Emission test
RF emissions
CISPR11
RF emissions
CISPR 11
Harmonic Emissions
IEC 61000-3-2
Voltage Fluctuations/
Flicker Emissions
IEC 61000-3-3
Immunity test
Electrostatic discharge (ESD)
acc. to 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
supply input lines
IEC 61000-4-11
Power frequency (50/60 Hz)
magnetic field IEC 61000-4-8
Comment: U
is the a.c. supply voltage prior to application of the test level.
T
6/20
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.
Compliance
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.
Class B
The device is suitable for use in all establishments, including domestic establishments 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.
Class A
Symmetrical three-phase devices and other devices.
Passed
Guidance and manufacturer declaration - Electromagnetic immunity
The OMEGA 500 is intended for use in the electromagnetic environment specified below.
The customer or the user of the OMEGA 500 should assure that it is used in such environment.
IEC 60601 test level
± 6 kV contact discharge
± 8 kV air discharge
± 2 kV for mains cables
± 1 kV for input and output lines
± 1 kV voltage phase – phase,
± 2 kV voltage phase – earth
< 5% U
, (>95% dip in U
T
T
for 1/2 period
40% U
, (60% dip in U
)
T
T
for 5 periods
70% U
, (30% dip in U
)
T
T
for 25 periods
<5% U
, (>95% dip in U
T
T
for 5 seconds
3 A/m
Electromagnetic environment – Guidelines
Compliance level
± 6 kV contact discharge
± 8 kV air discharge
± 2 kV for mains cables
± 1 kV for input and output lines
± 1 kV voltage phase – phase
± 2 kV voltage phase – earth
)
< 5% U
, (>95% dip in U
T
for 1/2 period
40% U
, (60% dip in U
T
for 5 periods
70% U
, (30% dip in U
T
for 25 periods
)
<5% U
, (>95% dip in U
T
for 5 seconds
3 A/m
med 1712 2013-10-02
Electromagnetic environment – Guideline
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 %.
The supply voltage 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
T
commercial or hospital environment. If the user
)
of the device requires continued operation during
T
power mains interruptions, it is recommended that
)
the device be powered by a UPS (uninterruptible
T
power supply) or a battery.
)
T
Power frequency magnetic fields should be at
levels characteristic of a typical location in a
typical commercial or hospital environment.