The AliveCor iPhone ECG Monitor - Your questions answered

PictureA 12 lead ECG as recorded in a hospital or clinic
What is an ECG? An ECG or electrocardiogram is a recording of the electrical activity of the heart. There are different types of ECG, some recorded by putting electrodes on the arms and legs (limb leads) and some by putting additional leads on the chest (12 lead ECG).  In a hospital or surgery usually a 12-lead ECG will be recorded. This gives the most detailed information about the heart and is used to diagnose problems with the heart rhythm, the conduction system or to detect problems with the blood supply of the heart. However it is also possible to record the ECG using a single lead. This type of recording is mainly for detection of abnormal heart rhythms.   Since most symptoms of palpitations occur at random it is unusual for the patient to be having an ECG when the symptom comes on. Although it is possible to fit a monitor for up to a week sometimes symptoms occur less frequent and therefore nothing is detected during the monitoring period.  This can be frustrating for the doctor and the patient both of who are trying to get to the bottom of the symptoms.
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What does an ECG show? The ECG allows a clinician to assess the cardiac rhythm. There are a number of waves on the ECG called PQRS and T. The P wave is a small upwards deflection at the beginning of the trace. It is followed by a large spike called the QRS complex and finally the T wave. For the purposes of rhythm analysis the detection of a P wave is critical to assessing whether the rhythm is in normal rhythm.
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What is the AliveCor monitor? The AliveCor monitor is an attachment for the iPhone (and some smartphones) which turns the phone into an ECG recorder. Until now ECG recorders were limited to hospitals or clinics because of their cost. This new disruptive technology is cheaper but very accurate. Also because people carry their phone with them most of the time it means they are very likely to able to record an ECG if symptoms occur. The attachment is very light at just 37g and is designed to be left on the phone all the time. The ECG strip below shows a typical recording from the AliveCor Monitor.
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How does the AliveCor monitor work? The device incorporates electrodes into an iPhone case and uses ultrasound to transmit the ECG recording to the phone and display the results using an App. The ECG is obtained by simply holding the iPhone and placing at least 1 finger from each hand on the electrodes embedded into the back of the phone case. Within just a few seconds the ECG appears on the screen in real time and after this it is automatically uploaded wirelessly for remote interpretation.
Is the AliveCor monitor accurate? Studies have shown that the monitor is very accurate and shown equivalency to other single lead ECG machines. In a recently published study the AliveCor monitor was used in 109 patients (70 in normal rhythm and 39 in an abnormal rhythm called atrial fibrillation). The participants had a 12-lead ECG and an iPhone ECG which was uploaded to the server and reported by 2 cardiologists or a computer. The cardiologists did not know the results of the 12 lead ECGs. The results showed a high level of accuracy and agreement between the 12 lead ECG and the iPhone ECG.  In another study 12-lead ECGs and lead I ECGs (AliveCor) were recorded in 67 patients.  In 62 patients, two physicians found the QRS morphology to be the same between the two devices, though the iPhone-based ECG had more baseline noise than the standard ECG.
How do I get a AliveCor monitor? The monitor is available through Amazon and costs £169. There are no ongoing costs apart from occasional replacement of the battery.
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How do I set up the monitor? When the monitor arrives simply take your iPhone out of its current case and put the new case on. Download the AliveECG App from the AppStore and follow the on-screen instructions. You need to register for an AliveCor account using your name and an email address. After this you can record your own ECG.

How do I record an ECG?  By holding the phone as shown below between your right and left hands with the function button on the right a recording of ECG is obtained. Make sure at least 1 finger from each hand is on the electrodes. This recording is called lead I (left-hand picture).  Sometimes analysis of the ECG is easier to read when lead II is recorded. This which can be done by placing the left hand electrode on the left knee and holding the right hand electrode with your right hand (right picture). This makes the P wave on the ECG much easier to see and therefore much easier to interpret.
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Lead I recorded using fingers of the left and right hands on the electrodes
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Lead II recorded with the device on the left knee and held with the right hand. Notice the larger and more distinct P wave in this trace compared to the one on the left
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What is the difference between lead I and lead II? The ECG trace looks different depending on the position of the recording electrodes. Imagine the heart is in the middle of an inverted triangle. Lead I goes from Left arm to Right Arm. Lead II from Left leg to Right arm and Lead III from Left leg to Left Arm. The ECG trace looks slightly different in each of these views but typically the P wave which indicates the top part of the heart called the atria shows up best in lead II. 

When should I use the monitor? The monitor can be used as often as you wish. You may choose to record a 30 second or 1 minute ECG once or twice a day even if you feel well. Alternatively if you have a symptom such as palpitations, shortness of breath or dizziness you may wish to use the machine at that time.
What happens to the ECG when it is recorded? The ECG is immediately stored on your phone and uploaded to your AliveCor account which you can view over the internet.  Alternatively you can print out the ECG or email it to your doctor.
Can my doctor see the ECG? Yes, if your doctor knows that you have a monitor they can invite you to let them have access to your recordings. When you record an ECG then immediately your doctor will be able to see the results. This doesn’t mean that they will automatically look at every result immediately it is recorded but they have the option to view them.
Can I print out my ECG? Yes it is possible to save the ECG recording as a PDF file and email it to your cardiologist or take it to your doctor.
Can I get my ECG analysed by someone other than my own doctor? Yes the company which makes the device has an analysis service and they will analyse and send you a report within 24h. Each time you use this service there is a charge to your credit card.
What should I do if I feel very unwell when I record the ECG? If you feel unwell then you should seek medical advice urgently as you would normally do.
Can I use the device if I have a pacemaker or a defibrillator? Pacemaker spikes have short pulse widths and are difficult to detect with ambulatory ECG machines. The AliveCor monitor does not meet some of the general requirements for detecting pacing spikes and therefore is not recommended for the detection of pacemaker activity. The device will sometimes detect and record pacing spikes but this is not guaranteed. Therefore the manufacturers do not recommend using the monitor on patients with a cardiac pacemaker. If the monitor is used on the chest to assess cardiac rhythm it is advisable that it be switched to Airplane mode so no radio frequency interference is generated.
Will my insurance cover the Heart Monitor? No the AliveCor Heart Monitor is not currently covered by insurance
 Can I get an AliveCor Monitor without a prescription? The AliveCor Heart Monitor is available without a prescription.
Can I use the AliveCor Monitor on multiple family members? Yes, after you record an ECG you can indicate if it is your own ECG, or a family member's, within the App. All ECGs can be annotated, and names can be edited.
Can I use the monitor when I travel abroad? Yes, it can be used to record your ECGs anywhere as long as there is cellular or Wi-Fi coverage to sync automatically with the AliveCor server, email, or print directly from the AliveECG app. If you don’t 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.
Is the AliveCor Heart Monitor suitable for children?  The monitor is FDA cleared for individual use of those weighing more than 10kg
Do I have to use a smartphone? The Heart Monitor does require an iOS or Android mobile device, such as iPhone 5/5S, Samsung S3 or S4, or iPod touch. It must have the capability to download the App.
How do I attach the Heart Monitor with Universal Attachment plate? This is for non-iPhone devices. The Universal Attachment Plate sticks directly to the mobile device or mobile device case of your choice using single-use, double-sided adhesive.  While the monitor can be removed from the Universal Attachment Plate between uses, the Universal Attachment Plate itself is meant to stay adhered to the mobile device or mobile device case. To remove the monitor from the plate, place your thumbs on the electrodes, press down firmly and clockwise about 45 degrees to "unlock". Once it's "unlocked" the monitor can then be lifted out of the attachment plate very easily.
What do I do if the monitor won’t record, or if the battery is dead? If you are using iOS 7? Then you need to allow the app to access the iPhone microphone by Tap on iPhone "Settings", Tap on "Privacy", Tap on "Microphone", Ensure that "AliveECG" is turned on (the background of the slider is green). If that doesn't resolve the issue, replace the battery. Using a 1.6mm Phillips screwdriver, press down firmly and turn counterclockwise to remove the screw in the battery door. Remove the used battery and replace it with a new 3V coin cell battery matched to your model. The battery is available at most general stores. Orient the battery with the positive terminal up, so that you can see the writing. Remove the protective sticker from the battery, as applicable.
What battery does the monitor need? CR2016 for Heart Monitor case for iPhone 4/4s, CR2025 for Heart Monitor case for iPhone 5/5s, CR2032 for Heart Monitor with Universal Attachment Plate and Heart Monitor case for iPhone 5/5s
What if I don’t have phone service or Wi-Fi? The monitor does not require a Wi-Fi or mobile connection to record an ECG and save it to the mobile device, however it requires 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.
What web browsers does AliveCor support? Chrome, Safari (Version 5.1 and up), Firefox (Version 5 and up), Internet Explorer 10/9. Mobile: Safari Mobile, Android, Known Issues On Unsupported Browsers: IE7 - View PDF does not work, IE8 – Doctor Dashboard does not work. Will potentially crash IE8.
Is the monitor approved by regulatory authorities? The device has regulatory CE mark approval in Europe and has FDA 510(k) clearance