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Masimo
Product Description, Indications, and
Contraindications
Product Description
SedLine® Sedation Monitor is a patient-connected, 4-channel processed
electroencephalograph (EEG) monitor designed specifically for intraoperative or intensive
care use. It displays electrode status, EEG waveforms, Density Spectral Array (DSA), and
Patient State Index (PSi), EMG Index, Suppression Ratio (SR) and Artifact (ARTF).
The operator controls the unit using menus and dedicated buttons to select various display
options. The system consists of 4 major components: Root, SedLine Module, SedLine Patient
Cable, and SedLine Sensors.
Indications for Use
The SedLine® Sedation Monitor is intended to monitor the state of the brain by real-time
data acquisition and processing of EEG signals. The system includes the Patient State Index
(PSi), a proprietary computed EEG variable that is related to the effect of anesthetic agents.
The agents include: Alfentanil, Desflurane, Fentanyl, Isoflurane, Nitrous Oxide, Propofol,
Remifentanil, and Sevoflurane. The SedLine® Sedation Monitor is intended for use with adult
patients (18 years of age and older) in the operating room (OR), intensive care unit (ICU), and
clinical research laboratory.
Contraindications
This device is not intended for use in children less than 18 years of age.
