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Cliniporator model EPS02 – User manual
3 SAFETY INSTRUCTIONS
3.1 Warnings
1. The device should only be used by a staff who received proper training and was instructed
to correctly use the equipment. Please contact IGEA or its authorised distributors to receive
proper training.
2. For electrical safety reasons C L I N I P O R A T O R needs grounding. Use only power supply
cords provided by the manufacturer or authorised suppliers. Make sure that the equipment
is connected to a properly grounded mains system, and that the power supply cord plug is
fully compatible with mains socket.
3. Before plugging the power supply cord to the mains, make sure that the power supply cords
are not damaged. Replace the mains cords if they are damaged: they cannot be repaired.
4. Do not connect or disconnect the power supply cords from the equipment or from the mains
with wet hands.
5. Internal parts of the C L I N I P O R A T O R reach High Voltage (above 1000V). Do not open
the device during use.
6. As applied part, use only disposable sterile electrodes approved by IGEA.
7. While treating the patient, avoid putting the applied part (electrode) on the ground by using,
for example, an external measuring device like an oscilloscope.
8. Avoid penetration of liquids or dirt into parts of the device - such as plastic cover junctions -
that could be hard to reach and clean. If necessary, cover the device's upper part with a
suitable material.
9. Observe law prescriptions if the C L I N I P O R A T O R is installed near devices that make use
of flammable anaesthetic mixtures with oxygen or nitrous oxide or parts that have been
connected to such devices and might contain flammable mixtures.
10. Electroporation treatment can cause sparks at the electrode. Treatment must not be
performed if the concentration of flammable mixtures in the area is such that they could
explode in the presence of sparks. If anesthetic substances containing oxygen or nitrous
oxide are used, a safe distance between pipes or parts containing the flammable mixture
and the CLINIPORATOR or the area to be treated is required, as required by the standards.
A mixture of the vapour of a flammable disinfection or cleaning agent with air can be treated
as a flammable anaesthetic mixture with air, subject to national or local regulations.
11. 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 site to be treated 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.
12. The induction of ventricular fibrillation following delivery of treatment into the thoracic cavity
is more likely if the patient has a history of cardiac cycle conditions that could lower the
ventricular fibrillation threshold or affect the timing of the refractory period of the cardiac
cycle .
13. If the R-wave detection device used to synchronize treatment with the cardiac cycle is not
compatible with the CLINIPORATOR's input specifications, or if it is not reliable to identify
the R-wave, the treatment impulses may be out of from the absolute refractory period of the
cardiac cycle, exposing the patient to the possible risk of ventricular fibrillation or the onset
of cardiac arrhythmias.
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