Description
Medical device accessory for syringes that allows, through its nebulizing action, to perform nasal washes of patients' nasal cavities (infants, children and adults) with saline solution to prevent or support the treatment of upper airway congestion.
Specially designed for the noses of infants and children to nebulize saline solution continuously and non-invasively, allowing for a gentle and complete nasal wash.
Indicated for:
• daily cleaning of the nasal cavities;
• aiding proper and free breathing by facilitating nose blowing;
• facilitating easy mucus aspiration in infants;
• indirectly preventing the spread of infection to the ears;
• keeping nasal passages clean and clear and preventing the onset of colds;
• restoring the natural moisture of the nasal mucous membranes in case of dryness and crusting.
Made with non-toxic materials and colors, it is phthalate and bisphenol-free.
Tested for biocompatibility with nasal mucous membranes according to standard 10993:1.

Instructions for use
Draw up saline solution using a 2.5 ml or 5 ml syringe. In the case of syringes with needles, remove the needle before assembly with the FIORDINASO device.
Attach the FIORDINASO device to the syringe. Gently insert the soft end of FIORDINASO into one nostril, so that the petals touch its edge, then press the syringe plunger all the way down to activate the nebulization of the saline solution.
For infants and children under 3 years of age, use a 2.5 ml syringe and perform the operation by laying the child on their side, with their head tilted to the side, and inserting FIORDINASO into the upper nostril.
For children and adults, it is recommended to lean the torso forward and tilt the head sideways, inserting the nasal adapter into the nostril opposite to the direction of the tilt.
Repeat the solution drawing and nebulization operation in the other nostril as well. During and after treatment, saline solution may drip from the nose.
After nebulization, follow the instructions in the Cleaning paragraph to safely store and preserve the device.

For pediatric application (infants and children), follow the instructions of your pediatrician.
Adults can perform the wash 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 used syringe with running water, then attach the FIORDINASO main body and nebulize all the water. Repeat the operation 2-3 times to free the device from any saline residues.
Rinse both the main body of FIORDINASO and the syringe with running water, making sure to remove the plunger from the syringe body for cleaning.
Finally, let it dry and then assemble the various components.
After use, dispose of in plastic.

Warnings
Use the device only in accordance with the indicated uses.
Use the 2.5 ml syringe for infants and children (using 2.5 ml for each nostril) and the 5 ml syringe for adults (using 5 ml for each nostril).
Store the product away from moisture, heat sources, and light.
Before each use, check that the components are not damaged and that the nebulization hole is free of obstructions. In case of damage or obstruction, do not use the device.
FIORDINASO is intended for single patient use for multiple nebulizations. For hygienic reasons, follow the instructions in the Cleaning paragraph.
Once the package is opened, it is recommended to replace FIORDINASO every 12 months, unless the nebulization capacity is lost before this time.
Store FIORDINASO in a dry place after cleaning and when not in use. Always keep the packaging with the lot number.
The product contains small parts. Small parts, if swallowed, could block the airways and cause a choking hazard. Make sure to keep the product out of the reach and sight of infants and children.
In the event of any serious incident related to the device, immediately report it to the manufacturer and the competent authority of the Member State in which the user and/or patient is established.
For proper 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 autonomous use by adult patients. Pediatric patients and people with limited capabilities (e.g., sensory, physical, mental) must be supervised during use by a person responsible for their safety.
Do not use in case of ongoing or recently concluded epistaxis.
Do not use in infants less than 1 month old.

Storage
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 expiry date indicated on the packaging. The expiry date refers to the intact product, correctly stored.
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
One FIORDINASO flower-shaped nebulizer device for nebulization of saline solution, compliant with European Regulation 2017/745.

Code. 3217