Components Of The Safety Check; Testing Intervals; Notes On The Test Method In Accordance With Iec 62353 - KaVo Primus 1058 Life TM Instructions For Use Manual

Instructions for use Primus 1058 Life
7 Safety check - Test instructions | 7.1 Introduction
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 Testing intervals

▪ Testing interval every 2 years according to device type IIa (without HF sur-
gery)
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 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.
92 / 126