User's Manual

16. MAIN FUNCTIONS
16.6. 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 one
programmable EGM channel which can be selected, in addition to RV EGM.
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 by a warning (pop-up message) to immediately notify the user.
For example, the following types of event can trigger a warning or an alert: technical
problem during a shock, lead impedance or shock continuity measurements out-of-range,
battery depletion, …
16.7. 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 to the SMARTVIEW monitor, a small transmitter
placed in the patient's home.
Implant data are first transmitted to the SMARTVIEW monitor via RF. Data are then rooted
through the phone line or via GPRS to an internet website. This website is responsible for
transforming the implant data into a comprehensive report that can be consulted by the
physician.
16.7.1. 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 where the patient usually sleeps. The SMARTVIEW monitor
connects to the phone line of the patient and the power plug. Regular transmissions are
done during the night when the patient is asleep next to the SMARTVIEW monitor without
any intervention from the patient.
16.7.2. Transmission trigger
There are 3 different triggers for a remote transmission:
─ the remote follow-up transmission is scheduled by the physician to occur regularly
(according to the programming).
─ the alert transmission will take place when the implant has recorded an abnormal
event. The list of abnormal event is available in a following paragraph. Alert conditions
are checked daily.
─ the on-demand follow-up transmission is triggered by the patient himself through the
use of a specific button on the SMARTVIEW monitor.
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SORIN – PLATINIUM CRT-D – U459A