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Guidance and manufacturer’s declaration – electromagnetic immunity
The 4000 Respiratory Monitor lung monitor is intended for use in the electromagnetic
environment specified below. The customer or the user of the 4000 Respiratory Monitor lung
monitor should assure that it is used in such an environment.
Immunity test
IEC 60601
Test level
Compliance level
Electromagnetic
environment-
guidance
Electrostatic discharge
(ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floors should be
wood, concrete or
ceramic tile. If floors
are covered with
synthetic material, the
relative humidity
should be at least 30%
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV for power supply
lines
±1 kV for input/ output
lines
Battery operated
device
Surge
IEC 61000-4-5
±1kV differential mode
±2kV common mode
Battery operated
device
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines
IEC 61000-4-11
<5 %
100V
(>95% dip
in
100V
) for 0,5 cycle
40 %
100V
(60% dip
in
100V
) for 5 cycles
70 %
100V
(30% dip
in
100V
) for25 cycles
<5%
100V
(>95% dip
in
100V
) for 5 sec
Battery operated
device
Power frequency
(50/60 Hz) magnetic
field
IEC 61000-4-8
3 A/m
Performance A
Power frequency
magnetic fields should
be at levels
characteristic of a
typical location in a
typical commercial or
hospital environment.
