3
Introduction
The User Manual provides instructions on how to operate NObreath® 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 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
NObreath® is CE marked according to the Medical Device Directive 93/42/EEC.
Please refer to the ‘Safety Information’ section of this manual for more information on the
compliance of the NObreath®.
Intended Use
The NObreath® is a breath nitric oxide (NO) test system intended to measure fractional exhaled
nitric oxide (FeNO) in parts per billion (ppb) in exhaled breath.
The measurement is taken to evaluate airway inflammation and should be used in conjunction with
other clinical and laboratory evaluations where appropriate when making a diagnosis or treatment
plan.
The measurements are intended for interpretation by healthcare professionals and for use in a
healthcare environment, where patients will complete measurements under supervision.
Contraindications
There are no known contraindications.
