Medtronic and Medtronic logo are trademarks of Medtronic.
AdaptiveStim™, Sequentia™, SoftStart/Stop™, and Vanta™ are
Importer
trademarks of a Medtronic company.
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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-specic 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
specications, product-specic 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 specications, instructions for use, and
maintenance information.
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Table of Contents
Description of the Programming System ������������ 7
Model A71200 Vanta / Sequentia LT
clinician programmer application
The Medtronic Model A71200 Vanta / Sequentia LT clinician
programmer application (app) is intended for use by clinicians
in the programming of the Medtronic Model 977006 Vanta and
Model 977005 Sequentia LT implantable neurostimulators for pain
therapy.
Intended purpose
The clinician programmer application is intended for use by clinicians
in the programming of Medtronic neurostimulators for pain therapy.
Other components of the
programming system
The clinician programmer app is intended for use with the following
components.
Model CT900 Clinician Tablet
The clinician programmer app is installed on the Model CT900
Clinician Tablet with Android-based operating system.
Model A901 Communication Manager
application
The Model A901 Communication Manager application is an
application on the clinician tablet that manages the telemetry
communications for the clinician tablet.
Model A902 Patient Data Service application
The Model A902 Patient Data Service application is an application
on the clinician tablet that manages the storage of patient session
data on the clinician tablet. The Patient Data Service app can be
used to access or delete patient session data for any patients whose
Medtronic devices have been programmed using any clinician
programmer app on the clinician tablet.
Model 8880T2 Communicator
The Model 8880T2 Communicator is a handheld device used in
conjunction with the clinician tablet and clinician programmer app to
communicate with Medtronic neurostimulators.
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Description of the Programming System
Programmable Settings
The clinician programmer app is used to enter, review, and modify
programmable settings in the neurostimulator. These programmable
settings dene the stimulation therapy delivered to the patient.
Pulse width, amplitude, and electrode conguration are assigned
at the program level: that is, each program within a group can have
different values. Rate is assigned at the group level, and the rate of
each program within a group can be set as a fraction of the group
rate.
Stimulation parameters
Stimulation is delivered in the form of electrical pulses. Stimulation
parameters dene the attributes of these pulses and can be adjusted
■Pulse width: Duration of each pulse in microseconds (μs).
■Rate: Frequency of pulses in hertz (Hz).
■Amplitude: Strength of a pulse in milliamps (mA).
Groups and programs
A program is a specic combination of pulse width, rate, and
amplitude settings acting on a specic electrode conguration. The
program denes the stimulation pulses that will be delivered for
therapy. The Model 977005 Sequentia LT neurostimulator supports
one program.
For the Model 977006 Vanta neurostimulator, multiple programs can
be combined into groups.
When using more than one program, the pulses are delivered
sequentially—rst a pulse from one program, then a pulse from the
next program, and so on. Pulses from different programs are never
delivered simultaneously. Each group and its associated programs
can be used to provide therapy for specic areas of coverage or
specic patient activities.
Optional features
Optional features are available for adjusting the stimulation to
the patient's needs. Some features are not available for the
Model 977005 Sequentia LT neurostimulator.
■Adjustment: Allows the patient to increase or decrease
amplitude for all programs in the active group at the same time.
■AdaptiveStim Technology: Adjusts stimulation automatically
when the patient changes position.
■Cycling: Cycles stimulation on and off at clinician-determined
intervals.
■Electrode Redistribution: Assigns a lower or a higher
percentage of the program amplitude to an individual electrode
in a program.
■Equalize: Sets program amplitude to zero and recongures
the active electrodes to provide equal distribution of amplitude.
■IntelliStim: A semi-automated feature for selecting electrodes
to deliver therapy. IntelliStim is a scanning process in which
common combinations of electrodes are scanned across the
lead using the selected amplitude.
■Move: Sets program amplitude to zero and allows a congured
electrode combination to be moved up, down, or across the
lead or leads.
■Patient Limits: Identies the stimulation parameters that
the patient can adjust and sets the upper limits for those
parameters.
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Programmable Settings
■SoftStart/Stop: Slowly increases the amplitude when
stimulation is turned on and slowly decreases the amplitude
when stimulation is turned off.
Data Security and Network
Connectivity
Data security
The clinician programming system uses and stores data about the
patient's health and implanted medical device. This data is protected
by application-level controls and encryption provided by the clinician
tablet. The clinician programming system does not provide data
protection for data exported to another destination. Exported data
should be handled in accordance with your facility’s security policy for
data handling and storage.
Medtronic recommends that you always save exported data to the
default reports location on the clinician tablet.
Network connectivity
Network connectivity is required for initial app registration and for
installation of Medtronic app updates and communicator rmware
updates. Network connectivity is not required for neurostimulator
programming. To protect your clinician programming system,
Medtronic recommends you implement the following security
measures:
■Secure your clinician tablet by disabling network connectivity
during any programming session.
■Use a managed, trusted Wi-Fi connection when network
connectivity is needed.
■Connect the clinician tablet to the network periodically to check
for notications 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,
A71200 English 2022-01-15
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Data Security and Network Connectivity
and upgrading equipment; upgrading or installing software; or
changing network congurations could also introduce additional risks.
Analyze, evaluate, and control any identied risks.
If you suspect a cybersecurity event has occurred, stop using the app
(if possible) and contact your IT Security team or Medtronic Technical
Services to document and respond to the suspected incident.
If your clinician tablet is lost or stolen, contact Medtronic using the
contact information listed on the back cover of this manual.
Installing application updates
For assistance with downloading, registering, or installing the
application, contact Medtronic using the information on the back
cover of this manual. In the U.S., call 1-800-707-0933 for Medtronic
Technical Services.
Medtronic periodically updates the therapy app and will not install
updates without notifying you. Network connectivity is required to
update the app. When notied that an app update is available, follow
the instructions provided by Medtronic to install the update.
Installing communicator updates
When notied to install a communicator rmware update, connect the
communicator to the clinician tablet using the USB connector cable.
Follow the instructions provided by Medtronic to install the update.
Returning the clinician tablet
If you need to return the clinician tablet for disposal or replacement,
contact Medtronic using the contact information listed on the back
cover of this manual. Instructions will be provided for preparing the
clinician tablet for return.
General Warnings and Cautions
If a serious incident related to the app occurs, immediately report the
incident to Medtronic and the applicable competent authority.
MRI warning for scan eligibility
Warning: Always program the following component information
accurately:
■Neurostimulator and lead model numbers
■Neurostimulator implant location and lead tip location
■Presence of any abandoned leads, extensions, and pocket
adaptors
If this information is not up-to-date or is entered incorrectly, MRI scan
eligibility data will be inaccurate, and the patient is at risk for one of
the following:
■The patient is allowed to have an MRI scan inappropriate for
the implanted components, which could cause tissue heating,
resulting in tissue damage or serious patient injury.
■The patient is unnecessarily restricted from having an MRI
scan.
Refer to the MRI Guidelines for Medtronic Neurostimulation Systems for Chronic Pain instructions for use manual for MRI scan eligibility
information, MRI scan conditions, and MRI-specic warnings and
cautions for conducting an MRI scan.
Sterile eld warning for
programming components
Warning: To use the programming components (external
and nonsterile) in a sterile eld, place a sterile barrier between the
patient and the programming components to prevent infection. Do
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General Warnings and Cautions
not sterilize any of the programming components. Sterilization may
damage the programming components.
EMI caution for telemetry signal
disruption
Caution: Electromagnetic interference (EMI) can disrupt
programming and telemetry communication. If EMI interference
is suspected, such as from radio frequency identication (RFID)
equipment, move away from the likely source of EMI and try again.
Cautions related to clinician
programming and possible
interactions with other devices
Refer to the Information for Prescribers booklet for cautions related
to clinician programming and possible interactions with other devices
(such as cardiac devices).
Setting up the Programming
System
Clinician tablet with
clinician programmer app
Power button
The connector cable is required for pairing
the communicator to the clinician tablet.
After pairing, the communicator and the clinician tablet can
communicate using BLUETOOTH wireless technology.
For wireless communication, make sure the clinician tablet
Figure 1. Components of the programming system.
remains within range.
Preparing the clinician tablet
Refer to the Model CT900 Clinician Tablet quick start guide for
instructions on how to turn on the tablet and to complete initial setup.
Check the battery level of the clinician tablet.
■The tablet's battery level is shown on the tablet status bar
(uppermost row on the tablet screen).
■Recharge the tablet if the battery level is low.
USB
connector cableCommunicatorNeurostimulator
Power button
Proximal Telemetry
Hold communicator directly
over neurostimulator.
BLUETOOTH
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Setting up the Programming System
Finding and opening the app
1. Navigate to the Apps on the clinician tablet.
2. Find the Vanta app icon.
Note: Vanta app is used to program both the Vanta and
Sequentia LT neurostimulators.
3. Tap the Vanta app icon to open the app.
Pairing the communicator to the
clinician tablet
Refer to the Model 8880T2 Communicator technical manual for
additional instructions, if needed. Only one communicator can be
paired with a clinician tablet at a time.
1. Connect the USB connector cable to the communicator and
the clinician tablet.
2. Turn on the communicator (slide the power button down, then
release).
3. A message appears on the clinician tablet, which asks
permission to open the Communication Manager when the
USB device is connected:
a. Select to use the USB device by default. This selection
prevents this message from appearing again.
b. Select OK.
4. On the initial app screen, tap CONNECT. Pairing begins and
the communicator displays a green LED light between the
tablet icon and the communicator icon.
Once the communicator is paired, you can disconnect the USB
connector cable. The communicator and clinician tablet communicate
using BLUETOOTH wireless technology. For wireless communication,
make sure the clinician tablet remains within range.
Note: If you have trouble pairing, either with the USB connector cable
or BLUETOOTH, restart the tablet and try again.
Initiating communication with the
neurostimulator
1. Hold the communicator directly over the neurostimulator.
Notes:
■The target symbol (
indicates the location of the internal antenna. The target
should be facing and centered over the neurostimulator.
■After making the initial connection, you can make future
connections at a greater distance for 12 hours following
the initial connection, or until the communicator
connects to a different neurostimulator.
2. On the Search for Device screen, tap FIND DEVICE.
Or
Press the communicate button (
3. Select the serial number of the neurostimulator you intend to
congure, and tap CONNECT.
4. After connecting to the neurostimulator, the CURRENT DEVICE STATUS screen will display.
From this screen, you can select workow options under
the SELECT FLOW heading. Refer to the "Neurostimulator
Workows" section on page 16 for workow details.
) on the back of the communicator
) on the communicator.
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Setting up the Programming System
Notes:
■If you have problems establishing communication, refer to
"Communicator and clinician tablet troubleshooting" on page
53.
■Do not leave the clinician tablet unattended during an active
programming session.
■When a congured neurostimulator is interrogated, a lead
connectivity test is performed to check for impedance issues.
The patient may feel a stimulation change during the test.
Overview of the Clinician
Programmer App
Using Demo mode
Use Demo mode to explore the clinician programmer app without
interrogating or updating a neurostimulator.
When the app is in Demo mode, it is not communicating with a real
neurostimulator and does not require the use of a communicator. Any
data displayed in Demo mode is not actual.
Demo mode can be used for training and demonstration purposes
and to familiarize yourself with the app interface before starting an
actual programming session.
1. On the initial Vanta/Sequentia LT app screen, tap DEMO.
2. Select a device, and tap CONNECT.
3. Navigate through the workow. One workow 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 workow will return you to the initial app screen
where you can select DEMO again and select another device
to explore.
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Navigating through workows
The screens typically used during a programming session are
grouped into workows. The workows vary depending on the device
model and device status (new versus congured). The workows may
also vary depending on neurostimulator features.
13
Overview of the Clinician Programmer App
After you start a workow, a workow navigator appears at the top
of the screen. For example, the Followup workow for the Vanta
neurostimulator contains these screens:
Device
AdaptiveStim
Lead Select Tip Location Programs Impedance
Diaries Reports Summary
■To move from screen to screen, swipe left or right.
■Alternatively, you can tap on the screen name in the workow
navigator to go directly to that screen.
–If the workow navigator extends beyond the width of
the screen, swipe the workow 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 workow 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 workow can be accessed from the Side
Menu. For example, the Patient Info screen is in the new device
workow, but not in the Followup workow. To change patient data in
a congured device, you need to access the Patient Info screen from
the Side Menu. To access the Side Menu, tap the Side Menu button
(
) in the top-left corner on the action bar.
On-screen help
Help information is available in the clinician programmer app for most
workow 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 workows. Table
1 describes the buttons and indicators that may appear on the action
bar.
Table 1. Buttons and indicators.
Button / IndicatorDescription
Side Menu button: Tap to access
screens outside of the workow.
Back button: Tap to close a screen you
accessed from the Side Menu and return
to the previous workow screen.
Demo mode indicator: Appears in the
action bar when in Demo mode.
Stimulation toggle: Tap to turn
stimulation on or off. Green (switch to the
right) indicates that stimulation is on.
Appears in the action bar when at least
one program exists.
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Overview of the Clinician Programmer App
Button / IndicatorDescription
AdaptiveStim indicator: Applicable
to neurostimulators with AdaptiveStim
Technology (977006 Vanta).
Appears in the action bar when
AdaptiveStim Technology is enabled.
MRI Status indicator: Appears in the
action bar when stimulation is off and
MRI Mode has been activated.
The MRI Status indicator does not
provide MRI scan eligibility information.
Help button: Tap to display help
information for the current screen.
Tap the Help button (or tap anywhere on
the screen) to close the help screen.
Go to Summary screen button: Tap to
go directly to the Summary screen. You
can exit the workow from the Summary
screen to properly end the programming
session.
When the app is placed in the
background
When you navigate away from the Vanta clinician programmer app
while in a programming session, the app is placed in the background
and is represented as a oating widget (Vanta Session in Progress)
to remind you that you are still in a session.
■Press and drag the oating widget to move it on the tablet
screen.
■Tap on the oating widget to return to the app and resume the
session.
Overview of the Communicator
The Model 8880T2 Communicator is a nonsterile component used in
conjunction with the clinician tablet and clinician programmer app to
communicate with Medtronic neurostimulators.
Warning: To use the communicator in a sterile eld, place
a sterile barrier between the patient and the communicator
to prevent infection. Do not sterilize any of the programming
components. Sterilization may damage the programming
components.
The communicator is handheld and battery-operated. Communication
between the communicator and the clinician tablet can occur
wirelessly using BLUETOOTH technology or wired using the USB
connector cable.
For information on the Model 8880T2 Communicator, including
description, specications, components, instructions for use,
maintenance, and troubleshooting, refer to the Model 8880T2
Communicator technical manual.
Using the USB connector cable
The following situations require the use of the USB connector cable:
■First-time pairing of any communicator with a clinician tablet.
■Firmware updates to the communicator.
■Environments where multiple devices are using BLUETOOTH
wireless technology and thereby creating interference.
■Environments where BLUETOOTH wireless technology is
prohibited.
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Overview of the Communicator
Communicator icons on the tablet
status bar
Table 2 describes the icons that appear in the tablet status bar
(uppermost row on the tablet screen) indicating the status of the
connection between the communicator and the clinician tablet.
Table 2. Communicator icons in the tablet status bar.
Communicator IconDescription
The communicator is in the process of
connecting to the clinician tablet.
The communicator is communicating
with the clinician tablet via the USB
connector cable.
The communicator requires the USB
connector cable to communicate with the
clinician tablet.
The communicator is communicating
with the clinician tablet using
BLUETOOTH wireless technology.
Neurostimulator Workows
When an implantable neurostimulator (INS) is interrogated, the
clinician programmer app determines if the INS is new or if it has
been previously congured. Based on the status of the INS, the
clinician programmer app automatically presents the applicable
workow options.
■Start Usage > Implant Device workow – go to page 17.
Use when a new INS is being congured (programmed) for the
rst time.
■Followup workow – go to page 19.
Use at followup sessions with the patient.
■View MRI workow – go to page 20.
Use to determine MRI scan eligibility and prepare a patient's
neurostimulation system for an MRI scan.
Notes:
■To display on-screen help information, tap the Help button (
■The screens typically used during a programming session are
shown in the workow navigator. Additional screens not in the
current workow can be accessed from the Side Menu (
■Unsaved information may be lost if the application is improperly
terminated during a programming session. To end a session,
go to the Summary screen and tap the EXIT WORKFLOW
button. Ending a session generates a complete session record
that is stored in a database on the clinician tablet.
■Some functions, such as multiple groups and programs,
and AdaptiveStim, are not available with the Sequentia LT
neurostimulator.
).
).
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Neurostimulator Workows
Start Usage > Implant Device
workow
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, conrm that the
device information corresponds with the intended INS.
2. Tap START USAGE.
This action takes the neurostimulator out of shelf state and
sets the In Use Date/Implant Date elds to the current date.
■The In Use Date and Implant Date are the same date.
■The In Use Date is shown on the CURRENT DEVICE
STATUS screen, and the Implant Date is shown on the
About System screen.
■The About System screen is available after an implant
location is selected on the DEVICE screen.
■You can change the implant date on the About System
screen, but this change will not impact the clock inside
the neurostimulator that determines ERI and EOS.
3. Under IMPLANT DEVICE, tap START.
4. Use Table 3 to guide you through the screens and tasks in the
workow.
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Neurostimulator Workows
Table 3. Implant Device workow.
ScreenTasksMore information
DeviceCheck the battery status of the neurostimulator.Page 21
Select the implant location.Page 21
Patient InfoEnter patient information.Page 21
Pain MapTap 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 SelectSelect 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 LocationIndicate whether extensions and pocket adaptors are implanted. Indicate whether abandoned leads
remain implanted. Select the tip location for each lead.
Programs (and
subscreens)
Create programs in groups. Tap a group to make it active. A highlighted box around a group indicates
the group is active. Tap the plus sign to add a program within a group.
Program subscreen: Assign the electrode conguration for the lead(s). Assign pulse width, rate,
and amplitude.
Lead Manipulation subscreen: Use to represent the relative positioning of the implanted leads as
viewed from the patient’s back.
Energy subscreen: Set parameters for SoftStart/Stop and cycling. Estimate battery life based
on various congurations and hours per day of group use with the Estimated Battery Longevity
feature.
Patient Access subscreen: Assign the stimulation parameters that the patient can adjust.Page 31
ImpedanceMeasure 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).
SummaryConrm therapy settings.
End the session properly by tapping the EXIT WORKFLOW button.
Page 21
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Neurostimulator Workows
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