CAIRE AirSep FreeStyle 5, Patient Manual

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FreeStyle 5™ EN
MN167-1 rev. D EN-40
“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 5 is intended for use in the electromagnetic environment specified below. The
customer or the user of the FreeStyle 5 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 %
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
Mains power quality should be that
of a typical commercial or hospital
environment. If the user of the
FreeStyle 5 requires continued
operation during power mains
interruptions, it is recommended
that the FreeStyle 5 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.