VNS Therapy SENTIVA M3000 Programmer, SENTIVA M2000 Wand, SENTIVA VNS Therapy System Technical Manual

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Technical Guide

Table of Contents

PRODUCT OVERVIEW

VNS Therapy System Components and Support Materials

SENTIVA SYSTEM MANAGEMENT

Getting Started In Oce Programming

Manual Programming Tachycardia Detection/ Prone Position/Low Heart Rate Detection Guided Programming Scheduled Programming Day/Night Programming Therapy Protocols Viewing Device Data Session Reports Export Full Programmer Copy Trend Data Timestamp Data

Functions of the Magnet End of Service Device Diagnostics In the Operating Room

Preoperative System Checks Programming & Diagnostics

GENERAL DOSING GUIDELINES

SenTiva Dosing Guidelines

MRI

SenTiva MRI Guidelines

9 22 23 24 30 33 35 37 39 39 40 41 42 45 45 46 50 50 51

TROUBLESHOOTING

Screen Freeze Wand Connection or Communication Issues Patient Cannot Feel Stimulation Patient Cannot Feel Magnet Stimulation Patient Does Not Perceive AutoStim Activation High/Low Lead Impedance and Low Output Current Issues Generator Battery Issues Heartbeat Detection Issues Tachycardia Detection Issues

66 67 71 72 73 74 77 79 80

INDICATIONS FOR USE

The VNS Therapy Programming System supports the delivery of personalized Vagus Nerve Stimulation (VNS) Therapy for drug-resistant epilepsy (DRE).

This guide contains information on the use of the VNS Therapy® Programming System with the Model 3000 Programmer and Model 2000 Programming Wand. Please refer to the VNS Therapy® Programming System Physician’s Manual for additional important prescribing and safety information.

Indication for Use

The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in patients 4 years of age and older with partial onset seizures that are refractory to antiepileptic medications.

This overview is not intended to be a substitute for the VNS Therapy Physician’s Manual.

Please note that not all products shown in this Technical Guide are cleared for sale in all markets. Please check with your local representative to see what is available in your area.

CONTACT INFORMATION

General inqiuries (for questions about LivaNova, LivaNova products, warranties, etc. or to request a call from company representative) http://www.livanova. com/contact-us/

24-hour Technical Support (for technical questions with programmer, generator, or wand)

• 1 (866) 882-8804 (US and Canada)

• 1 (281) 228-7330 (Worldwide)

• 32 2 790 27 73 (Europe/EMMEA)

Mailing Address

LivaNova USA, Inc (formerly Cyberonics, Inc.) 100 Cyberonics Boulevard Houston, TX 77058 USA

LivaNova Belgium NV Ikaroslaan 83 B-1931 Zavantem, BELGIUM

Product Overview

INTRODUCTION TO VNS THERAPY

The VNS Therapy® System supports the delivery of personalized Vagus Nerve Stimulation (VNS) Therapy for drug-resistant epilepsy (DRE).

The VNS Therapy® System includes four parts:

• Generator and lead

• Programmer (tablet and software)

• Wand

• Magnet

Vagus Nerve

VNS Therapy

Generator

VNS Therapy

Lead

Pager Style

Magnet

Watch Style

Magnet

Programmer

Programming

Wand

Generator and Lead

The implanted portion of the VNS Therapy® System consists of the generator and a lead. The generator delivers electrical signals, or pulses, to the vagus nerve via the lead.

VNS Therapy

Lead

Vagus Nerve

VNS Therapy

Generator

Programmer (M3000)

The external portion of the VNS Therapy® System consists of a programmer (a computer tablet with VNS Therapy® programmer software pre-installed) and a wand (M2000). The programmer and the wand connect wirelessly. This training module is developed for the M3000 programmer and M2000 wand. The programmer and wand are required for use.

The programmer and wand work together to:

• Interrogate (communicate with the generator) in order to adjust therapy parameters for the generator

• Assess whether the generator and lead are functioning as expected

• View device histories

• Export session reports

Programmer

Programming

Wand

Wand (M2000)

The wand is designed to communicate wirelessly with the programmer (M3000) at distances up to 3 meters (10 feet) under most conditions. If communication is unstable, use the supplied USB cable to connect the wand and the programmer instead.

Hold the wand no more than 1 inch away from the generator in order to maintain good communication.

The wand operates on two AA lithium or alkaline batteries.

Programmer

Programming

Wand

Programmer

Charger

Wand

USB Cable

Magnet

The VNS Therapy® System has a patient controlled feature that can be activated with a specially designed magnet.

The magnet can be used to:

• Attempt to reduce the intensity of or abort an oncoming seizure or seizure in progress

• Temporarily inhibit stimulation

• Verify the generator is providing stimulation

• Reset the generator (in combination with the programmer and wand)

The magnet is available in two styles.

Pager Style

Magnet

Watch Style

Magnet

Product Compatibility

There are di erent VNS Therapy® generator models, including the new SenTiva® generator.

The VNS Therapy® Programmer, Model 3000, and Wand, Model 2000, allow you to interrogate and program the following VNS Therapy® generators:

• Model 102 Pulse™

• Model 102R Pulse Duo™

• Model 103 Demipulse®

• Model 104 Demipulse Duo®

• Model 105 ApsireHC®

• Model 106 AspireSR®

• Model 1000 SenTiva®

Please see the following chart to determine the generator’s compatibility

with other VNS Therapy® components.

The table below details the compatibility for all components

of the VNS Therapy®system

Programming

Lead

Tunneler

Wand

(Programmer)

Accessory

Pack

Patient

Essentials Kit

300* 302† 303† 304† 402 502 220201

102† Pulse

102R† Pulse

Duo

103† Demipulse

104† Demipulse

Duo

105† AspireHC

106† AspireSR

1000† SenTiva

* No longer distributed † Not for sale in all markets

     

2000

(M250)

(M3000)

       

      

VNS Therapy® Modes

The VNS Therapy® System can function in three dierent modes:

NORMAL MODE

In Normal Mode, the generator initiates intervals of stimulation at preset ON and OFF times throughout the day. Speciﬁc stimulation parameters are set by the healthcare provider.

MAGNET MODE

Magnet Mode is an on-demand stimulation that attempts to abort or de-intensify an oncoming seizure or a seizure in progress. The patient or caregiver initiates Magnet Mode by passing a VNS magnet over the implanted generator.

AUTOSTIM MODE

Automatic stimulation, or AutoStim, is an optional feature in some generator models. AutoStim delivers stimulation when the generator detects a rapid relative heart rate increase (≥20%) that may be associated with a seizure. This feature works in conjunction with Normal Mode and can be inhibited using the VNS magnet.

SenTiva System Management

GETTING STARTED

To get started, collect all the components of the VNS Therapy® System: a) Touch-screen programmer preloaded with VNS Therapy®

programmer software

b) Wireless wand (Model 2000) with two AA lithium or alkaline batteries c) Programmer charger d) Type A-C USB cable (used to connect to charger to charge the programmer) e) Type C USB cable (option to connect programmer to wand) f) Type A-C USB drive (used to import/export protocols and export

session reports)

Before Using the Programming System in a Patient Session

1. Charge the programmer

2. Turn the programmer ON

3. Check the programmer battery: Check the battery status on the

BATTERY INDICATOR at the top right corner of the programmer screen

4. Check the wand batteries: Conﬁrm that the wand batteries are not low

5. Change the date and time if necessary. Accurate patient and device history

stored in the programmer depend on correct date and time settings

6. Connect the wand to the programmer

7. Interrogate the generator (check communication between the programmer

and the generator)

Charge the Programmer

Charge the programmer before use so that there is adequate battery power during a patient session.

To charge the programmer:

1. Connect the adapter cord to the programmer and to the AC adapter

2. Plug the AC adapter into an outlet

A fully discharged battery may take four to ﬁve hours to charge.

Programmer Adapter Cord AC Adapter Outlet

Turn the Programmer ON/OFF

Charge the programmer before use so that there is adequate battery power during a patient session.

To turn programmer ON: Press and hold the POWER button for 3 seconds and then release. You will then see an on-screen logo, and the VNS software will start.

To turn programmer OFF: Press and hold the POWER button for 3 seconds and then release. Follow the on-screen instructions to shut down the programmer.

- After 10 minutes of inactivity, the screen will automatically turn o

- To manually turn the screen o: Quickly press and release the POWER button. Use this method when you want to preserve battery, but not shut down the Programmer

NOTE:

The POWER button may not respond if the programmer is still shutting down. Wait for 30 seconds after a shutdown to restart the programmer.

Navigation

There are two main screens on the programmer. Each of these screens acts as a launching point for other functions.

Main Screen – the ﬁrst screen you see after turning on the programmer, when the programmer is still OUT OF SESSION (programmer is not yet communicating with a generator)

Summary Screen – the ﬁrst screen you see once you are IN SESSION (programmer is communicating with a generator)

OUT OF SESSION VS. IN SESSION

Available functions change based on whether the programmer is out of session or in session.

• OUT OF SESSION (programmer is not communicating with a generator)

• IN SESSION (programmer is communicating with a generator)

Quick Access Bar – From any software screen, tap the VNS Therapy® logo on the title bar (black bar at the top of the screen) to access programmer settings and system information.

This drop-down menu shows the following:

• Programmer date and time (OUT OF SESSION only)

• Wand connection status

• Programmer battery level

• Sliders to adjust the system volume and display brightness

• Programmer software version

• Wand software version and generator ﬁrmware (IN SESSION only)

Navigation Bar – From any software screen, tap the icons at the bottom of the screen to access additional features

Patient ID Bar – If the blue patient ID Bar is showing on the screen, the programmer is IN SESSION. To end the session, tap on the

END SESSION button at the left of the Patient ID Bar

Quick Access Bar

Patient ID Bar

Main Screen (Out of Session) Summary Screen (In Session)

Navigation Bar

Check the Programmer Battery

Before using the programmer with a patient, conﬁ rm that the battery is fully charged.

To check the battery:

Look at the BATTERY INDICATOR in the top right corner of every screen

Battery Indicator

Check the Wand Batteries

1. To turn wand ON: Press and release the POWER button

• If the battery is OK, green arcs around the power button will light up to indicate that the wand has power

- Two green arcs indicate that the wand is available for connection with the programmer

- Four green arcs indicate that the wand is connected to the programmer

• If the battery is low, the Low Battery Indicator will light up. If this happens, replace the batteries before using the device

• If only the Low Battery Indicator lights up (no green arcs), no communication will be possible until you replace the batteries

2. To replace batteries: If batteries are low, remove the battery compartment cover on the back of the wand and replace the batteries with two new AA lithium ion or alkaline batteries

Turn Wand Power On

Low Battery Indicator

Battery OK Indicator

Low Battery Power/

No Communication

Push and slide to open battery compartment

Wand Battery

Replacement

NOTE:

When illuminated, the ﬂashing white icon at the top of the screen indicates that there is communication with the generator.

Change Date and Time

Accurate patient and device history stored in the programmer depends on correct date and time settings. Before using the programmer with a patient, verify that the time and date on the programmer are correct. This will ensure that the session is properly time-stamped.

1. Navigate to the Date & Time screen:

• OPTION 1: From the Main Screen, tap the VNS Therapy® logo on the title bar (black bar at the top of the screen)

• OPTION 2: From the Main Screen, select SETTINGS from the bottom navigation bar

• On the Settings Screen, tap the EDIT button at the top of the page near the time

2. To change time: Tap the current display time and scroll up or down

3. To change date: Use LEFT or RIGHT ARROW to adjust the calendar,

and then tap the desired date

Title Bar

Navigation Bar

Main Screen

Tap and scroll to change time

Use left and right arrows to change month

Tap the desired date

NOTE:

You must adjust the programmer manually for time zones or Daylight Savings Time.

Connect the Wand to the Programmer

The programmer and the wand can be connected wirelessly or with a backup USB cable.

WIRELESS CONNECTION

To set up wireless connection:

1. Turn on the programmer

2. Turn on the wand. Look for two green lights on the wand, indicating that

power is on and the wand is ready to connect

3. From the Main Screen on the programmer, tap on SETTINGS in the Navigation Bar at the bottom of the screen

4. From the Settings Screen on the programmer, tap on WAND SETTINGS >

PREFERRED WAND

5. Tap on the preferred wand serial number (found on the back of the wand) to enable the preferred wand or to change wands

6. Tap on BACK (upper left) to return to the Main Screen

7. Look for two green arcs on the wand to indicate the wand is available for connection with the programmer. Once availablity is established, four green arcs on the wand to indicate that the programmer and the wand are connected. The green lights will stay on for 10 minutes when the programmer and wand are connected. When they are not connected, the green lights will go o after 2 minutes

Main Screen

NOTE: Wireless

“Preferred” connection - recommended for wands and programmers that are always used together. Provides a quicker connection when interrogating a patient’s generator because the programmer automatically looks for the preferred wand. “Choose a wand” connection recommended if there are several interchangeable programming systems in your area. When interrogating a patient’s generator, the programmer searches for all available wands in range.

SHORTCUT

You can set up a wireless connection automatically by starting the interrogation. The programmer will prompt you to save the preferred wand information as part of the workﬂ ow.

WIRED CONNECTION

Use the supplied USB cable to connect the wand to the programmer.

To set up wired connection:

1. Connect the programmer to the wand using the USB cable

2. Tap INTERROGATE on the programmer. The programmer will automatically

connect to the preferred wand and display the wand’s information on the screen, indicating that the programmer and the wand are connected

3. Look for four green lights on the wand to indicate that the programmer and the wand are connected. The green lights will stay on for 10 minutes when the programmer and wand are connected. When they are not connected, the green lights will go o after 2 minutes

Interrogate the Generator

You must interrogate the generator before performing other functions, such as changing parameters or performing diagnostic tests.

To interrogate the generator:

1. Turn on the programmer

2. Turn on the wand. Look for two green lights on the wand, indicating that

power is on and the wand is ready to connect

3. On the Main Screen, tap INTERROGATE

4. Preferred wand: If you have set up a preferred wand, the programmer

will automatically connect to the preferred wand and display the wand’s information on the screen, indicating that the programmer and the wand are connected

5. No preferred wand: If you have not set up a preferred wand, the programmer will show all powered-on wands in range. Select the serial number for the wand you intend to use. The programmer will connect to that wand and display the wand’s information on the screen, indicating that the programmer and wand are connected

6. Place the wand over the generator

7. If the interrogation is working, a generator icon will ﬂ ash on the

wand screen

NOTE:

When the ADVANCED INTERROGATION box on the Main Screen is checked, the programmer will download detailed data from the generator for the previous 180 days during interrogation. These data will be displayed in the Events and Trends tab which is accessible from the Navigation Bar.

For rapid interrogation, uncheck the ADVANCED INTERROGATION box.



NOTE:

Check box only appears if the programmer does not have a preferred wand. If a preferred wand is selected, the programmer will search and automatically connect to the preferred wand.

After a successful interrogation, the Summary Screen will display. From this screen, you can perform the following functions:

•

View generator ID information, including model number and serial number

•

View and edit patient data, such as patient ID and implant date

•

View last known diagnostics data, such as lead impedance and battery status

•

Change settings to generator parameters, such as Normal, Magnet, AutoStim, or Detection settings

•

Perform Diagnostics

•

View events and trends such as magnet activations and daily average AutoStims

•

Access device history, including parameter settings associated with prior o ce visits

•

Interrogate the generator again to verify parameters or refresh data

•

End programming session

•

Access other software options

Current Programmer date and time

Wand connection and Programmer battery status

Ends current session

Generator and patient information

Interrogate generator

Last known diagnostics measurements

View stimulation events

Current parameters

Navigation bar to additional software features

Shortcut buttons

6 7

10 10

IN OFFICE PROGRAMMING

The SenTiva® (M1000) VNS Therapy System oers a number of new features that help simplify and customize patient care.

The generator’s output current for the programmed stimulation in all modes must be 0 mA for the ﬁrst 14 days after implantation.

Manual Programming



Manually adjust parameters

Prone Position/Low Heart Rate Detection



Monitor the patient for episodes of low heart rate and prone body position after an AutoStim or magnet activation

Guided Programming



Simpliﬁes programming with option of Standard or Custom Therapy Protocols

Scheduled Programming



Automatically change parameter steps according to a preset schedule

Day/Night Programming



Delivers two independent sets of therapy parameter schedules at dierent times during a 24-hour period

NOTE:

The programmer must be IN SESSION to access these features.

NOTE:

At the end of each oce visit, the generator must be interrogated by tapping the INTERROGATE button followed by tapping the END SESSION button to ensure creation and accuracy of the session reports.

Manual Programming

Use Manual Programming to adjust stimulation and/or detection parameters individually.

To manually program parameters:

1. From the Summary Screen, tap on the EDIT PARAMETERS button, or tap on PARAMETERS in the Navigation Bar at the bottom of the screen

2. On the Parameters screen, select the Stimulation or Detection Tab. Follow the on-screen prompts to make change to parameters

3. Tap APPLY CHANGES to program your changes

NOTE:

• After Implant: Set output current to 0 mA, slowly increase by 0.25 mA increments until patient feels stimulation at a comfortable level

• Replacement Generators: Set output current at 0 mA, slowly increase by 0.25 mA to previous therapy level to allow patient time to re-adjust

NOTE:

At the end of each o ce visit, the generator must be interrogated by tapping the INTERROGATE button followed by tapping the END SESSION button to ensure creation and accuracy of the session reports.

Edit Parameters

Parameters

Stimulation Tab

Detection Tab

Tachycardia Detection

You may enable or disable Detection. If Detection is Disabled, then the model 1000 generators use only Normal and Magnet stimulation. If Detection is Enabled, then parameters for AutoStim will become available, in addition to Normal and Magnet parameters.

When you enable Detection for the ﬁrst time, the software will prompt you to set the Heartbeat Detection setting and AutoStim Threshold. These settings work together to ensure the generator is accurately detecting the patient’s heartbeats, and set the criterion for AutoStim delivery based on changes in heart rate, respectively. Once Detection is enabled, you can adjust the settings from the Detection tab as needed.

In order for the generator to accurately detect heartbeats, the heartbeat detection must be set for the individual patient. Manually select from a range of heartbeat detection sensitivity values: 1 (least sensitive; for use with largest amplitude ECG signals) to 5 (most sensitive; for use with smallest amplitude ECG signals). The setting will not change unless manually programmed to a dierent value.

When Detection is enabled, the software will walk you through heartbeat detection setting veriﬁcation and AutoStim Threshold selection.

To Verify Heartbeat Detection:

1. Select VERIFY on the Detection Tab to conﬁrm the accuracy of the heart

rate detected by the generator or to change the Heartbeat Detection setting

2. Place the Wand over the generator and press START to begin the test. Keep the Wand over the generator during the entire Verify Heartbeat Detection process. The generator will transmit a signal and the Programmer will display the detected heart rate in beats per minute (BPM) for up to two minutes

Wait for the heart rate display to stabilize (at least 10 seconds) and compare

3. the generator-detected heart rate displayed on the Programmer with an independent source (such as BPM from another ECG monitor or a manual pulse count). Accurate detection should be within ±5 BPM or 10%. If the heart rate reported by the Programmer is too high, then the Heartbeat Detection setting should be adjusted downward (toward setting 1). If the heart rate reported by the Programmer is too low or displays “?? BPM”, then the Heartbeat Detection setting should be adjusted upward (toward setting 5). Refer to “Troubleshooting” in the Physician’s Manual for more information If the heartbeat detection is veriﬁed before the two minute test completes,

keep the Wand over the generator and select STOP on the screen. Once you observe accurate heartbeat detection, you have completed the veriﬁcation process. If you are enabling Detection, select NEXT to set the AutoStim Threshold. Otherwise, select DONE to return to the Parameter Screen

CAUTION:

For generators capable of heartbeat detection, if AutoStim or Magnet stimulation is programmed on, the Verify Heartbeat Detection feature may be interrupted if AutoStim or Magnet stimulation is activated during the Verify Heartbeat Detection process. In this case, “?? BPM” will display on the screen. If “?? BPM” displays, LivaNova recommends you temporarily disable all output currents for generators capable of heartbeat detection (i.e. program to 0 mA) and retry the heartbeat veriﬁcation. After the calibration process is completed, you may reprogram the output currents as appropriate.

To set the AutoStim Threshold:

The AutoStim Threshold is a setting on the Detection Tab that can be set from 20% to 70% (in 10% increments). This setting allows you to determine the minimum heart rate change required for AutoStim, and should be tailored to the individual patient. For the most sensitive detection and the smallest heart rate change for stimulation, choose 20%. For the least sensitive detection and thus the largest heart rate change for stimulation, choose 70%.

NOTE:

Additional guidance for how to program this patient-speciﬁc setting can be found in the VNS Therapy System Physician’s Manual.

Prone Position/Low Heart Rate Detection

To receive extra patient-speciﬁ c information, you can conﬁ gure the model 1000 generator to log low heart rate episodes and/or the occurrence of prone position when these events occur within 7.5 minutes of an AutoStim or Magnet Mode activation.

To enable Prone Position/Low Heart Rate Detection:

1. From the Summary Screen, tap on the EDIT PARAMETERS button, or tap on

PARAMETERS in the Navigation Bar at the bottom of the screen to go to

the Parameters Screen

2. On the Parameters Screen, tap on the DETECTION tab:

• Tap the LOW HEARTRATE THRESHOLD ﬁ eld and select a threshold from

the pop up menu (range 30-60 BPM)

• APPLY CHANGES

• Turn on Prone Position Detection. The programmer will prompt you to

calibrate the generator orientation within the body

NOTE:

Tachyardia Detection must be enabled before this feature can be enabled/programmed.

NOTE:

At the end of each o ce visit, the generator must be interrogated by tapping the INTERROGATE button followed by tapping the END SESSION button to ensure creation and accuracy of the session reports.

Low Heart Rate Threshold

Prone Position Toggle

To complete the Prone Position Detection setup:

1. Instruct the patient to sit or stand upright as straight as possible. Place the

wand over the generator and press NEXT on the programmer screen

2. Instruct the patient to lie down ﬂ at on their back in the supine position.

Place the wand over the generator and press NEXT on the programmer screen

3. Look for the on-screen conﬁ rmation that Prone Position Detection is

now enabled

CAUTION:

Low heart rate and prone position events are for informational purposes only. Detected events are not to be used for alarms or medical diagnosis.

Guided Programming

Use the Guided Programming feature to adjust parameters to the next step of a standard or custom protocol. This feature simpliﬁ es programming by allowing you to increase or decrease parameters with a single button. You can exit Guided Programming at any time to adjust the parameters manually.

In Guided Programming mode, the SenTiva M1000 generator will:

• Keep the current mode, protocol, and step in memory

• Increase or decrease parameters to the next protocol step in response to a single button

NOTE:

Guided Programming mode is unavailable if Day/Night programming is enabled.

To enable Guided Programming:

1. From the Summary Screen, tap on the EDIT PARAMETERS button, or tap on

PARAMETERS in the Navigation Bar at the bottom of the screen

2. On the Parameters Screen, tap on SWITCH TO GUIDED MODE button

at top of screen

3. On the Switch to Guided Mode Screen, select STANDARD PROTOCOL.

There is also an option of selecting a custom protocol

4. On the Parameters Screen - Guided Mode View, follow the on-screen

prompts to make selections. Tap APPLY CHANGES before leaving each screen

To review current therapy protocol steps:

In Guided Mode view, tap on the OVERVIEW button on the right side of the screen

Overview

To change parameters in Guided Programming:

1. Select INCREASE STEP to increase parameters to the next protocol step.

Tap APPLY CHANGES to save

2. Select DECREASE STEP to change the parameters to the previous

protocol step. Tap APPLY CHANGES to save

3. To exit Guided Programming, press EXIT GUIDED

Decrease Step Increase Step

Standard Protocol Steps

Standard Protocol Persistent Parameter Settings

For information on creating Custom Protocols, see page 37

NOTE:

Guided Programming mode is unavailable if Day/Night programming is enabled. In the Standard Therapy Protocol, maximum target for output current for Normal Mode is 1.750mA. Increases above that target must be done manually.

NOTE:

At the end of each o ce visit, the generator must be interrogated by tapping the INTERROGATE button followed by tapping the END

SESSION button to ensure creation and accuracy of the session reports.

Scheduled Programming

The generator must already be in Guided Mode before Scheduled Programming can be used. Use Scheduled Programming to automatically change parameter steps according to a preset schedule. Scheduled programming may be useful to patients who live far from their healthcare provider.

To enable Guided Programming:

1. From the Summary Screen, tap on the EDIT PARAMETERS button, or tap on

PARAMETERS in the Navigation Bar at the bottom of the screen

2. On the Parameters Screen, tap on SWITCH TO GUIDED MODE button at

top of screen

3. On the Switch to Guided Mode Screen, select either STANDARD or CUSTOM

protocol and tap NEXT

4. Tap APPLY CHANGES to enable Guided Mode

To turn on Scheduled Programming:

1. In Guided Mode View, tap the SCHEDULED-APPLY button

2. On the Scheduled-Apply Screen, tap on ENABLE NOW at the center

of the screen

3. On the next Scheduled-Apply screen, select the time interval between step

increases, then tap GENERATE SCHEDULE at the center of the screen. Once a schedule has been generated you can follow the on-screen prompts to make adjustments to the schedule

4. Tap APPLY CHANGES to program your changes

NOTE:

At the end of each o ce visit, the generator must be interrogated by tapping the INTERROGATE button followed by tapping the END SESSION button to ensure creation and accuracy of the session reports.

Scheduled Apply

NOTE:

If the patient resides in a di erent time zone or plans to travel, program the schedule based on the patient’s local time zone to ensure therapy changes occur at the intended times.

NOTE:

Protocols that utilize 0.25mA increases such as the Standard Protocol require a minimum of 14 days between scheduled automatic titration steps. Custom protocols that utilize 0.125mA increases require a 7-day minimum interval between scheduled titration steps.

To exit Scheduled Programming, select EXIT GUIDED.

Day/Night Programming

Use Day/Night Programming to deliver two independent therapy parameter schedules at di erent times during a 24-hour period. In Day/Night Programming mode, the SenTiva M1000 will:

• Deliver therapy according to two independent sets of parameters

• Deliver each therapy protocol at a speciﬁ ed time during a 24-hour period

To enable Day/Night Programming:

1. Conﬁ rm that the programmer date and time are correct

2. Tap on the EDIT PARAMETERS button, or tap on PARAMETERS in the

Navigation Bar at the bottom of the screen

3. On the Parameters Screen, select ENABLE DAY/NIGHT.

When asked “Do you want to create a Day/Night program,” tap YES

4. On the Nighttime Tab, follow the on-screen prompts to make selections for

active start and end times

5. On the Daytime Tab, the remaining hours from the 24-hour cycle are

automatically shown as the daytime active period. Customize stimulation parameters as desired

6. On the DETECTION TAB, set AutoStim thresholds for both day and night.

Tap APPLY CHANGES

7. On the Apply Changes Screen, review the changes made and then tap

CONFIRM

NOTE:

Day/Night Programming is only available in Manual mode and is not available in Guided Programming mode. Guided Programming mode is unavailable if Day/Night Programming is enabled. Day/Night Programming can be disabled at any time.

NOTE:

Time zone changes and Daylight Savings time changes must be programmed manually. The programmer does not automatically adjust for time changes.

Day AutoStim Threshold

Night AutoStim Threshold

NOTE:

After programming, the patient will experience 15 minutes of the alternate parameter set. Assess for tolerability during this time.

NOTE:

At the end of each o ce visit, the generator must be interrogated by tapping the INTERROGATE button followed by tapping the END SESSION button to ensure creation and accuracy of the session reports.

Therapy Protocols

You can access, create, and manage therapy protocols from the Main Screen prior to interrogation. This allows you to deﬁ ne the mode, output current, and parameter settings before you begin working with a patient.

To access therapy protocols:

1. From the Main Screen, tap on the SETTINGS button in the

Navigation Bar at the bottom of the screen

2. Tap on the GUIDED MODE OPTIONS button

3. From the Guided Mode Options screen, tap on

THERAPY PROTOCOLS button

To create a custom protocol:

1. From the Therapy Protocols screen, select CREATE PROTOCOL

2. From the Create Protocol - Select a Starting Point screen, select

START FROM SCRATCH or choose an existing protocol as base

3. Add or delete steps (maximum of 7) and set the output currents for

each therapy mode. When you are ﬁ nished, tap NEXT

4. Choose the custom persistent parameters that will be used in all

protocol steps. When you are ﬁ nished, tap NEXT

5. Follow on-screen prompts to name the custom protocol.

When you are ﬁ nished, tap SAVE

6. From the Therapy Protocols Screen, use the BACK arrow to

return to the Main Screen

Tap to delete steps

Viewing Device Data

Use the History tab to review historical information about the patient’s experience with the device. You can:

• View Summary Data

• Review Magnet Activation Counts and Timestamps

• Review Inhibited Stimulation Timestamps

• Run Daily and Hourly Histograms

NOTE:

At the end of each o ce visit, the generator must be interrogated by tapping the INTERROGATE Button followed by tapping the END SESSION button to ensure creation and accuracy of the session reports.

View History Data

Summary data are stored in several diﬀ erent locations:

1. To view current parameter settings:

After interrogation, parameter settings can be viewed on the Summary Screen

Events

Current parameters

Events

History

2. To view a history of parameters that have been used with this

patient over time:

From the Summary Screen, tap on the HISTORY button to access these data

3. To create a session report:

Select VIEW SESSION REPORTS. Select the date and time of desired report

View and Export Session Reports

To view all session reports saved on the Programmer, select REPORTS on the navigation bar from the Main Screen. Use the search ﬁ eld and drop down menus to ﬁ lter the reports by Date and Time, generator model, or Patient ID. Tap any session report to view.

This feature also allows you to export individual session reports to a USB drive.

To create an electronic copy (.pdf ):

1. Insert external media into the Programmer USB drive (type C)

2. View the session report of interest

3. Press EXPORT, and follow on-screen instructions

To transfer data between Programmers, select IMPORT/EXPORT on the Navigation Bar from the Main Screen. This may be used to consolidate patient data between multiple computers, or to copy a custom therapy protocol from one Programmer to another.

To export a full Programmer copy do the following:

1. Insert external media into the Programmer USB drive (type C)

2. Select EXPORT DATA, and follow on-screen instructions

To import data to a new Programmer do the following:

1. Insert the external media containing the copied data into the “new”

Programmer USB drive

2. Select IMPORT DATA

3. Choose the database copy that will be merged with the existing

Programmer database

View Events & Trends Data

To view a summary of the therapy that was delivered between o ce visits:

From the Summary Screen, tap on the

EVENTS button at the bottom of the screen

to access these data.

View Last Timestamps

Review Magnet Stimulation Counts and Timestamps

To view Magnet Stimulation counts and timestamps:

1. From the Summary Screen, tap on the EVENTS button at the bottom

of the screen

2. Tap on the EVENTS tab

3. Tap on VIEW LAST TIMESTAMPS button. The button reﬂ ects the total

number of timestamps recorded. The maximum number of timestamps shown are the most recent 50 for the M1000 generator

Review Inhibited Stimulation Timestamps

From the same screen where you can view the Magnet Stimulation timestamp information, you can also view the history of Magnet Inhibitions.

At the top are Magnet Stimulation timestamps and below are Magnet Inhibition timestamps.

In each case, you can select the “date” header to select the time intervals to view.

Stimulations

Inhibitions

NOTE:

Ensure ADVANCED INTERROGATION is selected on the Main Screen in order to view Events and Trends after generator interrogation.

Review Daily or Hourly Histograms of Trend Data

You can view histograms of trend data that may include:

• Tachycardia detections (without stimulation)

• AutoStim stimulations

• Magnet mode stimulations

• Prone position (model 1000 only)

• Low heart rate (model 1000 only)

NOTE:

The data download is only required for M1000 if the user wants to view speciﬁ c timestamps.

To view a histogram of trend data:

1. From the Summary Screen, tap on the EVENTS button in the Navigation Bar

at the bottom of the screen, and then select the TRENDS tab

2. To download timestamp information from the generator, place the wand

over the generator and tap the DOWNLOAD DATA button

3. Check the colored boxes to select the event types you want to include in

your histogram

4. Tap on the button displaying the date to adjust the timeframes

5. Tap on EVENTS PER DAY to show one month of detection data in a

day-by-day format

6. Tap on EVENTS PER HOUR to show detection data in an hour-by-hour

format. Choose the timeframe and event types you want to display

Events

NOTE:

To view more details, tap on the individual bars in the histogram.

FUNCTIONS OF THE MAGNET

On-demand Stimulation

• Programming is typically 0.25 mA more than Normal Mode output current.

• Apply or pass the magnet (with label-side of magnet facing chest) over

device for no more than 2 sec.

Inhibition

• Secure the magnet in place for > 65 secs with label-side of magnet facing

chest. When removed, stimulation will resume after one full o cycle has elapsed.

Resetting

• The magnet is necessary to perform a reset with a programming wand if

necessary. See the VNS Therapy Physician’s Manual.

• It is recommended, except in cases of a medical emergency, that the

physician consult a LivaNova technical representative before a reset is performed.

Daily Assessment of Generator Function

• Patients are instructed to swipe the magnet over the generator daily to

ensure that the device is working, particularly if they do not feel it or have no voice change. The higher output current for the daily test enables the patient to more readily detect the sensation caused by the stimulation.

Evaluating Magnet Mode Stimulation

• The Magnet Mode Diagnostics can be used to assess deliverability of the

magnet mode output current and the success of the initiation.

• The device retains detailed information on only the 50 most recent

activations but keeps count of all successful activations.

How to Replace the LivaNova Magnets

To order a new magnet, patients should contact their doctor. Doctors can contact LivaNova at 1.866.332.1375 to order additional magnets for patients.

END OF SERVICE

Device longevity is dependent on stimulation parameters, impedance, duration of implant, and battery voltage. Higher stimulation parameters as well as higher duty cycles aect the longevity of the device, making the projection shorter. Additional information can be found in the VNS Therapy Physician’s Manual.

DEVICE DIAGNOSTICS

Several Diagnostics tests are available in the programming software to assess functionality of the implanted system. You may access them after a completed interrogation by selecting DIAGNOSTICS, or PERFORM DIAGNOSTICS on the Summary Screen.

Depending on the model of generator interrogated, you may have access to dierent types of tests. Typical tests include System Diagnostics, Normal Mode Diagnostics, Magnet Diagnostics, and AutoStim Diagnostics. Make sure to follow all the instructions on the Programmer screen, as they vary for each selection.

It is important to note that the tests described in this section are designed for assessing system functionality using the implanted components. Another test, Generator Diagnostics, is designed speciﬁcally for use with a test resistor and should only be accessed for troubleshooting scenarios during implantation surgery. Please see “Troubleshooting” for more details on accessing Generator Diagnostics.

The various test parameters and their values/meanings across the dierent diagnostics tests are summarized in the following table.

Diagnostic/Parameter Result Summary

Lead Impedance

Description: Indicates measured or estimated impedance when delivering the

output current during testing and whether it’s within normal range.

Values/Results: Measured lead impedance value (ohms) and overall status of OK, LOW, or HIGH

What Does the Value or Result Mean?: OK: Impedance is within acceptable operating range.

No special attention is required. LOW: Impedance is lower than expected and it may be indicative of a short circuit condition or a defective generator. See “Troubleshooting” for additional instructions. HIGH: Impedance is higher than expected and the generator may not be able to deliver the programmed therapy. See “Troubleshooting” for additional instructions.

Generator Battery

Description: Indicates battery status of the generator using

one of the following:

• OK

• Intensiﬁed Follow-up Indicator (IFI)

• Near End of Service (N EOS)

• End of Service (EOS)

Values/Results: OK, IFI, N EOS, EOS

What Does the Value or Result Mean?: OK: Battery level is within normal operating range and no special attention

is required. IFI: The battery has depleted to a level where more frequent clinical monitoring is recommended.

N EOS: The Generator should be replaced as soon as possible. EOS: The generator is no longer supplying stimulation and immediate

replacement is recommended. If the generator is not replaced, it will eventually lose the ability to communicate with the software.

Output Current/Current Delivered

Description: Indicates the stimulation output current delivered during the

Diagnostics test, and the test status based on the programmed settings

Values/Results: Output current value (mA) and overall status of OK or LOW

What Does the Value or Result Mean?:

Value indicates the stimulation output delivered during the diagnostic test.

OK: Current is being delivered at the programmed level. LOW: Programmed current is possibly not being delivered at the speciﬁed level.

CAUTION:

Battery depletion can occur between oce visits. Therefore, LivaNova recommends that epilepsy patients with magnet activation enabled should perform a daily magnet activation to check stimulation. If stimulation is not felt, instruct the patient to consult with the physician to perform diagnostics testing.

All previously completed Diagnostics tests are listed in the history table on the Diagnostics screen. Use the drop down menus to ﬁlter the reports by type and/or date. Select any test to view details.

System Diagnostics

NOTE:

A System Diagnostics is performed for Model 1000 during the initial interrogation, regardless of the type of interrogation (Advanced or Rapid). The results are displayed on the Summary Screen and logged as part of Diagnostics history. To perform a diagnostic test for a Model 1000 after the initial interrogation you can manually perform a System Diagnostic test while in session.

The System Diagnostics test assesses the electrical continuity between the generator and the bipolar lead when connected. The test measures the generator’s ability to deliver programmed output current and the lead impedance status. You can perform this test on all generators supported by the Programming System during implantation and patient follow-up visits. A successful System Diagnostics during surgery or post-implant shows that both the generator and lead are working properly. LivaNova recommends you perform a System Diagnostics test before other diagnostic tests.

Magnet Mode Diagnostics

The Magnet Mode Diagnostics test will let you know if the generator is able to deliver the programmed magnet output current. To perform this test do the following:

1. Select TEST MAGNET

2. Quickly pass the magnet over the generator (no more than 2 seconds)

3. Place the wand over the generator and use the on-screen button to

start the test.

If you do not successfully activate magnet stimulation, a message will display on the screen indicating the magnet presence was not detected. Pass the magnet over the generator again and restart the test.

AutoStim Diagnostics

The AutoStim Diagnostics test determines if the generator is able to deliver the programmed AutoStim output current. The desired AutoStim output current should be programmed before you perform the diagnostic test.

Generator Diagnostics

The Generator Diagnostics test is designed speciﬁcally for use with a test resistor and should only be accessed for troubleshooting scenarios during implantation surgery. Go to “Troubleshooting” for more details on using Generator Diagnostics.

NOTE:

Once programmed ON, lead impedance measurement readings are automatically performed once every 24 hours for Model 103 and higher generators. Results from the 24-hour impedance check will be reported on the Summary Screen upon initial interrogation.

IN THE OPERATING ROOM

The programmer and the programming wand can be connected wirelessly or with a backup USB cable.

NOTE:

At the end of parameter adjustment in the Operating Room, the generator must be interrogated by tapping the INTERROGATE button followed by tapping the END SESSION button to ensure creation and accuracy of the session reports.

Initial Implant Overview

1. Conduct ECG to select implant location

2. Perform preoperative system checks

3. Program Patient ID and implant date

4. Access and expose the vagus nerve

5. Create the generator pocket

6. Tunnel the lead

7. Place the electrodes

8. Add strain relief and tie downs

9. Connect the generator and lead

10. Perform System Diagnostic #1

11. Insert generator into pocket

12. Turn heartbeat detection ON

(for M106 and M1000 only)

13. Verify heartbeat detection setting

14. Select AutoStim threshold

15. Secure generator to fascia

16. Perform System Diagnostic #2

and ﬁnal interrogation

17. Close incisions

Perform Preoperative System Checks

BEFORE the surgery, prepare the VNS Therapy® System:

1. Charge the programmer

2. Turn the programmer ON

3. Check the programmer battery: Check the battery status on the

battery indicator at the top right corner of the programmer screen

4. Check the wand batteries: Conﬁrm that the wand batteries are not low

5. Change the date and time if necessary. Accurate patient and device history

stored in the programmer depend on correct date and time settings

6. Connect the wand to the programmer

7. Interrogate the generator (check communication between the

programmer and the generator)

Program Patient ID and Implant Date

Enter or edit the patient data in the programmer during the preoperative preparation, immediately before surgery. In the Operating Room you will be prompted to enter the ID upon initial interrogation with the generator.

To enter or edit patient data:

1. Connect the wand to the programmer and interrogate the generator

2. On the Summary Screen, review the patient and generator information that

is displayed in the blue Patient ID bar at the top of the screen. Tap the EDIT button below the patient information

3. On the Edit Patient ID screen, enter or change information as needed

4. Tap APPLY CHANGES and CONFIRM to enter the data

Edit Button

Patient ID Bar

Perform System Diagnostic #1

System Diagnostic #1 tests the continuity of the lead and conﬁ rms delivery of the programmed output current to the vagus nerve.

To perform System Diagnostic #1:

1. From the Summary Screen, tap on the PERFORM DIAGNOSTICS button,

OR tap on the DIAGNOSTICS button in the Navigation Bar

2. On the Diagnostics screen, tap TEST SYSTEM to start the test and conﬁ rm

that the system is working correctly

3. Review the Diagnostics Test results and tap DONE

Turn Tachycardia Detection ON

Tachycardia Detection can be turned on from the Edit Parameters screen.

To turn Tachycardia Detection ON:

1. From the Summary Screen, tap on the EDIT PARAMETERS button,

OR tap on the PARAMETERS button in the Navigation Bar at the bottom of the screen

2. On the Parameters Screen, select the Detection Tab and then tap on

ENABLE NOW to turn on Tachycardia Detection

Edit Parameters Detection TabEnable Now

Verify Tachycardia Detection Setting

To verify the Tachycardia Detection setting:

1. From the Summary Screen, tap on the EDIT PARAMETERS button,

OR tap on the PARAMETERS button in the Navigation Bar at the bottom of the screen

2. On the Edit Parameters screen, select the Detection Tab and conﬁ rm that

Tachycardia Detection is enabled. Verify the Heartbeat Detection Setting by tapping the VERIFY button. If Detection has not been enabled, click on the ENABLE NOW button to enable Detection

3. On the Tachycardia Detection Setup screen, select a Heartbeat Detection

Setting between 1 and 5. Small ECG signals need high ampliﬁ cation (e.g. setting 5), while large ECG signals do not (e.g., setting 1)

4. Keep the wand over the generator and press STAR T on the programmer

screen to begin the test. Wait at least 10 seconds for the reading to stabilize

5. Compare the heart rate measured by the system in beats per minute (BPM)

to the actual heart rate of the patient, and adjust the Heartbeat Detection Setting until the system displays an accurate heart rate

6. Review changes, and then tap NEXT

NOTE:

Tachycardia Detection Setup (Step#3) is performed in the Operating Room during initial setup. This will only be required to be performed in the o ce if this step was not completed in the Operating Room or if an adjustment is required post implantation.

Select AutoStim Threshold

The AutoStim Threshold is the percent heart rate increase over baseline that is required to trigger automatic stimulation (AutoStim). Values range from 20% (most sensitive) to 70% (least sensitive) and should reﬂ ect the magnitude of heart rate increase associated with the patient’s seizure.

To select the AutoStim Threshold:

1. From the Summary Screen, tap on the EDIT PARAMETERS button,

OR tap on the PARAMETERS button in the Navigation Bar at the bottom of the screen

2. On the Parameters Screen, tap on the Detection Tab and conﬁ rm that

Tachycardia Detection is enabled

3. Select an AutoStim Threshold. The threshold is the amount of heart rate

increase needed to trigger an AutoStim (in the range of 20% to 70% increase from baseline)

4. Tap APPLY CHANGES

Perform System Diagnostic #2 and Final Interrogation

Before closing, perform Diagnostic Test #2 to conﬁ rm that the system is working properly and delivering the programmed output current.

To perform System Diagnostic #2 and Final Interrogation:

1. From the Summary Screen, tap on the PERFORM DIAGNOSTICS button,

OR tap on the DIAGNOSTICS button in the Navigation Bar at the bottom of the page

2. On the Diagnostics screen, tap TEST SYSTEM to start the test

3. Review the results, tap DONE

4. Tap INTERROGATE button on the top right corner of the screen and then

tap the END SESSION button at the top left of the screen

Perform Diagnostics Button

Test System

Diagnostics Button

NOTE:

At the end of parameter adjustment in the operating room, the generator must be interrogated by tapping INTERROGATE followed by tapping END SESSION to ensure creation and accuracy of session reports.

General Dosing Guidelines

SENTIVA DOSING GUIDELINES

Phase 1: Output Current

Increase Output Current to therapeutic effect as tolerated by the patient

NORMAL MODE: 0.25 mA steps to therapeutic eect

1,2

AUTOSTIM MODE

AutoStim should be comfortable for patients

MAGNET MODE: Normal Mode + 0.25 mA

Magnet Mode should be > than AutoStim Mode

: Normal Mode + 0.125 mA

STANDARD PROTOCOL

1Visit 2 3 4 5 6 7

Output Current

Signal Frequency

Pulse Width

NORMALAUTOSTIMMAGNET

Signal ON Time

Signal OFF Time

Output Current

Pulse Width

ON Time

Output Current

Pulse Width

ON Time

μsec

seconds

minutes

μsec

seconds

μsec

seconds

0.25

250

0.375

250

0.5

500

0.5

250

0.625

250

0.75

500

0.875

0.75

250

1.0

500

1.0

1.25

1.5

1.75

250

1.125

1.375

1.625

1.875

250

1.25

1.5

1.75

2.0

500

 Suggested programming settings ≥ 2 weeks post-op  More frequent visits (1 - 2 weeks) are suggested in Phase 1

 Multiple 0.25 mA increases may be made in a single visit to reach

therapeutic range sooner; ensure patient tolerability before making additional adjustments

Dosing Notes

 Continue to optimize dose to therapeutic effect or tolerability  Give patient time to adapt to parameter changes before making

additional adjustments

Phase 2: Duty Cycle

OFF TIME (minutes)

Not available with AutoStim Enabled

 Increase duty cycle over time and assess clinical outcome  Adjustments to duty cycle should be less frequent (3 - 6 months)

0.2 0.3 0.5 0.8 1.1

58 44 30 20 15 10 6 4 2

69 56 41 29 23 15 9 6 3

76 64 49 36 29 19 12 8 4

81 71 57 44 35 25 16 10

ON TIME (seconds)

89 82 71 59 51 38 27 18 10

Recommended

Recommended progression for duty cycle

LivaNova recommends that stimulation with N ormal Mode ON time > OFF tim e be avoided. Duty Cycle = (ON Ti me + 4 seconds) / (ON time + OFF Time), for which ON and O FF Time are measured in seco nds.

Not recommended

1.8 3 5 10

Additional Settings for SenTiva

Tachycardia Detection

Heartbeat Detection*

Range (1 - 5)

ON/OFF

Start with Sensitivity 1 and verify heartbeat detection update. Adjust setting if necessary until accurate detection is reached.

Threshold for AutoStim*

(% heart rate increase)

Range (20 - 70%)

Prone Position*

Low Heart Rate*

Range (30-60 BPM)

*Tachycardia detecti on must be enabled

Set at or below the patient’s typical heart rate increase during a seizure

If not available, start with 20% and adjust based on clinical benefit or tolerability

Configure generator to log the occurrence of prone position when they occur within 7.5 minutes of an AutoStim or Magnet Mode activation

Configure generator to log low heart rate episodes when they occur within 7.5 minutes of an AutoStim or Magnet Mode activation

Strategies to Manage Side Eects

 Evaluate tolerability after each adjustment  Side effects typically decrease over time

RECOMMENDED ORDER

1. Pulse Width If 500 250 µsec

2. Signal Frequency If 30 25 or 20 Hz

3. Output Current

FOR AUTOSTIM-RELATED SIDE EFFECTS*

1. Verify Heartbeat Detection

3,4

‡

0.125 mA

0.25 mA

Adjust Heartbeat Detection sensitivity, if necessary

Pulse Width

2. AutoStim Parameters

Output Current (0.125 mA) ON Time

3. Threshold for AutoStim 10%

Additional Information

Please see important safety information or visit www.VNSTherapy.com.

Incidence of adverse events following stimulation (>5%) were voice alteration, increased coughing, pharyngitis, paresthesia, dyspnea, dyspepsia, and nausea.

This information is not intended to serve as a substitute for a complete and thorough understanding of the material presented in the Physician’s Manuals for the VNS Therapy system and its component parts and does not represent full disclosure of all pertinent information concerning the use of this product, potential safety complications, or ecacy outcomes.

REFERENCES: 1. Helmers SL, et al. Application of a computational model of vagus nerve stimulation. Acta Neurol Scand. 2012 Nov;126(5):336-43. 2. Heck C, Helmers SL, DeGiorgio CM. Vagus nerve stimulation therapy, epilepsy, and device parameters: scientiﬁc basis and recommendations for use. Neurology. 2002 Sep 24;59(6 Suppl 4):S31-7. 3. Morris GL Ill, Mueller WM. The Vagus Nerve Stimulation Study Group E01-E05. Long-term treatment with vagus nerve stimulation in patients with refractory epilepsy. Neurology. 1999;53(7):1731-1735. 4. Ben-Menachem E. Vagus nerve stimulation, side eects, and long-term safety. J Clin Neurophysiol. 2001;18(5):415-418.

SenTiva MRI Guidelines

Scan Conditions - SenTiva® Model 1000

No special MRI equipment/coils required

GROUP A

Permissable Scan Area

MRI Exclusion Zone

Note: The scan iso-center must be outside the exclusion zone

Generator in upper left chest, at or above armpit (above rib 4)†

† Patients with implants in other locations must follow Group B scan conditions

Imaging techniques such as computed tomography, x-ray, and ultrasound are safe to perform in the MRI exclusion zone.

Review the most current labeling prior to performing an MRI scan. For full MRI safety information, refer to MRI Instructions for Use at www.easy-mri.com

GROUP A

MR Conditional Yes

Static Magnet Strength 1.5T or 3T

Scanner Type Horizontal field, cylindrical closed-bore 1.5T or

3T scanner

Operating Mode Normal Operating Mode

Exclusion Zone Body coil: C7-L3

Transmit-receive head or extremity coil: C7-T8

Max Spatial Gradient ≤3000 Gauss/cm

Max Slew Rate 200 T/m/s

RF Coil Transmit: Body coil or Transmit-receive head or

extremity coils

Receive: No Restrictions

Max SAR Transmit head coil: 3.2 W/kg

Transmit body coil: 2.0 W/kg

System Programming Stimulation OFF Sensing OFF*

*for select models with AutoStim mode Optional device features OFF (Model 1000 only)

Exposure Time Transmit head or extremity coil: No restrictions

Transmit body coil: ≤ 15 minutes of active scan

time within a 30 minute window

Additional Restrictions Transmit head or extremity coil: none

Transmit body coil: Circularized Polarized mode

only

For full MRI safety information, the VNS Therapy System Physician’s Manual can be found at www.easy-mri.com For technical product questions, contact LivaNova Technical Services at 1-866-882-8804

Scan Conditions - SenTiva® Model 1000 implanted lower than rib 4 (below armpit level)

Requires local transmit-receive coil

Availability may vary

GROUP B

MRI Exclusion Zone

Permissable scans include head, knee, ankle, and wrist

Imaging techniques such as computed tomography, x-ray, and ultrasound are safe to perform in the MRI exclusion zone.

Review the most current labeling prior to performing an MRI scan. For full MRI safety information, refer to MRI Instructions for Use at www.easy-mri.com

GROUP B

MR Conditional Yes

Static Magnet Strength 1.5T or 3T

Scanner Type Horizontal field, cylindrical closed-bore 1.5T or 3T scanner

Operating Mode Normal Operating Mode

Exclusion Zone C7-T8

Max Spatial Gradient ≤3000 Gauss/cm

Max Slew Rate 200 T/m /s

RF Coil Transmit-receive head or extremity coils

Max SAR Transmit-receive head coil: 3.2 W/kg

System Programming Stimulation OFF Sensing OFF *

*for select models with AutoStim mode Optional device features OFF (Model 1000 only)

Exposure Time Transmit head or ex tremity coil: No restrictions

Additional Restrictions None

For full MRI safety information, the VNS Therapy System Physician’s Manual can be found at www.easy-mri.com

For technical product questions, contact LivaNova Technical Services at 1-866-882-8804

Special Cases

Lead only

≤ 2 cm remaining*

Suspected Lead Break

Lead only

>2 cm remaining

Lead only

≤ 2 cm remaining*

Exclusion Zone C7-T8 None

MR Conditional Yes Yes

Static Magnet

1.5T or 3T 1.5T or 3T

Strength

Operating Mode Normal Operating

Normal Operating Mode

Mode

Max Spatial Gradient ≤3000 Gauss/cm ≤3000 Gauss/cm

Max Slew Rate 200 T/m/s 200 T/m/s

RF Coil Transmit-Receive head

or extremity coil only

Transmit: Body or transmit-receive head or extremity coils

Receive: No Restrictions

Max SAR Transmit/receive head

coil: 3.2 W/kg

Transmit head coil:

3. 2 W/kg

Transmit body coil:

2.0 W/kg

To ensure eective communication with the MRI center, complete the Patient MRI Form. Send with the patient to their MRI appointment. Download from easy-mri.com

Pre-MRI Instructions

An appropriate healthcare professional with access to a VNS Therapy programming system must prepare the VNS Therapy generator before the patient enters an MR system room.

1. Interrogate the VNS Therapy generator* and record the generator settings

2. Perform System Diagnostics to ensure proper operation of the generator

3. Reprogram the Output Current parameter settings for Normal Mode,

Magnet Mode, and AutoStim Mode† as follows:

• Output Current (mA): 0.0

• Magnet Current (mA): 0.0

• AutoStim Current (mA): 0.0 and Tachycardia Detection “OFF”

4. Turn o any other optional device features (Model 1000 only)

5. Interrogate the generator* to verify that programming was successful

6. Verify that placement of the VNS Therapy system is located between the

C7 and T8 vertebrae

7. Instruct the patient to notify the MR system operator of pain, discomfort,

heating, or other unusual sensations so the operator can terminate the procedure, if needed

Post-MRI Instructions

After the MRI procedure, an appropriate healthcare professional with access to a VNS Therapy programming system should assess the condition of the VNS Therapy system.

To assess the VNS Therapy system:

• Interrogate the VNS Therapy generator

• If the generator was reset during the scan, reprogram the serial

number, patient ID, and implant date, as needed

• Program the patient’s therapeutic parameters as they were before the MRI

procedure

• Perform System Diagnostics. Results should indicate Impedance=OK

• Interrogate the generator again to conﬁrm that reprogramming was

successful

* When an interrogation is performed by the programming software, the generator serial number, implant date, stimulation parameters, and generator operating time are automatically logged in the programmer database. This information may be retrieved from the database at any time after interrogation. † for select models with AutoStim mode

For full MRI safety information, the VNS Therapy System Physician’s Manual can be found at www.easy-mri.com. For technical product questions, contact LivaNova Technical Services at 1-866-882-8804

Troubleshooting

This section provides steps to resolve error conditions with the programming system components or with the implanted generator and lead. For other programming system issues not addressed in this section, please contact LivaNova.

General Inqiuries (for questions about LivaNova, LivaNova products, warranties, etc. or to request a call from a company representative) http://www.livanova.com/contact-us/

24-hour Technical Support (for technical questions with programmer, generator, or wand)

• 1 (866) 882-8804 (US and Canada)

• 1 (281) 228-7330 (Worldwide)

• 32 2 790 27 73 (Europe/EMMEA)

Mailing Address

LivaNova USA, Inc (formerly Cyberonics, Inc.) 100 Cyberonics Boulevard Houston, TX 77058 USA

LivaNova Belgium NV Ikaroslaan 83 B-1931 Zavantem, BELGIUM

Screen Freeze

1. Press and hold POWER button on the

programmer for at least three seconds; release and follow onscreen instructions to shut down the tablet

2. If the computer does not shut down,

press and hold POWER button to force a shutdown (may take 10+ seconds)

3. Restart the programmer

Wand Connection or Communication Issues

WAND NOT CONNECTING TO PROGRAMMER (WIRELESS)

Potential reasons for no wireless connection between the Wand and the Programmer include the following:

• Wand not powered on

• Depleted Wand batteries

• Electromagnetic interference (EMI), such as OR lights

• Defective Wand or Programmer

Error Messages

“Wand (serial number of connected wand) not found”

Check Wand Power - Press and release power button

“No wands found…”

Yes

Replace batteries

Verify Wand Selection

• Conﬁrm wand ID matches wand selected on programmer

Check for Interference

• Conﬁrm wand is 3-4 feet away from all electronic equipment

Reconnect to Wand

Connect with backup cable

Successful

Connection?

Yes

Is the low battery icon illuminated?

Retry connecting to wand

Successful

Connection?

Proceed with intended use

Connection?

Contact LivaNova Technical Support

Successful

Are the green

power indicator

Yes

lights on?

ANOMALOUS BEHAVIOR OR NON-RESPONSIVE SYSTEM

Non-responsive Programmer or Wand

Issue:

Solution Steps for Programmer:

Charge programmer – Plug programmer into A/C outlet Shut down – Press and hold the power button for 5 seconds,

and then release. Follow on-screen instructions to shut down If programmer is still non-responsive, press and hold power button to force a shut down (approximately 10 seconds)

Reboot – Power on the programmer

Solution Steps for Wand:

Verify wand battery power - If the orange low battery light is on,

replace the wand batteries Perform soft reset - Press and hold wand power button for 5 seconds and release

Device

Responsive?

Yes

Verify:

• Programmer has adequate charge

• Programmer has correct date/time

Contact LivaNova Technical Support

Yes

Proceed with intended use

WAND NOT CONNECTING TO PROGRAMMER (BACKUP CABLE)

Potential reasons for no connection between the Wand and the Programmer via backup cable include the following:

• Improper cable connection between Wand and Programmer

• Depleted Wand batteries

• Improper USB port recognition of the Programmer cable

• Defective Wand or Programmer

Error Messages

“Wand not connected…”

Check Wand Power - Press and release power button

Does wand power

indicator light appear?

YesNo

Replace batteries

Verify Cable Connection

• Conﬁrm cable is connected to wand and programmer. Reinsert if necessary

Successful

Connection?

Contact LivaNova Technical Support

Retry connecting to wand

Successful

Connection?

Yes

Proceed with intended use

Yes

WAND NOT COMMUNICATING WITH GENERATOR

Potential causes for communication issues between the Wand and generator include the following:

• Depleted Wand batteries

• Moving Wand away from generator during communication

• Electromagnetic interference (EMI), such as OR lights

• Generator battery at End of Service (EOS)

• Magnet placed over generator

• Defective Wand, Programmer, or generator

Error Messages

“Generator not found...”

“Error communicating with generator…”

Check Wand Placement

• Conﬁrm wand is placed over the generator

• Rotate wand 45 degrees

• Conﬁrm generator pocket is not more than 1 inch below the skin, not muscle (during surgery)

Remove Magnet Presence

• Conﬁrm magnet is not placed over the generator

Retry Communication

No Yes

Contact LivaNova Technical Support

Successful

Connection?

Proceed with session

Patient Cannot Feel Stimulation

• Possible causes:

- Patient has become accustomed to the programmed setting

- Generator battery at end of service (EOS)

- “High” lead impedance, defective, or disabled generator

- Short-circuit condition within the lead

• For more detailed information, consult the Troubleshooting section of the

VNS Therapy® System Physician’s Manual

Patient Report

“Cannot feel stimulation”

Interrogate the generator

“Disabled Message?”

YesNo

• Perform a System Diagnostics

• Record results

Lead Impedance Result

“Ok”

Output Current Result

“Ok” “Low”

The generator is able to deliver programmed output current and the VNS system is working properly

Probable Diagnosis: The patient has grown accustomed to stimulation but is still receiving the programmed therapy

“High” or

“Low”

For possible causes, see

“Troubleshooting” in the

programming system

“The generator is currently disabled due to [CAUSE]. The generator is NOT supplying stimulation.”

Note: If the CAUSE is “a wand reset” and the reset was intended, continue with the session

Physician’s Manual

The generator cannot deliver programmed output. Consider lowering output current while increasing pulse width

Contact Clinical Technical Support

Record the CAUSE

Patient Cannot Feel Magnet Stimulation

• Possible causes:

- Patient has become accustomed to the programmed setting

- Incorrect technique for swiping magnet

- Magnet output current is programmed to 0 mA

- Generator battery at end of service (EOS)

- Device implanted too deep in the chest

- Defective generator or disabled generator

- “High” lead impedance

- Short-circuit condition within the lead

Patient Report

“Cannot feel magnet activation”

Is Magnet Current ≥ the

Output Current? and

Magnet ON time

>7 seconds?

Yes

• Display Device History or Events

• Record number of magnet activations

• Swipe the magnet

• Reinterrogate the device

• Display Device History or Events

• Perform a System Diagnostics

• Record results

Lead Impedance “High” or “Low”

See “Troubleshooting” in the programming system Physician’s Manual

Lead Impedance “Ok”. Output Current “Ok” Magnet Mode stimulation is functioning properly and the patient may have become accustomed to the settings. Consider raising the magnet current if perceived stimulation is desired

Consider adjusting

Interrogate the

generator

Magnet settings

may be too low for

patient to perceive.

magnet setting

Did the magnet

activations increase?

Generator is delivering the magnet stimulation. Consider raising the magnet current if perceived stimulation is desired

Lead Impedance “Ok”. Output Current “Low” Generator cannot deliver the programmed magnet output due to increased impedance. Consider lowering magnet output current while increasing magnet pulse width

“Disabled Message?”

“The generator is currently disabled due to [CAUSE]. The generator is NOT supplying stimulation.”

Note: If the CAUSE is “a wand reset” and the reset was intended, continue with the session

Record the CAUSE

Yes

Indication that the generator did not sense a magnet.

Swipe the magnet again and repeat Magnet Mode Diagnostics. If the message appears again call Technical Support

Yes

Contact LivaNova Technical Support

Patient Does Not Perceive AutoStim Activation

• Possible causes:

- AutoStim Threshold is too high (e.g., 70% threshold versus 50%)

- Patient has become accustomed to the programmed setting

- AutoStim output current is programmed to 0 mA

- Generator battery at end of service (EOS)

- Defective generator or lead

- Disabled generator

Patient Report

“Cannot feel AutoStim”

Interrogate the generator

• Conﬁrm Detection is enabled

• Conﬁrm AutoStim output current is set to > 0 mA and ≥ Normal output current

Conﬁrm heartbeat detection (See “Troubleshooting” in the programming system Physician’s Manual

Perform an AutoStim Diagnostics and record results

Current Delivered

• Examine oce visit data in Device History or Events

• Investigate consecutive oce visits to identify any changes in the average number of AutoStims per day delivered

If > 0 If 0

The generator is delivering AutoStim. If perceived stimulation is desired, consider raising the AutoStim current

Re-evaluate at next oce visit

If the average number of AutoStim activations per day since last oce visit is 0 and the patient has had seizures during this period, adjust the AutoStim Threshold setting toward 20%

Repeat this process at subsequent oce visits until the patient perceives stimulation or the device conﬁrms the logging of events

Note: Decreasing the detection threshold increases the likelihood of detecting heart rate rises associated with seizures, but may increase the overall number of AutoStims delivered and impact battery longevity

“Disabled Message?”

“The generator is currently disabled due to [CAUSE]. The generator is NOT supplying stimulation.”

Note: If the CAUSE is “a wand reset” and the reset was intended, continue with the session

Current Not

Delivered

Contact Clinical Technical Support

Yes

Record the CAUSE

High/Low Lead Impedance and Low Output Current Issues

HIGH LEAD IMPEDANCE IN THE OR

If a System Diagnostics test results in high lead impedance, the following are possible causes:

• Improper connection between the lead and the generator

• Incorrect placement of lead on the nerve (initial implant only)

• Allowing nerve to become dry (initial implant only)

• Defective lead or generator

Error Message

Lead Impedance “HIGH”

Verify Lead Insertion into Generator

• Back out setscrew(s), remove lead pin(s), and leave the hex screwdriver engaged in setscrew(s)

• Verify the setscrew(s) is not visible in the lead receptacle(s)

• Insert connector pin(s) and tighten setscrew(s) until the hex screwdriver clicks

• Conﬁrm the lead pin(s) is past the back end of the connector block

• For single-pin generators, verify the end of the connector ring is inside of the lead receptacle

• For Initial Implant: Irrigate dry nerve site and remove pooled ﬂuid if necessary

• Verify proper lead electrode placement on the nerve

• Retry System Diagnostics

Troubleshoot Generator

• Back out setscrew(s) and remove lead pin(s)

• Insert test resistor into generator and tighten setscrew(s) with hex screwdriver until the screwdriver clicks

• Select MORE TROUBLESHOOTING on the programmer

• Select GENERATOR DIAGNOSTICS - START on the programmer

“High”

Lead Impedance

Value?

“Ok”

Proceed with implant

Lead Impedance

Value?

“Ok”“High”

Contact LivaNova Technical Support

Reinsert Lead into Generator

• Back out setscrew(s) and remove test resistor

• Verify the setscrew(s) is not visible in the lead receptacle(s)

• Engage the hex screwdriver in the setscrew(s)

• Insert connector pin(s) and tighten setscrew(s) until the hex screwdriver clicks

• Visually inspect the lead receptacle(s) and verify that the lead pin(s) is past the back end of the connector block(s)

• Retry System Diagnostics

“High”

Lead Impedance

Value?

“Ok”

Proceed with implant

LOW LEAD IMPEDANCE IN THE OR

If a System Diagnostics test results in low lead impedance, the following are possible causes:

• Incorrect placement of the lead on the nerve

• Excessive irrigation of the nerve

• Defective generator or lead

• Short-circuit condition within the lead (during generator replacement

surgery)

Error Message

“Lead Impedance “LOW”

Initial implant

Check the Lead

• Verify lead electrodes have been correctly placed on the nerve

• Remove pooled ﬂuid if nerve site is saturated

• Retry System Diagnostics

Lead Impedance

Value?

“OK”

Proceed with implant

Initial implant

Reinsert Lead into Generator

• Back out setscrew(s) and remove test resistor

• Verify the setscrew(s) is not visible in the lead receptacle(s)

• Engage the hex screwdriver in the setscrew(s)

• Insert connector pin(s) and tighten setscrew(s) until the hex screwdriver clicks

• Visually inspect the lead receptacle(s) and verify that the lead pin(s) is past the back end of the connector block(s)

• Retry System Diagnostics

Type of

Implant?

Troubleshoot Generator

• Back out setscrew(s) and remove lead pin(s)

• Insert test resistor into generator and tighten setscrew(s) with hex screwdriver until the screwdriver clicks

• Select MORE TROUBLESHOOTING on the programmer

• Select GENERATOR DIAGNOSTICS - START on the programmer

“Low”

“OK”

Type of

implant?

Contact LivaNova Technical Support

Generator replacement

Lead Impedance

Value?

“Low”

Lead Impedance

Value?

“OK”

Proceed with implant

HIGH/LOW LEAD IMPEDANCE OR LOW OUTPUT CURRENT AT FOLLOW-UP VISIT

Possible causes for high or low lead impedance or low output current at follow-up visits for the model 1000 generator include the following:

• Lead discontinuity

• Lead disconnected from generator

• Fibrosis between nerve and electrode

• Electrode detachment from nerve

• Defective generator

• Short-circuit condition within the lead

Error Message

“A LOW Lead Impedance

has been detected...”

Lead Impedance “LOW”

System Diagnostics

Values

Lead Impedance

“HIGH”

Output Current

“OK”

Possible Causes:

• Lead discontinuity

• Lead disconnection from the generator

• Fibrosis between the nerve and electrode

• Electrode detachment from the nerve

• Defective generator

Error Message

“A HIGH Lead Impedance

has been detected...”

Lead Impedance “HIGH”

• Perform a Systems Diagnostics

• Record results

Lead Impedance “OK”

Output Current “OK”

Lead Impedance

“HIGH”

Output Current

“LOW”

Possible Causes:

• Lead discontinuity

• Lead disconnection from the generator

• Fibrosis between the nerve and electrode

• Electrode detachment from the nerve

• Defective generator

Lead Impedance

“OK”

Output Current

“LOW”

Possible Causes:

• Increased impedance in the system

Error Message

“Programmed current

is possibly not being

delivered...”

Output Current “LOW”

Generator is delivering

stimulation as intended

Lead Impedance

“LOW”

Output Current

“OK”

Possible Causes:

• Short-circuit condition within the lead

• Defective generator

Contact LivaNova Technical Support

Generator Battery Issues

LOW BATTERY/END OF SERVICE INDICATIONS IN OR

If a generator displays a low battery or End of Service (EOS) indicator while implanting, the possible causes include the following:

Prior to Surgery:

• Generator has been recently

exposed to low storage temperatures

• Defective generator

• “Generator Battery N EOS…”

• “Generator Battery EOS…”

• “Frequent monitoring recommended. The Intensiﬁed Followup Indicator (IFI) is set…”

• “Generator disabled…”

• Perform System Diagnostics or Generator Diagnostics with device in sterile package

• Record results

During Surgery:

• Electrosurgical equipment used near the generator

• Generator exposed to electrostatic discharge (ESD)

Error Message

Diagnostic

Results

Same battery status indicator or warning

message as above

• Lead Impedance “any”

• Impedance Value “any”

• IFI = No

Proceed with implant

Wait approximately

30 minutes with generator

at room temperature

1 2

Number of

attempts

Contact LivaNova

Technical Support

NEW GENERATOR DISABLED DUE TO EOS AT FIRST OFFICE VISIT

Generator model 1000 battery can temporarily drain and become disabled if exposed to certain conditions. These conditions include the following:

• Electrosurgical equipment used near the generator

• Generator exposed to electrostatic discharge (ESD)

Error Message

“Generator is currently disabled...”

“IFI” = No “IFI” = Yes

Proceed with intended use

Monitor patient for low battery indicators

Note: Battery life will be shortened

Enable Stimulation and Check System

• Select OK

• Enter desired parameters

• Select Apply Changes

• Perform System Diagnostics Test

Battery Status?

All Other Errors

Contact LivaNova Technical Support

“N EOS”=Yes or

immediately

“EOS”=Yes

Replace

Generator

SUDDEN DECREASE IN REMAINING BATTERY POWER

If the remaining generator battery power suddenly decreases at an oce visit, the following are possible causes:

• First visit after VNS or other surgery: exposure to speciﬁc conditions in the

OR (see Low Battery/ End of Service Indications in OR) during surgery. If this condition occurred and was not detected in the OR, it is possible you may detect this at the follow up visit. Device will still function normally, but will have decreased battery life. Monitor the patient closely for any low battery indicators.

• Signiﬁcant change in the lead impedance or increase in programmed

stimulation parameters can also result in a change in the estimated battery power remaining. Evaluate battery power remaining between consecutive patient visits before adjusting stimulation parameters.

• Review lead impedance for any signiﬁcant changes.

If any device issue is suspected, contact LivaNova Technical Support.

Heartbeat Detection Issues

HEARTBEAT DETECTION INACCURATE (OVER/UNDER) IN OR OR AT FOLLOW-UP VISIT

The heartbeat detection setting may need to be adjusted to accurately detect heartbeats.

NOTE:

The Wand must be held over the generator during the entire Verify Heartbeat Detection process.

Heartbeat Detection is inaccurate

BPM is too high, low, or reports “??”

Check Hardware

• Conﬁrm the programmer is not plugged into a wall outlet

Check Software

• Conﬁrm Detection is enabled

Check Wand Placement

• Verify wand is over the generator

Retry with

dierent settings

BPM?

High

Adjust Heartbeat Detection

setting downward

(toward “1”)

Conﬁrm accuracy in dierent body positions

(e.g. o-the-shelf heart rate monitor)

Ok?

All settings

attempted with

out success?

Low

Yes

Adjust Heartbeat

Detection

setting upward

(toward “5”)

Contact LivaNova

Technical Support

Done

Contact LivaNova Technical Support

Tachycardia Detection Issues

INACCURATE AUTOSTIMS AT FOLLOW-UP VISIT

Sometimes generator detection settings may miss detecting heart rate changes that may be associated with a seizure. The following conditions may be potential causes:

Duty cycle

Because the generator can only detect events during OFF time, the OFF time aects accuracy. Shorter OFF time means less chance for the generator to detect events. Longer OFF time, on the other hand, means more chance for the generator to detect events.

Too many or too few AutoStims

Conﬁrm Heartbeat Detection settings (See Solution Steps for

Heartbeat Detection Inaccurate in OR or at Follow-up Visit)

Too many

Adjust Threshold for

AutoStim setting

toward 70%

Heart rate changes

Exercise, physical activity, and normal sleep can increase the heart rate and cause the generator to falsely declare an event.

Number

of AutoStims

Too few

Adjust Threshold for

AutoStim setting

toward 20%

Yes

Contact LivaNova Technical Support

Monitor accuracy over

course of therapy

Still Inaccurate

after several

adjustments?

Continue with

programmed setting

LivaNova USA, Inc. 100 Cyberonics Boulevard Houston, Texas 77058 Tel: +1.800.332.1375 Fax: +1.281.218.9332 www.VNSTherapy.com

LivaNova Belgium NV Ikaroslaan 83 1930 Zaventem Belgium Tel: +32.2.720.95.93 Fax: +32.2.720.60.53

SenTecGd19U1

VNS Therapy SENTIVA M3000 Programmer, SENTIVA M2000 Wand, SENTIVA VNS Therapy System Technical Manual

Specifications and Main Features

Frequently Asked Questions

User Manual