Page is loading ...
Controller 3537
for InterStim
®
Therapy
Clinician Programming Guide
! USA
Rx only
Explanation of symbols on product or package labeling
Refer to the appropriate product for symbols that apply.
Consult instructions for use
Manufacturer
XXX °F
XX °C
-XX °F
-XX °C
Temperature limitation
Keep dry
Ingress protection rating IP22, per 60601-1-11
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.
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 2015-09-01 English 3
MR
Magnetic Resonance (MR) Unsafe
4 English 3537 2015-09-01
Medtronic®, Verify®, and InterStim® are trademarks of Medtronic, Inc., registered in the U.S.
and other countries.
3537 2015-09-01 English 5
6 English 3537 2015-09-01
Table of contents
Description 9
Package contents 9
About this manual 9
Instructions for use 10
Setting up the controller 10
Pairing the controller to the external neurostimulator 17
Unlocking and locking the controller 22
Unlocking the controller 22
Locking the controller 24
Turning stimulation on or off 25
Turning stimulation on 25
Turning stimulation off 26
Programming stimulation using the Model 3575 Test Stimulation Cable 28
Increasing and decreasing amplitude on the Home screen 28
Adjusting advanced parameters 30
Programming stimulation for the Model 3057 Test Stimulation Lead(s) 34
Increasing and decreasing amplitude on the Home screen 34
Changing the active lead (if two leads were placed) 36
Adjusting advanced parameters 37
Programming stimulation for the Model 3093 or Model 3889 Tined Lead 41
Adjusting advanced parameters 41
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 2015-09-01 English 7
Increasing and decreasing amplitude on the Home screen 45
Usage Log 46
Reset Therapy 48
Changing preferences 50
Changing the vibration settings 50
Changing the brightness of the controller display 52
Changing the time 53
Changing the date 54
Changing the number format 55
Changing the language 56
Viewing information about the controller and the external neurostimulator 58
Checking and replacing batteries 59
Checking the external neurostimulator and controller batteries 59
Replacing the controller batteries 62
Labeling the controller 63
Troubleshooting 64
Troubleshooting reference guide 65
Device specifications 71
Device care and storage 71
8 English 3537 2015-09-01
Description
The Medtronic Model 3537 Controller is a hand-held device intended for use with the
Medtronic Model 3531 Verify 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)
The controller has a touchscreen, a display screen that reacts to touch and allows the user to
press buttons and functions that are displayed on the screen. Use one finger when pressing
buttons or functions. Using multiple fingers at once on the front face of the controller may not
allow the function or task to be performed. There are 3 different ways to use the touchscreen
depending on the function or task:
▪Short, light presses for a button selection.
▪Pressing and holding to unlock a screen.
▪Pressing lightly and sliding a slider bar to view additional selections.
Package contents
▪Model 3537 Controller
▪Carrying case
▪AA alkaline batteries (2)
▪Product literature
▪
! USA
Warranty card
About this manual
This manual contains the information the physician needs to set up, use, and troubleshoot
the controller (Figure 1).
3537 2015-09-01 English 9
Stimulation On/Off key
Touchscreen
Increase key
Decrease key
Figure 1. Features of the Model 3537 Controller.
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.
Notes:
▪After completing these setup instructions, you can change the settings at any time
using the Menu.
10 English 3537 2015-09-01
▪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. 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).
Figure 3. Pressing the Trial button.
3537 2015-09-01 English 11
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).
12 English 3537 2015-09-01
a. 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 while the external neurostimulator can be paired to the controller.
b. Press the Continue button on the controller touchscreen (Figure 8). The controller
will look for the external neurostimulator (Figure 9).
Light-emitting diode (LED) ENS button
Output jack
Figure 7. Turn on the external neurostimulator.
Figure 8. Pressing the Continue button.
14 English 3537 2015-09-01
Figure 9. Controller looking for the external neurostimulator.
7. Using the touchscreen, select the correct external neurostimulator number, 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.
Figure 10. Selecting the device to pair with the controller.
Notes:
▪If the controller fails to pair with the external neurostimulator, repeat step 6, then
press the Try Again button to try this step again (Figure 11).
▪Pressing the Exit button ( ) will abort the pairing process.
3537 2015-09-01 English 15
Figure 11. Pressing the Try Again button.
8. When the pairing is successful, a confirmation screen will appear (Figure 12). Press the
OK button to continue.
Figure 12. Confirming that the devices are paired.
Note: This screen appears before cables are connected to the external neurostimulator
or when a lead or cable is disconnected (Figure 13). If the system is not yet connected,
continue with lead placement and press the Recheck button when all connections are
secure.
16 English 3537 2015-09-01
Figure 13. Screen prompt to check connections.
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.
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.
3537 2015-09-01 English 17
Menu button
Figure 14. Pressing the Menu button.
2. Press the Enter Code button (Figure 15).
Figure 15. Pressing the Enter Code button.
3. Enter the four-digit code by pressing the number buttons on the touchscreen keypad,
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.
18 English 3537 2015-09-01
▪To cancel code entry, press the Exit button ( ) to exit and return to the previous
screen.
Undo button Exit button
Confirm button
Keypad
Figure 16. Entering the Menu code.
4. From the Menu, select the Pair Device button (Figure 17).
Slider bar
Exit button
Figure 17. Selecting the Pair Device button.
5. Initiate pairing as follows:
3537 2015-09-01 English 19
a. Press and hold the ENS button for one second to place the external neurostimulator
into discovery mode. The light on the external neurostimulator will repeatedly blink
while the external neurostimulator can be paired to the controller.
b. 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.
6. Using the touchscreen, select the correct external neurostimulator number, then press
the OK button to continue (Figure 20).
Note: The number displayed on the controller screen should match the serial number
printed on the back of the external neurostimulator.
20 English 3537 2015-09-01
/
