11
ELECTROMAGNETIC COMPATIBILITY DECLARATION
Guidance and manufacturer’s declaration-electromagnetic immunity
The device is intended for use in the electromagnetic environment specified below.
The customer or the user of the device 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
+ 2kV for power
supply lines
+ 1kV for input/output
lines
+ 2kV for power
supply lines
Not applicable
Mains power quality should be that of
a typical commercial or
hospital environment.
Surge IEC 61000-4-5
+ 1kV line(s) to line(s)
+ 2kV line(s) to earth
+ 1kV differential
mode
+ 2kV differential
d
Mains power quality should be that
of a typical commercial or
hospital environment.
Voltage Dips, short
interruptions and voltage
variations on power
supply input lines IEC
61000-4-11
<5% UT(>95% dip in
UT) for 0,5 cycle
40% UT(60% dip in
UT) for 5 cycles
70% UT(30% dip in
UT) for 25 cycles
<5% UT(>95% dip in
UT) for 5 s
<5% UT(>95% dip in
UT) for 0,5 cycle
40% UT(60% dip in
UT) for 5 cycles
70% UT(30% dip in
UT) for 25 cycles
<5% UT(>95% dip in
UT) for 5 s
Mains power quality should be that of
a typical commercial or
hospital environment. If the user
of the device requires continued
operation during power
mains interruptions, it is recommended
that the device be powered from
an uninterruptible power supply
or a battery.
Power frequency(50/60
Hz) magnetic field IEC
61000-4-8
3 A/m
3 A/m
The device power
frequency magnetic fields should
be at levels characteristic of a
typical location in a typical
commercial or hospital
environment.
NOTE
UT is the a.c. mains voltage prior to application of the test level.