No.
Check Item
Check Procedure
Criteria
14. Electrical Safety
01 Earth
Leakage
Current (NC)
Measure the earth leakage current of
normal condition using a safety tester.
According to test procedure of IEC 60601-1 19.
Earth Leakage Current (NC)
Should be
≤
0.1mA
02 Earth
Leakage
Current (SFC)
Measure the earth leakage current of
single failure condition using a safety
tester.
According to test procedure of IEC 60601-1 19
Earth Leakage Current
(SFC)
Should be
≤
0.5mA
03 Patient
Leakage
Current-I (NC)
Measure the patient leakage current-I of
normal condition using a safety tester.
According to test procedure of IEC 60601-1 19.
【
AC/DC
】
Patient Leakage Current-I
(NC)
≤
0.01mA
04 Patient
Leakage
Current-I (SFC)
Measure the patient leakage current-I of
single failure condition using a safety
tester.
According to test procedure of IEC 60601-1 19.
【
AC/DC
】
Patient Leakage Current-I
(SFC)
≤
0.05mA
Patient Leakage Current-III
(SFC)
≤
0.05mA
05 Patient
Leakage
Current-III (SFC)
Measure the patient leakage current-III of
single failure condition using a safety
tester.
According to test procedure of IEC 60601-1 19.
06 Patient
Leakage
Current (NC)
Measure the patient leakage current (NC)
of normal condition using a safety tester.
According to test procedure of IEC 60601-1 19.
【
AC/DC
】
Patient Leakage Current
(NC)
≤
0.01mA
07 Patient
Leakage
Current (SFC)
Measure the patient leakage current
(SFC) of single failure condition using a
safety tester.
According to test procedure of IEC 60601-1 19.
【
AC/DC
】
Patient Leakage Current
(SFC)
≤
0.05mA
No
Check Item
Check Procedure
Criteria
14. 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.
08 Protective
Ground
Resistance
Measure the protective ground continuity
resistance.
According to test procedure of IEC 60601-1 18.
Should be 0.1
Ω
or below
between the protective
ground terminal and
accessible conductive part.
Protective ground
resistance of the power
cable should be 0.1
Ω
or
below.
Should withstand applied
voltage.
09 Withstand
Voltage
Test (A-a1)
Apply AC1500V for 1 minute between
primary power source and accessible
metal part with protective ground (A-a1).
According to test procedure of IEC 60601-1 20.
Should withstand applied
voltage.
10 Withstand
Voltage
Test (A-a2)
Apply AC4000V for 1 minute between
primary power source and exterior
without protective ground (A-a2).
According to test procedure of IEC 60601-1 20.
11 Withstand
Voltage
Test (B-a)
Apply AC4000V for 1 minute between
primary power source and applied part
(B-a).
Note: The voltage differs depending on
the internal protective circuit
composition of the equipment.
According to test procedure of IEC 60601-1 20.
Should withstand applied
voltage.
7
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42
Summary of Contents for DynaScope 7000 Series
Page 46: ...MGU 701 MGU 702 Multigas Unit Optional Weight 1 8kg 1 6 ...
Page 47: ...2 1 Specification Chapter 2 Specification Performance 2 2 Specification 2 2 Performance 2 3 ...
Page 70: ...4 4 Blank Page ...
Page 71: ...Software Upgrade Chapter 5 Software Upgrade 5 2 Software Upgrade Verification 5 4 5 1 ...
Page 92: ...6 18 Blank Page ...