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AEROSOL THERAPY SET
Description
Medical device with risk class IIa (Regulation 2017/745) extremely efficient in the application of medical therapies administrable by aerosol nebulization. The medical device is used to deliver, in nebulized form, bronchodilator and antibiotic medicinal substances (administration of medicinal specialties by aerosol).
Instructions for use
PREPARATION
1. Remove the air tube from the nebulizer, leaving it connected to the air outlet nozzle of the device.
2. Rotate the upper part of the nebulizer counter-clockwise.
3. Detach the inner piston at the bottom of the nebulizer with simple finger pressure.
Before each use and/or after cleaning operations, pay particular attention to the integrity of all accessories supplied with the device. Turn off the appliance before each cleaning operation and disconnect the power cord from the electrical outlet.
CLEANING
Before and at the end of each use, clean all components of the nebulizer (except the air tube) using one of the two methods described below.
Method 1: thoroughly clean the components for 5 minutes, using warm (approx. 40 °C) potable tap water and/or neutral soap.
Method 2: clean the components (except for the air tube) by immersing them in a solution of 60% water and 40% white vinegar. After this, rinse thoroughly with warm (approx. 40 °C) potable water. After cleaning, rinse thoroughly, remove excess water, and air dry in a clean place.
Warnings
1. Use the nebulizer and its accessories following your doctor's instructions.
Any use other than that for which the nebulizer and its accessories are intended is to be considered improper and therefore dangerous: The manufacturer assumes no responsibility for damages resulting from improper, erroneous and unreasonable use.
2. The device contains small components that can be removed and easily swallowed by children: the use of this device by children and/or incapacitated persons always requires careful supervision by an adult with full mental faculties. 3. Dispose of the device in accordance with current regulations.
4. This device must be used exclusively for the purpose for which it was designed and as described in this manual.
5. Medical device not suitable for anesthesia and pulmonary ventilation.
6. In cases of risk of infection and microbial contamination, personal use is recommended (always consult your doctor).
7. The device must only be used with compressor devices for aerosol therapy compliant with current regulations. 8. Use the nasal fork only if expressly requested by the doctor and taking care never to insert the bifurcations into the nose, but only to bring them as close as possible.
9. The materials used for contact with drugs are thermoplastic polymers with high stability and chemical resistance. These materials have been tested with commonly used drugs (salbutamol, beclomethasone dipropionate, acetylcysteine, budesonide, ambroxol) and have shown no interaction phenomena. However, given the variety and continuous evolution of usable drugs, it is not possible to exclude interactions. Therefore, it is suggested to:
- always consume the drug as quickly as possible after opening;
- always avoid prolonged contact of the drug with the appropriate tray container and immediately perform cleaning procedures after each application;
- in the event of abnormal situations (e.g., softening or cracking) of the tray container, do not introduce any solution and do not perform inhalation. Contact technical service, specifying the method of use and the type of drug used.
10. Any serious incident that has occurred in relation to the product should be reported to the manufacturer and the competent authority of your country. If you do not have the contact information for such authority, contact the manufacturer (or distributor) whose contact information is provided in this instruction manual.
Medical device with risk class IIa (Regulation 2017/745) extremely efficient in the application of medical therapies administrable by aerosol nebulization. The medical device is used to deliver, in nebulized form, bronchodilator and antibiotic medicinal substances (administration of medicinal specialties by aerosol).
Instructions for use
PREPARATION
1. Remove the air tube from the nebulizer, leaving it connected to the air outlet nozzle of the device.
2. Rotate the upper part of the nebulizer counter-clockwise.
3. Detach the inner piston at the bottom of the nebulizer with simple finger pressure.
Before each use and/or after cleaning operations, pay particular attention to the integrity of all accessories supplied with the device. Turn off the appliance before each cleaning operation and disconnect the power cord from the electrical outlet.
CLEANING
Before and at the end of each use, clean all components of the nebulizer (except the air tube) using one of the two methods described below.
Method 1: thoroughly clean the components for 5 minutes, using warm (approx. 40 °C) potable tap water and/or neutral soap.
Method 2: clean the components (except for the air tube) by immersing them in a solution of 60% water and 40% white vinegar. After this, rinse thoroughly with warm (approx. 40 °C) potable water. After cleaning, rinse thoroughly, remove excess water, and air dry in a clean place.
Warnings
1. Use the nebulizer and its accessories following your doctor's instructions.
Any use other than that for which the nebulizer and its accessories are intended is to be considered improper and therefore dangerous: The manufacturer assumes no responsibility for damages resulting from improper, erroneous and unreasonable use.
2. The device contains small components that can be removed and easily swallowed by children: the use of this device by children and/or incapacitated persons always requires careful supervision by an adult with full mental faculties. 3. Dispose of the device in accordance with current regulations.
4. This device must be used exclusively for the purpose for which it was designed and as described in this manual.
5. Medical device not suitable for anesthesia and pulmonary ventilation.
6. In cases of risk of infection and microbial contamination, personal use is recommended (always consult your doctor).
7. The device must only be used with compressor devices for aerosol therapy compliant with current regulations. 8. Use the nasal fork only if expressly requested by the doctor and taking care never to insert the bifurcations into the nose, but only to bring them as close as possible.
9. The materials used for contact with drugs are thermoplastic polymers with high stability and chemical resistance. These materials have been tested with commonly used drugs (salbutamol, beclomethasone dipropionate, acetylcysteine, budesonide, ambroxol) and have shown no interaction phenomena. However, given the variety and continuous evolution of usable drugs, it is not possible to exclude interactions. Therefore, it is suggested to:
- always consume the drug as quickly as possible after opening;
- always avoid prolonged contact of the drug with the appropriate tray container and immediately perform cleaning procedures after each application;
- in the event of abnormal situations (e.g., softening or cracking) of the tray container, do not introduce any solution and do not perform inhalation. Contact technical service, specifying the method of use and the type of drug used.
10. Any serious incident that has occurred in relation to the product should be reported to the manufacturer and the competent authority of your country. If you do not have the contact information for such authority, contact the manufacturer (or distributor) whose contact information is provided in this instruction manual.
