Medtronic A710 Programming Guide
Medtronic Neuromodulation Clinician
Programmer App
Intellis™ neurostimulation systems and wireless external
neurostimulation system for pain therapy
Includes information about the Model A902 Patient Data Service app
A710
2021-07-15 Programming guide (app version 2.0)
Rx only
Label symbols
Explanation of symbols on this manual.
Conformité Européenne (European Conformity). This symbol means that the device fully complies
with applicable European Directives.
REP
EC
Authorized Representative in the European Community
Manufacturer
For USA audiences only
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Medtronic and the Medtronic logo are trademarks of Medtronic. AdaptiveStim™, Intellis™,
SoftStart/Stop™, and SureScan™ are trademarks of a Medtronic company.
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.
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Table of contents
Device description 13
Installing app versions and information about data security 14
App version history 14
App version not backward compatible 14
Installing and updating the app 15
Data security 15
Abbreviations and terminology in this manual 16
Abbreviations 16
Terminology 16
Overview: Programmable settings 17
The clinician programmer app (finding and opening) 18
To find and open the app 18
Demo Mode 19
To start Demo Mode 19
To exit Demo Mode 19
Navigating the app 20
Navigating through a workflow 20
Buttons and indicators in the action bar 20
When the app is placed in the background 21
General warnings and cautions 22
MRI warning for trial stimulation 22
Warning and precautions related to programming and possible interactions between other active
implanted devices 22
MRI warning for scan eligibility 22
Warning for when explanting an existing neurostimulator or when replacing any implanted
component 23
Caution for telemetry signal disruption caused by EMI 23
Caution related to implant locations and AdaptiveStim™ Technology 23
ENS – Starting a session with a wireless external neurostimulator 24
Wireless ENS preparation 24
Clinician tablet preparation 25
Using programming components (external and nonsterile) in the sterile field 25
Indicator icons in tablet status bar for ENS and BLUETOOTH
Starting a session with a wireless ENS 25
To start a session with a wireless ENS 25
ENS workflows 27
New ENS: Start Evaluation workflow 27
New ENS: Implant Device workflow (can be used for intraoperative testing) 30
Configured ENS: Followup workflow 34
®
wireless technology 25
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Configured ENS: End Evaluation workflow 35
Configured ENS: Implant Device workflow 37
ENS – at the end of the trial evaluation period 40
Eligibility screen (neurostimulators to consider for implant) 40
Removing patient-identifying information before ENS disposal 40
To remove patient-identifying information from the ENS 40
INS – Starting a session with an implantable neurostimulator 41
Overview 41
Clinician tablet preparation 42
Communicator preparation 42
Check the battery level of the communicator before and regularly during the session 42
Before moving INS into the sterile field 43
USB connector cable – when to use 43
Installing updates to the communicator 43
Communicator icons in tablet status bar 43
Pairing the communicator with a clinician tablet and finding the INS 44
To pair the communicator with the clinician tablet, then find and interrogate the INS 44
BLUETOOTH
®
wireless technology between the clinician tablet and the communicator after
pairing 45
INS workflows 47
New INS: Implant Device workflow 47
Configured INS: Followup workflow 50
View MRI workflow 52
Battery level 53
Status of the battery level for the ENS 53
Status of the battery level for the rechargeable implantable neurostimulators 53
Lead Select screen 54
To select leads and associate with the device electrode numbers 54
To check connectivity 54
To delete leads from the device 54
Fluoro screen 55
To enter the fluoro screen 55
To take a photo of the fluoro image displayed on the monitor 55
To choose an existing fluoro image saved in the tablet 55
To annotate the fluoro image 55
To delete a fluoro image 55
Programs screen and subscreens 56
What is a program? 56
A programming session is real-time programming 56
Programs screen 57
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To add (create) a program 58
To move or copy an existing program 58
To access existing programs to go to the Program subscreen 58
To delete a program 58
To activate a group and turn stimulation on for all the programs in the group 58
Program subscreen 59
Setting the pulse width 60
To set the pulse width 60
Setting the device rate and a program rate 61
To set the device rate 61
To set a program rate 61
Assigning electrode polarity 62
To assign electrode polarity manually 62
To delete all assigned electrodes from a program 62
Setting the intensity 62
To set the intensity 63
Moving the electrode combination 63
To move the electrode combination 64
Using IntelliStim 64
To use IntelliStim 64
Using electrode redistribution (assigning percentage of intensity for individual electrodes) 66
To use electrode redistribution 66
Equalizing intensity across electrodes 67
To equalize a single program 67
To equalize all programs with unequal distribution 67
Lead Manipulation subscreen 68
Energy subscreen 68
SoftStart/Stop feature 68
To change SoftStart/Stop settings 68
Cycling 68
To turn Cycling on 69
Energy Usage (for rechargeable implantable neurostimulators) 69
To check energy 69
Patient Access subscreen 70
Cycling 70
To enable cycling control for the patient 70
Adjustment 70
To enable the patient to adjust intensity for all active programs together 70
Limits 70
To enable patient control and then set upper limit for the stimulation parameter when
adjusting with the controller 70
Review programs in the Programs screen and activate a group for the patient to use 71
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To review programs in the Programs screen 71
To activate a group for the patient to begin to use 71
AdaptiveStim™ Technology 72
Overview of AdaptiveStim™ Technology 72
Allow a healing period before configuring AdaptiveStim™ Technology 72
Stimulation parameter considerations for AdaptiveStim™ Technology 73
Intensity and AdaptiveStim™ Technology 73
Pulse width and AdaptiveStim™ Technology 73
Rate and AdaptiveStim™ Technology 73
Initial setup and testing of the settings for AdaptiveStim™ Technology in the clinic 74
AdaptiveStim screen 78
What you can do in the AdaptiveStim screen 79
Adjusting position intensities for individual positions 80
To adjust position intensities for individual positions 80
Reconfiguring AdaptiveStim™ Technology (if needed) 80
To reorient only 80
To completely reconfigure a group (reorient and reassign position intensities) 81
Troubleshooting the settings for AdaptiveStim™ Technology 81
Settings for Position Diary and Stability Time (in the Options tab) 82
Position Diary 82
To turn the Position Diary on or off 82
Stability Time 82
To set a stability time 83
Setting Angles 83
To adjust position angles 83
Setting Transitions 83
To adjust position transitions 84
Setting the Mobility Rate 84
To adjust the mobility rate 84
To turn off mobility detection 84
The Overview chart (to confirm assigned intensity values for position intensities) 85
To use the Overview chart 85
Impedance screen (for checking system integrity) 86
To measure all impedances and assess results 86
Troubleshooting using impedance measurements 87
Diaries screen 89
Viewing the patient's therapy usage for the trial evaluation period with the ENS 89
Stimulation Usage 89
Group Usage 89
Position Trend 89
Adjustments 90
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Composite 90
Resting Trend 90
Recharge 90
Reports screen 91
To view, download, or delete a report 91
Patient Data Service app 91
Auto-delete feature 92
About System screen 93
To view system component information 93
To view the number of days, hours, and minutes that the ENS has been in use 93
To change the date and time for the ENS or INS and change the INS implant date 93
Medtronic Data Report 94
To compile a Medtronic Data Report 94
Trademarks and licenses 94
To view trademarks and license information 94
MRI – Preparing the neurostimulation system for an MRI scan 95
To activate MRI Mode 95
To deactivate MRI Mode 97
Alerts 98
To view alerts 98
To view or restore dismissed alerts 98
Troubleshooting 99
Notifications (pop-up messages) 99
Communicator and tablet troubleshooting 99
Troubleshooting stimulation below programmed intensity (OOR) 101
Troubleshooting AdaptiveStim™ Technology 101
Using impedance measurements for troubleshooting 101
Elective Replacement Indicator (ERI) 102
Appendix A: Clinician instructions for the controller 103
Overview 103
Setting up the controller 103
To set up a new controller 103
To pair a controller with the ENS for trial 105
To pair a controller with the INS for implant 106
To use the controller in Clinician mode 106
Technician Mode 107
To access Technician Mode 107
To reuse a controller for a new trial 108
To pair the patient's controller with a replacement INS 109
To disable or re-enable the INS 109
Recharging the INS 110
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To recharge the INS 110
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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-specific
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 specifications,
product-specific warnings and precautions, and instructions for use.
! USA
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 specifications, instructions for use, and
maintenance information.
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Device description
The Medtronic Model A710 Intellis™ clinician programmer application (app) is intended for use by
clinicians in the programming of the following Medtronic neurostimulators (external and implantable) for
pain therapy:
▪ External:
– Model 97725 Wireless External Neurostimulator (ENS)
▪ Implantable:
– Intellis™ with AdaptiveStim™ Technology Model 97715 Implantable Neurostimulator (INS)
with SureScan™ MRI Technology
– Intellis™ Model 97716 Implantable Neurostimulator (INS) with SureScan™ MRI Technology
This manual contains information for clinicians in programming and troubleshooting the programmable
parameters for the above listed neurostimulators.
Model 97745 Controller instructions
This manual also contains clinician instructions for using the controller that is provided to the patient
either during the trial evaluation period with the ENS or at the time of the neurostimulation system
implant. For instructions on using the controller, refer to page 103.
Model 8880T2 Communicator
The Model 8880T2 Communicator is intended for use by clinicians to use in conjunction with the
clinician tablet and clinician programmer app for communication with Medtronic Neuromodulation
implantable therapy devices.
Refer to the Model 8880T2 Communicator Technical Manual for operating instructions and
specifications.
Model A901 Communication Manager App
The Model A901 Communication Manager app is intended to manage the telemetry communications for
the clinician tablet.
Model A902 Patient Data Service App
The Model A902 Patient Data Service app is intended for use by clinicians to access reports for all
patients whose Medtronic devices have been programmed using the clinician programmer apps on the
clinician tablet.
Refer to "Patient Data Service app" on page 91 for instructions on using the Patient Data Service app.
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Installing app versions and information about data security
App version history
Table 1 outlines the versions and features developed for the Intellis clinician programmer application.
Not all versions are compatible with all Intellis neurostimulator models. An app update may be required
to access new features. Contact Medtronic for additional information.
Table 1. App version history
Version Description
1.2 Initial market release
1.3 Addition of IntelliStim, Electrode Redistribution, and Equalize features
2.0 Caution UPDATE NOTICE (See "App version not backward compatible " for more
information.)
Available in limited geographies: Additional lead select list, which requires a compatible
physical Medtronic component. Refer to the compatible Medtronic component manual for
programming instructions for the Lead Select screen.
App version not backward compatible
At the start of a patient session, the app will assess the version that exists in the ENS or the INS and
may display the following caution update notice.
The caution update notice means that the patient's ENS or INS was last programmed with an older
version of the clinician programmer app.
Caution:
UPDATE NOTICE
Continuing with programming will make this neurostimulator unable to be programmed with
previous versions of the clinician programmer application. This action is not recommended for a
patient who receives programming in a different country because this updated clinician application
version may not be available in other countries. For specific geography information, contact
Medtronic.
Note: An update of the clinician programmer app to the ENS or INS does not affect the use of the
patient's Model 97745 Controller. The patient can still use the controller to adjust stimulation. If the
patient requires an MRI scan, the controller can be used at the MRI appointment to show MRI scan-type
eligibility and to place the INS into MRI mode.
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Installing and updating the app
For assistance with downloading, registering, or installing the app, 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 app and will not install updates without notifying the user. Network
connectivity is required for initial app registration and for installation of app updates and communicator
firmware updates. Network connectivity is not required for neurostimulator programming. Connect the
clinician tablet to the network periodically to check for update notifications. When notified that an update
is available, follow the instructions provided by Medtronic to install the update.
Data security
Data is protected by application-level encryption and encryption provided by the tablet. The app does
not provide data protection for data exported to another destination. Data exported from the app should
be handled in accordance with your organization's security policy for data handling and storage.
To protect your clinician programmer system, Medtronic recommends you implement the following
security measures:
▪ Use a managed, trusted Wi-Fi connection when network connectivity is needed.
▪ Consider securing your tablet by disabling network connectivity during any programming session.
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, and upgrading equipment; upgrading or installing software; or changing network
configurations could also introduce additional risks. Analyze, evaluate, and control any identified risks.
If you suspect a cybersecurity event has occurred, stop using the app (if possible) and contact your IT
department or Medtronic to document and respond to the suspected incident.
If your clinician tablet is lost or stolen, contact Medtronic. If you need to return the clinician tablet for
disposal or replacement, contact Medtronic. Instructions will be provided for preparing the clinician
tablet for return.
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Abbreviations and terminology in this manual
Abbreviations
Table 2. Abbreviations used in this manual
Abbreviation Definition
app Software application
Demo mode Demonstration mode
ENS External neurostimulator
ERI Elective replacement indicator
fluoro Fluoroscopy
INS Implantable neurostimulator
LED Light-emitting diode
MR Magnetic resonance
MRI Magnetic resonance imaging
OOR Out of regulation
USB connector cable Universal serial bus connector cable
Terminology
Table 3 provides a brief list of terms used in this programming guide.
Table 3. Terminology used in this manual
Term Description
action bar The top row containing buttons and indicators on the clinician programmer app
clinician programmer app The Medtronic therapy software application intended for clinicians in the
configuring
programming
tablet
clinician tablet
tablet status bar The uppermost row of indicators on the tablet screen. The tablet status bar is
screen when in a workflow.
configuring and programming of Medtronic devices.
These two terms are used interchangeably.
The tablet hardware and operating system.
not a part of the clinician programmer app.
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Overview: Programmable settings
Throughout a programming session, the clinician programmer app facilitates the retrieval of settings
from and transfer to the neurostimulator.
Programming the neurostimulator involves reviewing and modifying the information, settings, and
features programmed in the neurostimulator. Information and settings may be from an earlier session or
may be the default values set during manufacturing.
▪ Stimulation parameters
– Electrode polarities: Programmed positive (+), negative (–), or off.
– Intensity: Strength of a pulse, sum of all negative (–) electrodes measured in milliamps (mA).
– Pulse width: Duration of each pulse in microseconds (µs).
– Rate: Frequency of pulses in hertz (Hz).
▪ Programming features
– AdaptiveStim™ Technology: Adjusts stimulation automatically when the patient changes
position.
– Cycling: Cycles stimulation on and off at clinician-determined intervals.
– Patient Access: Sets which parameters can be adjusted by the patient and the parameter
upper limit.
– SoftStart/Stop: Slowly increases the intensity when the stimulation is turned on. If the Cycling
feature is enabled, the SoftStart/Stop feature will also slowly decrease the intensity when the
stimulation is turned off.
– Move: Sets program intensity to zero and allows the electrodes to be moved up, down, or
across the lead or leads.
– IntelliStim: A semiautomated feature for selecting electrodes to deliver therapy. IntelliStim is a
scanning process in which common combinations of electrodes are scanned along the lead
using the selected intensity.
– 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 reconfigures the active electrodes to provide
equal distribution of intensity.
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The clinician programmer app (finding and opening)
Note: In this manual, figures of the app screens are representative. What is displayed on the actual
screens may differ.
To find and open the app
1. Navigate to the Apps on the clinician tablet.
2. Find the Intellis app icon:
3. Tap the Intellis app icon to open.
Figure 1 shows the initial screen that displays.
Tap to access the About screen for the model number of the Intellis
clinician programmer app and other identifying information.
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Figure 1. The initial screen.
▪ Tap DEMO to use Demo mode.
▪ Tap CONNECT to start a session with an ENS or INS.
▪ Tap REPORTS to view reports for a patient without having to start a session.
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 are 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.
To start Demo Mode
1. From the initial screen, select DEMO.
2. Check that DEMO appears in orange on the action bar of the app.
One workflow at a time can be explored in a Demo session. Exiting the workflow in that Demo
session will return you to the initial screen where you can select DEMO again and select another
workflow to explore.
To exit Demo Mode
1. Go to the Summary screen of the workflow.
2. Tap the EXIT WORKFLOW button.
You will be returned to the initial screen from which you can select DEMO again and choose
another workflow.
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Navigating the app
Navigating through a workflow
Figure 2. The workflow navigator (example).
▪ The workflow navigator contains the screens for a programming session using the workflow that
you selected.
▪ A line is shown beneath the screen name that is displayed.
▪ To move from screen to screen, swipe left or right on the screen.
▪ Or alternatively, you can tap on the screen name in the workflow navigator to go directly to that
screen.
– If the workflow navigator extends beyond the width of the screen, swipe the workflow navigator
left or right to be able to tap on those screens that were clipped off.
▪ If input is required in a workflow screen, you will not be able to advance to the next screen in the
workflow until that input is entered.
– The app will prompt you for the input that is required.
Buttons and indicators in the action bar
The action bar appears at the top of all screens in all workflows. Figure 3 shows an example of what
can appear on an action bar. Table 4 describes the buttons and indicators that appear on the action bar.
Figure 3. The action bar (example).
Table 4. Buttons and indicators on the action bar
Button or indicator What it means or what it does
Side Menu button
• Tap to access auxiliary screens available outside of the workflow.
access those screens.)
(Or alternatively, you can swipe from the left edge of the tablet to
• You must be in a workflow for the Side Menu button to appear in the
action bar.
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Table 4. Buttons and indicators on the action bar (continued)
Button or indicator What it means or what it does
Demo mode indicator
• Appears in the action bar when in Demo mode.
Patient name and patient ID
• Indicates the patient associated with the device you are programming.
• This information is what is entered in the Patient Info screen.
AdaptiveStim™ indicator
• Appears in the action bar when AdaptiveStim™ Technology is on.
MRI Mode indicator
• Appears in the action bar when MRI Mode is activated.
• When MRI Mode is activated, stimulation is turned off.
Stimulation toggle
• Appears in the action bar when at least one program exists.
(Example toggle shows stimulation is
"Stimulation Not Setup".)
• Tap to turn stimulation on or off.
on)
• Green indicates that stimulation is on.
Help button
• The Help button appears in the action bar for screens that have a help
screen.
• Tap the Help button to display the help 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, where you can exit the
workflow to properly end the session.
Back button
• The action bar on screens that are accessed by the Side Menu will
contain a back arrow button.
• This action bar button performs the same action as the CLOSE button
on the screen -- it closes the current screen and returns you to the
workflow screen that you were previously viewing.
(When no programs exist, the area in the action bar will read,
When the app is placed in the background
When you navigate away from the clinician programmer app while in a session, the app is placed in the
background and is represented as a floating widget on the tablet.
The floating widget is an overlay that floats on top of the screen to remind you that you are still in a
session.
▪ Press and drag the floating widget to move it on the tablet screen.
▪ Tap on the floating widget to access the app and resume the session.
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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.
Warning and precautions related to programming and
possible interactions between other active implanted
devices
Refer to the Information for Prescribers booklet for warnings and precautions related to programming
and possible interactions between the neurostimulator and other active implanted devices (such as
cardiac devices).
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-specific warnings
and cautions for conducting an MRI scan.
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Warning for when explanting an existing neurostimulator or when replacing any implanted component
Warning: Before explanting and replacing an existing neurostimulator, print a report from the
existing neurostimulator that shows implanted and any abandoned component information. When
adding, changing, or removing neurostimulators, leads, extensions, and accessories, always
program up-to-date component model numbers, implant locations, and any abandoned component
information to re-establish MRI-scan eligibility.
If this information is not updated or is entered incorrectly, MRI scan-type 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.
Caution for telemetry signal disruption caused by EMI
Caution: Electromagnetic interference (EMI) can disrupt programming and telemetry
communication. If EMI interference is suspected, such as from radio frequency identification (RFID)
equipment, move away from the likely source of EMI and try again.
Caution related to implant locations and AdaptiveStim™ Technology
Caution: The use of AdaptiveStim™ Technology associated with position changes in the cervical
location has not been shown to be safe and effective. The use of AdaptiveStim™ Technology
associated with position changes for locations outside of the thoracic or lumbar spine may result in
unintended stimulation.
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ENS – Starting a session with a wireless external neurostimulator
Clinician tablet with
clinician programmer app
BLUETOOTH
The clinician tablet must remain within 3 meters
(10 feet) of the ENS.
Figure 4. Components for programming the ENS.
Wireless external neurostimulator
(wireless ENS)
®
Wireless ENS preparation
▪ Refer to the wireless ENS user manual for the following instructions:
– Connecting the leads to the wireless ENS.
– Changing the batteries in the wireless ENS.
ENS button
▪ Check the battery level of the wireless ENS using the clinician programmer app:
– Start a session with the wireless ENS. Refer to page 25.
– 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 workflow 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.
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Clinician tablet preparation
Check the battery level of the tablet:
▪ The tablet's battery level is shown on the tablet status bar (uppermost row of indicators on the
tablet).
▪ Recharge the tablet if the battery level is low.
Note: Do not leave the clinician tablet unattended during an active programming session. End the
session properly by navigating to the Summary screen and tapping the EXIT WORKFLOW button.
Using programming components (external and nonsterile) in the sterile field
Warning: To use the programming components (external and nonsterile) in a sterile field, 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.
Indicator icons in tablet status bar for ENS and
BLUETOOTH
®
wireless technology
Table 5 shows the icons that appear in the clinician tablet status bar (uppermost row) indicating the
status of ENS communication with the clinician programmer app.
Table 5. ENS icons in tablet status bar
Icon that appears on
tablet status bar
What it means
The clinician programmer app is in process of finding ENS devices in the vicinity.
The clinician programmer app is in 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
To start a session with a wireless ENS
1. Press and hold the ENS button on the wireless ENS for approximately 1 second.
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▪ When the ENS button is pressed, the light-emitting diode (LED) on the ENS turns on (either
solid or flashing), 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 LED on the ENS will repeatedly flash for 90 seconds while the ENS is able to pair with the
clinician tablet
2. From the initial screen of the app, tap CONNECT.
3. Tap EXTERNAL for the device type.
4. 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.
▪ If more than one ENS is in the vicinity or used for the trial evaluation, 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.
5. Select the serial number of the ENS you intend to configure and tap CONNECT.
6. If configuring a new ENS, confirm the serial number of the ENS on the pop-up message. Tap
CONTINUE SESSION.
Or
If starting a follow-up session with an ENS, confirm the patient name and serial number of the ENS
on the pop-up message. Tap CONTINUE SESSION.
The resulting screen and workflow options to choose from will depend on whether the ENS is new
or already configured.
Note: If no programs were created in a previous programming session, the workflow options for a
new ENS will display. Once a program is created, the workflow options for a configured ENS will
display.
7. Go to "ENS workflows" on page 27 for information to proceed with configuring and programming
the ENS.
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ENS workflows
When the ENS is found and interrogated, the clinician programmer app determines if the ENS is new
(never been configured) or if it has been configured. Based on this, the clinician programmer app
automatically presents workflow options accordingly.
Intraoperative testing is primarily used to identify optimal lead position. The ENS may be set up prior to
use without being removed from the packaging.
Table 6 explains the ENS workflow options.
Table 6. ENS workflow options
ENS workflows When to use Go to
New ENS workflow
options
Start Evaluation
• Use at the start of the trial evaluation period, when the leads will be
implanted and a new ENS will be connected.
page 27
• Use prior to the lead implant procedure, when the ENS is still in its
packaging.
Implant Device
• Use when a new ENS is being used for intraoperative testing at the time
of INS implant.
page 30
• Use when the INS is still in its packaging.
– This workflow contains the Switch Device screen, which transfers
the information from the configured ENS to the new INS.
– The communicator is required for this workflow.
Configured ENS
workflow options
Followup
• Use at follow-up sessions with the patient during the trial evaluation
period.
page 34
• Use when a new ENS has already been configured.
End Evaluation
• Use at the last followup session with the patient at the end of the trial
evaluation period.
page 35
– This workflow contains the Eligibility screen, which lists the
implantable neurostimulators that allow the same parameters as the
programs that are currently active in the ENS.
Implant Device
• Use when a configured ENS is being used for intraoperative testing at
time of INS implant.
page 37
• Use when the INS is still in its packaging.
– This workflow contains the Switch Device screen, which transfers
the information from the configured ENS to the new INS.
– The communicator is required for this workflow.
New ENS: Start Evaluation workflow
1. After the ENS is found and interrogated, the CURRENT DEVICE STATUS screen will display.
a. Confirm that the patient and device information on the screen corresponds with the intended
patient.
b. Tap START USAGE.
A710 2021-07-15 English 27
c. Tap OK in the pop-up box to confirm that you want to start usage.
If you proceed from here, you start the beginning date for the trial evaluation period. The beginning
date is used for the "IN USE" information in the Device tab on the About System screen for the
ENS.
d. Tap START EVALUATION > START.
2. You are now in the New ENS: Start Evaluation workflow, which contains the following screens:
Device
Summary
3. Use Table 7 to guide you through the screens and typical tasks in the workflow.
When more detailed information is available in this manual, a page reference to that information is
provided.
Screen Tasks For more
1. Device
Patient Info Pain Map Lead Select Tip Location Programs Impedance
Table 7. New ENS: Start Evaluation workflow
• Confirm the information on the screen.
• Check the status of the ENS battery level. If the battery level is low,
replace the batteries.
details, if any
"Battery level"
on page 53.
• (Optional) Enter a DEVICE NAME and tap UPDATE.
• Swipe left to go to the next screen in the workflow.
2. Patient Info
• Enter patient-identifying information.
– First name: 20 characters
– Last name: 20 characters
– Patient ID: 10 characters
"Removing patient-identifying
Red asterisks indicate required fields.
information be-
Character limits:
fore ENS disposal" on
page 40.
– Notes: 250 characters
• Tap UPDATE and swipe left to go to the next screen in the workflow.
3. Pain Map
• Select the PAINT tool and tap the area on the human figure to
highlight where the patient feels pain.
—
• Use the ERASE tool to remove highlighting.
• Tap the ROTATE button to rotate the human figure from front to back
and from back to front.
• Tap UPDATE and swipe left to go to the next screen in the workflow.
4. Lead Select
• Select a lead from the scrollable drop-down lists.
• Press the selected lead, then drag and drop it at the appropriate
electrode numbers.
"Lead Select
screen" on
page 54.
• Tap UPDATE.
• Tap the CHECK CONNECTIVITY button.
– All green electrodes (with checkmarks) indicate that the lead or
extension contacts have a good connection to the ENS contacts.
– Red electrodes (with an "X") indicate a bad connection:
a. Gently reposition the lead or extension contacts in the
grooves in the ENS for a better connection to the ENS
contacts.
b. Tap the CHECK CONNECTIVITY button again.
• Swipe left to go to the next screen in the workflow.
28 English A710 2021-07-15
Table 7. New ENS: Start Evaluation workflow (continued)
Screen Tasks For more
5. Tip Location
• Select the tip location from the scrollable drop-down list for each lead.
• Tap the VIEW FLUORO button to open the fluoro screen.
details, if any
"Fluoro screen"
on page 55.
From the fluoro screen, you can take photos of the fluoro, import
existing fluoro photos, annotate the fluoro images, and delete fluoro
images.
6. Programs
(and subscreens)
• Create programs in groups.
• Set the pulse width.
• Set the device rate and, if desired, a program rate.
• Assign electrode polarity manually or use IntelliStim.
"Programs
screen and
subscreens" on
page 56.
• Tap the Stimulation toggle to turn stimulation on. Green indicates
that stimulation is on.
• Set the program intensity.
• Other features for configuring the electrodes:
– Move feature (sets intensity to zero and allows movement of the
electrodes up, down, or across the lead or leads).
– Electrode redistribution feature (refines program intensity for
individual electrodes).
– Equalize feature (equalizes program intensity across electrodes).
• Other subscreens (tabs) available from the Program subscreen:
– Lead Manipulation (to position the leads to represent the relative
positioning of the implanted leads as viewed from the patient's
back).
– Energy (to set parameters for cycling and the SoftStart/Stop
feature, if desired, and to check the estimated recharge interval
based on configured programs).
– Patient Access (to allow patient control using the controller for
cycling and for adjusting stimulation parameters, and then to set
upper limits for those parameters).
• Return to the Programs screen, tap the desired group to make it
active. Tap again to turn stimulation on for all the programs in the
group.
• Swipe left to go to the next screen in the workflow.
7. Impedance
(for checking
system integrity)
• Tap the MEASURE ALL IMPEDANCES button.
• A Start Measurement pop-up box will appear. Tap the START
button.
• Assess the results based on the information provided on the screen
(GOOD, AVOID, DO NOT USE).
"Impedance
screen (for
checking system integrity)"
on page 86.
• If electrode configuration adjustments are needed, return to the
Programs screen to make adjustments according to the results from
the impedance measurement.
• On the Impedance screen, take another impedance measurement
and then return to the Programs screen to make adjustments if
needed.
• Remain on the Programs screen for the next step.
A710 2021-07-15 English 29
button.
details, if any
"Programs
screen and
subscreens" on
page 56.
Table 7. New ENS: Start Evaluation workflow (continued)
Screen Tasks For more
8. Programs
(and subscreens)
• Decrease intensity to zero (0) in all the programs:
– Tap an existing program from a group on the Programs screen.
– In the Program subscreen using the Intensity control, tap the
Intensity to zero
– Tap CLOSE on the Intensity control.
– Repeat for all other configured programs on the Program
subscreen for that group.
– After decreasing intensity to zero for all the programs in the group,
tap CLOSE on the Program subscreen to return to the Programs
screen.
– If programs exist in other groups, repeat these steps to decrease
intensity to zero for all other programs.
• Turn off stimulation using the toggle on the action bar.
• Tap Summary on the workflow navigator to go to the Summary
screen.
9. Summary
• Check the Status area of the screen to confirm that the therapy
settings shown are what is intended for the patient.
Stimulation should be off, and the "Active Program Intensity" should
be 0.0 mA.
• Check the status of the ENS battery level. If the battery level is low,
replace the batteries.
• End the session properly by tapping the EXIT WORKFLOW button.
Ending a session generates a complete session report.
The following are the available screens outside of the workflow.
To access, tap the Side Menu
edge of the tablet.
Diaries
Reports
Eligibility
About System
• New ENS – no data exists yet for the diaries.
• Select a report to view, share, download, or delete.
• This screen lists the implantable neurostimulators that allow the same
• View model numbers, firmware numbers, version numbers, etc, for
• From the Device tab, update the ENS date and time if needed.
button in the upper left of the screen or swipe right from the left
parameters as the programs that are currently active in the ENS used
for the trial evaluation.
system components (device, tablet, controller).
"Diaries screen"
on page 89.
"Reports
screen" on
page 91.
"Eligibility
screen (neurostimulators to
consider for implant)" on
page 40.
"About System
screen" on
page 93.
—
New ENS: Implant Device workflow (can be used for intraoperative testing)
1. After the ENS is found and interrogated, the CURRENT DEVICE STATUS screen will display.
30 English A710 2021-07-15
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