A-2      BeneVision N17/BeneVision N15/BeneVision N12 Patient Monitor Service Manual 
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 Labelling 
Check the labels provided by the manufacturer or the healthcare facility are present and legible.   
  Main unit label 
  Integrated warning labels 
 
 
A.4 Scheduled Electrical Safety Inspection 
For scheduled electrical safety inspection, perform all the test items listed in A.6 Electrical Safety 
Inspection Test.   
 
 
A.5 Electrical Safety Inspection after Repair 
The following table specifies test items to be performed after the equipment is repaired. Refer to A.6 
Electrical Safety Inspection for the description of the test items. 
 
Repair with main unit not disassembled 
Test items: 1, 2, 3 
Repair with main 
unit 
disassembled 
When neither power supply PCBA nor 
patient electrically-connected PCBA is 
repaired or replaced 
Test items: 1, 2, 3, 4 
When power supply PCBA is repaired 
or replaced 
Test items: 1, 2, 3, 4, 5 
When patient electrically-connected 
PCBA is repaired or replaced 
Test items: 1, 2, 3, 4, 6, 7, 8 
When both power supply PCBA and 
patient electrically- connected PCBA 
are repaired or replaced 
Test items: 1, 2, 3, 4, 5, 6, 7, 8