Fukuda DS-8500 - Page 221

9-7
Chapter 9 Maintenance Check Daily and Periodic Check
02 Earth Leakage
Current (SFC)
Measure the earth leakage current under single
failure condition using a leak measurement
safety tester.
Test according to the test method of IEC 60601-
1.
It should be 10 mA or less.
03 Patient Leakage
Current I (NC)
Measure the patient leakage current under
normal condition using a leak measurement
safety tester.
Test according to the test method of IEC 60601-
1.
AC/DC
It should be 0.01 mA or less.
04 Patient Leakage
Current I (SFC)
Measure the patient leakage current under
single failure condition using a leak
measurement safety tester.
Test according to the test method of IEC 60601-
1.
AC/DC
It should be 0.05 mA or less.
05 Patient Leakage
Current III (SFC)
Measure the patient leakage current under
single failure condition using a leak
measurement safety tester.
Test according to the test method of IEC 60601-
1.
It should be 0.05 mA or less.
06 Patient Auxiliary
Current (NC)
Measure the patient auxiliary current (NC)
under normal condition using a leak
measurement safety tester.
Test according to the test method of IEC 60601-
1.
It should be 0.01 mA or less.
07 Patient Auxiliary
Current (SFC)
Measure the patient auxiliary current (SFC)
under single failure condition using a leak
measurement safety tester.
Test according to the test method of IEC 60601-
1.
It should be 0.05 mA or less.
No Check Items Check Procedure Criteria
14. Electrical Safety ( )
Perform the following check item as appropriate. Check these items when you have disassembled the equipment to
check or replace the boards or unit.
08 Protective ground
resistance
Measure protective ground continuity
resistance.
Test according to the test method of IEC 60601-
1.
It should be 0.1Ω or less between the
protective earth terminal and accessible
conductive part. The protective earth
conductor resistance in the power cable
should be 0.1Ω or less.
09 Withstand Voltage
Test (A-a1)
Apply 1500V for 1 minute between mains part
and accessible metal part which is protectively
earthed.
Test according to the test method of IEC 60601-
1
It should resist the applied voltage.
10 Withstand Voltage
Test (A-a2)
Apply 4000V for 1 minute between mains part
and exterior without protective earth.
Test according to the test method of IEC 60601-
1.
It should resist the applied voltage.
11 Withstand Voltage
Test (B-a)
Apply 4000V for 1 minute between mains part
and applied part.
[Caution] The test voltage may differ as the
internal protective circuit configuration differs
depending on the device.
Test according to the test method of IEC 60601-
1.
It should resist the applied voltage.