Fiordinaso Nebuliser for Nasal Irrigation

Description
Medical device accessory for syringes which, through its nebulising action, allows the nasal cavities of patients (newborns, children and adults) to be irrigated with saline solution to prevent or support the treatment of upper respiratory tract congestion.
Specially designed for the little noses of newborns and children, it nebulises saline solution continuously and non-invasively, allowing gentle, thorough nasal irrigation.
Indicated for:
• daily cleansing of the nasal cavities;
• helping correct, free breathing by making nose-blowing easier;
• making it easier to aspirate mucus in newborns;
• indirectly preventing the spread of infection to the ears;
• keeping the nasal passages clean and clear and preventing the onset of colds;
• restoring the natural moisture of the nasal mucosa in case of dryness and crusting.
Made with non-toxic materials and colours, it is phthalate- and bisphenol-free.
Tested for biocompatibility with the nasal mucosa according to standard 10993:1.

Directions for use
Draw up the saline solution using a 2.5 ml or 5 ml syringe. If the syringe has a needle, remove the needle before fitting the FIORDINASO device.
Attach the FIORDINASO device to the syringe. Gently insert the soft end of FIORDINASO into a nostril so that the petals touch its edge, then press the syringe plunger all the way down to nebulise the saline solution.
In newborns and children under 3 years of age, use a 2.5 ml syringe and carry out the procedure with the child lying on their side, head turned sideways, inserting FIORDINASO into the upper nostril.
In children and adults, lean the upper body forward and tilt the head sideways, inserting the nasal adapter into the nostril opposite the direction of tilt.
Repeat the drawing-up and nebulising procedure in the other nostril. During and after treatment, the saline solution may drip from the nose.
When nebulisation is complete, follow the instructions in the "Cleaning" section to store the device safely.

For paediatric use (newborns and children), follow the advice of your paediatrician.
In adults, irrigation can be carried out as needed. If in doubt, ask your doctor.

Cleaning:
After each use, remove the soft nasal adapter from the main body and wash the parts under running water with neutral soap.
Fill the syringe used completely with tap water, then attach the FIORDINASO main body and nebulise all the water. Repeat 2-3 times to clear the device of any saline residue.
Rinse both the FIORDINASO main body and the syringe under running water, taking care to remove the plunger from the syringe barrel for cleaning.
Finally, leave to dry and then reassemble the components.
At the end of its life, dispose of with plastics.

Warnings
Use the device only for the indicated purposes.
Use the 2.5 ml syringe for newborns and children (2.5 ml per nostril) and the 5 ml syringe for adults (5 ml per nostril).
Store the product away from moisture, heat and light.
Before each use, check that the components are not damaged and that the nebulising hole is unobstructed. If damaged or obstructed, do not use the device.
FIORDINASO is intended for use by a single patient for multiple nebulisations. For hygiene reasons, follow the instructions in the "Cleaning" section.
Once the pack has been opened, it is recommended to replace FIORDINASO every 12 months, unless the nebulising capacity diminishes sooner.
Store FIORDINASO in a dry place after cleaning and when not in use. Always keep the packaging bearing the batch number.
The product contains small parts. If swallowed, small parts could block the airways and cause a choking hazard. Make sure the product is kept out of the reach and sight of newborns and children.
Any serious incident in relation to the device must be reported immediately to the manufacturer and to the competent authority of the Member State in which the user and/or patient is established.
For correct nebulisation of the saline solution, apply sufficient pressure on the syringe to avoid coarse or droplet nebulisation.
The device is intended for independent use by adult patients. Paediatric patients and people with limited (e.g. sensory, physical or mental) capabilities must be supervised during use by a person responsible for their safety.
Do not use during or immediately after a nosebleed.
Do not use in newborns less than 1 month old.

Storage
Store at room temperature (0-55 °C), away from light, in a dry place away from sources of heat. Do not freeze.
Do not use the product after the expiry date shown on the packaging. The expiry date refers to the product unopened and correctly stored.
Do not use if the packaging or its parts are damaged.
Do not discard the components into the environment after use.
Keep out of the reach of children.

Pack contents
One flower-shaped FIORDINASO nebuliser device for nebulising saline solution, compliant with European Regulation 2017/745.

Code 3217