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Mindray DC-32 - Appendix A ELECTRICAL SAFETY INSPECTION FORM

Mindray DC-32
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ELECTRICAL SAFETY INSPECTION A-15
ELECTRICAL SAFETY INSPECTION FORM
Class I equipment
Overall assessment:
Scheduled inspection
Test item: 1, 2, 3, 4, 5, 6, 7
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
Opened repair type, modify the power part including
transformer
Test item: 1, 2, 3, 4, 5
Opened repair type, modify patient circuit board
Test item: 1, 2, 3, 4, 6, 7
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
Functional test (parameters tested):
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: _____________________________

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