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.

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External Neurostimulator Workows

Congured ENS: Followup workow

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

2. Under FOLLOWUP, tap START.

3. You are now in the Congured ENS: Followup workow. Use Table 6 to guide you through the screens and tasks in the

workow.

Table 6. Congured ENS: Followup workow.

Screen Tasks More information

Device Check the battery status of the neurostimulator. Page 28

Lead Select Review the information, and make any updates. Updates may delete programming. Page 28

Tip Location Review the information, and make any updates. Page 29

Programs (and subscreens)

Electrode Impedance

Diaries View the Stimulation Usage and Group Usage diaries to assess the patient’s use of the therapy. Page 54

Reports Select a report to view, download, or delete. Page 55

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

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. Page 35

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

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).

End the session properly by tapping the EXIT WORKFLOW button.

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External Neurostimulator Workows

Congured ENS: End Evaluation workow

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

2. Tap END EVALUATION > START.

3. You are now in the Congured ENS: End Evaluation

workow. Use Table 7 to guide you through the screens and tasks in the workow.

Table 7. Congured ENS: End Evaluation workow.

Screen Tasks More information

Device Check the battery status of the neurostimulator. Page 28

Lead Select Review the information, and make any updates. Updates may delete programming. Page 28

Tip Location Review the information, and make any updates. Page 29

Programs Review the groups, programs, and settings, and make any updates. Page 30

Diaries View the Stimulation Usage and Group Usage diaries to assess the patient’s use of the therapy. Page 54

Reports Select a report to view, download, or delete. Page 55

Clear Device Clear the patient and programming information from the device. This action prepares the external

neurostimulator for re-use.

Summary End the session properly by tapping the EXIT WORKFLOW button. --

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External Neurostimulator Workows

Implantable 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.

New INS:

■ Start Usage > Implant Device workow – go to page 24.

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

Congured INS:

■ Followup workow – go to page 26.

Use at followup sessions with the patient.

■ View MRI workow – go to page 27.

The View MRI workow is only applicable to neurostimulators

with SureScan MRI Technology (97702, 97712, 97713, 97714). 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.

New INS: 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 to the current date. For rechargeable neurostimulators, this action starts a clock inside the neurostimulator that determines the date when the Elective Replacement Indicator (ERI) and End Of Service (EOS) messages appear.

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. You can change the Implant Date on the About System screen, but it will not impact the clock inside the neurostimulator that determines ERI and EOS.

3. Under IMPLANT DEVICE, tap START.

4. You are now in the New INS: Implant Device workow. Use Table 8 to guide you through the screens and tasks in the

workow.

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Implantable Neurostimulator Workows

Table 8. New INS: Implant Device workow.

Screen Tasks More information

Device Check the battery status of the neurostimulator. Page 28

Select the implant location. 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. Indicate whether abandoned leads remain implanted (for

MRI models only). Select the tip location for each lead (for MRI models only).

(This screen is not supported for Itrel 4.)

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.

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Implantable Neurostimulator Workows

Congured INS: 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. You are now in the Congured INS: Followup workow. Use Table 9 to guide you through the screens and tasks in the

workow.

Table 9. Congured INS: Followup workow.

Screen Tasks More information

Device Check the battery status of the neurostimulator. Page 28

Lead Select Review the information, and make any updates. Updates may delete programming. Page 28

Tip Location Review the information, and make any updates. (This screen is not supported for Itrel 4.) Page 29

Programs (and subscreens)

Electrode Impedance

AdaptiveStim Congure the settings for AdaptiveStim Technology (RestoreSensor models 37714, 97714 only). Page 44

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

Reports Select a report to view, download, or delete. Page 55

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

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. Page 35

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

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).

screen is not supported for Itrel 4.)

End the session properly by tapping the EXIT WORKFLOW button.

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Implantable Neurostimulator Workows

Congured INS: View MRI workow

The View MRI workow is only applicable to neurostimulators with

SureScan MRI Technology (97702, 97712, 97713, 97714).

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 Congured INS: View MRI workow. Use Table 10 to guide you through the screens and tasks in the

workow.

Table 10. Congured INS: View MRI workow.

Screen Tasks More information

Device Conrm the neurostimulator information and implant location. Page 43

Patient Info Conrm the patient information. Page 43

Lead Select Conrm the implanted lead information. Page 43

Tip Location Conrm the extension, abandoned lead, and tip location information. Page 43

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 MRI status shows the device is ready for an MRI scan.

End the session properly by tapping the EXIT WORKFLOW button.

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Implantable Neurostimulator Workows

Working with Device and Patient Information

Checking battery status of the neurostimulator

The battery status for the neurostimulator (ENS or INS) is shown at the start and at the end of a programming session on the following screens:

■ CURRENT DEVICE STATUS screen

■ Device screen

■ Summary screen

For all neurostimulators, the battery status is displayed in volts. For rechargeable neurostimulators, a battery image also displays representing the battery level percentage: 0%, 25%, 50%, 75%, or 100%.

At the start of a programming session, if the battery voltage is below 25% for a rechargeable neurostimulator or an ENS, a message

noties you that the device is running on low battery.

If the battery voltage for a rechargeable neurostimulator or an ENS is too low to sustain therapy or a programming session, a message

noties you of the battery issue. You need to either recharge the

battery in the rechargeable neurostimulator or replace the batteries in the ENS.

For information on battery service life for implanted neurostimulators, refer to "Elective Replacement Indicator (ERI) message" on page 60 and "End Of Service (EOS) message" on page 60.

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: For neurostimulators with SureScan MRI Technology (97702, 97712, 97713, 97714), 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. Red asterisks indicate

the required elds.

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 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 list. Press the lead image, and then drag and drop it at the appropriate electrode numbers of the device.

■ 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.

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Working with Device and Patient Information

Notes:

■ Make sure the electrode numbering on the screen matches the electrode numbering of the implanted leads. If necessary, you can swap leads using the drag-and-drop feature.

■ On surgical leads, the blue box on the lead arm represents the white marker band on the actual lead. The marker band indicates the lead arm for electrodes 0-7.

■ For neurostimulators with SureScan MRI Technology (97702, 97712, 97713, 97714), 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 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 ( not visible, tap UPDATE on the Lead Select screen to save the lead data and activate the button.)

– Green electrodes indicate that the lead or extension

contacts have a good connection to the neurostimulator contacts.

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

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

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

). (If the button is

Entering extension, abandoned lead, or tip location information

The Tip Location screen is accessed through the workow navigator. The options on the screen will vary based on the neurostimulator model being programmed. The screen is not supported for Itrel 4 (37703, 37704).

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

■ Check the Yes or No checkbox to indicate whether abandoned leads remain implanted (for MRI models only).

■ Select the tip location for each lead from the scrollable drop- down list (for MRI models only).

Note: For neurostimulators with SureScan MRI Technology (97702, 97712, 97713, 97714), the abandoned lead, extension, and tip location information impacts the MRI scan eligibility shown on the MRI screen.

Clearing information in external neurostimulator for re-use

The Model 37022 External Neurostimulator is a re-usable device. The Clear Device screen accessed through the Congured ENS:

End Evaluation workow is used to clear the patient and therapy

information from the device and prepare the ENS for re-use.

■ On the Clear Device screen, tap the Clear Device button, and

then conrm the action.

■ A message appears after the device is cleared. Tap OK to end the session and return to the initial app screen.

The next time the external neurostimulator is interrogated, the device

is identied as a new ENS and the New ENS: Start Usage > Start Evaluation workow appears.

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Working with Device and Patient Information

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.

■ 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 drag that program to the intended location, and then select MOVE or COPY from the message that appears.

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

)�

■ To create a new program in the active group, tap the add symbol (+) on the desired program. The Program subscreen will display 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: For neurostimulators with AdaptiveStim Technology (37714,

97714), the AdaptiveStim indicator ( if AdaptiveStim Technology is enabled for the group.

Program subscreen

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

) appears next to the group name

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. Alternately, 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 31.

■ From the Program subscreen, you can access the Lead Manipulation, Energy, and Patient Access subscreens. Refer to the following sections for details about these subscreens:

"Positioning Leads Relative to Implant Location" on page 34.

"Customizing SoftStart/Stop and Cycling" on page 35.

"Enabling Patient Access" on page 36.

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.

Note: For neurostimulators with SureScan MRI Technology (97702, 97712, 97713, 97714), the MRI Status indicator ( action bar whenever stimulation is off. The MRI Status indicator does not provide MRI scan eligibility information.

) displays in the

) or off

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Working with Groups and Programs

Adjusting Stimulation Parameters

Stimulation is delivered in electrical pulses. The stimulation

parameters, which include electrode conguration, pulse width, rate,

and amplitude, are attributes of these pulses and can be adjusted to manage patient therapy.

High-output interlocks

This feature applies to RestoreUltra (37712, 97712), RestoreSensor (37714, 97714), and ENS (37022).

Certain combinations of high amplitude, pulse width, and rate settings are not allowed by the clinician programmer app. Highoutput interlocks can prevent certain values and features from being available for programming. If you attempt to program a parameter value that will cause the settings to exceed the high-output interlock limit, the desired parameter value can only be achieved by reducing one of the other parameter values.

Shared electrodes

This feature applies to RestoreUltra (37712, 97712), RestoreSensor (37714, 97714), and ENS (37022).

One electrode may be active in more than one program within a group. When more than one electrode is shared by more than one program, certain restrictions are applied to prevent rate and pulse

width upper limits from exceeding 260 Hz for rate or 450 μs for pulse

width. The collective rate for a group is calculated by multiplying the rate assigned to each program by the number of programs in that group. Shared electrodes appear grayed out on the Program subscreen when unavailable for programming.

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.

■ To assign polarity, tap on the appropriate electrode. Tap once for negative (–) polarity, twice for positive (+) polarity, or a third time to remove polarity. Tap Update when nished.

■ To delete an electrode, press and 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 V. The move feature is not available for Itrel 4 (37703, 37704).

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

Note: Adding or deleting an electrode after the amplitude is assigned will reset the amplitude to 0 V by default.

For Itrel 4 (37703, 37704), the neurostimulator can be programmed to deliver unipolar stimulation (using the neurostimulator case as a positive electrode). To assign the case as a positive electrode, tap the 'C' on the lead image.

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Adjusting Stimulation Parameters

Assigning pulse width, rate, and amplitude

Pulse width, rate, and amplitude are assigned on the Program subscreen.

During a programming session, the selected values for pulse width, rate, and amplitude 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 48.

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.

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 decrease and forward arrows ( ) to

) to stop stimulation from

) to jump to the new value

Assigning rate

Rate is the frequency of pulses per second, in hertz (Hz). For the devices that support more than one program in a group, the group rate is the rate for each program in that group.

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

2. Select the rate 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

Assigning amplitude

Amplitude is the strength of the pulse in volts (V). 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.

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Adjusting Stimulation Parameters

2. Select the amplitude using any of these controls:

■ Scrollable drop-down list.

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

■ Back arrows (

) to decrease and forward arrows ( ) to

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 (

) to stop stimulation from

increasing to the new value.

■ Tap the Jump button (

) to jump to the new value

without incremental increases.

■ Tap the Amplitude to zero button (

) to immediately

set amplitude to 0 V.

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Adjusting Stimulation Parameters

Positioning Leads Relative to Implant Location

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 drag a lead to the location of the other lead.

The positioning of the leads replaces how the leads are shown on the

Programs screen and Program subscreen.

Note: The Lead Manipulation screen is not supported for Itrel 4

(37703, 37704) or for surgical leads.

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Positioning Leads Relative to Implant Location

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.

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.

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”.

Refer to the System Eligibility, Battery Longevity, Specications reference manual for information about how cycling affects battery longevity and recharge intervals.

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

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.

Note: Cycling is not available when AdaptiveStim Technology is enabled for a group.

) or off ( ).

) or off

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Customizing SoftStart/Stop and Cycling

Enabling Patient Access

Use the Patient Access subscreen (accessed from the Program subscreen) to assign patient controls, if appropriate for the patient. There are three patient controls on the Patient Access subscreen: Limits, TargetMyStim, and Adjustment.

Note: The patient controls may vary depending on neurostimulator model.

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.

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).

) or disable ( ) patient control of the stimulation

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

5. To see the patient control settings for all groups, tap the

OVERVIEW button (

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.

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

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.

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Enabling Patient Access

TargetMyStim

Enabling the TargetMyStim patient control on the Patient Access subscreen allows the patient to move stimulation settings from electrode to electrode up and down the lead.

1. Under the TARGETMYSTIM heading, make sure that the

group you intend to congure is shown.

2. Tap the group name toggle to enable ( the patient control.

Notes:

■ The TargetMyStim patient control is not supported for Itrel 4 (37703, 37704), Restore (37711), and RestorePrime (37701).

■ TargetMyStim is only available if the following criteria are met:

– The electrode pattern for at least one program in the

group can be moved up or down the lead.

– Amplitude limit is enabled.

– For RestoreSensor (37714, 97714), RestoreUltra

(37712, 97712), and ENS (37022): No program in

the group has a pulse width greater than 450 μs; the

collective rate of all programs in the group is not greater than 260 Hz; there are no shared electrodes.

■ The TargetMyStim patient control is not available when AdaptiveStim Technology is enabled for a group.

) or disable ( )

Adjustment

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

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

Note: The Adjustment patient control is not supported for Itrel 4 (37703, 37704), Restore (37711), and RestorePrime (37701).

) or disable ( ) the

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Enabling Patient Access

Programming Scheduled Therapy

The Scheduled Therapy feature is used to activate specic groups

at programmed times during a 24-hour period. This feature is not supported for Itrel 4 (37703, 37704) and RestoreSensor (37714,

97714).

Therapy groups can be scheduled to activate and deactivate

at specic times during a 24-hour period. Each activation and

deactivation of a group is called an event. Up to 8 scheduled events can be programmed during a 24-hour period. Events cannot overlap, and only one group can be active at any given time. The minimum time for an event is 30 minutes.

The Schedule screen is accessed from the Side Menu ( groups available for scheduling are shown in the GROUP list. When events are scheduled, they display in the DAILY SCHEDULE.

■ To schedule a new event, tap on a group in the GROUP list and then assign the start and end times in the pop-up window.

(Alternately, you can drag a group from the GROUP list and drop it on the DAILY SCHEDULE. Then adjust the start and end times in the pop-up window.)

■ To edit an existing event, tap the event in the DAILY SCHEDULE, and then adjust the start and end times in the pop-up window.

(Alternately, you can move an event in the DAILY SCHEDULE using the drag-and-drop feature.)

■ To remove an existing event, drag the event from the DAILY SCHEDULE and drop it on the Trash icon (

(Alternately, you can tap an event in the DAILY SCHEDULE, and then tap the Trash icon (

) in the pop-up window.)

). The

■ To turn the Scheduled Therapy feature on or off, use the on/off toggle (green indicates that Scheduled Therapy is on)�

Note: Scheduled Therapy operation will be suspended during a programming session to prevent therapy changes from occurring during the session. When the session is exited, Scheduled Therapy operation resumes.

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Programming Scheduled Therapy

Checking System Performance

The measurement functions on the Electrode Impedance screen and Group Impedance screen assist in identifying problems with system components or the entire 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.

Before using any measurement functions, please note the following:

■ Measure electrode 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.

■ Measure group (therapy) impedance at the end of each programming session. These measurements provide documentation that pathways are intact and the current

provided is sufcient for the selected therapy.

Testing electrode impedance

The Electrode Impedance screen is accessed through the workow navigator or by tapping Impedance on the Side Menu (

part of a workow.

For Restore (37711) and RestorePrime (37701), preset rate, pulse width, and amplitude values are used during the electrode impedance test. For all other models, preset rate and pulse width values are used, and the amplitude value is selectable on the Start Measurement screen. At the end of the test, the most recently programmed settings are restored.

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

2. On the Start Measurement screen, select the amplitude value, if applicable.

3. Tap the START button.

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

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 range (low or high), the results appear in the OUT OF RANGE box. Refer to "Troubleshooting electrode impedance results" on page 40.

■ 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

) when not

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Checking System Performance

Electrode Impedance screen. You can also view or print the

Session Report, which shows the impedance measurements.

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

Troubleshooting electrode impedance results

The OUT OF RANGE box on the Electrode Impedance screen

identies where low impedance or high impedance was measured in

the system. The example in Figure 4 shows both low impedance and high impedance results.

< 50 Ω

13–15

> 10000 Ω

0: 14 1: 14 2: 14 3: 14 4: 14 5: 14 6: 14 7: 14 8: 14 9: 14 10: 14 11: 14 12: 14 13: 14 14: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 15 15: 14

Figure 4. Example of out-of-range electrode impedance results.

In this example, a low impedance value was measured for the electrode pair 13–15, and high impedance values were measured for several electrode pairs with electrode 14 common to those pairs. Electrode 14 is likely the electrode causing the high impedance issue.

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

High impedance troubleshooting

High impedance suggests a possible open circuit in the system.

High impedance for Restore (37711) and RestorePrime (37701):

>3,600 ohms

High impedance for all other models:

■ At 0.25 V: >4,000 ohms

■ At 0.70 V: >10,000 ohms

■ At 1.50 V: >20,000 ohms

■ At 3.00 V: >40,000 ohms

Follow these steps to troubleshoot high impedance values:

1. If applicable, perform the test again at the next highest amplitude up to 3.00 V (if within the patient's comfort range).

2. If impedance values remain high, consider these troubleshooting options:

■ Assess whether therapy can be achieved using other electrodes.

■ Check for misprogrammed 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 disconnects or damage.

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

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Checking System Performance

Low impedance troubleshooting

Low impedance suggests a possible short circuit in the system that can lead to rapid battery depletion or inadequate therapy. Do not use electrodes with a low impedance.

Low impedance for Restore (37711) and RestorePrime (37701):

<70 ohms

Low impedance for all other models:

■ At 0.25 V: <50 ohms

■ At 0.70 V: <50 ohms

■ At 1.50 V: <50 ohms

■ At 3.00 V: <150 ohms

2. The stimulation parameter ranges to be tested display on the Start Measurement screen. Tap the START button after

conrming the values.

3. Review the impedance and stimulation current results. Refer to "Troubleshooting group impedance results" on page 41.

Notes:

■ The neurostimulator reports current measurement values as current delivered during the stimulation pulse.

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

Testing group impedance

The Group Impedance screen is accessed through the workow navigator or by tapping Impedance on the Side Menu (

part of a workow.

Group (therapy) measurements are impedance and stimulation current measurements taken at the programmed settings for each program in a selected group.

Caution: During the group impedance test, stimulation changes to the parameter values for each program as the impedance is measured for the group. This may affect patient stimulation while the test is in progress. You may need to decrease stimulation parameters to avoid patient discomfort.

1. On the Group Impedance screen, tap the group name you want to test, and then tap the MEASURE IMPEDANCES button (

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) when not

Troubleshooting group impedance results

When impedance results are in the normal range, the impedance value (in ohms) and the stimulation current (in milliamps) display on the Group Impedance screen. Normal impedance ranges are:

■ 70 to 3,600 ohms for Restore (37711) and RestorePrime (37701)

■ 50 to 4,000 ohms for all other models

When impedance results are outside of the normal range, an indicator

displays (either < ## Ω or > #### Ω) where the value is the low or

high range threshold for the neurostimulator. Perform an electrode impedance test to help determine the likely cause of the circuit problem. Refer to "Testing electrode impedance" on page 39.

Notes:

■ If an impedance result is not available or out-of-regulation occurs, the message "HIGH AMPLITUDE" displays. Decrease

Checking System Performance

stimulation parameters or reduce the number of electrodes for that program, and then repeat the measurement.

■ If a program amplitude is too low for testing, the message "LOW AMPLITUDE" displays. Increase the amplitude for that program, and then repeat the measurement. Minimum amplitude values are:

– 0.24 V for Restore (37711) and RestorePrime (37701)

– 0.25 V for all other models

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Checking System Performance

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.

■ Stimulation must be off during an MRI scan.

■ To turn stimulation off, use the Stimulation toggle ( the action bar. Gray indicates that stimulation is off.

View MRI workow

The View MRI workow is only applicable to neurostimulators with

SureScan MRI Technology (97702, 97712, 97713, 97714).

1. On the Device, Lead Select, and Tip Location screens,

conrm that the following component information is complete

and accurate:

■ Neurostimulator and lead model numbers

■ Neurostimulator implant location and lead tip location

■ Presence of extensions or abandoned leads

This information impacts the MRI scan eligibility shown on the MRI screen.

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

3. On the MRI screen, review the MRI scan eligibility.

) on

5. To prepare the device for an MRI scan, turn stimulation off using the Stimulation toggle ( indicates that stimulation is off.

6. Conrm that the message “Device ready for MRI scan” displays in the status area and the MRI Status indicator ( displays in the action bar.

7. On the Reports screen, select MRI Report from the dropdown list. Refer to "Working with Reports" on page 55 for details about viewing and printing reports.

Note: If printing capabilities are not available, you can manually complete the MRI Eligibility Form in the MRI

Guidelines for Medtronic Neurostimulation Systems for Chronic Pain instructions for use manual.

8. Inform the patient of the following:

■ 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.

) on the action bar. Gray

)

4. Determine whether the patient is eligible for the intended MRI scan. Do not proceed if eligibility cannot be determined. Contact your Medtronic representative, if needed.

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9. 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.

Preparing System for an MRI Scan

AdaptiveStim Technology

The RestoreSensor neurostimulators with AdaptiveStim Technology (37714, 97714) can be programmed to adjust amplitude automatically when the patient changes body position. Amplitude settings can be assigned to the following positions:

■ Upright

■ Mobile

■ 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.

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 Technology with the wizard

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

all programmed groups and every position including Mobile are AdaptiveStim-enabled, 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 the

following programming features are not available for that group:

■ Patient access for rate

■ Patient access for pulse width

■ Cycling

■ TargetMyStim

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AdaptiveStim Technology

Note: Amplitude limit is automatically enabled when AdaptiveStim

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

group.

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

the group you want to 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 32.

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

position amplitudes for that group. You also have the option to reorient patient positions.

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

the group you want to recongure.

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

6. Follow the on-screen instructions to reorient the neurostimulator to the patient positions (if applicable) and 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.

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

stating that you have successfully congured AdaptiveStim

Technology for the group.

5. 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 reassign

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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 11 on page 46 for information about the tasks you can complete on the AdaptiveStim screen.

AdaptiveStim Technology

) when not part of a workow.

Table 11. Tasks on the AdaptiveStim screen.

Tasks on the AdaptiveStim screen More information

Review position amplitudes for all AdaptiveStim-enabled groups.

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

Test AdaptiveStim settings.

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

Adjust position amplitudes for individual positions.

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

Check patient positions.

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

Reorient patient positions.

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

Recongure an AdaptiveStim-enabled group.

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

Disable AdaptiveStim Technology for a group.

Use this task 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 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 Trend diary on or off.

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

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.

Page 48

Page 49

Page 45

Page 49

Page 50

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AdaptiveStim Technology

Tasks on the AdaptiveStim screen More information

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

Page 51

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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 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 blue. 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 32.

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.

Note: If the patient is in a position between the Upright and Lying

positions, the app identies the position as Transition Zone.

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 (

■ Green indicates that the group is enabled.

■ Gray indicates that the group is disabled.

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 Ye s 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.

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

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.

■ Green indicates that AdaptiveStim is enabled.

■ Gray indicates that AdaptiveStim is disabled.

2. Tap UPDATE to accept the changes.

AdaptiveStim Technology

Turning the Position Trend diary on or off

The Position Trend diary shows the time the patient spent in each position during the periods between the last four programming sessions. The diary is accessed through the Diaries screen.

By default, the Position Trend diary is turned on when AdaptiveStim

Technology is initially congured or recongured, or when patient

positions are reoriented. If the diary is turned off, from that point, position data is not saved. If the 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, tap the on/off toggle. Green indicates that the diary is on.

3. Tap UPDATE to accept the changes.

4. Tap CLOSE to return to the AdaptiveStim screen.

3. On the Angles diagram, tap the position name for the angle you want to adjust (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 accept the changes.

7. Tap CLOSE to return to the AdaptiveStim screen.

Note: To test the changes, refer to "Testing AdaptiveStim settings" on page 48.

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.

Adjusting position angles

Position angle is the range of a position and is used to ensure the neurostimulator properly recognizes the Upright position from the Lying positions. By default, the Upright position angle is set to X-Small and the Lying position angle is set to Large. All lying postures (Back, Front, Left, Right) use the same position angle value. There is a

Transition Zone between the Upright and Lying positions. The size of the Transition Zone is calculated based on the Upright and Lying

position angles.

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

2. Tap the Angles tab.

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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 the scrollable drop-down list and select a duration.

5. Make adjustments to other transition times as needed.

6. Tap UPDATE to accept the changes.

7. Tap CLOSE to return to the AdaptiveStim screen.

Note: To test the changes, refer to "Testing AdaptiveStim settings" on page 48.

AdaptiveStim Technology

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 on. 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 accept 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 48. To check patient positions, refer to "Checking patient positions" on page 49.

2. Tap the Mobility Rate tab.

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

4. Tap UPDATE to accept the changes.

5. Tap CLOSE to return to the AdaptiveStim screen.

Troubleshooting AdaptiveStim Technology

Refer to Table 12 on page 52 for a list of potential issues that can occur with AdaptiveStim Technology, as well as possible solutions for resolving those issues.

Turning off mobility detection

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

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AdaptiveStim Technology

Table 12. 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 Mobile 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 Upright 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 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 V.

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AdaptiveStim Technology

Problem Possible Solutions

Patient unable to adjust their rate.

■ Create multiple identical groups by copying the current AdaptiveStim-enabled group. Adjust the rate for each group to provide the patient with different rates with AdaptiveStim enabled. Provide the patient guidance on how to change 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. The Diaries screen is not supported for Itrel 4 (37703, 37704).

Stimulation Usage

The Stimulation Usage chart shows the patient's stimulation usage for the last 30 days. The chart displays the stimulation on-time percentage for each day. The metrics provide the average percentage of stimulation usage over the last 30 days and the percentage of stimulation on-time 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.

Adjustments

The Adjustments chart is only applicable to neurostimulators with AdaptiveStim Technology (37714, 97714). 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.

Resting Trend

The Resting Trend chart is only applicable to neurostimulators with AdaptiveStim Technology (37714, 97714). The chart shows the average number of position changes from one lying position to another during the periods between the last four programming sessions.

Group Usage

The Group Usage chart displays the percentage of time that each group was used for the last 30 days or since the last programming session if less than 30 days.

Position Trend

The Position Trend chart is only applicable to neurostimulators with AdaptiveStim Technology (37714, 97714). 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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Recharge

The Recharge chart is only applicable to rechargeable neurostimulators (37711, 37712, 37713, 37714, 97712, 97713,

97714). The chart displays the following information for the last six recharge sessions:

■ The percentage of battery charge at the start of the recharge session

■ The percentage of battery charge at the end of the recharge session

■ The length of the recharge session

■ The recharge session date

The metrics provide the average ending percentage of battery recharge, the average battery recharge time, the average battery recharge interval, and the median battery recharge coupling value.

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: Applicable to neurostimulators with SureScan MRI Technology (97702, 97712, 97713, 97714). 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 58.

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.

) when not part of a workow.

4. Tap one of the buttons shown in Table 13.

Table 13. 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.

Using the Reports screen

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

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.

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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 14. 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 55.

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 14.

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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.

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Patient Data Service app

Viewing System Information

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

This screen provides the following information:

■ System component information (such as model numbers,

serial numbers, rmware numbers, version numbers) for the

device (ENS or INS), clinician tablet, clinician programmer app, controller (patient programmer), recharger, and communicator.

Includes the component information for the controller (patient programmer), recharger, 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 ENS and INS.

■ Ability to change the INS 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.

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 (for INS models). 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.

Note: Changing the implant date does not impact the clock inside rechargeable neurostimulators that determines ERI and EOS.

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 55.

) to compile the

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.

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Viewing System Information

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.

Power on reset (POR) message

If a power on reset 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.

Overcharge message

An overcharge message indicates that the battery in a rechargeable

neurostimulator has been overcharged. Upon conrmation of the

message, the session will continue.

Overdischarge message

An overdischarge message indicates that the patient allowed the battery in a rechargeable neurostimulator to completely discharge, and telemetry is no longer available from the neurostimulator. Refer to "Physician Recharge mode" on page 64 for instructions on restoring the device.

Rapid discharge message

A rapid discharge message indicates that the rechargeable neurostimulator needs to be recharged at least once a day to provide 24-hour stimulation. This issue may be due to high parameter settings or reduced battery capacity. Parameter adjustment or neurostimulator replacement may be needed to increase therapy time between charges.

Elective Replacement Indicator (ERI) message

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

End Of Service (EOS) message

When an implanted neurostimulator reaches its end of service, a message displays. At EOS, therapy is not available and the device

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Troubleshooting

must be replaced. Refer to the System Eligibility, Battery Longevity, Specications reference manual for information about neurostimulator battery longevity.

Using impedance measurements for troubleshooting

Refer to "Checking System Performance" on page 39.

Communicator and clinician tablet troubleshooting

See Table 15 on page 62 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.

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Troubleshooting

Table 15. Communicator and clinician tablet troubleshooting.

Problem Possible Solutions

The communicator cannot communicate with the neurostimulator.

Cannot pair the communicator 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.

When attempting to connect through BLUETOOTH

■ 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

Refer to "Communicator icons on the tablet status bar" on page 19 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

thereby creating interference.

■ You have moved into an environment where the BLUETOOTH

Possible solutions:

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

■ Make sure that the BLUETOOTH

Refer to "Communicator icons on the tablet status bar" on page 19 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

wireless technology:

wireless technology is enabled on the clinician tablet.

wireless technology and

wireless technology is prohibited.

wireless technology is enabled on the clinician tablet.

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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

Physician Recharge mode

Physician Recharge mode is only applicable to neurostimulators that are rechargeable (37711, 37712, 37713, 37714, 97712, 97713,

97714).

If the patient allows the implanted neurostimulator to overdischarge, telemetry is no longer available from the neurostimulator. The patient will not be able to charge the neurostimulator battery using the charging system.

The patient must return to the clinic, and the physician must charge the neurostimulator battery using the Physician Recharge mode on the recharger. Typically, the neurostimulator will return to normal charging mode in less than 60 minutes. If it does not, the process should be repeated. If the neurostimulator cannot be charged, it must be replaced.

Notes:

■ If the battery is successfully recharged, it regains functionality but may require more frequent charging sessions by the patient.

■ The neurostimulator battery can be restored with the Physician Recharge mode only twice. If the battery is allowed to overdischarge a third time, the neurostimulator will reach end of service.

2. Simultaneously press and hold down the Start key and Audio key located on the front of the recharger (Figure 5) for 10 seconds. A screen with a 60-minute timer will appear, and charging begins.

Start key

Audio key

Figure 5. Recharger.

3. Continue charging until the recharger displays a new screen

indicating the battery charge level and charging efciency

(Figure 6).

Performing a physician charging session

Using the Model 37751 Recharger

1. Palpate the patient’s skin to determine the best location for the charging antenna, and place the antenna over the neurostimulator.

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Figure 6. Screen displaying charge level and charging efciency.

4. Repeat steps 1-3 if the new screen does not appear within 60 minutes.

Troubleshooting

5. Use the clinician programmer to check settings and to turn stimulation on.

Using the Model WR9200 Recharger

Note: If the volume on the recharger is turned off, you will be unable

to hear the audio feedback in the following steps. See the manual that came with the recharger for instructions to change the recharger volume.

1. Connect the charging dock to a power supply. Place the recharger on the dock as if to charge the recharger.

2. Palpate the patient’s skin to determine the approximate location of the neurostimulator.

7. After the reset, the recharger transitions to a special recharging session that may take up to 60 minutes if the neurostimulator battery needs to be recovered. Keep the recharger over the implant until it enters a normal recharging session.

Note: The recharger indicator light will turn green when the implanted neurostimulator enters a normal recharging session.

8. Check therapy status after performing Physician Recharge and turn on therapy if necessary.

For instructions on performing a normal recharging session using the Model WR9200 recharger, see the manual provided with the recharger.

3. With the recharger on the dock, enter Physician Recharge mode by using the button press sequence: short, short, long.

You will see the battery indicator ll up and hear a beep with

each button press.

Note: A short button press is 1-2 seconds. A long button press is 4-6 seconds.

4. The light on the power button indicator will show a spinning amber light and the recharger will beep.

5. Pick up the recharger from the dock and hold it over the patient’s implanted neurostimulator. Within 2 minutes, the

power button indicator will show a ashing amber light and

beeping will get faster. This means the recharger is preparing to reset the neurostimulator.

6. Keep the recharger over the implant after the beeping stops. The reset will start after the beeping ends and will take up to 1 minute to complete. The recharger indicator light will change to a slow pulse when the reset has completed.

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Patient programmer messages

The patient programmer displays text and iconic error and informational messages. The applicable messages vary based on neurostimulator model. Some messages provide an error code and tell the patients to contact their physician. These error codes and their troubleshooting procedures are displayed in Table 16.

Table 16. Contact Physician error codes on the patient

programmer.

Error code Explanation

536 Moisture was detected inside the ENS. The ENS

must be dried with a towel, the battery removed, and the battery compartment allowed to air dry at room temperature.

537 The Emergency stop key on the ENS is active.

Check the key and replace the device if needed.

574 No programs or groups were saved by the

clinician programmer. The neurostimulator must be reprogrammed.

Troubleshooting

Error code Explanation

OOR Out of regulation situation has occurred. Decrease

settings or reduce the number of electrodes.

POR The neurostimulator has undergone a power on

reset. No therapy is available until the device is reactivated.

556/589 The INS battery was overcharged or the wrong

batteries were placed in the ENS. The patient must come into the clinic, and the clinician programmer must be used to determine device status.

575/578 Invalid settings were detected in the INS/ENS. The

device must be reset and valid settings entered.

0 to 250 Invalid settings were detected in the patient

programmer. The patient should remove the programmer batteries and re-insert them after a few seconds. The error code should disappear. If it reappears, the patient programmer may need to be replaced.

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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

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

*M974907A016*

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

Working with Device and Patient Information

Checking battery status of the neurostimulator

Entering implant location

Entering patient information

Entering lead information

Testing lead connectivity

Entering extension, abandoned lead, or tip location information

Clearing information in external neurostimulator for re-use

Working with Groups and Programs

Programs screen

Program subscreen

Turning stimulation on or off

Adjusting Stimulation Parameters

High-output interlocks

Shared electrodes

Assigning pulse width, rate, and amplitude

Positioning Leads Relative to Implant Location

Customizing SoftStart/Stop and Cycling

Changing SoftStart/Stop settings

Turning cycling on or off

Enabling Patient Access

Limits

TargetMyStim

Adjustment

Programming Scheduled Therapy

Checking System Performance

Testing electrode impedance

Troubleshooting electrode impedance results

Testing group impedance

Troubleshooting group impedance results

Preparing System for an MRI Scan

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

Disabling AdaptiveStim Technology for a group

Reorienting patient positions