Minimum Requirements For The Ecg Synchronisation - IGEA Cliniporator EPS02 User Manual

Cliniporator model EPS02 – User manual
Treatment may interfere with cardiac activity if applied to the chest, left arm, or abdominal
cavity. It can cause atrial or ventricular fibrillation or other arrhythmias. We recommend the use
of an R-wave detector to synchronize treatment with the refractory period of the cardiac cycle,
unless there is reasonable certainty that the treatment site is sufficiently far from the heart and
the treatment can not interfere with the cardiac activity.
Cardiac synchronization ensures that the pulses are delivered exclusively during the ventricular
absolute refractory period to avoid the risk of ventricular fibrillation. If an atrial fibrillation event
occurs, following impulse delivery, it should be treated in the most appropriate way.

Minimum Requirements for the ECG Synchronisation

5.8
To synchronize the pulse delivery with an ECG signal through the "ECG sync" function - which
is only possible in case of ECT treatments, C L I N I P O R A T O R should be connected to an
external R-wave trigger recognized as a medical device in compliance with the MDD 93/42/EEC
and subsequent modifications, CE marked and equipped with the following features:
 TTL or CMOS compatible output signal, in positive logic, length 150 ms. Warning!
if the signal is in negative logic, the correct synchronism with the R wave is not
guaranteed
 capable of delivering a current of at least 15mA
 delay between R wave and trigger signal lower than 10ms
 RGU 174/U connection cable with a maximum length of 180cm that can be
connected to the BNC socket on rear panel of the C L I N I P O R A T O R
 protection against defibrillators discharge
 leakage current in the connection cable lower than 100 μA in normal conditions and
lower than 500 μA in first failure conditions.
C L I N I P O R A T O R synchronises with the leading edge of the trigger signal ensuring that the
interval between the two consecutive triggers is more than 500ms; this means that the
maximum allowed heart rate is 120 bpm
If the R-wave sensing device used to synchronize treatment with the cardiac cycle is not
compatible with the input specifications of the CLINIPORATOR, or if it is not reliable to identify
the R-wave, treatment pulses could be delivered out of the period absolute refractory of the
cardiac cycle, exposing the patient to the possible risk of ventricular fibrillation or the onset of
The trigger signal must always correspond to an R wave.
If the treatment with CLINIPORATOR is carried out in the thoracic region, each wrong trigger
CLINIPORATOR must be connected to a medical device for cardiac applications that meets
the essential safety requirements defined in IEC 60601-1.
WARNING
WARNING
cardiac arrhythmias.
can cause an extrasystole.
WARNING
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