sorin Intensia VR 124, Implant Manual

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14. IMPLANT PROCEDURE
14. IMPLANT PROCEDURE
14.1. NECESSARY EQUIPMENT
Implantation of INTENSIA VR 124 requires the following equipment:
─ Sorin dedicated programmer, equipped with the SMARTVIEW software interface and
with the programming head,
─
pacing system analyzer, as well as its sterile connecting cables, to evaluate the pacing
and sensing thresholds,
─ a ventricular pacing and defibrillation lead,
─ physiological signal monitor capable of displaying simultaneously the surface ECG and
arterial pressure,
─ an external defibrillator with sterile external paddles,
─ sterile cover for the telemetry head.
14.2. PACKAGING
14.2.1 . Contents
The INTENSIA VR 124 and its accessories are ethylene oxide sterilized and hermetically
sealed in two-ply clear packaging meeting international requirements.
The sterile packaging contains a defibrillator and one screwdriver.
The non-sterile items contained in the outer storage package are the implant manual, the
ICD Registration Form and its envelope, the patient booklet, the ICD ID card and 12
identification labels.
Once delivered, INTENSIA VR 124 is programmed to as-shipped values that are different
from nominal values (see Chapter “Programmable Parameters” for details).
14.3. OPTIONAL EQUIPMENT
The following equipment may be required during implantation of INTENSIA VR 124:
─ sterile water to clean traces of blood. Any parts cleaned with sterile water must be
thoroughly dried.
─ mineral oil to lubricate if necessary
─ a lead cap to isolate a lead which is not used
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.
SORIN – INTENSIA VR 124 – U153A 29
NOTE: In case you’re implanting a DF-4 lead, please verify its compatibility with standard
alligators pin; please refer to the lead user’s manual for more details.