Apnotrack: Apnea Screening
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Description
Sleep Apnea Screening with Just Your Smartphone
Apnotrack is a CE marked digital medical device (Class I under EU MDR) that screens for moderate to severe sleep apnea risk using only your smartphone. No wearables, no clinic visit required.
Intended Purpose
Apnotrack is intended to screen adult users for the risk of moderate to severe obstructive sleep apnea. Apnotrack is a screening tool and does not provide a medical diagnosis.
How It Works
Place your smartphone by the bed before sleep. Apnotrack uses the microphone to record breathing sounds during sleep and applies an algorithm to identify patterns associated with sleep apnea and snoring. In the morning, view your screening result along with sleep data.
Key Features
At Home Sleep Apnea Screening
Screen for moderate to severe sleep apnea risk from home.
Snoring Detection
Detect and record snoring patterns night by night.
Daily Sleep Report
Review total sleep time, sleep efficiency, sleep onset latency, and wake after sleep onset in a daily summary.
Sleep and Wake Alarms
Set bedtime reminders and wake up alarms.
No Extra Devices
Works with your smartphone only. No wearables, chest straps, or headbands required.
Easy to Use
Tap once to start. Apnotrack runs in the background during sleep.
About Apnotrack
Apnotrack is developed by Asleep Inc. The app holds CE marking under EU Medical Device Regulation 2017/745 as a Class I software medical device.
Manufacturer: Asleep Inc.
Address: JustCo Tower, 431 Teheran-ro, Gangnam-gu, Seoul, Republic of Korea
Device Name: Sleep Breath Monitoring Software
Model: Apnotrack
Intended Use: To screen and monitor breathing patterns during sleep to help users recognize potential sleep-related breathing issues.
UDI-DI: 08809933330015
Important Information
Apnotrack is a screening tool intended to assess the risk of moderate to severe obstructive sleep apnea. Apnotrack does not diagnose, treat, cure, or prevent any disease. If your screening result indicates risk, please consult a qualified healthcare professional for diagnosis and treatment options.
For best results, use Apnotrack in a quiet bedroom with your phone plugged in and placed within one meter of your head.
Apnotrack is intended for adults aged 18 and over.
Privacy
All audio data is processed securely. Asleep Inc. complies with the EU General Data Protection Regulation (GDPR).
For full Instructions for Use (IFU), please visit notion.so/e-IFU-36c02a57e80a806bab77f4dc5f105483.