OMS LINEA ESSE S.T.01/3S ED.0 REV.14 03/2017
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FUNCTIONAL SAFETY CHECKS
To guarantee the dental unit’s proper operation, the unit must be checked by a qualified OMS services
technician according to the maintenance schedule, CARE KIT has to be performed once in the year.
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.
CAUTION
It is mandatory perform periodic safety tests and checks at least every two years in
order to avoid 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.
DANGER
The use of the dental unit and chair is permitted only if all safety checks have been
successful past.
EXTRAORDINARY MAINTENANCE
Some extraordinary maintenance operations are described below; we recommend that all must be done by
authorized technicians O.M.S.
O.M.S. will provide on request all wiring diagrams, list of components, descriptions, calibration instructions, or
other information that assist the authorized technicians O.M.S. in the repair of the device.
EXTRAORDINARY MAINTENANCE
Activity Frequency By whom? Note/references
Fuse replacement When necessary Authorised
technician
Refer to technical documentation
Work due to malfunctions, faults or
downtime
When necessary
Authorised
technician
Refer to technical documentation
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