Corsano CardioWatch 287, Инструкция по эксплуатации

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As of 2021-11-23
Ι Revision status: 9
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A basic distinction should be made between AF detection (screening or progress
monitoring) and subsequent AF diagnosis.
AF should be exclusively diagnosed with an
ECG of the thoracic wall, generally performed by cardiologists, in accordance with
the guidelines.
Preventicus apps are not intended for the final diagnosis of AF with
therapeutic implications, but exclusively for AF screening or AF progress monitoring
without therapeutic implications. Any therapeutic implications should only arise based on a
real ECG, not on plethysmographic technology, as accurate as this may be.
10.2 Intended use
Preventicus Heartbeats can be used independently by anyone of either gender aged 18 or
older.
10.3 Additional notes and comments
ECGs are the gold standard for rhythmological diagnostics. An analysis of the heart
rhythm based on the pulse curve is an appropriate screening method as a preliminary step
to further diagnosis.
According to the studies conducted, Preventicus Heartbeats detects atrial fibrillation with
an overall accuracy of 96.5%. Its sensitivity (correct positive rate) is approximately 91.6%.
The sensitivity is the probability with which atrial fibrillation is recognised as such. At the
same time, the specificity (correct negative rate) provides the percentage of users not
suffering from atrial fibrillation, whose results were correctly displayed with a green traffic
light. The specificity of Preventicus Heartbeats is 99.6%.
This means that there is a very low residual risk that Preventicus Heartbeats will not
detect atrial fibrillation despite it being present in a measurement. If you feel unwell or
experience other worrying symptoms, please contact your treating physician directly.It
cannot be ruled out that existing conditions such as diabetes, vascular diseases or the
patient’s condition after cardiovascular surgery may affect the accuracy of Preventicus
Heartbeats.
10.4 Service life of the product
The service life of the product is the timeframe until a new version of the app is released.
This is indicated by an increase of at least the second digit of the version number. Details
of the version number can be found in the relevant app store.
Update information is provided by the operating system. Depending on the smartphone’s
user settings, the update will either be carried out automatically or will have to be actively
approved and started by you.
10.5 Data backup
Data can be backed up in the following way:
The reports can be exported and sent as PDF files, e.g. by email. This allows them to be
stored in other databases (e.g. PDMS, Praxis software) or on other storage media (e.g.