Medtronic A71300 Programming Guide

Stimulation Trialing Clinician
Programmer Application

Programming Guide

Neurostimulation systems for pain therapy
Model 97725 external neurostimulator

Application version 1.0

A71300

Explanation of symbols

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

For USA audiences only

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
Medtronic is under license.

®

Wi-Fi

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

Information available for the system:

The information for prescribers manual provides information about contraindications, warnings, precautions, adverse events, sterilization, patient selection,
individualization of treatment, and component disposal. For customers in Japan, the appropriate package insert provides information about safety,
contraindications, warnings, precautions, and adverse events.

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

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

MRI guidelines provide information about any MRI conditions and MRI-specic contraindications, warnings, and precautions for MRI scans with the

neurostimulation system.

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

specications, product-specic warnings and precautions, and instructions for use.

The clinical summary provides information about the clinical study results for the neurostimulation system.

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

Refer to the communicator technical manual for warnings, precautions, device description, package contents, device specications, instructions for use, and

maintenance information.

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Table of Contents

Description of the Programming System ������������ 6

Model A71300 Stimulation Trialing Clinician

Programmer Application ......................................................6

Intended purpose ................................................................. 6

Other components of the programming system ..................6

Setting up the Programming System ���������������� 10

Preparing the clinician tablet .............................................10

Finding and opening the app ............................................. 10

Wireless ENS preparation .................................................10

Indicator icons in tablet status bar for ENS and

BLUETOOTH wireless technology ....................................10

Starting a session with a wireless ENS ............................. 11

Programmable Settings ���������������������������������������� 7

Stimulation parameters ........................................................ 7

Groups and programs .......................................................... 7

Optional features .................................................................7

Data Security and Network Connectivity ������������ 8

Data security ........................................................................ 8

Network connectivity ............................................................ 8

Installing application updates .............................................8

Returning the clinician tablet ...............................................8

General Warnings and Cautions �������������������������� 9

MRI warning for trial stimulation ..........................................9

Sterile eld warning for programming components .............9

EMI caution for telemetry signal disruption .......................... 9

Cautions related to clinician programming and

possible interactions with other devices ..............................9

Overview of the Clinician Programmer App ���� 12

Using Demo mode ............................................................. 12

Navigating through workows ............................................ 12

Using the Side Menu .........................................................12

On-screen help .................................................................. 13

Buttons and indicators on the action bar ...........................13

When the app is placed in the background .......................13

External Neurostimulator Workows ���������������� 14

Start Usage > Start Evaluation workow ...........................14

Followup workow .............................................................16

End Evaluation workow ...................................................17

Implant Device workow .................................................... 18

Working with Device and Patient Information �� 19

Checking battery status of the external neurostimulator ...19

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

Mapping patient pain .........................................................19

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Entering lead information ................................................... 19

Testing lead connectivity .................................................... 20

Entering tip location information ........................................20

Adding uoro images ......................................................... 20

Switch Device ������������������������������������������������������ 29

Checking System Performance�������������������������� 29

Testing impedance ............................................................. 29

Working with Groups and Programs ����������������� 21

Programs screen ...............................................................21

Program subscreen ...........................................................21

Turning stimulation on or off ..............................................21

Adjusting Stimulation Parameters ��������������������� 22

Assigning electrode conguration ...................................... 22

Assigning intensity, pulse width, and program rate............ 22

Relative Lead Positioning ����������������������������������� 26

Customizing SoftStart/Stop and Cycling ���������� 27

Changing SoftStart/Stop settings ......................................27

Turning cycling on or off ....................................................27

Enabling Patient Access ������������������������������������� 28

Cycling ............................................................................... 28

Adjustment ......................................................................... 28

Limits .................................................................................28

Troubleshooting Electrode Impedance Results 30

High impedance troubleshooting ....................................... 31

Low impedance troubleshooting ........................................ 31

Eligibility ��������������������������������������������������������������� 32

Estimating battery longevity ............................................... 32

Removing patient-identifying information before ENS

disposal .............................................................................32

Viewing Diaries ���������������������������������������������������� 33

Stimulation Usage .............................................................33

Group Usage .....................................................................33

Working with Reports ����������������������������������������� 34

Using the Reports screen .................................................. 34

Patient Data Service app������������������������������������� 35

Finding and opening the app ............................................. 35

Accessing or deleting a patient session record .................35

Deleting multiple patient session records at once .............35

Setting the PDF auto-delete feature .................................. 36

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Viewing System Information ������������������������������ 36

Viewing information about system components ................36

Viewing information about trademarks and licenses .........36

Changing device date/time or implant date information ....37

Compiling a Medtronic Data Report ..................................37

Viewing Alerts ������������������������������������������������������ 37

Working with alerts ............................................................37

Troubleshooting �������������������������������������������������� 38

Data validation error message ........................................... 38

Power on reset (POR) message ........................................ 38

Out of regulation (OOR) message ..................................... 38

Using impedance measurements for troubleshooting .......38

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Description of the Programming System

Model A71300 Stimulation Trialing Clinician Programmer Application

The Medtronic Model A71300 Stimulation Trialing clinician
programmer application (app) is intended for use by clinicians in the
programming of the Medtronic Model 97725 external neurostimulator
(ENS) for pain therapy.

Intended purpose

The clinician programmer trialing application provides the

user interface for clinicians to congure stimulation and obtain

system information from an external neurostimulator as part of a
neurostimulation system for pain therapy.

Other components of the programming system

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

Model A901 Communication Manager
Application

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

Model A902 Patient Data Service Application

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

Model CT900 Clinician Tablet

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

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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 the form of electrical pulses. Stimulation

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

to manage patient therapy.

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

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

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

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

Groups and programs

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

Multiple programs can be combined into groups.

When using more than one program, the pulses are delivered

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

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

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

Pulse width, intensity, 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 device level, and the rate of each
program within a group can be set as a fraction of the device rate.

Optional features

Optional features are available for adjusting the stimulation to the
patient's needs.

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

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

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

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

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

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

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

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

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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 controls and encryption provided by the clinician
tablet. The clinician programming system does not provide data
protection for data exported to another destination. Exported data
should be handled in accordance with your facility’s security policy for
data handling and storage.

Medtronic recommends that you always save exported data to the
default reports location on the clinician tablet.

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 notications on available updates.

Note: Connecting the clinician tablet to a network that includes other
equipment could result in unforeseen risks to patients, operators, or
third parties. Changes to your network such as adding, disconnecting,

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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.

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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 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
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).

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General Warnings and Cautions

Setting up the Programming System

Clinician tablet with

clinician programmer app

The clinician tablet must remain within 3 meters

(10 feet) of the ENS.

Figure 1. Components for programming the ENS.

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.

Finding and opening the app

1. Navigate to the apps on the clinician tablet.

Wireless external neurostimulator

(wireless ENS)

ENS button

BLUETOOTH

2. Tap the Stim Trialing app icon to open the app.

Wireless ENS preparation

■ Refer to the 97725 Wireless External Neurostimulator user
manual for the following instructions:

– Connecting the leads to the wireless ENS

– Changing the batteries in the wireless ENS

■ Check the battery level of the wireless ENS using the clinician
programmer app:

– Start a session with the wireless ENS. Refer to page

11.

– If the battery level for the ENS is too low to sustain

therapy or a programming session, a pop-up message
will notify you of the battery status and to replace the
device batteries now.

– After the ENS has been interrogated, the battery level of

the ENS is shown on the CURRENT DEVICE STATUS

screen (the screen from which you select the workow

to use for the programming session).

Note: If the wireless ENS is unresponsive or if you cannot determine
the battery level using the clinician programmer app, use another
wireless ENS.

Indicator icons in tablet status bar for ENS and BLUETOOTH wireless technology

Table 1 shows the icons that appear in the clinician tablet status bar
(uppermost row) indicating the status of ENS communication with the
clinician programmer app.

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Setting up the Programming System

Table 1. ENS icons in tablet status bar.

Icon Description

The clinician programmer app is in the process of

nding ENS devices in the vicinity.

The clinician programmer app is in the process of
connecting to an ENS.

The clinician programmer app has established
communication with the ENS using BLUETOOTH
wireless technology.

Starting a session with a wireless ENS

1. Press and hold the ENS button on the wireless ENS for
approximately 1 second.

■ When the ENS button is pressed, the light on the ENS

turns on (either solid or ashing), showing that the ENS

has entered a discovery mode to begin searching for the
clinician tablet.

■ Make sure the clinician tablet is within 3 meters (10 feet)
of the ENS.

■ The light on the ENS will repeatedly ash for 90
seconds while the ENS can pair with the clinician tablet

■ If the clinician tablet detects more than one ENS, more
than one serial number may appear in the device search
results.

■ If a serial number is not provided on the back of the
ENS, do not use the device.

4. Select the serial number of the ENS you intend to congure
and tap CONNECT.

5. If conguring a new ENS, conrm the serial number of the ENS
on the pop-up message. Tap CONTINUE SESSION.

Or

If starting a follow-up session with an ENS, conrm the patient

name and serial number of the ENS on the pop-up message.
Tap CONTINUE SESSION.

The resulting screen and workow options to choose from will
depend on whether the ENS is new or already congured.

Note: If no programs were created in a previous programming

session, the workow options for a new ENS will display. Once
a program is created, the workow options for a congured

ENS will display.

6. Go to "External Neurostimulator Workows" on page 14 for

information to proceed with conguring and programming the

ENS.

2. From the initial screen of the app, tap CONNECT.

3. Watch the clinician tablet for the status of the device search
and search results.

■ If no devices are found, follow the on-screen instructions
to retry the search.

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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 an external neurostimulator (ENS).

When the app is in Demo mode, it is not communicating with a real
external neurostimulator. Any data displayed in Demo mode is not
actual.

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

1. On the initial Stimulation Trialing app screen, tap DEMO.

2. Select a device (new or congured ENS), and tap CONNECT.

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

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

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

where you can select DEMO again and select another device

(new or congured ENS) 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
status (new versus congured).

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

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

Device
Reports

Lead Select Tip Location Programs Diaries

Summary

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

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

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

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

show the screen names that are partially hidden.

■ The current screen is underlined and highlighted.

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

– The app will prompt you for the required input.

– Orange asterisks indicate required elds.

Using the Side Menu

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

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

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

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

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

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Overview of the Clinician Programmer App

On-screen help

Help information is available in the clinician programmer app for most

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

interface works and how to complete tasks on the screen.

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

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

) in the top-

Buttons and indicators on the action bar

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

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

Table 2. Buttons and indicators.

Button / Indicator Description

Side Menu button: Tap to access

screens outside of the workow.

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

to the previous workow screen.

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

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

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

Button / Indicator Description

Help button: Tap to display help

information for the current screen.

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

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

When the app is placed in the background

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

the background and is represented as a oating widget (Stimulation
Trialing Session in Progress) to remind you that you are still in a

session.

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

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

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Overview of the Clinician Programmer App

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. 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.

■ Start Usage > Start Evaluation workow – go to page 14

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

Use for testing lead placement.

■ Followup workow – go to page 16.

Use at followup sessions with the patient during the trial period
to update therapy settings, view charts and reports.

■ End Evaluation workow – go to page 17.

Use at the last followup session with the patient at the end
of the trial period and view list of eligible implantable devices
compatible with the current therapy settings.

■ Implant Device workow – go to page 18.

Start a session with external neurostimulator and transfer data
to internal neurostimulator during an implant procedure.

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.

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 eld to the current date.

3. Under START EVALUATION, tap START.

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

workow.

).

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External Neurostimulator Workows

Table 3. Start Evaluation workow.

Screen Tasks More information

Device Check the battery status of the external neurostimulator. Page 19

Patient Info Enter patient information. Page 19

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

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

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

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

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

Tip Location Select the tip location for each lead. Page 20

Programs (and
subscreens)

Create programs in groups. Tap a group to make it active. A highlighted box around a group indicates
that 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 intensity.

Lead Manipulation subscreen (only applicable with 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 27

Patient Access subscreen: Assign the stimulation parameters that the patient can adjust. Page 28

Impedance Measure electrode impedance.

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

Summary Conrm therapy settings.

End the session properly by tapping the EXIT WORKFLOW button.

Page 19

Page 19

Page 20

Page 21

Page 21

Page 26

Page 29

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External Neurostimulator Workows

Followup workow

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

2. Under FOLLOWUP, tap START.

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

workow.

Table 4. Followup workow.

Screen Tasks More information

Device Check the battery status of the external neurostimulator. Page 19

Lead Select Review the information, and make any updates. Updates may delete programmed settings. Page 19

Tip Location Review the information, and make any updates. Page 20

Programs (and
subscreens)

Diaries View the Stimulation Usage and Group Usage diaries to assess the patient’s use of the therapy. Page 33

Reports Select a report to view, download, or delete. Page 34

Summary Conrm therapy settings.

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

the intended group.

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

and intensity.

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 27

Patient Access subscreen: Assign the stimulation parameters that the patient can adjust. Page 28

End the session properly by tapping the EXIT WORKFLOW button.

Page 21

Page 21

Page 26

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External Neurostimulator Workows

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

workow.

Table 5. End Evaluation workow.

Screen Tasks More information

Device Check the battery status of the external neurostimulator. Page 19

Lead Select Review the information, and make any updates. Updates may delete programmed settings. Page 19

Tip Location Review the information, and make any updates. Page 20

Programs Review the groups, programs, and settings, and make any updates. Page 21

Diaries View the Stimulation Usage and Group Usage diaries to assess the patient’s use of the therapy. Page 33

Reports Select a report to view, download, or delete. Page 34

Eligibility Review the list of devices that are compatible with the therapy parameters and programs currently

active in the ENS. Estimate battery life for Vanta or Sequentia LT neurostimulators based on the
therapy parameters and programs currently active in the ENS.

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

Page 32

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External Neurostimulator Workows

Implant Device 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 IMPLANT DEVICE > START.

3. Use Table 6 to guide you through the screens and tasks in the

workow.

Table 6. Implant Device workow.

Screen Tasks More information

Device Check the battery status of the external neurostimulator. Page 19

Patient Info Enter patient information. Page 19

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

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

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

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

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

Tip Location Indicate whether extensions are implanted. Page 20

Programs (and
subscreens)

Switch Device Press the SWITCH DEVICE button to switch from an external neurostimulator to an implanted Model

Create programs in groups. Tap a group to make it active. A highlighted box around a group indicates
that 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 intensity.

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 27

Patient Access subscreen: Assign the stimulation parameters that the patient can adjust. Page 28

977006 Vanta or Model 977005 Sequentia LT neurostimulator.

Page 19

Page 19

Page 20

Page 21

Page 21

Page 26

Page 29

Summary Conrm therapy settings.

End the session properly by tapping the EXIT WORKFLOW button.

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--

External Neurostimulator Workows

Working with Device and Patient Information

Checking battery status of the external neurostimulator

The battery level for the external neurostimulator (ENS) 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

A battery image displays representing the battery level percentage:
0%, 25%, 50%, 75%, or 100%.

At the start of a programming session, if the battery level is below

25% for the ENS, a message noties you that the device is running

on low battery.

If the battery level for an ENS is too low to sustain therapy or a

programming session, a message noties you of the battery issue.

You need to replace the batteries in the ENS.

Entering patient information

Patient information such as patient name and diagnosis is entered on
the Patient Info screen. The Patient Info screen is accessed through
the workow navigator or by tapping Patient Info on the Side Menu
(

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

■ Enter the applicable patient information. Orange asterisks

indicate the required elds.

Mapping patient pain

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

part of a workow.

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

■ Use the ERASE option to remove highlighting.

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

) when the screen is not

Entering lead information

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

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

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

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

Notes:

■ Make sure that the electrode numbering on the screen
matches the electrode numbering of the implanted leads. If

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Working with Device and Patient Information

necessary, you can swap congured leads using the drag-and-

drop feature.

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

Testing lead connectivity

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

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

– Green electrodes indicate that the lead contacts and/

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

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

– If 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

Adding uoro images

The uoro screen is accessed using the View Fluoro button at the
bottom-left of the Tip Location screen.

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

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

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

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

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

■ Tap the Trash button (

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

select the image you want to delete.

) to delete an image. If more than one

Entering tip location information

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

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

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

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

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

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

Program subscreen.

Program subscreen

The Program subscreen is used to assign, review, and change
program settings for programs in the active group. The Program
subscreen is accessed by tapping a program on the Programs
screen.

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

)�

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

■ Use the Program subscreen to assign the electrode

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

intensity. Refer to "Adjusting Stimulation Parameters" on page

22.

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

– Lead Manipulation: For more information, refer to

"Relative Lead Positioning" on page 26.

– Energy: Refer to "Customizing SoftStart/Stop and

Cycling" on page 27.

– Patient Access: For more information, refer to

"Enabling Patient Access" on page 28.

Turning stimulation on or off

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

■ Tap the Stimulation toggle to turn stimulation on (
(

) at any time.

) or off

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Working with Groups and Programs

Adjusting Stimulation Parameters

Assigning electrode conguration

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

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

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

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

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

), and then tap the Trash icon ( ).

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

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

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

).

),

Assigning intensity, pulse width, and program rate

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

During a programming session, the selected values for intensity,
pulse width, and program rate are automatically programmed into the
neurostimulator. Once intensity 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).

Assigning intensity

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

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

intensity.

1. In the Program subscreen, tap INTENSITY to access the
intensity control.

2. Select the intensity using any of these controls:

■ Scrollable drop-down list.

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

■ Back arrows (
increase.

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

) to decrease and forward arrows ( ) to

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Adjusting Stimulation Parameters

3. Use these buttons, as needed:

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

■ Tap the Jump button (
without incremental increases.

■ Tap the Intensity to zero button (
intensity to 0.0 mA.

) to stop stimulation from

) to jump to the new value

) to immediately set

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 intensity to the perception threshold (the intensity

at which the patient rst perceives a sensation of stimulation)

before changing the pulse width. After changing the pulse
width, slowly increase the intensity.

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.

) to decrease and forward arrows ( ) to

) to stop stimulation from

■ Tap the Jump button (
without incremental increases.

) to jump to the new value

Assigning program rate and device rate

Rate is the frequency of pulses per second, in hertz (Hz). The device
rate is the initial rate for each program in that group. A program rate is
a fractioned value of the device rate.

To set a device rate

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

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

■ Scrollable drop-down list.

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

■ Back arrows (
increase.

To set a program rate

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

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

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

2. Select a program rate. That rate will be applied to all the
programs with the same number in the other groups as well.

Program rate example:

■ The device rate is set at 100 Hz.

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

) to decrease and forward arrows ( ) to

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Adjusting Stimulation Parameters

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

3. Tap CLOSE to close the control.

4. Reassess limits assigned in the Patient Access subscreen
after modifying stimulation parameters. Refer to "Limits" on
page 28.

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

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

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

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

1. To activate the Device Electrode Redistribution feature:

a. Tap the Display All (

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

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

DEVICE ELECTRODE REDISTRIBUTION toggle.
If the toggle is green and the switch is to the right
(

), the feature is activated. If the toggle is blue
and the switch is to the left, tap the toggle to activate the
feature.

) button in the Program

c. Tap the CLOSE button to return to the Program

subscreen.

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

Notes:

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

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

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

Notes:

■ Electrode intensity increases in increments.

■ If the neurostimulator is unable to deliver the intensity
value in combination with the values set for the pulse
width and rate, an alert will notify you that stimulation
output is below the programmed intensity. Refer to "Out
of regulation (OOR) message" in the Troubleshooting
section on page 38.

4. Repeat if you want to adjust another electrode.

5. Tap CLOSE to close the control.

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Adjusting Stimulation Parameters

Equalizing intensity across electrodes

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

To equalize a single program

1. In the Program subscreen, tap the Equalize (

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

) button.

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

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

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

It remains active across programming sessions.

1. To activate the Device Electrode Redistribution feature:

3. Use the INTENSITY control to select an intensity.

To equalize all programs with unequal distribution

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

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

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

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

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

) button.

Using IntelliStim

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

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

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

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

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

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

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

DEVICE ELECTRODE REDISTRIBUTION toggle.
If the toggle is green and the switch is to the right
(

), the feature is activated. If the toggle is blue
and the switch is to the left, tap the toggle to activate the
feature.

c. Tap the CLOSE button to return to the Program

subscreen.

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

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

■ Tap the Forward button (
pair down the lead.

■ Tap the Back button (
up the lead.

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

) to advance the electrode

) to advance the electrode pair

) to move the

)

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Adjusting Stimulation Parameters

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

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

is pressed for the rst time.)

4. Use the Intensity control to set the intensity.

■ If the neurostimulator is unable to deliver the intensity
value in combination with the values set for the pulse
width and rate, an alert will notify you that stimulation
output is below the programmed intensity. Refer to "Out
of regulation (OOR) message" in the Troubleshooting
section on page 38.

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

■ The button marked X2 shows the default speed. Tap
the button once to reduce speed (the button will now be
marked X1). Tap the button again to change the speed
back to X2.

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

Relative Lead Positioning

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

more than one lead is congured.

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

Repositioning the leads relative to each other on the Lead

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

The uoro screen can be accessed using the View Fluoro button at
the bottom-left of the Lead Manipulation subscreen (it also appears
at the bottom-left of the Tip Location screen). Refer to "Adding uoro
images" on page 20 for more information.

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

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

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Relative Lead Positioning

Customizing SoftStart/Stop and Cycling

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

Changing SoftStart/Stop settings

SoftStart/Stop slowly increases the intensity when stimulation is
turned on and slowly decreases the intensity 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.

Turning cycling on or off

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

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

) or off ( ).

■ When cycling is turned on, all existing programs are
enabled for cycling as the default per program number.
Green (
enabled.

■ To disable cycling for a program, tap the toggle next
to that program number. This will affect that program
number in all the groups.

) indicates that the program number is

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

3. Under the PROGRAM heading:

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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:

Cycling, Adjustment, and Limits.

Cycling

The Cycling patient control on the Patient Access subscreen
provides the ability to enable or disable patient control of cycling. It
can only be enabled when cycling has been turned on in the Energy
subscreen. The default setting for the cycling feature is “off."

Adjustment

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

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

Limits

The Limits patient control on the Patient Access subscreen
provides the ability to enable or disable patient control of stimulation
parameters (intensity, pulse width, device 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.

) or disable ( ) the

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

1. Under the LIMITS heading, tap the toggle next to the
stimulation parameter name to enable (
patient control of the stimulation parameter.

2. 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).

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

Intensity

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

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.

Device rate

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

Effect of subsequent parameter changes

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

) or disable ( )

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Enabling Patient Access

Switch Device

The Switch Device feature is used to transfer some data, including

patient and lead information, pain map, and uoro images, from the

external neurostimulator to a new implanted neurostimulator. The

Switch Device screen is accessed in the Implant Device workow
through the workow navigator

Note: The Switch Device feature is only available with the Model
977006 Vanta and Model 977005 Sequentia LT implantable
neurostimulators.

1. Choose between the Vanta (977006) and the Sequentia LT
(977005) neurostimulators in the dropdown menu.

2. Tap the SWITCH DEVICE button.

3. Tap the SWITCH DEVICE button in the pop-up box to conrm

that you want to transfer congured information from the ENS

to the implantable neurostimulator.

4. The relevant clinician programmer application will launch
automatically.

Checking System Performance

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

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

can inuence neurostimulator measurements. For example, changes

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

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

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

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

impedance can indicate a fractured lead conductor or a loose

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

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

Testing impedance

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

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

(

) when it is not part of a workow.

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

).

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

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

29

Switch Device

Notes:

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

■ If any impedance value is out of normal ranges (too low or too
high), the results appear in either the AVOID box or the DO
NOT USE box. Refer to "Troubleshooting Electrode Impedance
Results" on page 30.

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

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

Troubleshooting Electrode Impedance Results

The AVOID and DO NOT USE boxes on the Impedance screen
identify where low impedance or high impedance was measured in
the system. Refer to Table 7 for more information about impedance
results indicators.

Table 7. Impedance results indicators.

Icon Description

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

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

• Using these electrodes may increase energy

consumption or impact therapy efcacy.

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

Possible short circuit:

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

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

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

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

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Troubleshooting Electrode Impedance Results

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

High impedance troubleshooting

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

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

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

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

High impedance: >4,000 ohms

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

For more information about measuring electrode impedance,
refer to "Testing impedance" on page 29.

2. If a trend towards normal impedance range is not observed,
disconnect the lead from the extension (if applicable) and
reconnect the external neurostimulator to test the impedance
of the lead alone.

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

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

visually or uoroscopically inspect the lead for damage.

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

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

uoroscopically inspect the extension and extension

connection for damage.

■ If two extensions are being used (one on each of two
leads), switch the extensions with one another and
measure impedance again to see if the out-of-range

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

the extensions, consider replacing that extension.

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

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

Low impedance troubleshooting

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

Low impedance: <300 ohms

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

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Troubleshooting Electrode Impedance Results

Eligibility

The Eligibility screen is accessed through the workow navigator
in the End Evaluation workow or by tapping Eligibility in the Side
Menu (

The following information explains what the Eligibility screen does
and what it requires:

Estimating battery longevity

Battery longevity for the implantable neurostimulator depends on

the therapy conguration and usage. The ESTIMATE BATTERY
LONGEVITY FOR VANTA OR SEQUENTIA LT feature is a calculator

that allows you to estimate battery longevity based on the current
program and group settings, along with the number of hours per day
the patient might use each group.

1. In the Eligibility screen tap the ESTIMATE BATTERY

) when it is not part of a workow.

■ Lists the implantable neurostimulators that allow the same
parameters as the programs that are currently active in the
external neurostimulator (ENS) used for the trial evaluation.

■ Automatically updates each time you change parameters for
any active program and when you change the active group in
the ENS.

■ Requires at least one active program in the ENS in order to list
the implantable neurostimulators that are eligible to consider
for implant.

■ If the Model 977006 Vanta and/or Model 977005 Sequentia LT
implantable neurostimulators are eligible, use the ESTIMATE

BATTERY LONGEVITY FOR VANTA OR SEQUENTIA LT

feature to estimate battery life based on current programs.

LONGEVITY FOR VANTA OR SEQUENTIA LT button.

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

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

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

3. Tap ESTIMATE.

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

5. Tap CLOSE to return to the Eligibility screen.

Notes:

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

■ For all other implantable neurostimulator models, refer to the
System Eligibility and Battery Longevity reference manual for
more information about neurostimulator eligibility.

Removing patient-identifying information before ENS disposal

The Model 97725 external neurostimulator (ENS) is a single-use
device. Remove patient-identifying information from the ENS before
disposal.

1. Start a session with the ENS and select the IMPLANT DEVICE

workow.

2. Swipe to the Patient Info screen.

3. Replace the patient's name with an x in the FIRST NAME and

LAST NAME elds.

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4. Tap UPDATE.

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Eligibility

5. Go to the Summary screen and tap EXIT WORKFLOW.

Viewing Diaries

The charts accessed from the Diaries screen provide overviews of
how the patient is using the external neurostimulator.

Stimulation Usage

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

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

Group Usage

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

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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.

■ 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 37.

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

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

Using the Reports screen

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

) when not part of a workow.

Table 8. Report buttons.

Button Description

View button – to view the report in PDF format.

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

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

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

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

This action saves a PDF le in the default reports

folder on the clinician tablet.

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

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

session record does not delete any existing PDF les

created from that record and stored on the clinician
tablet.

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

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

4. Tap one of the buttons shown in Table 8.

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34

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 9. 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 34.

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 9.

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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.

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Patient Data Service app

) to delete the records. The number of

Setting the PDF auto-delete feature

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

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

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

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

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

2. Select PDF Auto Delete.

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

).

Viewing System Information

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

This screen provides the following information:

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

rmware numbers, version numbers) for the external

neurostimulator (ENS), clinician tablet, clinician programmer
app, and controller (patient programmer).

Includes the information for the controller (patient programmer)
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.

■ Ability to generate a Medtronic Data Report.

Viewing information about system components

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

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Viewing information about trademarks and licenses

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

36

Viewing System Information

Changing device date/time or implant date information

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

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

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

Compiling a Medtronic Data Report

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

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

To access previously compiled Medtronic Data Reports, refer to
"Working with Reports" on page 34.

) to compile the

Viewing Alerts

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

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

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

Working with alerts

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

– Swipe left or right to view individual alerts.

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

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

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

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

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

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Viewing Alerts

Troubleshooting

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

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

Data validation error message

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

Power on reset (POR) message

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

Using impedance measurements for troubleshooting

Refer to "Checking System Performance" on page 29.

Out of regulation (OOR) message

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

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Troubleshooting

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39

Manufacturer

Medtronic, Inc.
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Minneapolis, MN 55432
USA
www.medtronic.com
Tel. [phone]

REP

EC

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in the European Community

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The Netherlands
Tel. [phone]

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www.medtronic.eu
Tel. [phone]

Asia-Pacic

Medtronic International Ltd.
50 Pasir Panjang Road
#04-51 Mapletree Business City
Singapore 117384
Singapore
Tel. [phone]

*M006346C001*

© Medtronic, Inc. 2020
All Rights Reserved

M006346C001 Rev A
2021-02-15