AliveCor Kardia User Manual

Clinical-quality electrocardiogram

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Page 1 Kardia™ by AliveCor® © 2011-2017 AliveCor, Inc. All rights reserved. US Patent No: 8,301,232 and Patents Pending. AliveCor and Kardia are trademarks and trade names of AliveCor, Inc. in the United States and other countries. 08LB12 Revision 5 | 08June2017 AliveCor, Inc.
Page 2 Contents 1. PRODUCT DESCRIPTION ......................3 2. CAUTIONS ..........................5 3. SET UP KARDIA MOBILE OR KARDIA BAND SYSTEM AND TAKE THE FIRST EKG RECORDING .. 6 4. RECORD EKG RHYTHMS ......................8 5. ONCE THE RECORDING IS FINISHED..................10 6.
Page 3: Product Description
Kardia™ Band System with their Apple Watch. The duration of the recording is established by the Kardia phone and Kardia watch apps with a default setting of 30 seconds. The Kardia phone app may extend recordings to a maximum time of 5 minutes.
Page 4: Cautions
 Track events that may impact your heart health, such as symptoms, activities, diet, etc. After a user has created an account on the Kardia phone app and received an EKG analysis, the Kardia Mobile and Kardia Band products enable a user to: ...
Page 5  DO NOT take a recording while driving or during physical activity.  DO NOT use Kardia Mobile while charging your phone. DO NOT use Kardia Band while charging your watch.  DO NOT take a recording if the electrodes are dirty. Clean them first.
Page 6: Set Up Kardia Mobile Or Kardia Band System And Take The First Ekg Recording
For Kardia Mobile cases, place Kardia Mobile on your phone as you would any standard phone case. b) The Kardia Mobile can be attached directly to the smartphone or tablet or to the case of your choosing (the surface should be smooth and flat).
Page 7 3.3. Unpack Kardia Band (Kardia Band Users) 1. Remove Kardia Band from the box, which consists of 2 pieces – one band that attaches to the 12 o clock side of the watch body and the other band that attaches to the 6 o clock side of the watch body.
Page 8: Record Ekg Rhythms
4. RECORD EKG RHYTHMS NOTE: You will not be able to view your recordings or utilize any of Kardia s detectors until your over-read analysis is received. To gain access to these features, you must create an account on the Kardia phone app.
Page 9 2. Rest two or more fingers (it doesn t matter which fingers) on Kardia Mobile; your right hand should contact the electrode closest to the bottom of the smartphone or tablet, and your left hand should contact the electrode closest to the top of the smartphone or tablet. This is a Lead I EKG.
Page 10: Once The Recording Is Finished
 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.
Page 11: Enter An Event Without An Ekg (Kardia Phone App Only)
 Force touch the EKG tracing to replay the audio, invert the EKG, or delete the recording.  On the Home screen in the Kardia watch app, tap the Record EKG button to take another EKG recording or view the last EKG recorded.
Page 12: Email, Print, Or Delete Recordings
You may email/print recordings from either the Kardia phone app or your account on the server (www.alivecor.com). 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.
Page 13: Journal (Kardia Phone App Only)
2. Tap the dropdown icon to the right of the EKG that you want to delete. 3. Tap Delete . To delete or invert a recording in the Kardia watch app: 1. Go to the Home screen in the Kardia watch app.
Page 14: View An Ekg Recording On The Alivecor Website
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.
Page 15: Detectors (Atrial Fibrillation, Normal, Unreadable)
Normal detector will likely declare this recording to be normal. 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.
Page 16 All tracings 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 a tracing that is not Normal and not AF, and interference was not detected. An example of an unclassified tracing is one where tachycardia is observed.
Page 17: Medications (Kardia Phone App – Ios Only)
14. MEDICATIONS (KARDIA PHONE APP – IOS ONLY) You may track your medications with the Kardia phone app. To access and edit the medications:  Tap Insights in the Menu at the bottom of the screen. Scroll to the bottom of the Insights screen and tap Log Medications .
Page 18: Health App And Google Fit Integration
12-character referral code. The code may be entered during account creation or may be entered by tapping the heart icon located at the top right of the Home screen on the Kardia phone app. Once a valid code has entered, EKGs taken by you will be shared with the cardiac monitoring service.
Page 19: Weight
Blood pressure measurements may be transferred from Google Fit or manually entered into the Kardia phone app. If you have a blood pressure monitor that is connected to Google Fit, you may transfer your blood pressure measurements from Google Fit into the Kardia phone app.
Page 20: Personal Report
Apple Health app. 21. 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.
Page 21: Accessing Education (Kardia Phone App Only)
23. 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...
Page 22: Troubleshooting
(bottom of the iPhone in your right hand) in order to take a recording. If you re using iOS 7 or greater, ensure that the Kardia phone app has access to the iPhone microphone: 1. Tap on iPhone Settings 2.
Page 23 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.
Page 24 • 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.
Page 25 Is the manual This manual is available in English, Dutch, French, German, Italian, and available in another Spanish. language? AliveCor, Inc. For support, please email support@alivecor.com or visit www.alivecor.com...
Page 26: Kardia Specifications
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 (Kardia Band) ..... min. 90 Hours Operational Time, 2 years typical use Physical Characteristics AC-001 (for iPhone 4/4s) .........
Page 27 For the Kardia Band, two stainless-steel electrodes are exposed on the front and back of the Kardia Band. These electrodes make contact with the user s skin. The Kardia Band sensor may be removed and inserted a maximum of 50 times without performance degradation.
Page 28: European Authorized Representative
27. 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 AliveCor, Inc. For support, please email support@alivecor.com or visit www.alivecor.com...
Page 29: Electrical Safety
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.
Page 30 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. Electromagnetic environment - Immunity test...
Page 31 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. IEC 60601 test Compliance Immunity test...
Page 32 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.
Page 33 IEC60601-1-2:2014 Class BG for Electromagnetic Compatibility (EMC). Guidance and manufacturer's declaration - electromagnetic emissions Kardia Band is intended for use in the electromagnetic environment specified below. The customer or the user of Kardia Band should assure that it is used in such an environment.
Page 34 Guidance and manufacturer’s declaration—electromagnetic immunity Kardia Band is intended for use in the electromagnetic environment specified below. The customer or the user of Kardia Band should assure that it is used in such an environment. Electromagnetic environment - Immunity test...
Page 35 Guidance and manufacturer’s declaration—electromagnetic immunity Kardia Band is intended for use in the electromagnetic environment specified below. The customer or the user of Kardia Band should assure that it is used in such an environment. IEC 60601 test Compliance Immunity test...
Page 36 RF communications equipment and Kardia Band Kardia Band is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of Kardia Band can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and Kardia Band as recommended below, according to the maximum output power of the communications equipment.
Page 37: Symbols Used System Or Package Labeling
29. SYMBOLS USED SYSTEM OR PACKAGE LABELING Type BF Applied Part (Kardia Band) Type CF Applied Part (Kardia Mobile) European Conformity Mark Do not dispose with household waste Read instructions before use Manufacturer Temperature range Humidity range Model number Serial number AliveCor, Inc.

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