AirSep FreeStyle Patient Manual page 46

FreeStyle™
"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
Electrostatic
discharge (ESD)
IEC 61000-4-2
Electrical fast
transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short
interruptions and
voltage variations on
power.
IEC 61000-4-11
Power frequency
magnetic field
IEC 61000-4-8
NOTE U is the a.c. mains voltage prior to application of the test level.
T
®
AirSep Corporation
MN131-1 rev. B - 02/13
IEC 60601 test
level
± 6 kV contact
± 8 kV air
± 2 kV for power
supply lines
± 1 kV for
input/output lines
± 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 5s
3 A/m
Compliance 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 % 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
3 A/m
Electromagnetic environment ±
guidance
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 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 fields should
be at levels characteristic of a typical
location in a typical commercial or
hospital environment.
EN
EN-43