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

Initial information
1.3

Intended use/Indications for use

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The Bosch Vivatmo pro system is intended for quantitative measurement of fractional nitric oxide (FeNO) in human breath.
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Measurement of changes in the fractional nitric oxide concentration in expired breath aids in evaluating a patient's response to
anti-inflammatory therapy, as an adjunct to establish clinical and laboratory assessments of inflammatory processes such as
asthma.
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The Bosch Vivatmo pro system is a non-invasive measuring device intended to be used in healthcare environment (in vitro
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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.
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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.
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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
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American Thoracic Society (ATS).
FeNO is recommended by the ATS in the diagnosis of eosinophilic airway inflammation and in determining the likelihood of
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responsiveness to anti-inflammatory pharmacological therapy in individuals with chronic respiratory symptoms possibly due
to airway inflammation [ATS, 2011].
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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.
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8 © Bosch Healthcare Solutions GmbH Instructions for use