Test Protocol For The Safety Check - KaVo ESTETICA E30 Instructions For Use Manual

Instructions for use ESTETICA E30
7 Safety check - Test instructions | 7.3 Test protocol for the safety check
(Test of safety and function according to §7 section 3 Medical Device Operation Ordinance)
Operator
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Test before startup
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Recurrent test
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Test after repair
Manufacturer:
Equipment:
Serial number:
ID no.:
Test according to: IEC 62353 : 2014
Protection class:
Power connection: * ¹ PIE
Applied part, type:
Test:
Visual inspection:
Measurements:
Protective earth resistance
Insulation resistance
Equipment leakage current - Alternative measuring
me th od * ²
A ppl ie d pa rt leakage current - Alternative
measuring method
Functional test (according to manufacturer
instructions)
Defect/Comment/Assessment
Overall assessment:
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No safety or functional defects detected
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No immediate risk, detected defects can be remedied in the short term.
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Device must be taken out of commission until defects are remedied!
Device fails to meet requirements - Modification / replacement of components/de-commissioning
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recommended.
Date / signature
*¹
PIE Permanently installed equipment
NPS Non-DETACHABLE POWER SUPPLY CORD
DPS DETACHABLE POWER SUPPLY CORD
*² 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
Date this test protocol was created: 2021-07-28

7.3 Test protocol for the safety check

Test Protocol - Safety Check
I II
NPS DPS
B BF
Limit
0,3
optional: Measurement is not to be
10 mA
5 mA
Testing organisation
Name of the test engineer
Date of testing:
next recurrent test required in
6 12
Measuring device used:
Make:
Type:
Ser. no.:
Calibration date
Measured value
Ω Ω
performed
mA
mA
113 / 124
months
18 24
Passes test
no
yes
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