Abbot 3874 User Manual
NeuroSphere™ Virtual Clinic
Supplement
for Clinician Programmer
For Spinal Cord Stimulation Systems
Model 3874
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.
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-party trademark, which is property of its respective owner.
ompanies.
Contents
About This Manual ........................................................................................................... 1
Prescription and Safety Information ................................................................................... 1
Precautions ................................................................................................................................... 2
Overview of Remote Care Feature ...................................................................................... 3
Getting Started .................................................................................................................. 4
Downloading the Clinician Programmer App with NeuroSphere™ Virtual Clinic .............................. 4
Navigating the Home Screen ......................................................................................................... 5
Connecting the Clinician Programmer to a Generator ..................................................................... 6
Registering the Clinician Programmer for Remote Programming .................................................... 7
Enabling the Generator for Remote Programming ........................................................................ 10
Logging In the Clinician Programmer for Remote Session ............................................................. 11
Preparing for a Remote Session ................................................................................................... 13
Starting a Remote Session ........................................................................................................... 14
Programming in a Remote Session .................................................................................. 15
Navigating the Remote Session Screens ...................................................................................... 15
Switching Between Standard and Full Screen Views .................................................................... 18
Monitoring Network Connection Status ........................................................................................ 21
Adjusting and Managing Patient Therapy ..................................................................................... 22
Managing the Protected Recovery Program ................................................................................. 25
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Ending a Remote Session ............................................................................................................ 29
Logging Out of Remote Session ................................................................................................... 29
Restoring Program Due to Interruptions ....................................................................................... 30
Cybersecurity .................................................................................................................. 31
Privacy ........................................................................................................................... 32
Troubleshooting .............................................................................................................. 32
Troubleshooting Chart ................................................................................................................. 32
Enabling Device Settings ............................................................................................................. 40
Technical Support .......................................................................................................... 41
Appendix A: Optional Accessory Guidelines ..................................................................... 41
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About This Manual
This manual explains how to set up and use NeuroSphere™ Virtual Clinic (also known as the Remote
Care feature) in the St. Jude Medical™ Clinician Programmer application (app) (Model 3874) with
Abbott Medical neurostimulation systems. For information about using the clinician programmer app
with the neurostimulation system, refer to your clinician programmer app manual.
NOTE: This manual is a supplement to your clinician programmer app manual. Refer to the
"clinician programmer app manual" as directed for additional information, features, and
programming instructions.
Prescription and Safety Information
Read this section for precautions related to the Remote Care feature.
NOTE: Refer to your clinician programmer app manual to get additional prescription information
for the clinician programmer app. Refer to the clinician's manual for the appropriate
neurostimulation system to get prescription information, including indications for use and
contraindications. For specific instructions, warnings, precautions, and adverse effects about other
system components, see the clinician's manual for those components.
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Precautions
Remote Care patient selection. Select patients appropriately for neurostimulation. The patient should
be able to use the patient controller and correctly interpret the icons and messages that appear on the
screen.
Consider the following additional factors when selecting patients for remote programming:
Patient's cognitive and physical capabilities in performing technical activities to connect their
devices to the internet and troubleshoot any connection issues.
Level of available support from a caregiver.
Remote Care procedure selection. Assess the patient and the planned procedure to determine if an
in-office or remote session is more appropriate.
Alternate communication method. To ensure patient comfort and safety, you should have an alternate
means of contacting the patient available when engaging in a remote session. After an interrupted
session, you should contact the patient to ensure that the patient controller shows the expected therapy
settings, and then do any troubleshooting necessary to restore the remote connection.
Communication loss. If communication is lost between you and the patient during a remote session,
the system will apply the protected recovery program. A change in stimulation may result in effects
including unintended stimulation and coordination loss. To minimize discomfort, contact the patient to
ensure that the patient controller is connected to the generator and confirm the program settings.
Programmer device heating. Clinician programmer device heating during a remote session could lead
to superficial tissue irritation. If you encounter this issue, you may minimize discomfort by ensuring your
clinician programmer is used with an accessory. For considerations, refer to the optional accessory
guidelines appendix.
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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 mode for the patient's implantable
pulse generator (IPG) to establish communication between your clinician programmer and the patient’s
generator.
For patients with the Remote Care feature activated, you will be able to:
1. Log into the secure Remote Care system from your clinician programmer.
2. Securely connect to the patient via the patient’s connected patient controller after the patient has
enabled a remote session.
3. Assess your patient via audio and video feedback between the patient controller and your clinician
programmer.
4. Make therapy adjustments, manage programs, and view settings on the IPG.
5. Complete a patient programming session, end the remote connection and generate a final report
of the session.
During a remote session, you cannot enable the following features:
MRI Mode
Surgery Mode
Programming external pulse generator (EPG)
Lead type and configuration
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Getting Started
This section contains information about the clinician programmer app with Virtual Clinic and
instructions for pairing and connecting the clinician programmer to a patient's generator in-office or
remotely.
Downloading the Clinician Programmer App with NeuroSphere™ Virtual Clinic
NOTE: The clinician programmer app with Virtual Clinic is compatible with the Apple‡ iPad‡
mobile digital device provided by Abbott Medical. The patient controller app is compatible with an
Apple iOS‡ mobile digital device (either a device provided by Abbott Medical or a compatible
personal Apple iOS device).
To download the clinician programmer app with Virtual Clinic, follow the same download instructions
provided in your clinician programmer app manual.
After installation completes, the clinician programmer app with Virtual Clinic icon
appears on the clinician programmer Home screen.
NOTE: If managing patients enrolled for remote programming, always use the clinician
programmer app with Virtual Clinic.
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automatically
Navigating the Home Screen
When you launch the clinician programmer app with Virtual Clinic , the clinician programmer app
Home screen appears. From this screen, you can access the following areas:
Tap Generators to locate a generator for programming.
Tap Patient Records to open the patient records screen.
Tap Demonstration Mode to open a software demonstration. Demonstration Mode provides
representative functionality for the clinician programmer app, including creating programs and
adjusting parameter limits within available combinations.
Tap to open the Information popover where you can view clinician and programmer information
(including the clinician programmer app model number and software version).
NOTE: The first time you launch the clinician programmer app, the Legal Notices popover opens
along with a prompt requesting you to allow Bluetooth
Tap OK to allow the app to communicate with the generator. If not accepted, you can
later return to the clinician programmer Home screen, tap Settings > Bluetooth and
enable access.
Read and accept the legal notices to use the app. To view the legal notices again, tap
Legal Notices in the Information popover.
NOTE: The clinician programmer app times out after 30 minutes of inactivity; however, if you
navigate away from the app (such as press the clinician programmer Home button), the app times
out after 3 minutes of inactivity. During a remote session, do not navigate away from the app.
®
wireless communication access.
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Connecting the Clinician Programmer to a Generator
The clinician programmer app with Virtual Clinic allows you to manage a patient’s therapy either
in-office or remotely when the patient is outside your office. When you tap Generators on the clinician
programmer app Home screen, the Select Generator popover opens with the In-Office tab selected.
In-Office − Set up communication between the clinician programmer or patient controller and the
generator when the patient is in the medical office. Refer to your clinician programmer app
manual for the pairing instructions.
Remote − Set up remote communication with the patient’s generator. For instructions, see the
following sections.
- "Registering the Clinician Programmer for Remote Programming" (page 7)
- "Enabling the Generator for Remote Programming" (page 10)
- "Logging In the Clinician Programmer for Remote Session" (page 11)
Figure 1. Select Generators popover with Remote tab selected
1. In-Office tab
2. Remote tab
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NOTE: The first time you tap the Remote tab, prompts display requesting access to the camera
and microphone on your device. Tap
communication in the remote sessions. If not accepted, you can later return to the clinician
programmer Home screen, tap
Microphone and enable access.
OK on both messages to allow video and audio
Settings > Privacy > Camera and enable access. Then tap
Registering the Clinician Programmer for Remote Programming
Each clinician programmer must be registered for remote programming before you can set up remote
connections with patients enrolled for remote programming. All users must register to create an
account.
NOTE: If you have not registered, the Register screen displays when you tap Remote on the Select
Generator popover.
To register the clinician programmer for remote programming:
1. Tap Generators on the clinician programmer app Home screen.
2. On the Select Generator popover, tap Remote, and then tap Register.
The Register screen opens.
NOTE: The first time you tap the Register tab, a prompt displays requesting you to allow
notifications. Tap
receive the code, but later can return to the clinician programmer Home screen, tap
Notifications. Then tap the clinician programmer app icon, and tap Allow Notifications to enable
access.
Allow to receive a verification code when requested. Otherwise, you will not
Settings >
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Figure 2. Registering clinician programmer for remote programming
1. Select Generator popover
2. Remote tab
3. Register button
4. Register device screen
3. Tap the Email box and enter the email address you want to use for your Remote Care account.
4. Tap the Password box and enter a unique password you want to use for remote sessions. Then,
tap the Retype Password box and enter the password again.
For password guidelines, see "Cybersecurity" (page 31).
5. Tap Enroll.
When the registration process finishes, the Secure Connection popover opens.
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6. When a message displays with the verification code, enter the code in the Enter Code box and tap
Continue.
If you did not receive the verification code, tap Resend Code and repeat this step.
NOTE: If you did not accept the prompt to allow notifications, the verification code will not display.
You can enable notifications, return to this app and request a verification code again. To enable
the notifications: Return to the clinician programmer Home screen, tap
Tap the clinician programmer app icon, and then tap
Allow Notifications to enable access.
Settings > Notifications.
NOTES:
When the "Connection Secure" message displays, the clinician programmer is registered and
you are logged in for remote programming.
If no generators are found, the Select Generator popover opens displaying the "No Supported
Generators Found" message. Be sure the clinician programmer is connected to the internet.
If the clinician programmer has never established a remote connection with a patient's
generator, you must enable the generator for remote programming. For instructions, see
"Enabling the Generator for Remote Programming" (page 10).
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Enabling the Generator for Remote Programming
To set up remote programming for a patient, you must enable Remote Care service for the patient's
generator in the Abbott Medical Remote Care system. You can enable Remote Care service for the
patient's generator by connecting the clinician programmer to the generator using Bluetooth
technology.
NOTE: Your patient must enable the Remote Care feature in the patient controller app before you
can connect remotely to the patient’s generator.
To enable the generator for remote programming:
1. If you are not already logged in, see "Logging In the Clinician Programmer for Remote Session"
(page 11) for instructions
2. On the Select Generator popover, tap the In-Office tab, and then select the patient’s generator.
The "Connecting to Generator…" message displays while the clinician programmer is connecting
to the generator. When connected, the Program screen opens.
3. Tap at the top of the Program screen to view the generator details.
The Remote Care Mode button displays whether the patient’s generator is enabled for the remote
session.
4. If the Remote Care Mode toggle button is not enabled, tap it.
5. Tap outside the popover with the generator details. Tap Done and then End Session to exit.
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wireless
Logging In the Clinician Programmer for Remote Session
To log in for a remote session:
1. Tap Generators on the clinician programmer app Home screen.
2. On the Select Generator popover, tap the Remote tab, and then tap Login.
The Remote Login screen opens.
Figure 3. Logging in for a Remote Session
1. Select Generator popover
2. Remote tab
3. Login button
4. Remote Login screen
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