LEM LTA330 Mode D'emploi page 11

The surgical aspirator ASPIMED 3.3 is intended for use in the electromagnetic environment specified below.
The customer or the user of the surgical aspirator ASPIMED 3.3 should assure that it's used in such an environment.
Immunity Test
Electrostatic discharge (ESD)
IEC/EN 61000-4-2
Electrical fast transient / burst
IEC/EN 61000-4-4
Surge
IEC/EN 61000-4-5
Loss of voltage, brief voltage
interruptions and variations
IEC/EN 61000-4-11
Magnetic field
IEC/EN 61000-4-8
Conducted Immunity
IEC/EN 61000-4-6
Irradiated Conducted
IEC/EN 61000-4-3
Nota U is the value of the power supply voltage
T
At the end of the application switch the equipment off and clean all its accessories as follows:
•
Wear protection gloves and apron (if need be, also wear a face mask and glasses) to avoid getting in contact with contaminating substances;
•
Disconnect the tank from the equipment removing any tubes connected to the container and paying particular attention to avoiding accidental
contaminations.
•
Empty and dispose of the flacon content complying with hospital regulations as well as with any provisions in force, including local
regulations.
•
Separate all the parts of the lid (float device and rings).
After disposing of disposable parts and disassembling the jar wash in running cold water and rinse thouroughly. Then soak in warm water
(temperature shall not exceed 60°C). Wash thouroughly and if necessary use a non-abrasive brush to remove incrustations. Rinse in running warm
water and dry all parts with a soft cloth (non-abrasive).The jar and the cover can be autoclaved by placing the parts into the autoclave and running
one sterilization stem cycle at 121°C (1 bar relative pressure) making sure that the jar is positioned upsidedown. Mechanical resistance of the jar is
guaranteed up to 30 cycles of sterilization and cleaning at the indicated conditions (EN ISO 10079-1). Beyond this limit the physical-mechanical
characteristics of the plastic may decrease and replacement of the part is therefore recommended.
After sterilization and cooling at environment temperature of the parts make sure that these are not damaged.
Assemble the jar as follows:
•
Place the overflow valve into its seat in the cover (under VACUUM connector)
•
Insert floating valve keeping the o-ring towards the opening of the cage
•
Place the o-ring into its seat around the cover
•
After completing assembling operations always make sue that cover seals perfectly to avoid vacuum leackages or liquid exit
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.
DO NOT WASH, STERILIZE OR PUT IN AUTOCLAVE THE ANTIBACTERIAL FILTER
Guidance and manufacturer's declaration – electromagnetic Immunity
Compliance
± 6kV on contact
± 8kV in air
± 2kV power supply
± 1kV differential mode
5%U for 0.5 cycle
T
40%U for 05 cycle
T
70%U for 25 cycle
T
<5%U for 5 sec
T
3A/m
3Vrms 150kHz to 80MHz
(for appliances that aren't
life - supporting)
3V/m 80MHz to 2.5 GHz
(for appliances that aren't
life – equipment)
CLEANING OF ACCESSORIES
Electromagnetic environment - guidance
Floors should be wood, concrete or ceramic tile. If floors are
covered with synthetic material, the relative humidity should be at
least 30%.
Mains power quality should be that of a typical commercial
environment or hospital.
Mains power quality should be that of a typical commercial
environment or hospital.
Mains power quality should be that of a typical commercial environment
or hospital. If the user of the surgical aspirator ASPIMED 3.3 request that
the appliance operates continuosly, the use of a continuity unit is
recommended.
The power frequency magnetic field should be measured in the
intended installation location to assure that it's sufficiently low.
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