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RISK OF ELECTROMAGNETIC INTERFERENCE AND POSSIBLE REMEDIES
This section contains information regarding the conformity of the compliance with the EN 60601-1-2 Standard.
The Eolo is an electro-medical device that requires particular precautions regarding electro-magnetic 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 EOLO 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 EOLO Nebulizer is intended for use in the electromagnetic environment specified below.
The customers or the user of the EOLO Nebulizer should assure that it's used in such an environment.
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
Note U
is the value of the power supply voltage
T
Guidance and manufacturer's declaration – Electromagnetic Emissions
the EOLO 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
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
) for 0.5
T
T
cycle
40%U
(>60% dip U
) for 5
T
T
cycle
70%U
(>30% dip U
) for 25
T
T
cycle
<5%U
(>95% dip U
) for 5 sec
T
T
3A/m
The EOLO Nebulizer only used RF energy only for its
Electromagnetic environment - guidance
internal functioning. Therefore its RF emissions are very
low and are not cause interference in proximity of any
The EOLO Nebulizer can be used in all environments,
Electronic appliances.
including domestic and those connected directly to the public
mains distribution that supplies power to environments used
for domestic scopes or environments feeds to you from
batteries.
Compliance Level
Electromagnetic environments -
The device doesn't
Floors should be wood, or ceramic tile. If
change its state
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
change its state
typical commercial environment or
hospital
The device doesn't
Mains power quality should be that of a
change its state
typical commercial environment or
hospital
-
Mains power quality should be that of a
hospital If the user of the EOLO Nebulizer
typical commercial environment or
request that the appliance operates
continuosly, the use of a continuity unit is
recommended.
The device doesn't
The power frequency magnetic field
change its state
should be measured in the intended
installation location to assure that it's
sufficiently low.
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