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 indication of exposure to fluid spills (e.g., water, coffee,
chemicals, etc.).
No loose or missing parts (e.g., knobs, dials, terminals, etc.).
A.2.2 Physical 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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