Hologic Aquilex, Instructions For Use Manual

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Guidelines and Manufacturer's Statement - Electromagnetic Compatibility
en
12.3 Guidelines and Manufacturer's Statement/Electromagnetic In-
terference Immunity
TheAquilex Fluid Control System is intended for use in an electromagnetic envi-
ronment as described below. The user/operator of the Aquilex Fluid Control Sys-
tem must make sure the device is operated within such an environment.
*Note: U
T
is the mains alternating voltage before applying the test levels.
Electromagnetic
interference
immunity tests
IEC 60601-1-2
test level
Compliance
Levels
Electromagnetic environ-
ment/guidelines
Discharge of static
electricity (ESD)
according to
IEC 61000-4-2
± 8 kV contact
± 15 kV air
± 8 kV con-
tact ± 15 kV
air
Floors should be made
from wood or concrete or
covered with ceramic
tiles. If the floor covering
consists of synthetic
material, the relative
humidity should be at
least 30%.
Electrical fast
transients/bursts
according to
IEC 61000-4-4
± 2 kV for power
lines
± 1 kV for input
and output lines
Modulation
100 KHz
± 2 kV for
power lines
± 1 kV for
input and
output lines
Modulation
100 KHz
The quality of the supply
voltage should be the
same as the voltage of a
typical business or hospi-
tal environment.
Voltage surges
according to
IEC 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
The quality of the supply
voltage should be the
same as the voltage of a
typical business or hospi-
tal environment.
Blackouts, brown-
outs, and fluctua-
tions of the power
supply according
to IEC 61000-4-11
< 5% U
T
* (> 95%
dip in the U
T
) for
½ cycle
< 5% U
T
*
(> 95% dip in
the UT) for 1/
2 cycle 40%
U
T
(60% dip
in the U
T
) for
5 cycles 70%
U
T
(30% dip
in the U
T
) for
25 cycles <
5% U
T
(> 95%
dip in the U
T
)
for 5 seconds
0% U
T
; 1/2
cycle at 0°,
45°, 90°,
135°, 180°,
225°,270°,
and 315°0%
U
T
; 1 cycle
and 70% U
T
;
25/30 cycles
Single phase:
at 0°0% U
T
;
250/300
cycles
The quality of the supply
voltage should be the
same as the voltage of a
typical business or hospi-
tal environment. If the
user/operator of the sys-
tem requires the contin-
uation of functionality
after power interrup-
tions/disruptions, it is
recommended to supply
the device with power
from an uninterruptible
power supply.
< 40% U
T
(> 60%
dip in the U
T
) for
5 cycles
< 70% U
T
(> 30%
dip in the U
T
) for
25 cycles
< 5% U
T
(> 95%
dip in the U
T
) for
5 cycles
Supply frequency
magnetic field
(50/60 Hz) accord-
ing to
IEC 61000 4-8
30 A/m 30 A/m Magnetic fields of the
mains power frequency
should comply with the
typical values of business
and hospital environ-
ments.