OMS LINEA PATAVIUM, Инструкция по эксплуатации

Страница: 55 / 70

OMS LINEA PATAVIUM S.T.01/3X ED.0 REV.8 09/2017
55
FUNCTIONAL SAFETY CHECKS
To guarantee dental unit operating and functional safety, have an authorised OMS technician perform routine
maintenance once a year.
Medical electrical devices are built to guarantee patient, operator or third party safety in the event of fault.
Consequently, the actual level of safety must be periodically checked.
WARNING
Run periodic safety checks and tests at least once every two years to find any
electrical faults (i.e. damaged insulation) that could reduce the initial level of safety.
These checks should be performed by an authorised OMS technician with suitable tools and equipment
according to specific standards; regulation IEC 62353 is the reference standard for medical electrical device
controls manufactured in accordance with IEC 60601-1.
Periodic checks and tests include visual inspection, grounding connection measures and dispersed currents;
the results and values measured must be recorded in a specific form and kept to demonstrate device
compliance in time (complete with accessories) and to monitor device safety levels.
Technical safety checks must be performed and documented:

after first start up (installation),

after repairs or maintenance work,

during periodic tests.
DANGER
Dental unit use is only permitted if all safety checks were passed