Abbott NeuroSphere User Manual

NeuroSphere™ Virtual Clinic

Supplement

for Patient Controller

For Deep Brain Stimulation Systems For Dorsal Root Ganglion Neurostimulation Systems For Spinal Cord Stimulation Systems Model 3875

CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.

™ Indicates a trademark of the Abbott group of companies.

‡ Indicates a third

Bluetooth and Bluetooth logo are registered trademarks of Bluetooth SIG, Inc.

Pat.

http://www.abbott.com/patents

-party trademark, which is property of its respective owner.

Contents

About This Guide ...................................................... 1

Prescription and Safety Information .......................... 2

Precautions ......................................................... 2

Overview of Remote Care Feature ............................. 4

Getting Started ......................................................... 5

Connecting to Your Generator .............................. 6

Overview of the Therapy Screen .......................... 9

Using the Remote Care Feature .............................. 10

Preparing for a Remote Session ......................... 11

Starting the Remote Session .............................. 13

Navigating in the Remote Session ...................... 18

Restoring Program Due to Interruptions ............. 20

Cybersecurity ......................................................... 21

Privacy ................................................................... 21

Troubleshooting ...................................................... 22

Troubleshooting Messages for Remote Care

Feature ........................................................... 22

Enabling Device Settings ................................... 30

Technical Support .................................................. 32

Appendix A: Downloading the Patient Controller

App with NeuroSphere™ Virtual Clinic ................. 32

Appendix B: Pairing the Patient Controller to the

Generator ............................................................ 35

Unpairing the Bluetooth® Wireless Connection ... 35

Pairing the Bluetooth® Wireless Connection ....... 35

Appendix C: Optional Accessory Guidelines ............ 37

About This Guide

This guide explains how to use NeuroSphere™ Virtual Clinic (also known as the Remote Care feature) in the St. Jude Medical™ Patient Controller application (Model 3875) with your neurostimulation system.

The patient controller app supports remote programming on all Abbott Medical neurostimulation therapy platforms: deep brain stimulation (DBS), spinal cord stimulation (SCS), and dorsal root ganglion (DRG). For information about using the patient controller app with your neurostimulation system, refer to your patient controller app user’s guide.

NOTE: This guide is a supplement to your patient controller user’s guide. Refer to the "patient controller app user’s guide" as directed for additional information, features, and instructions to use the app.

Prescription and Safety Information

Read this section for precautions related to the Remote Care feature.

NOTE: Refer to your patient controller app user’s guide to get additional prescription information, including indications for use, contraindications, warnings, precautions, and adverse effects for the patient controller app and the neurostimulation system.

Precautions

Patient technical capacity. This system relies on the ability of the clinician and patient to connect their devices to the internet and troubleshoot any connection issues. Before approval for any remote sessions, your clinician should evaluate your capabilities to perform these technical activities without assistance.

Caregiver or assistant. If instructed by your clinician, have a caregiver or assistant available during remote sessions to render aid if unexpected side effects occur or to assist in managing your patient controller during the session.

Communication loss. If communication is lost between you and the clinician during a remote session, the system will restore your therapy to saved settings. A change in stimulation may result in effects including unintended stimulation (DBS, SCS, DRG) and coordination loss (SCS, DRG). To minimize discomfort, ensure your patient controller is connected to the generator and immediately contact your clinician to confirm your program settings.

Patient controller device heating. Patient controller device heating during a remote session could lead to superficial tissue irritation. If you encounter this issue, you may minimize discomfort by ensuring your patient controller is used with an accessory. For considerations, refer to the optional accessory guidelines appendix.

Overview of Remote Care Feature

The Remote Care feature requires the patient controller to be registered in the AirWatch‡ mobile device management service. In addition, you must enable the Remote Care feature to establish communication between your patient controller and generator to the clinician’s programmer.

The Remote Care feature allows you to:

1. Enable the clinician to connect to your patient

controller at the scheduled time.

2. Wait for the clinician to connect securely to your

patient controller.

3. Start the session and communicate with the

clinician while your therapy settings are adjusted.

During a remote session, you cannot enable:

 MRI Mode  Surgery Mode

Getting Started

Before you begin, be sure you are familiar with how to perform basic operational functions on your patient controller.

This section provides instructions about getting the patient controller ready for remote sessions.

 If you do not have the patient controller app with

Virtual Clinic downloaded, see "Appendix A" (page

32) for download instructions. NOTE: Once you use the patient controller

app with Virtual Clinic, you should not use the patient controller app available in the Apple‡ App Store.

 If you need to pair your patient controller and

generator, see "Appendix B" (page 35) for instructions.

NOTE: If your generator was previously paired with the patient controller app downloaded from the Apple App Store, you must remove that pairing and then pair your generator for use with the patient controller app with Virtual Clinic. For instructions, see "Appendix B" (page 35).

 To avoid interruption while adjusting your therapy,

Abbott Medical recommends enabling the Do Not Disturb mode on your patient controller prior to connecting to your generator. Refer to the user guide available at support.apple.com/manuals for the Apple‡ iOS‡ device you are using to run the patient controller app.

Connecting to Your Generator

To start the patient controller app with Virtual Clinic and connect to your generator:

1. Tap the patient controller app with Virtual Clinic icon on the patient controller Home screen to launch the app. While your app starts up, you will see the Start-up screen.

Figure 1. Start-up screen

NOTES:

 The first time you launch the patient

controller app, a message displays

requesting Bluetooth connection access. Tap

wireless

OK to allow the

app to communicate with the generator.

If not accepted, you can later return to the patient controller Home screen, tap Settings > Bluetooth and enable access.

 In some cases, use of Bluetooth®

wireless media devices (such as headphones or speakers) may prevent the patient controller from connecting to your generator. Abbott Medical recommends disconnecting these accessories before you attempt to adjust your therapy or start a remote session.

After your app starts up, the Generators selection screen displays.

Figure 2. Generators selection screen*

* The generator icon in this screen is a representation. The actual screen displays an icon of the implanted generator.

2. If the "No Generators Found" message displays, see "Appendix B: Pairing the Patient Controller to the Generator" (page 35) for instructions.

3. Select your generator. If you have multiple generators, select the generator you want to use for the remote session.

After selecting your generator, the patient controller app connects with the generator.

NOTE: The patient controller app times out after 3 minutes of inactivity.

Overview of the Therapy Screen

After the patient controller app connects with the generator, the Therapy screen displays with the Remote Care feature.

Figure 3. Therapy screen with Remote Care feature*

Displays whether Remote Care feature is on or off. Tap to display the Remote Care screen and then allow your clinician to modify your therapy remotely. See "Using the Remote Care Feature" (page 10).

* This screen is a representation; information varies depending on the therapy.

For more information about the Therapy screen descriptions, refer to your patient controller app user's guide.

Using the Remote Care Feature

You may be scheduled for remote sessions, which allow your clinician to connect securely to your patient controller and modify your therapy remotely as though you were in the medical office. This section provides information and instructions about what you need to do for a remote session.

NOTES:

 The Remote Care feature must be

enabled by your clinician.

 Only the features in this section are

available during remote sessions. When the remote session ends, you can resume using other patient controller features.

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