FLAEM Aspira Instrucciones Para El Uso página 16

STERILISABLE CANISTER
SANITISATION
Before and after each use, sanitise the collection canister and the connecting tubing choosing one of the methods de-
scribed below.
(method A): rinse each part (6, 8, 9, 10, 10a, 11, 11a, 14) with hot potable water (approximately 40°C) with gentle dish
washing soap (non-abrasive) or in the dishwasher set to a hot cycle
(method B): immerse each part (6, 8, 9, 10, 10a, 11, 11a, 14) in a solution of 50% water and 50% white vinegar. Lastly,
rinse abundantly with hot potable water (approximately 40°C).
(method C): boil each of the parts (6, 8, 9, 10, 10a, 11, 11a, 14) in water for 10 minutes; it is preferable to use de-miner-
alised 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 disinfecting,
which is available in any pharmacy.
Implementation:
- Fill a container big enough to hold all of the parts to disinfect with a solution of potable water and disinfectant, accord-
ing 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 concentra-
tion 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. Alternatively, 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 being treated have previously been sanitised. The procedure is validated in
compliance with ISO 17665-1.
Device: Fractionated vacuum overpressure steam steriliser in accordance with EN 13060.
Directions: 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 50 times for SILICONE TUBING (6,8,14) and the GASKET (11a)
- 121°C and a duration of 15 minutes for a maximum of 50 times for the POLYCARBONATE CANISTER (9).
Storage:
After sanitising, disinfecting or sterilising, reassemble the canister and the connecting tubing following the directions
provided in the "CONNECTION DIAGRAM".
At the end of each use store the medical device complete with accessories in a dry place away from dust.
• The tube and the manual vacuum flow control are single use sterile products and must be replaced after each
application.
• ATTENTION: The hydrophobic/antiviral and antibacterial filter (7) supplied with Flaem aspirators must strictly be
replaced for each new patient, or if said filter is saturated.
Should the aspirator be used on the same patient, the filter approved for Single-patient use must be replaced every
TWO MONTHS at most or if the filter is saturated.
The filter cannot be sanitised, disinfected, or sterilised.
It is in any case good practice to sanitise and disinfect the device and the accessories, with the exception of the Filter,
always after each use, whether it is for the same patient or for a new patient.
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