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Aerogen® Solo System Instruction Manual
166 167
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.
Immunity Test IEC/EN 60601
Test Level
Compliance
Level
Electromagnetic
Environment - Guidance
Electrostatic
discharge (ESD)
IEC/EN
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/EN
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 or hospital
environment.
Surge
IEC/EN
61000-4-5
±1 kV line(s) to
line(s)
±2 kV line(s) to
earth
±1 kV line(s) to
line(s)
±2 kV line(s) to
earth
Mains power quality
should be that of a typical
commercial or hospital
environment.
Voltage
dips, short
interruptions
and voltage
variations on
power supply
input lines
IEC/EN
61000-4-11
<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
<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
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
(50/60 Hz)
Magnetic field
IEC/EN
61000-4-8
3 A/m 3 A/m Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment.
Note: Ut is the A.C. mains voltage prior to application of the test level.
39


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