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Patient Leakage Current - Mains Voltage on the Applied Part

WARNING: AC power voltage will be present on the applied part terminals during

this test. Exercise caution to avoid electrical shock hazard.

WARNING: Do not touch the patient leads clips or the simulator parts connected

to patient leads during this test as an electrical shock will occur.

This test measures patient leakage current in accordance with IEC60601-1, clause 19, for

Class I, type CF equipment. In this test, 110% of mains voltage is applied between each

patient connection and earth (power ground). Patient leakage current is then measured

from any individual patient connection to earth.

Note: Keep the patient test cable length as short as possible during the leakage test.

Note: This test requires the same test cables for each patient connector as described in

the section Patient Leakage Current.

1. Configure the electrical safety analyzer as recommended by 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 test as recommended by the analyzer operating instructions.

6. Repeat the test for SpO

and temperature patient connections, using the appropriate

test cables.

Note: Patient leakage current is measured with normal and reverse mains polarity. For

each condition, the measured leakage current must not exceed that indicated in

Table 6.

Table 6. Patient Leakage Current Values - Mains Voltage on Applied Part

Test Condition Allowable Leakage Current (microamps)

Normal polarity (SFC) 50

Reverse polarity (SFCRM) 50

1 2 ... 30 31 32 33 34 35 36 37 38 39 40 ... 109 110

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