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8 MAINTENANCE
8.1 Routine Maintenance
Table 1 indicates the routine maintenance checks - recommended by the manufacturer - that
the user has to perform- to ensure the equipment correct operation.
In general it is not possible to carry out maintenance operations while the device is in use on the
patient. If necessary, the pedal can be replaced, taking care to exit the treatment screen in
advance. Handpieces and electrodes can be replaced without the need to restart the device.
CHECK
Handle replacement.
Pedal inspection to check for cable
abrasions,
cuts
or
connector cracks or bended contacts,
connector
and
pedal's
retention.
If any of these are found, replace the
pedal.
Power supply cord inspection to
check for cable abrasions, cuts or
tampering, plug bended contacts.
If any of these are found, replace the
power supply cord.
8.2 Periodical Preventive Maintenance
Table 2 shows preventive maintenance interventions recommended to ensure correct operation
of the equipment. They must be performed by the manufacturer or by an authorized distributor
in writing by the manufacturer. With the exception of the routine maintenance interventions
indicated in the previous section, the device does not contain any component that can be
repaired or replaced by the user technical support personnel.
TEST/SERVICE
Check the calibration and, if
necessary, re-calibrate the
device.
Verification
of
compliance
with EN60601-1 with regard
to electrical safety.
Replacement of the device's
internal parts.
The manufacturer recommends to perform a periodical check every 24 months on the
CLINIPORATOR in order to assess proper operation, calibration and electrical safety and for
preventive maintenance. The manufacturer disclaims any responsibility for adverse events or
damage, if the scheduled maintenance and the periodical check have not been performed on
the unit by the manufacturer or the authorised local dealer. No modification of this equipment is
allowed.
56
FREQUENCY
After
20
cycles or if damaged.
tampering,
Periodically, according to
sheath
the real frequency of use
of the device.
Periodically, according to
the real frequency of use
of the device.
Table 1 – Routine maintenance
FREQUENCY
Every 24 months
Every 24 months
After 500 treatment
sessions or 10
years
Table 2 – Preventive periodical maintenance
Cliniporator model EPS02 – User manual
PREVENTION
Preventing the degradation of the
performance of the Handles (After
sterilisation
these
sterilization
mechanical
cable begin to degrade).
Prevent
consequent inability to deliver the
treatment.
Avoid
electrical
inoperativity of the device.
PREVENTION
Check that the device features always comply
with the specifications.
Preventing electrical hazards.
Prevent adverse events (marginal/minor
severity class), maintain device's features.
cycles
the
properties
of
the
breakdowns
and
hazards
or
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