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Important Safety Information Regarding NIOX VERO® (United States)

NIOX VERO® is a portable system for the non-invasive, quantitative, simple and safe measurement of Nitric Oxide (NO) in human breath. Nitric Oxide is frequently increased in some inflammatory processes such as asthma. Measuring the fractional NO concentration in expired breath (FeNO) provides the physician with means of evaluating an asthma patient’s response to anti-inflammatory therapy, as an adjunct to the established clinical and laboratory assessments in asthma. NIOX VERO is intended for prescription use and should only be used as directed in the NIOX VERO User Manual by trained healthcare professionals. NIOX VERO is suitable for children, 7–17 years, and adults 18 years and older. NIOX VERO can be operated in two exhalation modes, 10 seconds or 6 seconds. The 10-second test mode is for age 7 and up. The 6-second test mode is for ages 7–10 only when a 10-second test is not successful. NIOX VERO cannot be used with infants or by children under the age of 7, as measurement requires patient cooperation. NIOX VERO should not be used in critical care, emergency care or in anesthesiology.