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Table 2 Guidance and manufacturer’s declaration –
electromagnetic immunity
Guidance and manufacturer’s declaration – electromagnetic immunity
M102 Mesh Nebulizers are intended for use in the electromagnetic
environment specified below. The customer or the user of these
YUWELL Nebulizers should assure that it is used in such environment.
Immunity test
IEC 60601
Test level
Compliance
level
Electromagnetic
environment–guidance
Voltage dips,
short
interruptions
and voltage
variations on
power supply
IEC 61000-4-11
<5% U
T
(>95% dip in U
T
)
for 0.5 cycle
40% U
T
(60% dip in U
T
)
for 5 cycles
70% U
T
(30% dip in U
T
)
for 25 cycles
<5% U
T
(95% dip in U
T
)
for 5 sec.
<5% U
T
(>95% dip in U
T
)
for 0.5 cycle
40% U
T
(60% dip in U
T
)
for 5 cycles
70% U
T
(30% dip in U
T
)
for 25 cycles
<5% U
T
(95% dip in U
T
)
for 5 sec.
Mains power quality
should be that of a
typical commercial
and/or hospital
environment.
If the user of the M102
nebulizers requires
continued operation
during power mains
interruption, it is
Recommendthat the
M102&M103 be
powered from an
uninterruptible power
supply or battery.
3 A/m 3 A/m
Power frequency
magnetic fields should
be at levels character-
istic of a typical location
in a typical commercial
or hospital environment. Power
frequency
(50/ 60 Hz)
magnetic field
IEC
61000-4-8
Electrostatic
discharge
IEC 61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floor should be wood,
concrete, or ceramic
tile. If floors are
covered with synthetic
material, the relative
humidity should be at
least 30% RH.
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV for
power supply
lines
±1 kV for
input/output
lines
±2 kV for
power supply
lines
±1 kV for
input/output
lines
Mains power quality
should be that of a
typical commercial
and/or hospital
environment.
Surge
IEC 61000-4-5
±1 kV
line to line
±2 kV
line to earth
±1 kV
line to line
±2 kV
line to earth
Mains power quality
should be that of a
typical commercial
and/or hospital
environment.