E-2
E.3
Device Labelling
Check the labels provided by the manufacturer or the healthcare facilities are present and legible.
Main unit label
Integrated warning labels
E.4
Patient Leakage Current
Patient leakage currents are measured between a selected applied part and mains earth. All measurements have a true
RMS only
The following outlet conditions apply when performing the Patient Leakage Current test.
normal polarity (Normal Condition)
reverse polarity (Normal Condition)
normal polarity with open neutral (Single Fault Condition)
reverse polarity with open neutral (Single Fault Condition)
normal polarity with open earth (Single Fault Condition)
reverse polarity with open earth (Single Fault Condition)
LIMITS
For CF
applied parts
10μA in Normal Condition
50μA in Single Fault Condition
For BF
applied parts
100μA in Normal Condition
500μA in Single Fault Condition
E.5
Mains on Applied Part Leakage
The Mains on Applied Part test applies a test voltage, which is 110% of the mains voltage, through a limiting resistance,
to selected applied part terminals. Current measurements are then taken between the selected applied part and earth.
Measurements are taken with the test voltage (110% of mains) to applied parts in the normal and reverse polarity
conditions
The following outlet conditions apply when performing the Mains on Applied Part test.
Normal Polarity
Reversed Polarity
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