Instructions for Use for KardiaMobile Card (AC-021)
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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 KardiaMobile family of devices has been extensively validated in clinical studies at several
leading institutions. KardiaMobile and KardiaMobile 6L devices have been favorably compared
to Lead I recordings of a standard FDA-cleared 12-lead device. Clinical equivalence of
recordings from these Kardia devices and the 12-lead EKG device were also validated by
board-certified Cardiac Electrophysiologists. See https://www.alivecor.com/research/ for details.
Environmental Specifications
Operational Temperature: -10°C to +40°C
Operational Humidity:
Up to 95% (non-condensing)
Storage Temperature:
+0°C to +40°C
Storage Humidity:
Up to 95% (non-condensing)
Atmospheric Pressure:
76 to 101 kPa
Expected Service Life
The expected service life for the KardiaMobile Card is 2 years.
Maintenance
1. No service or repair should be performed on the KardiaMobile Card device other than the
maintenance listed in this section.
To clean the device, wipe with a soft cloth damp with one of the following approved
cleaners:
a. Soap and water,
b. 70% isopropanol or ethanol alcohol, or
c. 0.55% bleach
You may also use a pre-prepared wipe with one of the approved cleaners listed above.
After cleaning, allow the device to dry before using or placing it back in any storage containers.
