Instructions for Use for KardiaMobile® (Model AC-019)
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Clinical Testing
The KardiaMobile® (Model AC-019) System was thoroughly evaluated in a clinical study to
ensure users can get a medical grade ECG. Overall, 44 subjects participated in the study, that
included patients with arrhythmias as well as normal subjects. The study showed that the
KardiaMobile® (Model AC-019) device records a 6-lead ECG equivalent to the same leads on a
standard FDA-cleared hospital 12-lead ECG device but at an ambulatory bandwidth. Clinical
equivalence was shown qualitatively, through a review by two Board Certified Cardiac
Electrophysiologists and quantitatively, through a statistical test of equivalence between the two
sets of ECGs assessing various variables.
Environmental Specifications
Operational Temperature: +10°C to +45°C
Operational Humidity:
10% to 95% (non-condensing)
Storage Temperature:
0°C to +40°C
Storage Humidity:
10% to 95% (non-condensing)
Expected Service Life
The expected service life for KardiaMobile® (Model AC-019) is 2 years.
