Mindray DC-8 EXP

Electrical Safety Inspection A-17
ELECTRICAL SAFETY INSPECTION FORM
（Class I equipment）
Overall assessment:
□
Scheduled inspection
Test item: 1, 2, 3
□
Unopened repair type
Test item: 1, 2, 3
□
Opened repair type, not modify the power part
including transformer or patient circuit board
Test item: 1, 2, 3, 4, 5
□
Opened repair type, modify the power part including
transformer or patient circuit board
Test item: 1, 2, 3, 4, 5, 6, 7, 8
Location:
Technician:
Equipment:
Control Number:
Manufacturer:
Model:
SN:
Measurement equipment /SN:
Date of Calibration:
INSPECTION AND TESTING
Pass/Fail
Limit
1
Power Cord Plug
2
Device Enclosure and Accessories
3
Device Labeling
4
Protective Earth Resistance
Ω
Max 0.2 Ω
5
Earth
Leakage
Normal condition(NC)
____μA
Max:
NC: 300μA(refer to
UL60601-1) *
NC: 500μA(refer to
IEC60601-1) *
SFC: 1000μA
Single Fault condition(SFC)
____μA
6
Patient
Leakage
Current
Normal condition(NC)
□BF___μA
Max:
BF applied part:
NC:100μA, SFC: 500μA
Single Fault condition(SFC)
□BF___μA
7
Mains on Applied Part Leakage
□BF___μA
Max:
BF applied part: 5000μA
8
Patient
Auxiliary
Leakage Current
Normal condition(NC)
□BF___μA
Max:
BF applied part:
NC:100μA, SFC: 500μA
Single Fault condition(SFC)
□BF___μA
Note:
The equipment which sell to America shall comply with the requirement of UL60601-1,
others shall comply with the requirement of IEC60601-1.
Name/ Signature: ____________________ Date:_____________________________