Corsano CardioWatch 287, Instruction Manual

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As of 2021-11-23
Ι Revision status: 9
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10 PREVENTICUS HEARTBEATS
The CORSANO app provides seamless integration with Preventicus Heartbeats, a CE
Class IIa certified medical device to analyse your heartbeat, but also and especially your
heart rhythm.
10.1 Purpose
The purpose of Preventicus Heartbeats is to detect signs of the presence of cardiac
arrhythmias in a non-clinical environment. This includes the following cardiac arrhythmias:
detection of signs of absolute arrhythmia with suspected atrial fibrillation, detection
of signs of extrasystoles as well as measuring the heart rate with signs of
bradycardia and tachycardia without further diagnostic differentiation.
Under no circumstances may this app be used for diagnosis in situations
considered to be life- threatening.
Using the PPG sensor in the bracelet, a pulse curve is captured continuously and the
heart rate data derived. If any evidence of arrhythmia is found, the user can store the
underlying information in a measurement report. The user is also recommended to
undergo further medical assessment by professionals. Preventicus has verified the
detection of atrial fibrillation and extrasystoles and the accuracy of the heart rate detected
with in-house clinical studies (see also:
www.preventicus.com/Studien) . These have
shown that the underlying algorithm of the app can distinguish between atrial fibrillation
and a regular heart rhythm with an accuracy of more than 96%.
Heart rate is displayed as normal (grey traffic light) or abnormal (orange traffic light) based
on a 1-minute measurement. Three categories are distinguished: no abnormalities (green
traffic light), slight arrhythmia (>5% of all beats are irregular -> yellow traffic light) or the
presence of severe arrhythmia (red traffic light) detected. In addition, the user is informed
of any suspected relevant bradycardia or tachycardia (without differentiating between
possible causes) and is advised that prompt cardiac assessment is necessary if this
occurs regularly and is not already under medical observation. Any interferences occurring
during the measurement (wobbling, coughing, shaking, etc.) are automatically detected
and eliminated.
The app also links to a measurement report of the results and allows you to print it off. The
report shows the original pulse curve over the course of maximum 5 minutes and
integrates symbolic R peaks in each cardiac cycle. This allows the treating physician to
visually assess the heart rhythm, understand the automatic interpretation and take any
further diagnostic measures.
The result obtained is purely a suspicion and not a diagnosis in the medical sense of the
word. The results obtained are for information purposes only and should under no
circumstances replace a personal diagnosis or personal advice, care or treatment by
medical or medically trained personnel.
Preventicus Heartbeats should not be used for decision-making in life-threatening
situations or for real-time monitoring of vital functions nor should it intervene with
existing diagnostic pathways or therapeutic measures according to the guidelines.