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The GE Healthcare Entropy module, E-ENTROPY, and accessories are indicated for adult and pediatric patients older than 2 years within a hospital for monitoring the state of the brain by data acquisition of electroencephalograph (EEG) and frontal electromyograph (FEMG) signals. The Entropy algorithm in the host monitor calculates the spectral entropies, Response Entropy (RE) and State Entropy (SE), which are processed EEG and FEMG variables. The Entropy measurement is to be used as an adjunct to other physiological parameters. In adult patients, Response Entropy (RE) and State Entropy (SE) may be used as an aid in monitoring the effects of certain anesthetic agents, which may help the user titrate anesthetic drugs according to the individual needs of adult patients. Furthermore in adults, the use of Entropy parameters may be associated with a reduction of anesthetic use and faster emergence from anesthesia. The Entropy module is indicated for use by qualified medical personnel only.

GE Healthcare Entropy Module, E-ENTROPY is a single-width plug-in parameter module for GE Healthcare modular monitoring systems. EEG signals reflect the underlying state of brain activity. As a person falls asleep or is anesthetized, the brain function (activity) starts to decrease and becomes more orderly and regular. EEG changes from irregular to more regular patterns when anesthesia deepens. Similarly, frontal EMG quiets down as the deeper parts of the brain are increasingly saturated with anesthetics. Entropy measurement is based on processing of raw EEG and FEMG signals by using the Entropy algorithm, a GE application of Spectral Entropy. The algorithm is published: Viertiö-Oja H et al. Description of the Entropy algorithm as applied in the Datex-Ohmeda S/5 Entropy Module. (Acta Anaesthesiologica Scandinavica 2004; Volume 48: Issue 2:154-161, 2004). Entropy measures irregularity of EEG and FEMG. The GE Entropy measurement devices are responsible for EEG and FEMG signal acquisition, amplification, filtering and digitization and electrode impedance measurement. The Entropy algorithm in the host monitor calculates the spectral entropies, Response Entropy (RE) and State Entropy (SE). The Entropy Module, E-ENTROPY-01 uses the identical Entropy algorithm and accessories as the predicate device, S/5TM Entropy Module, E-ENTROPY-00 (K061907).