8
AR1200VIEW
CARDIOLINE
®
is an et medical devices SpA brand
w w w . c a r d i o l i n e . b i z
4 Testing the safety characteristics
The safety regulations envisage two important tests:
The leakage currents test measures the value of the currents lost in relation to the safety of the patient and the operator.
Warning: All safety tests must be performed according to standards EN.60601-1(1990 paragraphs 19 - 20)
EN 60601-2-25 (1995) unless otherwise specified in the local safety regulations.
4.1 Leakage currents test
Warning: This test must be performed every time the device has been opened for inspection and/or
repair, and in any event every two years, unless otherwise specified by the local safety regulations.
Connect the electrocardiogram to the battery charger, and then connect this assembly to the measuring
instrument according to the instrument’s manual, recalling that:
'
The leakage current to the casing is measuring between the mains supply circuits and a metal sheet no greater than 20 x 10 cm
pressed against the casing of the device.
'
The leakage current in the patient is measured between the mains and the applied part. For connection to the applied part use the
patient lead itself.
"'
The leakage current in the patient with mains voltage directly on the applied part (first failure condition) is measured between the meta
sheet connected to the device and the applied part.
'
The auxiliary current in the patient is measured singly on each electrode (excluding the reference electrode) compared to all the other
electrodes connected together.
Note: Make the measurements following the indications in the instrument user manual, and check that the leakage current values
measured are less than or equal to those listed in table IV.
Table IV.
Admissible permanent values for leakage and auxiliary currents in the patient in mA (milliamperes).
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