Safety Testing
FM800Encore Service Manual
18
Note
: 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 in the table below.
Note
: Note: This test requires a test cable for each patient connector. Test cables can be
configured by wrapping each sensor end individually in aluminium foil filled with
conductive gel, (enough to ensure conductivity only). Attach a wire to the foil that is
connected to a test lead from the electrical safety analyser. For ECG, measurements
are made to each patient connection.
Test Condition
Allowable Leakage
Current (
µ
A)
Normal Condition (NC)
10
SFC Open Supply (SFC 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
6.4
Patient Leakage Current (Mains on applied parts)
AC mains voltage will be present on the applied part terminals during this test.
Exercise caution to avoid electrical shock hazard.
Do not touch the patient lead clips or the simulator parts connected to patient leads
during this test, as an electrical shock will occur.
This test measures patient leakage in accordance with IEC60601-1, Class1, Type CF
equipment. In this test, 110% of mains voltage is applied between each patient connection
and earth (power ground). Patient leakage current in this test is 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
‘Patient Leakage Current’ section 6.3.
1) Repeat No’s 1-7 as shown in ‘Patient Leakage Current’ section 6.3.
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 the table
below.
Test Condition
Allowable Leakage
Current (
µ
A)
Normal Condition (NC)
50
Normal Condition RM (NCRM)
50