Risk Of Electromagnetic Interference And Possible Remedies - Gima SUPERVEGA EVO Manual De Istrucciones

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 SUPERVEGA EVO surgical aspirator 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 surgical aspirator SUPERVEGA EVO is intended for use in the electromagnetic environment specified below.
The customers or the user of the surgical aspirator SUPERVEGA EVO 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 surgical aspirator SUPERVEGA EVO is intended for use in the electromagnetic environment specified below.
The customers or the user of the surgical aspirator SUPERVEGA EVO 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
Nota 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 )
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 surgical aspirator SUPERVEGA EVO 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 surgical aspirator SUPERVEGA EVO 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 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
commercial environment or hospital If the user of
the surgical aspirator SUPERVEGA EVO request
that the appliance 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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