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17
Guidance and manufacturer’s declaration - electromagnetic immunity
The device is intended for use in the electromagnetic environment specified below.
The customer or the user 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
±6 kV contact
Floors should be wood,
concrete or ceramic tile.
If floors are covered with
synthetic material, the
relative humidity should
be at least 30 %.
±8 kV air
±8 kV air
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV for power
supply
±2 kV for
power supply
Main power quality should
be that of a commercial or
hospital environment. If
the user of the device
requires continued
operation during power
mains interruptions, it is
needed that the device
be powered from an
uninterruptible power
supply
Surge IEC
61000-4-5
±1 kV line(s) to
line(s)
±1 kV line(s) to
line(s)
Voltage dips,
short interrup-
tions and volt-
age variations
on power supply
input lines IEC
61000-4-11
<5% UT (>95%
dip in UT) for 0.5
cycle
<5% UT (>95%
dip in UT) for
0.5 cycle
40% UT (60%
dip in UT) for 5
Cycles
40% UT (60%
dip in UT) for 5
Cycles
70% UT (30%
dip in UT) for 25
Cycles
70% UT (30%
dip in UT) for
25 Cycles
<5% UT (>95%
dip in UT) for
5 sec
<5% UT (>95%
dip in UT) for
5 sec
NOTE UT is the a.c. mains voltage prior to application of the test level.