User's Manual

40 – US-ENGLISH
Devices MUST NOT be interrogated and programmed within the
vicinity of other devices.
Also check the integrity of the sterile package. The sterility of the
contents is no longer guaranteed if the package has been pierced or
altered. If the defibrillator is no longer sterile, it should be returned in
its packaging to Sorin CRM. Any re-sterilization of the unit is at the
discretion of Sorin CRM.
14.5. PRIOR TO IMPLANTATION
Use the programmer to verify the defibrillator can be interrogated
before implantation.
Verify all shock therapies are disabled in order to avoid accidental
discharge during implantation.
It is not advisable to program the Smoothing function before
implantation, since the defibrillator may detect noise and pace at a
rate higher than the programmed basic rate.
CAUTION: Do not shake or tap sharply on the ICD package with the
ICD inside, because the ICD's sensing circuits can interpret this as P-
waves or R-waves and record these as an arrhythmia episode. If
unusual shaking or tapping of the package results in a stored
arrhythmia episode, erase the recording before using the ICD.
14.6. DEVICE PLACEMENT
The pocket should be prepared in the left pectoral position, either
subcutaneously or submuscularly. Subcutaneous device implantation
is recommended for optimal RF communication efficacy.
Implantation in an abdominal position is not advisable.
In its final position, the defibrillator should be no more than 4 cm
below the skin surface.