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11-8
No Check
Items
Check
Procedure
Criteria
15. Periodic Replacement Parts, Aftertreatment
01 NIBP
Unit
Check the number of measurements or date of
first usage.
It should not exceed 100,000 times, or six
(6) years from the first usage.
02
Lithium-Ion Battery
Pack BTO-005
Check the number of charging/discharging
times or the first usage date.
The number of charging/discharging
times should not exceed 300 times, or
usage duration should not exceed one
year.
03
CO
2
Unit
(When HCP-810/
HCP-820 is used)
Check the usage hours.
It should not exceed 30,000 hours.
04
Restore Backup Data
After the check procedure, restore the setup
data from the SD card or USB memory.
If the setting information before the check
procedure have been written down, restore the
settings to original state as written.
The settings should be properly
restored to original state.
No Check
Items
Check
Procedure
Criteria
16. Electrical safety
01 Earth
Leakage
Current (NC)
Measure the earth leakage current under
normal condition using a leak measurement
safety tester.
Test according to the test method of IEC 60601-1.
Earth Leakage Current (NC)
Should be 5mA or less
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.
Earth Leakage Current (SFC)
Should be 10mA or less
03
Touch Current (NC)
Measure the touch current under normal
condition using a leak measurement safety
tester.
Test according to the test method of IEC 60601-1.
Touch Current (NC)
Should be 100
μ
A or less
04
Touch Current (SFC)
Measure the touch current under single failure
condition using a leak measurement safety
tester.
Test according to the test method of IEC 60601-1.
Touch Current (NC)
Should be 500
μ
A or less
05 Patient
Leakage
Current (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] Type CF Applied Part
Patient Leakage Current (NC)
Should be10
μ
A or less
06 Patient
Leakage
Current (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] Type CF Applied Part
Patient Leakage Current (SFC)
Should be50
μ
A or less
07 Total
Patient
Leakage
Current (NC)
Measure the total patient leakage current under
normal condition using a leak measurement safety
tester.
Test according to the test method of IEC 60601-1.
[AC/DC] Type CF Applied Part
Patient Leakage Current (NC)
Should be 50
μ
A or less
08 Total
Patient
Leakage
Current (SFC)
Measure the total 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] Type CF Applied Part
Patient Leakage Current (SFC)
Should be 100
μ
A or less
09 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.
Patient Auxiliary Current (NC)
Should be10
μ
A or less
10 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.
Patient Auxiliary Current (SFC)
Should be 50
μ
A or less
Summary of Contents for DS-8400
Page 4: ......
Page 36: ...xxxii ...
Page 46: ...1 6 ...
Page 74: ...3 4 ...
Page 117: ...5 1 Wiring Diagram Chapter 5 Main Unit DSC 8400 5 2 ...
Page 120: ...5 4 ...
Page 128: ...6 8 ...
Page 130: ...7 2 DSC 8410 CPU Unit BLK ...
Page 132: ...7 4 DSC 8410 Power Supply Unit BLK ...
Page 135: ...7 7 DSC 8410 Assembly 1 Front Case Part ...
Page 137: ...7 9 DSC 8410 Assembly 2 CPU Unit Part ...
Page 139: ...7 11 DSC 8410 Assembly 3 Joint Part Expansion Module Part ...
Page 141: ...7 13 DSC 8410 Assembly 4 COM AUX Part Recorder Part ...
Page 143: ...7 15 DSC 8410 Assembly 5 Power Board Part Power Supply Unit Part ...
Page 145: ...7 17 DSC 8410 Assembly 6 Rear Case Sheet Metal Part Item number ...
Page 147: ...7 19 DSC 8410 Assembly 7 Rear Case Part Item number Connector position ...
Page 149: ...7 21 DSC 8410 Assembly 8 Front Rear Stand Part ...
Page 152: ...7 24 DSC 8410 Assembly 10 Super Unit Cover Assembly ...
Page 154: ...7 26 DSC 8410 Assembly 11 Super Unit Part Blank Cover Recorder Part Blank ...
Page 156: ...7 28 DSC 8410 Assembly 12 Labeling ...
Page 168: ...8 6 ...
Page 222: ...9 54 ...
Page 258: ...10 36 ...
Page 272: ...11 14 ...