End Of Life Disposal; Essential Performances - IGEA Cliniporator EPS02 User Manual

CLINIPORATOR includes an RFID device that has the following characteristics:
Antenna
Frequency band
Maximum power of RF signal
Modulation
Transmission standard
ERP
The transmitting antenna is normally off and is activated only when the menu of selection is
displayed on the screen

End of Life Disposal

9.10
The end of life disposal of C L I N I P O R A T O R does not cause any risk for environment or the
personnel, provided that the device and the electrical parts given as accessories are disposed
in accordance with the national regulation in force for the disposal of electric or electronic
equipment.

Essential performances

9.11
In accordance with EN 60601-1, "essential performance" is defined as the performance of a
clinical function for which loss or degradation beyond the limits specified by the manufacturer is
deemed to pose an unacceptable risk ".
The essential performances of CLINIPORATOR, identified by the manufacturer according to
this definition, are the control of the energy delivered during the treatment. It has been
estimated that uncontrolled energy delivery above 60 Joules would expose the patient to a risk
deemed unacceptable.
To ensure the maintenance of essential performances it is necessary to carry out the checks
and preventive maintenance interventions described in paragraph 8.2.
The verification of the essential performances requires the measurement, through an
oscilloscope equipped with a suitable high voltage probe, of the amplitude (V) of the supplied
pulses and of the duration (L) of the pulses. The following specifications must be respected:
- V ≤ 1.1 x V nominal (e.g. 1.1 x 730 V = 803 V);
- High Voltage Pulse: L ≤ 2.48 ms
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Cliniporator model EPS02 – User manual
Loop type; area < 0.05 m
13.553 – 13.567 Mhz
< 60 dBuA/m at 10 m
Backscatter ASK
ISO 15693
1.32 uW
2