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Les langues disponibles
GB
RISK OF ELECTROMAGNETIC INTERFERENCE AND POSSIBLE REMEDIES
The Mistral Nebulizer is an electro-medical device that requires particular precautions regarding electro-magnetic
This section contains information regarding the conformity of the compliance with the EN 60601-1-2 Standard.
compatibility and which must be installed and commissioned according to the electro-magnetic compatibility information
supplied. Portable and mobile radio communication devices (mobile phones, transceivers, etc.) may interfere with the
medical device and should not be used in close proximity with, adjacent to or on top of the medical device. If such use is
necessary and unavoidable, special precautions should be taken so that the electro-medical device functions properly in
its intended operating configuration (for example, constantly and visually checking for the absence of anomalies or
malfunctions). The use of accessories, transducers and cables different to those specified, with the exception of
transducers and cables sold by the appliance and system manufacturer as spare parts, can lead to an increase in emissions
or in a decrease of the immunity of the device or system. The following tables supply information regarding the EMC
(Electromagnetic Compatibility) characteristics of the electro-medical device.
The Mistral Nebulizer is intended for use in the electromagnetic environment specified below. The customers or the user of
Emissions Test
Irradiated / Conducted emissions
CISPR11
Irradiated / Conducted emissions
CISPR11
Harmonic emissions EN 61000-3-2
Voltage fluctuations / flicker emissions
EN 61000-3-3
The Mistral Nebulizer is intended for use in the electromagnetic environment specified below. The customers or the user of
Immunity Test
Electrostatic
discharge (ESD)
EN 61000-4-2
Electrical fast
transient / burst
EN 61000-4-4
Surge
EN 61000-4-5
Loss of voltage, brief
voltage interruptions
and variations
EN 61000-4-11
Magnetic field
EN 61000-4-8
Nota U
is the value of the power supply voltage
T
Guidance and manufacturer's declaration – Electromagnetic Emissions
the Mistral Nebulizer should assure that it's used in such an environment.
Compliance
Group 1
Class [B]
Class [A]
Complies
Guidance and manufacturer's declaration – Immunity Emissions
the Mistral Nebulizer should assure that it's used in such an environment.
Level indicated by the
EN 60601-1-2
± 6kV on contact
± 8kV in air
± 2kV power supply
lines
± 1kV for input /
output lines
± 1kV differential mode
5%U
(>95% dip U
)
T
T
for 0.5 cycle
40%U
(>60% dip U
)
T
T
for 5 cycle
70%U
(>30% dip U
)
T
T
for 25 cycle
<5%U
(>95% dip U
)
T
T
for 5 sec
3A/m
The Mistral Nebulizer only used RF energy only for its internal
Electromagnetic environment - guidance
functioning. Therefore its RF emissions are very low and are
not cause interference in proximity of any Electronic
The Mistral Nebulizer can be used in all environments,
appliances.
including domestic and those connected directly to the public
mains distribution that supplies power to environments used
for domestic scopes
Compliance Level
Electromagnetic environment - guidance
The device doesn't
Floors should be wood, conceret or ceramic tile.
change its state
If floors are covered with synthetic material, the
relative humidity should be at least 30%.
The device doesn't
Mains power quality should be that of a typical
change its state
commercial environment or hospital.
The device doesn't
Mains power quality should be that of a typical
change its state
commercial environment or hospital.
-
Mains power quality should be that of a typical
the Mistral Nebulizer request that the appliance
commercial environment or hospital If the user of
operates continuously, the use of a continuity
unit is recommended.
The device doesn't
The power frequency magnetic field should be
change its state
measured in the intended installation location to
assure that it's sufficiently low.
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