FAQs

Product Questions

What does the AliveCor Mobile ECG measure?

The AliveCor Mobile ECG is FDA-cleared, requires the free Kardia app, and is available for purchase without a prescription.

The AliveCor Mobile ECG is intended to record, store and transfer single-channel electrocardiogram (ECG) rhythms. The AliveCor Mobile ECG also displays ECG rhythms and detects the presence of atrial fibrillation and normal sinus rhythm (when prescribed or used under the care of a physician). The AliveCor Mobile ECG is intended for use by healthcare professionals, individuals with known or suspected heart conditions and health conscious individuals. The device has not been tested for and it is not intended for pediatric use.

The AliveCor Mobile ECG also measures heart rate in beats per minute (bpm). Users can also log and track their symptoms, activities, and medications. This data is viewable in the Kardia app and by sign in at app.alivecor.com.

Is the AliveCor Mobile ECG accurate?

In clinical studies, the AliveCor Mobile ECG has been shown to be accurate and effective. The Mobile ECG is FDA cleared and as such has shown equivalency to other ECG machines.

Two studies were recently published in peer-reviewed journals that further document the accuracy of the Mobile ECG. They are as follows: J.K. Lau etal., ‘iPhone ECG application for community screening to detect silent atrial fibrillation: A novel technology to prevent stroke.’, International Journal of Cardiology, Vol 165:193-194, 2013.

Read here.

L.A. Saxon etal., ‘Ubiquitous Wireless ECG Recording: A Powerful Tool Physicians Should Embrace‘, Journal of Cardiovascular Electrophysiology, Vol.24: 480-483, 2013.

Presented at the 2012 Heart Rhythm Society (HRS) 33rd Annual Scientific Sessions, ‘Evaluation of the Accuracy of the AliveCor Electrocardiograph Event Recorder Smartphone Case Through Comparison of Lead I Recording to a Standard 12-Lead ECG Recording Device,’ found that the iPhone-based event recorder is an accurate clinical tool for ECG assessment and could prove to be a new tool for allowing immediate recording and analysis of an ECG rhythm.

Twelve-lead ECGs (Mac5500, GE Healthcare) with gel-based electrodes and Lead I ECGs (AliveCor ECG, AliveCor) were recorded in 67 patients. Five patients with pacemakers had the iPhone placed directly on the chest to record a V3-V4rhythm strip, and two physician reviewers cross-validated these strips for pacing spikes. All recordings were performed with the iPhone in Airplane mode so no radio frequency interference was generated.

In 62 patients, two physicians found the QRS morphology to be the same between the two devices, though the iPhone-based ECG had more baseline noise than the standard ECG. The mean/SD of the R-wave amplitudes for the standard and iPhone recordings respectively were 0.77/0.24 (mV) and 0.78/0.24 (mV), P

Is my data safe?

The ECG rhythm data you collect using your AliveCor Mobile ECG is stored in two places: in the Kardia app on the mobile device and on AliveCor’s secure, encrypted US and EU servers (accessible by you and your physician from the web on AliveCor’s secure web app).

Will this work on my tablet or other smartphones?

Currently the Mobile ECG has been validated for a variety of Apple and Android smartphones and tablets. You can find the latest information on our compatibility chart.

Where can I get information on the warranty, service, batteries, storage and disposal of the Mobile ECG?

Information on the warranty, service, batteries, storage and disposal of the Mobile ECG can be found in the User Manual that can be accessed on your mobile device through the Kardia app in the Menu under Help. It is also available on the website here.

Where is the ECG data I collect stored?

The recordings are stored in two places: the Kardia app on the smartphone or tablet and on AliveCor’s secure, encrypted servers. Recordings are also accessible from the web on AliveCor’s secure web app.

How much data can be stored?

The amount of data you may store in the Kardia app is limited only by the space available on your smartphone or tablet. A 30-second ECG recording averages 18KB. At this time, there is no limit to the amount of data you may store securely on the AliveCor servers.

Do the previous generations of the AliveCor Mobile ECG work the same as the newest generation?

Yes. The 3rd generation AliveCor Mobile ECG is 50% thinner and 40% lighter, yet works exactly the same as the 2nd generation and 1st generation AliveCor Mobile ECGs. When used with the Kardia app, all generations of the AliveCor Mobile ECG will:

Work with Apple iOS and most Android OS devices

Record accurate ECGs with your smartphone or tablet

Keep in mind, any new software updates will be shared with you through the Kardia app in the App Store or Play Store.

Usage Questions

Where can I find the Instructions for Use?

The instructions for use can be found in the User Manual that can be accessed on your phone through the Kardia app in the Menu under Help. It is also available on the website here.

How can I get my ECG information to my doctor?

The easiest way to get your ECG to your doctor is by connecting to your doctor through the free Provider Dashboard where they can securely view your ECGs. Alternatively, you can email a PDF of each recording to your doctor or print the PDF using the mobile app. We suggest you discuss with your physician his or her preference for reviewing ECGs and which ECGs to send.

Can I use the Mobile ECG on multiple family members?

Yes, the Mobile ECG is available without a prescription. After a recording is taken, you can indicate if it is your ECG, or a family member’s, within the free Kardia app. All ECGs can be annotated, and names can be edited.

Can anyone use the AliveCor Mobile ECG?

The AliveCor Mobile ECG is FDA cleared for individual use of those weighing 10kg (22 lbs) or more. It is also CE marked. Currently the Mobile ECG is available in the U.S., UK, Ireland, India, and Australia for over the counter use.

Do I have to use a smartphone?

The Mobile ECG does require an iOS or Android smartphone or tablet. You can view our latest compatibility information at www.alivecor.com.hk/compatibility. It must have the capability to download the app.

How do I attach the Mobile ECG with Attachment Plate?

The Universal Attachment Plate attaches directly to the smartphone or tablet or case of your choice using single-use, double-sided adhesive. While the Mobile ECG can be removed from the Attachment Plate between uses, the Attachment Plate itself is meant to stay adhered to the smartphone or tablet or case.

What do I do if the Mobile ECG won’t record, or if the battery is dead?

Are you using iOS 7 or greater? If so, please do the following to allow the app to access the iPhone microphone:

Tap on iPhone “Settings”

Tap on “Privacy”

Tap on “Microphone”

Ensure that “Kardia” is turned on (the background of the slider is green)

If that doesn’t resolve the issue, replace the battery.

1st and 2nd generation Mobile ECGs – Using a 1.6mm Phillips screwdriver, press down firmly and turn counterclockwise to remove the screw in the battery door.

3rd generation Mobile ECGs – Insert a pen, pencil or other similarly shaped object into the cutout next to the battery door to pop the battery door off.

Remove the used battery and replace it with a new 3V coin cell battery matched to your model. The battery is available at most general stores. Orient the battery with the positive terminal up, so that you can see the writing. Remove the protective sticker from the battery, as applicable.

What if I don’t have phone service or Wi-Fi?

The Mobile ECG does not require a Wi-Fi or mobile connection to record an ECG and save it to the mobile device, however it requires one of these to: sync automatically with the AliveCor server, email, or print directly from the Kardia app. If you do not have a Wi-Fi or mobile connection at the time of the ECG recording, you can email or print the data later when you have such a connection and the sync will happen automatically at that time.

I have a pacemaker; can I still use the Mobile ECG?

The AliveCor Mobile ECG has not been tested for accuracy with paced-ECG recordings. We do not recommend use of the AliveCor Mobile ECG for users with pacemakers because we cannot guarantee the accuracy of the resulting ECG recordings.

What web browsers does AliveCor support?

For all our web applications we currently support:

Desktop:
Chrome
Safari (Version 5.1 and up)
Firefox (Version 5 and up)
Internet Explorer (Version 9 and up)

Mobile:
Safari Mobile
Android
Chrome
Known Issues On Unsupported Browsers:
IE7 – View PDF does not work
IE8 – Doctor Dashboard does not work. Will potentially crash IE8.

App Questions

How do I download the app?

The Kardia app can be downloaded for iOS devices through the App Store on your mobile device or through Google Play Store on your Android™ mobile device.

How do I set up the app?

Tap on “Kardia”.

Agree to the Terms of Service and Privacy Notice by tapping on the two required boxes.

Sign Up for a new account by tapping on the two required boxes.

Enter the email address and password that you would like to use for your AliveCor account. This will be the same email address and password that you will enter to access your account on www.alivecor.com/signin

Select whether you are a Medical Professional or an Individual User. Medical Professional assumes that you will annotate each recording with the patient’s information. Individual User assumes that each recording is yours or a “Guest” thus does not require that you enter your information in after each recording.

How do I take a recording?

To take a recording simply launch the Kardia app and place the Mobile ECG in any one of the following locations:

For a Lead I ECG, rotate your phone to landscape, rest the Mobile ECG on your fingers; the left hand should contact the electrode closer to the top of the smartphone/tablet, and the right hand should contact the electrode closer to the bottom of the smartphone/tablet. You should relax your arms and hands to reduce muscle noise. It is helpful to rest your arms and hands on a flat stable surface.

For a Lead II ECG, the left knee should contact the electrode closer to the top of the smartphone/tablet and the right hand should contact the electrode closer to the bottom of the smartphone/tablet.

For an Anterior Precordial Lead placement, place the device on the lower left side of the chest with the bottom of the device toward the center of the body.

How do I email recordings?

To email a recording to your physician from the Kardia app:

Tap Journal

Tap Share to the right of the recording you wish to email

How do I have an ECG analyzed?

Tap Journal and find the ECG you would like to send for analysis. Tap “SHARE” to the right of the recording, then “ECG Analysis”. Alternatively, you can tap on the ECG in the Journal screen, and then tap “Analysis” at the top right of the ECG Review screen.

How do I review a recording that has been analyzed?

Tap “Journal”

Tap the desired report below the ECG

Alternatively you can access ECG Analysis Reports from the ECG Review screen by tapping on “Analysis”

What is Beat Fluctuation (BFx)?

Beat Fluctuation (BFx) is a measure of how much your heartbeat changes from beat to beat. BFx varies from person to person and also changes with lifestyle, habits and activities. BFx is represented on a scale from 0 to 100 where lower values indicate less fluctuation.

BFx will appear on ECGs recorded for 30 seconds or longer. The BFx value will appear on the ECG in the Journal screen, on Data Entry, and in the ECG Review screen. You can turn off BFx at anytime in the Settings of the Kardia app.

BFx can be used in the following way:

Record an ECG that is 30 seconds or longer to obtain a BFx number.

Tag anything you think may be impacting that number.

Observe how BFx number changes throughout the day with changes to your lifestyle – like stress, sleep, activities, diet, etc.

I see I can now enter events without having to take a recording. How do I do that?

Yes, you can enter a tag or note without an ECG at anytime:

Tap Journal, then tap the blue “Plus” icon at the top left

In the Data Entry screen, you can enter notes, or select tags such as symptoms, activities, diet, etc. or create personalized tags. You can also select a different date/time for the event you are logging, for example alcohol from the previous evening, or a meal from a couple days ago.

All of your events will appear in the Journal screen in chronological order, and can be edited anytime by selecting the dropdown arrow to the right of the event on the Journal screen.

How do I access my account from a computer?

Go to www.alivecor.com

Click “SIGN IN” in the upper right corner

Enter the same email address and password that you use to log into the Kardia app on your smartphone or tablet

What is the length of the recording? Can this be used for continuous monitoring?

The AliveCor Mobile ECG can be used to record for 30 seconds, 1 minutes, 2 minutes, 3 minutes, 4 minutes, or 5 minutes. It is not intended for long term monitoring, but rather for conveniently and instantly capturing short ECG rhythm strips.

What is the Maximum Heart Rate measured by the AliveCor Mobile ECG?

The maximum heart rate is 300 bpm.

Purchase Questions

How can I get an AliveCor Mobile ECG?

The AliveCor Mobile ECG can be purchased at alivecor.com.hk/collections

Can I get an AliveCor Mobile ECG without a prescription?

Yes, the AliveCor Mobile ECG is available over the counter, without a prescription.

Health Professional Questions

Is the AliveCor Mobile ECG FDA cleared?

The AliveCor Mobile ECG is FDA cleared. The AliveCor Mobile ECG is intended to record, store and transfer single-channel electrocardiogram (ECG) rhythms. The AliveCor Mobile ECG also displays ECG rhythms and detects the presence of atrial fibrillation and normal sinus rhythm (when prescribed or used under the care of a physician). The AliveCor Mobile ECG is intended for use by healthcare professionals, individuals with known or suspected heart conditions and health conscious individuals. The device has not been tested for and it is not intended for pediatric use.

Can this replace a 12-lead ECG?

The Mobile ECG is a single-channel ECG device and is not intended to be a replacement for a 12-lead ECG.

How can I get an AliveCor Mobile ECG?

The AliveCor Mobile ECG can be purchased at alivecor.com.hk/collections

Is my patient’s data safe?

The ECG rhythm data collected using the AliveCor Mobile ECG is stored in two places: in the Kardia app on the smartphone or tablet and on AliveCor’s secure, encrypted US and EU servers.

Are there any known contraindications for the AliveCor Mobile ECG?

There are no known contraindications for the Mobile ECG, although care should be taken when considering using the device according to the warnings and precautions contained in the User Manual.

Compatibility

Will the Kardia app work on iOS 8?

The Kardia app works on iOS 8. Please check http://www.alivecor.com/compatibility for the latest updates on compatible operating systems and phones.

I have a Mobile ECG for the iPhone 5/5s. Will it work with an iPhone 6 or 6 Plus?

Yes! You can then either use the Mobile ECG in close proximity to the phone (< 1 ft.) or purchase an Attachment Plate so that you can attach the Attachment Plate to your new iPhone 6 or iPhone 6 Plus (or case) and slide your current Mobile ECG (without the To remove the oval shaped Mobile ECG from its iPhone 5/5s case: Remove the Mobile ECG (and case) from your iPhone 5/5s (press gently on the phone camera through the cutout and peel back from that corner of the Mobile ECG) Face the electrodes of the Mobile ECG away from you. Gently push the left side of the Mobile ECG toward you while at the same time gently pulling the left edge of the case away from the Mobile ECG itself. The oval shaped Mobile ECG should then “pop out” of its case.

I have a Mobile ECG with Attachment Plate. Will it work with an iPhone 6 or 6 Plus?

Yes! You can purchase a new Attachment Plate and remove the Mobile ECG from your current Attachment Plate:

For 2nd generation AliveCor Mobile ECGs

Place your thumbs on the electrodes and press down firmly.

Turn counterclockwise about 45 degrees to “unlock” the Mobile ECG.

Once it’s “unlocked” the Mobile ECG can then be lifted out of the Attachment Plate.

For 3rd generation AliveCor Mobile ECGs

Place your thumbs in between the electrodes

Push up to slide the Mobile ECG away from the Attachment Plate.

Are you planning to make a case for the iPhone 6? What about the iPhone 6 Plus?

We are in the process of designing a case form factor for the iPhone 6, which will be available early Spring 2015. At this time, we do not have plans to make a case for the iPhone 6 Plus.

Detectors

What are the AF, Normal, and Interference Detectors?

AliveCor has developed the following FDA-cleared detectors or algorithms:

The Normal Detector will notify you when no abnormalities are detected.

The Interference Detector will notify you when the recording is unreadable.

The AF Detector detects the presence of atrial fibrillation.

NOTE: The recording must be at least 30-seconds in length for the detectors to function.

Where are the Detectors available?

The Detectors are available in the Kardia iOS and Android OS app in the US, Australia, India, Ireland, New Zealand, and UK and is currently free of charge. There is no timeline for other countries yet.

What do I see when AF is detected? What do I do if AF is detected?

You will see the message, “Possible AF Detected. This result is not a diagnosis, only a possible finding. We recommend sending it for analysis or sharing it with a medical professional.” We recommend that you share the recording with a medical professional or send to AliveCor’s ECG analysis service for review.

How accurate is the AF Detector in detecting the possible presence of AF?

The AF Detector has 97% sensitivity and 98% specificity. These results are based on the patient ECGs captured in the Search AF trial.

What do I see when my recording is normal? What does “Normal” mean?

If no abnormalities are detected, you will receive the message “Normal. No abnormalities were detected in your ECG”. This means that the heart rate is between 50 and 100 BPM, there are no or very few abnormal beats, and the shape, timing and duration of each beat is considered normal. It is important to remember that there is a wide range of normal variability among different individuals. Changes in the shape or timing of an ECG might be normal for a single individual, but since the AliveCor Mobile ECG is used by a large and diverse population, the Normal Detector has been designed to be conservative with what it detects as normal.

If you have been diagnosed with a condition that affects the shape of your ECG (e.g., intraventricular conduction delay, left or right bundle branch block, Wolff-Parkinson-White Syndrome, etc.), experience a large number of premature ventricular or atrial contractions (PVC andPAC), are experiencing an arrhythmia, or took a poor quality recording it is unlikely that you will be notified that your ECG is normal.

It is also important to note that the Normal Detector looks at the entire signal before determining if it can be declared to be normal. If you experience a small number of PACs or PVCs in a recording of otherwise normal beats in normal rhythm, the Normal Detector will likely declare this recording to be normal.

What do I see when my recording has interference? What do I do if it says “Unreadable”?

You will see the message, “Unreadable. There was too much interference in this recording. Try to relax and hold still, rest your arms, or move to a quiet location.” You can then either try again or save the recording.

Per the User Manual, please try the following tips for acquiring the best quality ECG recording:

Ensure that the “Enhanced Filter” is on.

Clean the electrodes on the Mobile ECG with alcohol-based sanitizer.

If hands are very dry, use a water-based lotion before recording.

When recording from the hands, relax the arms and hands to reduce muscle noise. Rest the forearms and hands on a flat surface and let the Mobile ECG rest on the hands. Do not squeeze the Mobile ECG.

Ensure that your smartphone/ tablet is not charging/syncing and you are not using headphones with your smartphone or tablet during the recording.

Make sure that both the smartphone/tablet and you remain still during ECG recordings. Movement during recordings will cause noise in the tracing.

Make sure Mains Filter is set appropriately for your geographical location. This can be adjusted under the Kardia app Settings.

Try recording from the chest, right under the pectoral muscle in the mid line.

Will I have to pay for the Detectors?

We have noted that the Detectors are “Free for a limited time”. We anticipate this trial period to last well into 2015.

What does the message “We could not classify this ECG” mean?

“We could not classify this ECG” is a message you receive when the detectors could not classify your recording as “Normal”, “AF”, or “Unreadable”. You always have the option to send your ECG for analysis or share it with a medical professional. If you prefer not to receive this message, you can turn off the “Unclassified Message” in Settings.

Manage your heart health

Tracking medications, lifestyle choices, and ongoing symptoms gives you and your doctor a more comprehensive and reliable view of your heart health. This helps you and your doctor diagnose a possible condition, understand the cause of your symptoms and AF episodes, and make treatment decisions together.