Medtronic A71100 Programming Guide

Restore

Clinician Programmer

Application

Programming Guide

Neurostimulation systems for pain therapy Neurostimulator models 37022, 37701, 37702, 37703, 37704, 37711, 37712, 37713, 37714, 97702, 97712, 97713, 97714

Application version 1.0

A71100

Explanation of symbols

Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. AdaptiveStim™, GroupAdjust™, Itrel™, N'Vision™,

Conformité Européenne (European Conformity)

Authorized representative in the European Community

PrimeAdvanced™, Restore™, RestoreAdvanced™, RestorePrime™, RestoreSensor™, RestoreUltra™, SoftStart/Stop™, SureScan™, and TargetMyStim™ are trademarks of a Medtronic company.

Android™ is a trademark of Google LLC.

The BLUETOOTH

word mark and logos are registered trademarks

owned by Bluetooth SIG, Inc., and any use of such marks by

Manufacturer

Medtronic is under license.

Wi-Fi

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

For USA audiences only

Importer

Refer to the indications sheet for indications and related information.

Refer to the device implant manual for device description, package contents, device specications, and instructions for use.

Refer to the appropriate information for prescribers booklet for contraindications, warnings, cautions, adverse events summary, individualization of treatment,

patient selection, use in specic populations, resterilization, and component disposal.

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.

Refer to the System Eligibility, Battery Longevity, Specications reference manual for neurostimulator selection, battery longevity calculations, and specic neurostimulator specications.

Refer to the Model 8880T2 Communicator technical manual for warnings, cautions, device description, package contents, device specications, instructions

for use, maintenance information, and the electromagnetic compatibility (EMC) declaration.

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

Refer to the clinical summary booklet for information on the clinical study results of the neurostimulation system and individualization of treatment.

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Description of the Programming System �� 7

Model A71100 Restore Clinician Programmer Application .. 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 �� 10

Data security ...................................................................... 10

Network connectivity .......................................................... 10

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

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

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

General Warnings and Cautions ��11

MRI warning for scan eligibility .......................................... 11

MRI warning for trial stimulation ........................................ 11

Sterile eld warning for programming components ........... 11

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

Cautions related to clinician programming and

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

Setting up the Programming System �� 12

Preparing the clinician tablet ............................................. 12

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

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

Positioning the communicator over the neurostimulator .... 13

Initiating communication with the neurostimulator ............. 13

Overview of the Clinician Programmer App �� 15

Using Demo mode ............................................................. 15

Navigating through workows ............................................ 15

Using the Side Menu ......................................................... 15

On-screen help .................................................................. 16

Buttons and indicators on the action bar ........................... 16

When the app is placed in the background ....................... 17

Overview of the Communicator �� 18

Using the USB connector cable ......................................... 18

Checking battery status of the communicator ................... 18

Communicator icons on the tablet status bar .................... 19

External Neurostimulator Workows �� 20

New ENS: Start Usage > Start Evaluation workow .......... 20

Congured ENS: Followup workow ................................. 22

Congured ENS: End Evaluation workow ....................... 23

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Implantable Neurostimulator Workows �� 24

New INS: Start Usage > Implant Device workow .............24

Congured INS: Followup workow ................................... 26

Congured INS: View MRI workow .................................. 27

Working with Device and Patient Information �� 28

Positioning Leads Relative to Implant Location �� 34

Customizing SoftStart/Stop and Cycling �� 35

Changing SoftStart/Stop settings ......................................35

Turning cycling on or off ....................................................35

Checking battery status of the neurostimulator .................28

Entering implant location ...................................................28

Entering patient information ............................................... 28

Entering lead information ................................................... 28

Testing lead connectivity .................................................... 29

Entering extension, abandoned lead, or tip location

information ......................................................................... 29

Clearing information in external neurostimulator for

re-use ................................................................................29

Working with Groups and Programs �� 30

Programs screen ...............................................................30

Program subscreen ...........................................................30

Turning stimulation on or off ..............................................30

Adjusting Stimulation Parameters �� 31

High-output interlocks ........................................................ 31

Shared electrodes ............................................................31

Assigning electrode conguration ...................................... 31

Assigning pulse width, rate, and amplitude .......................32

Enabling Patient Access �� 36

Limits .................................................................................36

TargetMyStim ..................................................................... 37

Adjustment ......................................................................... 37

Programming Scheduled Therapy �� 38

Checking System Performance�� 39

Testing electrode impedance ............................................. 39

Troubleshooting electrode impedance results ...................40

Testing group impedance .................................................. 41

Troubleshooting group impedance results .........................41

Preparing System for an MRI Scan �� 43

View MRI workow ............................................................43

AdaptiveStim Technology �� 44

Caution regarding cervical location ...................................44

Caution regarding healing period ......................................44

Conguring AdaptiveStim Technology with the wizard ......44

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Reconguring an AdaptiveStim-enabled group .................45

What you can do on the AdaptiveStim screen ...................45

Reviewing position amplitudes for all AdaptiveStim-

enabled groups .................................................................. 48

Testing AdaptiveStim settings ............................................ 48

Adjusting position amplitudes for individual positions ........48

Checking patient positions ................................................. 49

Reorienting patient positions .............................................49

Disabling AdaptiveStim Technology for a group ................49

Enabling or disabling AdaptiveStim Technology for the

patient ................................................................................ 49

Turning the Position Trend diary on or off .......................... 50

Adjusting position angles ................................................... 50

Adjusting transition times ................................................... 50

Adjusting mobility rate .......................................................51

Turning off mobility detection .............................................51

Troubleshooting AdaptiveStim Technology ........................ 51

Working with Reports �� 55

Using the Reports screen .................................................. 55

Patient Data Service app�� 56

Finding and opening the app ............................................. 56

Accessing or deleting a patient session record .................56

Deleting multiple patient session records at once .............56

Setting the PDF auto-delete feature .................................. 57

Viewing System Information �� 58

Viewing information about system components ................58

Viewing information about trademarks and licenses .........58

Changing device date/time or implant date information ....58

Compiling a Medtronic Data Report ..................................58

Viewing Alerts �� 59

Working with alerts ............................................................59

Viewing Diaries �� 54

Stimulation Usage .............................................................54

Group Usage .....................................................................54

Position Trend ....................................................................54

Adjustments ....................................................................... 54

Resting Trend ....................................................................54

Recharge ........................................................................... 54

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Troubleshooting �� 60

Data validation error message ........................................... 60

Power on reset (POR) message ........................................ 60

Out of regulation (OOR) message ..................................... 60

Overcharge message ........................................................60

Overdischarge message .................................................... 60

Rapid discharge message ................................................. 60

Elective Replacement Indicator (ERI) message ................ 60

End Of Service (EOS) message ........................................ 60

Using impedance measurements for troubleshooting .......61

Communicator and clinician tablet troubleshooting ........... 61

Physician Recharge mode ................................................. 64

Patient programmer messages .........................................65

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Description of the Programming System

Model A71100 Restore Clinician Programmer Application

The Medtronic Model A71100 Restore Clinician Programmer Application (app) is intended for use by clinicians in the programming of the following Medtronic neurostimulators for pain therapy.

External Neurostimulator (ENS):

■ Model 37022 External Neurostimulator

Implantable Neurostimulators (INS):

■ Model 37703 Itrel 4 Implantable Neurostimulator

■ Model 37704 Itrel 4 Implantable Neurostimulator

■ Model 37711 Restore Implantable Neurostimulator

■ Model 37701 RestorePrime Implantable Neurostimulator

■ Model 37702 PrimeAdvanced Implantable Neurostimulator

■ Model 97702 PrimeAdvanced SureScan MRI Implantable Neurostimulator

■ Model 37712 RestoreUltra Implantable Neurostimulator

■ Model 97712 RestoreUltra SureScan MRI Implantable Neurostimulator

■ Model 37713 RestoreAdvanced Implantable Neurostimulator

■ Model 97713 RestoreAdvanced SureScan MRI Implantable Neurostimulator

■ Model 37714 RestoreSensor Implantable Neurostimulator

■ Model 97714 RestoreSensor SureScan MRI Implantable Neurostimulator

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 loaded on the Model CT900 Clinician Tablet with Android-based operating system.

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.

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.

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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.

Stimulation parameters

Stimulation is delivered in 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 volts (V).

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. For certain neurostimulator models, multiple programs can be combined into groups. Groups are designated as A, B, C, and so on in the programmer app, while programs are designated as 1, 2, 3, 4. Refer to Table 1 on page 9 for a summary of the group and program options available for each neurostimulator model.

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.

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: that is, each program within a group will have the same rate.

Optional features

Optional features are available for tailoring the stimulation to the patient's needs. Refer to Table 1 on page 9 for a summary of the features supported in each neurostimulator model.

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

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

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

■ Adjustment (also known as GroupAdjust): Allows the patient to increase or decrease all program amplitudes in the active group at the same time.

■ TargetMyStim: Allows the patient to move stimulation settings from electrode to electrode up and down the lead.

■ Scheduled Therapy: Schedules specic groups to be active at programmed times during a 24-hour period.

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

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Programmable Settings

Table 1. Neurostimulator features.

Model

Leads

Electrodes

Groups

Programs/Group

Total Programs

Cycling

SoftStart/Stop

Patient Limits

Adjustment

TargetMyStim

Scheduled Therapy

37022 ENS 4 16 8 4 16 –

37703 / 37704 Itrel 4 1 4 1 1 1 – – – –

37711 Restore 2 16 26 4 32 – – –

37701 RestorePrime 2 16 26 4 32 – – –

37702 PrimeAdvanced 4 16 26 4 32 –

97702 PrimeAdvancedMRI 4 16 26 4 32 –

37712 RestoreUltra 4 16 8 4 16 –

97712 RestoreUltraMRI 4 16 8 4 16 –

37713 RestoreAdvanced 4 16 26 4 32 –

97713 RestoreAdvancedMRI 4 16 26 4 32 –

37714 RestoreSensor 4 16 8 4 16 –

97714 RestoreSensorMRI 4 16 8 4 16 –

Legend: Feature is available. – Feature is not available.

AdaptiveStim

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Programmable Settings

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 encryption 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.

disconnecting, 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

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.

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 update notications.

Caution: 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,

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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.

Data Security and Network Connectivity

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: For neurostimulators with SureScan MRI Technology (97702, 97712, 97713, 97714), always program the following component information:

■ Neurostimulator and lead model numbers

■ Neurostimulator implant location and lead tip location

■ Presence of extensions or abandoned leads

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.

For all neurostimulators, 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.

on trial stimulation components and may cause heating of the lead electrodes, resulting in tissue damage or serious patient injury.

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 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).

MRI warning for trial stimulation

Warning: Physicians should not prescribe MRI for patients

undergoing trial stimulation or who have any neurostimulation system components that are not fully implanted. Explant all trial stimulation components if an MRI scan is required. MRI has not been tested

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General Warnings and Cautions

Setting up the Programming System

Clinician tablet with

clinician programmer app

Power button

USB

connector cable Communicator

Power button

Neurostimulator

(ENS or INS)

Finding and opening the app

1. Navigate to the Apps on the clinician tablet.

2. Find the Restore app icon.

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

Proximal Telemetry

Hold communicator directly

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

For wireless communication, make sure the clinician tablet

BLUETOOTH

remains within range.

wireless technology.

over neurostimulator.

Figure 1. Components of the programming system.

Preparing the clinician tablet

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

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. When pairing is complete, the LED light ( a solid green.

Once 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.

) on the communicator turns

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Setting up the Programming System

Positioning the communicator over the neurostimulator

The communicator uses near-eld magnetic induction communication

(also referred to as "proximal telemetry") to communicate with the external and implantable neurostimulators. This telemetry requires close proximity for successful programming.

1. Hold the communicator directly over the neurostimulator, and position the target symbol ( communicator so that it is centered over and facing the neurostimulator (Figure 2).

■ The target symbol on the communicator indicates the location of the internal antenna.

) on the back of the

can attach the neurostimulator directly to the communicator as shown in Figure 3.

■ Locate the slot on the front of the communicator. Place the external neurostimulator into the slot, and rotate it so the output jack faces toward the outer edge of the communicator. Then attach the trialing cable.

Sterile barrier

Target symbol

Figure 2. Position target symbol on communicator over

neurostimulator (INS shown, patient supine).

Note: For the external neurostimulator, you can either hold the

communicator over the neurostimulator as shown in Figure 2 or you

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Figure 3. External neurostimulator attached to communicator.

Note: Avoid placing the communicator directly on a metal surface.

Metal surfaces can interfere with communication between the communicator and the neurostimulator.

Initiating communication with the neurostimulator

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

Press the Communicate button (

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

Setting up the Programming System

) on the communicator.

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

From this screen, you can select workow options. Refer to the following sections for workow details:

■ "External Neurostimulator Workows" on page 20.

■ "Implantable Neurostimulator Workows" on page 24.

■ 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.

■ If the last programming session was completed with the Model 8840 N'Vision Clinician Programmer, programming changes

Notes:

■ If you have problems establishing communication, refer to

may occur upon interrogation with the app. Refer to Table 2 for a list of the potential programming changes.

"Communicator and clinician tablet troubleshooting" on page

61.

Table 2. Potential programming changes upon interrogation (if last programmed by N'Vision Clinician Programmer).

Feature Programming Change Notes

Amplitude Resolution

Patient Limits All programmed patient limits will be set to Custom limit

SoftStart/Stop All groups will be set to the highest SoftStart/Stop value

Cycling On/Off Times

AdaptiveStim Technology

Note: Alert messages in the app will provide details of the specic programming changes to the neurostimulator.

Amplitude resolution between 0 V and 10 V will be set to 0.05 V for all programs.

type.

Lower patient limits will be set to the following minimum

values: Amplitude 0.0 V, Pulse Width 60 μs, Rate 2 Hz.

previously congured in the neurostimulator.

Cycling On/Off times will be set to the highest programmed values for all groups with Cycling enabled.

For groups with AdaptiveStim enabled, all positions (except Mobile) will be enabled. If Mobile was previously enabled, there will be no change to that position. The position amplitude for newly enabled positions will be set to 0.0 V.

The patient will have to press the Increase or Decrease key twice for each change of 0.1 V.

The app only supports Custom limit type and upper limit customization for patient limits.

Existing values for upper patient limits will not change upon interrogation.

The app supports a single SoftStart/Stop value for all groups. If some groups are On and some groups are Off, the setting will change to On for all groups.

The app supports a single set of Cycling On/Off times for all groups. Cycling can be enabled/disabled at the group level.

The patient may perceive therapy changes due to the newly enabled positions. Make sure to review all AdaptiveStim settings before ending the programming session.

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Setting up the Programming System

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 are 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 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.

After you start a workow, a workow navigator appears at the top of the screen. For example, the Congured ENS: Followup workow

contains these screens:

Device Electrode Impedance

Lead Select Tip Location Programs

Diaries Reports Summary

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

■ Alternately, 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 screens that are clipped off.

■ 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.

– Red asterisks indicate required elds.

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.

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

type (external neurostimulator vs. implantable neurostimulator) and

device status (new vs. congured). The workows may also vary

depending on neurostimulator features, such as SureScan MRI Technology.

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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 congured device workow. To change patient data in a congured device, you would access the Patient Info

screen from the Side Menu.

■ To access the Side Menu, tap the Side Menu button ( the top left corner on the action bar.

■ Alternately, you can swipe from the left edge of the tablet to access the Side Menu.

Overview of the Clinician Programmer App

) in

On-screen help

Help information is available in the clinician programmer app for

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

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

Table 3. Buttons and indicators.

Button / Indicator Description

Side Menu button: Tap to access

screens outside of the workow.

(Alternately, you can swipe from the left edge of the tablet to access the Side Menu.)

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.

Button / Indicator Description

Stimulation toggle: Tap to turn

stimulation on or off. Green indicates that stimulation is on.

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

AdaptiveStim indicator: Applicable to neurostimulators with AdaptiveStim Technology (37714, 97714).

Appears in the action bar when AdaptiveStim Technology is enabled.

MRI Status indicator: Applicable to neurostimulators with SureScan MRI Technology (97702, 97712, 97713,

97714).

Appears in the action bar when stimulation is off and the device is ready for an MRI scan.

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, and

then exit the workow to properly end the

programming session.

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Overview of the Clinician Programmer App

When the app is placed in the background

When you navigate away from the clinician programmer app while in a programming session, the app is placed in the background and is

represented as a oating widget on the clinician tablet.

The oating widget is an overlay that oats on top of the screen 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 access the app and resume the session.

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Overview of the Clinician Programmer App

Overview of the Communicator

The Model 8880T2 Communicator is a non-sterile 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 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 prohibited.

technology or wired using the USB

wireless technology is

Checking battery status of the communicator

Check the battery status of the communicator before a programming session and regularly during a programming session. When you turn on the communicator, a battery LED indicator displays on the top right side of the communicator.

■ Solid Green: Communicator has been turned on. Battery level is acceptable and all communicator functions are enabled.

■ Solid Amber: Communicator has been turned on. Batteries should be replaced soon.

■ Flashing Red: Communicator has been turned on. Batteries should be replaced immediately. Communicate button ( is disabled.

When the communicator is paired to the clinician tablet, swipe down from the top of the tablet to view the following during a programming session:

■ The battery level of the communicator.

■ The status of the connection between the communicator and the clinician tablet.

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Overview of the Communicator

Communicator icons on the tablet status bar

Table 4 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 4. 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.

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Overview of the Communicator

External Neurostimulator Workows

When an external neurostimulator (ENS) is interrogated, the clinician

programmer app determines if the ENS is new or congured. An ENS is identied as 'new' if it is in shelf state or if it has been cleared for re-use. An ENS is identied as 'congured' if it has patient data stored

in it. Based on the status of the ENS, the clinician programmer app

automatically presents the applicable workow options.

New ENS:

■ Start Usage > Start Evaluation workow – go to page 20.

Use at the start of a trial period, when the leads are implanted and the ENS is connected.

Use for testing lead placement.

Congured ENS:

■ Followup workow – go to page 22.

Use at followup sessions with the patient during the trial period.

■ End Evaluation workow – go to page 23.

Use at the last followup session with the patient at the end of the trial period.

Use to clear the ENS for re-use.

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.

New ENS: Start Usage > Start Evaluation workow

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

2. Tap START USAGE.

This action sets the In Use Date to the current date.

3. Under START EVALUATION, tap START.

4. You are now in the New ENS: Start Evaluation workow. Use Table 5 to guide you through the screens and tasks in the

workow.

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External Neurostimulator Workows

Table 5. New ENS: Start Evaluation workow.

Screen Tasks More information

Device Check the battery status of the neurostimulator. Page 28

Patient Info Enter patient information. Page 28

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 data.

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

Tip Location Indicate whether extensions are implanted. Page 29

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 (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. Page 35

Patient Access subscreen: Assign the stimulation parameters that the patient can adjust. Page 36

Electrode 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).

Group Impedance

Measure group (therapy) impedance.

These measurements provide documentation that the pathways are intact and the current provided

is sufcient for the selected therapy.

Summary Conrm that the therapy settings shown are what is intended for the patient.

End the session properly by tapping the EXIT WORKFLOW button.

Page 28

Page 29

Page 30

Page 34

Page 39

Page 41

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+ 48 hidden pages

Medtronic A71100 Programming Guide

Specifications and Main Features

Frequently Asked Questions

User Manual

Table of Contents

Description of the Programming System

Model A71100 Restore Clinician Programmer Application

Other components of the programming system

Programmable Settings

Stimulation parameters

Groups and programs

Optional features

Data Security and Network Connectivity

Data security

Installing application updates

Network connectivity

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

MRI warning for trial stimulation

Setting up the Programming System

Finding and opening the app

Preparing the clinician tablet

Pairing the communicator to the clinician tablet

Positioning the communicator over the neurostimulator

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

Checking battery status of the communicator

Communicator icons on the tablet status bar