Medtronic 3537 Programming Manual

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.)

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MR

Magnetic Resonance (MR) Unsafe

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Medtronic®, Verify®, and InterStim® are trademarks of Medtronic, Inc., registered in the U.S.

and other countries.

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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.

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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

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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).

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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.

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▪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.

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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).

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AM/PM format 24-hour format

Figure 5. Setting the time.

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 6. Selecting the number format.

6. Initiate pairing as follows:

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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.

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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.

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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.

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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.

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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.

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▪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:

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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.

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Medtronic 3537 Programming Manual

Medtronic 3537 Programming Manual

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