16. MAIN FUNCTIONS
Protection against noise:
Allows the distinction between ventricular noise and ventricular fibrillation. If the device
senses ventricular noise, the ventricular sensitivity is decreased until noise is no longer
detected. Ventricular pacing can be inhibited to avoid a potential paced T-wave.
Automatic sensitivity control:
Optimizes arrhythmia detection and avoids late detection of T-waves and over-detection of
wide QRS waves. The device automatically adjusts the sensitivities based on the ventricular
sensing amplitude. In case of arrhythmia suspicion or after a paced event, the programmed
ventricular sensitivity will be applied. The minimum ventricular sensitivity threshold is 0.4 mV
(minimum programmable value).
16.5.
FOLLOW-UP FUNCTION
Storage of memory data:
AIDA+ (Automatic Interpretation for Diagnosis Assistance) software provides access up to 6
months of patient follow-up with day by day data collection, or up to 24 hours with hourly
data collection. Episodes of ventricular tachyarrhythmia are recorded with the programmable
EGM channels: either by selecting up to two traces, or by selecting "Double V" which
enables a one-channel recording that is twice as long.
Alerts / Warnings:
The device routinely performs security self-checks and technical measurements to ensure
system integrity. When system integrity is found to be at risk outside a follow-up, alerts are
stored in the device memory. When system integrity is found to be at risk during a follow-up,
the information is managed as a warning (pop-up message) to notify immediately the user.
For example, the following types of event can trigger a warning or an alert: technical
problem during a shock, pacing lead impedance or coil impedance measurements out-of-
range, battery depletion, …
16.6.
REMOTE MONITORING FUNCTION
Remote monitoring enables the automatic remote transmission of implant data to the
physician thanks to the wireless Radio Frequency (RF) communication ability of the implant
in order to provide a comprehensive report to the physician about device functioning and
patient cardiac status without having the patient physically in the clinic.
The data is transmitted from the implant and the SMARTVIEW monitor, a small transmitter
placed in the patient home.
Implant data are first transmitted to the SMARTVIEW monitor via RF. Data are then rooted
through the phone line to an internet website. This website is responsible for transforming
the implant data into a comprehensive report that can be consulted by the physician.
16.6.1 .
SMARTVIEW Monitor
The SMARTVIEW monitor is a small device equipped with an RF transmission module to
communicate with the implant and a modem to export data through the internet.
The SMARTVIEW monitor is delivered to the patient who has to install it at home. Preferably
the SMARTVIEW monitor will be placed on the nightstand of the patient, as close as
possible to the side of the bed the patient usually sleeps. The SMARTVIEW monitor shall be
connected to the phone line of the patient and the power plug. Regular transmissions are
SORIN – INTENSIA VR 124 – U153A
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