Medtronic A51300 Programming Guide

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CLINICIAN APP

FOR SACRAL NEUROMODULATION THERAPY

Clinician Programming Guide for InterStim™ systems

with Model 97800 InterStim X neurostimulator

A51300

Application version 1.0

SYMBOLS

Explanation of symbols in this manual

Refer to the appropriate product for symbols that apply.

Manufacturer

Authorized representative in the European community

For USA audiences only

Magnetic Resonance (MR) Conditional

Importer

Medtronic and the Medtronic logo are trademarks of Medtronic. Third party brands are trademarks of their respective owners. All other brands are trademarks of a Medtronic company.

Android

is a trademark of Google LLC.

The handset, as congured, does not support voice communication and therefore cannot be used to make any calls (including emergency calls).

Information available for the system:

The information for prescribers manual provides information about contraindications, warnings, precautions, adverse events, sterilization, patient selection, individualization of treatment, and component disposal.

For customers in Japan, the appropriate package insert provides information about indications, safety, contraindications, warnings, precautions, and adverse events.

The indications sheet provides information about indications and related information. For customers in Japan, the appropriate package insert provides information about indications.

The system eligibility, battery longevity, specications manual

provides information about neurostimulator selection, battery longevity calculations, and battery characteristics.

The system overview and compatibility insert provides information about component compatibility.

MRI guidelines provide information about any MRI conditions

and MRI-specic contraindications, warnings, and precautions

for MRI scans with the neurostimulation system.

Product manuals, such as programming guides, recharging guides, and implant manuals provide device descriptions,

package contents, device specications, product-specic

warnings and precautions, and instructions for use.

The clinical summary provides information about the

clinical study results for the neurostimulation system.

Refer to the literature provided by the clinician handset manufacturer for information regarding wireless use.

Refer to the Communicator technical manual for warnings, precautions, device description, package contents, device

specications, instructions for use, and maintenance

information.

GENERAL WARNINGS AND CAUTIONS ....9

OVERVIEW ................................................ 10

Intended Use ........................................................10

About This Guide ................................................10

QUICK TIPS ............................................... 11

Using the Workow Navigator ........................... 11

Indicators and Icons ........................................... 11

GETTING STARTED .................................. 13

Accessing the Clinician App .............................. 13

Creating a Password ...........................................13

Menu Screen ........................................................ 14

Demo Mode .......................................................... 14

Using the Communicator to Pair the Handset and

Neurostimulator ..................................................15

Setting Implant Date............................................16

WORKFLOWS ............................................ 18

Starting a Workow .............................................18

Conguring the Implanted Neurostimulator

(Congure Implant Workow) ............................ 18

Setting up implant conguration .....................................19

Entering patient information ............................................19

Checking device and system status ................................19

Therapy Parameter Settings ..............................21

Maximum settings .............................................................28

Optimizing device settings ...............................................28

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Selecting Cycling feature and time ..................................29

Performing an Integrity Measurement (Check

Impedance Workow) .........................................30

Electrode polarity ..............................................................31

Checking Neurostimulator MRI Eligibility (View

MRI Status Workow) .........................................32

MRI - PREPARING FOR AN MRI SCAN .... 33

WORKING WITH PROGRAMS .................. 37

Standard Programs ............................................. 37

Custom Programs ...............................................37

Enabling programs for patient use ..................................40

Reviewing a Therapy Programming Session ... 40

Ending a programming session .......................................41

Using the Stop Therapy feature .......................................41

DIAGNOSTICS ........................................... 42

Usage Graph ........................................................ 42

To view the usage graph: .................................................44

Event Log ............................................................. 44

Usage report ........................................................46

REPORTS .................................................. 47

Accessing a Downloaded Report ...................... 47

ADDITIONAL FEATURES .......................... 49

About Screen ....................................................... 49

Managing Devices .............................................. 49

Software Information ..........................................50

Data security ......................................................................50

Network connectivity ........................................................50

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Installing application updates ..........................................51

Installing communicator updates ....................................51

Returning the handset ......................................................51

Model A901 Communication Manager Application ........52

Model A902 Patient Data Service Application ................52

TROUBLESHOOTING ............................... 53

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GENERAL WARNINGS AND CAUTIONS

WARNINGS:

Wound contact — Do not use the communicator on an

unhealed wound. The communicator is not sterile, and contact with the wound may cause an infection. Keep a sterile bandage or barrier between the wound and device.

Sterile eld — When using the communicator in a

sterile eld, place the communicator in a sterile bag. The

communicator is not sterile and cannot be sterilized.

CAUTIONS:

Telemetry signal disruption from EMI — Do not attempt

telemetry near equipment that may generate electromagnetic interference (EMI). EMI may cause a disruption in clinician programmer function.

Unresponsive app or handset — Use the recommended troubleshooting steps if the clinician app or handset becomes unresponsive. An unresponsive app or handset may result in an inability to complete the implant procedure or other programming sessions.

Note: Other Warnings and Cautions are found throughout this manual.

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OVERVIEW

The Medtronic Model A51300 clinician application (app) is intended for use with the HH90 Handset and TM90 Communicator to program, adjust, and troubleshoot the Medtronic Model 97800 InterStim X neurostimulator.

Intended Use

The clinician app is intended to program neurostimulators for sacral neuromodulation therapy.

About This Guide

This programming guide contains information a clinician needs to set up, use, and troubleshoot the clinician app on the handset. This guide provides instructions on how to use the clinician app to program an implanted neurostimulator.

■ Before using the clinician app for the rst time, refer to the information provided with the handset for initial handset setup.

■ All patient-related instructions on using the patient app on the handset are included in the A52300 Patient Therapy App Patient User Guide for InterStim systems with Model 97800 InterStim X neurostimulator.

■ Patient-related instructions on using the communicator are included in the TM90 Communicator Instructions for Use provided with the device.

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QUICK TIPS

See the following information for helpful tips to aid you in using the clinician app, and to help you better understand the contents of this programming guide.

Using the Workow Navigator

The workow navigator is displayed at the top of every screen when you are in a workow and represents the

screens/ tasks that can be completed on each screen. A title

that is highlighted and underlined in the workow navigator indicates your position in that workow. For more information on workows, see “WORKFLOWS” on page 18.

You can use the workow navigator in the following ways:

■ Swipe to the left or right to view previous or subsequent screens within a workow.

■ Tap on a title to jump to a different screen.

A title that is highlighted and underlined indicates your position within a

workow.

Figure 1. Workow navigator

Indicators and Icons

The following is a list of the icons found in the clinician app along with their associated descriptions.

Notes:

■ The following is not an all-inclusive list of all the icons found in the clinician app, but rather a list of the more

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QUICK TIPS

important icons or those that appear most frequently within the app.

■ If an icon or button appears gray within the clinician app, that option is not available.

Icon Icon description

Tap for additional screen options.

Indicates that the neurostimulator device has been previously paired.

Tap to access the About screen, Manage Devices screen, or end a programming session. This icon appears only when in a

workow or on the Home screen.

Indicates that the clinician app is operating in Demo mode.

Displays the current electrode congurations

settings for a program.

Tap to check battery level.

Tap to check impedance.

Tap to exit the current screen and go back to the one you were previously on.

Indicates the program is enabled for patient use, and is visible to the patient.

Indicates the program is not enabled for patient use, and is not visible to the patient.

Tap to end the current programming session and exit the app.

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GETTING STARTED

Before using the clinician app to program the neurostimulator, see the following sections for basic information about:

■ Accessing the clinician app

■ Creating a password

■ Using the menu screen

■ Operating in Demo mode

■ Pairing to the implanted neurostimulator

Accessing the Clinician App

You can access the clinician app by locating the InterStim X Clinician icon on the main screen of the handset (Figure 2). Tap the icon to open and begin using the clinician app.

InterStim X

Clinician

Figure 2. A51300 Clinician app icon for the Model 97800

InterStim X neurostimulator

Note: The rst time you open the app, it will request

permission for data storage and session overlay. Tap OK to continue. Then tap ALLOW on the next message.

Creating a Password

The clinician app requires a password to use the app. A password is required to be entered under the following conditions:

■ Upon launch of the app

■ After 30 minutes of inactivity

Note: When you launch the clinician app for the rst time,

you will be asked to enter the default password. Contact

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Medtronic support for the default password. You will need to obtain the default password before creating your own unique password.

To create a password:

1. Enter the Medtronic default password in the appropriate

eld. Contact Medtronic support to obtain the default

password if you haven’t already.

2. Tap OK to continue to the next screen.

3. Enter your unique password in the appropriate eld.

Note: The password is case-sensitive and must contain at least six characters.

4. Conrm your new password by entering it a second

time in the appropriate eld and tap CREATE when nished.

Note: For information on resetting a forgotten password, see “TROUBLESHOOTING” on page 53.

5. Select your region using the options provided on the handset.

6. Tap NEXT to continue on to the Menu screen.

Menu Screen

Upon entering your password, you are taken to the Menu screen. On the Menu screen, you can access Demo mode, connect the communicator and neurostimulator to the handset, or access patient reports.

Demo Mode

Demo mode allows you to simulate using the clinician app without being paired to an actual neurostimulator device. DEMO is displayed next to the screen title when the clinician app is operating in Demo mode.

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Using the Communicator to Pair the Handset and Neurostimulator

All programming functionality takes place within the Connect option on the Menu screen. Tapping this option allows you to begin the process of using the communicator to pair the implanted neurostimulator to the clinician app on the handset.

To pair the handset and implanted neurostimulator using the communicator:

1. Press

on.

2. Navigate to the Menu screen, and tap CONNECT.

3. Place the communicator near the handset.

4. The communicator will attempt to connect to the

handset. The blue LED indicator on the communicator will continuously blink to indicate it is on and in discovery mode.

5. If you have previously paired the communicator to the

handset, the communicator will automatically attempt to connect to the handset. If the blue LED indicator on the communicator is solid and no longer blinking, the communicator is now connected to the handset, skip to step 8.

Note: If you are having trouble connecting the communicator to the handset, see

“TROUBLESHOOTING” starting on page 53.

6. If the communicator has not been previously paired to

the handset, tap SWITCH COMMUNICATOR on the handset.

7. Select the appropriate communicator device according

to the serial number shown on the Connection screen, and tap CONTINUE. The blue LED indicator on the communicator will be solid and no longer blinking. This

signies the communicator is now connected to the

handset.

on the communicator to turn the communicator

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Note: The serial number, e.g. NPA-xxxxxxx, is located on the back of the communicator, and should match what is listed on the Connection screen.



CAUTION: Ensure you are connecting to the proper

communicator by conrming the serial number on

the device. Failure to do so could extend the implant procedure or programming session.

8. Ensuring the communicator is on, place the communicator over the implanted neurostimulator site and tap FIND DEVICE on the handset.

9. Select the appropriate neurostimulator device according to the serial number and tap CONTINUE. If the neurostimulator serial number is not listed on the Connection screen, tap RETRY.

Notes:

■

displayed next to the serial number of the neurostimulator device indicates which device has been most recently paired to the handset.

■ Connecting to a new INS may take some time. If the

INS has not nished connecting after a few minutes,

press Cancel and try again.

■ If you are having problems pairing to the

neurostimulator, refer to “TROUBLESHOOTING” on

page 53.

Setting Implant Date

Set implant date in the eld shown on the screen in Figure 3.

To view implant date, navigate to the About screen.

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Figure 3. Set Implant Date screen (serial number shown is for

example only).

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WORKFLOWS

Workows are used to assist you in navigating programming sessions. Workows for programming an implanted

neurostimulator include:

■ Congure implant

■ Check impedance

■ View MRI status

Starting a Workow

Starting a workow allows you to complete tasks for a programming session. You can access workows on the

Home screen.

To start a workow:

1. Tap the name of a workow to see an expanded view and description.

2. Tap START to proceed with the desired workow.

Conguring the Implanted Neurostimulator (Congure Implant Workow)

The Congure Implant workow allows you to congure

the neurostimulator for a patient. The main features of the

Congure Implant workow include:

■ Manage implant conguration

■ Manage patient information

■ Congure therapy parameters

■ Check therapy and/or electrode impedance

■ Check battery status

■ Enable programs for patient use

■ Create custom programs

■ View a diagnostic report

■ View the summary screen

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Setting up implant conguration

The Congure Implant screen allows you to enter information

required for determining the patient’s MRI eligibility, such as lead model, device implant location, lead tip location, and the presence of abandoned product from removed systems. Even partial systems can have MRI interactions such as RF heating.

WARNING: Ensure the implant conguration is up-to-date

and accurate. If component information is entered incorrectly, the patient could be unnecessarily restricted from having an MRI scan or could be allowed to have an inappropriate MRI scan, which could cause serious or permanent patient injury.

Entering patient information

The Patient screen allows you to enter optional patient information (name, patient ID, gender, and date of birth).

Checking device and system status

The Status screen provides information about the neurostimulator and allows you to check the battery level of the neurostimulator and system impedance. Notice the battery and impedance rows; tap the battery and impedance icons for details. Table 1 displays the device status icons for impedance check and their associated description and meaning.

Table 1. Neurostimulator impedance check icons and descriptions

Icon Description Meaning

Orange circle with exclamation point

Green circle with check mark

Status is suspect. Requires further investigation.

Status is good. No further investigation needed.



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Note: A question mark appears in the impedance row if an impedance check has not been performed. Electrodes with impedance measurements outside the nominal impedance range will display an orange icon.

Checking battery level

Use the following steps to check the battery levels of the neurostimulator, handset, and communicator:

1. Navigate to the CONFIGURE IMPLANT workow.

2. Tap START.

3. Navigate to the Status screen and tap

next to the

battery level to see the current battery levels.

4. Tap DONE to exit the Battery screen when nished.

Table 2. Neurostimulator battery descriptions shows battery levels for the neurostimulator.

Table 2. Neurostimulator battery descriptions

Battery Status Battery Level

LOW

Battery is approaching End of Service, see below.

Notication: End of Service

End of Service

Therapy will be stopped and the neurostimulator will need to be replaced. You will not have access to the clinician application after you have received this

notication.

Notes:

■ Do not implant the neurostimulator if the battery status displays LOW or End of Service prior to implant.

■ If the neurostimulator battery level is LOW, a low battery

notication displays on the Home screen. The notication

persists until the neurostimulator is replaced; however,

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you have the ability to dismiss the notication at any

time.

Impedance measurements

You can check impedance on the Status screen of the

Congure Implant workow, or within the Check Impedance workow.

Note: Electrodes with impedance measurements outside

the nominal impedance range will display an orange icon.

See “Table 1. Neurostimulator impedance check icons and

descriptions” on page 19 for details.

To check impedance from the Congure Implant workow:

1. Select the CONFIGURE IMPLANT workow.

2. Tap Start.

3. Navigate to the Status screen.

4. Tap

5. Tap

6. Tap DONE when nished.

again to initiate an impedance check.

Notes:

■ Tapping Impedance screen where you can view the current impedance values of the respective electrode pairs and neurostimulator case.

■ You can tap the status icon on any electrode to view the current impedance values.

on the status screen will take you to the

Therapy Parameter Settings

You can adjust therapy parameter settings as needed for a program in order to provide optimal therapy. You can access therapy parameter settings by navigating to the Therapy

screen in the Congure Implant workow.

During a programming session, the clinician app modies the specied therapy parameters to program the neurostimulator.

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Table 3 lists the available therapy parameter settings along with their descriptions.

Table 3. Therapy parameter descriptions

Therapy

Description parameter setting

Amplitude Amplitude is the intensity or strength of the

Pulse Width

Rate Rate is the number of times per second a pulse is

Optional settings: The following are optional therapy parameters

that can be modied if optimal therapy is not provided through

default standard programs.

stimulation measured in milliamps (mA). By

increasing amplitude, you are increasing the

intensity of the stimulation and by decreasing it, you

are reducing the intensity. The goal is to use the

lowest effective amplitude that will provide optimal

patient symptom relief, minimize patient discomfort,

and maintain neurostimulator battery life to the best

possible extent.

A typical setting for amplitude is based on patient

comfort, which is determined during a programming

session. Available amplitude range is 0-12.5 mA.

Pulse width is the time or duration of the stimulation

pulse measured in microseconds (μsec). Increasing

pulse width increases pulse duration and

decreasing pulse width decreases pulse duration.

For example, when a patient feels the stimulation

too intensely in one body location, increasing the

pulse width spreads the stimulation and makes it

less intense in that location.

Default setting for pulse width is 210 μsec.

delivered, measured in pulses per second (pps)

or Hertz (Hz). Increasing the rate feels more like a

“utter” or “vibration” and decreasing the rate gives

more of a “tapping” or “thumping” sensation. You

can use patients’ preferences for the sensation they

are most comfortable with, to guide you in selecting

an appropriate rate.

Default setting for rate is 14 pulses per second.

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Therapy

Description parameter setting

Amplitude limit

Cycling Cycling is a feature used to control how often

Selecting an Amplitude Limit sets the boundary for

how high the amplitude value can be raised above

the programmed therapy amplitude value by the

patient. After a programming session, patients can

control therapy amplitude using the patient app, but

within the programmed Amplitude Limit set by the

clinician.

When Amplitude Limit is not dened, patients can

increase therapy amplitude to the maximum therapy

amplitude value allowed.

therapy is running. When the Cycling feature is off,

therapy is continuously running. When the Cycling

function is turned on, it automatically turns the

neurostimulator on and off at clinician-determined

intervals (from 2 seconds to 24 hours). When

Cycling On time is over, therapy turns off and

continues to stay off until Cycling Off time ends.

When Cycling Off time is over, therapy turns on

again and continues to stay on until Cycling On time

ends. This process repeats itself until the Cycling

feature is disabled or therapy is stopped. By default,

the Cycling feature is turned off.

Note: Due to a carryover effect, the patient may continue to experience symptom improvement during the Cycling Off time.

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Therapy

Description parameter setting

SoftStart/

Stop

This feature is intended to increase patient comfort

by providing a gentle or “soft” start as stimulation

begins and reduces the risk that the patient will be

startled by the start of a stimulation cycle. Using the

SoftStart/Stop feature helps avoid any unpleasant

sensation at the onset of stimulation. Programmable

ramp times for this feature (up and down) are 1, 2,

4, 8, 15, or 30 seconds. By default, SoftStart/Stop is

turned On with a ramp time of 4 seconds.

Therapy Parameter Settings Instructions For Use

To turn on therapy by setting the amplitude:

1. Select the CONFIGURE IMPLANT workow.

2. Tap START.

3. Navigate to the Therapy screen, and tap the program

you would like to congure (Figure 4).

4. Use the arrows to set the amplitude. Hold the Up or Down arrows to adjust the amplitude by increments of

0.5 mA.

Note: If the patient is experiencing discomfort, therapy can be stopped at any time. Tap

to stop therapy.

5. Tap DONE when nished.

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Indicates that the program is visible to the patient.

Displays the electrode conguration for

the program.

Figure 4. Therapy screen

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To set pulse width:

1. Select the CONFIGURE IMPLANT workow.

2. Tap START.

3. Navigate to the Therapy screen, and tap the program

you would like to congure (Figure 4).

4. Tap

5. Select Pulse Width from the list of options.

6. Use the arrows to set the pulse width.



CAUTION: Consider default settings for rate

and pulse width when conguring therapy settings.

Unsuitable stimulation could result in patient discomfort.

7. Tap UPDATE.

8. Tap DONE when nished.

9. Tap DONE again to return to the Therapy screen.

To set rate:

1. Select the CONFIGURE IMPLANT workow.

2. Tap START.

3. Navigate to the Therapy screen, and tap the program

you would like to congure (Figure 4).

4. Tap

5. Select Rate from the list of options.

6. Use the arrows to set the rate.



CAUTION: Consider default settings for rate

and pulse width when conguring therapy settings.

Unsuitable stimulation could result in patient discomfort.

7. Tap UPDATE when nished.

8. Tap DONE when nished.

9. Tap DONE again to return to the Therapy screen.

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To view electrode settings:

1. Select the CONFIGURE IMPLANT workow.

2. Tap START.

3. Navigate to the Therapy screen, and tap the program

you would like to congure (Figure 4).

4. Tap

5. Select Electrodes from the list of options. The

Electrode screen displays the current electrode settings for the selected program.

6. Tap DONE when nished.

Notes:

■ Electrode settings for programs 1-7 are set up by default and cannot be changed.

■ You can also view electrode settings for programs on the Therapy screen (Figure 4).

To set amplitude limit:

1. Select the CONFIGURE IMPLANT workow.

2. Tap START.

3. Navigate to the Therapy screen, and tap the program

you would like to congure (Figure 4).

4. Tap

5. Select Amplitude Limit from the list of options.

6. Tap the On/Off switch to enable amplitude limit.

Note: Tap the On/Off switch again to disable.

7. Use the arrows to set the amplitude limit.

8. Tap UPDATE when nished.

9. Tap DONE when nished.

10. Tap DONE again to return to the Therapy screen.

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Notes:

■ When the On/Off switch is turned on, the amplitude limit will default to the current amplitude setting.

■ The amplitude limit cannot be set at a value lower than the current amplitude setting for an active program.

Maximum settings

The system cannot use certain combinations of amplitude, pulse width, and rate because the neurostimulator has reached the limit of its therapy range. If this happens, a Maximum Settings Reached alert will appear, and an orange icon will appear to the left of the parameter value, indicating that stimulation is not being provided at the level that is shown on screen.

To resolve this condition, perform one of the following actions:

■ Slowly reduce the stimulation parameter until the icon disappears.

■ Reduce other parameter values to set a desired value higher. For example, if high amplitude is desired, reduce the rate or the pulse width.

For additional information on troubleshooting these types of

errors, refer to “Maximum Settings Reached troubleshooting”

on page 60.

Optimizing device settings

The clinician app offers features that you can optionally use to increase patient comfort and when certain parameters are used, extend neurostimulator battery life. These features include:

■ Cycling

■ SoftStart/Stop

See “Therapy Parameter Settings” on page 21 for more

information on setting additional therapy parameters.

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Selecting Cycling feature and time

The Cycling feature automatically turns the neurostimulator On and Off at clinician-determined intervals from 2 seconds to 24 hours. Cycling, by default, is disabled.

Note: When using both SoftStart/Stop and Cycling features, only SoftStart/Stop times that are less than or equal to the Cycling On and Cycling Off times are available for programming.

To enable SoftStart/Stop:

1. Navigate to the CONFIGURE IMPLANT workow.

2. Tap START.

3. Navigate to the Therapy screen, and tap the program

you would like to congure (Figure 4).

4. Tap

5. Tap SoftStart/Stop from the list of options.

6. Tap the On/Off switch to enable SoftStart/Stop.

7. Use the arrows to congure the SoftStart/Stop time for

8. Tap UPDATE.

9. Tap DONE when nished.

10. Tap DONE again to return to the Therapy screen.

Note: To disable, tap the On/Off switch again.

the implanted neurostimulator.

To enable Cycling:

1. Select the CONFIGURE IMPLANT workow.

2. Tap START.

3. Navigate to the Therapy screen, and tap the program

you would like to congure (Figure 4).

4. Tap

5. Tap Cycling from the list of options.

6. Tap the On/Off switch to enable Cycling.

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Note: Tap the On/Off switch again to disable.

7. Use the arrows to set the Cycle On time and Cycle Off time for the implanted neurostimulator. The length of Cycle On time and Cycle Off time is measured in seconds.

8. Tap UPDATE.

9. Tap DONE when nished.

10. Tap DONE again to return to the Therapy screen.

Performing an Integrity Measurement (Check Impedance Workow)

An impedance measurement can be run to check system integrity. Run an impedance check at the beginning of every programming session.

To check impedance from the Check Impedance workow:

1. Select the CHECK IMPEDANCE workow.

2. Tap START.

3. Tap

4. Tap DONE when nished.

to check electrode impedance (Figure 5).

Notes:

■ Tapping Impedance screen where you can view the previous impedance measurement of the electrodes.

■ You can tap the status icon on any electrode to view the individual impedance values.

on the status screen will take you to the

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Tap the numbered circle icons to view impedance

measurement values for the corresponding electrode.

Figure 5. Impedance screen

Electrode polarity

The stimulation pulse is delivered from the neurostimulator to the nerve through the electrodes on the leads. For the stimulation pulse to reach the nerve, you select the electrodes on the lead that best provide the stimulation and

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assign a negative or a positive polarity. At least one electrode (or the neurostimulator case) must be designated as positive and at least one electrode must be designated as negative. The negative electrode is called the active electrode; a pulse

ows from the active or negative electrode to the positive.

Thus, changing an electrode to active changes the location of the stimulation pattern.

Conguring electrodes depends on how the leads and

electrodes are placed in relation to the nerve that is being

stimulated. Approach conguration systematically, using a variety of electrode congurations and mapping sensory responses to each conguration. The four electrodes on a lead can be congured with or without the neurostimulator

case:

■ Unipolar—Using any combination of electrodes with at least one electrode as negative and the neurostimulator case as positive.

■ Bipolar —Using any combination of electrodes with at least one electrode as positive, one negative, and the case off.

Note: The neurostimulator case can only be congured as

positive. When the case is selected, lead electrodes can only be selected as negative.

Checking Neurostimulator MRI Eligibility (View MRI Status Workow)

The Model 97800 InterStim X neurostimulator may be eligible for MRI scans. Follow the instructions beginning on page 33 to assess neurostimulator eligibility and to prepare the neurostimulator for an MRI scan.

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MRI - PREPARING FOR AN MRI SCAN

Magnetic Resonance (MR) Conditional: Depending on

what kind of neurostimulation system components the patient has implanted, the patient may be eligible for one of the following types of magnetic resonance imaging (MRI) scans:

■ MRI scans of the head only (this is referred to as head- scan only eligible).

■ MRI scans of any part of the body (this is referred to as full-body scan eligible).

Use the clinician app on the patient’s handset to activate MRI mode, assess MRI eligibility, and prepare the patient’s InterStim system for an MRI scan. For the MR conditions and

MRI-specic warnings and precautions for conducting an

MRI scan, refer to the MRI Guidelines for InterStim systems Manual.

WARNING: Do not conduct an MRI scan on a patient before assessing MRI eligibility. Instruct the patient to inform the MRI clinician that the patient has an implanted device, and to activate MRI mode before the scan. Conducting an MRI scan on a patient who is ineligible for an MRI scan could result in device damage or serious or permanent patient injury.

CAUTION: Deactivate MRI mode when the MRI scan is complete and the patient is outside the MRI scanner (magnet) room. Failure to deactivate MRI mode and return amplitude to the previous therapy level may result in a return of symptoms.

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MRI - PREPARING FOR AN MRI SCAN

Instruct the patient prior to the MRI scan to:

■ Bring the handset and communicator to the MRI appointment, however not to take any patient control device into the MRI scanner (magnet) room.

■ Bring the patient identication (ID) card provided by Medtronic for the implanted neurostimulation system.

■ Tell the MRI clinician that they have an implantable device.

■ Activate MRI mode before MRI scan, outside the MRI scanner (magnet) room. MRI mode turns therapy off and prepares the system for MRI scanning. Because therapy is off, symptoms may return.

Notes:

-Remind the patient to make sure the handset and communicator are charged prior to the MRI appointment.

-Even though the patient’s implanted system is eligible for certain MRI scans, the patient’s scan-type eligibility depends on factors including:

■ The area of the patient’s body that needs to be scanned

■ The ability of the MRI facility to meet all the required conditions for scanning

Viewing the patient’s MRI scan-type eligibility and activating MRI mode:

1. From the Home screen, tap VIEW MRI STATUS.

2. From the Eligibility Identication screen, conrm that the information for the patient’s implanted components (ie, neurostimulator and lead model) and their location are current and accurate. Tap CONFIRM.

Note: If the information for the implanted components and their location is not up-to-date and accurate, the resulting MRI scan-type eligibility may be incorrect.

3. Place the communicator over the device and tap ACTIVATE to activate MRI mode. Activating MRI mode

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MRI - PREPARING FOR AN MRI SCAN

turns therapy off.

4. Determine which one of the following messages

appears on the MRI eligibility screen:

− MRI Conditional Full Body Scan Eligible

− MRI Conditional Head Scan Eligible with Transmit/ Receive Head Coil

− MRI eligibility cannot be determined

Note: If the handset screen says MRI eligibility cannot be determined, further assessment is necessary. Review reasons for result on screen.

5. See Table 4 for examples of the MRI eligibility

messages. The screen conrms the patient’s MRI scan-

type eligibility and whether MRI mode is activated.

6. If you will not be present at the MRI facility or are not activating MRI mode prior to the patient’s MRI scan, explain to the patient how to activate MRI mode using the handset at the MRI exam.

Note: You may also complete the MRI scan-type eligibility form provided in the MRI Guidelines for InterStim systems Manual and give the form to the patient so that they can take it to their MRI exam.

Table 4. SCAN ELIGIBILITY screen displays

Scan

Eligibility

MR Conditional Full Body Scan Eligible

Screen image, text and description

MRI Mode is Activated

MR Conditional Full Body Scan Eligible

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MRI - PREPARING FOR AN MRI SCAN

Scan

Screen image, text and description

Eligibility

MR Conditional Head Scan Eligible with Transmit/ Receive Head Coil

MR Conditional Head Scan Eligible with

Cannot be Determined

MRI mode is activated but scan-type eligibility cannot be determined. Review reasons for eligibility result on screen.

MRI Mode is Activated

Transmit/Receive Head Coil

MRI Mode is Activated

MRI eligibility cannot be determined

Notes:

Refer to the MRI Guidelines for InterStim systems Manual for more information about determining MRI eligibility.

The “consult instruction for use” symbol (

) when shown

with MRI scan eligibility means “consult the MRI guidelines

for this neurostimulation system.”

Deactivating MRI mode and turning therapy on after the patient’s MRI scan:

1. Connect to the neurostimulator as usual.

2. From the Home screen, tap VIEW MRI STATUS.

3. Tap DEACTIVATE at the bottom of the screen.

4. Tap DEACTIVATE a second time when prompted.

5. Tap YES when prompted to return to previous therapy settings, if desired.

Note: If the Home screen is not shown after completing step 1, refer to “TROUBLESHOOTING” on page 53.

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WORKING WITH PROGRAMS

Standard and custom programs are available within the clinician app. These features allow you to provide optimal therapy for the patient. Standard programs provide pre-

dened electrode congurations. If default electrode settings

from standard programs provide less than optimal therapy,

custom programs allow you to manually dene electrode

settings.

Standard Programs

Programs marked 1-7 under Program Library on the Therapy

screen of the Congure Implant workow signify standard programs with pre-congured electrode settings. Only one

program, either standard or custom, can be active at a time. The active program name is displayed at the top of the Therapy screen under ACTIVE PROGRAM.

Note: Upon switching from one active program to another, therapy amplitude automatically resets to zero.

Custom Programs

If the electrode settings for standard programs (1-7) do not provide optimal therapy results, you have the option to create custom programs using custom electrode settings. Programs A-D signify custom programs that you can create using

custom electrode conguration settings. You can create up to

four custom programs.

To create a custom program:

1. Select the CONFIGURE IMPLANT workow.

2. Tap START.

3. Navigate to the Therapy screen.

4. Scroll to the bottom of the screen, and tap

5. Tap

6. Set the electrode conguration by tapping in the box

to congure the electrodes for the custom

program.

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WORKING WITH PROGRAMS

for each electrode you want to congure. Tap once for

a positive (+) electrode, tap again for a negative (-) electrode, and once more to clear (Figure 6).

Notes:

■ Therapy must be off before modifying electrode conguration settings.

■ There must be at least one positive (+) electrode and one negative (-) electrode for a viable electrode

conguration.

■ If the case is set to positive (+), the lead electrodes used must be negative (-).

7. Tap UPDATE after the electrode congurations have been set.

8. Tap DONE when the update is complete.

9. Adjust the parameter settings as desired. For

step by step instructions, see “Therapy Parameter

Settings Instructions For Use” on page 24 for more information.

10. Tap DONE again to return to the Therapy screen.

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WORKING WITH PROGRAMS

Tap inside the individual numbered boxes to congure electrodes for custom

programs.

Figure 6. Set electrode congurations for custom programs

Deleting a custom program

In the event that a custom program is no longer needed or used, it can be deleted at any time.

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WORKING WITH PROGRAMS

To delete a custom program:

1. Navigate to the CONFIGURE IMPLANT workow.

2. Tap START.

3. Navigate to the Therapy screen, and tap the custom program you would like to delete.

4. Scroll to the bottom of the screen, and tap

Note: You cannot delete a custom program if the custom program is active.

Enabling programs for patient use

In order for patients to use a program, the program needs to be enabled for patient use.

To enable a program for patient use:

1. Navigate to the CONFIGURE IMPLANT workow.

2. Tap START.

3. Navigate to the Therapy screen, and tap the program you would like to enable.

4. On the bottom of the screen, tap the Enable for patient use switch once to make the program enabled for patient use.

Note: Tap the Enable for patient use switch again to disable the program for patient use.

5. Tap DONE when nished. program indicating that the program is visible to the patient.

is displayed next to the

Reviewing a Therapy Programming Session

The last screen in the Congure Implant workow is the

Summary screen. The Summary screen displays the active program setting and a list of patient enabled programs for a programming session.

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WORKING WITH PROGRAMS

Note: On the Summary screen, you can also view a session report. For more information, see “REPORTS” on page 47.

Ending a programming session

After completing the necessary programming tasks in a

workow, end the programming session.

CAUTION: End programming session — Do not leave a

programming session open in the clinician app once therapy

has been congured. Not ending a programming session may

result in patient access to the clinician app, resulting in the

patient being able to congure inappropriate therapy.

To end a programming session:

1. Tap

2. Tap End Session.

3. Conrm that you would like to end the programming

session by tapping END SESSION.

Note: Alternatively, you can also tap screen to end a programming session.

in the corner of the screen.

on the Home

Using the Stop Therapy feature

The Stop Therapy feature allows you to discontinue therapy

at any time while in the Congure Implant workow.

To stop therapy:

1. Select the CONFIGURE IMPLANT workow.

2. Tap START.

3. Navigate to the Therapy screen, and tap the program

you would like to congure.

4. Tap

5. Tap DONE to return to the Therapy screen.

Note: For instructions on turning therapy back on, see “To turn on therapy by setting the amplitude:” on

page 24.

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DIAGNOSTICS

The clinician app allows you to view the following diagnostics to analyze a patient’s therapy:

■ Usage graph

■ Event log

■ Usage report

Usage Graph

The usage graph represents daily patient activity while using the therapy (Figure 7). The usage graph displays programs used, the amplitude setting and adjustments, as well as the duration of time each program was used. Each program is represented in the graph through the use of different colors and program numbers.

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DIAGNOSTICS

Time-stamp on the y-axis represents the duration of the program used.

Indicates the program used.

Amplitude values on the x-axis represent the amplitude value each program is

set to.

Figure 7. Usage graph

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DIAGNOSTICS

To view the usage graph:

1. Select the CONFIGURE IMPLANT workow.

2. Tap START.

3. Navigate to the Diagnostics screen, and tap

Notes:

■ Amplitude adjustments are only displayed for amplitude values that have been programmed for 30 minutes or more.

■ The graph displays up to the last 30 days of patient data.

Event Log

The event log provides the following information (Figure 8):

■ Date and time of therapy changes

■ Amplitude adjustments (if programmed for 30+ minutes)

■ Program changes

■ Power-on-resets (POR)

■ Change in therapy status (ON/OFF)

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DIAGNOSTICS

Indicates changes in amplitude.

Indicates changes in programs.

Figure 8. Event log

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DIAGNOSTICS

To view the Event log:

1. Select the CONFIGURE IMPLANT workow.

2. Tap START.

3. Navigate to the Diagnostics screen.

4. Tap

Usage report

The usage report displays data from both the usage graph and event log.

To generate a usage report:

1. Select the CONFIGURE IMPLANT workow.

2. Tap START.

3. Navigate to the Diagnostics screen.

4. Tap GENERATE USAGE REPORT.

Note: You can access the generated report by navigating to REPORTS on the Menu screen.

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REPORTS

The clinician app allows you to generate reports that track data once the neurostimulator has been implanted and

congured for chronic therapy. Access reports by tapping

REPORTS on the Menu screen.

Table 5. Reports and descriptions

Report Description

Session report • Displays the patient’s active

Usage report • Includes information from the

Medtronic data report • Generated from the Device tab

program settings.

• Generates automatically anytime the clinician ends a programming session.

event log and usage graph.

• Generated from the Diagnostics screen.

on the About screen.

• Used by Medtronic to troubleshoot the system.

To view, download, or delete reports:

1. Navigate to the Menu screen and tap REPORTS.

2. From the list of options, tap the type of report that you would like to view.

3. Tap the desired report to view a list of options.

a. Tap

b. Tap

c. Tap

to view a report.

to download a report.

to delete a report.

Accessing a Downloaded Report

If you need to download a report, see the following instructions on how to download the report and access it using your computer.

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REPORTS

To download and access a report:

1. Navigate to the Menu screen and tap REPORTS.

2. From the list of options, tap the type of report that you would like to view.

3. Tap the desired report to view a list of options.

4. Tap

to download. A pop-up displays that the report

has been saved to the Reports folder.

5. Plug the handset into a computer using the micro USB cable that came with the handset.

6. Navigate to the Reports folder from your computer drive. The Reports folder stores the reports that were downloaded from the clinician app.

Note: Generated reports will remain on the handset for 24 hours before being deleted automatically.

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ADDITIONAL FEATURES

See the following sections for information on the additional features of the clinician app.

About Screen

You access the About screen by tapping in the corner of the screen and selecting About from the list of options. The About screen provides the following information:

■ Handset and app information such as model numbers, serial number, version numbers, etc.

■ Neurostimulator device information such as model number and serial number.

■ Communicator information such as rmware version number and serial number.

■ General licensing information

Managing Devices

The Manage Devices screen allows you to view, add or remove a neurostimulator device. The Manage Devices screen can be accessed in the following ways:

1. From the Menu screen:

a. Tap

b. Tap Manage Devices from the list of options.

2. After a device has already been connected:

a. Tap

b. Tap Manage Devices from the list of options.

3. Tap DONE when nished.

Note: Tap device. You will be redirected to either the Home screen or Menu screen depending on your selection.

to remove a device, or to add a new

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ADDITIONAL FEATURES

Software Information

The following is important information regarding Medtronic therapy application software.

Data security

InterStim system clinician apps use and store data about the patient’s health and implanted medical device. Data is protected by encryption within the application and encryption provided by the handset. The system does not protect data exported to another destination. Exported data should be handled in accordance with your facility’s security policy for data handling and storage.

■ Medtronic recommends that you always save exported data to the default reports location on the handset.

Network connectivity

Network connectivity is required for initial app registration and for installation of Medtronic app updates and communicator

rmware updates. Network connectivity is not required for

neurostimulator programming. To protect patient information, Medtronic recommends you implement the following security measures:

■ Secure the handset by disabling network connectivity during any programming session.

■ Use a managed, trusted Wi-Fi connection when network connectivity is needed.

■ Connect the handset to the network quarterly to check

for update notications.

■ Connect the handset to the network long enough for all updates to install successfully.

Note: Connecting the handset to a network that includes other equipment could result in unforeseen risks to patients, operators, or third parties. Changes to your network (such as adding, disconnecting, and upgrading equipment; upgrading

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ADDITIONAL FEATURES

or installing software; or changing network congurations)

could also introduce additional risks.

■ If your handset is lost or stolen, contact Medtronic right away using the contact information listed on the back cover of this manual.

■ If you suspect a cybersecurity event has occurred, stop using the app (if possible), and contact your IT department or Medtronic support to document and respond to the suspected incident.

If you have any further questions related to cybersecurity, contact your IT department or Medtronic support.

Installing application updates

The clinician app along with other related apps are provided pre-installed on the Android cannot be installed on a personal cellular phone. Medtronic periodically updates the therapy app and will not install updates without notifying the user. Network connectivity is

required to update the app. When notied that an app update

is available, follow the instructions provided by Medtronic to install the update. Remain connected to the network until

the update successfully installs and then conrm the correct

software version in the About screen.

platform-based handset and

Installing communicator updates

When you receive a notication to install a communicator rmware update, connect the handset to a network and follow

the instructions.

Returning the handset

If you need to return the handset for disposal or replacement, contact Medtronic using the contact information listed on the back cover of this manual. Instructions will be provided for preparing the clinician handset for return.

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ADDITIONAL FEATURES

Model A901 Communication Manager Application

The Model A901 Communication Manager app works with the Model A51300 Clinician Programming app to manage telemetry communication between the handset and the neurostimulator. You do not need to open or use this app.

Model A902 Patient Data Service Application

The Model A902 Patient Data Service app works with the Model A51300 Clinician Programming app to store patient and therapy device records that are used when generating a report. You do not need to open or use this app.

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TROUBLESHOOTING

The clinician app displays notications you may encounter

while using the app. If you are experiencing problems with the handset, check the app screen and follow the instructions to correct the issue. If you experience an issue not described in this section, contact your Medtronic support representative.

Table 6. Clinician app, handset, and communicator scenarios and solutions

Scenario Explanations and possible

solutions

I am unable to connect to the communicator

The communicator is not powered on. You will need to turn on the communicator to communicate with the implanted neurostimulator.

Once the communicator is powered on, follow the connection steps to attempt to reconnect to an existing communicator. See,

“Using the Communicator to Pair

the Handset and Neurostimulator” on page 15 for instructions.

Note: For information on features and functions of the communicator, refer to the TM90 Communicator Instructions For Use.

The communicator is not charged or is in the process of charging. You will need to charge the communicator using the charger provided with the product package.

Once charged, follow the connection steps to attempt to reconnect to an existing

communicator. See, “Using

the Communicator to Pair the Handset and Neurostimulator” on page 15 for instructions.

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TROUBLESHOOTING

Scenario Explanations and possible

solutions

The communicator is not paired to the handset.

Follow the connection steps to attempt to reconnect to an existing

communicator. See, “Using

the Communicator to Pair the Handset and Neurostimulator” on page 15 for instructions.

Note: The communicator must be

paired to the handset rst before

attempting to connect to the neurostimulator.

You received a replacement communicator. You will need to connect the new communicator to the handset and the implanted device.

1. Open the clinician app.

2. Make sure the communicator is on.

Note: For information on features and functions of the communicator, refer to the TM90 Communicator Instructions For Use.

3. A screen will be displayed showing that the communicator is not found. Tap SWITCH COMMUNICATOR to connect.

4. Select the communicator you would like to pair to. The serial number of the communicator should match the serial number shown on the screen.

5. If the communicator you would like to connect to is not shown, tap RETRY. Follow the remaining instructions on the

handset to nish pairing the

device.

6. If the issue persists, contact Medtronic support.

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TROUBLESHOOTING

Scenario Explanations and possible

solutions

I am unable to communicate with the implanted neurostimulator

Uncomfortable or intolerable therapy

The handset has no power or has lost power

The handset will not charge

The communicator is out of range.

1. Reposition the communicator over the neurostimulator and tap RETRY. Make sure the

communicator is ush with the

skin.

2. If the issue persists, contact Medtronic support.

The patient is experiencing side effects from the therapy (stimulation).

1. Turn the therapy (stimulation) down or off.

See “Therapy Parameter Settings” on page 21 for instructions.

2. If the issue still persists, contact Medtronic support.

The handset battery is depleted.

Recharge the handset battery using the charger.

The handset is damaged or malfunctioning.

Contact Medtronic support.

The charger is disconnected from the handset.

Connect the charger to the handset.

An incompatible charger is connected to the handset.

Connect the appropriate charger to the handset.

Charger is defective.

Contact Medtronic support. The charger will need to be replaced.

The handset is damaged or malfunctioning.

Contact Medtronic support.

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TROUBLESHOOTING

Scenario Explanations and possible

solutions

The patient is not receiving therapy

I cannot nd the clinician app on the handset

I have forgotten my password

The handset or clinician app is unresponsive

The therapy might be off.

Turn on the therapy.

The neurostimulator battery may be depleted.

The neurostimulator will need to be replaced.

A lead is damaged or has become disconnected.

Check the impedance on the lead. If impedance is out of range, the lead may be damaged. If impedance is in range, select a different program. If the issue persists, contact Medtronic support.

The clinician app may not have downloaded properly.

Contact Medtronic support.

The password needs to be reset. To reset the password

1. Tap the “Forgot Password” icon.

2. Take note of the six-character code. You will need to provide this code to Medtronic support in order to complete the steps to reset your password.

Note: This code is valid for 24 hours. After 24 hours, you will need to refresh the code.

3. Contact Medtronic support to complete the steps to reset your forgotten password.

If the handset or the clinician app is unresponsive:

1. Turn the handset Off, then turn the power back On and make sure the handset is charged.

2. If that doesn’t resolve the issue, use another handset, if available

3. If the issue persists, contact Medtronic support.

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TROUBLESHOOTING

Scenario Explanations and possible

solutions

I can’t nd my downloaded report

I want to unpair or disconnect the neurostimulator from the apps.

Downloaded reports can be found in the Reports folder on the handset.

You can access a downloaded report by navigating to the Reports folder on the handset or by connecting the handset to a PC and navigating to the Reports folder through the PC.

See “Accessing a Downloaded

Report” on page 47 for more information.

Note: Generated reports will remain on the handset for 24 hours before being deleted.

Disconnecting or unpairing a connected neurostimulator is done using the Manage Devices feature. To disconnect:

1. Tap

to open a list of options,

and select Manage Devices.

Note: the Manage Devices feature can also be accessed by tapping

on the Menu screen.

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TROUBLESHOOTING

Scenario Explanations and possible

solutions

2. Tap .

3. Tap REMOVE DEVICE to

conrm that you want to unpair

or disconnect the device from the clinician and patient apps.

Note: Removing the device from the clinician app will disconnect the device from the patient therapy app. All data will also be erased from the app.

Table 7. Clinician app system notications and solutions

App notication Explanations and solutions

Permission required Permission is needed to use the

System error The system has encountered an

Low battery The neurostimulator battery is low and

Neurostimulator End of Service

clinician app.

1. Tap EXIT.

2. Go to settings and select the clinician app.

3. Tap PERMISSIONS.

4. Slide from Off to On.

5. If the problem persists, contact Medtronic support.

unexpected problem.

1. Restart the clinician app.

2. If the problem persists, contact Medtronic support.

therapy will be unavailable soon.

Consider replacing the neurostimulator.

The neurostimulator has reached end of service.

The neurostimulator is no longer able to provide therapy. You will need to replace the neurostimulator to continue therapy.

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TROUBLESHOOTING

App notication Explanations and solutions

Communicator connection lost

Communicator low battery

Data lost Data has been lost.

Power on Reset

detected

The communicator may be turned off, out of range, or the battery may be depleted.

1. Ensure the communicator is on. Move the communicator closer to the handset, and attempt to reconnect following the instructions presented on the screen.

Note: If you are connecting to the communicator for the rst time, see,“Using the Communicator to Pair

the Handset and Neurostimulator” on page 15 for instructions.

2. If the issue persists, the communicator or handset may need to be charged. Recharge the battery using the charger that came with the product.

3. If you are still experiencing issues, contact Medtronic support.

The communicator battery is below 25% and needs to be charged.

The communicator battery LED indicator will be yellow when the battery is low. Charge the communicator using the charger that came in the product package.

Note: If the communicator battery is below 10%, it will need to be charged above 10% before use.

1. Check neurostimulator conguration and therapy programs.

2. If the problem persists, contact Medtronic support.

Device reset has occurred. Please check the neurostimulator battery level.

1. Check the neurostimulator battery level.

2. Go to therapy programming to turn therapy on if needed.

3. If the problem persists, contact Medtronic support.

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TROUBLESHOOTING

App notication Explanations and solutions

Invalid key Your password key has expired.

Refer to “I have forgotten my password”

on page 56 and follow the steps shown in that section.

Update required Updating the device will rewrite all

Maximum settings reached)

settings.

Click UPDATE to update the neurostimulator, or END SESSION to not update.

The neurostimulator battery is unable to produce the levels of energy required for the current stimulation settings.

See “Maximum Settings Reached” on

page 60.

Maximum Settings Reached

Considerations for troubleshooting

If a Maximum Settings Reached message appears during a programming session, the following are considerations for troubleshooting to return the system back to its expected functionality:

1. Take an impedance measurement to see if there is an open or a short circuit in the system.

2. If the Maximum Settings Reached message appears after a parameter has been changed, consider lowering that parameter.

3. Consider changing the electrodes that are currently providing stimulation.

4. If you are still experiencing issues, contact Medtronic support.

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Manufacturer

Medtronic, Inc. 710 Medtronic Parkway Minneapolis, MN 55432 USA www.medtronic.com Tel. +1-763-505-5000

Authorized Representative in the European Community

Medtronic B.V. Earl Bakkenstraat 10 6422 PJ Heerlen The Netherlands Tel. +31-45-566-8000

Europe/Africa/Middle East Headquarters

Medtronic International Trading Sàrl Route du Molliau 31 Case Postale 84 CH - 1131 Tolochenaz Switzerland www.medtronic.eu Tel. +41-21-802-7000

Asia-Pacic

Medtronic International Ltd. 50 Pasir Panjang Road #04-51 Mapletree Business City Singapore 117384 Singapore Tel. +65-6870-5510

M017455C001 Rev A

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*M017455C001*

Medtronic A51300 Programming Guide

Specifications and Main Features

Frequently Asked Questions

User Manual

TABLE OF CONTENTS

GENERAL WARNINGS AND CAUTIONS

OVERVIEW

Intended Use

About This Guide

QUICK TIPS

Indicators and Icons

GETTING STARTED

Accessing the Clinician App

Creating a Password

Menu Screen

Demo Mode

Using the Communicator to Pair the Handset and Neurostimulator

Setting Implant Date

WORKFLOWS

Entering patient information

Checking device and system status

Therapy Parameter Settings

Maximum settings

Optimizing device settings

Selecting Cycling feature and time

Electrode polarity

MRI - PREPARING FOR AN MRI SCAN

WORKING WITH PROGRAMS

Standard Programs

Custom Programs

Enabling programs for patient use

Reviewing a Therapy Programming Session

Ending a programming session

Using the Stop Therapy feature

DIAGNOSTICS

Usage Graph

To view the usage graph:

Event Log

Usage report

REPORTS

Accessing a Downloaded Report

ADDITIONAL FEATURES

About Screen

Managing Devices

Software Information

Data security

Network connectivity

Installing application updates

Installing communicator updates

Returning the handset

Model A901 Communication Manager Application

Model A902 Patient Data Service Application

TROUBLESHOOTING