Fiordinaso - nasal wash nebulizer

Product Description

Device designed for the nose of newborns and children, suitable for continuously and non-invasively nebulizing saline solution, allowing for delicate and complete nasal washing.

Features

Medical device accessory for syringe that allows, through its nebulization action, to perform washing of the nasal cavities of patients (newborns, children and adults) with saline solution to prevent or support the treatment of upper airway congestion.

Indicated for:

• performing daily cleaning of the nasal cavities;
• aiding correct and free breathing by facilitating nose blowing;
• facilitating easy suction of mucus in newborns;
• indirectly preventing the spread of ear infections;
• keeping the nasal passages clean and clear and avoiding the onset of colds;
• restore the natural moisture of the nasal mucous membranes in case of dryness and encrustations.

Produced with non-toxic materials and colors, it is free of phthalates and disphenol.
Tested for biocompatibility with nasal mucous membranes according to regulation 10993:1.

Directions for use

Use

1. Withdraw the saline solution using a 2.5 ml or 5 ml syringe. In the case of syringes with a needle, remove the needle before assembling it with the Fiordinaso device.
2. Connect the Fiordinaso device to the syringe. Gently insert the soft tip 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.

For newborns and children under 3 years of age, use a 2.5 ml syringe and perform the operation by taking care to lay the child on their side, with their head tilted to one side, and inserting Fiordinaso into the upper nostril. For 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 inclination direction. Repeat the solution collection and nebulization operation in the other nostril as well. During and after treatment, the saline solution may drip from the nose. Once nebulization is complete, follow the instructions in the "Cleaning" section to store and preserve the device safely. For use in pediatric patients (newborns and children), follow the instructions of your pediatrician. In adults, washing 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 used syringe with running water, then apply the Fiordinaso main body and spray all the water. Repeat the operation 2-3 times to free the device from any saline residue.
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 the plastic bin.

Warnings

Use the device only for the indicated uses.
Use the 2.5 ml syringe on newborns and children (using 2.5 ml for each nostril) and the 5 ml syringe on adults (using 5 ml for each nostril).
Store the product away from humidity, heat sources 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 for single patient use for multiple nebulizations. For hygiene reasons, follow the instructions in the "Cleaning" section.
Once opened, we recommend replacing FIORDINASO every 12 months, unless the nebulization capacity ceases before this time.
Store FIORDINASO in a dry place after cleaning and when not in use. Always keep the packaging with the batch number.
The product contains small parts. Small parts, if swallowed, could block the airways and cause a choking hazard. Be 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 correct nebulization of the saline solution, it is recommended to apply sufficient pressure to the syringe to avoid coarse or droplet nebulization.
The device is intended for independent use by adult patients. 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 in case of ongoing or recently completed nosebleeds.
Do not use in infants under 1 month of age.

Storage

Store at room temperature (0-55°C), protected 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 properly stored product.
Do not use if the package or its parts are damaged.
Do not dispose of the various components in the environment after use.
Keep out of reach of children.