Bureaucracy is a terrible force. It is because of her that the Ultra Wideband standard has not yet worked in Russia, eSIMs were unavailable for a long time, and the ECG function in Apple Watch locked until now. Just in order for all this to work, the approval of various authorities is necessary, which for some reason do not give it, under the guise of concern for public safety. Therefore, it was rather strange and at the same time joyful to learn that the sensor for measuring the level of oxygen in the blood, which is equipped with the new Apple Watch, will work for us too, and in the vast majority of countries in the world. But how did Apple achieve this?
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If you judge, it turns out to be a strange situation. After all, both the SpO2 sensor, which measures oxygen in the blood, and the ECG sensor are one field of a berry. Both are responsible for scanning vital signs and seem to even be able to save lives. But, nevertheless, the ECG sensor requires mandatory certification in the overwhelming majority of countries of the world, which is why it still does not work in Russia, and the blood oxygen measurement sensor started working on the first day without registrations and approvals.
Pulse Oximeter in Apple Watch
It turns out that the whole point is that the US Food and Drug Administration (FDA) establishes several categories of monitoring devices for the body: Health (health) and Wellness (wellness). A similar division exists in many countries around the world.
The first includes the ECG function, because, firstly, it deals with the interpretation of life-threatening situations, and, secondly, it directly competes with medical equipment. Pulse oximeters are devices of the Wellness category.
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After all, if you can buy a pulse oximeter belonging to the Wellness category at any pharmacy and order it on AliExpress without any problems, then you can hardly find an electrocardiograph on a free sale.
To get FDA approval to sell the Apple Watch with ECG, it took a lot of tests to prove that its heart rate scanning technique was indeed effective, accurate, and applicable at home.
Nothing of the kind was required in the case of a pulse oximeter due to its simplicity. Apple could have limited itself to internal testing and implemented an unapproved SpO2 sensor. Undoubtedly, someone will say that this is not fair. After all, both ECG and blood oxygen measurement can save lives. But there is a rather tangible difference here.
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The fact is that the sensor for measuring oxygen in blood is closer in purpose to an electric thermometer. Yes, this is a necessary thing, and a person can also die from a high temperature, as well as from hypoxia. But we can use thermometers, as well as pulse oximeters, without any problems. In addition, normal blood oxygen levels may differ for everyone.
Most people have a blood oxygen level of 95–99%. However, some people live with blood oxygen levels below 95% without any discomfort.
Whether it’s a heart rhythm disorder. Not only does it manifest itself in everyone the same way, we simply cannot measure the work of the heart using electrocardiography at home. To do this, we need not only specialized equipment, but also a doctor who can, firstly, turn it on, and, secondly, interpret the obtained indicators.
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What do we have at the end? ECG and SpO2 sensors are sensors of varying degrees of responsibility that are assigned to them. This can be seen in the example of the accuracy of the measurements. After all, if the ECG sensor, although wrong, in general it does not happen often. And here is the SpO2 sensor, which just debuted on the Apple Watch, has a tendency to miscalculate… As a result of several consecutive measurements, even on one person, the indicators can differ quite significantly – up to critical differences.
But Apple, realizing this, fenced itself off from possible lawsuits. She has clearly stated in advance that oxygen measurement is a non-medical function and the information she provides cannot be used to consult with doctors.