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General| Model | SENTIVA M3000 |
|---|---|
| Manufacturer | LivaNova |
| Power Source | Rechargeable battery |
| Device Type | Programmer |
| Intended Use | Programming and managing VNS Therapy devices |
| Compatibility | Compatible with VNS Therapy generators |
| Function | Programming, data retrieval, and device interrogation for VNS Therapy Systems. |
| Programming Parameters | Output Current, Signal Frequency, Pulse Width, Duty Cycle, On Time, Off Time |
| Data Logging | Stores therapy history and device diagnostics |
| Display | Touchscreen display |
| Connectivity | Wireless communication with VNS Therapy implant |
| Safety Features | Password protection, data encryption |
Overview of the VNS Therapy System and its four main components.
Details on the implanted portion of the VNS Therapy System, including the generator and lead.
Information on the external programmer (tablet and software) and its function.
Description of the programming wand (Model M2000) and its operation.
Explanation of the patient-controlled magnet feature and its uses.
Table detailing compatibility between VNS Therapy generators and other system components.
Generator initiates stimulation at preset ON and OFF times throughout the day.
On-demand stimulation initiated by the patient using a VNS magnet.
Automatic stimulation based on detected heart rate changes.
Initial steps and component collection to begin using the VNS Therapy System.
Pre-session checks for programmer and wand batteries, date, and time.
Turning the programmer on/off and navigating its interface.
Procedures for checking programmer battery status using the indicator.
Procedure to check wand batteries and replace them if needed.
Ensuring accurate time-stamping by setting the programmer's date and time.
Understanding the differences between the Main and Summary screens.
Using bars for settings, system info, and additional features.
Identifying session status and ending a session.
Steps for establishing a wireless connection between the wand and programmer.
Instructions for connecting the wand to the programmer using a USB cable.
Steps to communicate with the generator, including advanced vs. rapid modes.
Actions possible after a successful generator interrogation.
Procedure for manually adjusting stimulation and detection parameters.
Setting up Tachycardia, Heartbeat, AutoStim, and Prone/Low Heart Rate detection.
Using guided steps to adjust parameters per protocol.
Automatically changing parameter steps according to a schedule.
Configuring distinct therapy schedules for day and night.
Navigating to therapy protocols and creating custom protocols.
Viewing device history, session reports, and data transfer options.
Reviewing stimulation events, magnet, and inhibited stimulation timestamps.
Displaying histograms for various event types like tachycardia or AutoStim.
On-demand stimulation, inhibition, daily checks, and evaluation of magnet mode.
Procedure for ordering replacement magnets.
Running System, Magnet Mode, AutoStim, and Generator diagnostics.
Understanding lead impedance, battery status, and output current results.
Overview of implant steps and preparing the system before surgery.
Entering patient ID and implant date before surgery.
Performing diagnostic tests and final interrogation in the OR.
Guidelines for increasing output current to therapeutic effect.
Adjusting duty cycle and configuring detection/threshold settings.
Strategies for adjusting parameters to manage side effects.
MRI scan conditions for generator in upper left chest.
MRI scan conditions for generator implanted lower than rib 4.
MRI conditions for suspected lead breaks or lead-only scenarios.
Steps to prepare the generator before a patient undergoes an MRI.
Assessing the VNS Therapy system after an MRI procedure.
Contacting support and resolving a frozen programmer screen.
Troubleshooting wand connection to programmer and generator.
Resolving non-responsive programmer or wand issues.
Diagnosing why a patient cannot feel stimulation.
Troubleshooting lack of perceived magnet stimulation.
Diagnosing why a patient does not perceive AutoStim activation.
Troubleshooting lead impedance problems during OR or follow-up.
Addressing situations where programmed current is not delivered.
Identifying and resolving low battery or EOS issues in OR and at office visits.
Adjusting heartbeat detection settings for accurate readings.
Troubleshooting inaccurate AutoStim events due to detection settings.
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