Sleep Apnoea Feature

Intended Purpose

The Sleep Apnoea Feature is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone.

This feature is intended to detect signs of moderate-to-severe obstructive sleep apnoea in the form of significant breathing disruptions over a two-night monitoring period, for adult users 22 years or older. This feature is intended for on-demand use.

This feature is not intended for users who have previously been diagnosed with sleep apnea. Users should not use this feature to replace traditional methods of diagnosis and treatment by a qualified clinician. The data provided by this feature are also not intended to assist clinicians in diagnosing sleep disorders.

About these Instructions for Use

This section contains information on the symbols used in this document and in the Sleep Apnoea Feature, as well as how to access these instructions for use.

Symbols used

Accessing these Instructions for Use

These Instructions for Use are available electronically on the Samsung Health Monitor application and on the Samsung Health Monitor page of the Samsung website (samsung.com).

For a print copy of these Instructions for Use, you can download them from the Samsung website and print them or contact the official Samsung support centre in your country.

Customer support

If you have questions about the Sleep Apnoea Feature, contact Samsung customer support at healthmonitor@email.support.samsung.com.

Cautions

• DON'T use this Sleep Apnoea Feature if you've already been diagnosed with sleep apnoea.
• DON'T use this Sleep Apnoea Feature if you've been diagnosed with any of these conditions:
  • Movement-related conditions: for example, Parkinson's, tremor or Periodic Leg Movement During Sleep (PLMS)
  • Cardiac conditions: for example, Congestive Heart Failure (CHF) or atrial fibrillation
  • Lung conditions: for example, Chronic Obstructive Pulmonary Disease (COPD), chronic bronchitis, emphysema or pulmonary fibrosis.
• DON'T use this Sleep Apnoea Feature if you're under 22 years old.
• You shouldn't use this Sleep Aponea Feature if you're pregnant or have temporary symptoms of impaired breathing from flu, allergies, asthma, or any other condition, because your results may be inaccurate.
• DON'T change the dose or schedule of any medications based on results from this feature. Always talk to your healthcare professional first.
• Your Galaxy Watch can't catch every case of obstructive sleep apnoea. The watch only checks for signs of moderate to severe obstructive sleep apnoea (occurs when the throat muscles relax and block the airway) and can't detect central sleep apnoea (stop breathing while you sleep).
• Your Galaxy Watch is not approved by a regulatory body as a pulse oximeter.
• The Sleep Apnoea Feature is only a pre-diagnosis tool. The Sleep Apnoea Feature is not designed to replace professional medical or psychological advice and is not intended to identify, diagnose, treat, cure or mitigate any sleep disorder. If you aren't feeling well, or If you suspect that you may have sleep apnoea, contact a healthcare professional, even if the watch doesn't detect signs of sleep apnoea.
• For security reasons, always pair the Galaxy phone and Galaxy Watch via Bluetooth in a private (home-based) setting. It's NOT recommended that you pair your devices in a public space.

Using the Sleep Apnoea Feature

Getting started

The Sleep Apnoea Feature is compatible with the following watch models and watch/phone OS versions.

For regional availability, see the Samsung Health Monitor page on the Samsung website (samsung.com).

• Make sure your Galaxy Watch has the latest maintenance release (MR) and that the latest version of Samsung Health Monitor is installed on the watch and phone. If you haven't installed Samsung Health Monitor on your Galaxy phone, install it first and follow the on-screen instructions to set it up. Samsung Health Monitor is available from the Galaxy Store.
• To set up the Sleep Apnoea Feature, open Samsung Health Monitor on the phone, tap the Sleep Apnoea tab and follow the on-screen instructions.

Turning on the feature

Note: Make sure your Galaxy Watch is charged to at least 30% before you go to sleep.

1. On your Galaxy Watch or phone, open Samsung Health Monitor and tap Sleep Apnoea.
2. Tap the Sleep Apnoea Feature switch.
3. Wear your watch snugly while sleeping on 2 nights and within 10 days of turning on the feature. Wear your watch 2.5 to 5 cm above your wrist bone. The higher you wear it in that range, the more accurate your readings will be. Make sure it fits snugly and that the sensors maintain contact with your skin. Approximately 4 hours of sleep is required each night for the watch to get enough data for a result.

Receiving a notification

When the Sleep Apnoea Feature is on, the Galaxy Watch will use its photoplethysmography (PPG) based Oxygen saturation (SpO2) sensor and actigraphy to look for breathing disruptions based on how many relative decreases in blood oxygen you have while you're asleep. Breathing disruptions can indicate sleep apnoea. After two successful nights of measuring at least 4 hours of sleep each, the watch will let you know whether it detected signs of moderate-to-severe obstructive sleep apnoea. The result is saved in Samsung Health Monitor on your phone.

Note: It can take up to 90 minutes to analyse a night's sleep data.

If the watch detected signs of moderate-to-severe obstructive sleep apnoea:

• Your Galaxy Watch detected enough breathing disruptions to indicate moderate-to-severe obstructive sleep apnoea.
• Contact a healthcare professional for an evaluation.
• DON'T change the dose or schedule of any medications based on results from this feature.
• DON'T use the Sleep Apnoea Feature again before talking to your doctor. It won't provide a more accurate result.

If the watch didn't detect signs of moderate-to-severe obstructive sleep apnoea:

• Your Galaxy Watch didn't detect enough breathing disruptions to indicate moderate-to-severe obstructive sleep apnoea.
• Your Galaxy Watch can't catch every case of obstructive sleep apnoea.

Safety and Performance

If you aren't feeling well, contact a healthcare professional. This feature isn't a tracking or monitoring tool. Wait at least 30 days before using the feature again unless you experience a significant change in your health or lifestyle.

The Sleep Apnoea Feature was validated in a large, multi-centre study comprising 470 subjects who were 22 years old or older. Study subjects underwent a 2-night polysomnography (PSG) study while simultaneously wearing a Samsung Galaxy Watch with Sleep Apnoea Feature capability.

The Sleep Apnoea Feature showed a sensitivity of 82.67% by correctly identifying 167 out of 202 participants who exhibited moderate-to-severe obstructive sleep apnoea (OSA) on both nights of the PSG study. The Sleep Apnoea Feature also demonstrated a specificity of 87.69% by correctly identifying 235 out of 268 participants who did not exhibit moderate-to-severe OSA on both nights of the PSG study.

Furthermore, the Sleep Apnoea Feature demonstrated that it was consistent with the PSG study on 84.15% of the analysable nights.

Therefore, the Sleep Apnoea Feature is safe and effective in identifying users with signs of moderate-to-severe obstructive sleep apnoea.

Troubleshooting

If you have problems using the Sleep Apnoea Feature, see below for possible solutions.

Reasons you might not get a result:

• You weren't asleep for long enough. At least 4 hours of sleep is needed.
• You moved in your sleep in ways that your watch detected as wakefulness, so it didn't detect 4 hours of sleep.
• Your watch was too close to your wrist bone.
• You wore your watch while taking a nap during the day.
• Skin pigmentation or low peripheral blood flow might prevent the optical sensor on your watch from getting a strong enough signal to analyse.

Things you can try:

• Make sure your skin is clean and dry.
• Clean the sensor on the back of your watch.
• Wear your watch 2.5 to 5 cm above your wrist bone. The higher you wear it in that range, the more accurate your readings will be.
• Make sure the watch fits snugly and that the sensors maintain contact with your skin.
• If you have dense hair, a tattoo or a scar on your wrist, try to reposition the watch to avoid those areas.