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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.
Introduction
The production of nitric oxide is often found to be higher in inflammatory conditions such as asthma
and can therefore be used for the detection and management of such conditions
1
. Nitric oxide
measurement is not intended as a stand-alone method for diagnosis and should be used in
conjunction with other evaluation methods and tests
2
.
Product description
The NObreath® is a hand-held breath nitric oxide monitor supplied with the NObreath® Dock, and
FeNOCHART™ software.
The measurement system uses electrochemical sensor technology, which has been specifically
designed for this purpose. The sensor reacts to the presence of nitric oxide producing an electrical
output, which is then amplified with the result displayed. The sensor has ambient air flowing into
the sensor chamber while the unit is on, but not performing a breath test.
The sample system for the NObreath® has been specifically designed in order to meet the breath
test guidelines described in the ATS/ERS Recommendations. The ATS/ERS Recommendations are
standardized procedures for the online and offline measurement of exhaled upper respiratory nitric
oxide and nasal nitric oxide
3
.
The patient shall exhale at 50ml/sec, using the on screen flow indicator through the sample system,
into the instrument, until a reading is displayed.
The NObreath® shall also have the capability to perform an ambient air test as required.
Bedfont® privacy statement:
This product stores the personal information of patients and
measurement data. It is the sole obligation of the healthcare professional to make sure this
information is secure and compliant with your relevant data protection regulations.
