AirSep FreeStyle Manuel Du Patient page 219

"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.
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.
I test
MMUNITY
Electrostatic ± 6 kV contact
discharge (ESD)
± 8 kV air
IEC 61000-4-2
Electrical fast
± 2 kV for power
transient/burst supply lines
IEC 61000-4-4 ± 1 kV for input/output lines
Surge
± 1 kV line to line
IEC 61000-4-5
± 2 kV line to earth
Voltage dips, short <5 % U
interruptions and (>95 % dip in U
voltage variations
for 0,5 cycle
on power.
40 % U
IEC 61000-4-11
(60 % dip in U
for 5 cycles
70 % U
(>30 % dip in U
for 25 cycles
<5 % U
(>95 % dip in U
for 5s
Power frequency 3 A/m
magnetic field
IEC 61000-4-8
NOTE U is the a.c. mains voltage prior to application of the test level.
T
MN131-1 rev C
Guidance and manufacturer's declaration ± electromagnetic immunity
IEC 60601
Compliance level
test level
± 6 kV contact
± 8 kV air
± 2 kV for power
supply lines
Not Applicable
± 1 kV line to line
± 2 kV line to earth
<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 s
3 A/m
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
T
) hospital environment. If the user of the FreeStyle requires
T
continued operation during power mains interruptions, it is
recommended that the FreeStyle be powered from an
uninterruptible power supply (UPS) or a battery.
T
)
T
T
)
T
T
)
T
Power frequency magnetic fields should be at levels
characteristic of a typical location in a typical commercial or
hospital environment.
Electromagnetic environment ± guidance
EN-37