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PM-2031-01-03/2021
List of Harmonized EN Standards
The device is classified as a medical device, class IIa.
Applicable standards:
EN 13544-1:2007+A1 :2009
EN ISO 15223-1:2016
EN 1041:2008+A1 :2013
UNI EN ISO10993-1:2010
EN 10993-5 :2009
EN 10993-10:2010
EN 60601-1:2006/A11 :2011/A1 :2013
EN 60601-1-2:2015
EN 60601-1-11:2015
EN 60601-1-6:2010+A1:2015
EN 62366-1:2015
EN ISO 14971:2012
Cleaning of the device
Observe the rules below when cleaning or disinfecting parts. Failure to
observe these rules may result in damage, inefficient nebulization or
infection.
Carefully wash your hands before cleaning and disinfecting the nebulizer
parts. Clean and disinfect the Nebulizer Kit and its parts and accessories
(Masks, Mouthpiece and Adapter) before using them as follows:
- the first time after purchase (cleaning and disinfection)
- if the device has not been used for a long period of time (cleaning and
disinfection)
- if another person uses the same device (cleaning and disinfection)
- after each use (cleaning)
- after the last treatment of the day (cleaning and disinfection)
●
Cleaning the Nebulizer Kit, Masks, Mouthpiece (including all parts)
and Adapter:
Fully disassemble the nebulizer kit. Remove the valves from the
mouthpiece. Wash the parts in warm water and mild, neutral detergent.
Rinse them thoroughly with clean hot tap water, gently tap to remove
excess water and allow to air dry in a clean place. It is advisable to
