Technician's instructions KaVoLUX 540 LED U / T
11 Safety checks - Test instructions | 11.2 Ceiling mounting
44 / 56
Note
An ME system that is connected to the power supply mains by means of a multiple
socket outlet must be treated as one device during checks and testing.
Note
If the ME system or part of the system is connected to the power supply mains by
means of an isolating transformer, the transformer must be included in the meas-
urements.
Note
In ME systems, in which more than one ME device are interconnected via data lines
or otherwise, e. g. via electrically conductive attachments or coolant tubes, the earth
wire resistance of every single device must be checked.
Note
If it should be impossible to check single ME devices that are functionally connected
to an ME system individually for technical reasons, the ME system must be checked
as a whole.
Components of the safety checks
Visual inspection
Optical appraisal of the safe and usable condition of the medical device and its ac-
cessories.
Measurements
▪ Measurement of the earth wire resistance in accordance with IEC 62353 (DIN
VDE 0751-1)
▪ Measurement of the leakage current of the device EUL in accordance with IEC
62353 (DIN VDE 0751-1)
▪ Measurement of the leakage current of the user part EPL in accordance with IEC
62353 (DIN VDE 0751-1)
Note
Measurement of the insulation resistance in accordance with IEC 62353 (DIN VDE
0751-1) is not required. This check is covered by the measurement of the leakage
current provided a prescribed safety tester in accordance with IEC 62353 (DIN VDE
0751-1) Annex C is used!
Functional test
Medical device function test as well as testing of all safety shutdowns with reference to
accompanying documentation/ instructions for use.
Test intervals
▪ Check every 2 years in accordance with Type II
Notes on test procedure in accordance with IEC 62353
▪ Protection class 1
Summary of Contents for KaVoLUX 540 LED U
Page 1: ...Technician s instructions KaVoLUX 540 LED U T...
Page 54: ......
Page 55: ......
Page 56: ...1 008 8681 Fk 20161006 4 en...