GB
25
PROXIMITY FUNCTIONS:
Pressing the "Proximity" (Lights BLUE LED) is activated on / off the motor by an infrared proximity sensor that detects the
presence of the operator's hand from a few inches away. This allows the operator to use the device without touching or focus
on pressing the button.
The on / off button is also active with the function of proximity inserted and can be used as an alternative.
To remove the "Proximity" you have to re-press the button.
The "Proximity" is retained, or if it was active before power off, then on again to return to this, but if it was not active will remain
disabled. The function set to power down the card after 20 minutes after turning off the engine if it is not then on again.
The unwanted approach of the hand to the Proximity sensors causes the device to switch off. To reactivate the
function, place the hand close to the sensors.
NOTE:
It is up to the end user to activate or deactivate the Proximity sensor. With the Function off, the device is activated/deactivated
by pressing the ON/OFF key
.
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 BATTERY ASPIRATOR
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.
Guidance and manufacturer’s declaration – electromagnetic Emissions
The surgical
SUPERVEGA EVO BATTERY ASPIRATOR
is intended for use in the electromagnetic environment specifiedbelow.
The customers or the user of the surgical
SUPERVEGA EVO BATTERY ASPIRATOR
should assure that it’s used in such an environment.
Emissions test
Compliance
Electromagnetic environment - guidance
Irradiated / Conducted emissions
CISPR11
Group 1
The surgical
SUPERVEGA EVO BATTERY ASPIRATOR
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]
The surgical
SUPERVEGA EVO BATTERY ASPIRATOR
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.
Harmonic emissions EN 61000-3-2
Class [A]
Voltage fluctuations / flicker emissions
EN 61000-3-3
Complies
Guidance and manufacturer’s declaration – Immunity Emissions
The surgical
SUPERVEGA EVO BATTERY ASPIRATOR
is intended for use in the electromagnetic environment specified
below.
The customers or the user of the surgical
SUPERVEGA EVO BATTERY ASPIRATOR
should assure that it’s used in such an environment.
Immunity Test
Level indicated by the
EN 60601-1-2
Compliance Level
Electromagnetic environment - guidance
Electrostatic
discharge (ESD)
EN 61000-4-2
± 6kV on contact
± 8kV in air
The device doesn’t
change its state
Floors should be wood, conceret or ceramic tile.
If floors are covered with synthetic material, the
relative humidity should be at least 30%.
Electrical fast
transient / burst
EN 61000-4-4
± 2kV power supply
lines
± 1kV for input /
output lines
The device doesn’t
change its state
Mains power quality should be that of a typical
commercial environment or hospital.
Surge
EN 61000-4-5
± 1kV differential mode
The device doesn’t
change its state
Mains power quality should be that of a typical
commercial environment or hospital.
Loss of voltage, brief
voltage interruptions
and variations
EN 61000-4-11
5%U
T
(>95% dip U
T
)
for 0.5 cycle
40%U
T
(>60% dip U
T
)
for 5 cycle
70%U
T
(>30% dip U
T
)
for 25 cycle
<5%U
T
(>95% dip U
T
)
for 5 sec
-
Mains power quality should be that of a typical
commercial environment or hospital If the user of
the surgical
SUPERVEGA EVO BATTERY
ASPIRATOR
request that the appliance operates
continuously, the use of a continuity unit is
recommended.
Magnetic field
EN 61000-4-8
3A/m
The device doesn’t
change its state
The power frequency magnetic field should be
measured in the intended installation location to
assure that it’s sufficiently low.
Nota U
T
is the value of the power supply voltage
