RINONEB

Description
Medical device for the nebulization of topical solutions through the nasal route.
Medical device indicated for the nebulization into the nasal cavities of solutions containing aerosolized drugs, for topical treatments of the upper airways.
Medical device designed to allow the administration of topical solutions through the nasal route via nebulization. Solution particles with a size between 10-20 microns allow treatment of the upper airways, reaching the nasopharynx, the first step for upper airway pathologies and a site for bacterial biofilm formation.
The conical shape of the nebulizer, made of soft and non-porous material, allows a seal on the nostril, adapting ergonomically to both adults and children. The needle-cannula allows drawing aerosolized drug solutions from any type of vial.

How to use
1. Attach the needle-cannula to the syringe.
2. Open the solution vial and draw its content through the needle-cannula.
3. Replace the needle-cannula with the nebulizer.
4. Position the nebulizer in the nostril and push the syringe plunger for nebulization. Repeat the operations for the other nostril, trying to evenly divide the solution contained in the syringe between the two nostrils.
5. In older children and adults, keep the torso upright, with the head slightly tilted to one side, and insert the nebulizer into the nostril.
6. In infants and young children (under 3 years of age), the operation must be performed lying on one side, keeping the head tilted to one side and gently inserting the nebulizer into the upper nostril.
CLEANING
The Sobrefluid RINONEB medical device is intended for use by a single patient but can be used multiple times. For this reason, it is very important to perform thorough cleaning after each use to ensure its durability and proper functioning.
At the end of each use:
1. clean the nebulizer with warm running water and, if necessary, neutral soap. Before storing it in the packaging, thoroughly dry the device with a soft cloth;
2. wash the syringe under running water and thoroughly dry it with a soft cloth;
3. rinse the needle-cannula both internally and externally with running water, thoroughly dry it externally with a soft cloth, and wait for it to air dry internally. Make sure all components are completely dry before reusing them.
4. After cleaning, the three components can be stored inside the container box.

How to use
1. Screw the needle-cannula onto the syringe and remove the cap.
2. Open the solution vial, insert the needle-cannula, and draw the content. Unscrew the needle-cannula and remove it, closing it with the appropriate protective cap.
3. Hold the nebulizer by its two side wings and firmly screw it onto the syringe, rotating it clockwise until fully fixed, without exerting excessive force.
4. Position the device in the nostril and nebulize by pressing the plunger. Repeat the operations for the other nostril, dividing the solution evenly between the two nostrils.
5. In adults and children (from 3 years of age), keep the torso upright, with the head slightly tilted to one side, and insert the nebulizer into the nostril.
6. After consulting a doctor, in young children (above 3 months of age), the operation must be performed lying on one side, keeping the head tilted to one side and inserting the nebulizer into the upper nostril.

Warnings
The Sobrefluid RINONEB medical device is intended for use by a single patient but can be used multiple times. Use the product only for its intended purpose. Read the instruction leaflet carefully before use. The needle-cannula and syringe are intended for multi-use. Fill the syringe only by drawing the solution with the needle-cannula. Before each use, check that all components are intact and undamaged. For reuse, clean according to the instructions in the Cleaning paragraph. Store the product away from humidity, light, and heat sources. Do not use the device in children under 3 months of age. Use the medical device as long as its mechanical integrity and nebulization function are maintained, and in any case for no more than 6 months from the date of first use. Keep out of reach and sight of children. Do not use after the expiry date shown on the packaging.

Storage
Store the product at a temperature below 30°C.
Validity with intact packaging: 24 months.

Format
Package containing:
- 1 nebulizer device;
- 1 Luer Lock syringe, 5 ml;
- 1 needle-cannula, for drawing solutions.