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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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

Medtronic A71300 Programming Guide

Specifications and Main Features

Frequently Asked Questions

User Manual

Table of Contents

Description of the Programming System

Model A71300 Stimulation Trialing Clinician Programmer Application

Intended purpose

Other components of the programming system

Programmable Settings

Stimulation parameters

Groups and programs

Optional features

Data Security and Network Connectivity

Data security

Installing application updates

Network connectivity

Returning the clinician tablet

General Warnings and Cautions

MRI warning for trial stimulation

EMI caution for telemetry signal disruption

Cautions related to clinician programming and possible interactions with other devices

Setting up the Programming System

Preparing the clinician tablet

Finding and opening the app

Wireless ENS preparation

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

Starting a session with a wireless ENS

Overview of the Clinician Programmer App

Using Demo mode

Using the Side Menu