Product Manual

MN166-1 rev A 11/12
31
“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.