E-2
E.2 Device Enclosure and Accessories
E.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.).
E.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.
E.3 Device Labelling
Check the labels provided by the manufacturer or the healthcare facilities are present and
legible.
Main unit label
Integrated warning labels
Summary of Contents for uMEC10
Page 1: ...uMEC10 uMEC12 uMEC15 Patient Monitor Operator s Manual ...
Page 2: ......
Page 24: ...1 6 FOR YOUR NOTES ...
Page 29: ...2 5 2 3 2 uMEC12 uMEC15 1 6 7 2 8 9 10 3 4 5 ...
Page 36: ...2 12 FOR YOUR NOTES ...
Page 50: ...3 14 FOR YOUR NOTES ...
Page 58: ...4 8 FOR YOUR NOTES ...
Page 72: ...6 8 FOR YOUR NOTES ...
Page 118: ...8 28 FOR YOUR NOTES ...
Page 174: ...18 8 FOR YOUR NOTES ...
Page 186: ...20 6 FOR YOUR NOTES ...
Page 192: ...21 6 FOR YOUR NOTES ...
Page 202: ...23 4 FOR YOUR NOTES ...
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Page 224: ...26 10 FOR YOUR NOTES ...
Page 248: ...B 8 FOR YOUR NOTES ...
Page 266: ...C 18 FOR YOUR NOTES ...
Page 280: ...E 6 FOR YOUR NOTES ...
Page 286: ...F 6 FOR YOUR NOTES ...
Page 287: ......
Page 288: ...PN 046 008784 00 1 0 ...