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Guidance and manufacturer’s declaration – electromagnetic emissions
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 environment.
Emission test Compliance Electromagnetic environment – Guidelines
RF emissions
CISPR11
Group 1 The device uses RF energy only for its internal function. Therefore, RF-emission
is very low and it is unlikely that any interference in nearby electronic equipment.
RF emissions
CISPR 11
Class B The device is suitable for use in all establishments, including domestic establish-
ments and those directly connected to the public low-voltage power supply
network that supplies buildings used for domestic purposes.
Warning: This device is intended only for use by medical professionals. This is a
device of class A CISPR 11 in the domestic environment, this device may cause
radio interference, so that it may be necessary in this case, to take appropriate
remedial measures, as e.g. orientation, new arrangement or shielding of the
device or restrict the connection to the site.
Harmonic Emissions
IEC 61000-3-2
Not
applicable
Voltage Fluctuations/
Flicker Emissions IEC
61000-3-3
Passed
Guidance and manufacturer 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 environment.
Immunity test IEC 60601 test level Compliance level
Electromagnetic environment –
Guideline
Electrostatic discharge
(ESD) acc. to
IEC 61000-4-2
± 6 kV contact discharge
± 8 kV air discharge
± 6 kV contact discharge
± 8 kV air discharge
Floors should be wood, concrete or
covered with ceramic tiles. 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 mains cables
± 1 kV for input and
output lines
± 2 kV for mains cables
± 1 kV for input and
output lines
The supply voltage quality should be
that of a typical commercial or hospital
environment.
Surge IEC 61000-4-5 ± 1 kV voltage
phase – phase,
± 2 kV voltage
phase – earth
± 1 kV voltage
phase – phase
± 2 kV voltage
phase – earth
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% U
T
, (>95% dip in U
T
)
for 1/2 period
40% U
T
, (60% dip in U
T
)
for 5 periods
70% U
T
, (30% dip in U
T
)
for 25 periods
<5% U
T
, (>95% dip in U
T
)
for 5 seconds
< 5% U
T
, (>95% dip in U
T
)
for 1/2 period
40% U
T
, (60% dip in U
T
)
for 5 periods
70% U
T
, (30% dip in U
T
)
for 25 periods
<5% U
T
, (>95% dip in U
T
)
for 5 seconds
Mains power quality should be that
of a typical commercial or hospital
environment. If the user of the device
device requires continued operation
during power mains interruptions, it
is recommended that the device be
powered by a UPS (uninterruptible
power supply) or a battery.
Power frequency
(50/60 Hz)
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.
Comment: U
T
is the a.c. supply voltage prior to application of the test level.
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