Medtronic 3537 User Manual
Filename Date Time
UC2001xxxx EN
4.625 x 6 inches (117 mm x 152 mm)
CONTROLLER 3537
for InterStim® Therapy
PTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fm
Medtronic Confidential
Template version: 08-08-2011
Clinician Programming Guide
! USA
Rx only
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PTMClinPrgmManual.xsl - PTMClinPrgmTemplate.fm
Template version: 08-08-2011
Medtronic Confidential
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Explanation of symbols on product or package labeling
Refer to the appropriate product for symbols that apply.
Consult instructions for use
Manufacturer
XX °C
Temperature limitation
XXX °F
-XX °C
-XX °F
Serial number
Conformité Européenne (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 representa ti ve in the Eu rop ean com mu nity
REP
EC
! USA
For USA audiences only
IEC 60601-1/EN60601-1, Type BF equipment
Non-ionizing elec tro ma gne ti c ra diation
Medtronic Confidential
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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 di spo sal of this pr odu ct.
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.)
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Medtronic®, and InterStim® are trademarks of Medtronic, Inc., registered in the U.S. and other
countries.
FCC Information
! USA
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, i nclud i ng i nt erf ere nce th at m ay cau s e und esired operation.
IMPORTANT: Changes or modifications to this product not authorized by Medt ronic,
Inc., could void th e FCC Cert ific atio n and negat e your au thori ty to operate th is pro duct .
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.
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Table of contents
Description 7
Package contents 7
About this manual 7
Instructions for us e 8
Setting up the controller 8
Pairing the controller to the extern al neu rostimulator 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 stimulat i on 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 param eters 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 param eters 33
Refer to the indications sheet for indications and related information.
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Template version: 08-08-2011
Refer to the appropriate information for prescribers booklet for contraindications,
warnings, precautions, adverse events summary, individualization of treatment, patient
selection, use in specific populat ions, resteriliz ation, and component disposal.
Refer to System Eligibility, Battery Longevity, Specifications reference manual for
neurostimulator selection, battery longevity calculations, and specific neurostimulator
specifications.
Refer to the clinical summary booklet for information on the clinical study results
! USA
of the neurostimulation system and individualization of treatment.
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Adjusting stimulation parameters for the Model 3093 or Model 3889 Tined Lead 37
Adjusting advanced param eters 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 batt erie s 55
Checking the external neuro s tim ul at or an d controller batteries 55
Replacing the controller batteries 58
Labeling the controlle r 59
Troubleshooting 59
Troubleshooting reference guide 60
Device specifications 65
Device care and storage 65
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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 Control l er
▪
Carrying case
▪
Batteries (AA)
▪
Product literature
▪
Warranty card
! USA
▪
About this manual
This manual contains the information the physician needs to set up, use, and troubleshoot the
controller (Figure 1).
Stimulation On/Off key
Figure 1. F eat ures of the Model 3537 Contro l ler.
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Touchscreen
Increase key
Decrease key
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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.
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Instructions for use
# Caution: The device is not certified f or use in the pr esen ce of a fl a mm ab le ane s the tic
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 res ult in
damage to the device, causing the device to m alf u nctio n or be com e unu sabl e .
# 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 co n tro ller
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
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).
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Figure 2. Setting the language.
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3. To change the date, the month, or the year, press the touchscreen button with the incorrect
Figure 3. Pressing the Trial button.
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 contin ue (Figure 4).
Month
Date
Year
Figure 4. Setting the date.
4. To change the hour, the minute, or the time format, press the touchscreen button with the
incorrec t va l u e, t h en u s e th e 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).
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AM/PM format 24-hour format
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5. Using the touchscreen, press the radio button next to the desired number format for the
Figure 5. Setting the time.
controller, then press the OK button to continue (Figure 6).
Figure 6. Selecting the number format.
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Pairing the controller to the external neurostimulator
To ensure correct pairing between the controller and the external neurostimulator, consider the
following recommen dations:
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 neurostimul ato r ag ai n.
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 neurostim ulat or.
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)
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).
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ENS button
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Figure 8. Pressing the Continue button.
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3. Using the touchscreen, select the radio button next to the correct external neurostimulator,
Figure 9. Controller looking for the extern al neu rostimulator.
then press the OK button to continue (Figure 10).
Note: The number displ aye d on th e controller screen should match the serial number
printed on the back of the ex ternal neurostimulator.
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Notes:
▪
▪
4. When the pairing is successful, a confirmation screen will appear (Figure 12). Press the OK
button to continue.
Figure 10. Selecting the device to pair with the controller.
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.
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Note: If there is a connection problem, a screen will appear (Figure 13). Check all
Figure 12. Confirming that the devices are paired.
connections between the lead an d 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 neurostimu lato r wi th whi ch it was pr eviou s ly pai r ed.
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 touchscr een.
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Menu button
2. Press the Enter Code button (Figure 15).
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 corr ect cod e.
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Figure 14. Pressing the Menu button.
Figure 15. Pressing the Enter Code button.
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To cancel code entry, press the Exit button ( ) to exit and return to the previous screen.
▪
Undo button Exit button
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Confirm button
Keypad
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4. From the Menu, select the Pair Device button (Figure 17).
Figure 16. Entering the Menu code.
Figure 17. S e lecting the Pair Device button.
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Exit button
Slider bar
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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
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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 touchscr een .
7. Using the touchscreen, select the radio button next to the correct external neurostimulator,
Figure 19. Controller looking for the external neurost i mu lato r.
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 ne uro s tim ulator.
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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.
▪
Note: If there is a connection problem, a screen will appear (Figure 13). Check all
connections between the lead an d the external neurostimulator, and press the Recheck
button.
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Figure 20. Selecting the correct device from the list.
Figure 21. No Device Found screen.
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Figure 22. Screen prompt to check connections.
Unlocking and locking the controller
Unlocking the controller
To unlock the controller, press the Increase/Decrease key.
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Figure 23. The Unlock screen.
Note: W hen the co ntroller is locked , pressing the Stimulat ion On/Off key will provide the option
to bypass the Unlock screen and to turn stimulat ion on or off.
1. Press and hold the Lock button on the Unlock screen.
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As the Lock button is held, bars appear on the screen and move toward the Lock button
(Figure 24).
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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 neurostimul ato r.
Figure 25. The controller looking for the external neurostimulator.
The next screen that appears is the Home screen (Figure 26).
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Stimulation
value button
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Battery status button Lock button
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Menu 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).
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