Description
Non-sterile Class I medical device.
Indicated for the rhino-sinus administration of saline solutions and/or similar solutions for aerosol use for topical treatments of the upper airways.
A medical device specifically designed to allow rapid administration of the solution through nebulization in particles between 10 and 20 microns in size, ideal for treating the upper airways. The specially designed shape and material used for the dispenser make it suitable for children's nostrils, but can also be used by adults. The cannula needle, supplied with Buona Spray-sol, allows for the withdrawal of saline solutions and/or similar aerosol solutions from any type of vial or container.
The elephant syringe cover makes nose washing a fun and enjoyable experience for children.
The 5 ml Luer Lock syringe, included in the package, is a complimentary gift for using Buona Spray-sol.

How to use
1. Detach a single-dose vial, warm it between your hands before administering the solution and open it by twisting the cap.
2. Draw up the solution to be nebulized with the Luer Lock syringe:
- with NEBIAL 3% and ISONEBIAL vials it is not necessary to use the cannula needle as the opening of the vial fits perfectly into the Luer Lock syringe;
- with other types of vials or containers: attach the cannula needle to the syringe, draw up the solution to be nebulized and then detach the cannula needle from the syringe.
3. Attach the elephant syringe cover to the Spray-sol nebulizer, making sure that the elephant's face is facing the nebulizer, and screw the syringe filled with the solution onto the appropriate inlet nozzle of the Spray-sol nebulizer.
4. For infants and young children (under 3 years old, and depending on their level of cooperation), it is necessary to perform the irrigation while lying on one side, keeping the head tilted to one side and gently inserting the Spray-sol nebulizer into the upper nostril. Push down on the syringe plunger to nebulize the solution. For older children and adults, lean forward with the head slightly tilted to one side and insert the Spray-sol nebulizer into the upper nostril. Push down on the syringe plunger to nebulize the solution, making sure that the colored cap of the nebulizer does not detach from the transparent body.
5. Repeat step 4 for the other nostril, trying to divide the solution in the syringe equally between both nostrils. During treatment, the nebulized solution may drip from the nose.
6. After each use, before placing the components back in the appropriate case, wash them as follows:
- wash the Spray-sol nebulizer under running, cool water, possibly adding a drop of neutral (non-abrasive) soap. Before storing, dry the Spray-sol nebulizer with a soft cloth;
- rinse the body and piston of the syringe under running water and dry them thoroughly before reassembling the syringe;
- rinse the cannula needle both internally and externally with running water and let it air dry;
- Wash the elephant syringe cover and the customizable container under running water and dry them with a soft cloth. Make sure all components are completely dry before placing them back in the customizable container.
Buona Spray-Sol is intended for single-patient use, but can be used multiple times. Therefore, thorough cleaning after each use is very important to ensure optimal performance and a long life.
Medical device consisting of a Spray-sol nebulizer, cannula needle, 5 ml Luer Lock syringe, elephant syringe cover, and a customizable container for storing all components. The Spray-sol nebulizer consists of:
- a device body (A);
- a colored cap (B), snap-fitted onto the body of the device.
The body of the device is, in turn, composed of two chambers:
- the first, intended for the passage of the solution to be nebulized, is a hollow and transparent cylindrical chamber with a solid and colored internal part;
- the second, intended for the collection solution, consists of a small transparent corolla-shaped container.

Warnings
- Use the product only for its intended use.
- The use of the Spray-sol nebulizer and cannula needle by children or non-self-sufficient people must take place under the supervision of an adult who has read these instructions for use.
- Do not use Buona Spray-sol under 3 months of age.
- Before each use, check that the Spray-sol®, syringe and cannula needle are not damaged; if they are damaged, do not use them.
- During use, make sure that the colored cap of Spray-sol does not detach from its transparent body.
- For the frequency of use, follow the instructions on the label of the solution to be nebulized or the doctor's instructions.
- For hygiene reasons, the Spray-sol nebulizer is intended for single-patient use, but can be reused for multiple nebulizations. To reuse, clean it following the instructions above.
- The syringe and cannula needle provided can be reused several times as they are intended for nasal use.
- Use the Spray-sol nebulizer as long as mechanical integrity and the ability to nebulize the solution are maintained.
- It is recommended not to use the Spray-sol nebulizer, syringe and cannula needle for more than 6 months after first use.
- After each use, place the Spray-sol nebulizer, syringe, cannula needle and syringe cover in the appropriate container, after having washed and dried them properly.
- Keep the Buona Spray-Sol package where the batch number and manufacturing date are shown.
- Keep out of the reach and sight of children.
- Any adverse event relating to this product must be reported to Buona Spa Società Benefit, the distributor and the national health authority of your country.
- For the disposal of Buona Spray-sol components, follow the instructions of your Municipality.

Conservation
Store the product away from humidity, light and heat sources.

Format
Good Spray-Sol (Spray-Sol nebulizer, cannula needle, 5 ml luer lock syringe, elephant syringe cover and container).

Cod. 3064A1