What determines the quality

of a spirometry filter?

In order not to compromise the usage of a spirometry filter, it’s essential to choose a good quality filter. Manufacturing companies have to be transparent in their statements and their tests have to follow specific parameters in order to be trusted.

Essential requirements

Filtration efficiency

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)

Flow resistance

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)

Dead Space Measurement Test

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.

Aged Membrane Stability Test

Membrane is to maintain its physical and functional properties over time (5 years)

MADA filters

Have tests performed at 30-55-750 liters/minute with results higher than 99,9%.

MADA filters

Have tests performed at a flow rate of 14 l/s with a result of 0,79 cm H2O L/sec

MADA filters

MADA filters’ dead space is reduced, ranging from 32 ml up to 38,2 ml

MADA filters

Have relevant tests

Comfort for the patient

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

Manufacturing country

Verified and safe

Technical-Scientific Documentation

Has to be complete, public and in compliance with indications.

CE and ISO Certifications

European Directive 93/42/EEC refers to class IIa

MADA filters

Have all these features

MADA filters

Manufactured in Italy.

MADA filters

Have complete (over 25 tests), compliant and public documentation

MADA filters

Has IIa class
and ISO 13485 certification

MADA spirometry filters were subject to 25 tests

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