AliveCor Kardia Mobile User Manual

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AliveCor,*Inc.* For*support,*please*email*support@alivecor.com*or*visit*www.alivecor.com*
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AliveCor®*Kardia™*Mobile*
User*Manual*for*
Android*
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©*2011-2016*AliveCor,*Inc.*All*rights*reserved.*US*Patent*No:*8,301,232*and*Patents*
Pending.*AliveCor*is*a*trademark*and*trade*name*of*AliveCor,*Inc.*in*the*United*States*and*
other*countries.**
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09LB08*Revision*V*|*JUNE*2016* *

AliveCor Kardia Mobile Specifications

General

Connectivity	Bluetooth
Power Source	CR2016 coin cell battery
Recording Time	30 seconds per recording
Lead Type	Single-lead
FDA Cleared	Yes
Weight	18 grams
Compatibility	iOS and Android devices
Detection Capabilities	Atrial Fibrillation, Bradycardia, Tachycardia, Normal Sinus Rhythm

Summary

1. PRODUCT DESCRIPTION

1.1. Indications for Use - US

Details the intended use of Kardia Mobile for recording EKG rhythms in the US.

1.2. Indications for Use - OUS

1.3. Contraindications

2. GENERAL SAFETY PRECAUTIONS

3. STORAGE, HANDLING AND MAINTENANCE

4. WARNINGS

5. SET UP KARDIA MOBILE AND TAKE THE FIRST EKG RECORDING

5.1. Decide which smartphone or tablet to use

Helps users select a compatible smartphone or tablet for the Kardia Mobile.

5.2. Unpack Kardia Mobile by AliveCor

Instructions for unpacking the Kardia Mobile device from its packaging.

5.3. Download the Kardia phone app

Step-by-step guide to download and install the necessary Kardia phone app.

5.4. Set up an AliveCor Account

6. RECORD EKG RHYTHMS USING KARDIA MOBILE

7. ONCE THE RECORDING IS FINISHED

8. ENTER AN EVENT WITHOUT AN EKG

9. SETTINGS AND ADJUSTMENTS

9.1. Recording Adjustments

Details specific settings related to EKG recording parameters like sweep speed and gain.

9.2. Adjustable Settings

Key App Settings

Covers recording duration, AC mains filter, units, and PDF report configurations.

10. EMAIL, PRINT, OR DELETE RECORDINGS

11. VIEW PREVIOUSLY RECORDED EKG RECORDINGS – JOURNAL

12. SEARCH OR FILTER RECORDINGS

13. VIEW AN EKG RECORDING ON THE ALIVECOR SERVER

14. EKG ANALYSIS

15. DETECTORS (ATRIAL FIBRILLATION, NORMAL, UNREADABLE)

Atrial Fibrillation Detector

Details the function of the AF detector for identifying atrial fibrillation.

Normal Detector

Unreadable Detector

15.1 What is Atrial Fibrillation?

15.2 AF, Normal, and Unreadable Recordings in EKG review screen and Journal

15.3 Activation of the Detectors

15.4 Detector Usage

16. INSIGHTS

17. GOOGLE FIT APP INTEGRATION

18. REFERRAL CODE

19. PERSONAL REPORT

20. ACCESSING HELP

21. EDITING USER PROFILE

22. ACCESSING EDUCATION

23. PROVIDER DASHBOARD

24. ELECTRONIC HEALTH RECORD (EHR) INTEGRATION

25. TROUBLESHOOTING

Common Device Issues

Addresses problems like device not working, poor recording quality, and inverted rhythms.

Account and Data Issues

Covers forgotten passwords, lost EKGs, and PDF report display problems.

My credit card isn't being accepted

I need a printed version of the manual

Is the manual available in another language?

26. ALIVECOR KARDIA MOBILE SPECIFICATIONS

Device Specifications Overview

Covers performance, circuitry, output, power, physical, environmental specs, and user interface.

27. EUROPEAN AUTHORIZED REPRESENTATIVE

28. ALIVECOR CONTACT INFORMATION

29. ELECTRICAL SAFETY

Guidance and manufacturer's declaration - electromagnetic emissions

Device compliance with electromagnetic emission standards.

Guidance and manufacturer's declaration—electromagnetic immunity

Electromagnetic Immunity Guidance

Manufacturer's declaration on electromagnetic immunity compliance.

Guidance and manufacturer's declaration—electromagnetic immunity

RF Immunity and Separation Distances

Guidelines for RF immunity and recommended separation distances.

Recommended separation distances between portable and mobile RF communications equipment and Kardia Mobile by AliveCor

30. SYMBOLS USED SYSTEM OR PACKAGE LABELING

Device and Package Symbols Explained

Explains various symbols found on the device and its packaging.