A-2
A.2.2 Contextual Inspection
Test Item Acceptance Criteria
The enclosure and accessories
No unusual noises (e.g., a rattle inside the case).
No unusual odors (e.g., burning or smoky odor, particularly from ventilation holes).
No taped notes that may suggest device deficiencies or operator concerns.
A.3 Device Labelling
Check the labels provided by the manufacturer or the healthcare facility are present and legible.
Main unit label
Integrated warning labels
A.4 Scheduled Electrical Safety Inspection
For scheduled electrical safety inspection, perform all the test items listed in A.6 ELECTRICAL SAFETY INSPECTION
FORM.
A.5 Electrical Safety Inspection after Repair
The following table specifies test items to be performed after the equipment is repaired. Refer to A.6 ELECTRICAL
SAFETY INSPECTION FORM for the description of the test items.
Repair with main unit not disassembled
Test items: 1, 2, 3
Repair with
main unit
disassembled
When neither power supply PCBA nor
patient electrically-connected PCBA is
repaired or replaced
Test items: 1, 2, 3, 4
When power supply PCBA is repaired or
replaced
Test items: 1, 2, 3, 4, 5
When patient electrically-connected PCBA is
repaired or replaced
Test items: 1, 2, 3, 4, 6, 7, 8
When both power supply PCBA and patient
electrically- connected PCBA are repaired or
replaced
Test items: 1, 2, 3, 4, 5, 6, 7, 8
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