sorin Intensia DR 154, Руководство по имплантации

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17. PATIENT FOLLOW-UP
─
Markers: Atrial and ventricular markers, sensed, paced and in relative refractory periods,
─ EGM: onset and detection of the arrhythmia, on two therapies, and the return to slow
rhythm by recording electrogram.
Therapy history
For each arrhythmia detection, each therapy delivered (either automatically or during an
electrophysiological study) and at the end of each arrhythmia, INTENSIA DR 154 records
the type of majority rhythm, the number of ATP sequences delivered, the energy and the
number of shocks delivered.
17.3. RECOMMENDED REPLACEMENT TIME (RRT)
Recommended Replacement Time (RRT) (1) is controlled by:
─
magnet rate equal to 80 ± 1 bpm or
─ battery voltage equal to 2.66 V ± 0.01 V
Between the RTT and the EOS (End of Service) (2) , INTENSIA DR 154 can still function for:
─ 8.4 months (100% atrial and ventricular pacing in DDD mode, 500 ohms, with as-
shipped settings), and deliver 7 shocks at 34 J or
─ 6.4 months (0% pacing, sensors OFF, one 42 J shock every 2 weeks).
Once the Recommended Replacement Time (RRT) point has been reached, the device
operates normally, except that the charge time increases. Under normal conditions (and
without programmer use) the charge times are as follows:
Shock energy Charge time (sec)
BOS (3) 42 J 10 (± 2)
RTT 42 J 13 (± 3)
(1) Recommended Replacement Time (RRT) corresponds to Elective Replacement
Indicators (ERI) previously used.
(2) End of Service (EOS) corresponds to End of Life (EOL) previously used.
(3) Beginning of Service (BOS) corresponds to Beginning of Life (BOL) previously used.
17.4. EXPLANTATION
The defibrillator should be explanted in the following cases:
─
The Recommended Replacement Time (RRT) point is reached
─ Confirmed malfunction
─ Burial of the patient (for environmental reasons, the local regulation may require the
explantation of the devices containing a battery supply)
─ Cremation of the patient (the defibrillator may explode if placed in an incinerator)
The explanted defibrillator should not be reused in another patient.
All explanted defibrillators should be returned to Sorin, carefully cleaned of all traces of
contamination. This may be done by immersing them in an aqueous sodium hypochlorite
containing at least 1% chlorine, followed by rinsing copiously with water.
SORIN – INTENSIA DR 154 – U152A 45
CAUTION: The defibrillator should be replaced as soon as the Recommended Replacement
Time (RRT) point is reached.