A-2
A.2 Device Enclosure and Accessories
A.2.1 Visual Inspection
Test Item Acceptance Criteria
The enclosure and
accessories
No physical damage to the enclosure and accessories.
No physical damage to meters, switches, connectors, etc.
No residue of fluid spillage (e.g., water, coffee, chemicals, etc.).
No loose or missing parts (e.g., knobs, dials, terminals, etc.).
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 smells (e.g., burning or smoky smells, particularly from
ventilation holes).
No taped notes that may suggest device deficiencies or operator
concerns.
A.3 Device Labeling
Check the labels provided by the manufacturer or the healthcare facility are present and
legible.
Main unit label
Integrated warning labels
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