• The LUKE Cardiac Monitoring System is an investigational device and has not been cleared or approved by the U.S. Food and Drug Administration(FDA).
• The system is not intended to replace emergency medical care. Patients experiencing symptoms such as chest pain, shortness of breath, dizziness, or fainting should seek immediate medical attention.
• Data analysis and alerts are intended to support, not replace, the judgment of qualified healthcare professionals.
• Performance and safety have not yet been established for widespread clinical use.
• Device notifications and data outputs are intended to support clinician decision-making, not to serve as a sole basis for diagnosis or therapyinitiation.
• Patients experiencing acute chest pain, syncope, or related symptoms should seek immediate emergency care independent of device alerts.
