ECG APP
SAFETY AND PERFORMANCE
•The ability of the ECG application to accurately detect AFib and sinus rhythm in ECG recordings has been validated in a clinical study involving approximately 590 subjects. ECG application heart rate classification is compared to single-lead multi-channel ECG heart rate classification performed by a board-certified cardiologist. Among the classifiable records, the ECG application was able to correctly identify AFib 99.5% of the time and sinus rhythm (SR) 100% of the time.
•In the study, the ECG app determined 11.5 percent of records were inconclusive, including those deemed too poor quality to analyze. When these inconclusive records were included, the ECG application returned AFib results 86.5% of the time for AFib subjects and SR results 91.1% of the time for sinus rhythm subjects. Real-world performance can have higher uncertainty and poorer recorded results.
•The accuracy of the ECG application PDF report was assessed by comparing it with a standard lead I ECG recorded at the same time. Key features of the ECG waveform, such as PR and RR intervals, QRS duration, position and amplitude, and the presence and amplitude of P waves, were compared and found to be statistically equivalent within an acceptable margin of error. A comparison of simultaneous single-lead multichannel electrocardiograms and board-certified cardiologist heart rate classifications recorded by the ECG application had 96% agreement. No adverse events were observed during the clinical study.
RECORDING AN ECG ON YOUR FITAOS WATCH
Follow these instructions to record an ECG on your Fitaos watch.
1.Wear the watch just above your wrist bones on the wrist you selected during setup. Note: The watch should be snug but comfortable.
2.Open the ECG app on your watch and follow the on-screen instructions.
3.Sit comfortably, rest your arm and wrist on a table, and keep still.
4.Place your thumb and index finger on the metal ring around the watch face to start a recording.
5.Keep your fingers in place, and remain still for the entire 30-second recording.
6.After the recording is complete, you can view the ECG app result on your watch. Please see below for more information about results you might see.
PROBLEM: I CAN'T FIND THE ECG APP ON THE Fitaos WATCH.
SOLUTION:
·Make sure the ECG app is available for your Fitaos watch. Go to Fitaos.com/ECG.
·Make sure the ECG app is approved for use in your country. Go to Fitaos.com/ECG.
·Review and complete the setup in the Fitaos Connect app on your smartphone (see ECG App Setup).
·The ECG app can be found in the Apps and Activities menu on your Fitaos watch. For help finding this menu, please refer to how to Start an Activity in your Fitaos watch user manual.
PROBLEM: I CAN'T GET THE ECG APP TO CREATE A RECORDING.
SOLUTION:
·Review and complete the setup in the Fitaos Connect app on your smartphone (see ECG App Setup).
·Water and sweat can cause a poor recording. Clean and dry your wrist and your Fitaos watch.
·Dry skin, cold skin, a hairy wrist, wearing the watch on your wrist bones or too much movement can prevent the ECG app from recording your ECG.
·Use moisturizing lotion on your hands and wrist.
·Remove the watch, and rub your wrist gently to warm the skin. Put the watch back on, and try again.
·Wear the watch just above your wrist bones toward your elbow.
·Remain still during the recording.
PROBLEM: I GET THE INCONCLUSIVE (POOR QUALITY) RESULT, OR I SEE A LOT OF NOISE OR INTERFERENCE IN MY RECORDING.
SOLUTION:
·Sit comfortably, relax, and try to remain still.
·Rest your arms on a table while you take a recording.
·Check the fit of the Fitaos watch on your wrist. The band should be snug. The back of your Fitaos watch must be touching your wrist. Wear the watch just above your wrist bones toward your elbow.
·Use your thumb and index finger on the metal ring around the watch face.
·Move away from any electronics that are plugged into a power source to avoid electrical interference.
·Water and sweat can cause a poor recording. Clean and dry your wrist and your Fitaos watch.
PROBLEM: THE ECG WAVEFORMS APPEAR UPSIDE DOWN.
SOLUTION:
You may not be wearing the watch on the wrist you selected while setting up your Fitaos watch. You can either wear the watch on your other arm or change your user profile Wrist selection. To change your wrist selection, please refer to Setting Up Your User Profile in your Fitaos watch user manual, and select Wrist.
Understanding Your Results
After you complete an ECG recording, you will see one of the following results in the ECG app.
SINUS RHYTHM
A sinus rhythm result means your heartbeat pattern appears normal. It indicates that the upper and lower chambers of your heart are beating in sync.
Note: A sinus rhythm result only applies to that specific recording and DOES NOT mean your heart always beats normally.
ATRIAL FIBRILLATION (AFIB)
An AFib rhythm result means your heartbeat pattern appears irregular. AFib is an irregular heart rhythm caused by your heart’s upper and lower chambers not beating in sync. You should speak with your doctor if you receive an AFib rhythm result.
Left untreated, AFib can lead to serious health consequences. The irregular heart rhythm causes improper blood flow in the heart, which can lead to stroke, heart failure and/or other medical problems.
AFib can be temporary or persistent, but it is a manageable condition when treated by a doctor and with medication. Many people with AFib live healthy lives. Sometimes people with AFib do not have symptoms. However, others may experience one or more of these common symptoms:
HEART RATE TOO HIGH OR TOO LOW
If your heart rate is over 120 beats per minute (bpm) or under 50 bpm, the ECG app cannot check for AFib heart rhythms. In these cases, the result will be inconclusive, and your heart rhythm could not be classified. If you get this result repeatedly or you do not feel well, then you should speak with your doctor.
A heart rate below 50 bpm can be caused by taking some medications or by certain heart conditions. Some people with high fitness levels may also have a heart rate below 50 bpm.
A heart rate above 120 bpm is common while exercising and for a short time afterward. It can also be caused by high stress levels, an infection, dehydration, alcohol use or certain heart conditions, including AFib.
INCONCLUSIVE
An inconclusive result means your heart rhythm could not be classified. This could happen for several reasons, such as moving too much or poor skin contact during the ECG recording. Try resting your arm on a table, and make sure the watch is snug on your wrist. If you get this result repeatedly or if you do not feel well, then you should speak with your doctor.