User Manual

CAUTION: If the Lead Polarity Switch detects out-of-range lead impedance, investigate
possible lead system failures. Lead system failures can prevent adequate sensing or full
pacing support.
NOTE for the DR model: When operating on the atrial lead, the lead polarity switch changes
the pacing mode to VVI(R). For optimal use of pacemaker functions, the atrial lead should
be bipolar.
Programming constraints:
1. For both SR and DR models, Ventricular Lead Polarity Switch can be turned ON for
leads programmed in bipolar pacing modes only.
2. For the DR model, in order to turn ON Atrial Lead Polarity Switch, the pacing mode must
be programmed to a dual chamber pacing mode.
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 Right atrial autothreshold and Right ventricular autothrehsold are recorded with
3 EGM channels (EGM A, EGM V and RV Ring-CAN).
Episodes of SafeR (AV conduction), Fallback Mode Switch, A burst and V burst are recorded
with 2 EGM channels (EGM A and EGM V).
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.
REMOTE MONITORING FUNCTION
Remote monitoring enables the automatic remote transmission of implant data to the
physician thanks to the wireless Bluetooth Low Energy communication ability of the implant
in order to provide the physician with a comprehensive report about device functioning and
patient cardiac status without having the patient physically in the clinic.
The data are transmitted from the implant to the SMARTVIEW CONNECT monitor, a small
transmitter placed in the patient’s home.
Implant data are first transmitted to the SMARTVIEW CONNECT monitor via Bluetooth Low
Energy. Data are then routed through the mobile network to a protected remote server. This
server is responsible for transforming the implant data into a comprehensive report that can
be consulted by the physician on a dedicated website. The server also sends notifications to
the physician via SMS, email or fax when a new transmission report is available.
SMARTVIEW CONNECT monitor
The SMARTVIEW CONNECT monitor is a small device equipped with a Bluetooth Low
Energy transmission module to communicate with the implant and a modem to export data
15.8.
15.9.
15.9.1.
15. FUNCTIONS AND PARAMETERS
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