AirSep MN131-1 B - Manual (Page 255)

FreeStyle™ EN
AirSep
®
Corporation EN-43
MN131-1 rev. B - 02/13
“Specifications continued”
Medical equipment needs special precautions regarding EMC and need to be
installed and put into service according to the EMC information provided in this
section.
Guidance and manufacturer’s declaration ± electromagnetic immunity
The FreeStyle is intended for use in the electromagnetic environment specified below. The customer or the user of the
FreeStyle 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
± 2 kV for power supply
lines
Not Applicable
Mains power quality should be that
of a typical commercial 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 or hospital
environment.
Voltage dips, short
interruptions and
voltage variations on
power.
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 5s
<5 % U
T
(>95 % dip in U
T
)
for 0,5 cycle
40 % UT
(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 s
Mains power quality should be that of
a typical commercial or hospital
environment. If the user of the FreeStyle
requires continued operation during
power mains interruptions, it is
recommended that the FreeStyle be
powered from an uninterruptible power
supply (UPS) or a battery.
Power frequency
magnetic field
IEC 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 U
T
is the a.c. mains voltage prior to application of the test level.