Patient Safety Checks
162
Testin
the Instrument
Reporting safety test S(2) in the Service record
S(2):P/x
or
S(2):F/x
where P = Pass, F = Fail and x is the value defined in the test described above
S(3) Patient Leakage current - Single Fault Condition (S.F.C.) mains on applied
part
Expected test results:
Maximum leakage current, x = 50µA @ 250V (IEC60601-1 and UL2601-1)
Measures patient leakage current from applied Part to earth caused by external main
voltage on applied Part with switch S5 open and closed. Each polarity combination
possible is tested using S2 and S6. This test is applicable for every measurement input
(ECG / RESP, Invasive Pressure, CO
2
, SpO
2
, Temperature)
Reporting safety test S(3) in the Service record
S(3):P/x
or
S(3):F/x
where P = Pass, F = Fail and x is the value defined in the test described above
Insulating pad
R
S6
(*) Not present in Class 2
N (L)
Instrument under test
Applied part
PE
S1
S2
L (N)
S4
(*)
Signal part
in- and/or
output
L (N)
N (L)
S5
MD