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
HF emissions as per CISPR
11/EN55011
HF emissions as per CISPR
11/EN55011
Harmonic emissions as per
IEC 61000-3-2
Voltage fluctuations/
flicker emissions as per IEC
61000-3-3
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
Electrostatic discharge
(ESD) according to
IEC 61000-4-2
Electrical fast transient/
burst as per
IEC 61000-4-4
Surges according to
IEC 61000-4-5
Voltage drops, short-term
interruptions, and
fluctuations of the supply
voltage according to
IEC 61000-4-11
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11.
Electromagnetic compatibility
Compliance
Group 2
Class B
Class A
Complies
IEC 60601 Test Level
± 8 kV contact discharge
± 15 kV air discharge
± 2 kV power lines
± 1 kV for input and
output lines
± 1 kV conductor-
conductor
± 2 kV conductor-earth
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)
Electromagnetic environment – guidelines
The device must emit electromagnetic energy to perform
its intended function. Electronic devices in the area can be
affected.
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.
Electromagnetic environment –
Compliance level
guidelines
± 8 kV contact
Floors should be made of wood or
discharge
concrete, or covered with ceramic
tiles. If the floor is covered with
± 15 kV air
synthetic material, the relative air
discharge
humidity must be at least 30%.
± 2 kV power lines
The quality of the supply voltage
should correspond to that of a typical
± 1 kV for input and
business or hospital environment.
output lines
± 1 kV conductor-
The quality of the supply voltage
conductor
should correspond to that of a typical
business or hospital environment.
± 2 kV conductor-
earth
0% UT for 1/2
The quality of the supply voltage
period (100%
should correspond to that of a typical
break-in)
business or hospital environment.
0% UT for 1 period
If the user of the PRODUCT requires
continued operation even during
(100% break-in)
power interruptions, it is
40% UT for 5
recommended that the PRODUCT be
periods (60%
supplied by an uninterruptible power
break-in)
source or a battery.
70% UT for 25
periods (30%
break-in)
80% UT for 250
periods (20%
break-in)
0% UT for 250
periods (short
interruption)
M118000+M118000-01-210305-Rev002-UM-en