Descriptive sheet Rinorex
Nasal Nebulizer
Description
Accessory medical device and cannot be used unless in combination with another compatible medical device.
The compatibility of the RINOREX NASAL NEBULIZER with other medical devices is reported in the instructions of the medical devices with which it is associated.
The RINOREX NASAL NEBULIZER can only be used for the irrigation of the nasal cavities of medical devices containing saline solutions and intended for the irrigation of the nasal cavities.
How to use
Remove the syringe plunger. Pour the entire contents of the vial into the syringe. Re-insert the plunger into the syringe. Remove the protective cap from the nasal spray. Dispense the saline solution into the chosen nasal cavity by gently placing the spray against the nostril, avoiding inserting it into the nostril. Clean the RINOREX NASAL NEBULIZER and return the nasal spray to the container from which it was removed.
For further instructions, see the information on the Medical Device to which the RINOREX NASAL NEBULIZER is associated.
Cleaning mode
Clean the components after each use to remove any residue from the used solution. Wash with warm water (not exceeding 35°C) and only if necessary with a mild neutral detergent or as directed in the instructions for the device with which the RINOREX NASAL NEBULIZER is used. Do not use harsh disinfectants such as solutions containing sodium hypochlorite, hydrogen peroxide, ammonia, or quaternary ammonium compounds. Rinse thoroughly with clean warm running water, shake gently to remove excess water, and allow to air dry in a clean environment. Do not use a hairdryer or other heat-emitting devices to dry the device or its components.
Warnings
The components of the RINOREX NASAL NEBULIZER cannot be used individually but only in combination and only as described in the instructions for use in the package insert for the RINOREX NASAL NEBULIZER or the device with which it is associated.
Do not use the device for purposes other than nasal irrigation. The manufacturer cannot be held responsible for inappropriate use of the device.
Device intended for human use only.
Keep out of the reach and sight of children to avoid incorrect use of the product.
Avoid contact with eyes.
The RINOREX NASAL NEBULIZER is intended for a single patient (single-patient use) but can be reused for multiple irrigations with the same solution. Use of the RINOREX NASAL NEBULIZER by multiple patients may facilitate the transmission of infections.
The number of irrigations depends on the solutions, therefore this number is indicated in the instructions of the medical device to which the RINOREX NASAL NEBULIZER is associated.
The use of the RINOREX NASAL NEBULIZER by children or non-self-sufficient people must take place under the supervision of an adult who has read these instructions for use.
Keep the device out of reach of children unless an adult is present. The device may contain small parts that can be easily swallowed.
Do not use if nosebleeds are ongoing or have just ended, or if the nasal mucosa is not intact.
Do not use after the expiry date or if the package is opened or damaged.
In case of adverse reactions, discontinue use of the product and contact your doctor.
Do not use in case of accidental contamination after opening.
Failure to follow the warnings and instructions for use correctly could compromise the effectiveness of the product or cause existing problems to worsen, as well as causing the manifestation of problems that were not previously present.
In some cases, use of the product may cause a mild, transient feeling of local irritation. If you experience any side effects, whether described in the package leaflet or not, inform your doctor or pharmacist.
Do not expose the device or its components to direct sunlight. Keep away from chemicals.
Conservation
Store in the original packaging at a temperature between 5°C and 25°C, in a sheltered, dry and clean place, in order to avoid contamination of the product.
The expiry date indicated refers to the intact and correctly stored product.
Shelf life when packaged intact: 60 months.
Format
The package contains:
- 1 5 ml Luer Lock syringe (non-sterile);
- 1 nasal dispenser mounted on a Luer Lock syringe.