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 Labeling 
Check the labels provided by the manufacturer or the healthcare facility 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 
ALL COUNTRIES R = 0.2  Maximum