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Guidance and manufacturer's declaration – electromagnetic immunity for the
Aerogen Solo nebuliser system that is not life supporting
This Aerogen Solo nebuliser system is intended for use in the electromagnetic
environment specified below. The customer or the user of the Aerogen Solo nebuliser
system should assure that it is used in such an environment.
IEC/EN 60601
Immunity Test
Test Level
Electrostatic
±6 kV contact
discharge (ESD)
±8 kV air
IEC/EN
61000-4-2
Electrical fast
±2 kV for power
Transient/burst
supply lines
IEC/EN
±1 kV for input/
61000-4-4
output lines
Surge
±1 kV line(s) to
line(s)
IEC/EN
61000-4-5
±2 kV line(s) to
earth
Voltage
<5 % Ut
dips, short
(>95 % dip in Ut)
interruptions
for 0.5 cycle
and voltage
variations on
40 % Ut
power supply
(60 % dip in Ut)
input lines
for 5 cycles
IEC/EN
70 % Ut
61000-4-11
(30 % dip in Ut)
for 25 cycles
<5 % Ut
(>95 % dip in Ut)
for 5 sec
Power
3 A/m
frequency
(50/60 Hz)
Magnetic field
IEC/EN
61000-4-8
Note: Ut is the A.C. mains voltage prior to application of the test level.
Aerogen
Compliance
Level
±6 kV contact
±8 kV air
±2 kV for power
supply lines
±1 kV for input/
output lines
±1 kV line(s) to
line(s)
±2 kV line(s) to
earth
<5 % Ut
(>95 % dip in Ut)
for 0.5 cycle
40 % Ut
(60 % dip in Ut)
for 5 cycles
70 % Ut
(30 % dip in Ut)
for 25 cycles
<5 % Ut
(>95 % dip in Ut)
for 5 sec
3 A/m
Solo System Instruction Manual
®
Electromagnetic
Environment - Guidance
Floors should be wood,
concrete or ceramic tile.
If floors are covered with
synthetic material, the relative
humidity should be at least
30%.
Mains power quality
should be that of a typical
commercial or hospital
environment.
Mains power quality
should be that of a typical
commercial or hospital
environment.
Mains power quality
should be that of a typical
commercial or hospital
environment. If the user of
the Aerogen Solo nebuliser
system requires continued
operation during power
mains interruption, it is
recommended that the
Aerogen Solo nebuliser
system be powered from an
uninterruptible power supply
or battery.
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment.
167
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