Is the Apple Watch blood oxygen sensor at the level of medical devices
According to JBQ, The Blood Oxygen app allows you to measure your blood oxygen level directly from your wrist and provides insights into your overall health.
Measurements taken with the Blood Oxygen app are not intended for medical use and are intended for general fitness and health purposes only. The Blood Oxygen app is only available in certain countries and regions.
Your blood oxygen level indicates the percentage of oxygen your red blood cells carry from your lungs to the rest of your body. Knowing how well your blood performs this vital function can help you understand your overall health.
Most people have a blood oxygen level of 95 to 100 percent. However, some people live normal lives with blood oxygen levels below 95%. Slightly lower values are expected during sleep, and some users may experience values below 95%.
How to use the Blood Oxygen application
Make sure you meet the requirements below and follow the steps to set up the Blood Oxygen app.
Here is what you need
Make sure the Blood Oxygen app is available in your country or region. You can see this during the setup process.
Update your iPhone 6s or later to the latest version of iOS.
Update your Apple Watch Series 6 or Series 7, Series 8 or Ultra to the latest version of watchOS.
The Blood Oxygen application is not available for use by persons under the age of 18. You can verify or adjust your age in your health profile.
Set up Blood Oxygen app and background reading
- On your iPhone, open the Health app.
- Follow the steps on the screen. If you don’t see a prompt to set up, tap the Browse tab, then tap Respiratory > Blood Oxygen > Enable.
- After the setup is complete, open the Blood Oxygen app on your Apple Watch to measure your blood oxygen level.
If you still don’t see the Blood Oxygen app on your Apple Watch, you can search for Blood Oxygen in the App Store on your Apple Watch and download it.
The Blood Oxygen app is installed in the Health app at startup. If you’ve uninstalled the Blood Oxygen app, you can reinstall the Blood Oxygen app on your Apple Watch from the App Store if you’ve finished setting up the Blood Oxygen app.
How to measure blood oxygen
With the Blood Oxygen application, you can measure blood oxygen at any time.
- Make sure your Apple Watch is secure but comfortable on your wrist.
- Open the Blood Oxygen app on your Apple Watch.
- Stay still and make sure your wrist is straight and your Apple Watch is facing up.
- Tap Start, then hold your arm still for 15 seconds.
- The measurement takes 15 seconds. At the end of the measurement, you will receive the results.
- Tap Done.
How to get the best results
Place your arms on the table or in your lap while you measure. Keep your wrists and palms down and straight and as still as you can.
Make sure your Apple Watch is not loose on your wrist. The band should be firm but comfortable, and the back of your Apple Watch should touch your wrist.
Make sure the back of your Apple Watch is level with the top of your wrist. If your wrist bones interfere with this, move your watch 1 to 2 inches up your arm away from your wrist bone.
JBQ says, Even under ideal conditions, your Apple Watch may not be able to get a reliable blood oxygen measurement every time. For a small percentage of users, various factors may make it impossible to measure blood oxygen.
Skin perfusion (or the amount of blood flow through your skin) can affect the measurements. Skin perfusion varies significantly from person to person and can also be influenced by the environment. For example, if you are outside in cold weather, the skin perfusion in your wrist may be too low for the sensor to work with the Blood Oxygen app to measure.
Permanent or temporary changes to your skin, such as certain tattoos, can also affect performance. The ink, pattern, and saturation of some tattoos can block light from the sensor and make it difficult for the Blood Oxygen app to measure.
Motion is another factor that can affect your ability to obtain successful background or requested measurements. Certain postures, such as arms hanging by the side or fingers in fists, also lead to failed measurements.
If your resting heart rate is too high (over 150 beats per minute), you will not be able to successfully measure blood oxygen.
About background measurement
If Background Measurements is turned on, the Blood Oxygen app on your Apple Watch will occasionally measure your blood oxygen level. This usually happens when you are not moving. Depending on how active you are, the number of readings collected each day and the time between readings will vary. The blood oxygen measurement uses a bright red light that shines on your wrist, so it may be more visible in dark environments. You can turn off background metering if it distorts the light.
- Open the Settings app on your Apple Watch.
- Tap Blood Oxygen, then turn off Sleep Focus and Cinema Mode.
Blood oxygen measurement is performed only if the Track Sleep with Apple Watch setting is active during sleep.
View your health information
All blood oxygen readings, whether on-demand or in the background, are stored in the Health app on your iPhone.
- Open the Health app.
- Tap the Browse tab, then tap Respiratory > Blood Oxygen.
You can also filter and view measurements taken only during sleep or in high altitude environments.
Things you need to know
Blood Oxygen App measurements are not intended for medical use, including self-diagnosis or consultation with a physician, and are intended for general fitness and health purposes only.
The Blood Oxygen app is designed for users who are at least 18 years old.
During the unveiling of the Apple Watch Series 6, the company announced its newest addition — a blood oxygen monitor — as an addition to its existing health features.
Powerful Health Tool
However, the Apple Watch’s heart rate and rhythm tracking features have one key difference with the blood oxygen monitor: heart tracking features are cleared by the Food and Drug Administration (FDA), and the oxygen monitor is not. Apple went through a long and extensive process to develop and validate the EKG feature so that the watch can detect a condition called atrial fibrillation. There was no need to do the same for the pulse oximeter.
Blood oxygen monitors or pulse oximeters are considered Class II medical devices by the FDA. Generally, any company that wants to sell one in the U.S. must provide the agency with documentation that proves its product works as well as other versions of the same product on the market.
There is a workaround though: if the company says the product is just for fun or for general “health,” they don’t have to go through this process. They cannot claim that it can diagnose or cure any medical condition, but they can sell it. If the company says the product is just for fun or for general “health,” they don’t have to go through this process.
This is the path Apple took. They don’t say their monitor can diagnose any disease, it just provides information. Other health-focused apps and smart watches have taken the same approach and sidestepped the FDA process. “If you’re just providing information, they’re not going to regulate it,” says Matt Grennan, assistant professor of health care management at the Wharton School at the University of Pennsylvania. Digital health products are so ubiquitous, with so many new products entering the market every year, that it is difficult for the FDA to review them all. “They have to think about how they can allocate their resources,” says Grennan.
The agency steps in when companies want to use apps to influence the medical care people receive. The EKG feature falls into this category. It is supposed to serve a specific medical purpose: to detect abnormal heart rhythms. “It means interpreting and managing a potentially life-threatening situation,” says Michael Matheny, co-director of the Center for Improving Public Health Through Informatics at Vanderbilt University.
As part of the FDA approval process for the EKG, Apple had to submit and release data showing that the feature could indeed detect atrial fibrillation. Doctors and experts were able to verify this information, and there are dozens of published research studies that carefully examine how well this watch can detect dangerous heart rhythms.
Since the pulse oximeter is only a health product, Apple didn’t have to release any of this information. When Mattney looked for data showing how well the Apple Watch’s pulse oximeter performs compared to other devices on the market, he couldn’t find much. “It was disturbing to me,” he says. Anecdotal reports from people testing the Apple Watch suggest that the pulse oximeter feature is not accurate and difficult to use.
It is important to distinguish between a feature used for health and a feature used for medical monitoring one is cleared by experts and the other is not. But those differences are often not clear to people buying a product like the Apple Watch, especially when marketing blurs the line as Apple directly compared the watch’s heart-monitoring features to a new pulse oximeter. “A lot of times, patients and consumers don’t really understand the difference. So they’ll start using the device and relying on the information,” Matney says.
“A lot of times, patients and consumers don’t really understand the difference.”
It gets more complicated when two applications that fall into different categories are included in the same product, Grennan says. It’s confusing to think that one feature on a device is medical grade and another feature that appears to be medical really isn’t.
Grennan says the Apple Watch won’t be the last product to have some features cleared by the FDA and others classified as health gadgets. “I think we’re going to see a lot more. Pieces of technology are going to have multiple capabilities, and some are going to be explored more than others.”