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As of 2021-01-26 Ι Revision status: 5
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2 INTRODUCTION
Thank you for purchasing the 287 CardioWatch. Corsano CardioWatch not only analyses
heartbeat, but also and especially heart rhythm - simple and at any time. The bracelet has
been validated in clinical studies and detects irregular heartbeats (e.g. extrasystoles) as
well as the presence of absolute arrhythmia with suspected atrial fibrillation (AF).
However, irregular heartbeats (e.g. extrasystoles) and atrial fibrillation can only be
diagnosed in accordance with the guidelines with an ECG of the thoracic wall, generally
carried out by cardiologists.
If you or your patient are feeling unwell or experience other troubling symptoms,
please seek medical advice immediately.
3 SAFETY INSTRUCTIONS
This instruction manual provides you with important information about the Corsano 287
CardioWatch Bracelet. To ensure the safe and proper use of this bracelet, READ and
UNDERSTAND all of the safety and operating instructions. If you do not understand these
instructions or have any questions, contact [email protected] before attempting to use
this bracelet. For specific information about your own heartbeats, consult with your
physician.
Although clinical studies have shown that the bracelet in combination with a suitable heart
rhythm interpretation service is able to identify arrhythmias (such as atrial fibrillation) with
a very high accuracy level the slight possibility of a miscalculation still exists. Therefore,
the results provided should under no circumstances replace the personal diagnosis,
consultation, care or treatment by medical or medically trained staff.
In case any serious incident has occurred in relation to the device it has to be reported to
the manufacturer and the competent authority of the Member State in which the user
and/or patient is established.
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This device is a digital bracelet intended for use in measuring pulse rate and activity in
adult patient population. The device provides the data for further cardiovascular,
respiratory, and sleep analysis in order to provide a warning signal in case of the
appearance of irregular heartbeats during measurement.
Environments of Use: Hospital and Home Patient Population: Adult
Summary of Contents for CardioWatch 287-1
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