AliveCor KardiaMobile AC-019 Manual de instrucciones - Página 10
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Instructions for Use for KardiaMobile 6L
WARNING: After EKG analysis, the app may incorrectly identify ventricular flutter, ventricular bigeminy, and
ventricular trigeminy heart conditions as unreadable. Please consult with your physician.
NOTE: All historical EKGs and Instant Analysis results can be viewed, downloaded, and
emailed from the "History" section of the Kardia app.
Heart Rate
During your EKG recording, your real-time heart rate will be shown. When reviewing previous
EKGs, the average heart rate taken during that recording is displayed.
Heart rate is calculated as the time interval between consecutive heart beats; or more
specifically as the inverse of the time interval between consecutive R-waves in your QRS
complex. During an EKG recording, the current heart rate is measured from an average of this
inverse calculation over the last 5 seconds. For stored EKGs, the average heart rate is the
average of this inverse calculation over the entire 30 seconds of the recording.
Clinical Safety and Performance
The performance of the KardiaMobile 6L System for recording a 6-lead EKG was validated in a
clinical study. Overall, 44 subjects participated in the study, comprising nearly equal numbers of
healthy volunteers and arrhythmia patients. EKG recordings were simultaneously taken by the
KardiaMobile 6L and a standard clinical-grade 12-lead EKG device. Qualitative and quantitative
analyses of equivalence were performed on the 44 pairs of EKG results.
For qualitative assessment, two board-certified electrophysiologists compared 6-lead EKG
rhythm strips acquired from the KardiaMobile 6L device and the corresponding leads from the
reference standard 12-lead EKG device for diagnostic equivalence. All paired recordings (100%,
n=44 subjects), were deemed equivalent for assessing cardiac arrhythmias by both
electrophysiologists. The results of the assessment determined that the subject device records
a 6-lead EKG that is qualitatively equivalent to the recordings of corresponding leads from a
gold standard 12-lead EKG device.
For quantitative equivalence, median beat cross correlation for Lead I and II and RMS error for
all 6 limb leads were computed between the paired EKGs for each subject. This analysis was
conducted on the unfiltered EKG output as well as the enhanced filtered (EF) EKG output.
KardiaMobile 6L EKGs had a minimum correlation of 0.96 and a maximum RMS error of 47 µV
as compared to the corresponding lead of the 12-lead EKG. The results of the quantitative
analysis of the EKG recordings further confirmed that the KardiaMobile 6L device EKG has
equivalent output to that of the gold standard 12-lead EKG device.
or move to a quiet location or away
from electronics and machinery.
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