Users Manual

IFU-USA-2019-Rev.001 31
Manufacturer’s declaration-electromagnetic emissions
The System is intended for use in the electromagnetic environment (for home and professional healthcare) specied
below.
The customer or the user of the System should assure that it is used in such an environment.
Immunity test
IEC 60601
test level
Compliance
level
Electromagnetic environment-guidance
(for home and professional healthcare
environment)
Electrostatic
discharge(ESD)
IEC 61000-4-2
Contact:±8 kV
Air±2 kV,±4 kV,
±8 kV,±15 kV
Contact:±8 kV
Air±2 kV,±4 kV,
±8 kV,±15 kV
Floors should be wood, concrete or ceramic
tile. If oors are covered with synthetic
material, the relative humidity should be at
least 30%
Electrical fast
transient/burst
IEC 61000-4-4
+ 2kV for power
supply lines
+ 1kV for input/
output lines
+ 2kV for power
supply lines
Not applicable
Mains power quality should be that of a
typical home healthcare environment.
Surge
IEC 61000-4-5
+ 0.5kV, +1kV
line(s) to line(s)
+ 0.5kV, +1kV,+
2kV line(s) to earth
+ 0.5kV, +1kV
line(s) to line(s)
Not applicable
Mains power quality should be that of a
typical home healthcare environment.