Intended Use/Indications For Use - Bosch vivatmo pro Instructions For Use Manual

Initial information
1.4

Intended use/Indications for use

The Bosch Vivatmo pro system is intended for quantitative measurement of fractional nitric oxide (FeNO) in human breath.
Measurement of changes in the fractional nitric oxide concentration in expired breath aids in evaluating a patient's response to
anti-infl ammatory therapy, as an adjunct to establish clinical and laboratory assessments of infl ammatory processes such as
asthma.
The Bosch Vivatmo pro system is a non-invasive measuring device intended to be used in health care environment (in-vitro
diagnostic use) by healthcare professional users only.
The results of the Vivatmo pro should not be used as a sole parameter for the diagnosis or screening of airway diseases. The
Vivatmo pro measurement procedure requires patients' cooperation by breathing into the device via a disposable mouthpiece
(Oxycap). Patients should be 7 years or older and capable to complete the breathing maneuver.
The measurement procedure of the Vivatmo pro generates the fraction of the exhaled breath (FeNO) based on the
recommendations for the measurement of exhaled respiratory nitric oxide of the European Respiratory Society (ERS) and the
American Thoracic Society (ATS).
FeNO is recommended by the ATS in the diagnosis of eosinophilic airway infl ammation and in determining the likelihood of
responsiveness to anti-infl ammatory pharmacological therapy in individuals with chronic respiratory symptoms possibly due to
airway infl ammation [ATS, 2011].
The Vivatmo pro should only be used as directed in the Vivatmo pro Instruction for Use (IFU). Regardless of displayed measured
results mind signs or symptoms of chest tightness, shortness of breath, coughing or wheezing for decision about treatment.
10 © Bosch Healthcare Solutions GmbH Instructions for use