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Omron A3 Complete - Product Description and Features; Packaging Contents; General Description and Purpose; Indications for Use

Omron A3 Complete
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2
Packaging Contents
1. Nebulizer kit
2. Mouthpiece
3. Nosepiece
4. Adult Mask (PVC)
5. Child Mask (PVC)
6. Air Tube (PVC)
7. Spare Air Filters
8. Carrying bag
9. Instruction Manual
General description / purpose
Compressor nebulizer A3 Complete is a medical device meant for inhalation of
medication for respiratory disorders.
Application field
The unit is designed mainly for home use.
User
Users are persons who suffer from respiratory disorders and require inhalation of
medications.
Indications for use
This device is a compressor nebulizer intended to be used for inhaling medication for
respiratory disorders.
Features (particularities)
Unique nebulizer kit that can treat upper, mid and lower airways.
Compliant with the ERS guidelines for Inhaled Therapies
Designed for combined treatment of Asthma and associated upper Airways
diseases.
Applicable Directives: Medical Device Directive (MDD) 93/42/EEC
EN 60601-1:2006
EN 60601-1-2:2007 3rd edition
EN 13544-1:2009
EN 60601-1-11:2010
EN 980:2008
EN 62366:2008
UNI EN ISO 10993-1:2010
EN 10993-5:2009
EN 10993-10:2010
EN 14971:2012
UNI EN 1041:2013

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