Precautions for Use
- This product must be used only for its authorized indications and intended use. Any use outside of the authorized purpose and method is prohibited, and the user shall be solely responsible for any issues that arise from such use.
- Physicians should not rely solely on the results recorded by this medical device. This device is not intended to replace a full polysomnography (PSG) study when additional parameters such as sleep stages, limb movements, or EEG activity are required.
- Diagnosis must be determined through a systematic review and analysis that includes other clinical information of the patient.
- At least 6 hours of sleep measurement is required for more accurate results.
- In clinical trials, the accuracy of Apnotrack was confirmed with sensitivity (0.8689) and specificity (0.9231). However, clinical performance was derived from a limited dataset (adults aged 20 and older), and actual performance may vary depending on dataset composition and user environment.
Precautions Regarding Age and Health Conditions
- This product is intended for use only in individuals aged 20 years and older.
- Users should be aware of the potential risks of adverse events, critical side effects, or accidents that may result from device misuse or negligence.
- The product user manual must be carefully reviewed and understood prior to use.
General Warnings
- Be sure to familiarize yourself with the instructions before using this product.
- If any problems occur during use, discontinue use immediately and contact the manufacturer (Asleep, Inc.).
- In the event of cybersecurity threats or incidents during use, users must immediately contact Asleep’s emergency hotline and follow the manufacturer’s guidance to resolve the issue.
Application Precautions
- Consult the manufacturer before connecting this product to other equipment.