Instructions for use KaVoLUX 540 LED U / T
8 Safety check - Test instructions | 8.2 Ceiling mounting
Functional test
Medical device function test as well as testing of all safety shutdowns with refer-
ence 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
▪ Type B
▪ The device is firmly connected / threshold: SL < 0,3 Ω
▪ Measurement according to EUL / threshold limit: < 10 mA*
*The limit of the equipment leakage current corresponds to the value defined in
IEC 60601 (DIN EN 60601), taking comment 2 from table 2 into consideration.
Notes on repeat tests
Note
The value determined in these tests must be documented and evaluated to-
gether with the measuring processes. The measured values may not over-
shoot the specified values.
Note
Comparisons with previous measurements must be carried out if the meas-
ured values undershoot the threshold values by more than 10 %. The test in-
tervals should be reduced if a deterioration in values is determined!
8.2.2 Instructions for the safety check
Visual inspection
Check the following items in advance:
▪ Has the equipment of the ME device or the ME system been changed since
the last inspection?
▪ Has the change been documented and approved (test protocol of safety
check STK)?
▪ Are there any indications of insufficient safety?
Visual inspection and assessment of the medical device
and accessories
The following list is for exemplary purposes and makes no claim of being com-
plete.
Check the following items:
▪ Stability of the device
▪ No damage to the cladding or casing (cracks, breakage)
▪ Functioning of the carrier systems of the operating light (brakes, height ad-
justment, etc.)
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