14. IMPLANT PROCEDURE
14.4.
BEFORE OPENING THE PACKAGE
Before opening the package, check the "Use Before" date printed on the labels on the box
and on the sterile package. Defibrillators that have not been implanted before that date
should be returned to Sorin.
Interrogate the device:
─
if a warning is displayed, do not implant the device and contact your Sorin
representative.
─
if magnet rate is lower than 91 min-1, and if the last reforming/charge occurred more
than one week ago, do not implant the device. Otherwise wait for one more week before
checking the magnet rate again.
NOTE : The magnet rate and battery voltage can decrease before the expiration date is
reached. However, the magnet rate should be equal to or higher than 91 min-1 at the time of
implant.
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. Any re-sterilization of the unit is at the
discretion of Sorin.
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.
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.
14.7.
CHOOSING THE TYPE OF LEAD
The defibrillator should be connected to:
─
one bipolar atrial sensing/pacing lead
─
one quadripolar/tripolar ventricular defibrillation lead with sensing/pacing bipolar
electrodes, and one or two defibrillation electrodes.
The choice of leads and their configuration is left to the implanting physician’s judgment.
34
SORIN – INTENSIA DR 154 – U152A
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.
Summary of Contents for Intensia DR 154
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