FLAEM Suction pro Instrucciones Para El Uso página 12

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 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 60% water and 40% 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 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 effec-
tive 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 disinfect-
ing, 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,
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. 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 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 EN 13060.
Implementation: 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 up-
right position.
Following the device instruction manual, start the sterilisation cycle and select a temperature of:
- 134°C and a duration of 10 minutes for a maximum of 30 times for the SILICONE TUBING (6,8,14) AND the GAS-
KET (11a)
- 121°C and a duration of 15 minutes for a maximum of 50 times for the POLYCARBONATE CANISTER (9).
Storage: Store the sterilised parts as per the instructions for use of either the sterile barrier system or packaging.
After sanitising, disinfecting or sterilising, reassemble the canister and the connecting tubing following the direc-
tions provided in the "CONNECTION DIAGRAM".
• The aspirator tip and the manual vacuum flow control are single use sterilised products and must be replaced
after each use.
• ATTENTION: The hydrophobic/antiviral and antibacterial filter (7) supplied with Flaem aspirators must be strictly
replaced for each new patient, or if the said filter is saturated.
Should the aspirator be used directly on the patient, the filter for Single-patient use must be replaced within a
maximum period of TWO MONTHS, or if the said filter is saturated.
The filter cannot be sanitised, disinfected, or sterilised.
It is anyhow good practice to always sanitise and disinfect all devices and accessories supplied, excluding the
Filter, after each use whether the patient is the same or whether it is a new patient.
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