Description
CE Medical Device Class IIa (EU Regulation 2017/745).
Device for aerosol therapy. Fast, compact and ideal for the whole family. Equipped with an ampoule that ensures the speed and effectiveness of the therapy. With ampoule holder and handle.
Latex and phthalate-free.

Technical specifications
Rated voltage: approx. 230 V.
Frequency: 50 Hz.
Power consumption: 50 W.
Fuse: T2AH250V.
Maximum pressure: 2.57 ± 0.11 bar.
Operating pressure: 0.98 ± 0.06 bar.
Liquid protection: IP 21.
Device operating conditions: 20 minutes ON - 40 minutes OFF.
MMAD:

	0.1% Albuterol	Fluibron Solution (15 mg/2 ml of Ambroxol HCl)	Pulmaxan Suspension (0.5 mg/ml of Budesonide)
MMAD	3.59 ± 0.18 micrometers	3.85 ± 0.06 micrometers	4.55 ± 0.16 micrometers

Respirable fraction:

	0.1% Albuterol	Fluibron Solution (15 mg/2 ml of Ambroxol HCl)	Pulmaxan Suspension (0.5 mg/ml of Budesonide)
Respirable fraction (% <5 micrometers)	61.2 ± 0.02	60.3 ± 0.02	50.3 ± 0.03

Ampoule capacity: maximum 8 ml - minimum 2 ml.
Noise level: 60 dBA @50 cm - 58 dBA @100 cm.

How to use
Indicated for aerosol therapy treatment.
Operating temperature: between -5°C and +40°C.
Operating humidity: between 15% and 85% RH.
Operating pressure: between 700 and 1,060 hPa.
Cleaning and maintenance: Remove the mask from the ampoule. Disconnect the connecting tube from the ampoule. Disassemble all ampoule components. Discard any remaining medication. Wash components in water. Hand dry or air dry in a clean environment using a soft, clean, lint-free cloth. Assemble the ampoule and store in a dry place.
Disinfection procedure: disinfect the ampoule, mouthpiece, masks, or nasal fork after the last treatment of the day, according to the following procedure. Use a 70% ethyl alcohol solution:
Step 1. Immerse the components in the disinfectant solution for 10 minutes.
Step 2. Remove the components and discard the solution.
Step 3. Rinse the components with clean drinking water (60 seconds), shake off excess water, and allow to air dry in a clean environment.

Components
Child mask: PVC.
Connecting tube: PVC.
Ampoule: Polypropylene + Polycarbonate.

Warnings
Never immerse or wet the appliance in water or other liquids. For cleaning, use only a soft, clean, and dry cloth.
Do not boil the masks.
Never use benzene, thinners, or other flammable chemicals for cleaning. This cleaning procedure has been tested for 365 cleaning cycles. For greater hygiene and safety, never use the same accessories for more than one patient. It is advisable to clean and check the integrity of the accessories before and after each use and to replace them if damaged.

Storage
Store in a cool, dry place, away from heat sources and sunlight.
Storage temperature: between -25°C and +70°C.
Storage humidity: between 15% and 85% RH.
Storage pressure: between 700 and 1,060 hPa.
Validity in intact packaging: 12 months.

Format
Aerosol device.
Includes: nebulizer ampoule, adult mask, pediatric mask, connecting tube, mouthpiece, nasal fork, air filters, integrated ampoule holder and handle.

Code 5803822000010