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Idiomas disponibles
Idiomas disponibles
EN
RISK OF ELECTROMAGNETIC INTERFERENCE AND POSSIBLE REMEDIES
This section contains information regarding the conformity of the compliance with the EN 60601-1-2 (2015) Standard.
EOLO is a medical device particularly suitable for home applications. CISPR group and category classification: group 1, category B.
EOLO is an electromedical device that requires special precautions regarding electromagnetic compatibility and needs to be
installed and commissioned according to the information specified in the accompanying documents.
The device should not be used adjacent to or stacked with other equipment, as this could result in improper
operation. 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 other than those provided by the manufacturer of the device may
result in an increase in electromagnetic emissions and/or a decrease in the electromagnetic immunity of this device,
causing it to malfunction.
Portable and mobile radio communication devices (mobile phones, transceivers, including peripherals such as
antenna cables and external antennas, etc.) may interfere with the medical device and should not be used in close
proximity with (at a distance of more than 30 cm from any part of the device, including cables), 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 following tables supply information regarding the EMC (Electromagnetic Compatibility) characteristics of the electro-medical
device.
The aerosol EOLO is intended for use in the electromagnetic environment specified below. The customers or the user of the
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 aerosol EOLO is intended for use in the electromagnetic environment specified below.
The customers or the user of the aerosol EOLO 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
aerosol EOLO 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
± 8kV on contact
± 15kV in air
± 2kV power supply lines
± 1kV for input / output lines
± 0,5 kV and ± 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
30 A/m
Electromagnetic environment - guidance
The aerosol EOLO only used RF energy only for its internal
functioning. Therefore its RF emissions are very low and are
not cause interference in proximity of any Electronic
appliances.
The aerosol EOLO can be used in all environments, 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
typical commercial environment or
hospital If the user of the aerosol EOLO
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.
16
guidance
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