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Introduction
The User Manual provides instructions on how to operate FeNObreath™ FeNO monitor and its
accessories. It contains relevant information about the monitor, its uses and its care, including step-
by-step instructions with screens and illustrations.
Definitions
WARNING:
indicates a potentially hazardous situation, which, if not avoided, may result in minor or
moderate injury.
CAUTION:
indicates a potentially hazardous situation, which, if not avoided, may result in damage to
the device.
NOTE:
used to call attention to notable information that should be followed during use.
Compliance
FeNObreath™ is CE marked according to the Medical Device Directive 93/42/EEC.
FeNObreath™ is RoHS compliant.
Please refer to the ‘Safety Information’ section of this manual for more information on the
compliance of the FeNObreath™.
Intended Use
The FeNObreath™ is a portable, non-invasive device for the measurement of Fractional Exhaled
Nitric Oxide (FeNO) in human breath. The production of nitric oxide is often found to be increased in
inflammatory conditions such as asthma. Measurement of FeNO by FeNObreath™ is a method to
measure the decrease in FeNO concentration in asthma patients that often occurs after treatment
with anti-inflammatory pharmacological therapy, as an indication of the therapeutic effect in
patients with elevated FeNO levels.
The fractional NO concentration in expired breath (FeNO), can be measured by FeNObreath™
according to guidelines for NO measurement established by the American Thoracic Society.
FeNObreath™ is intended for children, 7-17 years, and adults 18 years and older. FeNObreath™ 12
second test mode is for age 7 and up.
