10
Guidance and manufacturer’s declaration – Electromagnetic Emissions
(as request by regulation EN 60601-1-2:2001)
The surgical aspirator
SUPER VEGA BATTERIA
is intended for use in the electromagnetic environment specified below. The customers or the user
of the surgical aspirator
SUPER VEGA BATTERIA
should assure that it’s used in such an environment.
Emissions Test
Compliance
Electromagnetic environment - guidance
Irradiated / Conducted emissions CISPR11
Group 1
The surgical aspirator SUPER VEGA BATTERIA 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 BATTERIA 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 or environments feeds to you from batteries.
Guidance and manufacturer’s declaration – Electromagnetic Emissions
(as request by regulation EN 60601-1-2:2001)
The surgical aspirator
SUPER VEGA BATTERIA
is intended for use in the electromagnetic environment specified below.
The customers or the user of the surgical aspirator
SUPER VEGA BATTERIA
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 covered 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 or environments feeds to you from batteries.
Surge
IEC/EN 61000-4-5
± 1kV differential mode
Mains power quality should be that of a typical commercial environment
or hospital or environments feeds to you from batteries.
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 BATTERIA
request that the appliance operates continuosly, 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
CLEANING OF ACCESSORIES
Wearing disposable latex gloves, proceed to clean the accessories as follows:
1.
Grip the jar with your hand and turn the cap in a counter-clockwise direction.
2.
Remove the red cage covering the float located in the jar cap (conical part with 3 openings)
3.
Once the cage is removed, the float with the red seal comes out of the jar cap.
4.
To disinfect the accessories, use either denatured alcohol or hypochlorate-based solutions, easily purchasable from chemist shops.
5.
Once cleaning has been completed, insert the float in the cage, with the seal facing towards the cage opening.
6.
Insert the opening of the cage into the seat in the jar cap.
7.
To facilitate the cleaning of the jar, fill it 1/3 full of ordinary water. The aspirated liquid, thus diluted, will then be easier to remove.
It is possible autoclave the accessories cover and jar: insert the parts in autoclave and to effect a cycle of sterilization having care to position turned
upside-down the graduated jar (with turned fund toward the tall one). After the sterilization and the cooling to the temperature the components'
environment, to verify that this last don't result damaged; disassembled therefore the container for inhaled liquids following the inverse operations to the
dismantlement.
The aspiration tubes can be sterilized on autoclave using a sterilization cycle at 120°C.
The conical connector can be sterilized on autoclave using a sterilization cycle at 121°C.
The device is ready for a new employment now.
During the sterilization operations the operator must use disposable gloves in latex, shirts and opportune mask not to enter contact with possible
substances contaminating.
DO NOT WASH, STERILIZE OR PUT IN AUTOCLAVE THE ANTIBACTERIAL FILTER
