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AliveCor Heart Monitor User Manual

Mobile, clinical-quality electrocardiogram (ecg) recorder manual for ios
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AliveCor® Heart Monitor
User Manual for iOS
NOTE: For the current information on your product please visit http://www.alivecor.com/user-
manual
© 2011-2015 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.
08LB05 Revision K | JAN 2015
AliveCor, Inc.
For support, please email support@alivecor.com or visit www.alivecor.com
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Summary of Contents for AliveCor Heart Monitor

  • Page 1 © 2011-2015 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. 08LB05 Revision K | JAN 2015 AliveCor, Inc.

  • Page 2: Table Of Contents

    3. STORAGE, HANDLING AND MAINTENANCE ................4 4. WARNINGS ..........................5 5. SET UP THE HEART MONITOR AND TAKE THE FIRST ECG RECORDING ........5 6. RECORD ECG RHYTHMS USING THE HEART MONITOR ............7 7. ONCE THE RECORDING IS FINISHED..................8 8.

  • Page 3: Product Description

    Patients with known or suspected heart conditions and health conscious individuals can use the AliveCor Heart Monitor to record an ECG daily or whenever they are feeling symptoms and share their recordings with their physician. Medical professionals can use the AliveCor Heart Monitor to quickly assess rate and rhythm, screen for arrhythmias, and remotely monitor and manage patients who use the AliveCor Heart Monitor.

  • Page 4: General Safety Precautions

    1.2. Contraindications There are no known contraindications for the Heart Monitor, 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.

  • Page 5: Warnings

     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.
  • Page 6 You can use the Heart Monitor with Universal Attachment Plate on all compatible mobile devices as listed on the Compatibility Chart. The Heart Monitor for iPhone 5/5s can also be used on all compatible mobile devices by removing the oval-shaped Heart Monitor from its case: 1.

  • Page 7: Record Ecg Rhythms Using The Heart Monitor

    AliveCor server, email, or print directly from the AliveECG app. If you do not have a Wi-Fi or mobile connection at the time of the ECG recording, you can email or print the data later when you have such a connection and the sync will happen automatically at that time.

  • Page 8: Once The Recording Is Finished

     Enhanced and Original Filter. The filter can be toggled by tapping the text labeled Enhanced Filter or Original Filter .  Invert the ECG recording. In the event that the Heart Monitor was oriented improperly while the ECG rhythms were recorded, it may appear inverted. To correct the orientation, tap on the center of the review screen, and then tap Invert .

  • Page 9: Email, Print Or Delete Recordings

    9. EMAIL, PRINT OR DELETE RECORDINGS NOTE: If you are not enrolled in Alivecor’s ECG Analysis service, you will not be able to view the recording. AliveCor will unlock this feature if you are under the guidance of a physician.

  • Page 10: View Previously Recorded Ecg Recordings On Your Mobile Device

    10. VIEW PREVIOUSLY RECORDED ECG RECORDINGS ON YOUR MOBILE DEVICE NOTE: If you are not enrolled in Alivecor’s ECG Analysis service, you will not be able to view the recording. AliveCor will unlock this feature if you are under the guidance of a physician.

  • Page 11: Af Detector

    3. Tap Analysis in the lower left. 13. AF DETECTOR NOTE: If you are not enrolled in Alivecor’s ECG Analysis service, you will not be able to view the recording. AliveCor will unlock this feature if you are under the guidance of a physician AF Detector is an algorithm in the AliveECG app that detects atrial fibrillation in an ECG tracing.

  • Page 12: Medications

     Symptoms and activities selected, including those where AF was detected  Medications that were selected 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.

  • Page 13: Accessing Help

    16. ACCESSING HELP Learn more about using your AliveCor Heart Monitor by tapping More in the lower right. Tap HELP to see all the options available.  Tutorials. Review these tutorials to learn about to navigate all the features of the app...

  • Page 14: Electronic Health Record (Ehr) Integration

    5. Click Send Email 20. 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 ECG recordings to your EHR. You can see the option if you tap the bottom left corner of the review screen and choosing this option.
  • Page 15 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. AliveCor, Inc. For support, please email support@alivecor.com or visit www.alivecor.com...
  • Page 16 Invert the ECG recording under Recording Adjustments . I forgot my password To reset your password, go to www.alivecor.com and click on "SIGN IN" in the and I’m unable to upper right corner and click on the "Forgot your password?" link below the reset it.

  • Page 17: Alivecor Heart Monitor Specifications

    Storage Temperature ................-20 to +60 degrees C Storage Humidity ..............10% to 95% (non-condensing) User Interface Two stainless-steel electrodes are exposed on the back of the Heart Monitor. These electrodes make contact with the user’s skin. AliveCor, Inc. For support, please email support@alivecor.com or visit www.alivecor.com...

  • Page 18: International Availability

    The AliveCor Heart Monitor is available for use by medical professionals and by individuals under the care and supervision of a physician in the USA. The Heart Monitor is available for use by any individual in launched countries within the European Union. The AliveCor Heart Monitor is a non- notified medical device and approved for use in India.

  • Page 19: Electrical Safety

    Guidance and manufacturer's declaration - electromagnetic emissions The AliveCor Heart Monitor is intended for use in the electromagnetic environment specified below. The customer or the user of the AliveCor Heart Monitor should assure that it is used in such an environment.
  • Page 20 Guidance and manufacturer’s declaration—electromagnetic immunity The AliveCor Heart Monitor is intended for use in the electromagnetic environment specified below. The customer or the user of the AliveCor Heart Monitor should assure that it is used in such an environment. Electromagnetic environment -...
  • Page 21 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the AliveCor Heart Monitor is used exceeds the applicable RF compliance level above, the AliveCor Heart Monitor should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the AliveCor Heart Monitor.
  • Page 22 RF communications equipment and the AliveCor Heart Monitor The AliveCor Heart Monitor is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the AliveCor Heart Monitor can help prevent electromagnetic interference by...

  • Page 23: Symbols Used System Or Package Labeling

    WEEE – Properly Dispose of Electronic Waste Consult Instructions for Use / User Manual Manufacturer Temperature Limits (Operational) Relative Humidity Limits (Operational) Model Number Serial Number Direct Current Power Source AliveCor, Inc. For support, please email support@alivecor.com or visit www.alivecor.com...

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