Users Manual

13. Maintenance and Inspection
69
No Check Item Check Procedure Criteria
03 Leakage current
when external
voltage is
applied to the
patient
connection in
the Type F
attaching part
(SFC)
Measure the leakage current
when external voltage is
applied to the patient
connection in the Type F
attaching part using a leak
measurement safety tester.
According to test procedure of
IEC 60601-1 8.7.4
Leakage current when
external voltage is
applied to the patient
connection in the Type
F attaching part. (SFC)
≤0.05mA.
04 Total patient
leakage current
that runs
through the
ground from the
total patient
connecting part.
(NC)
Measure the total patient
leakage current that runs
through the ground from the
patient.
According to test procedure of
IEC 60601-1 8.7.4
[AC/DC]
From the patient
connecting part to the
ground (NC)
≤0.05mA.
05 Leakage current
when external
voltage is
applied to the
patient
connection in
the Type F
attaching part
(SFC)
Measure the leakage current
when external voltage is
applied to the patient
connection in the Type F
attaching part using a leak
measurement safety tester
According to test procedure of
IEC 60601-1 8.7.4
Leakage current when
external voltage is
applied to the patient
connection in the Type
F attaching part. (SFC)
≤0.01mA.
06 Patient auxiliary
current (NC)
Measure the patient auxiliary
current (NC) using a leak
measurement safety tester
According to test procedure of
IEC 60601-1 8.7.4
Patient auxiliary
current (NC)
≤0.01mA.
No Check Item Check Procedure Criteria
8. Electrical Safety (*)
Perform the following check item as appropriate. Check these items when
you have disassembled the equipment to check/ replace the boards or units.
07 Withstand
Voltage Test
(the enclosure –
isolated
connecting part)
Apply AC 1500V for 1 minute
between the enclosure and a
connecting part.
Note: The voltage differs
depending on the internal
protective circuit composition
of the equipment.
According to test procedure of
IEC 60601-1 8.8.3
Should withstand
applied voltage.