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❑ Arrhythmia Detection
➢ This Product detects arrhythmia based on user's heart rate, heart rhythm
and ECG characteristics, and will label the type of arrhythmia on each R-
wave when it have detected arrhythmia event. For the types of
arrhythmia this product detects, please refer to page 18.
❑ Heart rate Detection and Notification
➢ This Product calculate heart rate based on time interval between two
continuous R-wave. The heart rate will renew based on 3-second averages.
➢ User can set a notification range in Einthoven iOS App; when the detected
heart rate is not within the set range, a notification will show in the App.
➢ This Product complies the requirement in ANSI EC57. The sensitivity and
positive predictivity of the Product based on the testing results by
conducting test with database data are listed in the table below:
Testing objective
QRS-wave detection
(average)
30 bpm ≤ Heart rate range
<165 bpm
QRS-wave detection (gross)
30 bpm ≤ Heart rate range
<165 bpm
Sensitivity (%)
AHA: 98.26
MIT-BIH: 99.12
AHA: 98.34
MIT-BIH: 99.05
positive predictivity (%)
AHA: 99.69
MIT-BIH: 99.84
AHA: 99.79
MIT-BIH: 99.83
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