Safety Tests
Performance Verification 33
Table 8 Enclosure Leakage Current
EN60601-1 (1990 + A1, A2, A11, A12, A13) and UL2601 (2
nd
Ed. 1997) US Deviations
Patient Leakage
Current
This test measures patient leakage current in accordance with EN60601-1,
Clause 19, for Class I, type CF equipment. Patient leakage current in this test
is measured from any individual patient connection to earth (power ground).
This test requires a sample patient cable for each device parameter. These
must be configured as recommended by the safety analyzer operating
instructions.
1. Configure the electrical safety analyzer as recommended by the analyzer
operating instructions.
2. • A1 - Connect the appropriate external power supply input power cord
to the analyzer as recommended by the analyzer operating instructions.
Connect the external power supply output cord to the monitor.
• A3 - Connect the monitor’s AC mains power cord to the analyzer as
recommended by analyzer operating instructions.
3. Connect the ECG test cable between the ECG connector on the monitor
and the appropriate input connector on the analyzer.
4. Turn the monitor on.
5. Perform the test as recommended by the analyzer operating instructions.
Patient leakage current is measured under various conditions of the AC mains
and protective earth conductor. For each condition, the measured leakage current
must not exceed that indicated below.
6. Repeat the test for SpO
2
and temperature patient connections, using appropriate
test cables.
Test Condition Polarity Allowable Leakage Current
Normal
Normal 100 µA
Reversed 100 µA
S.F.C
1
Open Supply
(A1 Only)
1. S.F.C = Single Fault Condition
Normal 150 µA
Reversed 150 µA
S.F.C
1
Open
Protective Earth
(A3 Only)
Normal 300 µA
Reversed
300 µA
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