Sleep assessment device

Intended purpose

The Falcon system is intended for use in the recording, displaying, analysis, printing, and storage of human biological parameters such as brain, heart and muscle activity, eye movement, breathing and body movements. The Falcon is designed for ambulatory and mobile operation and can be used in either the patient’s home, the hospital, or other environments, enabling patients to be investigated under as realistic conditions as possible. The Falcon is not intended for use as life support equipment such as vital signs monitoring in intensive care units. The Falcon is only to be used under the direction and supervision of a physician, technologist, or clinician. It will not prevent or restore the interruption or loss of any physiological system.