimulation turned off. 24 English 3537 2012-09 M943580A002 Rev X 2012-09 Filename Date Time UC2001xxxx EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential PTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fm Template version: 08-08-2011 Adjusting stimulation parameters using the Model 3575 Test Stimulation Cable Notes:
Before programming, ensure all connections are secure between the external neurostimulator 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 screen When using the test stimulation cable, the external neurostimulator uses the following default settings:
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, pulse width, 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 button 2. Press the Turn On button to turn stimulation on and continue (Figure 33). Figure 32. Pressing the Stimulation value button. 3537 2012-09 English 25 M943580A002 Rev X 2012-09 Filename Date Time UC2001xxxx EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential PTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fm Template version: 08-08-2011 Note: To cancel and go back to the Home screen, press the OK button. 3. Use the Increase and Decrease keys to adjust amplitude (Figure 34). Figure 33. Pressing the Turn On button. Figure 34. Adjusting amplitude. 26 English 3537 2012-09 M943580A002 Rev X 2012-09 Filename Date Time UC2001xxxx EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential PTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fm Template version: 08-08-2011 Note: Press and release the Increase or Decrease key once to change the parameter value by 0.1 milliamps. Press and hold to change the parameter value in 0.5-milliamp increments. 4. To adjust pulse width and rate, refer to "Adjusting advanced parameters". Adjusting advanced parameters 1. From the Home screen, press the Menu button in the top right corner of the touchscreen
(Figure 35). Menu button 2. Press the Enter Code button (Figure 36). Figure 35. Pressing the Menu button. 3537 2012-09 English 27 M943580A002 Rev X 2012-09 Filename Date Time UC2001xxxx EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential PTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fm Template version: 08-08-2011 Figure 36. Pressing the Enter Code button. 3. Enter the four-digit code by pressing the number buttons on the touchscreen keypad, then press 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 entire code, then re-enter the correct code. To cancel code entry, press the Exit button (
) to exit and return to the previous screen. Confirm button Undo button Exit button Keypad Figure 37. Entering the Menu code. 28 English 3537 2012-09 M943580A002 Rev X 2012-09 Filename Date Time UC2001xxxx EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential PTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fm Template version: 08-08-2011 4. Select the Therapy button from the Menu (Figure 38). Exit button Slider bar 5. Adjust the amplitude, pulse width, and rate (Figure 39). Figure 38. Selecting the Therapy button. Exit button Amplitude button Pulse width button Rate button Figure 39. Adjusting amplitude, pulse width, and rate. a. To change the amplitude, press the Amplitude button, then use the Increase and Decrease keys to adjust the amplitude parameter. 3537 2012-09 English 29 M943580A002 Rev X 2012-09 Filename Date Time UC2001xxxx EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential PTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fm Template version: 08-08-2011 Note: Press and release the Increase or Decrease key to change the parameter value by 0.1 milliamps. Press and hold to change the parameter value in 0.5-milliamp increments. b. To change the pulse width, press the Pulse width button, then use the Increase and Decrease keys to adjust the pulse width parameter. Note: Press and release the Increase or Decrease key to change the parameter value by 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 keys to 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 quickly adjust 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 stimulation parameters for the Model 3057 Test Stimulation Lead(s)" on page 30. If using the Model 3093 or Model 3889 Tined Lead, refer to "Adjusting stimulation parameters for the Model 3093 or Model 3889 Tined Lead" on page 37. Adjusting stimulation parameters for the Model 3057 Test Stimulation Lead(s) Notes:
Before programming, ensure all connections are secure between the external neurostimulator and the lead(s). For instructions on intraoperative test stimulation, refer to the appropriate lead manual. Increasing and decreasing amplitude on the Home screen When using the test stimulation lead, the external neurostimulator uses the following default settings:
The test stimulation lead is the cathode (-). If the Model 3676 Cable is used, the ground pad is the anode (+). If the Model 3579 Cable is 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, pulse width, 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 value button on that side. 30 English 3537 2012-09 M943580A002 Rev X 2012-09 Filename Date Time UC2001xxxx EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential PTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fm Template version: 08-08-2011 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 be available. If stimulation is already on, the Stimulation value button will be outlined in green. If this 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 31 M943580A002 Rev X 2012-09 Filename Date Time UC2001xxxx EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential PTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fm Template version: 08-08-2011 3. A confirmation screen will appear (Figure 42). Press the OK button to continue to the Home screen. 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 parameter value by 0.1 milliamps. Press and hold to change the parameter value in 0.5-milliamp increments. 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 to the inactive lead. 2. Press the Yes button to continue (Figure 43). 32 English 3537 2012-09 M943580A002 Rev X 2012-09 Filename Date Time UC2001xxxx EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential PTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fm Template version: 08-08-2011 3. Press the Yes button to confirm changing sides. Figure 43. Confirming change of therapy side. Note: Pressing the No button cancels the change and continues stimulation on the same side. 4. The active lead will change, and stimulation will be set to zero. Use the Increase/Decrease key to adjust stimulation (see "Increasing and decreasing amplitude on the Home screen"
on page 30). Adjusting advanced parameters 1. From the Home screen, press the Menu button in the top right corner of the touchscreen
(Figure 44). 3537 2012-09 English 33 M943580A002 Rev X 2012-09 Filename Date Time UC2001xxxx EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential PTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fm Template version: 08-08-2011 Menu button 2. Press the Enter Code button (Figure 36). Figure 44. Pressing Menu button. Figure 45. Pressing the Enter Code button. 3. Enter the four-digit code by pressing the number buttons on the touchscreen keypad, then press 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 entire code, then re-enter the correct code. 34 English 3537 2012-09 M943580A002 Rev X 2012-09 Filename Date Time UC2001xxxx EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential PTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fm Template version: 08-08-2011 To cancel code entry, press the Exit button (
) to exit and return to the previous screen. Confirm button Undo button Exit button Keypad 4. Select the Therapy button from the Menu (Figure 47). Figure 46. Entering the Menu code. Exit button Slider bar 5. Adjust the amplitude, pulse width, and rate (Figure 48). Figure 47. Selecting the Therapy button. 3537 2012-09 English 35 M943580A002 Rev X 2012-09 Filename Date Time UC2001xxxx EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential PTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fm Template version: 08-08-2011 Lead II button Lead I button Exit button Amplitude button Pulse width button Rate button Figure 48. Adjusting amplitude, pulse width, and rate. a. To change the amplitude, press the Amplitude button, then use the Increase and Decrease keys to adjust the amplitude parameter. Note: Press and release the Increase or Decrease key to change the parameter value by 0.1 milliamps. Press and hold to change the parameter value in 0.5-milliamp increments. b. To change the pulse width, press the Pulse width button, then use the Increase and Decrease keys to adjust the pulse width parameter. Note: Press and release the Increase or Decrease key to change the parameter value by 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 keys to 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 the parameter. 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.
) at the top right corner of the touchscreen to exit. 7. Press the Exit button (
8. When programming is finished, press the Lock button to lock the controller before giving the controller to the patient ("Locking the controller" on page 21). 36 English 3537 2012-09 M943580A002 Rev X 2012-09 Filename Date Time UC2001xxxx EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential PTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fm Template version: 08-08-2011 Adjusting stimulation parameters for the Model 3093 or Model 3889 Tined Lead Notes:
Before programming, ensure all connections are secure between the external neurostimulator and the lead. For instructions on intraoperative test stimulation, refer to the appropriate lead manual. Adjusting advanced parameters When using a Model 3093 or Model 3889 Tined Lead for test stimulation, advanced settings must 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 button 2. Press the Clinician Mode button (Figure 50). Figure 49. Pressing the Menu button. 3537 2012-09 English 37 M943580A002 Rev X 2012-09 Filename Date Time UC2001xxxx EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential PTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fm Template version: 08-08-2011 3. Press the Enter Code button (Figure 51). Figure 50. Pressing the Clinician Mode button. Figure 51. Pressing the Enter Code button. 4. Enter the four-digit code by pressing the number buttons on the touchscreen keypad, then press 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 entire code, 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 2012-09 M943580A002 Rev X 2012-09 Filename Date Time UC2001xxxx EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential PTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fm Template version: 08-08-2011 Confirm button Undo button Exit button Keypad 5. Select the Therapy button from the Menu (Figure 53). Figure 52. Entering the Menu code. Exit button Slider bar Figure 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 (no polarity), plus (positive), or minus (negative). 3537 2012-09 English 39 M943580A002 Rev X 2012-09 Filename Date Time UC2001xxxx EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential PTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fm Template version: 08-08-2011 b. To apply stimulation, there must be at least one positive electrode and one negative electrode. One can exit the screen if all electrodes are blank, but stimulation will not be turned on. c. Adjusting the electrode configuration automatically sets the amplitude to zero. Adjust the amplitude parameter again to the desired value. 7. Adjust the amplitude, pulse width, and rate (Figure 54). Program II button Program III button Program I button Electrode buttons Amplitude button Pulse width button Rate button Figure 54. Adjusting electrode configuration, amplitude, pulse width, and rate. a. To change the amplitude, press the Amplitude button, then use the Increase and Decrease keys to adjust the amplitude parameter. Note: Press and release the Increase or Decrease key to change the parameter value by 0.1 milliamps. Press and hold to change the parameter value in 0.5-milliamp increments. b. To change the pulse width, press the Pulse width button, then use the Increase and Decrease keys to adjust the pulse width parameter. Note: Press and release the Increase or Decrease key to change the parameter value by 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 keys to 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 the parameter. 8. If using multiple programs, ensure that stimulation parameters and electrode configurations are reviewed and adjusted for all programs. a. Press the Program I, Program II, or Program III button at the top of the screen to alternate between programs. 40 English 3537 2012-09 M943580A002 Rev X 2012-09 Filename Date Time UC2001xxxx EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential PTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fm Template version: 08-08-2011 b. Repeat step 6 through step 7 to review and adjust electrode configurations as desired. 9. When programming is finished, press the Exit button (
screen to exit to the Menu.
) at the top right corner of the Increasing and decreasing amplitude on the Home screen When using a Model 3093 or Model 3889 Tined Lead for test stimulation, advanced settings must 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 button Figure 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 41 M943580A002 Rev X 2012-09 Filename Date Time UC2001xxxx EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential PTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fm Template version: 08-08-2011 3. Use the Increase and Decrease keys to adjust amplitude. Figure 56. Pressing the Turn On button. Note: Press and release the Increase or Decrease key once to change the parameter value by 0.1 milliamps. Press and hold to change the parameter value in 0.5-milliamp increments. 4. To adjust pulse width, rate, and electrode configuration, refer to "Adjusting advanced parameters". 5. When programming is finished, press the Lock button to lock the controller before giving the controller to the patient ("Locking the controller" on page 21). Usage Log The Usage Log contains data on the patient test stimulation period, shown as a bar graph. The graph displays an approximate timeline of stimulation turned on or off. The graph is shaded in sections representing time when stimulation was on, and blank in sections representing time when 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 2012-09 M943580A002 Rev X 2012-09 Filename Date Time UC2001xxxx EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential PTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fm Template version: 08-08-2011 Exit button Slider bar Figure 57. Pressing the Usage button. 2. The Usage bar shows when stimulation was on or off. When stimulation was on, the Usage bar is lighter. When stimulation was off, the Usage bar is darker. Exit button Notification button Usage bar Day buttons Note: Scroll down using the touchscreen slider bar to see more days. Figure 58. The Usage Log screen. 3537 2012-09 English 43 M943580A002 Rev X 2012-09 Filename Date Time UC2001xxxx EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential PTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fm Template version: 08-08-2011 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 to the patient changing lead sides, changing programs, and turning stimulation on or off
(Figure 59). Exit button Slider bar Figure 59. Example of a Usage log notification. Note: It is possible for the amplitude is set to zero while stimulation is on. Reset Therapy The Reset Therapy function allows you to set all stimulation settings to their default values for any and all programs. 1. From the Menu, press the Reset Therapy button (Figure 60). 44 English 3537 2012-09 M943580A002 Rev X 2012-09 Filename Date Time UC2001xxxx EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential PTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fm Template version: 08-08-2011 Exit button Slider bar Figure 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 stimulation settings. If the reset was successful, a confirmation screen will appear (Figure 62). Press the OK button to continue to the Home screen. 3. 3537 2012-09 English 45 M943580A002 Rev X 2012-09 Filename Date Time UC2001xxxx EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential PTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fm Template version: 08-08-2011 Figure 62. Therapy Reset successful screen. Note: If the reset was not successful, a warning screen appears (Figure 63). If this screen appears, check all lead and cable connections, press the OK button, and repeat steps 1 through 3 to try again. Figure 63. Therapy Reset Failed warning screen. Changing preferences Note: In the Menu, use the touchscreen slider bar to view all options (Figure 64). Changing the vibration settings 1. Select the Vibration button from the Menu (Figure 64). 46 English 3537 2012-09 M943580A002 Rev X 2012-09 Filename Date Time UC2001xxxx EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential PTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fm Template version: 08-08-2011 Exit button Slider bar Figure 64. Selecting the Vibration button. 2. To change vibration settings using the touchscreen, press either the No vibration button or the Vibration button (Figure 65). No vibration button vibration button Figure 65. Changing the vibration settings on the controller. 3. Press the OK button to exit. 3537 2012-09 English 47 M943580A002 Rev X 2012-09 Filename Date Time UC2001xxxx EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential PTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fm Template version: 08-08-2011 Changing the brightness of the controller display 1. Select the Brightness button from the Menu (Figure 66). Exit button Slider bar Figure 66. Selecting the Brightness button. 2. Using the touchscreen, press the radio button below the desired brightness level
(Figure 67). Dimmest Brightest Figure 67. Changing the brightness of the controller screen. 3. Press the OK button to exit. 48 English 3537 2012-09 M943580A002 Rev X 2012-09 Filename Date Time UC2001xxxx EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential PTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fm Template version: 08-08-2011 Changing the time 1. Select the Time button from the Menu (Figure 68). Exit button Slider bar Figure 68. Selecting the Time button. 2. To change the hour, the minute, or the time format, press the touchscreen button with the incorrect value, then use the Increase and Decrease keys to change the value. Once the hour, minute, and time format are set correctly, press the OK button to exit (Figure 69). 3537 2012-09 English 49 M943580A002 Rev X 2012-09 Filename Date Time UC2001xxxx EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential PTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fm Template version: 08-08-2011 AM/PM format 24-hour format Figure 69. Changing the time on the controller. Changing the date 1. Select the Date button from the Menu (Figure 70). 50 English 3537 2012-09 M943580A002 Rev X 2012-09 Filename Date Time UC2001xxxx EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential PTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fm Template version: 08-08-2011 Exit button Slider bar Figure 70. Selecting the Date button. 2. To change the date, the month, or the year, press the touchscreen button with the incorrect value, 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). Date Month Year Figure 71. Changing the date on the controller. Changing the number format 1. Select the Numbers button from the Menu (Figure 72). 3537 2012-09 English 51 M943580A002 Rev X 2012-09 Filename Date Time UC2001xxxx EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential PTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fm Template version: 08-08-2011 Exit button Slider bar Figure 72. Selecting the Numbers button. 2. Using the touchscreen, press the radio button next to the desired number format for the controller, then press the OK button to exit (Figure 73). Figure 73. Changing the number format of the controller. Changing the language 1. Select the Language button from the Menu (Figure 74). 52 English 3537 2012-09 M943580A002 Rev X 2012-09 Filename Date Time UC2001xxxx EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential PTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fm Template version: 08-08-2011 Exit button Slider bar Figure 74. Selecting the Language button. 2. Using the touchscreen, select the desired language from the options available, then press the OK button to exit (Figure 75). Slider bar Figure 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 53 M943580A002 Rev X 2012-09 Filename Date Time UC2001xxxx EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential PTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fm Template version: 08-08-2011 Viewing information about the controller and the external neurostimulator 1. To view information about the controller or the external neurostimulator, use the touchscreen to select the About button from the Menu (Figure 76). Exit button Slider bar Figure 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 2012-09 M943580A002 Rev X 2012-09 Filename Date Time UC2001xxxx EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential PTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fm Template version: 08-08-2011 Toggle button Figure 77. The About screen. Checking and replacing batteries Always keep 2 new AA alkaline batteries available for replacement. Checking the external neurostimulator and controller batteries Note: You can see the battery levels of the controller and the external neurostimulator at the top of the Home screen (Figure 78). For more detailed information on battery levels, follow the steps below. Table 1 lists several examples of external neurostimulator battery levels and whether action is required. Table 1. Battery level definitions for the external neurostimulator External neurostimulator battery icon is green. Battery level 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 low batteries. Replace the external neurostimulator bat-
teries. 3537 2012-09 English 55 M943580A002 Rev X 2012-09 Filename Date Time UC2001xxxx EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential PTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fm Template version: 08-08-2011 Table 1. Battery level definitions for the external neurostimulator External neurostimulator battery icon is red. Stimula-
tion may no longer be available. Do not send a pa-
tient home with low batteries. Replace the external neurostimulator batteries. Table 2 lists several examples of controller battery levels and whether action is required. Table 2. Battery level definitions for the controller Controller battery icon is green. Battery level is full. No action is needed. Controller battery icon is green. Battery level is half full. No action is needed. Controller battery icon is orange. The controller bat-
teries are low. Consider changing controller batteries soon. Controller battery icon is red. The controller batteries are 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 the controller batteries. 1. From the Therapy Home screen, press the Battery status button (Figure 78). 56 English 3537 2012-09 M943580A002 Rev X 2012-09 Filename Date Time UC2001xxxx EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential PTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fm Template version: 08-08-2011 Battery status button Figure 78. Viewing the battery status on the Home screen. Note: Two battery icons are displayed (Figure 79). The upper battery icon shows the battery status of the controller. The lower battery icon shows the battery status of the external neurostimulator. Controller battery status External neurostimulator battery status 2. Press the Exit button (
) at the top right corner of the touchscreen to exit. Figure 79. Viewing the detailed battery status. 3537 2012-09 English 57 M943580A002 Rev X 2012-09 Filename Date Time UC2001xxxx EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential PTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fm Template version: 08-08-2011 Replacing the controller batteries Notes:
For information on replacing the external neurostimulator batteries, refer to the Model 3531 External Neurostimulator Technical Manual. If not using the controller for an extended period of time, remove the batteries from the controller 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 2012-09 M943580A002 Rev X 2012-09 Filename Date Time UC2001xxxx EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential PTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fm Template version: 08-08-2011 Figure 81. Inserting new batteries. 4. Close the battery compartment cover. 5. Dispose of old batteries according to local requirements. Labeling the controller Write your clinic contact information on an identification label and place the label on the back of the controller so the controller can be returned if lost (Figure 82). ID label Figure 82. Place the adhesive label on the back of the controller. Troubleshooting This section lists basic troubleshooting for the controller. 3537 2012-09 English 59 M943580A002 Rev X 2012-09 Filename Date Time UC2001xxxx EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential PTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fm Template version: 08-08-2011 The controller displays three different types of screens: warning screens, alert screens, and notification screens. These screens provide you with information about your system, alert you to 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 guide Message System Problem Cannot continue. Please call your clinician. 2. Table 3. Warning messages Explanation and Solution Explanation: The system is not working correctly. Stimula-
tion may have stopped. 1. Remove and reinsert the controller batteries, then retry the action that caused the error screen to ap-
pear. For instructions on removing and inserting the controller batteries, refer to "Checking and replac-
ing batteries" on page 55. If the issue persists, remove and reinsert the exter-
nal neurostimulator batteries, then retry the action that caused the error screen to appear. For instruc-
tions on removing and inserting external neurosti-
mulator batteries, refer to the manual packaged with the external neurostimulator. If the issue persists and if using the Model 3093/3889 Lead, remove all electrode configurations by setting all electrodes to blank for all programs, then repro-
gram electrode configurations and retry the action that caused the error screen to appear. For instruc-
tions on programming electrodes, refer to "Adjust-
ing stimulation parameters for the Model 3093 or Model 3889 Tined Lead" on page 37. If the steps above do not resolve the issue, the ex-
ternal neurostimulator and/or controller need to be replaced. 3. 4. 60 English 3537 2012-09 M943580A002 Rev X 2012-09 Filename Date Time UC2001xxxx EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential PTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fm Template version: 08-08-2011 Message Software Problem Cannot continue. Please call your clinician. Button Jammed Cannot provide stimulation. Release the external device button. Batteries Empty (external device) External device batteries need to be changed. Call your clinician. Battery Empty (controller) Cannot continue. Replace the controller batteries. Change External Device Cannot provide stimulation. Call your clinician. Table 3. Warning messages Explanation and Solution Explanation: The software is not working correctly. Stimu-
lation may have stopped. 1. Remove and reinsert the controller batteries, then retry the action that caused the error screen to ap-
pear. For instructions on removing and inserting the controller batteries, refer to "Checking and replac-
ing batteries". If the issue persists, replace the controller and refer to "Pairing a new controller to an external neurosti-
mulator" for instructions on pairing the new control-
ler to the external neurostimulator. 2. Explanation: The ENS button on the external neurostimu-
lator is stuck in the pressed position. Solution: Press and release the ENS button, then press the OK button. If the problem persists, the external neurostimulator may need to be replaced. Explanation: The external neurostimulator batteries are depleted and stimulation is not available. Solution: Replace the external neurostimulator batter-
ies. For more information on replacing the external neurostimulator batteries, refer to the Model 3531 Ex-
ternal Neurostimulator Technical Manual. 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. Explanation: The external neurostimulator has reached the end of service. This is related to device function, not to battery level. This external neurostimulator can no longer provide stimulation. Solution: Replace the external neurostimulator. 3537 2012-09 English 61 M943580A002 Rev X 2012-09 Filename Date Time UC2001xxxx EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential PTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fm Template version: 08-08-2011 Table 4. Alert messages Explanation Explanation: The controller cannot find the paired external neurostimulator. The external neurostimulator may be out of range or the external neurostimulator batteries may be depleted. Solution: Move the controller closer to the external neurostimulator and make sure your hand is not cov-
ering the top of the controller, then press the Try Again button. If the issue persists, the external neurostimulator bat-
teries may need to be replaced. For instructions on re-
placing the external neurostimulator batteries, see the appropriate technical manual packaged with the exter-
nal neurostimulator. Explanation: The external neurostimulator is nearing the end of service. Stimulation will not be available soon. Solution: Replace the external neurostimulator. Explanation: The external neurostimulator batteries are low and stimulation will not be available soon. Solution: Replace the external neurostimulator batter-
ies. For more information on replacing the external neurostimulator batteries, refer to the Model 3531 Ex-
ternal Neurostimulator Technical Manual. 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. Explanation: One or more stimulation parameters, includ-
ing electrode configuration, was left unprogrammed. Solution: Check stimulation parameters. Ensure that at least one electrode is negative and at least one elec-
trode is positive, or that all electrodes are blank. Explanation: You are attempting to connect to an incom-
patible external neurostimulator. Solution: Replace the external neurostimulator with a compatible model. Message No Device Found Try the following: Move the controller closer to the exter-
nal device. Change External Device Call your clinician. Stimulation hour(s) remaining: XX Batteries Low (external de-
vice) External device batteries need to be changed. Call your clinician. Battery Low (controller) Replace the controller batter-
ies soon. Incomplete Settings Valid electrodes configura-
tion, pulse width, and rate set-
tings required. Incompatible Device Change external device. 62 English 3537 2012-09 M943580A002 Rev X 2012-09 Filename Date Time UC2001xxxx EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential PTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fm Template version: 08-08-2011 Message Incompatible System Com-
ponent Ensure batteries and other system components are com-
patible. Connection Changed Cable or lead changed. Ther-
apy settings were reset. Check Connection Ensure all cable and lead con-
nections are secure. Table 4. Alert messages Explanation 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 need to be replaced. For instructions on replacing the con-
troller batteries, see "Checking and replacing batter-
ies". Explanation: The external neurostimulator has detected that a different cable type has been connected. Solution: Press the OK button. Stimulation parameters for the new connection need to be programmed to de-
sired settings. Explanation: The external neurostimulator has detected that either a cable or a lead is not connected. Solution: Ensure all cable and lead connections are secure. Press the OK button. Table 5. Notification messages Message Stimulation is off Settings cannot be changed with stimulation off. Upper limit Settings cannot be increased any higher. Lower limit Settings cannot be decreased any lower. Explanation and solution Explanation: You tried to adjust stimulation/therapy when stimulation/therapy was off. Solution: Turn stimulation/therapy on, then try adjust-
ing stimulation/therapy again. Explanation: You tried increasing a stimulation parameter above the highest value allowed. You can not increase the stimulation any higher. Solution: Press the OK button and consider adjusting other stimulation parameters. Explanation: You tried decreasing a stimulation parameter below the lowest value allowed. You can not decrease the amplitude below zero. Solution: Press the OK button and consider adjusting other stimulation parameters. 3537 2012-09 English 63 M943580A002 Rev X 2012-09 Filename Date Time UC2001xxxx EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential PTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fm Template version: 08-08-2011 Message Settings Not Available Cannot provide your desired settings. Call your clinician. Retry ENS Unable to find device Memory Problem Data has been lost. Repeat set-up process. Table 5. Notification messages Explanation and solution Explanation: Your combined settings can not currently be delivered 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. Explanation: The controller cannot find the paired external neurostimulator. The external neurostimulator may be out of range or the external neurostimulator batteries may be depleted. Solution: Move the controller closer to the external neurostimulator and make sure your hand is not cov-
ering the top of the controller, then press the Try Again button. 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 the appropriate 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 the external neurostimulator" on page 11 Explanation: Controller settings are not available, but tele-
metry is still available. The controller batteries may have been removed or depleted for an extended period of time. Solution: Follow the on-screen prompts to reconfigure controller settings, including pairing to the external neurostimulator. 64 English 3537 2012-09 M943580A002 Rev X 2012-09 Filename Date Time UC2001xxxx EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential PTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fm Template version: 08-08-2011 Table 6. Additional scenarios Scenario The controller is unrespon-
sive. The controller screen goes blank, then returns to the Un-
lock screen. 2. Explanation Explanation: the controller has encountered a problem and must 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. If batteries are inserted correctly, the batteries are depleted. Replace the controller batteries. For in-
structions on replacing controller batteries, see
"Replacing the controller batteries" on page 58. If the issue persists, replace the controller. 3. Explanation: The controller encountered a problem and has automatically reset. Solution: Unlock the controller. If necessary, navigate back to the screen that was in use when the controller was reset and continue the intended task. Device specifications Table 7. Model 3537 Controller specificationsa Specification Two alkaline AA batteries (nonrechargeable) 9 C to 43 C (49 F to 110 F)
-30 C to 57 C (-22 F to +135 F) 12.0 x 6.0 x 2.4 cm (4.7 x 2.4 x 0.9 in) 150 g (5.3 oz) 46 weeks average for alkaline batteries Short Parameter Power source Operating temperature Temperature limitation Controller size Controller weight, including batteries Battery life Operating time a All 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 65 M943580A002 Rev X 2012-09 Filename Date Time UC2001xxxx EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential PTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fm Template version: 08-08-2011 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 cleaners will not damage the device or labels. The battery contacts may be cleaned periodically with a cotton swab dampened with alcohol. Do not use a pencil eraser or sandpaper. Store the device at room temperature. Avoid extreme hot or cold temperatures and direct sunlight. 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 2012-09 M943580A002 Rev X 2012-09 Filename Date Time UC2001xxxx EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential PTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fm Template version: 08-08-2011 3537 2012-09 English 67 M943580A002 Rev X 2012-09 Filename Date Time UC2001xxxx EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential PTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fm Template version: 08-08-2011 Contacts:
Asia:
Medtronic International Ltd. Tel. 02919-1362 Fax 02907-3998 Medtronic Asia Ltd. Tel. (02)-548-1148 Fax (02)-518-4786 Australia:
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Medtronic France S.A.S. Tel. 01-5538-1700 Fax 01-5538-1800 Germany:
Medtronic GmbH Tel. (02159)-81490 Fax (02159)-8149100 M943580A002 Rev X 2012-09 Greece:
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Medtronic Russia Tel. (8495) 580-7377 Fax (8495) 580-7378 Slovakia Medtronic Slovakia, o.z. Tel. 0268 206 911 Fax 0268 206 999 Filename Date Time UC2001xxxx EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential PTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fm Template version: 08-08-2011 U.K.:
Medtronic U.K. Ltd. Tel. 01923-212213 Fax 01923-241004 USA:
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Medtronic B.V. Tel. (045)-566-8000 Fax (045)-566-8668 M943580A002 Rev X 2012-09 Filename Date Time UC2001xxxx EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential PTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fm Template version: 08-08-2011 Manufacturer Medtronic, Inc. 710 Medtronic Parkway Minneapolis, MN 55432-5604 USA www.medtronic.com Tel. +1-763-505-5000 Fax +1-763-505-1000 Medtronic E.C. Authorized EC REP Representative/Distributed by Medtronic B.V. Earl Bakkenstraat 10 6422 PJ Heerlen The Netherlands Tel. +31-45-566-8000 Fax +31-45-566-8668 Europe/Africa/Middle East Headquarters Medtronic International Trading Srl Route du Molliau 31 Case Postale 84 CH-1131 Tolochenaz Switzerland www.medtronic.eu Tel. +41-21-802-7000 Fax +41-21-802-7900 Asia-Pacific Medtronic International Ltd. Suite 1106-11 16/F, Tower 1, The Gateway 25 Canton Road, Tsimshatsui Kowloon Hong Kong Tel. +852-2919-1362 Fax +852-2907-3998 Contacts for specific countries are listed inside this cover.
*M943580A002*
Medtronic, Inc. 2012 All Rights Reserved M943580A002 M943580A002 Rev X 2012-09
1 | User Manual 2 | Users Manual | 2.31 MiB | July 06 2012 / April 12 2012 |
Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 01-18-2012 CONTROLLER Patient Programming Manual for Test Stimulation 3537
! USA Rx only 0123 M943578A001 Rev X 2013-3 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 01-18-2012 Medtronic and InterStim are trademarks of Medtronic, Inc., registered in the U.S. and other countries.
! USA FCC Information The following is communications regulation information on the Model 3537 Controller. FCC ID: LF597745 This 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 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 is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device. M943578A001 Rev X 2013-3 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 01-18-2012 Label symbols Explanation of symbols on products and packaging. Refer to the appropriate product to see symbols that apply. Consult instructions for use Manufacturer XX C XXX F Temperature limitation
-XX C
-XX F Serial number EC REP
! USA Conformit Europenne (European Conformity). This symbol means that the device fully complies with MDD 93/42/EEC
(NB 0123) and R&TTE Directive 1999/5/
EC. Authorized representative in the European community For USA audiences only IEC 60601-1/EN60601-1, Type BF Equipment Non-ionizing electromagnetic radiation 3537 2013-3 English M943578A001 Rev X 2013-3 l s o b m y s l e b a L 3 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 01-18-2012 System meets the applicable (CAN/CSA-
C22.2 No. 60601-1) electrical safety standard requirements. Do not dispose of this product in the unsorted municipal waste stream. Dispose of this product according to local regulations. See http://recycling.medtronic.com for instructions on proper disposal of this product. Chinese Standard (SJ/T11364-2006) Logo:
Electronic Information Products Pollution Control Symbol. (The date in this logo means the environmental protection use period of the product.) l s o b m y s l e b a L 4 English 3537 2013-3 M943578A001 Rev X 2013-3 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 01-18-2012 Table of contents Label Symbols 3 Glossary 7 1 Introduction 10 How to use this manual 10 Patient guides 11 2 Using your controller 14 How your controller works 14 Controller screen and keys 15 Unlocking and locking your controller 17 Unlocking your controller 17 Locking your controller 21 Turning your stimulation on or off 22 Turning your stimulation on 23 Turning your stimulation off 25 Adjusting stimulation 27 Switching stimulation sides (if your clinician placed two leads) 28 Changing programs (if applicable) 31 3537 2013-3 English M943578A001 Rev X 2013-3 t s t n e n o c f o l e b a T 5 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 01-18-2012 Home screen 34 Checking and replacing batteries 38 Checking the batteries (external neurostimulator and controller) 38 Replacing the batteries (controller only) 45 Using the carrying case 46 Always carry your controller 47 3 Troubleshooting 50 Controller screens 50 Warning screens 51 Alert screens 56 Notification screens 61 Possible problems and solutions 64 4 Maintenance and assistance 74 Cleaning and care 74 Safety and technical checks 75 Battery and controller disposal 75 Declaration of conformity 75 Specifications 76 Assistance for the controller 76 Index 78 English 3537 t s t n e n o c f o l e b a T 6 M943578A001 Rev X 2013-3 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 01-18-2012 Glossary Amplitude - The strength or intensity of an electrical pulse. Caution - A statement describing actions that could result in damage to or improper functioning of a device. Clinician - A healthcare professional such as a doctor or nurse. Controller - A hand-held device that allows you to turn your neurostimulator on and off and check your neurostimulator battery. It is also used to adjust some of the stimulation settings. External neurostimulator (ENS) - See Neurostimulator. Lead - A thin wire with protective coating that has metal electrodes on one end and a connector on the other. Neurostimulator - The power source of a neurostimulation system. It contains the battery and electronics that control the stimulation. 3537 2013-3 English y r a s s o G l 7 M943578A001 Rev X 2013-3 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 01-18-2012 Precaution - See Caution. Program - A specific combination of stimulation settings assigned to deliver therapy to a specific site. Settings - See Stimulation settings. Stimulation - The delivery of electrical pulses to a specific site. Stimulation settings - Refers to all the features assembled to define the stimulation you feel. The clinician programs all stimulation. You can adjust some stimulation settings within clinician-defined limits. Test stimulation - A postoperative multiday trial period of a patients reaction to stimulation using an external neurostimulator and implanted leads. Therapy - Treatment of a disease or condition. When neurostimulation therapy is prescribed, a neurostimulation system is used to deliver stimulation to a specific site. English 3537 2013-3 y r a s s o G l 8 M943578A001 Rev X 2013-3 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 01-18-2012 1 Introduction M943578A001 Rev X 2013-3 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 01-18-2012 How to use this manual Use this manual during test stimulation. Ask your clinician to explain anything that is unclear. A glossary is provided at the beginning of this manual to describe terms that may be unfamiliar to you. Chapter 1 "Introduction" describes how to use this manual, a list of patient guides, and information on your patient identification card. Chapter 2 "Using your controller" describes the controller and how to perform specific tasks, including turning your stimulation on and off, adjusting your stimulation, changing stimulation sides (if applicable), changing programs (if applicable), and checking and replacing batteries. This chapter also describes how to use the controller carrying case, how to label your controller, and an overall description of the Home screen. 1 n o i t c u d o r t n I 10 English 3537 2013-3 M943578A001 Rev X 2013-3 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 01-18-2012 Chapter 3 "Troubleshooting" describes controller warning and information screens, how to solve possible problems, and who to 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, as well as device specifications and user assistance. Please read this entire manual before using your controller. This manual will help you understand and use your InterStim system so you can adjust your stimulation as your needs change. Patient guides In addition to this manual, you should receive the following documents during test stimulation:
Model 3537 Patient Test Stimulation Quick Reference Card InterStim Patient Therapy Guide 3537 2013-3 English M943578A001 Rev X 2013-3 1 n o i t c u d o r t n I 11 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 01-18-2012 Note: For additional warnings, precautions, and adverse events related to InterStim Therapy, refer to the InterStim Patient Therapy Guide provided by your clinician. If you did not receive these documents, contact your clinician or Medtronic Patient Services. Refer to the Medtronic contacts at the end of this manual. 1 n o i t c u d o r t n I 12 English 3537 2013-3 M943578A001 Rev X 2013-3 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 01-18-2012 2 Using your controller M943578A001 Rev X 2013-3 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 01-18-2012 How your controller works The controller is used to control and monitor your external neurostimulator. You will use your controller to perform the following tasks:
Turn your stimulation on or off. Check the external neurostimulator and controller battery status. Change stimulation settings. The controller communicates wirelessly with your external neurostimulator by sending signals to and receiving signals from the external neurostimulator. Your clinician has already set up the controller according to your specific test stimulation needs. Note: Make sure to keep your controller with you at all times in the event that you need to adjust or turn your stimulation off. 2 r e l l o r t n o c r u o y i g n s U 14 English 3537 2013-3 M943578A001 Rev X 2013-3 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 01-18-2012 Controller External neurostimulator Figure 2.1 A patient using her controller. Controller screen and keys Your controller has a touchscreen, a display screen that reacts to your touch, that allows you to press buttons that are displayed on the screen. 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 of the controller. This port is not for patient use. 2 r e l l o r t n o c r u o y i g n s U 3537 2013-3 English 15 M943578A001 Rev X 2013-3 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 01-18-2012 Stimulation On/Off key Touchscreen Increase key Decrease key Figure 2.2 Controller keys. See Table 2.1 for a list of these keys and their functions. Key Table 2.1 Controller keys Function Turns stimulation on or off. Stimulation On/Off 2 r e l l o r t n o c r u o y i g n s U 16 English 3537 2013-3 M943578A001 Rev X 2013-3 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 01-18-2012 Table 2.1 Controller keys (continued) Key Increase/
Decrease Function Increases or decreases stimulation when you are on the Home screen. Press and release the Increase/
Decrease key to slowly increase or decrease the stimulation value (by 0.1). Press and hold to quickly increase or decrease the stimulation value (by 0.5). Unlocking and locking your controller Unlocking your controller When the Increase/Decrease key is pressed, the Unlock screen appears (Figure 2.3). 2 r e l l o r t n o c r u o y i g n s U 3537 2013-3 English 17 M943578A001 Rev X 2013-3 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 01-18-2012 Figure 2.3 The Unlock screen. Notes:
If the controller does not display the Unlock screen, the controller may not have been properly initiated. Call your clinician if the Unlock screen does not appear. When the controller is locked, pressing the Stimulation On/Off key will provide the option to bypass the Unlock screen and to turn stimulation on or off. 1. Press and hold the Lock button on the Unlock screen. 2 r e l l o r t n o c r u o y i g n s U 18 English 3537 2013-3 M943578A001 Rev X 2013-3 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 01-18-2012 As the Lock button is held, bars appear on the screen and move toward the Lock button (Figure 2.4). Figure 2.4 Unlocking the controller. 2. Stop pressing the screen when the screen changes to a circle of dots (Figure 2.5). The controller is searching for your external neurostimulator. 2 r e l l o r t n o c r u o y i g n s U 3537 2013-3 English 19 M943578A001 Rev X 2013-3 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 01-18-2012 Figure 2.5 The controller searching for your external neurostimulator. After unlocking the controller, the first screen you see is the Home screen
(Figure 2.6). 2 r e l l o r t n o c r u o y i g n s U 20 English 3537 2013-3 M943578A001 Rev X 2013-3 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 01-18-2012 Battery status button Lock button Menu button Stimulation value buttons Figure 2.6 The Home screen. If the Home screen does not appear, see
"Possible problems and solutions" on page 64. Locking your controller Your controller can be locked, so if buttons or keys are accidentally pressed, there will not be an unexpected change in your stimulation. Note: The controller screen will dim after 15 seconds of inactivity, and will automatically lock itself after 2 minutes of inactivity. You can 2 r e l l o r t n o c r u o y i g n s U 3537 2013-3 English 21 M943578A001 Rev X 2013-3 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 01-18-2012 also press the Lock button to lock the controller immediately. 1. From the Home screen, press the Lock button to lock the controller (Figure 2.7). Lock button Figure 2.7 Pressing the Lock button. Turning your stimulation on or off You can turn stimulation on or off at any time. Follow these steps to turn your stimulation on or off. 2 r e l l o r t n o c r u o y i g n s U 22 English 3537 2013-3 M943578A001 Rev X 2013-3 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 01-18-2012 Turning your stimulation on 1. To turn stimulation on, press the Stimulation On/Off key, which is located on the top of your controller. Note: Pressing the Stimulation value button on the Home screen also allows you to turn stimulation on. 2. Press the On button to turn stimulation on
(Figure 2.8). Note: If you do not wish to turn stimulation on or off, but want to access the Home screen, press the Go To Unlock button and unlock your controller. 2 r e l l o r t n o c r u o y i g n s U 3537 2013-3 English 23 M943578A001 Rev X 2013-3 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 01-18-2012 Figure 2.8 Turning stimulation on. 3. A confirmation screen will appear
(Figure 2.9). Press the OK button to continue to the Home screen. 2 r e l l o r t n o c r u o y i g n s U Figure 2.9 Stimulation turned on. 24 English 3537 2013-3 M943578A001 Rev X 2013-3 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 01-18-2012 Turning your stimulation off 1. To turn stimulation off, press the Stimulation On/Off key, which is located on 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, but instead wish to access the Home screen, press the Go To Unlock button and unlock your controller. 2 r e l l o r t n o c r u o y i g n s U 3537 2013-3 English 25 M943578A001 Rev X 2013-3 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 01-18-2012 Note: If your controller was already on, you will instead have the option to lock the controller. Note: If stimulation is uncomfortable and you need to turn off your stimulation immediately, but your controller is unavailable or not responding, press and hold the ENS button on the external neurostimulator for 3 seconds
(Figure 2.11). ENS button Figure 2.11 The ENS button on the external neurostimulator. 2 r e l l o r t n o c r u o y i g n s U 26 English 3537 2013-3 M943578A001 Rev X 2013-3 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 01-18-2012 4. A confirmation screen will appear
(Figure 2.12). Press the OK button to continue to the Home screen. Figure 2.12 Stimulation turned off. Adjusting stimulation Notes:
Stimulation needs to be turned on before adjusting your stimulation. If stimulation is not on, see "Turning your stimulation on or off" on page 22. Every time you turn your stimulation on, the stimulation value starts at zero. 2 r e l l o r t n o c r u o y i g n s U 3537 2013-3 English 27 M943578A001 Rev X 2013-3 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 01-18-2012 1. From the Home screen, press the Increase or Decrease key to adjust your stimulation as advised by your clinician. Press and release the Increase/
Decrease key to slowly increase or decrease stimulation (by 0.1). Press and hold to quickly increase or decrease stimulation (by 0.5). Note: When you press and hold the Increase key, stimulation will continue to quickly increase until you release the button. 2. When finished adjusting stimulation, press
) to lock the controller. the Lock button (
Switching stimulation sides (if your clinician placed two leads) Notes:
Instructions on when to switch stimulation sides are provided by your clinician. 2 r e l l o r t n o c r u o y i g n s U 28 English 3537 2013-3 M943578A001 Rev X 2013-3 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 01-18-2012 If your clinician placed only one lead, switching stimulation sides will not be available. Figure 2.13 shows what your Home screen looks like if you have one lead, and what your Home screen looks like if you have two leads. One lead Two leads Figure 2.13 Home screens for one lead and for two leads. Follow these steps to switch stimulation sides:
1. Press the Stimulation value button on the inactive side of the Home screen. A screen 2 r e l l o r t n o c r u o y i g n s U 3537 2013-3 English 29 M943578A001 Rev X 2013-3 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 01-18-2012 will appear asking you to confirm that you wish to change stimulation sides
(Figure 2.14). Figure 2.14 Confirming switch of stimulation sides. 2. Press the Yes button to confirm switching stimulation sides. Note: Pressing the No button cancels the change and continues stimulation on the same side. 3. Your stimulation will switch sides, and the amplitude will be set to zero. Use the Increase/Decrease key to adjust 2 r e l l o r t n o c r u o y i g n s U 30 English 3537 2013-3 M943578A001 Rev X 2013-3 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 01-18-2012 stimulation (see "Adjusting stimulation" on page 27). Changing programs (if applicable) Notes:
Instructions on when to change programs, and which program to select, are provided by your clinician. Depending on how your clinician set up your system, you may not be able to change programs. 1. Press the Menu button (
) in the top right corner of the Home screen. A screen appears with two buttons: Programs and Clinician Mode (Figure 2.15). 2 r e l l o r t n o c r u o y i g n s U 3537 2013-3 English 31 M943578A001 Rev X 2013-3 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 01-18-2012 Figure 2.15 The Patient menu. Note: If your screen does not look like Figure 2.15 but instead asks you to enter a code, then your clinician has set up your system so that changing programs is not available. Press the Exit button to go back to the Menu, and then press the Exit button again to go back to the Home screen. 2. Press the Programs button. A screen appears with three buttons: Program I, Program II, and Program III (Figure 2.16). The button outlined in green represents the program that is currently active. 2 r e l l o r t n o c r u o y i g n s U 32 English 3537 2013-3 M943578A001 Rev X 2013-3 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 01-18-2012 Note: If only one program is available, your clinician set up your system so that changing programs is not possible. Press the Exit button to return to the Menu. Press the Exit button again to return to the Home screen. Figure 2.16 Selecting a program. Note: Your system may have been set up so that one or more programs is not available. Available program buttons become highlighted in green when they are pressed. 3. Select an available program as instructed by your clinician. 2 r e l l o r t n o c r u o y i g n s U 3537 2013-3 English 33 M943578A001 Rev X 2013-3 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 01-18-2012 Note: After switching programs, amplitude automatically decreases to zero. 4. Press the Exit button (
Menu. 5. Press the Exit button (
Home screen.
) to return to the
) to return to the 6. Adjust stimulation as advised by your clinician. See "Adjusting stimulation" on page 27. Home screen The Home screen is the first screen to appear after unlocking your controller. The Home screen provides an overview of your stimulation settings (Figure 2.17). Note: Your Home screen may look slightly different than the one shown. 2 r e l l o r t n o c r u o y i g n s U 34 English 3537 2013-3 M943578A001 Rev X 2013-3 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 01-18-2012 Battery status button Lock button Menu button Stimulation value buttons Figure 2.17 The Home screen. Information on the Home screen is split into two sides: the Left side and the Right side. Note: It is normal for some patients to be able to adjust only the left side or only the right side. This means you have only one lead placed for test stimulation instead of two leads. The buttons at the top of the Home screen allow you to perform the following tasks:
Check the battery status of the controller. 2 r e l l o r t n o c r u o y i g n s U 3537 2013-3 English 35 M943578A001 Rev X 2013-3 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 01-18-2012 Check the battery status of the external neurostimulator. Lock the controller. Access the Programs screen. Note: Whether you can access the Programs screen depends on how your clinician set up your test stimulation system. Discuss this with your clinician. Refer to Table 2.2 for more information on these buttons. Table 2.2 Home screen buttons Description Battery status button The left icon on this button displays the controller battery status. The right icon on this button displays the external neurostimulator battery status. Press this button to check the battery status in detail. For more information on checking batteries, see "Checking and replacing batteries" on page 38. Icons 2 r e l l o r t n o c r u o y i g n s U 36 English 3537 2013-3 M943578A001 Rev X 2013-3 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 01-18-2012 Table 2.2 Home screen buttons (continued) Icons Description Lock button Press this button to lock the controller. Menu button Press this button to access the Patient menu (if applicable). The body figure at the center of the Home screen indicates which side is receiving stimulation (if two leads were placed). The number shown in the Stimulation value button is the amplitude of that stimulation
(Figure 2.18). 2 r e l l o r t n o c r u o y i g n s U 3537 2013-3 English 37 M943578A001 Rev X 2013-3 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 01-18-2012 Battery status button Lock button Menu button Stimulation value buttons Figure 2.18 The Home screen. Checking and replacing batteries Checking the batteries (external neurostimulator and controller) Check the status of the batteries in your external neurostimulator and your controller every day. You can check the status of the batteries at any time. 2 r e l l o r t n o c r u o y i g n s U 38 English 3537 2013-3 M943578A001 Rev X 2013-3 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 01-18-2012 Note: The battery levels of the controller and the external neurostimulator are shown on the Battery status button on the Home screen
(Figure 2.19). For further detail about battery levels, follow the steps below. Battery status button Figure 2.19 Viewing the battery status on the Home screen. 1. From the Home screen, press the Battery status button. Two battery figures appear
(Figure 2.20). 2 r e l l o r t n o c r u o y i g n s U 3537 2013-3 English 39 M943578A001 Rev X 2013-3 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 01-18-2012 Controller battery status External neurostimulator battery status Figure 2.20 Example of a Battery status screen. 2. Press the Exit button (
) at the top right corner of the touchscreen to exit. Table 2.3 lists several examples of external neurostimulator battery levels and whether action is needed. Table 2.3 Battery level definitions for the external neurostimulator External neurostimulator battery icon is green. Battery level is full. No action is needed. 2 r e l l o r t n o c r u o y i g n s U 40 English 3537 2013-3 M943578A001 Rev X 2013-3 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 01-18-2012 Table 2.3 Battery level definitions for the external neurostimulator (continued) External neurostimulator battery icon is green. Battery level is half full. No action is needed. External neurostimulator battery icon is orange. Stimulation is still being provided, but the external neurostimulator batteries need to be replaced soon. Call your clinician. External neurostimulator battery icon is red. Stimulation may no longer be available. The external neurostimulator batteries need to be replaced. Call your clinician. Table 2.4 lists several examples of controller battery levels and whether action is needed. Table 2.4 Battery level definitions for the controller Controller battery icon is green. Battery level is full. No action is needed. Controller battery icon is green. Battery level is half full. No action is needed. 2 r e l l o r t n o c r u o y i g n s U 3537 2013-3 English 41 M943578A001 Rev X 2013-3 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 01-18-2012 Table 2.4 Battery level definitions for the controller (continued) Controller battery icon is orange. The controller batteries are low. Replace the controller batteries. See "Replacing the batteries (controller only)" on page 45. Controller battery icon is red. The controller batteries are nearly depleted and programming will not be possible soon. Replace the controller batteries. See "Replacing the batteries (controller only)" on page 45. Table 2.5 lists the warning and alert screens associated with the batteries for the external neurostimulator and the controller. 2 r e l l o r t n o c r u o y i g n s U 42 English 3537 2013-3 M943578A001 Rev X 2013-3 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 01-18-2012 Table 2.5 Battery message screens for the controller and the external neurostimulator The external neurostimulator batteries are low and stimulation will not be available soon. Call your clinician. Press the OK button to exit this screen. Cause: The external neurostimulator batteries are depleted and stimulation is not available. Action: The external neurostimulator batteries need to be replaced. Call your clinician. Press the OK button to exit this screen. 2 r e l l o r t n o c r u o y i g n s U 3537 2013-3 English 43 M943578A001 Rev X 2013-3 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 01-18-2012 Table 2.5 Battery message screens for the controller and the external neurostimulator
(continued) The controller batteries are depleted. Programming is not possible. Replace the controller batteries now. Refer to
"Replacing the batteries
(controller only)" on page 45. The controller batteries are low. Programming will not be possible soon. Replace the controller batteries now. Refer to
"Replacing the batteries
(controller only)" on page 45. Press the OK button to exit this screen. 2 r e l l o r t n o c r u o y i g n s U 44 English 3537 2013-3 M943578A001 Rev X 2013-3 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 01-18-2012 Replacing the batteries (controller only) Note: This section is for replacing the controller batteries. Do not attempt to replace the external neurostimulator batteries unless directed 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 as shown on the battery compartment label
(Figure 2.22). 2 r e l l o r t n o c r u o y i g n s U 3537 2013-3 English 45 M943578A001 Rev X 2013-3 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 01-18-2012 Figure 2.22 Inserting new batteries. 4. Close the battery compartment cover. 5. Dispose of old batteries according to local regulations. Using the carrying case The carrying case has a pouch to hold the controller (Figure 2.23). The carrying case also has a clip on the back that can be attached to a belt. 2 r e l l o r t n o c r u o y i g n s U 46 English 3537 2013-3 M943578A001 Rev X 2013-3 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 01-18-2012 Figure 2.23 Insert the controller into the carrying case. Always carry your controller Because your controller is the only way to adjust or turn your stimulation on, you should always carry your controller with you. The controller is also the recommended way to turn your stimulation off. In particular, always bring your controller with you to follow-up appointments. 2 r e l l o r t n o c r u o y i g n s U 3537 2013-3 English 47 M943578A001 Rev X 2013-3 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 01-18-2012 In addition, always bring your controller to appointments with other health care providers. During certain procedures, you may need to turn your external neurostimulator off. You should also bring your InterStim Therapy Patient Guide. It contains important information about the InterStim system that your health care providers should be aware of. 2 r e l l o r t n o c r u o y i g n s U 48 English 3537 2013-3 M943578A001 Rev X 2013-3 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 01-18-2012 3 Troubleshooting M943578A001 Rev X 2013-3 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 01-18-2012 This chapter will help you solve problems with your controller. Note: If a problem is not solved after several attempts, or if a problem is not described here, contact your clinician. Controller screens The controller displays three different types of screens: warning screens, alert screens, and notification screens. These screens provide you with information about your system, alert you to 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' (
). 3 g n i t o o h s e b u o r T l 50 English 3537 2013-3 M943578A001 Rev X 2013-3 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 01-18-2012 Warning screens Warning screens indicate a problem with the controller or the external neurostimulator. Table 3.1 describes the possible warning screens and provides instructions (see blue text) on how to resolve the problem and clear the screen. 3 g n i t o o h s e b u o r T l 3537 2013-3 English 51 M943578A001 Rev X 2013-3 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 01-18-2012 Table 3.1 Warning screens Screen System Problem Cannot continue. Please call your clinician. Cause and action Explanation: The system is not working correctly. Stimulation may have stopped. Solution: Write down the message on the screen and the screen number in the bottom right corner, then follow these steps:
1. Remove and reinsert the controller batteries, then retry the action that caused the error screen to appear. For instructions on removing and inserting the controller batteries, refer to
"Replacing the batteries
(controller only)" on page 45. If this does not solve the problem, call your clinician. 2. 3 g n i t o o h s e b u o r T l 52 English 3537 2013-3 M943578A001 Rev X 2013-3 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 01-18-2012 Table 3.1 Warning screens (continued) Screen Software Problem Cannot continue. Please call your clinician. Cause and action Explanation: The software is not working correctly. Stimulation may have stopped. Solution: Write down the message on the screen and the screen number in the bottom right corner, then follow these steps:
1. Remove and reinsert the controller batteries, then retry the action that caused the error screen to appear. For instructions on removing and inserting the controller batteries, refer to
"Replacing the batteries
(controller only)" on page 45. If this does not solve the problem, call your clinician. 2. 3 g n i t o o h s e b u o r T l 3537 2013-3 English 53 M943578A001 Rev X 2013-3 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 01-18-2012 Table 3.1 Warning screens (continued) Cause and action Cause: The external neurostimulator batteries are depleted and stimulation is not available. Action: The external neurostimulator batteries need to be replaced. Write down the message on the screen and the screen number in the bottom right corner, and call your clinician. Press the OK button to clear the screen. Screen 3 g n i t o o h s e b u o r T l 54 English 3537 2013-3 M943578A001 Rev X 2013-3 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 01-18-2012 Table 3.1 Warning screens (continued) Screen Cause and action Cause: The ENS button on the external neurostimulator is stuck in the pressed position. Action: Press and release the ENS button, then press the OK button to clear the screen. If this does not solve the problem, write down the message on the screen and the screen number in the bottom right corner, and call your clinician. Explanation: The controller batteries are depleted. Programming is not available. Replace the controller batteries now. Refer to
"Replacing the batteries
(controller only)" on page 45. 3 g n i t o o h s e b u o r T l 3537 2013-3 English 55 M943578A001 Rev X 2013-3 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 01-18-2012 Table 3.1 Warning screens (continued) Screen Cause and action Cause: The external neurostimulator has reached the end of service. This external neurostimulator will no longer provide stimulation. Action: Write down the message on the screen and the screen number in the bottom right corner, and call your clinician. Alert screens Alert screens indicate a pairing or other connection problem between the controller and the external neurostimulator. Table 3.2 describes the possible alert screens and provides instructions (see blue text) on how to resolve the problem and clear the screen. 3 g n i t o o h s e b u o r T l 56 English 3537 2013-3 M943578A001 Rev X 2013-3 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 01-18-2012 Screen Table 3.2 Alert screens Cause and action The external neurostimulator batteries are low and stimulation will not be available soon. Action: Write down the message on the screen and the screen number in the bottom right corner, and call your clinician. Press the OK button to exit this screen. The controller batteries are low. Programming will not be possible soon. Replace the controller batteries now. Refer to
"Replacing the batteries
(controller only)" on page 45. Press the OK button to exit this screen. 3 g n i t o o h s e b u o r T l 3537 2013-3 English 57 M943578A001 Rev X 2013-3 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 01-18-2012 Table 3.2 Alert screens (continued) Screen 3 g n i t o o h s e b u o r T l Cause and action Cause: The controller cannot find the paired external neurostimulator. The external neurostimulator may be out of range or the external neurostimulator batteries may be depleted. Action: Move the controller closer to the external neurostimulator and make sure your hand is not covering the top of the controller, then press the Try Again button. If this does not solve the problem, the external neurostimulator batteries may need to be replaced. Write down the message on the screen and the screen number in the bottom right corner, and call your clinician. Press the Cancel button to clear the screen. 58 English 3537 2013-3 M943578A001 Rev X 2013-3 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 01-18-2012 Table 3.2 Alert screens (continued) Screen Cause and action Cause: The external neurostimulator has less than 24 hours of service remaining. This external neurostimulator will be unable to provide stimulation soon. Write down the message on the screen and the screen number in the bottom right corner, and call your clinician. Press the OK button to clear the screen. Explanation: The external neurostimulator has detected that either a cable or a lead is not connected. Solution: Ensure all cable and lead connections are secure. Press the OK button to clear the screen. 3 g n i t o o h s e b u o r T l 3537 2013-3 English 59 M943578A001 Rev X 2013-3 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 01-18-2012 Table 3.2 Alert screens (continued) Screen 3 g n i t o o h s e b u o r T l Cause and action Cause: The system has detected that one or more components in the system is not intended for use with your system. If you replaced the controller batteries with new batteries that were not given to you by your clinician, remove the new batteries and use correct batteries as instructed by your clinician. If the issue persists, the controller batteries may need to be replaced. For instructions on replacing the controller batteries, see
"Replacing the batteries
(controller only)". If this does not solve the problem, write down the message on the screen and the screen number in the bottom right corner, and call your clinician. Press the OK button to clear the screen. 60 English 3537 2013-3 M943578A001 Rev X 2013-3 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 01-18-2012 Notification screens The information screens provide information about therapy settings, error conditions, and battery levels. Table 3.3 describes the possible information screens and provides instructions on how to proceed (see blue text) when these messages appear. Table 3.3 Notification screens Screen Description and action Cause: You tried to adjust your stimulation when stimulation was off. Action: Press the Turn On button on the controller screen to turn stimulation on, then try adjusting stimulation again. To keep stimulation off and not change settings, press the Cancel button to clear the screen. 3 g n i t o o h s e b u o r T l 3537 2013-3 English 61 M943578A001 Rev X 2013-3 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 01-18-2012 Table 3.3 Notification screens (continued) Description and action Cause: You tried increasing your stimulation above the highest value allowed. You can not increase your stimulation any higher. Action: Press the OK button to clear the screen and return to the highest allowed setting. If not receiving symptom relief, call your clinician. Cause: You tried decreasing your stimulation below the lowest value allowed. You can not decrease your stimulation below zero. Press the OK button to clear the screen and return to the lowest allowed setting. If feeling discomfort, call your clinician. Screen 3 g n i t o o h s e b u o r T l 62 English 3537 2013-3 M943578A001 Rev X 2013-3 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 01-18-2012 Table 3.3 Notification screens (continued) Screen Description and action Cause: Your combined settings can not currently be delivered by the external neurostimulator. Action: Press the OK button to clear the screen. If not receiving symptom relief, call your clinician. Cause: Controller settings are not available. Action: Write down the message on the screen and the screen number in the bottom right corner, and call your clinician. Press the OK button to clear the screen. 3 g n i t o o h s e b u o r T l 3537 2013-3 English 63 M943578A001 Rev X 2013-3 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 01-18-2012 Possible problems and solutions Table 3.4 will help you solve problems or identify when to call your clinician. Problems are described in the left column (bold black text). The right column lists possible causes of the problem (plain text) and how to correct the problem (bold blue text). Note: If a problem is not solved after several attempts, or if a problem is not described here, contact your clinician. 3 g n i t o o h s e b u o r T l 64 English 3537 2013-3 M943578A001 Rev X 2013-3 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 01-18-2012 Table 3.4 Troubleshooting problems Problems Uncomfortable or Intolerable stimulation You are experiencing side effects from the stimulation. Causes and actions 1. Use your controller to turn stimulation down or off. See "Adjusting stimulation" on page 27 for instructions on adjusting stimulation. See
"Turning your stimulation on or off" on page 22 for instructions on turning stimulation off. If your controller is unavailable or not responding, press and hold the ENS button on the external neurostimulator for 3 seconds. If not receiving symptom relief, call your clinician. 2. 3. Call your clinician. Stimulation area changes You notice an unexpected change in where you feel stimulation. 3 g n i t o o h s e b u o r T l 3537 2013-3 English 65 M943578A001 Rev X 2013-3 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 01-18-2012 Table 3.4 Troubleshooting problems
(continued) Causes and actions 1. Turn stimulation down or off. See "Adjusting stimulation" on page 27. If this does not work, call your clinician. 1. Check that your stimulation is on, then increase stimulation as needed. If this does not solve the problem, call your clinician. 2. 2. Problems Stimulation is too strong Not receiving symptom relief You think that your stimulation may be turned off, or that your stimulation might not be strong enough. 3 g n i t o o h s e b u o r T l 66 English 3537 2013-3 M943578A001 Rev X 2013-3 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 01-18-2012 Table 3.4 Troubleshooting problems
(continued) Problems Controller is unresponsive. The display screen is blank when you press a key. Causes and actions 1. Make sure to press only 2. 3. one button. The controller does not respond when two or more buttons are pressed at the same time. If this does not work, check that the batteries are inserted correctly as shown in the battery compartment. If batteries are inserted correctly, the batteries are depleted. Replace the controller batteries. For instructions on replacing controller batteries, see
"Checking and replacing batteries" on page 38. 3 g n i t o o h s e b u o r T l 3537 2013-3 English 67 M943578A001 Rev X 2013-3 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 01-18-2012 Table 3.4 Troubleshooting problems
(continued) Causes and actions 1. Unlock the controller. The controller screen may return to the screen you were on when the controller reset. If the controller continues to reset and you are unable to program your stimulation, call your clinician. 1. Turn stimulation down or off. If this does not solve the problem, call your clinician. 2. 2. Problems Controller automatically resets. Controller screen blinks and returns to the Unlock screen. Uncomfortable tapping sensation You feel a tapping sensation that is too slow or too fast. 3 g n i t o o h s e b u o r T l 68 English 3537 2013-3 M943578A001 Rev X 2013-3 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 01-18-2012 Table 3.4 Troubleshooting problems
(continued) Causes and actions Before engaging in any of these activities, consult the InterStim Patient Therapy Guide for details. WARNING: Failure to follow the recommendations in the InterStim Patient Therapy Guide may injure you or damage your InterStim system. Turn your stimulation off and call your clinician. Call your clinician. Problems You will be passing through a theft detector or security device. You will be using potentially dangerous equipment. You will be having a medical or dental procedure. External defibrillation You received external defibrillation. Controller settings Controller settings (eg, brightness) are making it difficult to adjust your stimulation. 3 g n i t o o h s e b u o r T l 3537 2013-3 English 69 M943578A001 Rev X 2013-3 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 01-18-2012 Table 3.4 Troubleshooting problems
(continued) Problems Dropped controller Your controller fell or was dropped. Causes and actions The controller is designed to withstand a short drop to a hard surface and still operate normally, even if the case is chipped or nicked. Turn your stimulation off and call your clinician. 3 g n i t o o h s e b u o r T l 70 English 3537 2013-3 M943578A001 Rev X 2013-3 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 01-18-2012 Table 3.4 Troubleshooting problems
(continued) Problems Fluid on the controller Fluid was spilled onto the controller or the controller was dropped into water. Causes and actions The controller is not waterproof, and water can damage the device. Immediately remove the controller from the water, then dry with a soft towel. Remove the batteries, then allow the battery compartment to air dry at room temperature for 24 hours. Clean any spills from the controller with a damp towel. If the controller does not work, or if you need to adjust stimulation while the controller is drying, call your clinician. 3 g n i t o o h s e b u o r T l 3537 2013-3 English 71 M943578A001 Rev X 2013-3 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 01-18-2012 3 g n i t o o h s e b u o r T l 72 English 3537 2013-3 M943578A001 Rev X 2013-3 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 01-18-2012 4 Maintenance and assistance M943578A001 Rev X 2013-3 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 01-18-2012 Cleaning and care Follow these guidelines to ensure that the controller and accessories function properly. Keep the device out of the reach of children and pets. Use the device only as explained to you by your clinician or as discussed in this manual. 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 cleaners will not damage the device or labels. The device is not waterproof. Do not allow moisture to get inside the device. Keep fresh batteries available. Replace low or depleted batteries. 4 e c n a i t s s s a d n a e c n a n e n a M t i 74 English 3537 2013-3 M943578A001 Rev X 2013-3 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 01-18-2012 Safety and technical checks Periodic safety and technical checks or periodic maintenance of the controller are not required. The controller contains no user-
serviceable parts. If repair or service is needed, contact your clinician or a Medtronic sales office. Refer to the Medtronic contacts at the end of this manual. Battery and controller disposal Dispose of depleted batteries and worn out devices according to local requirements. Return your controller to your clinician. Declaration of conformity Medtronic declares that this product is in conformity with the essential requirements of Directive 1999/5/EC on Radio and Telecommunications Terminal Equipment, and Directive 93/42/EEC on Medical Devices. For additional information, contact Medtronic. Refer to the list of Medtronic contacts at the end of this manual. 4 e c n a i t s s s a d n a e c n a n e n a M t i 3537 2013-3 English 75 M943578A001 Rev X 2013-3 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 01-18-2012 Specifications Table 4.1 Controller specifications Item Power source Specification 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) Approximately 12.0 cm x 6.0 cm x 2.4 cm (4.7 in x 2.4 in x 0.9 in) Approximately 150 g (5.3 oz.) Size Weight, including batteries Battery life 2 months (average) for alkaline batteries Continuous Mode of operation Assistance for the controller The controller has been designed and tested to provide trouble-free service. If repair or service is needed, contact your clinician or a Medtronic sales office. Refer to the Medtronic contacts at the end of this manual. 4 e c n a i t s s s a d n a e c n a n e n a M t i 76 English 3537 2013-3 M943578A001 Rev X 2013-3 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 01-18-2012
! USA For assistance in the US, call Medtronic Patient Services at: 1-800-510-6735. Patient Services hours are Monday through Friday, 8 am to 5 pm Central Time. If your controller stops working, first try the steps in Chapter 3 "Troubleshooting" on page 49. Contact your clinician if indicated by the troubleshooting information or if you need additional assistance. If you lose your controller, contact your clinician to order a new controller. 4 e c n a i t s s s a d n a e c n a n e n a M t i 3537 2013-3 English 77 M943578A001 Rev X 2013-3 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 01-18-2012 Index Adjusting stimulation 28 Assistance 76 Batteries inserting or replacing 45 Batteries (controller) checking 38 disposing of 75 Batteries (external neurostimulator) checking 38 Buttons home screen 36 Carrying case, controller 46 Changing programs 31 Checking batteries controller 38 external neurostimulator 38 Controller checking battery level 38, 41 cleaning and care 74 disposing of 75 English 3537 2013-3 x e d n I 78 M943578A001 Rev X 2013-3 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 01-18-2012 how to use 14 keys 16 locking 22 screens 50 specifications 76 troubleshooting 6768-71 unlocking 18 use 47 Decrease key 17 Disposing of controller batteries 75 controller 75 Errors troubleshooting 50 Home screen buttons 36 Home screen 34 Increase key 17 Information screens 61 Keys (controller) 16 Locking the controller 22 Neurostimulator (external) checking battery level 38, 40 3537 2013-3 English M943578A001 Rev X 2013-3 x e d n I 79 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 01-18-2012 Problems troubleshooting 50 Programs changing 31 Repair 75 Specifications 76 Stimulation On/Off key 16 Stimulation adjusting 28 changing programs 31 switching sides 28 troubleshooting 66, 69 turning off 22, 25 turning on 22, 23 uncomfortable 65 Switching stimulation sides 28 Troubleshooting 50 Turning stimulation on or off 22 Uncomfortable stimulation troubleshooting 65 Unlocking the controller 18 Warning screens 51 English 3537 2013-3 x e d n I 80 M943578A001 Rev X 2013-3 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 01-18-2012 x e d n I 81 3537 2013-3 English M943578A001 Rev X 2013-3 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 01-18-2012 Contacts:
Asia: Medtronic International Ltd. Tel. 02919-1362 Fax 02907-3998 Medtronic Asia Ltd. Tel. (02)-548-1148 Fax (02)-518-4786 Australia: Medtronic Australasia Pty. Ltd. 97 Waterloo Road North Ryde, NSW 2113 Australia Tel. +61-2-9857-9000 Fax +61-2-9878-5100 Toll free 1-800-668-6700 Austria: Medtronic sterreich GmbH Tel. 01-240440 Fax 01-24044-100 Belgium: Medtronic Belgium S.A. Tel. 02-456-0900 Fax 02-460-2667 Canada: Medtronic of Canada Ltd. Tel. (1-905)-460-3800 Fax (1905)-826-6620 Czech Republic: Medtronic Czechia s.r.o. Tel. 2-965-795-80 Fax 2-965-795-89 Denmark: Medtronic Danmark A/S Tel. 45-32-48-18-00 Fax 45-32-48-18-01 Finland: Medtronic Finland Oy/LTD Tel. (09)-755-2500 Fax (09)-755-25018 France: Medtronic France S.A.S. Tel. 01-5538-1700 Fax 01-5538-1800 Germany: Medtronic GmbH Tel. (02159)-81490 Fax (02159)-8149100 Greece: Medtronic Hellas S.A. Tel. 210-67-79-099 Fax 210-67-79-399 M943578A001 Rev X 2013-3 Hungary: Medtronic Hungria Kft. Tel. 1-889-06-00 Fax 1-889-06-99 Ireland: Medtronic Ireland Ltd. Tel. (01)-890-6522 Fax (01)-890-7220 Italy: Medtronic Italia SpA Tel. 02-241371 Fax 02-241381 Tel. 06-328141 Fax 06-3215812 Japan: Medtronic Japan Tel. 03-6430-2016 Fax 03-6430-7110 Latin America: Medtronic, Inc. Tel. (1305)-500-9328 Fax (1786)-709-4244 Norway: Medtronic Norge AS Tel. 067-10-32-00 Fax 067-10-32-10 Poland: Medtronic Poland Sp. z.o.o. Tel. (022)-465-69-00 Fax (022)-465-69-17 Portugal: Medtronic Portugal, Lda. Tel. 21-724-5100 Fax 21-724-5199 Russia: Medtronic Russia Tel. (8495) 580-7377 Fax (8495) 580-7378 Slovakia Medtronic Slovakia, o.z. Tel. 0268 206 911 Fax 0268 206 999 Spain: Medtronic Ibrica, S.A. Tel. 91-625-0400 Fax 91-650-7410 Sweden: Medtronic AB Tel. 08-568-585-00 Fax 08-568-585-01 Switzerland: Medtronic (Schweiz) AG Tel. 031-868-0100 Fax 031-868-0199 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 01-18-2012 The Netherlands: Medtronic B.V. Tel. (045)-566-8000 Fax (045)-566-8668 U.K.: Medtronic U.K. Ltd. Tel. 01923-212213 Fax 01923-241004 USA: Medtronic, Inc. Tel. (1763)-505-5000 Fax (1763)-505-1000 Toll-free: (1-800)-328-0810 M943578A001 Rev X 2013-3 Filename Date Time UC200xxxxxx EN 4.625 x 6.0 inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: 01-18-2012 Manufacturer Medtronic, Inc. 710 Medtronic Parkway Minneapolis, MN 55432-5604 USA www.medtronic.com Tel. +1-763-505-5000 Fax +1-763-505-1000 Authorized Representative EC REP in the European Community Medtronic B.V. Earl Bakkenstraat 10 6422 PJ Heerlen The Netherlands Tel. +31-45-566-8000 Fax +31-45-566-8668 Europe/Africa/Middle East Headquarters Medtronic International Trading Srl Route du Molliau 31 Case Postale 84 CH-1131 Tolochenaz Switzerland www.medtronic.eu Tel. +41-21-802-7000 Fax +41-21-802-7900 Asia-Pacific Medtronic International Ltd. Suite 1106-11 16/F, Tower 1, The Gateway 25 Canton Road, Tsimshatsui Kowloon Hong Kong Tel. +852-2919-1362 Fax +852-2907-3998 Contacts for specific countries are listed inside this cover.
*M943578A001*
Medtronic, Inc. 2013 All Rights Reserved M943578A001 M943578A001 Rev X 2013-3
1 | User Manual 3 | Users Manual | 87.82 KiB | July 06 2012 / April 12 2012 |
Alleviating Pain - Restoring Health Extending Life May 31%, 2012 Certification and Engineering Bureau Industry Canada P.O. Box 11490, Station H 3701 Carling Avenue (Building 94) Ottawa, Ontario K2H 882 Re: Attestation of User Manual To whom it may concern, Per the Industry Canada requirement of the warning statements be in both English and French, we submitted our draft manual in English. Once our manual is final, then the manual will be translated to French and other languages based on our marketing requirements. The released manual will comply with the Industry Canada requirement to have the warning statement be in French. Sincerely, Anne Coldwell, Director, Quality and Reliability
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2012-06-07 | 2402 ~ 2480 | DSS - Part 15 Spread Spectrum Transmitter | Original Equipment |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 | Effective |
2012-06-07
|
||||
1 | Applicant's complete, legal business name |
Medtronic, Inc.
|
||||
1 | FCC Registration Number (FRN) |
0008250839
|
||||
1 | Physical Address |
8200 Coral Sea Street NE
|
||||
1 |
Mounds View, Minnesota 55112
|
|||||
1 |
United States
|
|||||
app s | TCB Information | |||||
1 | TCB Application Email Address |
d******@nwemc.com
|
||||
1 | TCB Scope |
A4: UNII devices & low power transmitters using spread spectrum techniques
|
||||
app s | FCC ID | |||||
1 | Grantee Code |
LF5
|
||||
1 | Equipment Product Code |
3537
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 | Name |
G**** G******
|
||||
1 | Title |
Sr. RF Regulatory Program Manager
|
||||
1 | Telephone Number |
763-5********
|
||||
1 | Fax Number |
651-3********
|
||||
1 |
G******@medtronic.com
|
|||||
app s | Technical Contact | |||||
n/a | ||||||
app s | Non Technical Contact | |||||
n/a | ||||||
app s | Confidentiality (long or short term) | |||||
1 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | If so, specify the short-term confidentiality release date (MM/DD/YYYY format) | 12/04/2012 | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 | Equipment Class | DSS - Part 15 Spread Spectrum Transmitter | ||||
1 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | 3537 | ||||
1 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 | Modular Equipment Type | Does not apply | ||||
1 | Purpose / Application is for | Original Equipment | ||||
1 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | No | ||||
1 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 | Grant Comments | Output power is listed is conducted. The antenna(s) used for this transmitter must not be collocated or operating in conjunction with any other antenna or transmitter within a host device, except in accordance with FCC multi-transmitter product procedures. | ||||
1 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 | Firm Name |
Northwest EMC, Inc.
|
||||
1 | Name |
G**** K****
|
||||
1 | Telephone Number |
503-8********
|
||||
1 | Fax Number |
503-8********
|
||||
1 |
g******@nwemc.com
|
|||||
Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | 2402.00000000 | 2480.00000000 | 0.0027900 |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC