BRAIN SENTINEL, INC. SPC15-90055 AccuSense Sensitive Electrode Patch SPC15-90055 EU

The SPEAC® System, formerly known as the Brain Sentinel® Monitoring and AlertingSystem, is a physiological, surface electromyography (sEMG) monitor with or without alarms that recordsand stores data for review by a physician for characterization of seizure events.The System records sEMG data at 1,000 Hz and distributes physiological data. Data can be analyzed withan algorithm using the default threshold or by a modified threshold ordered by the physician.The sEMG monitor is worn unilaterally on the belly of the patient’s biceps and it analyzes for sEMG GTCseizures and provides local, remote, audible, and visual seizure alarms when a GTC Seizure pattern thatmay be associated with such seizures are detected.The SPEAC System provides sEMG recordings and audio data to physicians (or other trained healthcareprofessionals) for post-hoc review so that they may quantify and qualify the types of seizure events thattheir patients experience. Every 24 hours, the sEMG monitor is removed from the patient and replacedwith the second sEMG Monitor on the opposite arm of the patient.The sEMG Monitor that is removed after 24-hours is then attached to a Base Station. By connecting thesEMG Monitor to the Base Station, the monitor charges and the recorded data is downloaded to the BaseStation. The recorded data is then automatically uploaded to Brain Sentinel’s cloud-based storage unit,Data Distribution System (DDS), where it awaits review by a physician. All patient data is cyber-securedwithin Microsoft Azure which is FedRAMP certified.