Tests have to be performed at a flow of 750 l/m, the results must prove a removal capacity higher than 99,5% both of bacteria and viruses. The correct reference parameter to validate a spirometry filter is a flow at 750 l/m (see maximum value achievable by peak-flow)
It has to be lower than 1,5 cm H2O l/s at a flow rate of 14 l/s (American Thoracic Society A.T.S. guidelines)
Americal Thoracic Society declares that “for spirometry filter usage the dead space must be lower than 1,5-2 ml/kg of bodyweight”. To calculate it, the dead space in ml has to be divided by 2.
Membrane is to maintain its physical and functional properties over time (5 years)
Have tests performed at 30-55-750 liters/minute with results higher than 99,9%.
Have tests performed at a flow rate of 14 l/s with a result of 0,79 cm H2O L/sec
MADA filters’ dead space is reduced, ranging from 32 ml up to 38,2 ml
Have relevant tests
The mouthpiece has to be oval, in anatomical shape, it has to follow the dental arch structure, with a protruding edge to allow secure grip between the teeth
Verified and safe
Has to be complete, public and in compliance with indications.
European Directive 93/42/EEC refers to class IIa
Have all these features
Manufactured in Italy.
Have complete (over 25 tests), compliant and public documentation
Has IIa class
and ISO 13485 certification
Bacterial and viral filtration efficacy – at 30-55-750 L/min Nelson Laboratories (USA) – HPA PD (UK)
Flow resistance – at 14 L/Sec – Politecnico di Milano
Biocompatibility – Coronati Consulting Lab..
Dead space measurement – Politecnico di Milano
Aged membrane stability study – Studio Ambiente
