Device Type: Anesthesiology - Monitoring
FDA Description:
An apnea monitor is a Class II medical device designed to alert users to the cessation of breathing, typically timed from the last detected breath. It may also monitor indirect indicators such as heart rate and other physiological parameters associated with respiration. The FDA product code for an apnea monitor is FLS.
General Description:
An apnea monitor is a medical device designed to detect and alert users to instances of apnea, a temporary cessation of breathing. Commonly used for infants, adults with sleep apnea, or patients in critical care, these monitors play a vital role in early detection and intervention. They continuously track respiratory activity and often measure related physiological parameters, such as heart rate or oxygen saturation, depending on the device type.
The device typically consists of sensors placed on the patient’s chest or abdomen to monitor breathing movements or airflow. In the case of neonatal apnea monitors, these are often paired with sensitive electrodes or belts that detect small chest wall movements. If breathing ceases for a predetermined period, the monitor triggers an audible or visual alarm to alert caregivers or medical staff.
Modern apnea monitors often integrate advanced features like wireless connectivity, allowing real-time data tracking through mobile apps or central monitoring systems. This facilitates remote patient monitoring and data analysis for long-term care management.
Engineered for safety and reliability, apnea monitors meet stringent regulatory standards, including FDA requirements, to ensure accurate performance. They are used in home, clinical, and neonatal intensive care settings, providing critical support for patients at risk of respiratory complications.