FHIT TEC_FHIT_M Rev.1 11/2016
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5.2.
REGOLAZIONI
REGULATION
Attivity
Frequency
Who does it
?
Note/reference
Power cycle the PC
End of day
Operator
Power cycle the Sensor
End of exam
Operator
5.3.
REGULATION AND SETTINGS
SCHEDULED MAINTENANCE
Activity
Frequency
Who does it?
Note/reference
Verify the general function
by manufacturer
Half year
Manufacturer
Instructions for shipping are
inside the product case.
Verify the general function
Annualy or after 50
work hours
Authorized technician
Instructions for shipping are
inside the product case.
Periodic verify of
security/performance
– IEC
62353
Two years
Authorized technician
Mandatory
5.3.1.
FUNCTIONAL AND SECURITY CHECK
To guarantee the operational and functional security of the fHIT device it is necessary to submit the device to
the planned maintenance annually. The task is performed by an authorized BEON SOLUTIONS SRL
technician.
Electromedical devices are built to guarantee the patient, operator or third party safety in case of first failure,
for this it is necessary to frequently check the security level offered by the device.
It is necessary do safety test and check every two years, to identify possible electrical damage (ex. damage to
the isolation), that could reduce the security level.
This control must be done by an Authorized BEON SOLUTIONS SRL technician, with appropriate tools and
equipment complying to precise standards; IEC 62353 standard is the reference for electromedical device
check product compliance with IEC 60601-1 standard.
Periodical tests foresee visual inspection, measurement of dispersion currents: results and measured values
need to be registered in dedicated forms and must be archived to demonstrate the maintenment in the time of
the device compliance (with all its accessory), and make the security device level under control.
Security technical check must be documented and implemented:
-
Following the first installation
-
After the maintenance and reparation work
-
During the periodic check
N.B The use o the fHIT device is allowed only if all the security checks gave a positive result.
