Accessory Compartment - FLAEM Aspira GO Manual De Instrucciones

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 50 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 components 10,10a,
11.
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 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 manual vacuum flow control (15) is a sterile disposable product and must be replaced after each use.

ACCESSORY COMPARTMENT

The accessory compartment (17) can easily be removed for thorough cleaning. See the disassembly sequence on
page 1 in drawings 8-9-10-11.
CANISTER HOLDER
For convenience, the canister holder can be detached and reattached on the most suitable side (left or right).
Using a tool (dwg.12) release the canister holder from the bottom of the device (dwg.13) and turn it so that is disen-
gaged (dwg.14). Reattach it, repeating the procedure in the reverse order, on the chosen side.
Ensure that the canister holder is properly fastened to the bottom of the device. This system ensures the connection
of up to two canister holders. (dwg.15)
ACCESSORY SPECIFICATIONS
- single-use hydrophobic antibacterial/antiviral filter
- PC collection canister w/ compl. lid
- Ø 13 x 7.5 mm L 1300 mm silicone tubing
- Ø 13 x 7.5 mm L 250 mm silicone tubing
- Ø 13 x 7.5 mm L 40 mm silicone tubing
- manual vacuum flow control (single use)
MICROBIAL CONTAMINATION
In the presence of pathologies with the risk of infection and microbial contamination, we recommend personal use of
the accessories, collection canister and connecting tubing (consult your doctor).
Interactions:
The materials used for contact with the secretions are highly stable and chemical resistant thermoplastic polymers
(PP, PC, SI). We cannot, however, exclude interactions. Therefore, it is suggested: a) to always avoid prolonged contact
of liquid with the canister or tubing and sanitise immediately after use. b) Should anomalous situations occur, i.e.
softening or cracking of the accessories, quickly terminate the procedure and substitute the used materials. Contact
the authorised service centre and specify how the product was used.
The materials used in the device are biocompatible in accordance with the provisions of Directive 93/42 EC
and subsequent amendments. However, the possibility of occurrence of allergic reactions cannot be entirely
excluded.
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