Wired
At the same time as the release of iOS 14.2, the iOS app developer discovered and released the Japanese version description of the Apple Watch ECG app, which is expected to be available in Japan. I hope that it will be available in Japan soon.
Is it about to be released? ??Following the explanation image in Japanese, the explanation was also found
The ECG function of Apple Watch has been available since Apple Watch Series 4, but it remains unavailable in Japan because it has not been approved as a medical device.
However, since the “ECG” app was approved as a medical device in September 2020, it is expected that it will soon be available in Japan.
The other day, iOS app developer App Shack (@ ZuwFNRuFlGZ6Ivc), who discovered an image introducing how to use the “ECG” app from the beta of iOS 14.2, analyzed iOS 14.2 beta and Japanese for the “ECG” app. I found the description of the version and published the full text on the blog.
The content of the description of the “ECG” app is a translation of the content published in a foreign language into Japanese, and it is expected that preparations for publication in Japan are in progress.
Not intended for use under the age of 22
“Precautions” include not recommending it to users with known arrhythmias and not a replacement for traditional diagnostic or therapeutic methods.
The “ECG” App is a software-only mobile medical application for use with the Apple Watch. Create, record, save, transfer, and view a 1-channel ECG (ECG) that corresponds to the first lead. The “ECG” app determines if atrial fibrillation (AFib) is present or sinus rhythm based on a classifiable waveform. The “ECG” app is not recommended for users with known arrhythmias.
The “ECG” app is used over-the-counter (OTC). The ECG data displayed by the “ECG” app is for informational purposes only. The user may not interpret or receive clinical practice based on the output from this device without consulting a qualified healthcare professional. This ECG waveform supplements the rhythm classification to distinguish between atrial fibrillation (AFib) and normal sinus rhythm and is not a replacement for traditional diagnostic or therapeutic methods.
There is also a statement that “it is not intended for use by people under the age of 22”.
30 seconds to record
The following procedure is described as a method of recording an electrocardiogram using the “ECG” app.
- Fit your Apple Watch snugly on the wrist on the side you select in Settings> General> Watch Orientation.
- Open the “ECG” app on your Apple Watch.
- Place your arms on your desk or lap and place your fingers on the Digital Crown. You don’t have to hold down the Digital Crown during the session.
- Recording takes 30 seconds.
4 types of result display
When the electrocardiogram reading is completed successfully, one of the following four classifications will be displayed.
- Sine rhythm: The result of sinus rhythm means that the heart is beating in a constant pattern of 50-100 BPM.
- Atrial fibrillation: The result of atrial fibrillation means that the heart is beating in an irregular pattern of 50-120 BPM.
- Undeterminable: An undeterminable result means that the records cannot be classified. This can happen for a variety of reasons, such as not having your arms on your desk during recording, or wearing your Apple Watch loosely. In rare cases, physiological conditions may not produce enough signals to create a record.
- Low / High Heart Rate: When the heart rate is below 50 BPM or above 120 BPM, the ability of the “ECG” app to check for atrial fibrillation (AFib) is affected and the record is considered undeterminable.
Talk to your doctor if you have any subjective symptoms or anxiety
There are the following explanations on how to read the results.
- Even if the electrocardiogram results show the presence of atrial fibrillation (AFib), this is just one candidate for the finding. Talk to your doctor if you have any subjective symptoms or anxiety. If you feel that you are in an emergency, call an ambulance.
- The result of “sinus rhythm” means that the heart rate is 50-100 per minute and the heart is beating in a constant pattern.
- The result of “undecidable” is that there are many artifacts and noise and it is not possible to obtain an appropriate signal, the presence of arrhythmia other than atrial fibrillation (AFib) that cannot be classified by the “ECG” app is suspected, or the heart rate is 100. It means that it is ~ 120 BPM. In rare cases, physiological conditions may not produce enough signals to create a record. You can find out more about “undecidable” during onboarding. To do this, view the instructions in the “ECG” area of the “Healthcare” app on your iPhone, or tap the “i” icon in the “EC” app to see more information.
- Low heart rates may be measured due to the effects of certain medications or improper transmission of electrical signals from the heart. Training to train top athletes also lowers your heart rate.
- High heart rate may be measured due to exercise, stress, tension, alcohol dehydration, infections, atrial fibrillation (AFib) and other arrhythmias.
Atrial fibrillation (AFib) classified by sensitivity 98.3% in clinical trials with 600 people
The “Safety and Performance” section describes the results of clinical trials.
The ability of the “ECG” app to accurately classify ECG records into atrial fibrillation (AFib) and sinus rhythm has been extensively tested in clinical trials with approximately 600 subjects. We compared the 12-lead ECG rhythm classification by a cardiologist with the ECG rhythm classification collected simultaneously from the “ECG” app. As a result, the “ECG” app classified atrial fibrillation (AFib) with a sensitivity of 98.3% and sinus rhythm with a specificity of 99.6% among the classable records.
In this clinical trial, 12.2% of the records were undeterminable and were not classified as sinus rhythm or atrial fibrillation (AFib). Including undeterminable records in the analysis, the “ECG” app correctly corrects 90.5% of subjects with sinus rhythm to sinus rhythm and 85.2% of subjects with atrial fibrillation (AFib) to atrial fibrillation (AFib). I classified it. The results of this clinical trial are for use in a controlled environment. In an environment that actually uses the “ECG” app, the number of records that are considered undeterminable and cannot be classified may increase.
The morphology of the waveform was also examined in this clinical trial. The amplitudes of the PQRST wave and R wave are visually evaluated by comparing them with the reference materials. No adverse events were seen in this clinical trial.
Full page translation available for iOS14.2 and Safari
At the time of this writing, iOS14.2 was released in beta 4 for developers on October 20, local time, and public beta 4 for registered users on the following day, 21st.
In iOS14.2, we know that emoji will be added and new wallpapers will be added.
In addition, Safari’s page-wide translation function is expected to be available in Japan as well.
The full text of the “ECG” app description can be read on App Shack’s blog “Content View”.
Source: ContentView
Photo: ContentView
(hato)
Source: iPhone Mania