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Patient Safety Tests
Testing the Monitor
4-43
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.
Table 4-6. Patient Leakage Current Values
What to record on the service record:
S(4): P or S(4): F
Step Action
1 Configure the electrical safety analyzer as recommended by the analyzer
operating instructions.
2 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 (Max.)
Type CF
Normal Normal 10 µA
Reversed 10 µA
S.F.C.(Open Earth/Ground) Normal 50 µA
Reversed 50 µA