Section 3: Performance Verification
3- 18
3.4.2.2 Patient Leakage Current
This test is in compliance with AAMI Standard ES1, paragraph 3.3.2 and
IEC 601-1. Patient Leakage Current is measured between any individual
patient connection and power (earth) ground.
1.
Configure the electrical safety analyzer as follows:
Function:
Patient Leakage
Range:
µ
A
2.
Connect the monitor AC plug to the electrical safety analyzer as
recommended by the analyzer operating instructions for Patient Leakage
Current.
3.
Connect the electrical safety analyzer patient leakage input lead to the
monitor's patient connector.
4.
The equipotential terminal is not connected to ground.
5.
All functional earth terminals are not connected to ground.
6.
The leakage current must not exceed the values shown in the table
below:
Table 3-2: Patient Leakage Current Limits
AC LINE
POLARITY
NEUTRAL
LINE
POWER LINE
GROUND
CABLE
LEAKAGE
CURRENT
Normal
Closed
Closed
10
µ
A
Normal
Open
Closed
10
µ
A
Normal
Closed
Open
10
µ
A
Reverse
Closed
Closed
10
µ
A
Reverse
Open
Closed
10
µ
A
Reverse
Closed
Open
10
µ
A
3.4.2.3 Patient Leakage Current (Mains Voltage on the Applied Part)
This test is in compliance with AAMI Standard ES1, paragraph 4.4 and IEC
601-1. Patient Leakage Current is the measured value in a patient
connection if a source of 240 Volts, 50 Hz with respect to power (earth)
ground, is connected to that patient connection.
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 (MOAP)
Range:
µ
A
