Contents
1. PRODUCT DESCRIPTION ............................................................................................................ 3
2. CAUTIONS.................................................................................................................................. 5
3. SET UP YOUR KARDIA MOBILE OR KARDIABAND SYSTEM AND TAKE YOUR FIRST EKG RECORDING
5
4. RECORDING AN EKG .................................................................................................................. 8
5. ONCE THE EKG RECORDING IS FINISHED ................................................................................ 10
6. SMARTRHYTHM (KARDIA WATCH APP REQUIRED) ................................................................ 11
7. ENTER AN EVENT WITHOUT AN EKG (KARDIA PHONE APP ONLY) ......................................... 12
8. SETTINGS AND ADJUSTMENTS ................................................................................................ 13
9. EMAIL, PRINT, OR DELETE RECORDINGS................................................................................. 14
10. HISTORY (KARDIA MOBILE PHONE APP ONLY) ....................................................................... 14
11. CLINICIAN REVIEW (KARDIA PHONE APP ONLY) ..................................................................... 15
12. DETECTORS (ATRIAL FIBRILLATION, NORMAL, UNREADABLE) ............................................... 16
13. MEDICATIONS (KARDIA PHONE APP – IOS ONLY) .................................................................. 19
14. INSIGHTS (FOR IOS) / TRENDS AND ANALYSIS (ANDROID) (KARDIA PHONE APP ONLY)........ 19
15. HEALTH APP AND GOOGLE FIT INTEGRATION ........................................................................ 19
16. REFERRAL CODE ...................................................................................................................... 20
17. BLOOD PRESSURE ................................................................................................................... 20
18. WEIGHT ................................................................................................................................... 21
19. PERSONAL REPORT ................................................................................................................. 21
20. ACCESSING HELP ..................................................................................................................... 22
21. EDITING USER PROFILE (KARDIA PHONE APP ONLY) .............................................................. 22
22. ACCESSING EDUCATION (KARDIA PHONE APP ONLY) ............................................................ 22
23. TROUBLESHOOTING ................................................................................................................ 23
24. KARDIA DEVICE SPECIFICATIONS ............................................................................................ 27
25. EUROPEAN AUTHORIZED REPRESENTATIVE ........................................................................... 29
26. ALIVECOR CONTACT INFORMATION ....................................................................................... 29
27. ELECTRICAL SAFETY ................................................................................................................. 30
28. SYMBOLS USED SYSTEM OR PACKAGE LABELING................................................................... 38
PRODUCT DESCRIPTION
Kardia™ by AliveCor® is a smartphone and smartwatch application that supports AliveCor’s family
of mobile, clinical-quality electrocardiogram (EKG or ECG) recorders. Users may use Kardia to
record and display EKGs using Kardia Mobile with their smartphone or tablet, or the KardiaBand
with their Apple Watch. The Kardia application also provides instant analysis of the recorded EKG to
evaluate whether the heart rhythm is normal or if atrial fibrillation is detected.
The default duration of the recording is 30 seconds. Users may extend Kardia Mobile recording
duration on the Kardia phone app to a maximum time of 5 minutes. Kardia allows users to take an
unlimited number of recordings and mail each to themselves or their physicians. In addition, Kardia
can store and allow access to your entire EKG history in the cloud (Premium feature).
Patients with known or suspected heart conditions as well as health conscious individuals can use
Kardia Mobile or KardiaBand to record an EKG daily or whenever they are feeling symptoms and to
share their recordings with their physician. Medical professionals can quickly assess rate and
rhythm, screen for arrhythmias, and remotely engage with patients who use Kardia.
The Kardia Mobile product is used with a user-supplied compatible smartphone or tablet. The
Kardia Mobile product consists of:
1. Kardia Mobile – a device that has electrodes to sense and transmit EKG rhythms to the
smartphone or tablet and that can optionally attach to your compatible smartphone with
the provided attachment plate;
2. Attachment Plate – an optional accessory to attach to the back of your smartphone that
your Kardia Mobile device can slide in and out of;
3. Kardia phone app – used to collect, view, and save (Premium feature) EKG recordings and to
wirelessly transmit to the AliveCor server.
The KardiaBand product is paired with a user-supplied compatible iOS iPhone and a user-supplied
compatible Apple Watch to form the KardiaBand System, which consists of:
1. KardiaBand – Apple Watch watchband with embedded electrodes that sense and transmit
EKG rhythms to the Apple Watch;
2. Kardia watch app (a companion to the Kardia phone app) – used to collect, view, and save
(Premium feature) recordings on the Apple Watch, and wirelessly transmit recordings to the
Kardia phone app.
3. Kardia phone app – used to collect, view, and save (Premium feature) EKG recordings and to
wirelessly transmit to the AliveCor server.
NOTE: The Kardia Mobile and KardiaBand System products have the ability for users to connect to
their physicians (Kardia Pro) with a referral code. When connected, the user’s EKG recordings are
available to be viewed by their physicians. Users without a referral code may send their EKG
recordings to their physician by emailing the PDF from the Kardia app on the smartphone.
The Kardia Mobile and KardiaBand System products enable users to:
• Collect and store single-channel EKG recordings.
• Record voice memos that are automatically transcribed to notes.
• Edit user data associated with recordings.
• Wirelessly transmit EKG recordings to the AliveCor server.
• Access past EKG recordings stored on the AliveCor server. (Premium feature).
• Print or save EKG recordings in PDF format.
• Request professional clinical interpretation and analysis of EKG recordings.
• Track events that may impact your heart health, such as symptoms, activities, diet, etc.
(Premium feature).
After a user has created an account on the Kardia phone app and received an EKG analysis, users
can:
• View EKG recordings in real-time and after the recording.
• View the output of the Atrial Fibrillation, Normal, and Unreadable detectors.
• Email EKG recordings to their physician or other recipients of their choice.
1.1. Indications for Use – U.S.
Kardia Mobile:
The Kardia Mobile product is intended to record, store and transfer single-channel
electrocardiogram (EKG) rhythms. The Kardia Mobile product also displays EKG rhythms and
detects the presence of atrial fibrillation and normal sinus rhythm (when prescribed or used
under the care of a physician). The Kardia Mobile product is intended for use by
healthcare professionals, patients with known or suspected heart conditions and health
conscious individuals. The product has not been tested and it is not intended for pediatric use.
KardiaBand System:
The KardiaBand System is intended to record, store and transfer single-channel
electrocardiogram (EKG) rhythms. The KardiaBand System also displays EKG rhythms and
detects the presence of atrial fibrillation and normal sinus rhythm (when prescribed or used
under the care of a physician). The KardiaBand System is intended for use by healthcare
professionals, adult patients with known or suspected heart conditions and health conscious
individuals.
1.2. Clinical Validation and Research
The Kardia Mobile and KardiaBand System have been extensively validated in clinical studies at
several leading institutions. All Kardia devices have been favorably compared to Lead I
recordings of a standard FDA-cleared 12-lead device. Clinical equivalence of recordings from
the Kardia devices and the 12-lead EKG device were also validated by board-certified Cardiac
Electrophysiologists. See https://www.alivecor.com/research/ for details.
1.3. Contraindications
There are no known contraindications for the Kardia Mobile or KardiaBand System products,
although care should be taken when considering using the device according to the warnings
and precautions in this manual.
CAUTIONS
General:
• DO NOT use with a cardiac pacemaker, ICDs, or other implanted electronic devices.
• DO NOT use to self-diagnose heart related conditions. Consut with your physician
before making any medical decision, including altering your use of any drug or
treatment.
• DO NOT store in extremely hot, cold, humid, wet, or bright conditions.
• DO NOT expose to strong electromagnetic fields.
• DO NOT expose the device to a magnetic resonance (MR) environment.
• DO NOT wear during cautery and external defibrillation procedures.
• DO NOT take recordings in close vicinity to other equipment emitting ultrasonic
acoustics.
• DO NOT take a recording while driving or during physical activity.
• DO NOT use Kardia Mobile while charging your phone. DO NOT use KardiaBand while
charging your watch.
• DO NOT take a recording if the electrodes are dirty. Clean them first.
• DO keep components out of reach of children.
• DO use this device to record heart rate and heart rhythm only.
• DO NOT use the sensor on a portion of the body with too much body fat, body hair or
very dry skin, as a successful recording may not be possible.
• DO NOT continue use until further instructed by a physician if your skin is irritated or
inflamed around the sensor or band.
• AliveCor makes no warranty for any data or information that is collected erroneously
by the device, or misuse or malfunction as a result of abuse, accidents, alteration,
misuse, neglect, or failure to maintain the products as instructed. Interpretations made
by this device are potential findings, not a complete diagnosis of cardiac conditions. All
interpretations should be reviewed by a medical professional for clinical decision-
making.DO NOT drop or bump device.DO NOT use in the presence of flammable
anesthetics, drugs or pressurized oxygen.
• After EKG analysis, the app may incorrectly identify ventricular flutter, ventricular
bigeminy, and ventricular trigeminy heart conditions as unreadable. Please consult with
your physician.
• AliveCor does not guarantee that you are not experiencing an arrhythmia or other
health conditions when labeling an EKG as normal. You should notify your physician for
possible changes in your health.
SET UP YOUR KARDIA MOBILE OR KARDIABAND SYSTEM AND TAKE YOUR FIRST EKG RECORDING
3.1. Compatibility
For help deciding which smartphone, smartwatch, or tablet to use, please consult the latest list of
compatible devices on AliveCor’s website: https://www.alivecor.com/#compatibility.
Kardia Mobile Compatibility:
iOS
• iPhone 5/5s, 5c, 6/6 Plus, 6s/6s Plus, 7/7 Plus, and SE (iOS 11.1)
• iPad Air, Air 2, and Mini (iOS 9.3.5)
• iPad Mini 2 and Mini 3 (iOS 10.0.2)
• iPad Pro 9.7-inch (iOS 10.0.2)
• iPod Touch 5G (iOS 9.3.5)
Android
• Google Pixel and Pixel XL (Android 7.1.1)
• Samsung Note 3 (Android 5.0)
• Samsung Note 5 (Android 6.0.1)
• Samsung Galaxy S3 (Android 4.3)
• Samsung Galaxy S4 (Android 5.0.1)
• Samsung Galaxy S5, S6, and S7 (Android 6.0.1)
• Samsung Galaxy J1 (Android 5.1.1)
• LG Nexus 5 (Android 6.0.1)
• HTC One M7 (Android 4.3)
• Jitterbug Touch 3 (Android 4.3)
KardiaBand Compatibility:
KardiaBand requires a paired set of iPhone and Apple Watch. See the list of compatible devices
below.
iPhone:
• iPhone 5s, 5c, 6/6 Plus, 6s/6s Plus, 7/7 Plus, and SE (iOS 11.1)
Apple Watch:
• Apple Watch Series 1, 38mm and 42mm (WatchOS 4.1)
• Apple Watch Series 2, 38mm and 42mm (WatchOS 4.1)
• Apple Watch Series 3, 38mm and 42mm (WatchOS 4.1)
NOTE: Any devices and operating systems not listed here or on AliveCor’s website are not
supported.
3.2. Unpack Kardia Mobile (Kardia Mobile Users)
1. Remove Kardia Mobile from the box.
2. Choose Kardia Mobile placement.
a) For Kardia Mobile phone cases (sold separately), insert the Kardia Mobile device into the
phone case and snap it on your phone as you would any standard phone case.
b) The Kardia Mobile can be attached to the smartphone or to its case of your choosing
with the included attachment plate (the surface should be smooth and flat).
a. AC-001 - AC-007: With the AliveCor logo right side up, the top of the smartphone
or tablet should be on the right.
b. AC-009 devices with an Alivecor logo should be positioned with the top of the
Alivecor logo pointing towards the top of the smartphone.
c. AC-009 devices with the Kardia logo should have the ‘K’ of the Kardia logo closest
to the top of the smartphone or tablet.
c) You may choose to carry the Kardia Mobile loose, in a pocket or bag. When ready to
take a recording, rest the Kardia Mobile in both hands or place on a flat surface with the
device within 1 foot of your smartphone or tablet.
NOTE: Do not use the attachment plate with your tablet. Instead, rest Kardia Mobile in both
hands or place it on a flat surface less than one foot away from the iPad to record EKGs.
3.3. Unpack KardiaBand (KardiaBand System Users)
1. Remove KardiaBand from the box. The KardiaBand consists of 2 straps – one strap with a
buckle and another strap that houses the electrode module.
2. Remove existing watchband from the Apple Watch – consult the Watch user manual if
necessary.
3. Attach both sides of the KardiaBand to the Apple Watch – consult the watch user manual if
necessary. Ensure that you attach the strap that houses the electrode module to the 6
o’clock side of the watch body and the strap with the buckle to the 12 o’clock side of the
watch body.
For more information on how to attach the bands to the watch, refer to a video at
https://www.youtube.com/watch?v=p7ZnT_ubEFY.
NOTE: Wrist hair may affect the performance of the device. We recommend removing excess
hair from your wrist below KardiaBand’s sensor.
3.4. Download the Kardia phone app
1. Using your smartphone or tablet, search for Kardia in the App Store or Google Play store.
2. Download and install the Kardia phone app.
NOTE: The Apple Watch only works with compatible Apple iPhones – consult the Watch user
manual, if necessary.
3.5. Add Kardia watch app to Apple Watch (KardiaBand System Users)
1. After installing the Kardia phone app (see above), open the Watch app on your iPhone.
2. Scroll down to Kardia and tap on “Install”. Installation may take a short amount of time.
3. To adjust your watch’s Wake Screen to ensure that it stays on while recording an EKG, follow
Steps 3-5.
4. In the Watch app on your iPhone, scroll to and tap on “General”.
5. Scroll down and tap on “Wake Screen”.
6. In the “On Tap” section, select the “Wake for 70 seconds” option.
3.6. Set up a Kardia Account
You will use your Kardia account to access, print, and save your EKG recordings stored on the
Kardia phone app and the AliveCor server. Follow the instructions presented when you open
the Kardia phone app and tap “Create Account”. You can go back later and edit your
information if necessary.
NOTE: KardiaBand users and Kardia Mobile users alike should use the Kardia phone app to
setup their account and go through onboarding.
3.7. Free Trial of Premium Features
Once an account has been created, you have access to Premium features for 30 days. At the
end of the free trial, your access to those features ends. If you wish to continue to access the
Premium features, follow the onscreen instructions for purchasing a subscription.
3.8. Security
Add a passcode (personal identification number [PIN]), or Touch ID (fingerprint) to your
smart device to add a layer of security. It is important to secure the smart device since you
will be storing personal health information. Review the manual of the smart device for
information on how to add a layer of security.
RECORDING AN EKG
NOTE: You will not be able to view your recordings or utilize any of Kardia’s detectors until you set
up your free Kardia account. To gain access to the app’s features, you must create an account on
the Kardia phone app. Follow instructions on the Kardia phone app to take a first recording as part
of setting up the device.
USA CUSTOMERS ONLY: There will be a lock period lasting up to 24 hours from the time your first
recording is completed, to when you may record further EKGs.
4.1. To take an EKG recording with Kardia Mobile with your smartphone or tablet, follow the
instructions below.
Before taking each recording:
• Disconnect headphones, charger cables, or any other connected devices.
• If you wear hearing aids, please turn off.
• Clean the two electrodes with alcohol-based sanitizer.
• Using your smartphone or tablet, launch the Kardia phone app.
1. From the Kardia phone app home screen, select “Record your EKG”, or alternatively “Add
Resting HR”. The standard recording is recommended for taking an EKG at any time, e.g.
when you are feeling symptomatic. The resting heart rate option is recommended to
establish your resting heart rate baseline. We recommend taking resting heart rate EKGs
when you first rise in the morning; the time of day when the body is most rested.
NOTE: The Kardia app is setup for your personal use. If you wish to have another person use
the Kardia Mobile device, have them set up the Kardia app on their smartphone/tablet or
log out of your account on the Kardia app so that they can log in to their account on the
Kardia app. The Kardia Mobile device can be used with more than one Kardia account
and/or smart device.
NOTE: The Kardia app builds a personalized model of your EKGs and will detect if someone
accidently uses your smart device to record an EKG. To build this model, the app will
sometimes ask if you or someone else took the EKG after completion of a recording.
2. Rest two or more fingers (it doesn’t matter which fingers) on Kardia Mobile, with your right
hand on one electrode and your left hand on the other. Recording of a Lead I EKG on the
Kardia phone app will begin automatically when you make good contact with the Kardia
Mobile electrodes.
3. While recording your EKG, you may speak your symptoms (e.g. “I’m feeling palpitations.
Maybe due to anxiety”) into the smartphone. Any voice memo recorded will be transcribed
to text and added to the Notes section for that EKG recording.
You may also choose from two other placements:
• For a Lead II EKG, the left knee should contact one electrode and the right hand should
contact the other electrode.
• For an Anterior Precordial Lead, the device can be placed on the lower left side of the
chest, just below the pectoral muscle.
NOTE: Kardia Mobile allows users to record EKGs as Lead II or Anterior Precordial Lead. The
detectors have been trained and tested on Lead I recordings only. Due to the difference in the
waveform from Lead II or Anterior Precordial Lead recordings, detector analysis messages
(e.g. “Normal”, “Unreadable”, etc.) of these recordings may be incorrect and you should not
use the results of the detector. Please consult your physician or perform a Clinical Review if
you wish to get an analysis of the recorded non-Lead-I EKG.
4.2. To take an EKG recording with the KardiaBand System, follow the instructions below.
NOTE: For the sake of clarity, the instructions below are specific for those who wear their Apple
Watch on their left wrist. If you wear your watch on your right wrist, follow the instructions by
swapping left and right.
1. Tap the Kardia watch app on the Apple Watch to open the application.
2. Follow any stated directions to complete login or setup activities displayed on the Watch.
3. Tap the “Record EKG” button. A “waiting for signal” indicator will be displayed.
4. With your right hand, grasp your left hand. Rest your right thumb on the outer electrode on
the KardiaBand EKG. Press your right thumb with enough force to ensure that the inner
electrode is in contact with the skin of your left wrist for the entire duration of the
recording. This is a Lead I EKG.
5. While recording your EKG, you may speak your symptoms (e.g. “I’m feeling palpitations”) to
the smartwatch. Any voice recording taken will be transcribed to text, which will be found in
the Notes section for that EKG recording in the Kardia phone app.
6. The recording takes 30 seconds.
NOTES:
• The Kardia Mobile and KardiaBand System do not require a Wi-Fi or mobile data connection
to record an EKG and save it to the device’s local memory; however, they do require a
connection to sync automatically with the AliveCor server, email, or print directly from the
Kardia phone app. If you do not have a Wi-Fi or mobile data connection at the time of the
EKG recording, you may email or print the data later when you have such a connection and
the sync will happen automatically at that time.
• Kardia Mobile may be used up to a distance of 30 cm (1 ft.) from the smartphone or tablet.
Using Kardia Mobile at a distance greater than 30 cm (1 ft.) may lead to communication
issues between the devices and your recording may not be successful.
• KardiaBand must be attached to the Apple Watch. Using KardiaBand at a greater distance
may lead to communication issues between the devices and your recording may not be
successful.
• On the paired iPhone, Bluetooth must be turned on to transfer data from the Apple Watch.
• To reduce muscle noise, rest your arms on a flat surface to increase stability while you are
recording.
• The recording must be at least 30 seconds to complete, and to be analyzed by the
detectors.
• If you are in a noisy area (e.g. train station, coffee shop, etc.), the voice recording with the
KardiaBand may pick up other conversations and will be found in the Notes for that EKG.
You may edit the Notes to remove any unwanted text in the Kardia phone app.
ONCE THE EKG RECORDING IS FINISHED
5.1. For Kardia Mobile users:
• On the Kardia phone app, immediately after recording, you will be shown an analysis of
your EKG if there was a successful 30-second recording.
• After a recording, you are also prompted to add tags such as symptoms, activities, diet, etc.
to the Data Entry screen. You may also enter personalized tags or notes and edit the
transcribed voice memo. After making your choices, tap “Save” to continue.
• You may review the EKG in the History screen, or go to Insights and view the trending of
your EKGs, heart rate, symptoms, activities, etc. You may also tap the EKG on the History
screen for a larger view of the EKG on the EKG Review screen. EKGs can be starred, emailed,
shared, or sent for analysis from the History screen, or on the EKG Review screen.
• Additionally, you may add notes or tags to the recording. Tags include symptoms, activities,
diet, etc. that are relevant to heart health. You may go to the History screen, and tap the
dropdown arrow to the right of the EKG recording, then tap Edit. This will also take you to the
Data Entry screen where you may add or edit notes and tags.
5.2. For Kardia Band users:
• If an EKG was successfully recorded on your Kardia watch app, an analysis result – if
available - for your EKG appears.
• To view the full EKG, use the digital crown or swipe right to left on the result screen. These
actions both will scroll through the EKG.
• Return to the home screen from an EKG by tapping “Close” in the upper left corner.
• On the home screen in the Kardia watch app, tap the “Record EKG” button to take another
EKG recording. Past EKG recordings are marked by a circular dot that is color-coded based
on the analysis result. To view a past EKG, tap on the dot (Premium Feature).
• Additionally, you may add notes or tags to the recording in the Kardia phone app (Premium
Feature). Tags include symptoms, activities, diet, etc. that are relevant to heart health. You
may go to the History screen, and tap the dropdown arrow to the right of the EKG
recording, then tap Edit. This will also take you to the Data Entry screen where you may add
or edit notes and tags.
NOTE: The Kardia watch app will store all unsynced recordings until the Apple Watch has
connected and synced to the Kardia phone app.
NOTE: Due to the limited size of the Apple Watch screen, you may view the EKG on your phone,
tablet, or computer for interpretation or analysis.
SMARTRHYTHM (KARDIA WATCH APP REQUIRED)
6.1. About
SmartRhythm is a Premium feature for use with the Kardia watch app. SmartRhythm monitoring
uses deep neural networks to continuously evaluate your heart rate received from the Apple
Watch. An expected heart rate pattern is calculated using factors such as your activity level
(captured by your Apple Watch), time of day, location, and more. SmartRhythm notifies you to
take an EKG when your heart rate pattern is different from SmartRhythm’s predictions.
6.2. Set up
To get started with SmartRhythm, you must have a Kardia account (See section 3.6), a compatible
Apple Watch and a KardiaBand. You should also first complete the general Kardia and KardiaBand
account and application setup decribed in Section 3.
To set up SmartRhythm:
1. Open Kardia phone app on your iPhone. Scroll down on the home screen to “SmartRhythm”
and tap on “Get started”.
2. Follow the in-app instructions.
Note: SmartRhythm uses “Workout mode” on your Apple Watch. To use SmartRhythm
monitoring, your watch must be unlocked with the Kardia watch app running. Using other
workout apps on your watch may halt SmartRhythm’s monitoring.
Note: SmartRhythm will significantly affect Apple Watch battery life. A Series 2 watch or newer
is recommended.
Note: While using SmartRhythm monitoring, the Kardia app is shown instead of your watchface
when waking your watch screen.
6.3. Expected Heart Rate Range and Notifications
The SmartRhythm artificial intelligence calculates your expected heart rate range. This is
visualized with a colored band in the home screen chart. When your heart rate pattern is
different from SmartRhythm’s predictions, SmartRhythm may prompt you with a notification –
you may choose to take an EKG at this time. This helps you to better manage your heart health.
There are many reasons for different heart rate patterns:
• Normal reasons include stress, fear, a cold or flu, caffeine, alcohol, exercise that is not
detected by your watch such as weightlifting or riding a bike, your watch band is too
loose, and a high resting heart rate.
• Other reasons include an ongoing arrhythmia, response to certain medications.
CAUTION: If you receive a notification to take an EKG because SmartRhythm detected that your
heart rate pattern may be different from its predictions, it does not necessarily mean that you
have a heart abnormality. Please call your physician before making any medical decision,
including altering your use of any drug or treatment.
ENTER AN EVENT WITHOUT AN EKG (KARDIA PHONE APP ONLY)
You may enter a tag or note without an EKG at anytime. This may help you track your symptoms,
activities, diet, etc. either before or after an EKG:
• Tap the EKG History button, then tap the green “Plus” icon at the top left.
• In the Data Entry screen, you may enter notes, or select tags such as symptoms, activities,
diet, etc., or create personalized tags.
• In the Data Entry screen, you may 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 History screen in chronological order, and may be
edited anytime by selecting the dropdown arrow to the right of the event on the History
screen.
SETTINGS AND ADJUSTMENTS
8.1. Kardia Phone App Settings and Adjustments
8.1.1. Recording Review Adjustments
• Enhanced Filter. The Enhanced Filter suppresses noise in the EKG. The filter may be
toggled on a particular EKG from the EKG Review screen. To enable or disable the
Enhanced Filter, tap “MORE” at the bottom of the EKG Review screen, and then tap the
“ENHANCED” switch to toggle the filter ON or OFF.
• Invert the EKG Recording. In the event that Kardia Mobile was oriented improperly when
the EKG was recorded, it may appear inverted. The orientation may be toggled on a
particular EKG from the EKG Review screen. Tap “MORE” at the bottom of the EKG Review
screen, and then tap the “INVERT” switch to toggle it ON or OFF.
8.1.2. Adjustable Settings
To access the Settings, tap the Menu icon at the upper left and then tap “Settings”.
• Duration. Recording Duration is the maximum length of time the Kardia phone app will
record a single EKG recording. For example, if the recording duration is set to 30 seconds,
the Kardia phone app will automatically stop recording after 30 seconds of data has been
collected.
• Audio Recording. While recording your EKG, with audio recording turned on, you are able
to say outloud the symptoms you are experiencing and have the audio recording saved with
your EKG. The audio recording will also be transcribed as a text memo that is saved with the
EKG.
• Mains Filter. The Mains Filter removes any mains interference from the EKG; it should be
set to match the frequency of the alternating current (AC) used in your location. For the
United States, Canada and Mexico, this is 60 Hz; in most other countries, it is 50 Hz.
• Paper Size. Paper Size of the PDF report can be changed to accommodate Letter and A4
paper sizes.
• Unreadable. Toggling the Unreadable setting to OFF removes the “Unreadable” result. In
the default setting, with Unreadable turned ON, Kardia classifies any readings that appear
noisy as “Unreadable” rather than classifying based on the result detectors.
• Reminders. Reminders allow the EKG analysis reminder to be turned on or off. It also allows
you to turn on or off the EKG reminder, and to set the frequency and time for the reminder.
You can also modify your medication reminders.
8.2. Kardia Watch App Settings
To access the Kardia watch app settings, force touch on the Kardia watch app home screen and
tap “Settings.”
• SmartRhythm Monitoring. With SmartRhythm monitoring turned on, your watch will be
put into workout mode which will allow Kardia to request the Apple Watch to sample
your heart rate frequently. To take full advantage of the Kardia watch app, keep
SmartRhythm toggled ON.
• Voice Recording. While recording your EKG, with voice recording turned on, you are able
to say outloud the symptoms you are experiencing and have the voice recording saved
with your EKG. The voice recording will also be transcribed as a text memo that is saved
with the EKG.
• SmartRhythm Sensitivity. Higher sensitivity will trigger more notifications. There are 3
levels of notification sensitivity. The default level is Medium.
EMAIL, PRINT, OR DELETE RECORDINGS
To email a recording from the Kardia phone app:
1. Tap the envelope icon next to the EKG you would like to email/print on the History screen.
Alternatively, you may tap the EKG, then tap the envelope icon on the EKG Review screen.
2. Tap Email. The PDF version of the EKG recording will then be attached to a new email in
whatever email account you have set up on your smartphone or tablet.
Note: To email a recording from the Kardia phone app, you must have an email account set up
on your smartphone or tablet. If you need assistance setting up an email account or
troubleshooting your email account, contact your smartphone or tablet provider for assistance.
To print a recording from the Kardia phone app:
1. Tap the envelope icon next to the EKG that you would like to email/print on the History
screen. Alternatively, you may tap the EKG, then tap the envelope icon on the EKG Review
screen
2. Tap Print.
3. Select the appropriate printer to send the EKG to print.
Note: To print a recording from the Kardia phone app on Apple iPhones, you must have an
AirPrint compatible printer set up on your smartphone or tablet. If you need assistance setting
up an AirPrint compatible printer or troubleshooting your AirPrint compatible printer, contact
your smartphone or tablet provider for assistance.
To delete a recording:
1. Go to the History screen.
2. Tap the dropdown icon to the right of the EKG that you want to delete.
3. Tap “Delete”.
HISTORY (KARDIA MOBILE PHONE APP ONLY)
History is a Premium feature where your previously recorded EKG recordings are displayed. To
access it, tap the “History” icon.
• Launch the Kardia phone app.
• Tap History at the top of the screen to see a list of all EKG recordings on your smartphone or
tablet (excluding any previously deleted).
• Tap the EKG recording you wish to view.
NOTE: You may listen to the voice memo associated with the EKG by tapping the Play button.
10.1. Search or filter recordings (kardia phone app only)
You may search or filter the events in the History screen by using the search icon on the top right of
the screen.
To filter:
1. Tap the search icon on the top right.
2. Select one of the existing filters. The filters allow you to choose one of the following: Custom
Search…, Starred, Atrial Fibrillation, Analysis Reports, My EKGs, and Guest EKGs.
3. Your History screen will show you EKGs that meet the filter criteria until you disable the filter.
4. You may disable the filter by tapping the “x” icon next to the filter name at the upper right of
the History screen.
To search:
1. Tap the search icon at the top right.
2. Tap “Custom Search” at the top of the search menu.
3. Type in the term you are searching for in your events using the keyboard. For example, you may
be looking for “Caffeine” or “Walked the dog” in your tags and notes.
4. Tap outside of the keyboard area if you would like to remove the keyboard for better scrolling
through your records.
5. You may disable the search view by tapping “Cancel” on the top right of the screen or edit your
search term by tapping in the search bar and entering another term.
CLINICIAN REVIEW (KARDIA PHONE APP ONLY)
The Kardia phone app includes the ability to request professional clinical interpretation and
analysis of your EKG recordings. Due to telemedicine restrictions, your location may restrict your
ability to use this service. AliveCor does not know your location; it is your responsibility to ensure
this service is legal according to your local telemedicine laws. This service is not intended to replace
medical advice, please seek professional medical assistance if you are suffering from any medical
problem.
NOTE: Some users with a referral code to a cardiac monitoring service do not have access to this
feature. EKGs from such users are automatically sent to that monitoring service. Users may
additionally use the email an EKG or print an EKG feature to share information with their physician.
To request a Clinician Review:
1. Tap History and find the EKG you would like to send for analysis. Tap the envelope icon to the
right of the recording, then “Clinician Review”. Alternatively, you may tap the EKG, and then tap
the envelope icon at the top right of the EKG Review screen.
2. Select one of the listed options.
3. If you haven’t already entered your name, date of birth and gender, you will be prompted to
enter these details. Enter the required details and tap “Next”.
4. Select or enter your credit card information. Enter your card details and tap “Next”.
5. Confirm that the purchase order is correct and tap “Purchase” to place the order.
Your order is then processed and you will be sent an email confirmation. Another email will be sent
when the report is available.
NOTE: The “Clinician Review” option is only visible if the analysis service is available in your
country.
To view an EKG Analysis Report:
1. Tap “History”.
2. Tap the desired report below the EKG.
Alternatively, you may access EKG Analysis Reports from the EKG Review screen by tapping
“Analysis”.
NOTE: To view PDF reports on your smartphone or tablet you must have a PDF reader, such as
Adobe Reader, built-in or installed on your Android smartphone or tablet. Support for printing
depends on the built-in printing options on your Android smartphone or tablet, or you may need to
install a printer app from the Google Play Store. PDF functionality is built in to iOS devices.
DETECTORS (ATRIAL FIBRILLATION, NORMAL, UNREADABLE)
NOTE: Your EKG must be at least 30 seconds long to use the Atrial Fibrillation and Normal
detectors. If an EKG is recorded that is less than 30 seconds, neither the Atrial Fibrillation nor the
Normal detector will display a result.
Atrial Fibrillation Detector
The Atrial Fibrillation (AF) detector detects atrial fibrillation in an EKG tracing. After you take an
EKG, if atrial fibrillation is detected you will be notified within the app. This finding is not a
diagnosis, it is only a potential finding for the recorded EKG. You should contact your physician to
review any EKG recording in which atrial fibrillation was detected, or send it for clinician review
(see section 11 on page 15). If you are experiencing any symptoms or concerns contact a medical
professional.
Caution: If the Kardia app detects AF in an EKG, please consult with your physician before making
any medical decision, including altering your use of any drug or treatment.
Caution: The AF detector evaluates for atrial fibrillation (AF) only. It will not detect other potentially
life threatening arrhythmias, and it is possible that other cardiac arrhythmias may be present.
Caution: The AF detector only evaluates for AF after you have taken an EKG recording. It does NOT
continuously monitor your heart and therefore cannot alert you if AF happens at any other time.
Normal Detector
The Normal detector notifies you when a recording is “normal”. This means that the heart rate is
between 50 and 100 beats per minute, there are no or very few abnormal beats, and the shape,
timing and duration of each beat is considered normal sinus rhythm. 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 EKG might be normal for a single individual, but since the apps are 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 EKG (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
and PAC), are experiencing an arrhythmia, or took a poor-quality recording it is unlikely that you
will be notified that your EKG 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 that EKG
recording to be normal.
The Normal detector will not declare an EKG outside the heart beat rate of 50-100 beats per
minute as normal, even if the EKG has normal sinus rhythm. As a result, if you typically get
"Normal” results but take an EKG immediately after any physical activity that raises your heart rate
above 100 beats per minute, you may not get a “Normal” result.
CAUTION: AliveCor does not guarantee that you are not experiencing an arrhythmia or other health
conditions when labeling an EKG as normal. You should notify your physician for possible changes
in your health.
Unreadable Detector
The Unreadable detector determines whether a recording can be accurately interpreted or not.
After you take an EKG, if interference is detected you will be notified within the app that your
recording has “No analysis” and given some suggestions for acquiring good quality EKG recording.
You subsequently have the option to Save the recording, or Try Again. If the recording can be
analyzed, the AF and Normal detectors will run on the EKG and inform you as described above.
CAUTION: After EKG analysis, the app may incorrectly identify ventricular flutter, ventricular
bigeminy, and ventricular trigeminy heart conditions as unreadable. Please consult with your
physician.
12.1. What is Atrial Fibrillation?
The most common type of non-sinus tachyarrhythmia is atrial fibrillation. In atrial fibrillation,
disorganized electrical impulses that originate in the atria and pulmonary veins initiate the
electrical activity in the conduction system of the heart. This causes what are commonly
termed as “irregularly irregular” heart beats.
When a heart is in atrial fibrillation, its two upper chambers, the right and left atria,
essentially quiver instead of beating efficiently. This does not allow for complete emptying of
the atria and thus blood may become stagnant and create blood clots. This can lead to major
health problems, including strokes, transient ischemic attacks (TIAs), and pulmonary emboli
(PEs); depending which chamber of the heart has the blood clot in it.
Approximately 15 percent of strokes occur in people with atrial fibrillation. As age increases in
a population, so too does the incidence of atrial fibrillation, which peaks at about 3-5% in
people over the age of 65.
The most common presenting symptoms of atrial fibrillation are palpitations, dizziness, fast
pulse rate, irregularly irregular rhythm, an abnormal heart sound (S1), chest pain, chronic
shortness of breath, abnormal jugular venous pressure, fatigue, and impaired exercise
tolerance. Other symptoms related to TIAs and strokes may be the initial symptoms of atrial
fibrillation.
Some of the most common causes of atrial fibrillation are long-standing hypertension,
congestive heart disease, cardiac valvular lesions, myocardial infarctions, history of coronary
artery bypass grafts, hyperthyroidism, alcohol abuse, smoking, diabetes mellitus, and
electrolyte imbalances.
12.2. Possible AFib, Normal, Unreadable, and Unclassified Recordings in EKG review screen and
History
All EKG recordings analyzed as positive for atrial fibrillation, normal, or unreadable will have a
tag for future review. The Kardia phone app and Kardia watch app may display the
“Unclassified” message for an EKG recording that was not detected as Normal, nor as Possible
AFib, and not as Unreadable. Unclassified recordings may be normal rhythms, such as when
your heart rate is higher than 100 beats per minute after physicial activity, or abnormal
rhythms; if you consistently get “Unclassified” recordings, you may want to review these EKGs
with your physician or alternatively send these EKGs for Clinician Review from the Kardia app.
These tags will be visible in the History screen, Data Entry screen, and the EKG review screen.
12.3. Deactivation of the Unreadable Detector
The Unreadable detector can be turned on or off in the settings of the Kardia phone app
only.
12.4. Detector Usage
Kardia Mobile allows users to record EKGs as Lead II or Anterior Precordial Lead. The
detectors have been trained and tested on Lead I recordings only. Due to the difference in the
waveform from Lead II or Anterior Precordial Lead recordings, detector analysis messages
(e.g. “Normal”, “Unreadable”, etc.) of these recordings may be incorrect and you should not
use the results of the detector. Please consult your physician or perform a Clinical Review if
you wish to get an analysis of the recorded non-Lead-I EKG.
MEDICATIONS (KARDIA PHONE APP – IOS ONLY)
You may track your medications with the Kardia phone app. To access and edit the medications:
• Open the Kardia phone app and scroll down to Medication; tap “Get started”. You may edit
your medications or select those taken that day.
• Tap on “Edit your medications” to go to your Medications List. Here you may add new
medications or delete existing medications.
• On the Medication Logging page you may mark a medication as taken by tapping on the
medication and then hitting “Save” in the upper right corner.
• Alternatively, tap the medication push notification that is sent to you by default at 9:00am
every day. You may then edit your medications or select those taken that day.
• You may select a medication more than once per day by tapping “Log medication” on the home
screen and tapping the specific medication again. The number to the right of the medication
will update.
• To add or edit medication reminders go to Menu > Settings from the home screen and scroll
down to “Medication Reminders”.
INSIGHTS (FOR IOS) / TRENDS AND ANALYSIS (ANDROID) (KARDIA PHONE APP ONLY)
(Premium Feature) This app screen displays and graphs your data over time. The graphed data
includes your EKGs, EKG results, heart rate, symptoms and medications (iOS only). To access it, tap
the labeled button at the bottom of the home screen.
HEALTH APP AND GOOGLE FIT INTEGRATION
The Kardia phone app is integrated with the Apple Health and Google Fit apps. Apple Health app
access is required for use of the SmartRhythm features for the Apple Watch. Additionally,
information about your activities and vitals helps us provide you with a monthly Personal Report
(Premium). You have the option of turning off the integration within the Apple Health and Google
Fit apps; however, doing so will limit the information available in your Personal Report and prohibit
use of SmartRhythm monitoring. The Kardia phone app shares the following information with the
Apple Health and Google Fit app:
• Heart Rate
• Height
• Weight
• Blood Pressure
The Kardia phone app collects the following pieces of information from the Apple Health and
Google Fit apps:
• Active Energy
• Blood Glucose
• Diastolic Blood Pressure
• Flights Climbed
• Heart Rate
• Height
• Oxygen Saturation
• Resting Energy
• Sleep Analysis
• Steps
• Systolic Blood Pressure
• Walking + Running Distance
• Weight
• Workouts
REFERRAL CODE
If you were prescribed Kardia by your doctor or through a cardiac monitoring service, you should
have received a 12-character referral code. The code may be entered during account creation or
may be entered by tapping the shield icon located at the top right of the Home screen on the
Kardia phone app. Once a valid code has been entered, EKGs taken by you will be shared with the
cardiac monitoring service. To see if you are sharing EKGs with a cardiac monitoring service, tap the
shield icon located at the top right of the Home screen.
NOTE: Some users with a referral code to a cardiac monitoring service do not have access to the
Clinician Review feature described in section 11 on page 15.
BLOOD PRESSURE
AliveCor has a partnership with Omron that allows you to upload blood pressure readings directly
into the Kardia phone app.
Pair your Omron blood pressure monitor* to the Kardia phone app:
1. From the Home screen, scroll to Blood Pressure and tap “Get started”.
2. Turn on the blood pressure monitor.
3. On the blood pressure monitor, press and hold the Transfer or Clock button until you see a
flashing “P” or “o”.
4. Tap the Pair now button in the Kardia phone app to begin pairing.
NOTE: If you experience an error, repeat the above steps
Upload your blood pressure readings into the Kardia phone app:
1. From the Home screen, tap Blood Pressure.
2. After taking a recording, with the results displayed on the monitor’s screen, tap the Transfer
recording button in the Kardia phone app.
NOTE: *Only Omron blood pressure monitors that are compatible with the Apple iPhone may be
compatible with the Kardia phone app. Check with Omron for more information.
Connect to Google Fit (Android Only)
1. From the Home screen, tap Blood Pressure.
2. Tap the Learn more button and tap Next on the next screen.
3. Tap the Connect to Google Fit button.
Manual entry (Android Only)
1. From the Home screen, tap Blood Pressure.
2. By default, the systolic value is set at 120 and the diastolic value is set at 80. Tap the + and –
buttons to change the values.
3. Tap the Submit button to record the blood pressure measurements.
WEIGHT
You may track your weight over time in the Kardia phone app. You have the option to enter your
weight manually or the Kardia phone app or to enable the Kardia app to pull your weight data from
the Apple Health or Google Fit apps.
To connect to Apple Health or Google Fit:
1. From the Home screen, tap Weight.
2. Tap the Learn more button and tap Next on the next screen.
3. Tap the Connect to Google Fit or Connect to Health button.
To enter manually:
1. From the Home screen, tap Weight.
2. Scroll the scale gradations to the left or right to set the correct weight. Use the + or –
buttons to add or subtract 0.1 lbs.
3. Tap the Submit button to record the weight.
The Body Mass Index (BMI) value is calculated using a person’s weight and height. Although BMI
does not measure body fat directly, research has shown that BMI is moderately correlated with
other body fat measurement techniques. The BMI categories are derived from the BMI value (see
the CDC website at https://www.cdc.gov/healthyweight/assessing/bmi/index.html). To view the
weight and BMI results, go to the History screen and tap Weight.
PERSONAL REPORT
The Personal Report (Premium feature) is a monthly report that displays associations between your
Kardia data and your activity data. The Personal Report provides you with analysis and insights to
help you care for your heart. The report becomes more illustrative as you share more of your
activity data through the Apple Health app.
ACCESSING HELP
Learn more about using your Kardia Mobile by tapping the Menu icon at the top left of the Home
screen. Tap “Support” to see all the options available.
• Tutorials. Review these tutorials to learn about to navigate all the features of the app.
o Recording an EKG
o Alternate Recording Positions
• Reference. Access the user manual and provide feedback.
o User Manual
o Feedback
Learn more about using your KardiaBand by tapping the information icon accessed through the
menu in the Kardia watch app (force touch on the Kardia watch app home screen). Instructions for
accessing the user manual will appear.
EDITING USER PROFILE (KARDIA PHONE APP ONLY)
• Launch the Kardia phone app.
• Tap the Menu icon at the top left of the Home screen.
• Tap “Your Profile”.
• User details can be edited.
ACCESSING EDUCATION (KARDIA PHONE APP ONLY)
• Launch the Kardia phone app.
• Tap Menu icon at the top left of the Home screen.
• Tap “Heart Education”. Users have the ability to learn about:
o Cardiac Anatomy
o What is an EKG
o Arrhythmia Library
o External Resources
NOTE: The information contained within this section is for educational purposes only. This
information has been written and verified by medical professionals.
Do not attempt to use this information to interpret your own EKG. This information is not intended
to replace medical advice, please seek professional medical assistance if you are suffering from any
medical problem.
TROUBLESHOOTING
Problem
Solution
My Kardia Mobile is
not working.
Ensure that the Kardia phone app has access to the iPhone microphone:
1. Tap on iPhone “Settings”
2. Tap on “Privacy”
3. Tap on “Microphone”
4. Ensure that “Kardia” is turned on (the background of the slider is green)
Change the battery
1. Expose the battery door at the back of Kardia Mobile:
a. Remove the case from the smartphone or tablet by pushing the
iPhone through the camera cutout, while peeling back Kardia Mobile
from this corner.
OR
b. Remove Kardia Mobile from the attachment plate:
1. AC-001 - AC-007: Place your thumbs on the electrodes and press
down firmly. Turn counterclockwise about 45 degrees to "unlock"
Kardia Mobile. Once it's "unlocked", Kardia Mobile can then be
lifted out of the plate.
2. AC-009: Use your thumbs to slide Kardia Mobile toward the
open end of the plate.
2. Remove the battery door:
a. AC-001 - AC-007: Use a 1.6mm Phillips screwdriver, press down firmly
and turn counterclockwise to remove the screw in the battery door.
b. AC-009: Insert a pen, pencil or other similarly shaped object into the
cutout next to the battery door to pop the battery door off.
3. Remove the used battery and replace it with a new 3V coin cell battery
matched to your model.
4. Orient the battery with the positive terminal up, so that you can see the
writing. Remove the protective sticker from the battery, as applicable. AC-
009: Ensure that the battery slides under the two battery tabs.
Problem
Solution
My KardiaBand is not
working.
Ensure that the Kardia watch app has access to the smartwatch’s microphone:
1. On the iOS smartphone, tap the “Settings” app.
2. Scroll down the screen until you see Kardia and tap it.
3. Tap the “Microphone” toggle.
4. Ensure that “Kardia” is turned on (the background of the slider is green).
Check for obstructions
Ensure that the watch microphone is unobstructed. In the event an
obstruction exists, consult your watch user manual.
Change the battery
1. Gently pull the watchband and gently push the KardiaBand sensor from the
groove of the watchband.
2. Remove the battery door. Use a Torx T3 screwdriver, press down firmly and
turn counterclockwise to remove the screw in the battery door. Repeat for
the remaining screws.
3. Remove the used battery and replace it with a new 3V CR1620 coin cell
battery.
4. Orient the battery with the positive terminal up, so that you can see the
writing. Remove the protective sticker from the battery, as applicable.
5. Replace the battery door; note that the battery door only fits in one
orientation and you may need to rotate the door to achieve the correct fit.
6. Replace the four screws and hand-tighten with the Torx T3 screwdriver.
My Apple Watch face
goes black when
recording an EKG with
my KardiaBand
System.
Ensure that the Apple Watch wake screen is set to 70 seconds.
1. In the Watch app on your iPhone, scroll to and tap on “General”.
2. Scroll down and tap on “Wake Screen”.
3. In the “On Tap” section, select the “Wake for 70 seconds” option.
Problem
Solution
I have a lot of artifact,
noise, interference, or
see “No EKG” in my
recording
Try the following tips for acquiring the best quality EKG recording:
• Ensure that the “Enhanced Filter” is on.
• Clean the electrodes on Kardia Mobile with an 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 Kardia
Mobile rest on the hands. Do not squeeze Kardia Mobile.
• Ensure that your smartphone or 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 or tablet and the user remain still
during EKG 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 phone app Settings.
The EKG rhythms
appear upside down
To invert a recording on your smartphone or tablet, see “Invert the EKG
recording” under “Recording Adjustments” in Section 8.1.1.
I forgot my password
and I’m unable to
reset it
If you forget your password, tap on the “Forgot Password” link in the Kardia
phone app login screen. We’ll send a link and further instructions to the email
address that you used to set up and access Kardia.
Follow the reset instructions in the email. Note, the reset link contained in the
email is only active for a short while.
The PDF Report looks
slightly different on
the Web and in my
App
There is a 2.5 millisecond (thousandth of a second) difference in where the
PDF starts for the Web Application and the Mobile Application. There is no
difference in the recording and it will not impact how your EKG is interpreted.
My personal
information (name,
DOB, etc.) disappears
when I’m trying to
create an account
If you navigate backwards when creating your account, the personal
information you entered on the previous page is deleted and will have to be
re-entered.
The HUD symbol is
covered up when I
rotate my phone
The heads up display (HUD) symbol can sometimes be partially obstructed
when you rotate your phone while it’s busy. This isn’t a concern; the HUD
symbol is just letting you know that the app is working. This doesn’t impact
your recording or any of your information.
Problem
Solution
I see large spikes at
the start of my
recording
Large amounts of noise/artifact can be seen for the first few milliseconds of a
recording when the Enhanced Filter is looking for your heartbeat. This is very
rare and only lasts until your first heartbeat is seen in the app; this doesn’t
affect the rest of your recording.
I can’t see my age in
the PDF report
If your first and last names are longer than 35 characters combined, your age
may be covered due to size restrictions in the PDF report. Please consider
using initials for your first or last name in order to ensure your age is visible.
My credit card isn’t
being accepted
In rare occasions, the error message indicating that your credit card is
incorrect or invalid is automatically cleared by rotating the phone from
portrait to landscape or vice versa. Please ensure that your credit card
information is valid before processing payments.
I need a printed
version of the manual
Contact support@alivecor.com for a printed copy of this manual.
Is the manual
available in another
language?
This manual is available in English, Dutch, French, German, Italian, Spanish
and Norwegian.
KARDIA DEVICE SPECIFICATIONS
Performance Characteristics
EKG Channel ..................................................................................................... Single Channel
Input Dynamic Range ................................................................................ 10mV Peak-to-Peak
Memory length ...................................................................................... Practically Unlimited
Recording Format ................................................................................................. Continuous
Shelf Life ...................................................................................................... Estimated 2 years
Circuitry
Frequency Response ....................................................................................... 0.5 Hz to 40 Hz
CMRR............................................................................................................................... 76 dB
Input Impedance ................................................................................................ > 100 MOhm
Differential Range ..................................................................................................... +/- 5 mV
A/D Sampling Rate ................................................................................. 300 samples/second
Resolution ...................................................................................................................... 16 bit
DC Offset Correction ............................................................................................. +/- 300 mV
Output
Modulation ...................................................... Frequency Modulated Ultrasonic Audio Tone
Center Frequency .......................................................................................................... 19 kHz
Frequency Deviation ............................................................................................. 200 Hz/mV
Power Requirements
Battery Type (AC-001) ................................................................................................. CR2016
Battery Type (AC-003) ................................................................................................. CR2025
Battery Type (AC-004 & AC-007) ................................................................................ CR2032
Battery Type (AC-009) ................................................................................................. CR2016
Battery Type (AC-011) ................................................................................................. CR1620
Battery life (Kardia Mobile).......... min. 200 Hours Operational Time, 12 months typical use
Battery life (KardiaBand) ...................... min. 90 Hours Operational Time, 2 years typical use
Physical Characteristics
AC-001 (for iPhone 4/4s) ................................. 40 grams 118 x 62 x 15 mm 9 cm
2
Electrode
AC-003 (for iPhone 5/5s) ................................. 41 grams 128 x 62 x 15 mm 9 cm
2
Electrode
AC-004 & AC-007-I5-A (for iPhone 5/5s)……….. 33 grams 126 x 62 x 11 mm 10cm
2
Electrode
AC-004 & AC-007-UA-A (w/Attachment Plate). 28 grams 89 x 48 x 9 mm 10cm
2
Electrode
AC-009 ..............................................................18 grams 82 x 32 x 3.5 mm 9 cm
2
Electrode
AC-009-UA-DI ...................................................18 grams 82 x 32 x 3.5 mm 9 cm
2
Electrode
AC-011 (sensor only) .........................................30.6 grams 2.1 x 2.0 x 0.8 cm 3 cm
2
Electrode
Environmental Specifications
Operational Temperature ..................................................................... +10 to +45 degrees C
Operational Humidity ............................................................. 10% to 95% (non-condensing)
Operational Altitude ......... based on your smartphone, smartwatch, or tablet specification
Storage Temperature ............................................................................. -20 to +60 degrees C
Storage Humidity .................................................................... 10% to 95% (non-condensing)
Ingress Protection Marking. KardiaBand is IP64 rated, meaning that it is splash resistant but that
submerging it in water is not recommended. KardiaBand is compliant with standard IEC60601-1-
11:2015.
Expected Service Life. The expected service life is 2 years for KardiaBand.
Warm up time. Warm up time is not required for Kardia Mobile or for KardiaBand for their
intended uses.
User Interface
Two stainless-steel electrodes are exposed on the back of Kardia Mobile. These electrodes make
contact with the user’s skin. For the KardiaBand, two stainless-steel electrodes are exposed on
the front and back of the KardiaBand. These electrodes make contact with the user’s skin.
The KardiaBand sensor may be removed and inserted from the band strap a maximum of 50
times without performance degradation.
EUROPEAN AUTHORIZED REPRESENTATIVE
Obelis SA
BD General Wahis 53
1030, Brussels
Belgium
Tel: +(32) 2. 732.59.54
Fax: +(32) 2.732.60.03
E-Mail: [email protected]
ALIVECOR CONTACT INFORMATION
AliveCor, Inc.
444 Castro Street, Suite 600
Mountain View, CA 94041
United States
www.alivecor.com
AliveCor, Ltd.
Herschel House
58 Herschel Street
Slough
SL1 1PG
United Kingdom
ELECTRICAL SAFETY
27.1. KARDIA MOBILE ELECTRICAL SAFETY
Guidance and manufacturer's declaration - electromagnetic emissions
Kardia Mobile is intended for use in the electromagnetic environment specified below. The customer or the user of
Kardia Mobile should assure that it is used in such an environment.
Emissions test
Compliance
Electromagnetic environment - guidance
RF emissions
CISPR 11
Group 1
Kardia Mobile uses RF energy only for its internal function.
Therefore, RF emissions are very low and are not likely to
cause any interference in nearby electronic equipment.
RF emissions
CISPR 11
Class B
Kardia Mobile is suitable for use in all establishments other
than domestic and those directly connected to the public
low-voltage power supply network that supplies buildings
used for domestic purposes.
Harmonic emissions
IEC 61000-3-2
N/A
Voltage fluctuations /
flicker emissions
IEC 61000-3-3
N/A
Guidance and manufacturer’s declaration—electromagnetic immunity
Kardia Mobile is intended for use in the electromagnetic environment specified below. The customer or the user of
Kardia Mobile should assure that it is used in such an environment.
Immunity test
IEC 60601 test level
Compliance level
Electromagnetic environment
- guidance
Electrostatic
Discharge (ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floors should be wood,
concrete, or ceramic tile. If
floors are covered with
synthetic material, the relative
humidity should be at least
30%.
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV for power
supply lines
±1 kV for
input/output lines
±2 kV for power
supply lines
±1 kV for
input/output lines
Mains power quality should be
that of a typical commercial or
hospital environment.
Surge
IEC 61000-4-5
±1 kV differential
mode
±2 kV common
mode
±1 kV differential
mode
±2 kV common
mode
Mains power quality should be
that of a typical commercial or
hospital environment.
Voltage dips, short
interruptions, and
voltage variations on
power supply input
lines
IEC 61000-4-11
<5 % U
T
(>95 % dip in U
T
)
for 0.5 cycle
40 % U
T
(60 % dip in U
T
)
for 5 cycles
70 % U
T
(30 % dip in U
T
)
for 25 cycles
<5 % U
T
(>95 % dip in U
T
)
for 5 sec
<5 % U
T
(>95 % dip in U
T
)
for 0.5 cycle
40 % U
T
(60 % dip in U
T
)
for 5 cycles
70 % U
T
(30 % dip in U
T
)
for 25 cycles
<5 % U
T
(>95 % dip in U
T
)
for 5 sec
Mains power quality should be
that of a typical commercial or
hospital environment. If the
user of Kardia Mobile requires
continued operation during
power mains interruptions, it
is recommended that the
Kardia Mobile be powered
from an uninterruptible power
supply or a battery.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m
3 A/m
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment.
NOTE— U
T
is the a.c. mains voltage prior to application of the test level.
Guidance and manufacturer’s declaration—electromagnetic immunity
Kardia Mobile is intended for use in the electromagnetic environment specified below. The customer or the user of
Kardia Mobile should assure that it is used in such an environment.
Immunity test
IEC 60601 test
level
Compliance
level
Electromagnetic environment - guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80
MHz
3 V/m
80 MHz to 2.5
GHz
3 V
3 V/m
Portable and mobile RF communications
equipment should be used no closer to any part of
Kardia Mobile, including cables, than the
recommended separation distance calculated from
the equation applicable to the frequency of the
transmitter.
Recommended separation distance
80 MHz to 800 MHz
800 MHz to 2.5 GHz
where P is the maximum output power rating of
the transmitter in watts (W) according to the
transmitter manufacturer and d is the
recommended separation distance in meters (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey,
a
should be less than the compliance level in each
frequency range.
b
Interference may occur in the vicinity of equipment
marked with the following symbol:
NOTE 1—At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2—These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects, and people
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile
radios, amateur radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy.
To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the location in which Kardia Mobile is used exceeds the applicable RF
compliance level above, Kardia Mobile should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as re-orienting or relocating Kardia Mobile.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
P
V
d ]
5.3
[
1
P
E
d ]
5.3
[
1
P
E
d ]
7
[
1
Recommended separation distances between
portable and mobile RF communications equipment and Kardia Mobile
Kardia Mobile is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
The customer or the user of Kardia Mobile can help prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communications equipment (transmitters) and Kardia Mobile as
recommended below, according to the maximum output power of the communications equipment.
Rated maximum output
power of transmitter
W
Separation distance according to frequency of transmitter
m
150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2.5 GHz
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters
(m) can be determined using the equation applicable to the frequency of the transmitter, where P is the maximum
output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1—At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2—These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects, and people.
P
V
d ]
5.3
[
1
P
E
d ]
5.3
[
1
P
E
d ]
7
[
1
27.2. KARDIABAND ELECTRICAL SAFETY
The KardiaBand has been tested and deemed in conformance with the relevant
requirements in IEC60601-1-2:2014 Class B for Electromagnetic Compatibility (EMC).
Guidance and manufacturer's declaration - electromagnetic emissions
KardiaBand is intended for use in the electromagnetic environment specified below. The customer or the user of
KardiaBand should assure that it is used in such an environment.
Emissions test
Compliance
Electromagnetic environment - guidance
RF emissions
CISPR 11
Group 1
KardiaBand uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely to
cause any interference in nearby electronic equipment.
RF emissions
CISPR 11
Class B
KardiaBand is suitable for use in all establishments, including
domestic establishments and those directly connected to the
public low-voltage network that supplies buildings used for
domestic purposes.
Harmonic emissions
IEC 61000-3-2
N/A
Voltage fluctuations /
flicker emissions
IEC 61000-3-3
N/A
Guidance and manufacturer’s declaration—electromagnetic immunity
KardiaBand is intended for use in the electromagnetic environment specified below. The customer or the user of
KardiaBand should assure that it is used in such an environment.
Immunity test
IEC 60601 test level
Compliance level
Electromagnetic environment
- guidance
Electrostatic
Discharge (ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
±8 kV contact
±15 kV air
Floors should be wood,
concrete, or ceramic tile. If
floors are covered with
synthetic material, the relative
humidity should be at least
30%.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m
30 A/m
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment.
Guidance and manufacturer’s declaration—electromagnetic immunity
KardiaBand is intended for use in the electromagnetic environment specified below. The customer or the user of
KardiaBand should assure that it is used in such an environment.
Immunity test
IEC 60601 test
level
Compliance
level
Electromagnetic environment - guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
N/A
3 V/m
80 MHz to 2.7
GHz
N/A
10 V/m
Portable and mobile RF communications
equipment should be used no closer to any part of
KardiaBand, including cables, than the
recommended separation distance calculated from
the equation applicable to the frequency of the
transmitter.
Recommended separation distance
80 MHz to 800 MHz
800 MHz to 2.7 GHz
where P is the maximum output power rating of
the transmitter in watts (W) according to the
transmitter manufacturer and d is the
recommended separation distance in meters (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey,
a
should be less than the compliance level in each
frequency range.
b
Interference may occur in the vicinity of equipment
marked with the following symbol:
NOTE 1—At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2—These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects, and people
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile
radios, amateur radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy.
To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the location in which KardiaBand is used exceeds the applicable RF
compliance level above, KardiaBand should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as re-orienting or relocating KardiaBand.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.
P
E
d ]
5.3
[
1
P
E
d ]
7
[
1
Recommended separation distances between
portable and mobile RF communications equipment and KardiaBand
KardiaBand is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The
customer or the user of KardiaBand can help prevent electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment (transmitters) and KardiaBand as recommended below,
according to the maximum output power of the communications equipment.
Rated maximum output
power of transmitter
W
Separation distance according to frequency of transmitter
m
150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2.7 GHz
0.01
0.035
0.035
0.070
0.1
0.11
0.11
0.22
1
0.35
0.35
0.70
10
1.1
1.1
2.2
100
3.5
3.5
7.0
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters
(m) can be determined using the equation applicable to the frequency of the transmitter, where P is the maximum
output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1—At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2—These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects, and people.
P
V
d ]
5.3
[
1
P
E
d ]
5.3
[
1
P
E
d ]
7
[
1
SYMBOLS USED SYSTEM OR PACKAGE LABELING
Type BF Applied Part (KardiaBand)
Type CF Applied Part (Kardia Mobile)
European Conformity Mark
Do not dispose with household waste
Read instructions before use
Manufacturer
Temperature range
Humidity range
QTY
Quantity of device included in the package
Model number
Serial number
