Essential Parts Of The Safety Check; Testing Intervals; Notes On The Test Method In Accordance With Iec 62353 - KaVo ESTETICA E30 Instructions For Use Manual

Instructions for use ESTETICA E30
7 Safety checks - testing instructions | 7.1 Introduction
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.

7.1.3 Essential parts of the safety check

Visual inspection
Optical appraisal of the safe and usable condition of the medical device and its
accessories.
Measurements
▪ Measurement of the protective earth resistance in accordance with IEC
62353 (DIN VDE 0751-1)
▪ Measurement of the leakage current of the device EUL in accordance with
IEC 62353
▪ 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 refer-
ence to accompanying documentation/instructions for use.

7.1.4 Testing intervals

▪ Check every 2 years in accordance with Type II
7.1.5 Notes on the test method in accordance with IEC
62353
▪ Protection class 1
▪ Type BF
▪ The device is firmly connected / threshold: SL < 0,3 Ω
▪ Measurement according to EUL / threshold: < 10mA*
▪ Measurement according to EGA / threshold: < 5 mA*
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