Assessment And Documentation - KaVo ESTETICA E30 Instructions For Use Manual

Instructions for use ESTETICA E30
7 Safety check - Test instructions | 7.2 Instructions for the safety check
Safety shutdown actu-
ated
① Stirrup on foot control
② Assistant element
③ Backrest
④ Kickplate
⑤ bench for right/left
conversion with bench re-
moved

7.2.5 Assessment and documentation

NOTE
All tests conducted must be documented comprehensively. The docu-
ments must contain at least the following particulars:
Name of the test centre
Name of tester
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 results of the measurements
Data, type and results of the functional tests
Measuring/test equipment including SN/test equipment number and calibra-
tion period
Final assessment
Date and signature of the tester
There is a copy of a test report template at the end of the chapter on Safety
Checks. KaVo recommends to use 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 res-
ults, the equipment or system must be marked accordingly and the
potential hazard associated with 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 was determined and rectified. But the defect must be re-
corded in the protocol.
LED on assistant ele-
ment
112 / 124
LED on dentist ele-
ment