AliveCor AC-021 Gebruiksaanwijzing - Pagina 10

Blader online of download pdf Gebruiksaanwijzing voor {categorie_naam} AliveCor AC-021. AliveCor AC-021 17 pagina's.

Instructions for Use for KardiaMobile Card (AC-021)

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.

Operational Temperature:

Operational Humidity:

Storage Temperature:

Storage Humidity:

Atmospheric Pressure:

The expected service life for the KardiaMobile Card is 2 years.

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.

-10°C to +40°C

Up to 95% (non-condensing)

+0°C to +40°C

Up to 95% (non-condensing)

76 to 101 kPa

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