Patient Safety Tests

Patient This test measures patient leakage current in accordance with EN60601-1, Clause 19, for Leakage Class I, type CF equipment. Patient leakage current in this test is measured from any Current 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.

 

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 SpO2 and temperature patient connections, using

 

 

appropriate test cables.

 

 

 

 

Table 4-6. Patient Leakage Current Values

 

 

 

 

 

 

 

 

 

 

 

 

Allowable Leakage

 

Test Condition

 

Polarity

 

Current (Max.)

 

 

 

 

 

 

 

 

 

 

Type CF

 

 

 

 

 

 

 

Normal

 

Normal

 

10 µA

 

 

 

 

 

 

 

 

 

 

 

Reversed

 

10 µA

 

 

 

 

 

 

S.F.C.(Open Earth/Ground)

Normal

 

50 µA

 

 

 

 

 

 

 

 

 

 

 

Reversed

 

50 µA

 

 

 

 

 

 

 

 

What to record on the service record:

S(4): P or S(4): F

Testing the Monitor 4-43

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Philips 862474, 862478 manual Patient Leakage Current Values

862474, 862478 specifications

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