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facturer of the appliance may cause an increase in the electromagnetic emissions and/or a
reduction in the electromagnetic immunity of the device, thus causing a malfunction.
Portable and mobile radio communication devices (mobile phones, transceivers, in-
cluding peripheral devices like antennas cables and external antennas, etc.) may affect the
medical device and should not be used close to (at more than 30cm from any part of the
device, including cables), adjacent to or overlapped on the medical device. If such use is
necessary and inevitable, special precautions shall be adopted so that the electromedical
device works properly in its standard configuration (for instance, by steadily and visually
checking the absence of anomalies or malfunctions).
The tables below provide information on the EMC characteristics (Electromagnetic Compat-
ibility) of this electromedical appliance.
ENGLISH
Guide and declaration of the manufacturer – Electromagnetic Emissions
The Mistral aerosol can be used in the following electromagnetic environment. The Cus-
tomer and/or the user of the Mistral aerosol shall make sure that the appliance is used in
such environment.
Emission test
Conformity
Guide to the electromagnetic
environment
Radiated emissions /
Conductions CISPR11
Group 1
The Mistral aerosol uses RF energy only for
Internal function. Therefore, its RF emissions
are very low and do not cause any interfer-
ence with other nearby electronic applianc-
es.
Radiated emissions /
Conductions CISPR11
Class [B]
The Mistral aerosol is designed for use in
any environment, including households and
those directly connected to the public power
distribution grid which supplies power to en-
vironments intended for domestic use.
Harmonic currents EN
61000-3-2
Class [A]
Voltage fluctuations /
flicker EN 61000-3-3
Compliant
Guide and declaration of the manufacturer – Electromagnetic Immunity
The Mistral aerosol can be used in the following electromagnetic environment. The Cus-
tomer and/or the user of the Mistral aerosol shall make sure that the appliance is used in
such environment.
Immunity test
Standard of proof
Level of
conformity
Guide to the electromag-
netic environment
Electrostatic
discharge (ESD)
EN 61000-4-2
± 8kV contact
± 15kV air
The appliance
does not alter
its status
Floors should be in wood,
cement or ceramics. If floors
are covered by synthetic
material, the relative humid-
ity should be at least 30%.
Fast transient / burst
EN 61000-4-4
± 2kV power supply
± 1kV signal cables
The appliance
does not alter
its status
The power supply should be
that of a typical commercial
premise or hospital.
