E - 2
BeneVision N1 Patient Monitor Operator’s Manual
E.2.2
Contextual Inspection
E.3
Device Labeling
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
E.5
Earth Leakage Test
Run an Earth Leakage test on the device being tested before performing any other leakage tests.
The following outlet conditions apply when performing the Earth Leakage test:
■
normal polarity (Normal Condition),
■
reverse polarity (Normal Condition),
■
normal polarity with open neutral (Single Fault Condition),
■
reverse polarity with open neutral (Single Fault Condition)
LIMITS
For UL60601-1,
◆
300
μ
A in Normal Condition
◆
1000
μ
A in Single Fault Condition
For IEC60601-1,
◆
500
μ
A in Normal Condition
◆
1000
μ
A in Single Fault Condition
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.
