Medtronic A71200 Programming Guide

Download

Vanta

/ Sequentia

LT Clinician

Programmer Application

Programming Guide

Neurostimulation systems for pain therapy

Vanta Sequentia

Application version 2.0

with AdaptiveStimTM Technology Model 977006 and

LT Model 977005 neurostimulators

A71200

Explanation of symbols

Medtronic and Medtronic logo are trademarks of Medtronic. AdaptiveStim™, Sequentia™, SoftStart/Stop™, and Vanta™ are

Importer

trademarks of a Medtronic company.

Android™ is a trademark of Google LLC.

For USA audiences only

The BLUETOOTH

word mark and logos are registered trademarks owned by Bluetooth SIG, Inc., and any use of such marks by Medtronic is under license.

Wi-Fi

and Wi-Fi Alliance® are registered trademarks of Wi-Fi Alliance.

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 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 and battery longevity manual describes programming considerations and provides battery longevity information to aid in the appropriate neurostimulator selection.

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 tablet 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.

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Description of the Programming System �� 7

Model A71200 Vanta / Sequentia LT clinician

programmer application ....................................................... 7

Intended purpose ................................................................. 7

Other components of the programming system ..................7

Programmable Settings �� 8

Stimulation parameters ........................................................ 8

Groups and programs .......................................................... 8

Optional features .................................................................8

Data Security and Network Connectivity �� 9

Setting up the Programming System �� 11

Preparing the clinician tablet ............................................. 11

Finding and opening the app ............................................. 12

Pairing the communicator to the clinician tablet ................12

Initiating communication with the neurostimulator ............. 12

Overview of the Clinician Programmer App �� 13

Using Demo mode ............................................................. 13

Navigating through workows ............................................ 13

Using the Side Menu .........................................................14

On-screen help .................................................................. 14

Buttons and indicators on the action bar ...........................14

When the app is placed in the background .......................15

Data security ........................................................................ 9

Network connectivity ............................................................ 9

Installing application updates ...........................................10

Installing communicator updates ....................................... 10

Returning the clinician tablet .............................................10

General Warnings and Cautions �� 10

MRI warning for scan eligibility .......................................... 10

Sterile eld warning for programming components ...........10

EMI caution for telemetry signal disruption ........................ 11

Cautions related to clinician programming and

possible interactions with other devices ............................ 11

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Overview of the Communicator �� 15

Using the USB connector cable ......................................... 15

Communicator icons on the tablet status bar ....................16

Neurostimulator Workows �� 16

Start Usage > Implant Device workow ............................. 17

Followup workow .............................................................19

View MRI workow ............................................................20

Working with Device and Patient Information �� 21

Checking battery status of the neurostimulator .................21

Entering implant location ...................................................21

Entering patient information ............................................... 21

Mapping patient pain .........................................................21

Entering lead information ................................................... 21

Testing lead connectivity .................................................... 22

Entering extensions, pocket adaptors, abandoned

leads, or tip location information ........................................ 22

Adding uoro images ......................................................... 23

Working with Groups and Programs �� 23

Programs screen ...............................................................23

Program subscreen ...........................................................23

Turning stimulation on or off ..............................................24

Limits .................................................................................31

Checking System Performance�� 32

Testing impedance ............................................................. 32

Troubleshooting Electrode Impedance Results 33

Intra-operative troubleshooting .......................................... 34

Post-implant troubleshooting ............................................. 35

Preparing System for an MRI Scan �� 36

To check MRI scan eligibility and enter MRI Mode ............ 36

To deactivate MRI Mode .................................................... 37

Adjusting Stimulation Parameters �� 24

Assigning electrode conguration ...................................... 24

Assigning amplitude, pulse width, and program rate ......... 25

Relative Lead Positioning �� 29

Customizing SoftStart/Stop and Cycling �� 30

Changing SoftStart/Stop settings ......................................30

Turning cycling on or off ....................................................30

Estimating Battery Longevity �� 31

Enabling Patient Access �� 31

Adjustment ......................................................................... 31

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AdaptiveStim Technology �� 38

Caution regarding cervical location ...................................38

Caution regarding healing period ......................................38

Conguring AdaptiveStim ..................................................38

Reconguring an AdaptiveStim-enabled group .................39

What you can do on the AdaptiveStim screen ...................39

Reviewing position amplitudes for all AdaptiveStim-

enabled groups .................................................................. 42

Testing AdaptiveStim settings ............................................ 42

Adjusting position amplitudes for individual positions ........42

Checking patient positions ................................................. 43

Reorienting patient positions .............................................43

Disabling AdaptiveStim Technology for a group ................ 43

Enabling or disabling AdaptiveStim Technology for the

patient ................................................................................ 43

Turning the Position Diary on or off ...................................43

Setting stability time ........................................................... 44

Adjusting position angles ................................................... 44

Adjusting transition times ................................................... 44

Adjusting mobility rate .......................................................45

Turning off mobility detection .............................................45

Troubleshooting AdaptiveStim Technology ........................ 45

Viewing System Information �� 51

Viewing information about system components ................51

Viewing information about trademarks and licenses .........51

Changing device date/time or implant date information ....52

Compiling a Medtronic Data Report ..................................52

Viewing Alerts �� 52

Working with alerts ............................................................52

Viewing Diaries �� 48

Stimulation Usage .............................................................48

Group Usage .....................................................................48

Position Trend ....................................................................48

Adjustments ....................................................................... 48

Composite .........................................................................48

Resting Trend ....................................................................48

Working with Reports �� 49

Using the Reports screen .................................................. 49

Patient Data Service app�� 50

Finding and opening the app ............................................. 50

Accessing or deleting a patient session record .................50

Deleting multiple patient session records at once .............50

Setting the PDF auto-delete feature .................................. 51

Troubleshooting �� 53

Data validation error message ........................................... 53

Power on reset (POR) message ........................................ 53

Out of regulation (OOR) message ..................................... 53

Elective Replacement Indicator (ERI) message ................ 53

End of Service (EOS) message ......................................... 53

Using impedance measurements for troubleshooting .......53

Communicator and clinician tablet troubleshooting ........... 53

To reset a neurostimulator ................................................. 53

Patient programmer messages .........................................57

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Description of the Programming System

Model A71200 Vanta / Sequentia LT clinician programmer application

The Medtronic Model A71200 Vanta / Sequentia LT clinician programmer application (app) is intended for use by clinicians in the programming of the Medtronic Model 977006 Vanta and Model 977005 Sequentia LT implantable neurostimulators for pain therapy.

Intended purpose

The clinician programmer application is intended for use by clinicians in the programming of Medtronic neurostimulators for pain therapy.

Other components of the programming system

The clinician programmer app is intended for use with the following components.

Model CT900 Clinician Tablet

The clinician programmer app is installed on the Model CT900 Clinician Tablet with Android-based operating system.

Model A901 Communication Manager application

The Model A901 Communication Manager application is an application on the clinician tablet that manages the telemetry communications for the clinician tablet.

Model A902 Patient Data Service application

The Model A902 Patient Data Service application is an application on the clinician tablet that manages the storage of patient session data on the clinician tablet. The Patient Data Service app can be used to access or delete patient session data for any patients whose Medtronic devices have been programmed using any clinician programmer app on the clinician tablet.

Model 8880T2 Communicator

The Model 8880T2 Communicator is a handheld device used in conjunction with the clinician tablet and clinician programmer app to communicate with Medtronic neurostimulators.

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Description of the Programming System

Programmable Settings

The clinician programmer app is used to enter, review, and modify programmable settings in the neurostimulator. These programmable

settings dene the stimulation therapy delivered to the patient.

Pulse width, amplitude, and electrode conguration are assigned

at the program level: that is, each program within a group can have different values. Rate is assigned at the group level, and the rate of each program within a group can be set as a fraction of the group rate.

Stimulation parameters

Stimulation is delivered in the form of electrical pulses. Stimulation

parameters dene the attributes of these pulses and can be adjusted

to manage patient therapy.

■ Electrode conguration: Programmed negative (–) polarity, positive (+) polarity, or off.

■ Pulse width: Duration of each pulse in microseconds (μs).

■ Rate: Frequency of pulses in hertz (Hz).

■ Amplitude: Strength of a pulse in milliamps (mA).

Groups and programs

A program is a specic combination of pulse width, rate, and amplitude settings acting on a specic electrode conguration. The program denes the stimulation pulses that will be delivered for

therapy. The Model 977005 Sequentia LT neurostimulator supports one program.

For the Model 977006 Vanta neurostimulator, multiple programs can be combined into groups.

When using more than one program, the pulses are delivered

sequentially—rst a pulse from one program, then a pulse from the

next program, and so on. Pulses from different programs are never delivered simultaneously. Each group and its associated programs

can be used to provide therapy for specic areas of coverage or specic patient activities.

Optional features

Optional features are available for adjusting the stimulation to the patient's needs. Some features are not available for the Model 977005 Sequentia LT neurostimulator.

■ Adjustment: Allows the patient to increase or decrease amplitude for all programs in the active group at the same time.

■ AdaptiveStim Technology: Adjusts stimulation automatically when the patient changes position.

■ Cycling: Cycles stimulation on and off at clinician-determined intervals.

■ Electrode Redistribution: Assigns a lower or a higher percentage of the program amplitude to an individual electrode in a program.

■ Equalize: Sets program amplitude to zero and recongures the active electrodes to provide equal distribution of amplitude.

■ IntelliStim: A semi-automated feature for selecting electrodes to deliver therapy. IntelliStim is a scanning process in which common combinations of electrodes are scanned across the lead using the selected amplitude.

■ Move: Sets program amplitude to zero and allows a congured electrode combination to be moved up, down, or across the lead or leads.

■ Patient Limits: Identies the stimulation parameters that the patient can adjust and sets the upper limits for those parameters.

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Programmable Settings

■ SoftStart/Stop: Slowly increases the amplitude when stimulation is turned on and slowly decreases the amplitude when stimulation is turned off.

Data Security and Network Connectivity

Data security

The clinician programming system uses and stores data about the patient's health and implanted medical device. This data is protected by application-level controls and encryption provided by the clinician tablet. The clinician programming system does not provide data protection for 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 clinician tablet.

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 your clinician programming system, Medtronic recommends you implement the following security measures:

■ Secure your clinician tablet by disabling network connectivity during any programming session.

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

■ Connect the clinician tablet to the network periodically to check

for notications on available updates.

Note: Connecting the clinician tablet 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,

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Data Security and Network Connectivity

and upgrading equipment; upgrading or installing software; or

changing network congurations could also introduce additional risks. Analyze, evaluate, and control any identied risks.

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

If your clinician tablet is lost or stolen, contact Medtronic using the contact information listed on the back cover of this manual.

Installing application updates

For assistance with downloading, registering, or installing the application, contact Medtronic using the information on the back cover of this manual. In the U.S., call 1-800-707-0933 for Medtronic Technical Services.

Medtronic periodically updates the therapy app and will not install updates without notifying you. 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.

Installing communicator updates

When notied to install a communicator rmware update, connect the

communicator to the clinician tablet using the USB connector cable. Follow the instructions provided by Medtronic to install the update.

Returning the clinician tablet

If you need to return the clinician tablet 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 tablet for return.

General Warnings and Cautions

If a serious incident related to the app occurs, immediately report the incident to Medtronic and the applicable competent authority.

MRI warning for scan eligibility

Warning: Always program the following component information accurately:

■ Neurostimulator and lead model numbers

■ Neurostimulator implant location and lead tip location

■ Presence of any abandoned leads, extensions, and pocket adaptors

If this information is not up-to-date or is entered incorrectly, MRI scan eligibility data will be inaccurate, and the patient is at risk for one of the following:

■ The patient is allowed to have an MRI scan inappropriate for the implanted components, which could cause tissue heating, resulting in tissue damage or serious patient injury.

■ The patient is unnecessarily restricted from having an MRI scan.

Refer to the MRI Guidelines for Medtronic Neurostimulation Systems for Chronic Pain instructions for use manual for MRI scan eligibility

information, MRI scan conditions, and MRI-specic warnings and

cautions for conducting an MRI scan.

Sterile eld warning for programming components

Warning: To use the programming components (external

and nonsterile) in a sterile eld, place a sterile barrier between the

patient and the programming components to prevent infection. Do

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General Warnings and Cautions

not sterilize any of the programming components. Sterilization may damage the programming components.

EMI caution for telemetry signal disruption

Caution: Electromagnetic interference (EMI) can disrupt

programming and telemetry communication. If EMI interference

is suspected, such as from radio frequency identication (RFID)

equipment, move away from the likely source of EMI and try again.

Cautions related to clinician programming and possible interactions with other devices

Refer to the Information for Prescribers booklet for cautions related to clinician programming and possible interactions with other devices (such as cardiac devices).

Setting up the Programming System

Clinician tablet with

clinician programmer app

Power button

The connector cable is required for pairing

the communicator to the clinician tablet.

After pairing, the communicator and the clinician tablet can

communicate using BLUETOOTH wireless technology.

For wireless communication, make sure the clinician tablet

Figure 1. Components of the programming system.

remains within range.

Preparing the clinician tablet

Refer to the Model CT900 Clinician Tablet quick start guide for instructions on how to turn on the tablet and to complete initial setup.

Check the battery level of the clinician tablet.

■ The tablet's battery level is shown on the tablet status bar (uppermost row on the tablet screen).

■ Recharge the tablet if the battery level is low.

USB

connector cable Communicator Neurostimulator

Power button

Proximal Telemetry

Hold communicator directly

over neurostimulator.

BLUETOOTH

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Setting up the Programming System

Finding and opening the app

1. Navigate to the Apps on the clinician tablet.

2. Find the Vanta app icon.

Note: Vanta app is used to program both the Vanta and Sequentia LT neurostimulators.

3. Tap the Vanta app icon to open the app.

Pairing the communicator to the clinician tablet

Refer to the Model 8880T2 Communicator technical manual for additional instructions, if needed. Only one communicator can be paired with a clinician tablet at a time.

1. Connect the USB connector cable to the communicator and the clinician tablet.

2. Turn on the communicator (slide the power button down, then release).

3. A message appears on the clinician tablet, which asks permission to open the Communication Manager when the USB device is connected:

a. Select to use the USB device by default. This selection

prevents this message from appearing again.

b. Select OK.

4. On the initial app screen, tap CONNECT. Pairing begins and the communicator displays a green LED light between the tablet icon and the communicator icon.

Once the communicator is paired, you can disconnect the USB connector cable. The communicator and clinician tablet communicate

using BLUETOOTH wireless technology. For wireless communication, make sure the clinician tablet remains within range.

Note: If you have trouble pairing, either with the USB connector cable or BLUETOOTH, restart the tablet and try again.

Initiating communication with the neurostimulator

1. Hold the communicator directly over the neurostimulator.

Notes:

■ The target symbol ( indicates the location of the internal antenna. The target should be facing and centered over the neurostimulator.

■ After making the initial connection, you can make future connections at a greater distance for 12 hours following the initial connection, or until the communicator connects to a different neurostimulator.

2. On the Search for Device screen, tap FIND DEVICE.

Press the communicate button (

3. Select the serial number of the neurostimulator you intend to congure, and tap CONNECT.

4. After connecting to the neurostimulator, the CURRENT DEVICE STATUS screen will display.

From this screen, you can select workow options under

the SELECT FLOW heading. Refer to the "Neurostimulator

Workows" section on page 16 for workow details.

) on the back of the communicator

) on the communicator.

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Setting up the Programming System

Notes:

■ If you have problems establishing communication, refer to "Communicator and clinician tablet troubleshooting" on page

53.

■ Do not leave the clinician tablet unattended during an active programming session.

■ When a congured neurostimulator is interrogated, a lead connectivity test is performed to check for impedance issues. The patient may feel a stimulation change during the test.

Overview of the Clinician Programmer App

Using Demo mode

Use Demo mode to explore the clinician programmer app without interrogating or updating a neurostimulator.

When the app is in Demo mode, it is not communicating with a real neurostimulator and does not require the use of a communicator. Any data displayed in Demo mode is not actual.

Demo mode can be used for training and demonstration purposes and to familiarize yourself with the app interface before starting an actual programming session.

1. On the initial Vanta/Sequentia LT app screen, tap DEMO.

2. Select a device, and tap CONNECT.

3. Navigate through the workow. One workow at a time can be explored in a Demo session.

4. To exit Demo mode, go to the Summary screen and tap EXIT WORKFLOW.

Exiting the workow will return you to the initial app screen

where you can select DEMO again and select another device to explore.

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Navigating through workows

The screens typically used during a programming session are

grouped into workows. The workows vary depending on the device model and device status (new versus congured). The workows may

also vary depending on neurostimulator features.

Overview of the Clinician Programmer App

After you start a workow, a workow navigator appears at the top

of the screen. For example, the Followup workow for the Vanta neurostimulator contains these screens:

Device AdaptiveStim

Lead Select Tip Location Programs Impedance

Diaries Reports Summary

■ To move from screen to screen, swipe left or right.

■ Alternatively, you can tap on the screen name in the workow navigator to go directly to that screen.

– If the workow navigator extends beyond the width of

the screen, swipe the workow navigator left or right to

show the screen names that are partially hidden.

■ The current screen is underlined and highlighted.

■ If input is required in a workow screen, you will not be able to advance to the next screen until you enter the required input.

– The app will prompt you for the required input.

– Orange asterisks indicate required elds.

Using the Side Menu

Screens not in the current workow can be accessed from the Side

Menu. For example, the Patient Info screen is in the new device

workow, but not in the Followup workow. To change patient data in a congured device, you need to access the Patient Info screen from

the Side Menu. To access the Side Menu, tap the Side Menu button (

) in the top-left corner on the action bar.

On-screen help

Help information is available in the clinician programmer app for most

workow screens. View the help information to learn how the app

interface works and how to complete tasks on the screen.

■ To display help information, tap the Help button ( right corner on the action bar.

■ Tap the Help button (or tap anywhere on the screen) to close the help screen.

) in the top-

Buttons and indicators on the action bar

An action bar appears at the top of all screens in all workows. Table

1 describes the buttons and indicators that may appear on the action bar.

Table 1. Buttons and indicators.

Button / Indicator Description

Side Menu button: Tap to access

screens outside of the workow.

Back button: Tap to close a screen you accessed from the Side Menu and return

to the previous workow screen.

Demo mode indicator: Appears in the action bar when in Demo mode.

Stimulation toggle: Tap to turn stimulation on or off. Green (switch to the right) indicates that stimulation is on.

Appears in the action bar when at least one program exists.

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Overview of the Clinician Programmer App

Button / Indicator Description

AdaptiveStim indicator: Applicable

to neurostimulators with AdaptiveStim Technology (977006 Vanta).

Appears in the action bar when AdaptiveStim Technology is enabled.

MRI Status indicator: Appears in the action bar when stimulation is off and MRI Mode has been activated.

The MRI Status indicator does not provide MRI scan eligibility information.

Help button: Tap to display help information for the current screen.

Tap the Help button (or tap anywhere on the screen) to close the help screen.

Go to Summary screen button: Tap to go directly to the Summary screen. You can exit the workow from the Summary screen to properly end the programming session.

When the app is placed in the background

When you navigate away from the Vanta clinician programmer app while in a programming session, the app is placed in the background and is represented as a oating widget (Vanta Session in Progress) to remind you that you are still in a session.

■ Press and drag the oating widget to move it on the tablet screen.

■ Tap on the oating widget to return to the app and resume the session.

Overview of the Communicator

The Model 8880T2 Communicator is a nonsterile component used in conjunction with the clinician tablet and clinician programmer app to communicate with Medtronic neurostimulators.

Warning: To use the communicator in a sterile eld, place

a sterile barrier between the patient and the communicator to prevent infection. Do not sterilize any of the programming components. Sterilization may damage the programming components.

The communicator is handheld and battery-operated. Communication between the communicator and the clinician tablet can occur wirelessly using BLUETOOTH technology or wired using the USB connector cable.

For information on the Model 8880T2 Communicator, including

description, specications, components, instructions for use,

maintenance, and troubleshooting, refer to the Model 8880T2 Communicator technical manual.

Using the USB connector cable

The following situations require the use of the USB connector cable:

■ First-time pairing of any communicator with a clinician tablet.

■ Firmware updates to the communicator.

■ Environments where multiple devices are using BLUETOOTH wireless technology and thereby creating interference.

■ Environments where BLUETOOTH wireless technology is prohibited.

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Overview of the Communicator

Communicator icons on the tablet status bar

Table 2 describes the icons that appear in the tablet status bar (uppermost row on the tablet screen) indicating the status of the connection between the communicator and the clinician tablet.

Table 2. Communicator icons in the tablet status bar.

Communicator Icon Description

The communicator is in the process of connecting to the clinician tablet.

The communicator is communicating with the clinician tablet via the USB connector cable.

The communicator requires the USB connector cable to communicate with the clinician tablet.

The communicator is communicating with the clinician tablet using BLUETOOTH wireless technology.

Neurostimulator Workows

When an implantable neurostimulator (INS) is interrogated, the clinician programmer app determines if the INS is new or if it has

been previously congured. Based on the status of the INS, the

clinician programmer app automatically presents the applicable

workow options.

■ Start Usage > Implant Device workow – go to page 17.

Use when a new INS is being congured (programmed) for the rst time.

■ Followup workow – go to page 19.

Use at followup sessions with the patient.

■ View MRI workow – go to page 20.

Use to determine MRI scan eligibility and prepare a patient's neurostimulation system for an MRI scan.

Notes:

■ To display on-screen help information, tap the Help button (

■ The screens typically used during a programming session are

shown in the workow navigator. Additional screens not in the current workow can be accessed from the Side Menu (

■ Unsaved information may be lost if the application is improperly terminated during a programming session. To end a session, go to the Summary screen and tap the EXIT WORKFLOW button. Ending a session generates a complete session record that is stored in a database on the clinician tablet.

■ Some functions, such as multiple groups and programs, and AdaptiveStim, are not available with the Sequentia LT neurostimulator.

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Neurostimulator Workows

Start Usage > Implant Device workow

You can initiate communication with the INS in the package before

it is moved into the sterile eld. Tasks such as checking the battery

status and entering device and patient information can be performed without removing the INS from the package.

1. On the CURRENT DEVICE STATUS screen, conrm that the device information corresponds with the intended INS.

2. Tap START USAGE.

This action takes the neurostimulator out of shelf state and sets the In Use Date/Implant Date elds to the current date.

■ The In Use Date and Implant Date are the same date.

■ The In Use Date is shown on the CURRENT DEVICE

STATUS screen, and the Implant Date is shown on the About System screen.

■ The About System screen is available after an implant location is selected on the DEVICE screen.

■ You can change the implant date on the About System screen, but this change will not impact the clock inside the neurostimulator that determines ERI and EOS.

3. Under IMPLANT DEVICE, tap START.

4. Use Table 3 to guide you through the screens and tasks in the

workow.

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Neurostimulator Workows

Table 3. Implant Device workow.

Screen Tasks More information

Device Check the battery status of the neurostimulator. Page 21

Select the implant location. Page 21

Patient Info Enter patient information. Page 21

Pain Map Tap the PAINT button, then use your nger to highlight the area on the human gure where the

patient feels pain. To remove highlight from an area on the gure, tap the ERASE button and then tap the highlighted area.

Lead Select Select the implanted leads. Select a lead from the scrollable drop-down list, and then drag and drop

it at the appropriate electrode numbers. Tap UPDATE to save the selected lead.

Ensure leads are properly connected to the neurostimulator, and then check connectivity by tapping the CHECK CONNECTIVITY button.

Tip Location Indicate whether extensions and pocket adaptors are implanted. Indicate whether abandoned leads

remain implanted. Select the tip location for each lead.

Programs (and subscreens)

Create programs in groups. Tap a group to make it active. A highlighted box around a group indicates the group is active. Tap the plus sign to add a program within a group.

Program subscreen: Assign the electrode conguration for the lead(s). Assign pulse width, rate,

and amplitude.

Lead Manipulation subscreen: Use to represent the relative positioning of the implanted leads as viewed from the patient’s back.

Energy subscreen: Set parameters for SoftStart/Stop and cycling. Estimate battery life based on various congurations and hours per day of group use with the Estimated Battery Longevity feature.

Patient Access subscreen: Assign the stimulation parameters that the patient can adjust. Page 31

Impedance Measure electrode impedance.

These measurements verify the integrity of lead, extension, and connector pathways. They may provide information about lead problems (such as lead breakage, short circuit, open circuit).

Summary Conrm therapy settings.

End the session properly by tapping the EXIT WORKFLOW button.

Page 21

Page 22

Page 23

Page 29

Page 30

Page 32

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Neurostimulator Workows

Followup workow

1. On the CURRENT DEVICE STATUS screen, conrm that the patient and device information corresponds with the intended patient and INS.

2. Under FOLLOWUP, tap START.

3. Use Table 4 to guide you through the screens and tasks in the

workow.

Table 4. Followup workow.

Screen Tasks More information

Device Check the battery status of the neurostimulator. Page 21

Lead Select Review the information, and make any updates. Updates may delete programmed settings. Page 21

Tip Location Review the information, and make any updates. Page 22

Programs (and subscreens)

Impedance Measure electrode impedance.

AdaptiveStim Congure the settings for AdaptiveStim Technology (Vanta Model 977006 only). Page 38

Diaries Select a diary to view from the drop-down list. Diaries provide information on therapy usage. Page 48

Reports Select a report to view, download, or delete. Page 49

Summary Conrm therapy settings.

Review the groups, programs, and settings, and make any updates. Conrm that the active group is

the intended group.

Program subscreen: Assign the electrode conguration for the lead(s). Assign pulse width, rate,

and amplitude.

Lead Manipulation subscreen (only applicable if more than one lead): Use to represent the relative positioning of the implanted leads as viewed from the patient’s back.

Energy subscreen: Set parameters for SoftStart/Stop and cycling. Estimate battery life based on various congurations and hours per day of group use with the Estimated Battery Longevity feature.

Patient Access subscreen: Assign the stimulation parameters that the patient can adjust. Page 31

These measurements verify the integrity of lead, extension, and connector pathways. They may provide information about lead problems (such as lead breakage, short circuit, open circuit).

End the session properly by tapping the EXIT WORKFLOW button.

Page 23

Page 29

Page 30

Page 32

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Neurostimulator Workows

View MRI workow

1. On the CURRENT DEVICE STATUS screen, conrm that the patient and device information corresponds with the intended patient and INS.

2. Tap VIEW MRI > START.

3. Use Table 5 to guide you through the screens and tasks in the

workow.

Table 5. View MRI workow.

Screen Tasks More information

Device Conrm the neurostimulator information and implant location. Page 36

Patient Info Conrm the patient information. Page 36

Lead Select Conrm the implanted lead information. Page 36

Tip Location Conrm the conguration and tip location information. Page 36

MRI Review the MRI scan eligibility.

Determine whether the patient is eligible for the intended MRI scan.

If patient is eligible, turn stimulation off to prepare the patient’s neurostimulation system for the scan.

Reports Prepare the MRI Report. The MRI Report contains information intended for MRI clinicians about the

MRI scan eligibility of the implanted system.

Summary Conrm that stimulation is off and that MRI status shows the device is ready for an MRI scan.

End the session properly by tapping the EXIT WORKFLOW button.

Page 36

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Neurostimulator Workows

Working with Device and Patient Information

Checking battery status of the neurostimulator

The current battery level for the neurostimulator, along with the estimated battery life remaining, appears on the Current Device Status and Device screens. The estimated battery life remaining is shown next to the Estimated Battery Remaining (Based on Last 7

Days) eld.

The current battery level also appears on the Summary screen. For information on battery service life for implanted neurostimulators, refer to "Elective Replacement Indicator (ERI) message" on page 53 and "End of Service (EOS) message" on page 53.

Entering implant location

The implant location for implantable neurostimulators is entered on the Device screen. The Device screen is accessed through the

workow navigator.

■ Select the implant location from the scrollable drop-down list.

Note: The implant location impacts the MRI scan eligibility shown on the MRI screen.

Entering patient information

Patient information such as patient name and diagnosis is entered on the Patient Info screen. The Patient Info screen is accessed through

the workow navigator or by tapping Patient Info on the Side Menu (

) when the screen is not part of a workow.

■ Enter the applicable patient information. Orange asterisks

indicate the required elds.

Mapping patient pain

The Pain Map screen is used to highlight areas of the body where the patient feels pain. There are two options for updating the patient's pain map: PAINT and ERASE. Only one can be selected at a time. The Pain Map screen is accessed through the workow navigator or by tapping Pain Map on the Side Menu (

part of a workow.

■ Select the PAINT option and tap the area on the human gure to highlight where the patient feels pain.

■ Use the ERASE option to remove highlighting.

■ Tap the ROTATE button to rotate the human gure from front to back and from back to front.

■ Tap UPDATE and swipe left to go to the next screen in the

workow.

) when the screen is not

Entering lead information

The Lead Select screen is used to identify which lead models are implanted, associate the lead electrode numbering to the neurostimulator electrode numbering, and check connectivity of the lead contacts or extension contacts with the neurostimulator contacts. The Lead Select screen is accessed through the workow navigator.

■ To assign a lead, select the lead model from the scrollable drop-down lists. Press and hold, then drag the lead image to the appropriate electrode numbers of the device.

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Working with Device and Patient Information

■ To delete a lead, tap the lead image, and then tap the X that appears.

■ To change a lead, you must rst delete the current lead, and then assign a new lead.

Notes:

■ Make sure the electrode numbering on the screen matches the electrode numbering of the implanted leads. If necessary, you

can swap congured leads using the drag-and-drop feature.

■ On Medtronic surgical leads, the blue box on the lead arm represents the marker band on the actual lead. For more information about surgical leads, refer to the lead implant manual. The marker band indicates the lead arm for electrodes 0-7.

■ The assigned leads impact the MRI scan eligibility shown on the MRI screen.

Testing lead connectivity

Once the implanted lead(s) are assigned on the Lead Select screen, you can check the connectivity of the lead contacts and/or extension contacts with the neurostimulator contacts. Prior to running the test, ensure the leads or extensions are properly connected to the neurostimulator.

■ Tap the CHECK CONNECTIVITY button ( disabled, tap UPDATE on the Lead Select screen to save the lead data and enable the button.)

– Green electrodes indicate that the lead contacts and/

or extension contacts have a good connection to the neurostimulator contacts.

– Red electrodes (with an “X”) indicate a bad connection.

). (If the button is

– If there are red electrodes, gently reconnect the leads or

extensions for a better connection to the neurostimulator contacts. Then repeat the connectivity check.

Entering extensions, pocket adaptors, abandoned leads, or tip location information

The Tip Location screen is accessed through the workow navigator.

■ Check the Yes or No checkbox to indicate whether abandoned leads remain implanted.

■ Check the Yes or No checkbox to indicate whether extensions are implanted. If the No checkbox is selected for extensions, the No checkbox for pocket adaptors is automatically selected.

■ Check the Yes or No checkbox to indicate whether pocket adaptors are implanted.

■ Select the tip location for each lead from the scrollable drop- down lists.

Note: The abandoned lead, extension, pocket adaptor, and tip location information impacts the MRI scan eligibility shown on the MRI screen.

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Working with Device and Patient Information

Adding uoro images

The uoro screen is accessed using the View Fluoro button at the bottom-left of the Tip Location screen. This feature is not available for the Model 977005 Sequentia LT neurostimulator.

Note: The View Fluoro button also appears at the bottom-left of the Lead Manipulation subscreen (which is accessed from the Program

subscreen).

■ Use the Add Photo button to add existing uoro images saved

in the tablet or take a photo of the uoro image displayed on

the monitor. The app can store up to four images.

■ Annotate images with the Text button. Tap where you want the text to appear on the image and enter the text. Edit existing text by tapping the Text button and then tapping the text you want to edit on the screen.

■ Tap the Trash button (

uoro image exists in the uoro screen, swipe left or right to

select the image you want to delete.

) to delete an image. If more than one

Working with Groups and Programs

Programs screen

The Programs screen is used to create, copy, move, and delete

programs within groups and to dene the active group. The

Programs screen is accessed through the workow navigator.

Note: For patients implanted with Sequentia LT, only one program is

available for programming.

■ Only one group can be active at a time. A highlighted box around a group indicates the active group.

■ To make another group active, tap that group name.

■ To copy or move a program, press and hold, then drag that program to the intended location, and then select MOVE or COPY from the message that appears.

■ To delete a program, press and hold, then drag that program to the Trash icon (

■ To create a new program, tap the add symbol (+) on the desired program. This will launch the Program subscreen, where you can assign the program settings.

■ To view the program settings for an existing program, rst make the group active, and then tap the program to view the

Program subscreen.

Note: The AdaptiveStim indicator (

if AdaptiveStim Technology is enabled for the group.

)�

) appears next to the group name

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Program subscreen

The Program subscreen is used to assign, review, and change program settings for programs in the active group. The Program

Working with Groups and Programs

subscreen is accessed by tapping a program on the Programs screen.

■ A line is shown under the program number that is currently displayed on the Program subscreen.

■ To move from program to program within the active group, swipe left or right on the screen. Alternatively, you can tap a program number.

■ Use the Program subscreen to assign the electrode

conguration for the leads and to set pulse width, rate, and

amplitude. Refer to "Adjusting Stimulation Parameters" on page 24.

■ From the Program subscreen, you can access the following subscreens:

– Lead Manipulation: For more information, refer to

"Relative Lead Positioning" on page 29.

– Energy: Refer to "Customizing SoftStart/Stop and

Cycling" on page 30. For estimating battery life based

on various congurations and hours per day of group

use, refer to "Estimating Battery Longevity" on page

31.

– Patient Access: For more information, refer to

"Enabling Patient Access" on page 31.

Turning stimulation on or off

The Stimulation toggle is found on the action bar at the top-right corner of the screen. The toggle is available when at least one program exists. When no programs exist, the area in the action bar reads “Stimulation Not Setup”.

■ Tap the Stimulation toggle to turn stimulation on ( (

) at any time.

) or off

Adjusting Stimulation Parameters

Assigning electrode conguration

Electrode conguration for the leads is assigned on the Program subscreen.

Electrode conguration must include at least one negative (–) and one positive (+) electrode. You cannot set amplitude for the program until you have assigned at least one negative (–) and one positive (+) electrode to the lead.

■ Tap an electrode to change its polarity to negative (–), positive (+), or off. Tap Update when nished.

■ To delete an electrode, press and hold, then drag that electrode to the Trash icon (

■ To delete all assigned electrodes, tap the Select All button (

), and then tap the Trash icon ( ).

■ To move all electrodes at once, tap the Select All button ( and then press and drag the electrodes to a new location on a lead. This action will set the amplitude to 0.0 mA.

■ To move an individual electrode, you must rst delete that electrode and then assign a new electrode.

Note: Adding or deleting an electrode after the amplitude is assigned will reset the amplitude to 0.0 mA for the affected program.

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Adjusting Stimulation Parameters

Assigning amplitude, pulse width, and program rate

Amplitude, pulse width, and program rate are assigned on the Program subscreen.

During a programming session, the selected values for amplitude, pulse width, and program rate are automatically programmed into the neurostimulator. Once amplitude is set and stimulation is turned on, the neurostimulator changes stimulation to the new setting every time a stimulation parameter is changed.

Caution: To prevent possible uncomfortable or unexpected stimulation (jolting or shocking sensation) during a programming session, adjust stimulation parameters in small increments above the perception threshold (the parameter

values at which the patient rst perceives a sensation of

stimulation).

Caution: Changing the pulse width or rate in a program may affect AdaptiveStim therapy. Test each of the AdaptiveStim postures in the group for appropriate stimulation after making pulse width or rate changes. Refer to "Testing AdaptiveStim settings" on page 42.

Assigning amplitude

Amplitude is the strength of the pulse in milliamps (mA). The

electrode conguration for the leads must be assigned before you can

set amplitude.

1. In the Program subscreen, tap AMPLITUDE to access the amplitude control.

2. Select the amplitude using any of these controls:

■ Scrollable drop-down list.

■ Dial (press and drag the dot on the dial).

■ Back arrows ( increase.

Note: Amplitude increases in increments. When amplitude is decreased, amplitude decreases immediately to the new value.

3. Use these buttons, as needed:

■ Tap the Stop button ( increasing to the new value.

■ Tap the Jump button ( without incremental increases.

■ Tap the Amplitude to zero button ( set amplitude to 0.0 mA.

) to decrease and forward arrows ( ) to

) to stop stimulation from

) to jump to the new value

) to immediately

Assigning pulse width

Pulse width is the duration of the pulses in microseconds (μs).

Caution: To prevent possible uncomfortable or unexpected stimulation (jolting or shocking sensation), decrease the amplitude to the perception threshold (the

amplitude at which the patient rst perceives a sensation of

stimulation) before changing the pulse width. After changing the pulse width, slowly increase the amplitude.

1. In the Program subscreen, tap PULSE WIDTH to access the pulse width control.

2. Select the pulse width using any of these controls:

■ Scrollable drop-down list.

■ Dial (press and drag the dot on the dial).

■ Back arrows ( increase.

) to decrease and forward arrows ( ) to

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Adjusting Stimulation Parameters

3. If stimulation is on, the Stop and Jump buttons become available when the pulse width is increased. Use these buttons, as needed.

■ Tap the Stop button ( increasing to the new value.

■ Tap the Jump button ( without incremental increases.

) to stop stimulation from

) to jump to the new value

Assigning program rate and group rate

Rate is the frequency of pulses per second, in hertz (Hz). For the Vanta neurostimulator, which supports more than one program in a group, the group rate is the initial rate for each program in that group. A program rate is a fractioned value of the group rate.

To set a group rate

1. In the Program subscreen, tap PROGRAM RATE to access the rate control.

2. Select the group rate using any of these controls:

■ Scrollable drop-down list.

■ Dial (press and drag the dot on the dial).

■ Back arrows ( increase.

To set a program rate

A program rate is a fractioned value of the group rate.

The rate ratios available: 1/1, 1/2, 1/3, 1/4, and so on, up to 1/20.

1. If you need to set a program rate, tap the pop-up scrollable list next to PROGRAM RATE in the rate control.

) to decrease and forward arrows ( ) to

2. Select a program rate. This rate will only be applied to the selected program.

Program rate example:

■ The group rate is set at 100 Hz.

■ 1/2: 50 Hz is selected as the program rate for that program in the group.

■ This program will now deliver pulses at 50 pulses per second. Meanwhile, the other programs set with the group rate will still deliver 100 pulses per second.

3. Tap CLOSE to close the control.

4. Reassess limits assigned in the Patient Access subscreen after modifying stimulation parameters. Refer to "Limits" on page 31.

Using electrode redistribution (assigning percentage of amplitude for individual electrodes)

In most programming sessions, the value selected for the amplitude is distributed evenly among the assigned electrodes. Use the electrode redistribution feature when you want to assign a lower or a higher percentage of the amplitude to an individual electrode in the program.

Note: This feature is not available for the Model 977005 Sequentia LT neurostimulator.

On the Program subscreen, the distribution of the amplitude among the electrodes is shown as percentages for the positive (+) electrodes and as a value for the negative (–) electrodes.

Note: The Device Electrode Redistribution feature must be activated before you can use the feature. The feature only needs to be activated once. It remains active across programming sessions.

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Adjusting Stimulation Parameters

1. To activate the Device Electrode Redistribution feature:

a. Tap the Display All (

subscreen. The Display All subscreen can only be accessed from an active program with at least one electrode pair.

b. In the Display All subscreen, check the status of the

DEVICE ELECTRODE REDISTRIBUTION toggle. If the toggle is green and the switch is to the right ( feature is activated. If the toggle is blue and the switch is to the left, tap the toggle to activate the feature.

c. Tap the CLOSE button to return to the Program

subscreen.

2. In the Program subscreen, tap the electrode you intend to adjust.

Notes:

■ To maintain the overall balance of energy between the polarities, the electrodes that will be impacted by the redistribution will have the same polarity as the electrode that you selected to adjust.

■ Electrode redistribution will automatically rebalance the delivered stimulation amplitudes. After making adjustments, review the electrode contribution percentages.

3. Select the percentage of the amplitude that you want to assign to the electrode.

Notes:

■ Electrode amplitude increases in increments.

■ If the neurostimulator is unable to deliver the amplitude value in combination with the values set for the pulse width and rate, an alert will notify you that

) button in the Program

), the

stimulation output is below the programmed amplitude. Refer to "Out of regulation (OOR) message" in the Troubleshooting section on page 53.

4. Repeat if you want to adjust another electrode.

5. Tap CLOSE to close the control.

Equalizing amplitude across electrodes

Use the Equalize feature to evenly distribute amplitude across the assigned electrodes. You can equalize amplitude for a single program or for all programs with unequal distribution.

Note: This feature is not available for the Model 977005 Sequentia LT neurostimulator.

To equalize a single program

1. In the Program subscreen, tap the Equalize (

2. Tap YES in the conrmation pop-up to proceed.

3. Use the AMPLITUDE control to select an amplitude.

To equalize all programs with unequal distribution

1. In the Program subscreen, tap the Display All ( The Display All subscreen can only be accessed from an active program with at least one electrode pair.

2. In the Display All subscreen, tap the DEVICE ELECTRODE REDISTRIBUTION toggle.

3. Tap DISABLE in the conrmation pop-up.

This action equalizes amplitude across all programs with unequal distribution and reduces the amplitude to zero for those programs. It also disables the electrode redistribution and IntelliStim features.

) button.

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Adjusting Stimulation Parameters

4. Tap the CLOSE button to return to the Program subscreen.

Using IntelliStim

IntelliStim is a scanning process in which common combinations of electrodes are scanned across the lead using the selected amplitude.

IntelliStim can help nd which electrodes to select to deliver therapy.

Note: This feature is not available for the Model 977005 Sequentia LT neurostimulator.

When IntelliStim begins, the lead is automatically populated with a negative (–) and positive (+) electrode pair:

■ Electrode number 0 is assigned a negative (–) polarity.

■ Electrode number 1 is assigned a positive (+) polarity.

You can either start the scanning process from the 0 and 1 electrodes, or you can move the negative and positive electrode pair to another position on the lead and start the scanning process from there.

To use IntelliStim, you must rst activate the Device Electrode Redistribution feature. The feature only needs to be activated once.

It remains active across programming sessions.

1. To activate the Device Electrode Redistribution feature:

a. In the Program subscreen, tap the Display All button.

The Display All subscreen can only be accessed from an active program with at least one electrode pair.

b. In the Display All subscreen, check the status of the

c. Tap the CLOSE button to return to the Program

subscreen.

), the

2. In the Program subscreen, tap the INTELLISTIM button ( and follow the on-screen instructions.

3. Position the electrode pair on the lead where you want to start the scanning process.

■ Tap the Forward button ( pair down the lead.

■ Tap the Back button ( up the lead.

■ Tap the Jump Forward button ( electrode pair to the top of the lead or electrode column (if a surgical lead) on the right.

■ Tap the Jump Back button ( pair to the top of the lead or electrode column (if a surgical lead) on the left.

■ Or move the electrode pair directly to another location on the lead by tapping a target electrode on the lead. (This option becomes unavailable once the Play button

is pressed for the rst time.)

4. Use the Amplitude control to set the amplitude.

■ If the neurostimulator is unable to deliver the amplitude value in combination with the values set for the pulse width and rate, an alert will notify you that stimulation output is below the programmed amplitude. Refer to "Out of regulation (OOR) message" in the Troubleshooting section on page 53.

5. Tap the Play and Pause buttons to start and pause the scanning process.

■ The X2 button is the default speed. Tap the X1 button for a slower speed than the default speed.

) to advance the electrode

) to advance the electrode pair

) to move the

) to move the electrode

)

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Adjusting Stimulation Parameters

6. Ask the patient to provide their feedback during the scanning process to assess which electrodes to select to deliver therapy.

7. Tap DONE if you nd an effective electrode combination.

8. If desired, use IntelliStim to create another program in the same group for the other lead or other electrode column (if programming a surgical lead).

Relative Lead Positioning

Use the Lead Manipulation subscreen (accessed from the Program subscreen) to represent the relative positioning of the implanted leads as viewed from the patient’s back. The subscreen is only applicable if

more than one lead is congured.

■ To swap the relative position of the leads (for example, to switch the position of lead #2 with lead #1), press and hold, then drag a lead to the location of the other lead.

Repositioning the leads relative to each other on the Lead

Manipulation subscreen updates how the leads are shown on the Programs screen and Program subscreen.

The uoro screen can be accessed using the View Fluoro button at the bottom-left of the Lead Manipulation subscreen (it also appears at the bottom-left of the Tip Location screen). Refer to "Adding uoro images" on page 23 for more information.

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Relative Lead Positioning

Customizing SoftStart/Stop and Cycling

Use the Energy subscreen (accessed from the Program subscreen) to customize the optional device settings for the SoftStart/Stop and Cycling features. These features are designed to increase patient comfort and ease of use.

Turning cycling on or off

Cycling turns stimulation on and off at clinician-determined intervals. Due to a carryover effect, the patient may continue to experience symptom suppression during the cycling off time. The default setting for the cycling feature is “off.”

1. In the Energy subscreen, tap the CYCLING toggle to turn cycling on (

) or off ( ).

Changing SoftStart/Stop settings

SoftStart/Stop slowly increases the amplitude when stimulation is turned on and slowly decreases the amplitude when stimulation is turned off. The slow ramping may feel more comfortable to sensitive patients.

SoftStart/Stop is assigned at the device level: that is, it is either on or off for all groups. The SoftStart/Stop feature defaults to “on” with a duration of 4 seconds.

■ In the Energy subscreen, use the SOFTSTART/STOP drop- down list to select a duration or to turn SoftStart/Stop off.

If AdaptiveStim Technology and SoftStart/Stop are both enabled and the amplitude increases or decreases because of a change in position:

■ The amplitude will slowly increase using the ramping programmed for SoftStart/Stop.

■ The amplitude will decrease immediately without ramping.

2. If cycling is on, select the durations for the ON TIME and OFF TIME intervals.

3. Tap the group name toggle to turn cycling on ( (

) for a specic group. The setting affects all programs in

the group.

4. Tap UPDATE to apply the changes.

Note: Use the BATTERY LONGEVITY function in the Energy subscreen to see how cycling affects battery longevity.

) or off

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Customizing SoftStart/Stop and Cycling

Estimating Battery Longevity

Battery longevity for the INS depends on the therapy conguration

and usage. The Estimated Battery Longevity feature is a calculator that allows you to estimate battery longevity based on the current program and group settings, along with the number of hours per day the patient might use each group.

Note: This feature estimates battery longevity based on expected usage. To see a battery life estimate based on previous actual usage (the last seven days), refer to the Estimated Battery Remaining (Based on Last 7 Days) eld on the Device screen�

To estimate battery longevity using the Estimated Battery Longevity feature:

1. In the Energy subscreen (accessed from the Program subscreen), tap the ESTIMATE button.

2. For each group, press and drag the dot on the slider to set hours per day of group usage.

■ Use the GROUP drop-down lists to view the programs within each group.

■ Group usage can be set to a total of 24 hours among all groups.

3. Tap ESTIMATE.

4. Review the estimates. Estimates are shown for three different impedance ranges.

5. Tap CLOSE to return to the Energy subscreen.

Note: Battery longevity should be re-estimated if changes are made to programming.

Enabling Patient Access

Use the Patient Access subscreen (accessed from the Program subscreen) to assign patient controls, if appropriate for the patient. There are two patient controls on the Patient Access subscreen:

Limits and Adjustment.

Note: The Adjustment patient control is not available for the

Model 977005 Sequentia LT neurostimulator.

Adjustment

Enabling the Adjustment patient control on the Patient Access subscreen allows the patient to increase or decrease amplitude for all programs in the active group at the same time.

■ Under the ADJUSTMENT heading, tap the ALL PROGRAMS TOGETHER toggle to enable ( patient control.

Limits

The Limits patient control on the Patient Access subscreen provides the ability to enable or disable patient control of stimulation parameters (amplitude, pulse width, group rate). When patient control is enabled for a stimulation parameter, the patient can adjust that stimulation parameter using the patient programmer.

If patient control is enabled, the upper patient limit for the stimulation parameter must be assigned. The lower patient limit is set to the lowest possible value by default and is not customizable. Patient control of stimulation parameters is assigned at the group level.

Note: By default, patient control of amplitude is enabled, and patient control of pulse width and group rate is disabled.

1. Next to the LIMITS heading, make sure that the group you

intend to congure is shown.

) or disable ( ) the

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Estimating Battery Longevity

2. Tap the toggle next to the stimulation parameter name to enable ( parameter.

3. For enabled stimulation parameters, set the upper patient limit using any of these controls:

■ Scrollable drop-down list.

■ Dial (press and drag the dot on the dial).

4. After the patient controls are dened, tap UPDATE.

Amplitude

■ The lowest allowable option for the upper patient limit is determined by the highest amplitude setting in the group's existing programs.

■ When AdaptiveStim Technology is enabled for a group, patient control is automatically enabled for amplitude and cannot be disabled for that group.

Pulse width

■ The lowest allowable option for the upper patient limit is determined by the highest pulse width setting in the group's existing programs.

■ When AdaptiveStim Technology is enabled for a group, patient control is not available for pulse width.

Group rate

■ The lowest allowable option for the upper patient limit is determined by the current rate setting for the group.

Effect of subsequent parameter changes

■ During a subsequent programming session, if a parameter is increased above the upper patient limit, the upper patient limit automatically changes to that new value.

) or disable ( ) patient control of the stimulation

Checking System Performance

The measurement functions on the Impedance screen assist in identifying problems with components of the implanted system.

Measurements and diagnostic data obtained from the clinician programmer app are intended to aid in your clinical assessment. However, as with any electronic system, internal and external factors

can inuence neurostimulator measurements. For example, changes

in lead position can affect the stimulation current or the impedance measurement. If you obtain a reading that seems inconsistent with your observations, repeat the measurement.

Note: Measure impedance at the beginning of each programming session. These measurements verify the integrity of lead, extension,

and connector pathways. They may provide information about lead problems (such as lead breakage, short circuit, open circuit). For

example, measurements that show a signicant increase in electrode

impedance can indicate a fractured lead conductor or a loose

setscrew. Conversely, a signicant decrease in electrode impedance

can indicate shorted conductors or a break in lead insulation. Measurements taken at the beginning of the session may be useful in interpreting diagnostic data collected since the previous session.

Testing impedance

The Impedance screen is accessed through the workow navigator.

Note: The Impedance screen can be accessed in the Side Menu

(

) when it is not part of a workow.

1. On the Impedance screen, tap the MEASURE ALL IMPEDANCES button (

2. Tap the START button on the pop-up screen.

3. After the test is complete, review the impedance results.

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Checking System Performance

Notes:

■ If all impedance values are within range, the message "All impedances are within normal range" appears in the GOOD box.

■ If any impedance value is out of normal ranges (too low or too high), the results appear in either the AVOID box or the DO NOT USE box. Refer to "Troubleshooting Electrode Impedance Results" on page 33.

■ The impedance value shown for each electrode is measured with respect to the selected reference electrode. Use the REFERENCE ELECTRODE scrollable drop-down list to select a different reference electrode, if applicable.

■ Once an impedance test is performed, results can be viewed at any time during the programming session by returning to the Impedance screen. You can also view or print the Session Report, which shows the impedance measurements.

Troubleshooting Electrode Impedance Results

The AVOID and DO NOT USE boxes on the Impedance screen identify where low impedance or high impedance was measured in the system. Refer to Table 6 for more information about impedance results indicators.

Table 6. Impedance results indicators.

Icon Description

GOOD (green electrodes with a check mark): Indicates that the impedance measurement value for the electrode is within the normal range (300 - 4,000 ohms).

AVOID (orange electrodes with an exclamation point): Possible open circuit:

• Using these electrodes may increase energy

consumption or impact therapy efcacy.

• Indicates that a high impedance (4,000 - 40,000 ohms) has been detected between electrodes. The Avoid icon is displayed and adjacent to the number of the electrodes where high impedance has been detected.

Possible short circuit:

• Indicates that a low impedance (under 300 ohms) has been detected between electrodes.

• The electrode combinations where possible shorts are detected are listed under the text. The electrodes in these combinations will also be listed in the Avoid list.

DO NOT USE (red electrodes with an "X"): Indicates that there is a strong likelihood of an open circuit (over 40,000 ohms) in the system.

Refer to the troubleshooting details for high impedance and low impedance on the following pages. For further assistance with

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Troubleshooting Electrode Impedance Results

troubleshooting electrode impedance results, contact Medtronic using the contact information listed on the back cover of this manual.

Intra-operative troubleshooting

High impedance troubleshooting

High impedance suggests a possible open circuit in the system. High impedance could be caused by a broken wire, loose connection, or highly resistive tissue.

High impedance: >4,000 ohms

1. Analyze electrode impedance measurement results. An outlier measurement may indicate an issue with a setscrew or wire. Ensure that all leads and extensions are fully inserted and setscrews are properly tightened and measure impedance again.

For more information about measuring electrode impedance, refer to “Testing impedance” on page 32.

2. If a trend towards normal impedance range is not observed, disconnect the lead from the extension (if applicable) and the neurostimulator. Reconnect to the Wireless External Neurostimulator (WENS) and use the A71300 Stimulation Trialing clinician programmer application to test the impedance of the lead alone.

■ Refer to the A71300 Stimulation Trialing Clinician Programmer Application programming guide for instructions for measuring impedance with the WENS.

■ If the impedance value is between 300 and 4,000 ohms, then the lead is intact.

■ If the impedance value is greater than 4,000 ohms,

visually or uoroscopically inspect the lead for damage.

3. If lead is intact, reconnect the lead to the extension (if applicable) and use the WENS to test the impedance of the lead and extension together.

■ If the extension impedance value is between 300 and 4,000 ohms, the extension is intact. If the extension impedance value exceeds 4,000 ohms, visually or

uoroscopically inspect the extension and extension

connection for damage.

■ If two extensions are being used, switch the extensions with one another and measure impedance again to see

if the out-of-range impedance value is specic to one of

the extensions. If the out-of-range impedance value is

specic to one of the extensions, consider replacing that

extension.

4. Reconnect the neurostimulator to the lead and extension (if applicable). Ensure that the neurostimulator is in the pocket and retest the system. If the impedance value remains high,

visually or uoroscopically inspect the connection between

the neurostimulator and the lead (or the connection between the neurostimulator and the extension, if applicable) and the neurostimulator connector block for damage.

■ If the neurostimulator impedance value is between 300 and 4,000 ohms, the neurostimulator is intact.

■ If the neurostimulator impedance value exceeds

4,000 ohms, visually or uoroscopically inspect the

neurostimulator and neurostimulator-to-lead (or extension, if applicable) connection for damage.

■ If two neurostimulators are being used, swap the neurostimulators with one another and measure impedance again to see if the out-of-range impedance

value is specic to one of the neurostimulators. If the out-of-range impedance value is specic to one

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Troubleshooting Electrode Impedance Results

of the neurostimulators, consider replacing that neurostimulator.

5. If the previous steps fail to reveal the underlying issue, assess whether it is possible to achieve therapy without using the electrodes with high impedance.

6. If troubleshooting measures fail to resolve the high impedance values, consider substituting new system components as needed.

Low impedance troubleshooting

Low impedance suggests a possible short circuit in the system that can lead to inadequate therapy.

Low impedance: <300 ohms

Avoid using electrodes with a low impedance. Assess whether it is possible to achieve therapy without using the electrodes with low impedance. If the low-impedance electrodes are necessary for programming, revision surgery may be needed.

Post-implant troubleshooting

Caution: When troubleshooting issues related to impedance measurements, follow these instructions correctly and completely to identify and resolve the issue.

■ Mistaking an undamaged component as damaged could result in unnecessary surgical revision.

■ Failure to identify a damaged component could result in unresolved intermittent or loss of stimulation.

High impedance troubleshooting

High impedance suggests a possible open circuit in the system. High impedance could be caused by a broken wire, loose connection, or highly resistive tissue.

High impedance: >4,000 ohms

Follow these steps to troubleshoot high impedance values:

1. If impedance values are high (>4,000 ohms), consider these troubleshooting options:

■ Assess whether therapy can be achieved using other electrodes.

■ Check for incorrect information. For example, check the Lead Select screen to ensure the electrode numbering on the screen matches the electrode numbering of the implanted lead(s).

■ Consider using x-ray to inspect the system components for improper connections or damage.

2. If troubleshooting measures fail to resolve the high impedance values, consider replacing system components as needed.

Low impedance troubleshooting

Low impedance suggests a possible short circuit in the system that can lead to inadequate therapy.

Low impedance: <300 ohms

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Preparing System for an MRI Scan

Refer to the MRI Guidelines for Medtronic Neurostimulation Systems for Chronic Pain instructions for use manual for the MRI conditions

and MRI-specic warnings and cautions for conducting an MRI scan.

Always obtain the latest MRI guidelines. Refer to the contact information at the back of this manual, or go to www.medtronic. com/mri.

When the MRI Mode feature is activated, stimulation is turned off. Stimulation must be off during the MRI scan.

To check MRI scan eligibility and enter MRI Mode

The information in the View MRI workow impacts the MRI scan eligibility shown on the MRI screen.

1. On the CURRENT DEVICE STATUS screen, conrm that the patient and device information corresponds with the intended patient and INS.

2. Tap VIEW MRI > START.

3. You are now in the View MRI workow.

Note: You can also access the MRI screen on the Side Menu (

) when not part of a workow.

4. On the Device screen, conrm that the following information is complete and accurate:

■ Neurostimulator model number

■ Neurostimulator implant location

5. On the Patient Info screen, conrm that the patient information is complete and accurate.

6. On the Lead Select screen, conrm that the lead model numbers are accurate.

7. On the Tip Location screen, conrm that the information for the following components is complete and accurate:

■ Presence of abandoned leads, extensions, and pocket adaptors

■ Lead tip location

8. On the MRI screen, review the MRI scan eligibility. You will see one of several possible eligibility outcomes, with icons and symbols. Explanations of the outcomes and their icons are described in Table 7.

Do not proceed if eligibility cannot be determined, or if the system is designated as MR Unsafe. Contact your Medtronic representative, if needed.

Table 7. MRI eligibility icons

Icons shown Explanation

Full-body scan eligible — The implanted

neurostimulation system is eligible to have MRI scans of any part of the body,

including a head scan, using specic

conditions. The MRI clinician must consult the MRI guidelines for those conditions.

Head scan eligible with transmit/ receive head coil — The implanted

neurostimulation system is eligible for MRI scans of the head only using an RF transmit/receive head coil and under other

specic conditions. The MRI clinician

must consult the MRI guidelines for those conditions.

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Preparing System for an MRI Scan

The neurostimulation system MRI scan eligibility cannot be conrmed —

The MRI clinician must consult the MRI guidelines to determine how to proceed or contact Medtronic technical support.

MR Unsafe: Patients implanted with a neurostimulation system that is designated as MR Unsafe on the MRI screen are ineligible for MRI scans. Therefore, activating MRI Mode is not applicable for MR Unsafe systems.

9. To prepare the device for an MRI scan, set the MRI MODE toggle to Activated (

10. Conrm that the message “Device ready for MRI scan” appears above the MRI MODE toggle and the MRI status indicator (

) displays in the action bar.

11. An MRI report can be generated in the Reports screen by selecting MRI Report from the drop-down list. Refer to "Working with Reports" on page 49 for details about viewing and printing reports.

Note: If you cannot print your reports, you can manually complete the MRI Eligibility Form in the MRI Guidelines

for Medtronic Neurostimulation Systems for Chronic Pain

instructions for use manual.

12. Inform the patient of the following:

■ When the MRI Mode feature is activated, stimulation is turned off. Stimulation must be off during the MRI scan.

■ Because stimulation is off, pain symptoms may return.

■ Bring the most up-to-date patient ID card to all MRI appointments.

■ Bring the patient programmer to all MRI appointments.

■ After the MRI scan is complete and the patient is outside of the magnet room, stimulation can be turned back on using the patient programmer. Or, if appropriate, the patient can revisit the clinician after the MRI scan to have stimulation turned back on with the clinician programmer app.

13. Give the MRI Report to the patient or send the report to the MRI center.

The MRI clinician uses the MRI Report to conrm the

neurostimulator model, session date, patient information, and MRI scan eligibility of the patient’s implanted system.

To deactivate MRI Mode

There are two different ways to deactivate MRI Mode and restart stimulation:

1. Start a workow with the INS. If the MRI status indicator ( displays in the action bar, stimulation will be off.

2. Tap the Stimulation toggle in the action bar to turn stimulation on and deactivate MRI Mode.

3. A pop-up message will appear that says turning stimulation on will deactivate MRI Mode. Tap STIM ON.

1. From the MRI screen, tap the Deactivated/Activated toggle.

2. A pop-up message will appear that says deactivating MRI Mode will not turn on stimulation automatically. Tap DEACTIVATE.

3. Tap the Stimulation toggle in the action bar to turn stimulation on.

)

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Preparing System for an MRI Scan

AdaptiveStim Technology

The Model 977006 Vanta neurostimulator with AdaptiveStim Technology can be programmed to adjust amplitude automatically when the patient changes body position. Amplitude settings can be assigned to the following positions:

■ Upright

■ Mobile

■ Reclining

■ Lying Front

■ Lying Back

■ Lying Right

■ Lying Left

When AdaptiveStim Technology is turned on for a patient, the neurostimulator automatically adjusts the amplitude based on the patient's body position and the clinician-programmed settings. If the patient makes an amplitude adjustment with the patient programmer, the neurostimulator associates the new amplitude with the patient's body position as long as the patient stays in that position for at least three minutes. The next time the patient enters that position, the neurostimulator will return to the new amplitude. In this way, AdaptiveStim Technology can respond to patient feedback.

Note: During a programming session, AdaptiveStim settings are not active.

To accommodate the individual needs of the patient, the following AdaptiveStim settings can be adjusted by the clinician:

■ Position angles: The range or area of a position.

■ Transition times: The amount of time that must elapse after moving into a new position (and remaining in the new position) before the amplitude will change.

■ Mobility rate: The intensity of movement that is considered a change from the stationary position of Upright to the moving position of Mobile.

Caution regarding cervical location

Caution: The use of AdaptiveStim Technology associated with position changes in the cervical location has not been shown to be safe and effective. The use of AdaptiveStim Technology associated with position changes for locations outside of the thoracic or lumbar spine may result in unintended stimulation.

Caution regarding healing period

Caution: Do not congure AdaptiveStim Technology during the implant procedure. A four-week healing period is recommended after implanting the neurostimulator to allow time for the implanted components to stabilize. If the tissue around the neurostimulator is

not sufciently healed, movement of the neurostimulator is possible

and may affect orientation.

Conguring AdaptiveStim

When you congure AdaptiveStim Technology with the setup wizard,

AdaptiveStim Technology is enabled for all programmed groups and every position, including Mobile, no matter what settings were previously assigned to those groups.

When a group is AdaptiveStim-enabled, the AdaptiveStim indicator ( appears next to the group name on the Programs screen, and patient access for pulse width is not available for that group:

Note: Amplitude limit is automatically enabled when AdaptiveStim

Technology is congured for a group and cannot be disabled for that

group.

)

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AdaptiveStim Technology

1. Go to the Programs screen, and tap a group name to activate

the group you want to congure.

2. Go to the AdaptiveStim screen, tap the Settings button ( and then tap Congure.

2. Select AdaptiveStim in the workow, and tap CONFIGURE to start the setup wizard.

3. Follow the on-screen instructions for all applicable positions.

■ On the orientation screen, have the patient get in the position and tap NEXT to complete the orientation.

Note: You can tap SKIP to bypass certain positions. Orientation still occurs for the position and a position amplitude of zero is assigned to that position.

■ On the programming screen, tap the program number

you want to congure, and then set the position

amplitude using the amplitude control. Refer to "Assigning amplitude" on page 25.

■ If applicable, tap another program number, and then set the position amplitude. When nished, tap NEXT to go to the next position.

4. A conrmation screen will appear when AdaptiveStim Technology has been congured for the group. Tap CLOSE to go to the AdaptiveStim screen.

Reconguring an AdaptiveStimenabled group

If you want to recongure an AdaptiveStim-enabled group, complete

these steps to delete the existing AdaptiveStim settings and to reassign position amplitudes for that group. You also have the option to reorient patient positions. To reorient only, refer to "Reorienting patient positions" on page 43.

1. Go to the Programs screen, and tap a group name to activate

the group you want to recongure.

3. Tap Start Over.

4. (Optional) Tap the Reorient checkbox if you also want to reorient the neurostimulator to the patient positions.

5. Tap Yes to proceed.

6. Follow the on-screen instructions to reorient the neurostimulator to the patient positions (if applicable) and to reassign position amplitudes for the programs in the active group.

7. When the wizard is nished, a conrmation screen displays

stating that you have successfully recongured AdaptiveStim

Technology for the group.

8. Tap CLOSE to go to the AdaptiveStim screen.

What you can do on the AdaptiveStim screen

The AdaptiveStim screen displays when an AdaptiveStim-enabled group is the active group and you select AdaptiveStim in the

workow. The AdaptiveStim screen can also be accessed by tapping AdaptiveStim on the Side Menu (

Refer to Table 8 on page 40 for information about the tasks you can complete on the AdaptiveStim screen.

Note: Some tasks may not be available until AdaptiveStim

Technology has been congured.

) when not part of a workow.

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AdaptiveStim Technology

Table 8. Tasks on the AdaptiveStim screen.

Tasks on the AdaptiveStim screen More information

Review position amplitudes for all AdaptiveStim-enabled groups.

Use this feature to view a summary of the position amplitudes for all AdaptiveStim-enabled groups and programs.

Test AdaptiveStim settings.

Use this feature to test AdaptiveStim settings during a programming session.

Adjust position amplitudes for individual positions.

Use this feature to adjust position amplitudes for individual positions in the active group.

Check patient positions.

Use this feature to determine if the neurostimulator correctly detects the patient positions.

Reorient patient positions.

Use this feature to reorient the neurostimulator to the patient positions without changing any group settings.

Recongure an AdaptiveStim-enabled group.

Use this feature to delete all existing AdaptiveStim settings for a group and to reassign position amplitudes. You also have the option to reorient patient positions.

Disable AdaptiveStim Technology for a group.

Use this feature to clear all existing AdaptiveStim settings for a group. All other AdaptiveStim-enabled groups are not impacted.

Enable or disable AdaptiveStim Technology for the patient.

If the feature is enabled, AdaptiveStim Technology and all assigned settings will be on when the programming session ends.

If disabled, AdaptiveStim Technology and all assigned settings will be off when the programming session ends. However, the patient can turn on AdaptiveStim Technology using the patient programmer.

Turn the Position Diary on or off.

The Position Diary feature enables the Position Trend chart to be populated in the Diaries screen. The Position

Trend chart shows the time the patient spent in each position during the periods between the last four programming sessions.

Setting stability time

Stability time is the amount of time that the patient needs to be in a position before that new intensity for that position will be saved.

Page 42

Page 43

Page 39

Page 43

Page 44

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AdaptiveStim Technology

Tasks on the AdaptiveStim screen More information

Adjust position angles.

Position angle is the range or area of a position and is used to ensure the neurostimulator properly recognizes the Upright position from the Lying positions.

Adjust transition times.

Transition time is the amount of time that must elapse between changes in position before the amplitude will change.

Adjust mobility rate.

Mobility rate is the intensity of movement that is considered a change from the stationary position of Upright to the moving position of Mobile.

Turn off mobility detection.

Turning off mobility detection disables the Mobile position for AdaptiveStim Technology.

Troubleshoot AdaptiveStim Technology.

Table 9 lists potential issues that can occur with AdaptiveStim Technology, as well as possible solutions for resolving those issues.

Page 44

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AdaptiveStim Technology

Reviewing position amplitudes for all AdaptiveStim-enabled groups

A summary of the position amplitudes for all AdaptiveStim-enabled groups and programs can be viewed from the AdaptiveStim screen.

1. Go to the AdaptiveStim screen, tap the Settings button ( and then tap Overview.

Adjusting position amplitudes for individual positions

Complete these steps to adjust position amplitudes for individual positions in a group.

1. Go to the Programs screen, and tap a group name to activate the group you want to adjust.

2. Review the position amplitudes assigned to the AdaptiveStimenabled groups. If all groups and programs are not visible, you may need to swipe left or right to see all of the data.

3. Tap CLOSE to return to the AdaptiveStim screen.

Testing AdaptiveStim settings

During a programming session, AdaptiveStim settings are suspended. The Test AdaptiveStim feature can be used to test AdaptiveStim settings in session and to obtain patient feedback. There must be at

least two different position amplitudes dened in a program to run the

test.

1. Go to the Programs screen, and tap a group name to activate the group you want to test.

2. Go to the AdaptiveStim screen, and tap the TEST ADAPTIVESTIM button (

3. Follow the on-screen instructions to test the AdaptiveStim settings and obtain patient feedback.

4. Tap STOP to end the test.

2. Go to the AdaptiveStim screen, and tap the position you want to adjust.

On the screen, you see the current programs in the group. Within each program box, the program amplitude is displayed in white and the position amplitude is displayed in green. A

white box around a program identies the active program.

3. Tap the program number you want to adjust.

4. Use the amplitude control to adjust the program amplitude (the stimulation the patient is receiving). Refer to "Assigning amplitude" on page 25.

The white dot represents the program amplitude. As you make

amplitude changes, the white dot moves to reect the current

amplitude.

Note: You can also drag the white dot to assign amplitude. Stimulation ramps up to the amplitude value.

5. When you nd an acceptable amplitude, tap SET POSITION AMPLITUDE to assign the stimulation the patient is receiving as the position amplitude.

The blue dot represents the position amplitude.

6. When nished making adjustments, tap CLOSE to return to the

AdaptiveStim screen.

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AdaptiveStim Technology

Checking patient positions

Complete these steps to determine if the neurostimulator correctly detects the patient positions.

1. Place the patient in the position you intend to check.

2. Go to the AdaptiveStim screen, and tap the CHECK POSITION button (

3. Conrm that the position shown on the AdaptiveStim screen corresponds to the patient's body position.

Reorienting patient positions

Complete these steps to reorient the neurostimulator to the patient positions without changing any group settings.

1. Go to the AdaptiveStim screen, tap the Settings button ( and then tap Congure.

2. Tap Reorient Only.

3. Tap Yes to clear the current orientation.

4. Follow the on-screen instructions to reorient the neurostimulator to the patient positions.

5. (Optional) Tap SKIP if you want to bypass a position.

6. When all positions have been reoriented, a conrmation screen displays.

7. Tap CLOSE to go to the AdaptiveStim screen.

Disabling AdaptiveStim Technology for a group

Complete these steps to clear all existing AdaptiveStim settings for a group. All other AdaptiveStim-enabled groups will not be impacted.

1. Go to the Programs screen, and tap a group name to activate the group.

2. Go to the AdaptiveStim screen, and tap the on/off toggle next to the Settings button (

3. Tap UPDATE, and then conrm the disable notication.

) to enable or disable AdaptiveStim.

Enabling or disabling AdaptiveStim Technology for the patient

You can choose to either enable or disable AdaptiveStim Technology for the patient. If enabled, AdaptiveStim Technology and all assigned settings will be on when the programming session ends. If disabled, AdaptiveStim Technology and all assigned settings will be off when the programming session ends. However, the patient can turn on AdaptiveStim Technology using the patient programmer.

1. Go to the AdaptiveStim screen, and tap the RESUME on/off toggle to enable or disable AdaptiveStim.

2. Tap UPDATE to apply the changes.

Turning the Position Diary on or off

The Position Diary feature enables the Position Trend chart to be populated in the Diaries screen. The Position Trend chart shows the time the patient spent in each position during the periods between the last four programming sessions. The chart is accessed through the

Diaries screen.

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AdaptiveStim Technology

AdaptiveStim must be congured for position data to be tracked. Refer to "Conguring AdaptiveStim" on page 38 for instructions. By

default, the Position Diary is turned on when AdaptiveStim Technology

is initially congured or recongured, or when patient positions are

reoriented. If the Position Diary is turned off, from that point, position data is not saved. If the Position Diary is on and AdaptiveStim Technology is turned off, position data continues to be tracked.

1. Go to the AdaptiveStim screen, tap the Settings button ( and then tap Settings.

2. On the Options tab under POSITION DIARY, tap the on/off toggle. Green (toggle to the right) indicates that the Position Diary is on.

3. Tap UPDATE to apply the changes.

4. Tap CLOSE to return to the AdaptiveStim screen.

from the Lying positions. By default, the Upright position angle is set to Small and the Lying position angle is set to XX-Large. All Lying positions (Back, Front, Left, Right) use the same position angle value.

1. Go to the AdaptiveStim screen, tap the Settings button ( and then tap Settings.

2. Tap the Angles tab.

3. On the Angles diagram, tap the position name for the angle you want to adjust (for example, Upright, Lying Back, or Lying Front).

4. Press and drag one of the delimiter dots to set a larger or smaller angle.

5. Make other adjustments to the position angles as needed.

6. Tap UPDATE to apply the changes.

Setting stability time

The Stability Time setting is the amount of time that the patient needs to be in a position (after having set a new intensity value with the patient programmer) before the intensity value for the position is saved to the neurostimulator. The default setting is 0 seconds.

1. Go to the AdaptiveStim screen, tap the Settings button ( and then tap Settings.

2. Tap the STABILITY TIME drop-down list and select a duration.

3. Tap UPDATE to apply the changes.

4. Tap CLOSE to return to the AdaptiveStim screen.

Adjusting position angles

Position angle is the range or area of a position and is used to ensure that the neurostimulator properly recognizes the Upright position

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7. Tap CLOSE to return to the AdaptiveStim screen.

Note: To test the changes, refer to "Testing AdaptiveStim settings" on

page 42.

Adjusting transition times

Transition time is the amount of time that must elapse between changes in position before the amplitude will change. You can adjust transition times for each position change.

1. Go to the AdaptiveStim screen, tap the Settings button ( and then tap Settings.

2. Tap the Transitions tab.

3. Swipe up and down on the screen to scroll and nd the position change you want to adjust.

4. Tap to open the scrollable drop-down list and select a duration.

AdaptiveStim Technology

5. Make adjustments to other transition times as needed.

6. Tap UPDATE to apply the changes.

7. Tap CLOSE to return to the AdaptiveStim screen.

Note: To test the changes, refer to "Testing AdaptiveStim settings" on page 42.

Turning off mobility detection

Turning off mobility detection disables the Mobile position for AdaptiveStim Technology. When mobility detection is off, the Mobile position button is dimmed in the AdaptiveStim screen.

1. Go to the AdaptiveStim screen, tap the Settings button ( and then tap Settings.

Adjusting mobility rate

Mobility rate is the intensity of movement that is considered a change from the stationary position of Upright to the moving position of Mobile. The mobility rate is only accessible if the Mobile posture is enabled.

1. Go to the AdaptiveStim screen, tap the Settings button ( and then tap Settings.

2. Tap the Mobility Rate tab.

3. Conrm that the on/off toggle is in the on position. Green indicates that the Mobile posture is enabled.

4. Press and drag the Mobility Rate dot on the slider.

■ Low (L): Takes less motion for the neurostimulator to detect the Mobile position.

■ High (H): Takes more motion for the neurostimulator to detect the Mobile position.

5. Tap UPDATE to apply the changes.

6. Tap CLOSE to return to the AdaptiveStim screen.

Note: To test the change in mobility rate, refer to "Testing AdaptiveStim settings" on page 42. To check patient positions, refer to "Checking patient positions" on page 43.

2. Tap the Mobility Rate tab.

3. Tap the on/off toggle. Gray indicates that the Mobile position is disabled.

4. Tap UPDATE to apply the changes.

5. Tap CLOSE to return to the AdaptiveStim screen.

Troubleshooting AdaptiveStim Technology

Refer to Table 9 on page 46 for a list of potential issues that can occur with AdaptiveStim Technology, as well as possible solutions for resolving those issues.

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AdaptiveStim Technology

Table 9. Troubleshooting AdaptiveStim Technology.

Problem Possible Solutions

The delay between a position change and the amplitude change is too slow or too fast for the patient.

The amplitude changes too often for the patient.

The amplitude changes to the amplitude for the Mobile position while the patient is in the Upright position but not mobile.

The amplitude does not change to the amplitude for Mobile when the patient is moving.

The patient does not like that the amplitude changes to the Mobile amplitude when starting to walk from the Upright position.

Neurostimulator may have

rotated or ipped within the

pocket.

Patient feels the amplitude for the Upright position when lying down.

Patient is not getting adequate therapy in a position programmed with AdaptiveStim.

■ Use the Transitions setting to increase or decrease the delay between position changes and amplitude changes.

■ Use the Test AdaptiveStim feature to obtain patient feedback and make adjustments as needed.

■ Use the Angles setting to increase the angle for the position that is changing too often. Or

■ Use the Transitions setting to increase the delay between position change and amplitude change.

■ Use the Mobility Rate setting to increase the intensity of movement that is required to change to the amplitude for the Mobile position.

■ Have the patient remain still in the Upright position for at least one minute.

■ Use the Check Position feature to conrm the patient’s position. If “Mobile” is shown instead of “Upright” for the patient’s current position, increase the mobility rate.

■ Use the Mobility Rate setting to decrease the intensity of movement that is required to change to the amplitude for the Mobile position.

■ Have the patient walk down the hall for at least one minute.

■ Use the Check Position feature to conrm the patient’s position. If “Upright” is shown instead of “Mobile” for the patient’s current position, decrease the mobility rate.

■ Turn off the Mobility Rate feature.

■ When the Mobility Rate feature is turned off, the Mobile position is no longer enabled for AdaptiveStim Technology.

■ Reorient the neurostimulator to the patient positions.

■ Use the Angles setting to increase the angle for the Lying positions.

■ Review position amplitudes, and check that the position amplitude is not set to 0 mA.

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AdaptiveStim Technology

Problem Possible Solutions

Patient unable to adjust their stimulation rate.

■ Create multiple identical groups by copying the current AdaptiveStim-enabled group. Adjust the stimulation rate for each group to provide the patient with different stimulation rates with AdaptiveStim enabled. Provide the patient guidance on how to switch groups.

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AdaptiveStim Technology

Viewing Diaries

The charts accessed from the Diaries screen provide overviews of how the patient is using the neurostimulator. Not all types of diaries are supported by the Model 977005 Sequentia LT neurostimulator.

Stimulation Usage

The Stimulation Usage chart shows the patient's stimulation usage. The chart displays the percentage of time per day that stimulation is on over a 30-day period. The metrics provide the average percentage of stimulation usage over the last 30 days and the percentage of time stimulation was on since the last programming session.

Note: If 30 days of stimulation usage data is not available, the calculations are based on the available number of days.

Group Usage

The Group Usage chart displays the percentage of time that each group was used since the last programming session.

Adjustments

The Adjustments chart is only applicable to neurostimulators with AdaptiveStim Technology. The chart shows the number of amplitude adjustments made by the patient since the last programming session. Data is shown for each position and AdaptiveStim-enabled group.

Composite

The Composite chart is only applicable to neurostimulators with AdaptiveStim Technology. The chart shows the number of hours of stimulation usage for time spent reclining, mobile, upright, and lying within the last 30 days.

■ Tap the toggle to display the graph for a position on the chart. Multiple positions can be selected to show the position graphs together. Green indicates that the position has been selected.

■ The background graph that is displayed (before any position graphs are added) represents stimulation usage.

■ Select a start time and end time if you want to see usage

during a specic time period.

Position Trend

The Position Trend chart is only applicable to neurostimulators with AdaptiveStim Technology. The chart shows the time the patient spent in each position during the periods between the last four programming sessions. The default view shows all positions and the amount of time in percentages.

■ Select a position from the scrollable drop-down list if you want

to view a specic position only.

■ Select Time if you want to see the average amount of time per day in hours and minutes.

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Resting Trend

The Resting Trend chart is only applicable to neurostimulators with AdaptiveStim Technology. The chart shows the average number of position changes from one lying position to another during the periods between the last four programming sessions.

Viewing Diaries

Working with Reports

The following report types are available from the Reports screen:

■ Session Report: Contains information about the settings programmed into the neurostimulator during a programming session as well as therapy usage and system status information.

■ MRI Report: Contains information intended for MRI clinicians about the MRI scan eligibility of the implanted system for the selected patient.

■ Medtronic Data Report: Contains information about the Medtronic data collected from the neurostimulator. This report is used by Medtronic personnel when troubleshooting. To compile a Medtronic Data Report, refer to "Compiling a Medtronic Data Report" on page 52.

The Reports screen is accessed through the workow navigator or by tapping Reports on the Side Menu ( You can also tap REPORTS on the initial app screen to view reports for a patient without having to start a session.

Note: Any report generated in Demo mode is labeled DEMO MODE at the top of the report.

Using the Reports screen

1. Select a report type from the drop-down list. The default is Session Report.

) when not part of a workow.

5. If applicable, tap the checkbox to remove the device serial number from the report, and then tap CONFIRM.

Table 10. Report buttons.

Button Description

View button – to view the report in PDF format.

This action takes you out of the clinician programmer app. The app runs in the background and your session data remains intact.

Share button – to send the PDF report to another destination.

This action takes you out of the clinician programmer app. The app runs in the background and your session data remains intact.

Download button – to download and save the PDF report on the clinician tablet.

This action saves a PDF le in the default reports

folder on the clinician tablet.

Delete button – to delete the selected patient session record from the clinician tablet.

When a session record is deleted, the data no longer exists on the clinician tablet. However, deleting a

session record does not delete any existing PDF les

created from that record and stored on the clinician tablet.

2. (Optional) Use the lter options to nd the patient data you want.

3. Tap the desired patient session record in the scrollable list. The most recent patient session record appears at the top.

4. Tap one of the buttons shown in Table 10.

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Working with Reports

Patient Data Service app

The Patient Data Service app manages the storage of patient session data in a locally stored database on the clinician tablet.

The Patient Data Service app can be used to access or delete patient session data for any patients whose Medtronic devices have been programmed using any clinician programmer app on the clinician tablet.

The Patient Data Service app can also be used to adjust (or disable)

the PDF auto-delete feature, which automatically deletes PDF les

from the default reports folder on the clinician tablet after a designated amount of time.

Finding and opening the app

1. Navigate to the Apps on the clinician tablet.

2. Find the icon for the Patient Data Service app.

3. Tap the icon to open the app.

Table 11. Patient Data Service buttons.

Button Description

Import button – to import the selected session

record into the Reports screen in the clinician programmer app.

Refer to "Using the Reports screen" on page 49.

Delete button – to delete the selected patient session record from the clinician tablet.

When a session record is deleted, the data no longer exists on the clinician tablet. However, deleting a

session record does not delete any existing PDF les

created from that record and stored on the clinician tablet.

Deleting multiple patient session records at once

1. In the Patient Data Service app, use the lter options to nd the patient data you want.

Accessing or deleting a patient session record

1. In the Patient Data Service app, use the lter options to nd the patient data you want.

2. Tap the desired patient session record in the scrollable list. The most recent patient session record appears at the top.

3. Tap one of the buttons shown in Table 11.

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2. Tap and hold on any record in the results list to activate the multiple record selection feature.

3. Tap the applicable checkboxes to select all records you want to delete from the scrollable list.

4. Tap the Trash icon ( records to be deleted is shown next to the icon.

Note: To cancel without deleting records, tap the back arrow in the upper left corner.

Patient Data Service app

) to delete the records. The number of

Setting the PDF auto-delete feature

Use the auto-delete feature to automatically delete PDF les stored

on the clinician tablet based on a timeframe you select. The autodelete feature is enabled by default with a preset amount of time.

This feature only deletes PDF les from the default reports folder on

the clinician tablet. It does not affect patient session data stored in the database.

1. In the Patient Data Service app, tap the Settings button (

2. Select PDF Auto Delete.

3. Select the appropriate auto-delete settings, and then tap UPDATE.

Viewing System Information

The About System screen is accessed from the Side Menu ( ).

This screen provides the following information:

■ System information (such as model numbers, serial numbers,

rmware numbers, version numbers) for the neurostimulator,

clinician tablet, clinician programmer app, controller (patient programmer), recharger, and communicator.

Includes the information for the controller (patient programmer), and communicator that most recently communicated with the neurostimulator or was paired with the clinician tablet.

■ Trademarks and licenses information.

This screen provides the following capabilities:

■ Ability to change the device date and time for the neurostimulator.

■ Ability to change the neurostimulator implant date.

■ Ability to generate a Medtronic Data Report.

Viewing information about system components

On the About System screen, tap the tab for the component information you want to view.

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Viewing information about trademarks and licenses

On the About System screen, tap the Licenses tab, and then tap the button for the information you want to view.

Viewing System Information

Changing device date/time or implant date information

The Device tab on the About System screen shows the device date, device time, and implant date. You can change the date and time information if needed.

■ Tap the date that you want to change. Use the calendar selector to select a new date, and then tap outside the calendar.

■ Tap the time that you want to change. Use the time selector to select a new time, and then tap outside the time.

Compiling a Medtronic Data Report

The Medtronic Data Report tab on the About System screen is used to compile a report containing information about the Medtronic data collected from the neurostimulator.

■ Tap the COMPILE REPORT button ( Medtronic Data Report. You cannot cancel the action after it is initiated.

To access previously compiled Medtronic Data Reports, refer to "Working with Reports" on page 49.

) to compile the

Viewing Alerts

The clinician programmer app displays alerts to inform you of specic

events or changes in the system. There are three levels of alerts in the clinician programmer app: warning, caution, and information.

When alerts are present, an ALERTS button displays on the screen. The button shows the number of alerts that need to be acknowledged. Read and follow the instructions given in the alert.

Working with alerts

■ To view alerts, tap the ALERTS button in the lower left corner of the screen. Each alert appears in a separate pop-up box.

– Swipe left or right to view individual alerts.

■ To close an alert without dismissing it, tap the X (or anywhere outside of the alert pop-up box).

■ To dismiss an alert, tap the DISMISS button. The alert will be marked as a dismissed alert.

■ When all alerts are dismissed, the ALERTS button reads "NO ALERTS". Those alerts, however, now exist as dismissed alerts and can still be viewed.

■ To view dismissed alerts, tap the NO ALERTS button, and then tap the SHOW DISMISSED button.

■ To restore a dismissed alert, tap the RESTORE button.

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Viewing Alerts

Troubleshooting

Approach troubleshooting conservatively. Prior to performing invasive procedures, ensure that all noninvasive solutions have been considered. If additional assistance is needed, contact Medtronic using the contact information listed on the back cover of this manual.

The clinician programmer app displays messages to inform you of issues in the system. Follow the instructions given in the message.

Data validation error message

During initial interrogation, the app performs a data validation check to ensure that the data in the neurostimulator is valid and can be understood. If data is found to be invalid, the app displays a data validation error message and provides the option to clear the invalid data.

Elective Replacement Indicator (ERI) message

When an implanted neurostimulator reaches its recommended replacement date, a message displays. Refer to the System Eligibility and Battery Longevity reference manual for information about neurostimulator battery longevity.

End of Service (EOS) message

When an implanted neurostimulator reaches its end of service (EOS), a message displays. At EOS, therapy is not available and the device must be replaced. Refer to "Estimating Battery Longevity" on page 31 for information about neurostimulator battery longevity.

Note: Impedance can be measured at EOS. Refer to "Testing impedance" on page 32 for more information.

Power on reset (POR) message

If a power on reset (POR) message displays at initial interrogation, this indicates that one or more POR events occurred since the last programming session. If a power on reset message displays while in a current programming session, the session will end and any unsaved data will be lost.

Out of regulation (OOR) message

An out of regulation (OOR) message indicates that the delivered amplitude may be lower than the programmed amplitude for the indicated programs because of low impedance. If an out of regulation situation occurs, decrease settings or reduce the number of electrodes for the indicated programs.

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Using impedance measurements for troubleshooting

Refer to "Checking System Performance" on page 32.

Communicator and clinician tablet troubleshooting

Refer to Table 12 on page 55 for a list of potential issues that can occur with the communicator or the clinician tablet, as well as possible solutions for resolving those issues.

To reset a neurostimulator

If a neurostimulator persistently cannot be found and communication to the neurostimulator has been lost, use the following steps to reset the neurostimulator.

Troubleshooting

1. Open the application.

2. Tap the Settings button (

) in the top-right corner of the

CONNECT screen, then tap About.

3. Tap the Device tab.

4. After reading the on-screen text, tap the RESET

NEUROSTIMULATOR(S) button, then conrm the action.

After sending the reset command, the communicator will beep.

Note: Therapy is automatically stopped after resetting the neurostimulator. To resume therapy, refer to "Initiating communication with the neurostimulator" on page 12.

Contact the appropriate Medtronic representative listed on the back cover of this manual if additional assistance is needed.

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Troubleshooting

Table 12. Communicator and clinician tablet troubleshooting.

Problem Possible Solutions

The communicator cannot communicate with the neurostimulator.

The communicator cannot pair with the clinician tablet.

The communicator cannot communicate wirelessly with the clinician tablet during a programming session.

■ The communicator may not be positioned correctly over the neurostimulator. – Position the target symbol (

facing the neurostimulator.

■ The communicator may be too far away from the neurostimulator. – Move the communicator closer to the neurostimulator.

■ Metal surfaces can interfere with communication between the communicator and the neurostimulator. – If the communicator is on a metal table or a metal tray, move the communicator to a nonmetal

surface.

■ There could be radio-frequency (RF) interference. – Move the communicator closer to the neurostimulator.

■ The communicator may have interrogated a different device. – Place the communicator directly over the neurostimulator (use a sterile barrier, if applicable) and

tap FIND DEVICE on the clinician programmer app.

BLUETOOTH communication requires an initial pairing with a USB cable. Refer to “Pairing the communicator to the clinician tablet” on page 12 if this initial pairing has not been completed.

When attempting to connect through BLUETOOTH wireless technology:

■ Make sure the communicator is turned on and within range of the clinician tablet. See the 8880T2

Technical Manual for details.

■ Make sure that the BLUETOOTH wireless technology is enabled on the clinician tablet.

Refer to "Communicator icons on the tablet status bar" on page 16 for what the communicator icons mean when displayed in the tablet status bar.

Possible reasons:

■ You are in an environment where multiple devices are using BLUETOOTH wireless technology and

thereby creating interference.

■ You have moved into an environment where the BLUETOOTH wireless technology is prohibited.

Possible solutions:

■ Use the USB connector cable to connect the communicator to the clinician tablet.

■ Make sure that the BLUETOOTH wireless technology is enabled on the clinician tablet.

Refer to "Communicator icons on the tablet status bar" on page 16 for what the communicator icons mean when displayed in the tablet status bar.

) on the back of the communicator so that it is centered over and

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Troubleshooting

Problem Possible Solutions

The communicator battery level is low.

The clinician tablet, the clinician programmer app, or the communicator is unresponsive.

The communicator is damaged or overheats.

If the communicator requires repair, is damaged, or is nonfunctional and a replacement is needed, contact Medtronic using the contact information listed on the back cover of this manual.

■ Open the battery case and replace the batteries. – If needed, refer to the instructions for replacing the communicator batteries in the Model 8880T2

Communicator technical manual.

■ After replacing the communicator batteries, the clinician programmer app reconnects with the

communicator using the BLUETOOTH wireless technology and resumes the session.

■ Turn off the power for the clinician tablet or the communicator, then turn the power on.

■ If you continue to have communication problems or cannot use the app to program, contact Medtronic

using the contact information listed on the back cover of this manual.

Use a different communicator:

■ Ensure that the damaged communicator is turned off before using another communicator.

■ If using a replacement communicator prior to starting a programming session, use the USB

connector cable and pair the replacement communicator to the clinician tablet.

– Refer to "Pairing the communicator to the clinician tablet" on page 12.

– If replacing the communicator while in a programming session, use the USB connector cable to

connect the communicator to the clinician tablet and continue with the programming session.

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Troubleshooting

Patient programmer messages

The patient programmer displays text and iconic error and informational messages. Messages provide a service code and tell the patients to contact their clinician. These service codes and their troubleshooting procedures are displayed in Table 13. If additional assistance is needed, contact Medtronic using the contact information listed on the back cover of this manual.

Table 13. Service codes on the patient programmer

indicating the need to contact a clinician.

Service

code

201 or 204 Elective Replacement Indicator (ERI)

302 End of Service (EOS)

303 Update App

Explanation and Possible Solutions

One of these service codes will display when an implanted neurostimulator reaches its recommended replacement date.

The implanted neurostimulator has reached its end of service, a message displays. At EOS, therapy is not available and the neurostimulator must be replaced.

A “System Update Needed” alert will display on the patient programmer app if the app is not

compatible with the neurostimulator. Conrm that

the patient has the correct programmer model for their neurostimulator. The patient or clinician should connect to a Wi-Fi network to update the patient programmer app. When the update is complete, WiFi capability can be turned off again.

Service

Explanation and Possible Solutions

code

306 Remove Neurostimulator

This message will appear if the user attempts to remove a paired neurostimulator from the About screen in the patient programmer app. A paired neurostimulator is required to use the patient programmer app.

307 Remove Communicator

This message will appear if the user attempts to remove a paired communicator from the “About” screen in the patient programmer app. A paired communicator is required to use the patient programmer app with the neurostimulator.

311 Unexpected Command Response

Patient will see an “Error Found” alert. Contact Medtronic with the service code.

312 Unexpected Device Status

Patient will see an “Error Found” alert. Contact Medtronic with the service code.

318 Invalid Therapy Control Settings

Patient will see an “Update Settings” alert after invalid settings are detected. Resolve this issue by updating the neurostimulator settings with the clinician programmer app.

319 No Therapy

A “No Therapy” alert will display on the patient programmer app when the neurostimulator has not been programmed yet with the clinician programmer app.

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Troubleshooting

Service

Explanation and Possible Solutions

code

322 Firmware not Running

A “No Therapy” alert will display on the patient

programmer app when a rmware issue has been

detected. Contact Medtronic with the service code.

323 Unexpected Therapy Off

A “Therapy Off” alert will display on the patient programmer app and the neurostimulator will turn stimulation off when settings are too high. Reprogram the neurostimulator with reduced settings (fewer electrodes and programs; lower amplitude, pulse width, and rate).

324 Unexpected Telemetry Error

Patient will see an “Error Found” alert. Contact Medtronic with the service code.

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Troubleshooting

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Manufacturer

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

REP

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

*M006345C007*

M006345C007 Rev B 2022-01-15

Medtronic A71200 Programming Guide

Specifications and Main Features

Frequently Asked Questions

User Manual

Table of Contents

Description of the Programming System

Model A71200 Vanta / Sequentia LT clinician programmer application

Intended purpose

Other components of the programming system

Programmable Settings

Stimulation parameters

Groups and programs

Optional features

Data Security and Network Connectivity

Data security

Network connectivity

Installing application updates

Installing communicator updates

Returning the clinician tablet

General Warnings and Cautions

MRI warning for scan eligibility

EMI caution for telemetry signal disruption

Cautions related to clinician programming and possible interactions with other devices

Setting up the Programming System

Preparing the clinician tablet

Finding and opening the app

Pairing the communicator to the clinician tablet

Initiating communication with the neurostimulator

Overview of the Clinician Programmer App

Using Demo mode

Using the Side Menu

On-screen help

Buttons and indicators on the action bar

When the app is placed in the background

Overview of the Communicator

Using the USB connector cable

Communicator icons on the tablet status bar

Working with Device and Patient Information

Checking battery status of the neurostimulator

Entering implant location

Entering patient information

Mapping patient pain

Entering lead information

Testing lead connectivity

Entering extensions, pocket adaptors, abandoned leads, or tip location information

Working with Groups and Programs

Programs screen

Program subscreen

Turning stimulation on or off

Adjusting Stimulation Parameters

Assigning amplitude, pulse width, and program rate

Relative Lead Positioning

Customizing SoftStart/Stop and Cycling

Turning cycling on or off

Changing SoftStart/Stop settings

Estimating Battery Longevity

Enabling Patient Access

Adjustment

Limits

Checking System Performance

Testing impedance

Troubleshooting Electrode Impedance Results

Intra-operative troubleshooting

Post-implant troubleshooting

Preparing System for an MRI Scan

To check MRI scan eligibility and enter MRI Mode

To deactivate MRI Mode

AdaptiveStim Technology

Caution regarding cervical location

Caution regarding healing period

What you can do on the AdaptiveStim screen

Reviewing position amplitudes for all AdaptiveStim-enabled groups

Adjusting position amplitudes for individual positions

Testing AdaptiveStim settings

Checking patient positions

Reorienting patient positions

Disabling AdaptiveStim Technology for a group

Enabling or disabling AdaptiveStim Technology for the patient

Turning the Position Diary on or off

Setting stability time