NIOX PRO® Important Safety Information

NIOX PRO® measures Nitric Oxide in human breath (Fractional exhaled Nitric Oxide, FeNO) and Nasal Nitric Oxide (nNO) in the aspirated air from the nasal cavity. NIOX PRO® is for use only as an In Vitro Diagnostic Device (IVD) and intended for near-patient testing.

FeNO
FeNO is increased in some airway inflammatory processes and decreases in response to anti-inflammatory treatment. FeNO measurement with NIOX PRO® is quantitative, non-invasive, simple, safe, and is used as part of assessment and monitoring of patients with conditions related to airway inflammation. NIOX PRO® is suitable for patients aged 4 and above for FeNO measurements.

As measurement requires patient cooperation, some children below the age of 7 may require additional coaching and encouragement. NIOX PRO® should be used as directed in the NIOX PRO® User Manual.

NIOX PRO® for FeNO measurement can be operated with two different exhalation times, 10 seconds and 6 seconds. The 10 second test is the preferred mode. For children who are not able to perform the 10 second test, the 6 second test is an alternative. The 6 second test should be used with caution in patients over the age of 10 years. It should not be used in adult patients.

nNO
Nasal Nitric Oxide has been shown to be decreased in patients with Primary Ciliary Dyskinesia (PCD). Measurement of nNO is a screening tool that can assist in the identification of cases of PCD according to ERS guidelines¹. Measurement of nNO with the NIOX PRO® Nasal Measurement Mode is non-invasive, simple, safe and repeatable in patients age 5 and above when measured according to the NIOX PRO® Nasal Measurement Mode User Manual. Suspected cases of PCD following screening with nNO should be confirmed according to published recommendations for PCD diagnosis and management.

1. Beydon N et al. Nasal nitric oxide measurement in children for the diagnosis of primary ciliary dyskinesia: European Respiratory Society technical standard. European Respiratory Journal. 2023;61(4).

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NIOX VERO® Important Safety Information

NIOX VERO® is a portable system for the non-invasive quantitative simple and safe measurement of Nitric Oxide (NO) in human breath (FeNO) and Nasal Nitric Oxide (nNO) in the aspirated air from the nasal cavity. For FeNO: Nitric Oxide is frequently increased in some inflammatory processes such as asthma and decreases in response to anti-inflammatory treatment. FeNO measurements should be used as part of a regular assessment and monitoring of patients with these conditions. NIOX VERO FeNO is suitable for patients age 4 and above. As measurement requires patient cooperation, some children below the age of 7 may require additional coaching and encouragement. NIOX VERO FeNO can be operated with 2 different exhalation times, 10 seconds and 6 seconds. The 10 second mode is the preferred mode. For children who are not able to perform the 10 second test, the 6 second is an alternative. The 6 second test should be used in caution with patients over the age of 10. It should not be used in adult patients. Incorrect use of the 6 second exhalation test may result in falsely low FeNO values, which can lead to incorrect clinical decisions. For nNO: nNO has been shown to decrease in patients with Primary Ciliary Dyskinesia (PCD) and measurement of nNO can assist in the identification of cases of PCD. Measurement of nNO is suitable for patients age 5 and above. Suspected cases of PCD following screening with nNO should be confirmed according to published recommendations for PCD diagnosis and management.