AliveCor Kardia Mobile User Manual
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AliveCor Kardia Mobile User Manual

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© 2011-2016 AliveCor, Inc. All rights reserved. US Patent No: 8,301,232 and Patents
Pending. AliveCor is a trademark and trade name of AliveCor, Inc. in the United States and
AliveCor, Inc.
AliveCor® Kardia™ Mobile
Android
other countries.
For support, please email support@alivecor.com or visit www.alivecor.com
09LB08 Revision V | JUNE 2016
1

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  • Page 1 AliveCor® Kardia™ Mobile User Manual for Android © 2011-2016 AliveCor, Inc. All rights reserved. US Patent No: 8,301,232 and Patents Pending. AliveCor is a trademark and trade name of AliveCor, Inc. in the United States and other countries. 09LB08 Revision V | JUNE 2016 AliveCor, Inc. For support, please email support@alivecor.com or visit www.alivecor.com...

  • Page 2: Table Of Contents

    STORAGE, HANDLING AND MAINTENANCE .................. 5 WARNINGS .............................. 5 SET UP KARDIA MOBILE AND TAKE THE FIRST EKG RECORDING ............ 6 RECORD EKG RHYTHMS USING KARDIA MOBILE ................ 7 ONCE THE RECORDING IS FINISHED ...................... 8 ENTER AN EVENT WITHOUT AN EKG ..................... 9 SETTINGS AND ADJUSTMENTS ....................... 9 EMAIL, PRINT, OR DELETE RECORDINGS ..................10 VIEW PREVIOUSLY RECORDED EKG RECORDINGS – JOURNAL ............ 11 SEARCH OR FILTER RECORDINGS ...................... 11 VIEW AN EKG RECORDING ON THE ALIVECOR SERVER ..............12 EKG ANALYSIS ............................12 DETECTORS (ATRIAL FIBRILLATION, NORMAL, UNREADABLE) ............ 13 INSIGHTS ............................... 16 GOOGLE FIT APP INTEGRATION ......................16 REFERRAL CODE ........................... 17 PERSONAL REPORT ..........................17 ACCESSING HELP ..........................17 EDITING USER PROFILE ........................18 ACCESSING EDUCATION ........................18 PROVIDER DASHBOARD ........................18 ELECTRONIC HEALTH RECORD (EHR) INTEGRATION .

  • Page 3: Product Description

    2. The Kardia phone app is used to collect, view, save, and wirelessly transmit recordings to the AliveCor server. 3. A user-supplied compatible smartphone or tablet. CAUTION: Kardia Mobile has features that are only available to users who are under the care of a physician. These features are available to prescription users only. Kardia Mobile enables users to: • Collect and store single-channel EKG recordings using the smartphone or tablet. • Record voice memos that are automatically transcribed to notes. • Edit user information data associated with the recording. • Wirelessly transmit EKG recordings to the AliveCor server. • Access EKG recordings stored on the AliveCor server. • Print or save the recording in PDF format. • Request professional clinical interpretation and analysis of your EKG recordings. • Track events that may impact your heart health, such as symptoms, activities, diet, activity, etc. After a user has created an account on the Kardia phone app and received an EKG analysis, Kardia Mobile enables a user to: • View EKG recordings real-time and after the recording.

  • Page 4: General Safety Precautions

    1.2. Indications for Use - OUS Kardia Mobile by AliveCor is intended to record, display, store, and transfer single- channel electrocardiogram (EKG or ECG) rhythms. Kardia Mobile by AliveCor also detects the presence of atrial fibrillation and normal sinus rhythm in each recording. Kardia Mobile by AliveCor is intended for use by healthcare professionals, patients with known or suspected heart conditions, and health conscious individuals. 1.3. Contraindications There are no known contraindications for Kardia Mobile, although care should be taken when considering using the device according to the warnings and precautions below. 2. GENERAL SAFETY PRECAUTIONS • The device should not be used near water, or in a wet environment. • Do not use this device in locations subject to high or low temperatures or humidity. It should be used within the temperature and humidity range according to the product label. • Do not sterilize this device with an autoclave or glass sterilizer. • Audio and video products and similar equipment may cause interference. Please stay away from such equipment when you are recording.

  • Page 5: Storage, Handling And Maintenance

    • This device does not detect or measure all heart rate, heart rhythm, and heart waveform changes, especially those related to ischemic heart conditions. • Do not attempt self-diagnosis or self-treatment based on the recording results and analysis. Self-diagnosis or self-treatment may lead to deterioration of your health. • Users should always consult their physician if they notice changes in their health. • Do not use in the presence of flammable anesthetics, drugs, or pressurized oxygen (such as in a hyperbaric chamber, ultraviolet sterilizer or oxygen tent). • Do not use this device during an MRI scan. • Keep out of reach of infants, small children, or anyone incapable of using the device properly. • The device has not been tested for use on infants weighing less than 10kg. AliveCor does not recommend using on humans less than 10kg. • It is not recommended to place a mobile phone directly next to a pacemaker on the chest. • Do not use this device with a defibrillator. • AliveCor does not recommend using on individuals with a cardiac pacemaker, ICDs, or other implanted electronic devices. AliveCor, Inc. For support, please email support@alivecor.com or visit www.alivecor.com...

  • Page 6: Set Up Kardia Mobile And Take The First Ekg Recording

    • The Unreadable Detector may incorrectly identify ventricular flutter, ventricular bigeminy, and ventricular trigeminy as unreadable. If you have been diagnosed with one or more of these arrhythmias, we recommend turning off the Unreadable Detector in your Settings. • AliveCor cannot guarantee that you are not experiencing an arrhythmia or other health condition when labeling an EKG as normal. You should notify your doctor of a possible change in your health. 5. SET UP KARDIA MOBILE AND TAKE THE FIRST EKG RECORDING 5.1.

  • Page 7: Record Ekg Rhythms Using Kardia Mobile

    • Download and install the Kardia phone app. 5.4. Set up an AliveCor Account You will use your AliveCor 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 for the first time. You can go back later and change your information if necessary. Signing up for an AliveCor account also enables you to send an EKG for analysis (select countries only). EKG analysis can be used any time you want a medical professional to interpret your EKG recording and is required if you would like to view your recordings or utilize Kardia’s Detectors. 6. RECORD EKG RHYTHMS USING KARDIA MOBILE Before taking each recording: • Disconnect headphones, charger cables, or any other connected devices.

  • Page 8: Once The Recording Is Finished

    • Alternatively, you can go to the Journal 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 can add or edit notes and tags. NOTES: • Kardia Mobile does not require a Wi-Fi or mobile connection to record an EKG and save it to the smartphone or tablet, however it does require one of these 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 connection at the time of the EKG recording, you can email or print the data later when you have such a connection and the sync ill happen automatically at that time. • Kardia Mobile can 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 9: Enter An Event Without An Ekg

    12.5mm/s, 25mm/s, or 50mm/s. This option is only available to health professionals. • Gain. Gain of the EKG in the PDF report can be set to 5mm/mV, 10mm/mV or 20mm/mV. This option is only available to health professionals. • Enhanced Filter. The Enhanced Filter suppresses noise in the EKG. The filter can 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 on the 'Enhanced Filter' 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 can be toggled on a particular EKG from the EKG Review screen. Tap “MORE” at the bottom of the EKG Review screen, and then tap on the 'Invert' switch to toggle it ON or OFF. AliveCor, Inc. For support, please email support@alivecor.com or visit www.alivecor.com...

  • Page 10: Email, Print, Or Delete Recordings

    10. EMAIL, PRINT, OR DELETE RECORDINGS NOTE: If you are not enrolled in Kardia’s EKG Analysis service, you will not be able to view the recording (US only). AliveCor will unlock this feature if you are under the guidance of a physician. 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 mobile device. If you need assistance setting up an email account or...

  • Page 11: View Previously Recorded Ekg Recordings - Journal

    To print a recording from the server: 1. Go to www.alivecor.com. 2. Click on “SIGN IN” and enter your email address and password. 3. Select the desired recording by clicking on the appropriate “View EKG” button on the right. 4. Click the “View PDF” link. 5. Print from your computer as you would any PDF. To delete a recording: 1. Go to the Journal screen. 2. Tap the dropdown icon to the right of the EKG that you want to delete. 3. Tap “Delete”. 11. VIEW PREVIOUSLY RECORDED EKG RECORDINGS – JOURNAL NOTE: If you are not enrolled in Kardia’s EKG Analysis service, you will not be able to view the recording (US only). AliveCor will unlock this feature if you are under the guidance of a physician. Journal is a premium feature where your previously recorded EKG recordings are displayed. To access it, tap the “Journal” icon. • Launch the Kardia phone app. • Tap Journal in the menu to see a list of all EKG recordings on your mobile device (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. 12. SEARCH OR FILTER RECORDINGS You may search or filter the events in the Journal screen by using the search icon on the top right of the screen.

  • Page 12: View An Ekg Recording On The Alivecor Server

    To search: 1. Tap the search icon on 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 can disable the search view by tapping “Cancel” on the top right of screen or edit your search term by tapping in the search bar and entering another term. 13. VIEW AN EKG RECORDING ON THE ALIVECOR SERVER NOTE: If you are not enrolled in Kardia’s EKG Analysis service, you will not be able to view the recording (US only). AliveCor will unlock this feature if you are under the guidance of a physician. • On your web browser, go to www.alivecor.com and click “SIGN IN”. • Enter your email address and password you created when you set up your AliveCor account. Click “Sign In”. • The EKG recordings you collected were automatically synced to the AliveCor server and will appear in list form. Each transmission is stored as an Adobe Acrobat PDF file and can also be viewed in HTML. Click the “View EKG” button. • Click the back button in your browser to return to your AliveCor account homepage. 14. EKG ANALYSIS 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.

  • Page 13: Detectors (Atrial Fibrillation, Normal, Unreadable)

    15. DETECTORS (ATRIAL FIBRILLATION, NORMAL, UNREADABLE) NOTE: If you are not enrolled in Kardia’s EKG Analysis service, you will not be able to view the recording (US only). AliveCor will unlock this feature if you are under the guidance of a physician. 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...
  • Page 14 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. WARNING: AliveCor cannot guarantee that you are not experiencing an arrhythmia or other health condition when labeling an EKG as normal. You should notify your doctor of a possible change in your health. Unreadable Detector The Unreadable Detector in the Kardia phone app determines whether a recording can be accurately interpreted or not. After you take an EKG, if interference is detected, you...
  • Page 15 15.1 What is Atrial Fibrillation? The most common type of non-sinus tachyarrhythmia is atrial fibrillation. In this case, 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 problems, namely, 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. 15.2 AF, Normal, and Unreadable Recordings in EKG review screen and Journal All tracings analyzed as positive for atrial fibrillation, normal or unreadable will have a tag for future review. The Kardia phone 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. These tags will be visible in the Journal screen, Data Entry screen, and the EKG review screens. 15.3 Activation of the Detectors The Unreadable and Unclassified Detectors can be turned on or off in the settings of the Kardia phone app. AliveCor, Inc. For support, please email support@alivecor.com or visit www.alivecor.com...

  • Page 16: Insights

    • Number of EKGs recorded, including the number of AF recordings and Normal Recordings • Heart rate (bpm) in each EKG recording • Symptoms, activities, diet, etc NOTE: Your Insights are also available by logging into your account on www.alivecor.com. Insights data is available in 30-day increments, from when you first created your account. Note that this feature is available for individual users only, not for medical professionals. 17. GOOGLE FIT APP INTEGRATION The Kardia phone app is integrated with the Google Fit app. Information about your activities and vitals helps us provide you with a monthly (premium) Personal Report –...

  • Page 17: Referral Code

    If you were prescribed Kardia through a cardiac monitoring service, you should have received 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. Once a valid code has 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 heart icon located at the top right of the Home screen. 19. PERSONAL REPORT The Personal Report, a premium feature, is a monthly report that displays any associations between your AliveCor data and your activity data. The Personal Report provides you with analysis, insights, and actionable advice to help you care for your heart. The report quality improves as you share more of your activity data through the Google Fit app. 20. ACCESSING HELP To access Help, tap the menu icon at the top left of the home screen and select the “Support” menu item. Learn more about using your AliveCor Kardia Mobile from the following tutorials included in the Kardia phone app: •...

  • Page 18: Editing User Profile

    21. EDITING USER PROFILE To access Profile, tap the menu icon at the top left of the home screen, and select the “Your Profile” menu item. • name@emailaddress.com: Email address of the current AliveCor account. • User Profile: Details of the account holder. o For health professionals, enter your name and organization, which will be stored with each EKG recorded and printed on the reports. o For individual users enter your name and other details that will be stored with each new EKG recording. • Credit Cards: Add or remove credit card details for purchasing EKG analysis reports. • Sign In/Log out: Allows you to Log in or setup a new AliveCor account, or to log out if you are already logged in.

  • Page 19: Electronic Health Record (Ehr) Integration

    24. ELECTRONIC HEALTH RECORD (EHR) INTEGRATION Send to EHR: If you are a physician and your AliveCor account has been setup for integration with an Electronic Health Record system (EHR) you can send EKG recordings to your EHR. Tap the 'Send to EHR' icon to send the EKG. AliveCor, Inc. For support, please email support@alivecor.com or visit www.alivecor.com...

  • Page 20: Troubleshooting

    • 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 In the future, ensure that the left hand contacts the electrode closer to the top of the upside down. smartphone or tablet, and the right hand contacts the electrode closer to the bottom of the smartphone or tablet. To invert a recording on your smartphone or tablet, see “Invert the EKG recording” under “Recording Adjustments”. I forgot my password and To reset your password, go to www.alivecor.com and click on "SIGN IN" in the upper right I’m unable to reset it. corner and click on the "Forgot your password?" link below the Password field. On the Forgot Password screen, enter your email address and click Submit. Follow the reset instructions in the email. Note the reset link contained in the email is only active for a short while. The EKG was lost when I Rotating your phone while recording so that the screen “flips” from portrait to landscape was recording it mode will automatically stop the recording and that EKG will not be saved. Please do not rotate your phone while recording as this will impact the quality of your recording. I can’t see my age in the If your first and last name are longer than 35 characters combined, your age may be PDF report covered due to size restrictions in the PDF report. Please consider using initials for your first or last name in order to ensure you age is visible. AliveCor, Inc. For support, please email support@alivecor.com or visit www.alivecor.com...
  • Page 21 Problem Solution My credit card isn’t being In rare occasions, the error message indicating that your credit card is incorrect or invalid accepted is automatically cleared by rotating the phone from portrait to landscape or vice versa. Please double check that your credit card information is valid before processing payments. I need a printed version of Please contact support@alivecor.com for a printed copy of this manual. the manual Is the manual available in This manual is available in English, Dutch, French, German, Italian, and Spanish. another language? AliveCor, Inc. For support, please email support@alivecor.com or visit www.alivecor.com...

  • Page 22: Alivecor Kardia Mobile Specifications

    26. ALIVECOR KARDIA MOBILE SPECIFICATIONS Performance Characteristics EKG Channel ....................Single Channel Input Dynamic Range ................10mV Peak-to-Peak Memory length .................. P ractically Unlimited Recording Format ....................Continuous Shelf Life ....................Estimated 2 years Circuitry Frequency Response .................. 0 .5 Hz to 40 Hz CMRR .......................... 7 6 dB Input Impedance .................... > 100 MOhm Differential Range ..................... + /- 5 mV A/D Sampling Rate ................. 3 00 samples/second Resolution ........................ 1 6 bit DC Offset Correction .

  • Page 23: European Authorized Representative

    27. 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: mail@obelis.net 28. ALIVECOR CONTACT INFORMATION AliveCor, Inc. 30 Maiden Lane, Suite 600 San Francisco, CA 94108 United States www.alivecor.com AliveCor, Inc. For support, please email support@alivecor.com or visit www.alivecor.com...

  • Page 24: Electrical Safety

    29. ELECTRICAL SAFETY Guidance and manufacturer's declaration - electromagnetic emissions Kardia Mobile by AliveCor is intended for use in the electromagnetic environment specified below. The customer or the user of Kardia Mobile by AliveCor should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment - guidance Kardia Mobile by AliveCor uses RF energy only for RF emissions its internal function. Therefore, its RF emissions are Group 1 CISPR 11 very low and are not likely to cause any interference in nearby electronic equipment. RF emissions Class B CISPR 11 Kardia Mobile by AliveCor is suitable for use in all Harmonic emissions establishments other than domestic and those N/A IEC 61000-3-2 directly connected to the public low-voltage power supply network that supplies buildings used for Voltage fluctuations / domestic purposes. flicker emissions N/A IEC 61000-3-3 AliveCor, Inc. For support, please email support@alivecor.com or visit www.alivecor.com...
  • Page 25 Guidance and manufacturer’s declaration—electromagnetic immunity Kardia Mobile by AliveCor is intended for use in the electromagnetic environment specified below. The customer or the user of Kardia Mobile by AliveCor should assure that it is used in such an environment. IEC 60601 test Electromagnetic Immunity test Compliance level level environment - guidance Floors should be wood, concrete, or ceramic tile. If Electrostatic ±6 kV contact ±6 kV contact floors are covered with Discharge (ESD) ±8 kV air ±8 kV air synthetic material, the IEC 61000-4-2 relative humidity should be at least 30%. ±2 kV for power ±2 kV for power Mains power quality should Electrical fast supply lines supply lines be that of a typical transient/burst ±1 kV for ±1 kV for commercial or hospital IEC 61000-4-4 input/output lines input/output lines environment. ±1 kV differential ±1 kV differential Mains power quality should...
  • Page 26 Guidance and manufacturer’s declaration—electromagnetic immunity Kardia Mobile by AliveCor is intended for use in the electromagnetic environment specified below. The customer or the user of Kardia Mobile by AliveCor should assure that it is used in such an environment. Immunity IEC 60601 Complianc Electromagnetic environment - guidance test test level e level Portable and mobile RF communications equipment should be used no closer to any part of Kardia Mobile by AliveCor, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance 3 Vrms 80 MHz to 800 MHz Conducted RF 150 kHz to 3 V IEC 61000-4-6 80 MHz 800 MHz to 2.5 GHz where P is the maximum output power rating of the transmitter in watts (W) according to the Radiated RF 3 V/m 3 V/m transmitter manufacturer and d is the IEC 61000-4-3 80 MHz to recommended separation distance in meters 2.5 GHz (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range.
  • Page 27 Recommended separation distances between portable and mobile RF communications equipment and Kardia Mobile by AliveCor Kardia Mobile by AliveCor is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of Kardia Mobile by AliveCor can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and Kardia Mobile by AliveCor as recommended below, according to the maximum output power of the communications equipment. Separation distance according to frequency of transmitter Rated maximum output power of 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz transmitter 0.01 0.12 0.12 0.23 0.1 0.38 0.38 0.73 1.2 1.2 2.3 3.8 3.8 7.3 100 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. AliveCor, Inc. For support, please email support@alivecor.com or visit www.alivecor.com...

  • Page 28: Symbols Used System Or Package Labeling

    30. SYMBOLS USED SYSTEM OR PACKAGE LABELING AliveCor, Inc. For support, please email support@alivecor.com or visit www.alivecor.com...

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