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Guidance and manufacturer’s declaration – Electromagnetic Emissions
The surgical aspirator
SUPER VEGA CARRELLATO
is intended for use in the electromagnetic environment specified below.
The customers or the user of the surgical aspirator
SUPER VEGA CARRELLATO
should assure that it’s used in such an environment.
Emissions Test
Compliance
Electromagnetic environment - guidance
Power disturbance
CISPR11
Group 1
The surgical aspirator
SUPER VEGA CARRELLATO 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.
Irradiated / Conducted emissions CISPR11
Class [B]
Harmonic emissions
IEC/EN 61000-3-2
Class [A]
Voltage fluctuations /
flicker emissions IEC/EN 61000-3-3
Complies
The surgical aspirator
SUPER VEGA CARRELLATO 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.
Guidance and manufacturer’s declaration – Electromagnetic Immunity
The surgical aspirator
SUPER VEGA CARRELLATO
is intended for use in the electromagnetic environment specified below.
The customers or the user of the surgical aspirator
SUPER VEGA CARRELLATO
should assure that it’s used in such an environment.
Immunity Test
Compliance
Electromagnetic environments - guidance
Electrostatic discharge (ESD)
IEC/EN 61000-4-2
± 6kV on contact
± 8kV in air
Floors should be wood, conceret or ceramic tile. If
floors are coverei with synthetic material, the
relative humidity should be at least 30%.
Electrical fast transient / burst
IEC/EN 61000-4-4
± 2kV power supply
Mains power quality should be that of a typical
commercial environment or hospital
Surge
IEC/EN 61000-4-5
± 1kV differential mode
Mains power quality should be that of a typical
commercial environment or hospital
Loss of voltage, brief voltage interruptions and
variations
IEC/EN 61000-4-11
5%U
T
for 0.5 cycle
40%U
T
for 05 cycle
70%U
T
for 25 cycle
<5%U
T
for 5 sec
Mains power quality should be that of a typical
commercial environment or hospital If the user of
the surgical aspirator SUPER VEGA
CARRELLATO request that the appliance
operates continuously, the use of a continuity unit
is recommended.
Magnetic field
IEC/EN 61000-4-8
3A/m
The power frequency magnetic field should be
measured in the intended installation location to
assure that it’s sufficiently low.
Conducted Immunity
IEC/EN 61000-4-6
3Vrms 150kHz to 80MHz
(for appliances that aren’t life - supporting)
-
Irradiated Conducted
IEC/EN 61000-4-3
3V/m 80MHz to 2.5 GHz
(for appliances that aren’t life - equipment)
-
Note U
T
is the value of the power supply voltage
ACCESSORIES SUPPLIED
DESCRIPTION
N°2 COMPLETE ASPIRATION JAR 2000cc
CONICAL FITTING
TUBES SET 8 mm x 14 mm
ANTIBACTERIAL AND HYDROFOBIC FILTER
SUCTION PROBE CH20
FOOTSWITCH CONTROL cod. 52130
(for versions equipped with footswitch control)
Replacing the antibacterial filter:
The filter is made of hydrophobic material that stops the passage of liquids into the same filter.
If you suspect the filter may have been contaminated and/or got wet or discoloured, always remove and replace the filter.
If the equipment is to be used on patients with unknown pathological conditions or should you evaluate the possibility of indirect contamination, remove and
replace the filter after each utilization
. The filter is not designed for decontamination, disassembly and/or sterilization. If you suspect the filter may have
been contaminated and/or got wet or discoloured, always remove and replace the filter. If the equipment is to be used on patients whose pathologies are
known and not implying any indirect contamination risks, we recommend to remove and replace the filter at the end of each work shift or else every month,
even if the equipment has not been used.
On request, are available versions with disposable collection system (FLOVAC® 2000ml) composed by a reusable polycarbonate vessel and polyethylene
disposable bag (collection liner for fluids suction canisters).
The suction probe must be changed at the end of each application.
WARNING: Suction tubes for insertion in the human body purchased separately from the machine should comply with ISO 10993-1 standards on
material biocompatibility.
