Omron | AC-009-I5-A | User manual | Omron AC-009-I5-A 3rd Generation AliveCor Mobile Heart Monitor (ECG) User Manual

Omron AC-009-I5-A 3rd Generation AliveCor Mobile Heart Monitor (ECG) User Manual
AliveCor® Heart Monitor
User Manual for iOS
NOTE: For the current information on your product please visit http://www.alivecor.com/usermanual
© 2011-2014 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 H | AUG 2014
AliveCor, Inc.
For support, please email support@alivecor.com or visit www.alivecor.com
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Contents
1. PRODUCT DESCRIPTION ............................................................................................................ 3
2. GENERAL SAFETY PRECAUTIONS .............................................................................................. 3
3. STORAGE, HANDLING AND MAINTENANCE.............................................................................. 4
4. WARNINGS ................................................................................................................................ 4
5. SET UP THE HEART MONITOR AND TAKE THE FIRST ECG RECORDING .................................... 5
6. RECORD ECG RHYTHMS USING THE HEART MONITOR ............................................................ 6
7. ONCE THE RECORDING IS FINISHED.......................................................................................... 7
8. SETTINGS AND ADJUSTMENTS.................................................................................................. 8
9. EMAIL, PRINT OR DELETE RECORDINGS ................................................................................... 8
10. VIEW PREVIOUSLY RECORDED ECG RECORDINGS ON YOUR MOBILE DEVICE ......................... 9
11. VIEW AN ECG RECORDING ON THE ALIVECOR SERVER ............................................................ 9
12. ECG ANALYSIS ......................................................................................................................... 10
13. AF DETECTOR .......................................................................................................................... 10
14. GRAPHING TOOL ..................................................................................................................... 11
15. ACCESSING HELP ..................................................................................................................... 12
16. EDITING USER PROFILE ........................................................................................................... 13
17. ACCESSING EDUCATION .......................................................................................................... 13
18. ACCESSING HEART STATS........................................................................................................ 13
19. PROVIDER DASHBOARD .......................................................................................................... 13
20. ELECTRONIC HEALTH RECORD (EHR) INTEGRATION............................................................... 13
21. TROUBLESHOOTING ................................................................................................................ 14
22. ALIVECOR HEART MONITOR SPECIFICATIONS ........................................................................ 16
23. INTERNATIONAL AVAILABILITY ............................................................................................... 17
24. ALIVECOR CONTACT INFORMATION ....................................................................................... 17
25. EUROPEAN AUTHORIZED REPRESENTATIVE ........................................................................... 17
26. ELECTRICAL SAFETY ................................................................................................................. 18
27. SYMBOLS USED SYSTEM OR PACKAGE LABELING................................................................... 22
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1. PRODUCT DESCRIPTION
The AliveCor® Heart Monitor (Heart Monitor) is a mobile, clinical-quality electrocardiogram (ECG)
recorder. The duration of the recording is customizable from 30 seconds to continuous. The
software application can store thousands of recordings on your mobile device and these recordings
are also accessible to authorized users on AliveCor, Inc. (AliveCor) servers (www.alivecor.com). The
device consists of three components:
1. The Heart Monitor, which attaches to your compatible mobile device and has electrodes to
transmit ECG rhythms to the mobile device.
2. The AliveECG mobile application (AliveECG app) is used to collect, view, save, and wirelessly
transmit recordings to the AliveCor server.
3. A user-supplied compatible mobile device.
CAUTION: The AliveCor Heart Monitor has features that are only available to those users who are
under the care of a physician. These features are available to prescription users only.
The Heart Monitor enables users to:
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Collect and store single-channel ECG recordings using the mobile device.
Edit user information data associated with the recording.
Wirelessly transmit ECG recordings to the AliveCor server.
Access ECG recordings stored on the AliveCor server.
Print or save the recording in PDF format.
Request professional clinical interpretation and analysis of your ECG recordings.
After a user has created an account on the AliveECG app and received an ECG analysis, the Heart
Monitor enables a user to:
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View ECG recordings real-time and after the recording.
View the output of the atrial fibrillation detection algorithm.
1.1. Indications for Use
The AliveCor Heart Monitor is intended to record, store and transfer single-channel
electrocardiogram (ECG) rhythms. The AliveCor Heart Monitor also displays ECG rhythms and
detects the presence of atrial fibrillation (when prescribed or used under the care of a
physician). The AliveCor Heart Monitor is intended for use by healthcare professionals,
patients with known or suspected heart conditions and health conscious individuals.
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
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AliveCor, Inc.
The device should not be used near water, or in a wet environment.
Do not use this unit 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 unit with an autoclave or glass sterilizer.
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Audio and video products and similar equipment may cause interference. Please stay away
from such equipment when you are recording.
Do not take recordings in a location where the unit will be exposed to strong
electromagnetic forces, such as near an arc welder, high-power radio transmitter, etc.
Signal quality may degrade by detecting signals from other ultrasonic acoustic sources. Do
not use the device in close vicinity to other equipment emitting ultrasonic acoustics such as
espresso machines, some ventilation systems or another AliveCor Heart Monitor.
The mobile device power adapter may degrade signal detection. Do not use the monitor
while charging the mobile device.
Disperse any static electricity from your body before using the unit.
Do not take recordings in a moving vehicle.
Do not expose the unit to strong shocks or vibrations.
Do not disassemble, repair, or modify the unit.
Do not insert battery with polarity reversed.
Do not use batteries of a type other than that specified for use with the device.
Do not take a recording if the electrodes are dirty. Clean them first.
Do not use for any purpose other than obtaining an electrocardiogram.
If the portion of the body where the electrode is applied has too much body fat, body hair
or very dry skin, a successful recording may not be possible.
Some children and adults with very sensitive auditory ability may hear a high-pitched hum
or buzz emitting from the device when activated. This is due to normal device function.
3. STORAGE, HANDLING AND MAINTENANCE
Do not store the unit in:
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Locations exposed to direct sunlight,
Locations subject to high temperatures and high humidity,
Wet or damp locations where water may get on the unit,
Dusty locations,
Near fires or open flames,
Locations exposed to strong vibration, or
Locations exposed to strong electromagnetic fields.
No maintenance of this system is required, except:
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The battery should be replaced when necessary.
The electrodes should be cleaned using an alcohol-based sanitizer before each use.
To prevent potential cross-infection of diseases between users, clean the device using
alcohol prior to each use.
4. WARNINGS
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AliveCor, Inc.
This device is not designed or intended for complete diagnosis of cardiac conditions. This
device should never be used as a basis for starting or modifying treatment without
independent confirmation by medical examination.
This device records heart rate and heart rhythm only.
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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.
Interpretations made by this device are potential findings, not a complete diagnosis of
cardiac conditions. All interpretations should be reviewed by a medical professional.
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.
Do not attempt ECG data acquisition while there is an external microphone plugged in to
the mobile device.
ECG reports viewed or printed at any magnification other than 100% may appear distorted
and could lead to misdiagnosis.
The heart rate is based on the heart rhythm; therefore the rate is only valid if there is a valid
rhythm (QRS complex visible).
5. SET UP THE HEART MONITOR AND TAKE THE FIRST ECG RECORDING
5.1. Decide which mobile device to use
Your Heart Monitor is compatible with all of the devices listed on AliveCor’s website:
http://www.alivecor.com/compatibility. These devices include:
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iPhone 4/4S, 5/5S, 5C
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iPad Air, iPad Mini
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iPod Touch 5G
The AliveECG App is compatible with iOS versions 5.1 - 7.1
5.2. Unpack the Heart Monitor
1. Remove the Heart Monitor from the box.
2. Choose Heart Monitor placement.
a) For Heart Monitor cases, place the monitor on your phone as your would any standard
phone case.
b) The Heart Monitor with Universal Attachment Plate can be attached to the mobile device
directly or to the case of your choosing (the surface should be smooth and flat).
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c) For use with an iPad, AliveCor does not recommend attaching the Heart Monitor to your
device. Instead, rest the monitor in both hands or place it on a flat surface less than one
foot away from the iPad to record ECGs.
Caution: The Heart Monitor must be less than 1 foot from the mobile device to ensure
communication between devices.
5.3. Download the AliveECG App
1. Using your mobile device, access the appropriate mobile application store.
2. Search for “AliveECG”
3. Download and install the AliveECG app.
5.4. Set up an AliveCor Account
You will use your AliveCor account to access, print and save your ECG recordings stored on the
AliveECG app and the AliveCor server. Follow the instructions presented when you open the
AliveECG 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 ECG for analysis.
ECG analysis can be used any time you want a medical professional to interpret your ECG
recording and is required if you would like to view your recordings or utilize AliveCor’s
interpretive algorithms.
6. RECORD ECG RHYTHMS USING THE HEART MONITOR
Before taking each recording:
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Disconnect headphones, charger cables, or any other connected devices.
Clean the two electrodes with alcohol-based sanitizer.
Using your mobile device, launch the AliveECG app.
Rest the monitor on your fingers; your right hand should contact the electrode closest to the
bottom of the mobile device, and your left hand should contact the electrode closest to the top of
the mobile device. This is a Lead I ECG.
You may also choose from two other placements:
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For a Lead II ECG, the left knee should contact the electrode closer to the top of the mobile
device and the right hand should contact the electrode closer to the bottom of the mobile
device.
For an Anterior Precordial Lead, the device can be placed on the lower left side of the chest,
just below the pectoral muscle. The bottom of the mobile device should be pointing
towards the center of the body.
NOTE: You will not be able to view your recordings or utilize any of AliveCor’s interpretive
algorithms until you are under the care of a physician. To gain access to these features, you
must create an account on the AliveECG app. Your first recording will then be automatically
sent for a free analysis by a cardiologist. Once you have received the ECG analysis, you will have
access to view that recording and subsequent recordings.
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After your display is unlocked, you may swipe your finger across the screen to scroll through
each ECG recording. Additionally you can add notes about the recording:
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Tap the “Annotate” icon in the upper right corner to add notes:
- Medical Professional – Add patient details such as Patient ID, Name, etc.
- Individual User – Add symptoms and activities
Tap “Save” to return to the review screen. This information will automatically synchronize
with the AliveCor server.
NOTES:
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The monitor does not require a Wi-Fi or mobile connection to record an ECG and save it to
the mobile device, however it does require one of these to: sync automatically with the
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.
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The monitor can be used up to a distance of 30 cm (1 ft.) from the mobile device. Using the
monitor at a distance greater than 30 cm (1 ft.) may lead to communication issues between
the devices and your recording may not be successful.
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In order to reduce muscle noise, rest your arms on a flat surface to increase stability while
you are recording.
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You must maintain contact with the electrodes for at least 10 seconds for the recording to
be saved. If you remove contact after 10 seconds, but before the selected recording
duration is complete, the ECG will be saved and you will be able to review it.
7. ONCE THE RECORDING IS FINISHED
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AliveCor, Inc.
Immediately after recording, you may select symptoms and activities on the next screen.
You can also enter personalized symptoms and activities, or comments and notes. After
making your choices tap “Save” to move on to the ECG History screen.
If this is a guest recording, immediately after recording, scroll down to the bottom of the
symptoms and activities screen and tap “Not [Your Name]?" You can then enter the guest’s
name and email them more information about AliveCor.
When you are finished recording an ECG and enter symptoms and activities, you can review
the ECG through ECG History or go to Insights and view the trending of your ECGs, heart
rate, symptoms and activities, and medications.
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8. SETTINGS AND ADJUSTMENTS
8.1. Recording Adjustments
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Paper Speed and Gain (or Zoom). Changes to the paper speed and gain can be performed
by medical professionals only. These changes are made while viewing in landscape
orientation by tapping the text in the lower left portion of the review screen and selecting
the preferred setting. The scaling will adjust on the screen automatically. Also, these
changes can be made prior to the recording. Alternately, you can pinch and zoom when
viewing the recording as a PDF (tap the box with the arrow in the lower left corner and tap
“PDF”.
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”.
8.2. Adjustable Settings
To access the Settings screen in the AliveECG app, tap on the “More” icon at the lower right and
then tap on “Settings”.
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Duration. Recording Duration is the maximum length of time the AliveECG app will record a
single ECG recording. For example, if the recording duration is set to 30 seconds, the
AliveECG app will automatically stop recording after 30 seconds of data has been collected.
Mains Filter. The Mains Filter removes any mains interference from the ECG; 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.
Reminders. Reminders allow the ECG analysis reminder to be turned on or off. It also allows
you to turn on or off the ECG reminder, set the frequency, and time for the reminder. You
can also turn the AF Detector on or off, and modify your medication reminders.
Mode. Tap to modify device transmission settings. Normal mode is recommended for most
users. If your facility or location limits wireless communication, the Airplane/ICU setting
may be selected.
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.
You may email/print recordings from either the AliveECG app or your account on the server
(www.alivecor.com).
To email a recording from the AliveECG app, you must have an email account set up on your mobile
device. If you need assistance setting up an email account or troubleshooting your email account,
please contact your mobile device provider for assistance.
1. After selecting the desired ECG recording from ECG History, tap the square with the arrow
in the upper right.
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2. Tap Email. The PDF version of the ECG recording will then be attached to a new email in
whatever email account you have set up on your mobile device.
To email a recording from the server:
1. Go to www.alivecor.com.
2. Click on “SIGN IN” in the upper right corner and enter your email address and password.
3. Select the desired recording by clicking on the appropriate “VIEW ECG” button on the right.
4. Email from your computer as you would any PDF.
To print a recording from the AliveECG app, you must have an AirPrint compatible printer set up on
your mobile device. If you need assistance setting up an AirPrint compatible printer or
troubleshooting your AirPrint compatible printer, please contact your mobile device provider for
assistance.
1. After selecting the desired ECG recording from ECG History, tap the square with the arrow
in the upper right.
2. Tap Print.
To print a recording from the server:
1. Go to www.alivecor.com.
2. Click on “SIGN IN” in the upper right corner and enter your email address and password.
3. Select the desired recording by clicking on the appropriate “VIEW ECG” button on the right.
4. Print from your computer as you would any PDF.
To delete a recording:
1. Go to ECG History.
2. Tap “Edit” in the upper right, or swipe a recording from right to left and select “Delete”.
Deleting a recording from the AliveECG app also deletes it from the server. Deleted recordings
cannot be retrieved.
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.
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Launch the AliveECG app.
Tap History in the menu at the bottom to see a list of all ECG recordings on your mobile
device (excluding any previously deleted).
Tap the ECG recording you wish to view.
11. VIEW AN ECG RECORDING ON THE ALIVECOR SERVER
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.
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On your web browser, go to www.alivecor.com and click on “SIGN IN”.
Enter your email address and the password you created when you set up your AliveCor
account. Click “Sign In”.
The ECG recordings you collected were automatically synced to the AliveCor server and will
appear in list form, and each transmission is stored as an Adobe Acrobat PDF file and can
also be viewed in HTML. Click on the “VIEW ECG” button.
Click the back button in your browser to return to your AliveCor account homepage.
12. ECG ANALYSIS
The AliveECG app includes the ability to request professional clinical interpretation and analysis of
your ECG 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.
To have a recording analyzed:
1. Tap the "ECG ANALYSIS" button that appears in the lower left of a new recording or when
you view recordings from your history.
2. Select the type of service desired.
3. If you haven’t already entered your name, date of birth and gender, you will be prompted
to enter these details.
4. Tap "Add new card".
5. Enter credit card information.
6. Tap "Submit New Card".
7. Confirm and tap "PURCHASE" to proceed.
You will receive a notification once your analysis has been returned.
NOTE: The ECG analysis option is only visible if the analysis service is available in your country.
To view an ECG analysis that has been returned:
1. Tap “History”.
2. Tap the desired report
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.
After you take an ECG, if atrial fibrillation is detected you will be notified within the app. This
finding is not a diagnosis, it is only a potential finding. You should contact your physician to review
any ECG recording in which atrial fibrillation was detected, or send it to ECG Analysis. If you are
experiencing any symptoms or concerns please contact a medical professional.
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The AF Detector algorithm monitors 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.
The AF Detector only monitors for AF while you are taking a recording. It does not continuously
monitor your heart and therefore cannot alert you if AF happens at any other time.
13.1. 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.
13.2. AF recordings in ECG review screen and History List
All tracings analyzed as positive for AF will have “AF” tagged for future review. These tags will
be visible on the ECG History List as well as on the ECG review screen.
13.3. Activation of the AF Detector
The AF Detector can be turned on or off in the settings of the AliveECG App.
14. MEDICATIONS
You can track your medications with the AliveECG app.
1. To access and edit the medications:
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o Tap “Insights” in the Menu at the bottom of the screen. Scroll to the bottom of the
Insights screen and tap “Log Medications”. You can edit your medications or select
those taken that day.
o Alternatively, tap on the medication push notification that is sent to you by default
at 9:00am every day. You can then edit your medications or select those taken that
day.
o You can also edit your medications by accessing your Profile. Tap “More”, “Profile”,
“Medications”.
o You can view medications selected on the Insights screen.
o You can select a medication more than once per day by tapping “Medications
Logged” at the bottom of the Insights screen, and tapping the specific medication
again. The number to the right of the medication will update.
15. INSIGHTS
Your data will be graphed in the Insights section of the AliveECG App. To access it, tap the “Insights”
icon in the menu at the bottom of the screen. The following items are graphed in Insights over a 7day period, and over a 14-day period when the AliveECG app is turned to landscape view.
 Number of ECGs recorded, including the number of AF recordings
 Heart rate (bpm) in each ECG recording, including those where AF was detected
 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.
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
o Quick Tutorial
o Recording an ECG
o AF Detection
o Sending for ECG analysis
o Retrieving ECG analysis
o Alternate positions
 Other Documentation. Learn about ECG analysis; access the user manual, feedback and
privacy and terms.
o What is ECG analysis
o User Manual
o Feedback
o Privacy and terms
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17. EDITING USER PROFILE
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Launch the AliveECG app.
Tap “More” in the lower right.
Tap “Profile”.
All user details can be edited by tapping “Edit” in the upper right.
18. ACCESSING EDUCATION
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Launch the AliveECG app.
Tap “More” in the lower right.
Tap “Education”. Users have the ability to learn about:
o Cardiac Anatomy
o What is an ECG
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 ECG. This information is not
intended to replace medical advice, please seek professional medical assistance if you are
suffering from any medical problem.
19. PROVIDER DASHBOARD
The Provider Dashboard allows medical professionals the ability to view their patients’ recordings
automatically from their own account. To create a medical professional account, download the
AliveECG app and follow the prompts to create a new account.
In order to view a patient’s future recordings, you must send them an invite via email. To send an
email invite:
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Go to www.alivecor.com
Click on “SIGN IN” in the upper right corner and enter your email address and password
Click on “Invite a Patient”
Type in the patient’s email address (this must be the email address they use for their
AliveCor account)
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.
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21. TROUBLESHOOTING
Problem
Solution
My monitor is not
working.
If you’re taking your first recording, please ensure that your Apple iPhone
“Portrait Orientation Lock” is not on as you must be able to turn your phone
to landscape orientation in order to take a recording.
If you’re using iOS 7 or greater, ensure that the AliveECG app has access to
the iPhone microphone:
1. Tap on iPhone “Settings”
2. Tap on “Privacy”
3. Tap on “Microphone”
4. Ensure that “AliveECG” is turned on (the background of the slider is green)
Change the battery:
1. Use a 1.6mm Phillips screwdriver, press down firmly and turn
counterclockwise to remove the screw in the battery door.
2. Remove the used battery and replace it with a new 3V coin cell battery
matched to your model.
3. 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
14
Problem
Solution
I have a lot of artifact,
noise or interference
in my recording.
Try the following tips for acquiring the best quality ECG recording:
• Ensure that the “Enhanced Filter” is on.
• Clean the electrodes on the monitor with alcohol-based sanitizer.
• If hands are very dry, use a water-based lotion before recording.
• When recording from the hands, relax the arms and hands to reduce
muscle noise. Rest the forearms and hands on a flat surface and let the
heart monitor rest on the hands. Do not squeeze the monitor.
• Ensure that your mobile device is not charging/syncing and you are not
using headphones with your mobile device during the recording.
• Make sure that both the mobile device and the user remain still during ECG
recordings. Movement during recordings will cause noise in the tracing.
• Make sure Mains Filter is set appropriately for your geographical location.
This can be adjusted under the AliveECG app Settings.
• Try recording from the chest, right under the pectoral muscle in the mid
line.
The ECG rhythms
appear upside down.
In the future, ensure that the left hand contacts the electrode closer to the
top of the mobile device, and the right hand contacts the electrode closer to
the bottom of the mobile device. To invert a recording on your mobile
device, see “Invert the ECG recording” under “Recording Adjustments”.
I forgot my password
and I’m unable to
reset it.
To reset your password, go to www.alivecor.com and click on "SIGN IN" in the
upper right 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. Please note the reset link contained
in the email is only active for a short while.
AliveCor, Inc.
For support, please email support@alivecor.com or visit www.alivecor.com
15
22. ALIVECOR HEART MONITOR SPECIFICATIONS
Performance Characteristics
ECG 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 ......................................................................................................... 3V Coin Cell
Battery life ................................... min. 100 Hours Operational Time, 12 months typical use
Physical Characteristics
AC-001 (for iPhone 4/4s) ................................. 40 grams ......................... 118 x 62 x 15 mm
AC-003 (for iPhone 5/5s) ................................. 41 grams ......................... 128 x 62 x 15 mm
AC-004 & AC-007-I5-A (for iPhone 5/5s)……….. 33 grams…………………………126 x 62 x 11 mm
AC-004 & AC-007-UA-A (w/Attachment Plate). 28 grams ............................. 89 x 48 x 9 mm
Environmental Specifications
Operational Temperature ..................................................................... +10 to +45 degrees C
Operational Humidity ............................................................. 10% to 95% (non-condensing)
Operational Altitude ........................................... based on your mobile device specification
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
16
23. 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 nonnotified medical device and approved for use in India.
24. ALIVECOR CONTACT INFORMATION
AliveCor, Inc.
30 Maiden Lane, 6th Floor
San Francisco, CA 94108
United States
www.alivecor.com
25. EUROPEAN AUTHORIZED REPRESENTATIVE
Oregon Scientific Italia S.p.A
Centro Direzionale Colleoni Viale Colleoni 3, Palazzo Taurus 2,
20041 Agrate Brianza (MI), Italy
AliveCor, Inc.
For support, please email support@alivecor.com or visit www.alivecor.com
17
26. 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.
Emissions test
RF emissions
CISPR 11
Group 1
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations /
flicker emissions
IEC 61000-3-3
AliveCor, Inc.
Compliance
Electromagnetic environment - guidance
The AliveCor Heart Monitor 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.
Class B
N/A
N/A
The AliveCor Heart Monitor 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.
For support, please email support@alivecor.com or visit www.alivecor.com
18
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.
Immunity test
IEC 60601 test level
Electrostatic
Discharge (ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV for power
supply lines
±1 kV for
input/output lines
Surge
IEC 61000-4-5
Voltage dips, short
interruptions, and
voltage variations on
power supply input
lines
IEC 61000-4-11
±6 kV contact
±8 kV air
±2 kV for power
supply lines
±1 kV for
input/output lines
±1 kV differential
±1 kV differential
mode
mode
±2 kV common
±2 kV common mode
mode
<5 % UT
<5 % UT
(>95 % dip in UT)
(>95 % dip in UT)
for 0.5 cycle
for 0.5 cycle
40 % UT
40 % UT
(60 % dip in UT)
(60 % dip in UT)
for 5 cycles
for 5 cycles
70 % UT
70 % UT
(30 % dip in UT)
(30 % dip in UT)
for 25 cycles
for 25 cycles
<5 % UT
(>95 % dip in UT)
for 5 sec
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
Compliance level
3 A/m
<5 % UT
(>95 % dip in UT)
for 5 sec
3 A/m
Electromagnetic environment guidance
Floors should be wood,
concrete, or ceramic tile. If
floors are covered with
synthetic material, the relative
humidity should be at least
30%.
Mains power quality should be
that of a typical commercial or
hospital environment.
Mains power quality should be
that of a typical commercial or
hospital environment.
Mains power quality should be
that of a typical commercial or
hospital environment. If the
user of the AliveCor Heart
Monitor requires continued
operation during power mains
interruptions, it is
recommended that the
AliveCor Heart Monitor be
powered from an
uninterruptible power supply
or a battery.
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical commercial
or hospital environment.
NOTE— UT is the a.c. mains voltage prior to application of the test level.
AliveCor, Inc.
For support, please email support@alivecor.com or visit www.alivecor.com
19
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.
Immunity test
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
IEC 60601 test
level
3 Vrms
150 kHz to 80
MHz
3 V/m
80 MHz to 2.5
GHz
Compliance
level
3V
3 V/m
Electromagnetic environment - guidance
Portable and mobile RF communications equipment
should be used no closer to any part of the AliveCor
Heart Monitor, including cables, than the
recommended separation distance calculated from
the equation applicable to the frequency of the
transmitter.
Recommended separation distance
3.5
d [ ] P
V1
3.5
d  [ ] P 80 MHz to 800 MHz
E1
7
d  [ ] P 800 MHz to 2.5 GHz
E1
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 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.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
AliveCor, Inc.
For support, please email support@alivecor.com or visit www.alivecor.com
20
Recommended separation distances between
portable and mobile 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
maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the
AliveCor Heart Monitor 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
80 MHz to 2.5 GHz
3.5
3.5
7
d [ ] P
d [ ] P
d [ ] P
E1
E1
V1
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.
AliveCor, Inc.
For support, please email support@alivecor.com or visit www.alivecor.com
21
27. SYMBOLS USED SYSTEM OR PACKAGE LABELING
Type CF Applied Part
European Conformity Mark
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
22
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