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M118000-01-210305-Rev002-UM-en
11. Electromagnetic compatibility
Electrical equipment is subject to special precautions regarding EMC and must be installed and
commissioned in accordance with the guidance below.
Portable and mobile HF devices (e.g. mobile phones) may affect medical electrical equipment.
The use of third-party accessories may increase the emission or reduce the immunity of the device.
Do not use mobile phones or similar devices that emit electromagnetic fields near the product. This
could adversely affect the functionality of the product.
Guidance and manufacturer's declaration - electromagnetic emissions
This PRODUCT is intended for use in the electromagnetic environment specified below. The customer or the user of
the PRODUCT should make sure that it is used in such an environment.
Emission tests
Compliance
Electromagnetic environment – guidelines
HF emissions as per CISPR
11/EN55011
Group 2
The device must emit electromagnetic energy to perform
its intended function. Electronic devices in the area can be
affected.
HF emissions as per CISPR
11/EN55011
Class B
The PRODUCT is suitable for use in all establishments,
including domestic establishments and those directly
connected to the public low-voltage network that supplies
buildings used for domestic purposes.
Harmonic emissions as per
IEC 61000-3-2
Class A
Voltage fluctuations/
flicker emissions as per IEC
61000-3-3
Complies
Guidance and manufacturer’s declaration - electromagnetic immunity
This PRODUCT is intended for use in the electromagnetic environment specified below. The customer or the user of
the PRODUCT should make sure that it is used in such an environment.
Immunity tests
IEC 60601 Test Level
Compliance level
Electromagnetic environment –
guidelines
Electrostatic discharge
(ESD) according to
IEC 61000-4-2
± 8 kV contact discharge
± 15 kV air discharge
± 8 kV contact
discharge
± 15 kV air
discharge
Floors should be made of wood or
concrete, or covered with ceramic
tiles. If the floor is covered with
synthetic material, the relative air
humidity must be at least 30%.
Electrical fast transient/
burst as per
IEC 61000-4-4
± 2 kV power lines
± 1 kV for input and
output lines
± 2 kV power lines
± 1 kV for input and
output lines
The quality of the supply voltage
should correspond to that of a typical
business or hospital environment.
Surges according to
IEC 61000-4-5
± 1 kV conductor-
conductor
± 2 kV conductor-earth
± 1 kV conductor-
conductor
± 2 kV conductor-
earth
The quality of the supply voltage
should correspond to that of a typical
business or hospital environment.
Voltage drops, short-term
interruptions, and
fluctuations of the supply
voltage according to
IEC 61000-4-11
0% UT for 1/2 period
(100% break-in)
0% UT for 1 period
(100% break-in)
40% UT for 5 periods
(60% break-in)
70% UT for 25 periods
(30% break-in)
80% UT for 250 periods
(20% break-in)
0% UT for 250 periods
(short interruption)
0% UT for 1/2
period (100%
break-in)
0% UT for 1 period
(100% break-in)
40% UT for 5
periods (60%
break-in)
70% UT for 25
periods (30%
break-in)
80% UT for 250
periods (20%
break-in)
0% UT for 250
periods (short
interruption)
The quality of the supply voltage
should correspond to that of a typical
business or hospital environment.
If the user of the PRODUCT requires
continued operation even during
power interruptions, it is
recommended that the PRODUCT be
supplied by an uninterruptible power
source or a battery.