Gima CORSIA Manual De Istrucciones página 16

GB
RISK OF ELECTROMAGNETIC INTERFERENCE AND POSSIBLE REMEDIES
The CORSIA PROFESSIONAL NEBULIZER is an electro-medical device that requires particular precautions regarding electro-
This section contains information regarding the conformity of the compliance with the EN 60601-1-2 Standard.
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 CORSIA PROFESSIONAL NEBULIZER is intended for use in the electromagnetic environment specified below. The
customers or the user of the CORSIA PROFESSIONAL NEBULIZER should assure that it's used in such an environment.
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 CORSIA PROFESSIONAL NEBULIZER is intended for use in the electromagnetic environment specified below.
The customers or the user of the CORSIA PROFESSIONAL NEBULIZER should assure that it's used in such an environmen
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
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 cycle
T T
40%U (>60% dip U ) for 5 cycle
T T
70%U (>30% dip U ) for 25 cycle
T T
<5%U (>95% dip U ) for 5 sec
T T
3A/m
The CORSIA PROFESSIONAL NEBULIZER only used RF
Electromagnetic environment - guidance
energy only for its internal functioning. Therefore its RF
emissions are very low and are not cause interference in
The CORSIA PROFESSIONAL NEBULIZER can be used in all
proximity of any Electronic appliances.
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 Electromagnetic environments -
Level
The device Floors should be wood, or ceramic tile. If
doesn't change floors are covered with synthetic
its state material, the relative humidity should be
at least 30%.
The device Mains power quality should be that of a
doesn't change typical commercial environment or
its state hospital
The device Mains power quality should be that of a
doesn't change typical commercial environment or
its state hospital
- Mains power quality should be that of a
typical commercial environment or
hospital If the user of the aerosol CLINEB
request that the appliance operates
continuosly, the use of a continuity unit is
recommended.
The device The power frequency magnetic field
doesn't change should be measured in the intended
its state installation location to assure that it's
sufficiently low.
16
t.
guidance