Testing Intervals; Notes On The Test Method In Accordance With Iec 62353; Notes On Recurrent Testing - KaVo ESTETICA E30 Instructions For Use Manual

Instructions for use ESTETICA E30
7 Safety check - Test instructions | 7.1 Introduction
Measurements
▪ Measurement of the protective earth resistance in accordance with IEC
62353
▪ Measurement of the equipment leakage current - Alternative measuring
method in accordance with IEC 62353
▪ Measurement of the applied part leakage current - Alternative measuring
method in accordance with IEC 62353
NOTE
A measurement of the insulation resistance in accordance with IEC 62353
need not be carried out. This check is covered by the measurement of the
leakage current provided a safety tester specified in IEC 62353 Annex C is
used!
Functional test
Medical device function test as well as testing of all safety shutdowns with refer-
ence to accompanying documentation/instructions for use.

7.1.4 Testing intervals

Testing interval for type IIa devices is every 2 years
7.1.5 Notes on the test method in accordance with IEC
62353
▪ Protection class 1
▪ Type BF
▪ The device is permanently installed / threshold: PE conductor test < 0.3 Ω
▪ Measurement of the equipment leakage current - alternative measuring
method / threshold: < 10 mA*
▪ Measurement of applied part leakage current - alternative measuring
method / threshold: < 5mA
*The limit of the equipment leakage current corresponds to the value
defined in IEC 60601 (DIN EN 60601), taking comment 2 from table 3 into
consideration.

7.1.6 Notes on recurrent testing

NOTE
The value determined in these tests must be documented and evaluated to-
gether with the measuring process. The measured values must not exceed
the specified values.
NOTE
Comparisons with previous measurements must be carried out if the meas-
ured values are lower than the threshold values by more than 10 %. The test
intervals should be reduced if a deterioration in values is determined!
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