ADE M322600, Instruction Manual

Page: 101 / 108

M322600-210429-Rev004-UM-nl Seite 101 von 108
11. Elektromagnetische compatibiliteit
Medical 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.