Maintenance of the Medical Surgical Device
CAUTION Risk of injury to the patient's eye!
A device malfunction could result in a risk of injury to the
patient!
• Have the device checked by the authorized technical
service in accordance with the provisions of IEC
62353 in the following cases:
– during the installation of the Medical Device,
– at regular intervals (every 12 months),
– during maintenance work,
– after repairs, upgrades, calibrations and updates of
software and firmware.
INFORMATION Risk of damaging the Medical Device!
• To keep the device safe, check the unit in accordance
with the limits of electrical leakage, as established by
the EN 60601-1 standard at least once a year. Contact
the medtech division of your installation, your
authorized distributor or the OPTIKON 2000 S.p.A.
technical service.
• Store the R-EVO SMART in a dry and clean place.
• Remove the I/A cassette after each use.
• To avoid a decrease in the safety of the device, due to
ageing, wear, etc. the user must ensure, in compliance
with the applicable national regulations, that the
normal safety technical checks have been carried out,
prescribed for this Medical Device within the scheduled
times and the stipulated measure. The technical safety
checks must be carried out exclusively by the
manufacturer or by qualified personnel. The scope of
the security engineering controls should include at least
the following items:
– Availability of the user manual
– Visual inspection of the Medical Device and its
accessories to verify the absence of damage and
the readability of the labels
– Grounding Tests
– Current leakage test
– Test operation of all device switches, buttons, sockets
and tell-tales.
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