BUONA
Buona Spray-sol
Description
Non-sterile class I medical device.
Indicated for the rhinosinusal administration of saline solutions and/or similar aerosol solutions for topical treatment of the upper airways.
Medical device specifically designed to allow rapid administration of the solution by nebulisation into particles of between 10 and 20 microns, ideal for treating the upper airways. The specially designed shape and the material used for the nozzle make it suitable for a child's nostril, but it can also be used by adults. The cannula needle supplied with Buona Spray-sol allows saline and/or similar aerosol solutions to be drawn from any type of vial or container.
The elephant syringe cover turns nose washing into a pleasant, playful moment for children.
The 5 ml Luer Lock syringe included in the pack is a free gift for use with Buona Spray-sol.
Directions for 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 nebulised with the Luer Lock syringe:
- with NEBIAL 3% and ISONEBIAL vials the cannula needle is not needed, as the vial opening fits the Luer Lock syringe perfectly;
- with other types of vials or containers: attach the cannula needle to the syringe, draw up the solution to be nebulised and then detach the cannula needle from the syringe.
3. Attach the elephant syringe cover to the Spray-sol nebuliser, making sure the elephant's face points towards the nebuliser, and screw the filled syringe onto the inlet nozzle of the Spray-sol nebuliser.
4. For infants and young children (under 3 years and in any case depending on how cooperative they are), the wash should be carried out lying on one side, with the head tilted to one side, gently inserting the Spray-sol nebuliser into the upper nostril. Press the syringe plunger to nebulise the solution. For older children and adults, lean the upper body forward with the head slightly tilted to one side and insert the Spray-sol nebuliser into the upper nostril. Press the syringe plunger to nebulise the solution, taking care that the coloured cap of the nebuliser does not come off the transparent body.
5. Repeat step 4 for the other nostril, trying to divide the solution in the syringe equally between the two nostrils. During treatment the nebulised solution may drip from the nose.
6. After each use, before putting the components back in their case, wash them as follows:
- wash the Spray-sol nebuliser under cool running water, adding a drop of neutral (non-abrasive) soap if needed. Dry the Spray-sol nebuliser with a soft cloth before putting it away;
- rinse the syringe barrel and plunger under running water and dry them thoroughly before reassembling the syringe;
- rinse the cannula needle inside and out with running water and leave it to air-dry;
- wash the elephant syringe cover and the customisable case with running water and dry with a soft cloth. Make sure all components are completely dry before putting them back in the customisable case.
Buona Spray-Sol is intended for use by a single patient but can be used several times. Thorough cleaning after each use is therefore very important to ensure optimal operation and durability.
Medical device consisting of Spray-sol nebuliser, cannula needle, 5 ml Luer Lock syringe, elephant syringe cover and customisable case for storing all components. The Spray-sol nebuliser consists of:
- a device body (A);
- a coloured cap (B), snap-fitted onto the device body.
The device body in turn consists of two chambers:
- the first, for the passage of the solution to be nebulised, is a hollow, transparent cylindrical chamber with a solid coloured inner part;
- the second, for collecting the solution, is a small transparent corolla-shaped container.
Warnings
- Use the product only for its intended purpose.
- Children or dependent persons should use the Spray-sol nebuliser and cannula needle only under the supervision of an adult who has read these instructions for use.
- Do not use Buona Spray-sol in babies 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, take care that the coloured cap of the Spray-sol does not come off its transparent body.
- For frequency of use, follow the directions on the label of the solution to be nebulised or your doctor's advice.
- For hygiene reasons the Spray-sol nebuliser is intended for a single patient, but can be reused for several nebulisations. Before reuse, clean it following the instructions above.
- The syringe and cannula needle supplied can be reused several times as they are intended for nasal use.
- Use the Spray-sol nebuliser as long as its mechanical integrity and ability to nebulise the solution are maintained.
- It is advisable not to use the Spray-sol nebuliser, syringe and cannula needle for more than 6 months from first use.
- After each use, put the Spray-sol nebuliser, syringe, cannula needle and elephant syringe cover back in their case, after washing and drying them properly.
- Keep the Buona Spray-Sol pack showing the batch number and date of manufacture.
- Keep out of the sight and reach of children.
- Any adverse event relating to this product must be reported to Buona Spa Società Benefit, to the distributor and to the national health authority of your country.
- For disposal of the Buona Spray-sol components, follow your local council's guidelines.
Storage
Store the product away from moisture, light and heat sources.
Pack size
Buona Spray-Sol (Spray-Sol nebuliser, cannula needle, 5 ml Luer Lock syringe, elephant syringe cover and case).
Code 3064A1