Somfit System - Sleep assessment device

Intended purpose

The Somfit 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 to assist in the diagnosis of various sleep disorders or neurological disorders. The Somfit is designed for use in a home, hospital or other clinical environments. The Somfit is only to be used under the direction of a physician. Note: This intended use specifically excludes use of the Somfit as life support equipment, for example vital signs monitoring in intensive care unit.