Intended Use (EU/Rest of the World)

NIOX MINO® Airway Inflammation Monitor measures Fractional Exhaled Nitric Oxide (FENO) in human breath. The level of Nitric Oxide is elevated when eosinophilic airway inflammation is present and decreases as a response to anti-inflammatory treatment. The FENO concentration in expired breath can be measured by NIOX MINO ® with assurance that such measurements are repeatable and according to recommendations for NO measurement established jointly by the European Respiratory Society and the American Thoracic Society.

Measurement of FENO by NIOX MINO ® is a quantitative, non-invasive, simple and safe method to measure the FENO concentration in patients with asthma-like airway symptoms in order to establish and monitor the presence of eosinophilic airway inflammation.

NIOX MINO ® is suitable for children, approximately 4 - 17 years, and adults 18 years and older.

FENO measurements should be used as part of the regular assessment and monitoring of asthma patients to improve the patient’s asthma management. NIOX MINO ® should be used as directed in the NIOX MINO ® User Manual. NIOX MINO ® may not be used with infants or by children approximately under the age of 4, as measurement requires patient cooperation.