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
E.4
Protective Earth Resistance
1.
Plug the probes of the analyzer into the device’s protective earth terminal and protective earth terminal of the AC
power cord.
2.
Test the earth resistance with a current of 25 A.
3.
Verify the resistance is less than limits.
LIMITS
For all countries, R = 0.2 Ω Maximum
Summary of Contents for BeneView T1
Page 1: ...BeneView T1 Patient Monitor Operator s Manual...
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Page 8: ...VI FOR YOUR NOTES...
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