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© Bosch Healthcare Solutions GmbH8Instructions for use
en
Your Vivatmo me
1.3 Intended use / Indications for use
Intended use: The Vivatmo me is intended for quantitative
measurement of fractional nitric oxide in human breath.
Indication: 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 established clinical and laboratory
assessments of inflammatory processes such as asthma.
The Bosch Vivatmo me system is an automated, non-
invasive self-testing device intended to be used at home
(in-vitro diagnostic use) as an aid to monitor airway
diseases whilst under the care of their physician or
healthcare expert. Vivatmo me measurement procedure
requires patient’s cooperation by breathing into the device
via a disposable mouthpiece. Patients should be 7 years
or older and capable to complete the breathing maneuver.
The measurement procedure of the Vivatmo me system
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 inflammation and in determining the likelihood of
responsiveness to anti-inflammatory pharmacological
therapy in individuals with chronic respiratory symptoms
possibly due to airway inflammation [ATS, 2011].
Vivatmo me should only be used as directed in the
Vivatmo me Instructions for use and as recommended
by healthcare professionals. Regardless of displayed
test results, if signs or symptoms of chest tightness,
shortness of breath, coughing or wheezing occur, the user
should contact their healthcare professional immediately.
Contra-indications: Not known.
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Others manual(s) of Bosch Vivatmo me

Bosch Vivatmo me Quick start guide - German - 6 pages

Bosch Vivatmo me User Manual - German - 40 pages

Bosch Vivatmo me User Manual - Dutch - 39 pages

Bosch Vivatmo me User Manual - French - 40 pages

Bosch Vivatmo me User Manual - Italian - 40 pages

Bosch Vivatmo me User Manual - Portuguese - 39 pages

Bosch Vivatmo me User Manual - Spanish - 39 pages


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