B481SPC15900541 - AccuSense Sensitive Electrode Patch-SPC15-90054 US | 2019-11-15 The SPEAC® System, formerly known as the Brain Sentinel® Monitoring and Alerting
System, is a physiological, surface electromy |
B481SPC15900551 - AccuSense Sensitive Electrode Patch SPC15-90055 EU | 2019-11-15 The SPEAC® System, formerly known as the Brain Sentinel® Monitoring and Alerting
System, is a physiological, surface electromy |
B481SPC15900580 - SPEAC System Assy, Mini Monitor, EU | 2019-09-13The SPEAC® System, formerly known as the Brain Sentinel® Monitoring and Alerting System (Predicate), is a physiological, surface electromyography (sEMG) monitor with or without alarms that records and stores data for review by a physician for characterization of seizure events.
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The System records sEMG data at 1,000 Hz and distributes physiological data. Data can be analyzed with an 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 GTC seizures and provide local, remote, audible, and visual seizure alarms when a GTC Seizure pattern that may be associated with such seizures that are detected.
The SPEAC System provides sEMG recordings and audio data to physicians (or other trained healthcare professionals) for post-hoc review so that they may quantify and qualify the types of seizure events that their patients experience. Every 24 hours, the sEMG monitor is removed from the patient and replaced with the second sEMG Monitor on the opposite arm of the patient.
The sEMG that is removed after 24-hours is then attached to a Base Station. By connecting the sEMG Monitor to the Base Station, the monitor charges and the recorded data is downloaded to the Base Station. The recorded data is then automatically uploaded to Brain Sentinel’s cloud-based storage unit, Data Distribution System (DDS), where they await review by a physician. All patient data is cyber-secured within Microsoft Azure which is FedRAMP certified. Below, Tables 1 and 2 list the functional and operational outputs designed to provide feedback to the patient and caregiver. |
B481SPC15900580 - SPEAC System Assy, Mini Monitor, EU | 2019-09-13 The SPEAC® System, formerly known as the Brain Sentinel® Monitoring and Alerting System (Predicate), is a physiological, surfa |
B481SPC150 - SPEAC System | 2018-07-06 The Brain Sentinel Monitoring and Alerting System is indicated for use as an adjunct to
seizure monitoring in adults in the home |