Guidance and manufacturer’s declaration – electromagnetic Immunity
The surgical aspirator NEW ASKIR 20 is intended for use in the electromagnetic environment specified below.
The customer or the user of the surgical aspirator NEW ASKIR 20 should assure that it’s used in such an environment.
Immunity Test
Compliance
Electromagnetic environment - guidance
Electrostatic discharge (ESD)
IEC/EN 61000-4-2
± 6kV on contact
± 8kV in air
Floors should be wood, concrete 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.
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 NEW ASKIR 20 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)
-
Nota U
T
is the value of the power supply voltage
CLEANING OF ACCESSORIES
To clean the plastic housing of the device wear disposable latex gloves and clean with denaturated alcohol or hypoclorite solutions.
Washing and / or cleaning the autoclavable jar as to be carried out as follows:
•
Wear protection gloves and apron (glasses and face mask if necessary) to avoid contact with contaminating substances;
•
Disconnect the jar from the device
•
Disconnect all tubes from the jar and the protection filter
•
Empty and dispose of the content and of the suction catheter according to the laws in force in your country;
•
Separate all parts of the cover (overflow valve, o-ring);
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
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