PiC Solution KAPPY Description Medical device class IIa CE (EU Reg. 2017/745). Aerosol therapy device. Fast, compact and ideal for the whole family. Equipped with a nebulizer that ensures fast and effective therapy. Includes nebulizer holder and handle. Free of latex and phthalates. Technical specifications Nominal 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. Protection against liquids: IP 21. Operating conditions: 20 minutes ON - 40 minutes OFF. MMAD: 0.1% Albuterol Fluibron solution (15mg/2ml) (of Ambroxol hydrochloride) Pulmaxan Suspension (0.5 mg/ml budesonide) MMAD 3.59 ± 0.18 micrometers 3.85 ± 0.06 micrometers 4.55 ± 0.16 micrometers Respirable fraction: 0.1% Albuterol Fluibron solution (15mg/2ml) (of Ambroxol hydrochloride) Pulmaxan Suspension (0.5 mg/ml 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 at 50 cm - 58 dBA at 100 cm. How to use Indicated for aerosol treatment. Operating temperature: between -5°C and +40°C. Operating humidity: 15% to 85% relative humidity. Operating pressure: between 700 and 1,060 hPa. Cleaning and Maintenance: Remove the mask from the nebulizer. Disconnect the tubing from the nebulizer. Disassemble all components of the nebulizer. Discard any remaining medication. Wash the components with water. Hand dry or air dry in a clean environment using a soft, clean, lint-free cloth. Reassemble the nebulizer and store in a dry place. Disinfection procedure: Disinfect the vial, mouthpiece, masks or nosepiece after the last treatment of the day, according to the following procedure. Use a 70% ethyl alcohol solution: Step 1. Soak 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 Childrens mask: PVC. Connection pipe: PVC. Vial: Polypropylene + Polycarbonate. warnings Never immerse or immerse the device in water or other liquids. For cleaning, use only a soft, clean, dry cloth. Do not boil the masks. Never use benzene, thinner or other flammable chemicals for cleaning. This cleaning procedure has been tested for 365 cleaning cycles. For reasons of increased hygiene and safety, never use the same accessories on more than one patient. It is recommended to clean and check the integrity of the accessories before and after each use and replace them if damaged. Conservation 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% relative humidity. Storage pressure: between 700 and 1,060 hPa. Shelf life in unopened packaging: 12 months. Format Aerosol device. Includes: nebulizer kit, adult mask, child mask, connection tube, mouthpiece, nosepiece, air filters, stand and integrated nebulizer handle. Code 5803822100010