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Section 3: Performance Verification
3-12
Table 3-4: Patient Leakage Current Limits
AC LINE
POLARITY
NEUTRAL
LINE
POWER LINE
GROUND
CABLE
IEC 601-1
AAMI/ANSI
ES1
STANDARD
Normal
Closed
Closed
100 µA
10 µA
Normal
Open
Closed
500 µA
50 µA
Normal
Closed
Open
500 µA
50 µA
Reverse
Closed
Closed
100 µA
10 µA
Reverse
Open
Closed
500 µA
50 µA
Reverse
Closed
Open
500 µA
50 µA
3.4.2.4
Patient Isolation Risk Current - (Mains Voltage on the Applied Part)
This test is in compliance with AAMI Standard ES1 (patient isolation risk
current [sink current]), and IEC 601-1 (patient leakage current). Patient Leakage
Current is the measured value in a patient connection if mains voltage is
connected to that patient connection. The applied voltage for AAMI/ANSI is 120
VAC 60 Hz, and for IEC 601-1 the applied voltage is 264 VAC 50 to 60 Hz.
Warning: AC mains voltage will be present on the patient applied part
terminals during this test. Exercise caution to avoid electrical shock hazard.
1.
Configure the electrical safety analyzer as follows:
Function:
Patient Leakage (Mains On Applied Part)
Range:
µA
2.
Connect the monitor AC plug to the electrical safety analyzer as
recommended by the operating instructions for patient sink (leakage)
current.
3.
Connect the electrical safety analyzer patient leakage input lead to all
connectors in the patient cable at the patient end of the cable.
4.
The equipotential terminal is not connected to ground.
5.
All functional earth terminals are not connected to ground.
6.
The analyzer leakage current must not exceed the values shown in the table
below.
Table 3-5: Patient Leakage Current Test Configurations -
Mains Voltage on the Applied Part
AC LINE
POLARITY
NEUTRAL
LINE
POWER
LINE
GROUND
CABLE
IEC 601-1
AAMI/ANSI
ES1
STANDARD
Normal
Closed
Closed
5 mA
50 µA
Reverse
Closed
Closed
5 mA
50 µA