OMS ARCADIA EXT S.T.01/3R ED.0 REV.8 09/2020
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6.2. SCHEDULED MAINTENANCE
General functional checks
Annual or after 8000
hours of use
Periodic checks of general
safety/performance - IEC 62353
6.3. FUNCTIONAL AND SAFETY CHECKS
In order to guarantee the operational and functional safety of the chair, it is necessary to do an annual
maintenance procedure, that must be done with authorized OMS technicians.
Medical devices are built to ensure safety even in the event of first failure for the patient, the operator or third
parties, must follow the periodically checks, the level of effective safety.
It is necessary to perform periodic safety tests and checks at least every two
years in order to identify any electrical failures (e.g. damaged insulation),
which may reduce the initial safety level.
Such checks must be done by a OMS authorized technician, with appropriate tools and equipment and
according to well-defined standards; The IEC 62353 standard is the benchmark for the control of electro-
medical devices manufactured in accordance with IEC 60601-1.
Periodic tests and checks shall include visual checks, measurements of ground connections and dispersed
currents; The results and measured values are necessarily recorded on specific forms and must be stored in
order to demonstrate the maintenance of the appliance (complete with its accessories) in time, and to monitor
the safety level of the device.
Following the first commissioning (installation),
After repair or maintenance work,
During periodic checks.
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