
28
Note: The analyzer leakage current indication must not exceed the values listed in Table 4.
Table 4. Enclosure Leakage Current
Test Condition Allowable Leakage Current (microamps)
Normal Condition (NC) 100
SFC Open Supply (OS) 500
SFC Open Earth (SFC OE) 500
Normal Condition RM (NCRM) 100
SFC Open Supply RM (SFC OSRM) 500
SFC Open Earth RM (SFC OERM) 500
Patient Leakage Current
This test measures patient leakage current in accordance with IEC60601-1, 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).
1. Configure the electrical safety analyzer as recommended by the analyzer operating
instructions.
2. Connect the monitor’s AC power cord to the analyzer as recommended by the 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 on the monitor.
5. Perform the patient leakage current test as recommended by the analyzer operating
instructions.
6. Repeat the patient leakage current test for the SpO
2
and temperature patient
connections, using the appropriate test cables.
Note: Patient leakage current is measured under various conditions of the AC power and
protective earth conductor. For each condition, the measured leakage current must
not exceed that indicated in Table 5.
Note: This test requires a test cable for each patient connector. For example, the ECG
test cable consists of the ECG cable connector, with all conductors shorted together,
connected to a test lead from the electrical safety analyzer. Test cables for SpO
2
and temperature can be configured in a similar manner, by wrapping each sensor
end individually with aluminum foil filled with conductive gel (only enough gel to
ensure conductivity). Attach a wire to the foil that is connected to a test lead from
the electrical safety analyzer.
Table 5. Patient Leakage Current Values
Test Condition Allowable Leakage Current (microamps)
Normal Condition (NC) 10
SFC Open Supply (OS) 50
SFC Open Earth (SFC OE) 50
Normal Condition RM (NCRM) 10
SFC Open Supply RM (SFC OSRM) 50
SFC Open Earth RM (SFC OERM) 50
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