Assessment And Documentation - KaVo ESTETICA E30 Instructions For Use Manual

Instructions for use ESTETICA E30
7 Safety checks - testing instructions | 7.2 Instructions for safety checks

7.2.5 Assessment and documentation

Note
All tests conducted must be documented comprehensively. The doc-
uments must contain at least the following particulars:
▶ Name of the test centre
▶ Name of the test engineer
▶ Name of the tested device (e. g. type, serial number)
▶ Tests and measurements
▶ Data, type and measuring results of the visual inspections
▶ Data, type and measuring results of the measurements
▶ Data, type and measuring results of functional tests
▶ Measuring/test equipment including SN/test equipment number and cal-
ibration period
▶ Final evaluation
▶ Name, date and signature of test engineer
There is a copy of a test report template at the end of chapter STK. KaVo re-
commends the use of this template.
Note
Following testing, repair or adjustment, it must be verified whether the ME
equipment or ME system has been restored to the state that is required for
the intended usage before it is employed once again.
Note
If the safety of the tested ME equipment or ME system has not been
established, e.g. the tests have not been completed with positive
results, the equipment or system must be marked accordingly and
the potential hazard emanating from the equipment or system must
be communicated in writing to the RESPONSIBLE ORGANISATION
(to the operator, as a rule). This action is not required if the cause of
the malfunction could be determined and rectified. The defect must
be recorded in the protocol.
120 / 134