Description
Medical device accessory for syringe that allows, through its nebulization action, to wash the nasal cavities of patients (neonates, children and adults) with physiological solution to prevent or support the treatment of upper airway congestion.
Specially designed for the nose of newborns and children to nebulize the saline solution continuously and non-invasively, allowing for a delicate and complete nasal wash.
Suitable for:
• perform daily cleaning of the nasal cavities;
• help correct and free breathing by facilitating nose blowing;
• facilitate easy suctioning of mucus in newborns;
• indirectly prevent the spread of ear infection;
• keep the nasal passages clean and clear and avoid the onset of colds;
• restore the natural moisture of the nasal mucosa in case of dryness and encrustations.
Made with non-toxic materials and colors, it is free from phthalates and disphenol.
Tested for biocompatibility with nasal mucosa according to standard 10993:1.

How to use
Withdraw the saline solution using a 2.5 ml or 5 ml syringe. In the case of syringes with needle, remove the needle before assembling with the FIORDINASO device.
Fit the FIORDINASO device onto the syringe. Gently insert the soft end of FIORDINASO into one nostril, so that the petals touch the edge, then press the syringe plunger all the way down to activate the nebulization of the saline solution.
In newborns and children under 3 years of age, use a 2.5 ml syringe and perform the operation taking care to lay the child on his side, with his head tilted to the side, and insert FIORDINASO into the upper nostril.
In children and adults, it is recommended to keep the torso forward and tilt the head to the side, inserting the nasal adapter into the nostril opposite to the direction of inclination.
Repeat the solution collection and nebulization operation in the other nostril. During and after treatment, the saline solution may drip from the nose.
Once nebulization is finished, follow the instructions in the "Cleaning" section to store and preserve the device safely.

For application in pediatrics (newborns and children) follow the instructions of your pediatrician.
Washing in adults can be done as needed. If in doubt, ask your doctor.

Cleaning :
After each use, remove the soft nasal adapter from the main body and wash its parts under running water, with neutral soap.
Completely fill the syringe used with running water, then apply the main body FIORDINASO and spray all the water. Repeat the operation 2-3 times to free the device from any salt residues.
Rinse both the main body of FIORDINASO and the syringe with running water, taking care to remove the piston from the syringe body for cleaning.
Finally, let it dry and then assemble the various components.
At the end of use, dispose of in plastic.

Warnings
Use the device only for its intended use.
Use the 2.5 ml syringe on neonates and children (using 2.5 ml in each nostril) and the 5 ml syringe on adults (using 5 ml in each nostril).
Store the product away from humidity, heat and light.
Before each use, check that the components are not damaged and that the nebulization hole is free from obstructions. If damaged or obstructed, do not use the device.
FIORDINASO is intended to be used by a single patient for multiple nebulizations. For hygiene reasons, follow the instructions in the "Cleaning" section.
Once the package has been opened, it is recommended to replace FIORDINASO every 12 months, unless the nebulization capacity ceases before this time.
Store FIORDINASO in a dry place after cleaning and during periods of non-use. Always keep the packaging with the batch number.
This product contains small parts. Small parts, if swallowed, may block the airway and cause a choking hazard. Be sure to keep this product out of the reach and sight of infants and children.
In the event of any serious incident in relation to the device, report it immediately to the manufacturer and to the competent authority of the Member State in which the user and/or patient is established.
For correct nebulization of the saline solution, it is recommended to apply sufficient pressure on the syringe to avoid coarse or droplet nebulization.
The device is intended for use by adult patients independently. Paediatric patients and persons with limited capabilities (e.g. sensory, physical, mental) must be supervised during use by a person responsible for their safety.
Do not use if nosebleeds are ongoing or have just ended.
Do not use in infants less than 1 month old.

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

Format
A FIORDINASO flower-shaped nebulizer device for nebulizing saline solution, compliant with European Regulation 2017/745.

Code 3217