FLAEM Aspira Go P1611EM-20 Manual De Instrucciones página 17

SANITISATION
Before and after each use, sanitise the collection canister and the connecting tubing choosing one of the
methods described below.
(method A): rinse each part (6,8,9,10,10a,11,11a,14) with hot potable water (approximately 40°C) with gentle
washing up liquid (non-abrasive) or in the dishwasher on a hot cycle.
(method B): soak each part (6,8,9,10,10a,11,11a,14) in a solution of 50% water and 50% white vinegar. Fi-
nally, rinse with plenty of hot potable water (approximately 40°C).
(method C): boil each of the parts (6,8,9,10,10a,11,11a,14) in water for 20 minutes; it is preferable to use
de-mineralised or distilled water to prevent calcium deposits.
After having sanitised the accessories, shake them vigorously and place them on a paper towel. Alternatively,
dry them with a jet of hot air (for example, a hair dryer).
DISINFECTION
The accessories which can be disinfected are (6,8,9,10,10a,11,11a,14)
The disinfection procedure described in this paragraph is to be followed before using the accessories. It
is effective on the parts that undergo this treatment only if each step is followed and only if the parts to be
treated have previously been sanitised.
The disinfectant must be an electrolytic chloroxidizer (active principle: sodium hypochlorite) specific for dis-
infecting, which is available in any pharmacy.
Procedure:
- Fill a container big enough to hold all of the parts to disinfect with a solution of potable water and disinfect-
ant, according to the proportions indicated on the packaging of the disinfectant.
- Completely immerse each part in the solution, taking care to avoid the formation of air bubbles on the parts.
Leave the parts immersed for the amount of time indicated on the packaging of the disinfectant associated
with the concentration chosen for the solution.
- Remove the disinfected parts and rinse abundantly with warm potable water.
- After having disinfected the accessories, shake them vigorously and place them on a paper towel. Alterna-
tively, dry them with a jet of hot air (for example, a hair dryer).
- Dispose of the solution following the instructions provided by the disinfectant manufacturer.
STERILISATION
The accessories that can be sterilised are (6,8,9,10,10a,11,11a,14)
The sterilisation procedure described in this paragraph is effective on the parts that undergo this treatment
only if every step is followed and only if the parts to be treated have previously been sanitised. The procedure
is validated in its conformity to ISO 17665-1.
Device: Fractionated vacuum overpressure steam steriliser in accordance with standard EN 13060.
Procedure: Wrap every single part to be treated with a sterile barrier system or packaging in accordance
with Norm EN 11607. Place the wrapped parts into the steam steriliser, ensuring that the canister (9) is in an
upright position.
Following the device instruction manual, start the sterilisation cycle and select a temperature of:
- 134°C for 10 minutes for a maximum of 30 times for the SILICONE TUBES (6,8,14) and the GASKET (11a)
- 121°C for 15 minutes for a maximum of 50 times for the POLYCARBONATE CANISTER (9) and for compo-
nents 10,10a, 11.
Storage: Store the sterilised parts as per the instructions for use of either the sterile barrier system or pack-
aging.
After sanitising, disinfecting or sterilising, reassemble the canister and the connecting tubing following the
directions provided in the "CONNECTION DIAGRAM".
• The aspirator tip and the manual vacuum flow control are single use sterilised products and must be re-
placed after each use.
FILTER
The hydrophobic/antiviral and antibacterial filter supplied with Flaem aspirators must be strictly replaced
for each new patient, or if the said filter is saturated. Should the aspirator be used on the same patient, the
filter for Single-patient use must be replaced within a maximum period of TWO MONTHS or if the filter is
saturated. The filter cannot be sanitised, disinfected, or sterilised. It is in any case a good idea to sanitise
and disinfect the device and the accessories, with the exception of the Filter, always after each use, wheth-
er it is for the same patient or for a new patient. The parts that can be sterilised, which are indicated in the
user manual, must be sterilised every time the device is used for a new patient.
15