User Manual

16. MAIN FUNCTIONS
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, …
16.7. 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 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.
16.7.1 . 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 the patient usually sleeps. The SMARTVIEW monitor shall be
connected 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 remote-monitor.
16.7.3 . Data transmitted
The data transmitted are identical to the data available during a standard interrogation with
the dedicated programmer. All counters, histograms, IEGMs and diagnosis available in the
device are transmitted containing (not exhaustive list):
─ programmed parameters
─ Information on patient and system implanted
─ battery status
─ lead status (brady leads and defibrillation coils)
─ pacing counters and mean heart rate (brady)
SORIN – INTENSIA CRT-D 174 – U151A
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