Instructions for use ESTETICA E70 Vision / E80 Vision
7 Safety check - Test instructions | 7.1 Introduction
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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 Components of the safety check
Visual inspection (inspection by examination)
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
▪ Measurement of the equipment leakage current - Alternative measuring
method in accordance with IEC 62353
▪ Measurement of the equivalent patient leakage current - Alternative meas-
uring 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 Test intervals
▪ Check every 2 years in accordance with Type II
7.1.5 Notes on test procedure 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 measure-
ment / threshold: < 10 mA*
▪ Measurement of the equivalent patient leakage current - Alternative meas-
urement / threshold: < 5 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.
Содержание ESTETICA E70 Vision
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