Tabla de contenido
Idiomas disponibles
Idiomas disponibles
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 NEW VAPINAL Thermal Water Inhaler 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.
Guidance and manufacturer's declaration – Electromagnetic Emissions
The NEW VAPINAL Thermal Water Inhaler is intended for use in the electromagnetic environment specified below..
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 NEW VAPINAL Thermal Water Inhaler is intended for use in the electromagnetic environment specified below.
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
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
)
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
Electromagnetic environment - guidance
The Thermal Water Inhaler NEW VAPINAL 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 Thermal Water Inhaler NEW VAPINAL 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.
Compliance Level
Electromagnetic environments -
The device doesn't
Floors should be wood, conceret or
change its state
ceramic tile. 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
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 Thermal
Water Inhaler NEW VAPINAL 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.
17
GB
guidance
Tabla de contenido
