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.
Operating and Measurement conditions
Analytical precision:< 3 ppb of measured value < 30 ppb< 10 % of measured value ≥ 30 ppbExpressed as one standard deviation for replicate measurements with the same instrument, using a certified gas concentration of Nitric Oxide reference standard.
Clinical precision: < 3 ppb of measured value < 30 ppb< 10 % of measured value ≥ 30 ppbDetermination based on consecutive measurements from the same patient, performed by different operators.
Analytical Accuracy: ± 5 ppb or max 15% Expressed as the upper 95% confidence limit, based on mean of absolute differences from certified gas concentration of Nitric Oxide reference standard.
InhalationInhalation to TLC (Total Lung Capacity) before start of exhalation, to secure proper handling:Minimum -3 cm H2O (trigger only)
Exhalation10 s (standard mode, clinical use)6 s (special mode, research use) All exhalations are to be performed at an exhalation pressure of 10 - 20 cm H2O, to maintain a fixed flow rate of 50 ±5 mL/s.
Memory capacity: 1500 measurements (Instrument memory)2000 measurements (Test Card memeory)
Instrument: Minimum 3 years at time of delivery or 1500 measurements, whatever comes first
Sensor: Minimum 9 months at time of delivery
According to IEC 60601-1 Class II Type B
Main voltage:
100 to 240 V ~ 50 to 60 Hz
Secondary voltage:
6 V DC (external power adapter)
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