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The BrainPulse is intended for use on a patient's head to non-invasively detect, amplify and capture the skull motion caused by pulsatile flow from the cardiac cycle. The BrainPulse is not in the diagnosis of neurological conditions, diseases, or disorders.

The BrainPulse™ 1100 is a non-invasive device having three basic components that are provided as an entire system and all are non-sterile and reusable: . Headset with detachable cable that is patient contacting and includes: One Photoplethysmograph (PPG) sensor for o detecting the heart rate and timing; One Sound Pressure Level (SPL) sensor for o detecting ambient environment noise; and Six Accelerometer sensors to detect the o acceleration at six selected locations. ● Data Collector, which digitizes the analog signals from the headset . Computer, which incorporates the device Software and space to store the BrainPulse recording data and, . Device Software, which provides the user interface, hardware control software libraries The BrainPulse collects and stores skull motion caused by pulsatile flow from the cardiac cycle. The normal brain structure produces a motion that is driven by and synchronized with the heart rate, and is manifested by slight acceleration of the skull. The device uses piezoelectric-based accelerometer sensors that measure skull motion rather than brain sounds. The typical frequencies that are employed with the BrainPulse are below 20 Hz and mostly below 10 Hz, well below the lower limit of audible sound. The headset senses the motion and the Data Collector digitizes the signal. The computer mainly provides the user interface and stores the data for further processing. Users place the device's headset on patients and setup the user interface to perform a BrainPulse recording. Typically, a recording is about 2-3 minutes long, though users may obtain recordings up to 30 minutes long depending on their applications. Recordings may be obtained at any time.

The BrainPulse is intended for use on a patient's head to non-invasively detect, amplify and capture the skull motion caused by pulsatile flow from the cardiac cvcle. The BrainPulse is not indicated to aid in the diagnosis of neurological conditions, diseases, or disorders.

As described above, the BrainPulse, Model 1100 (BrainPulse) is designed to measure skull motion caused by pulsatile blood flow. The BrainPulse measures these cranial pulsatile movements via an array of accelerometers placed on the scalp. The system consists of three main components: a headset, data collector, and computer. The headset contains a forehead photoplethysmograph (PPG) sensor that measures the patient's pulse rate, a Sound Pressure Level (SPL) sensor for detecting ambient environment noise, and six accelerometers to detect the acceleration of the skull at six selected locations. These acceleration measurements typically fall in the range of 0.001 - 0.03 g. The data collector converts the analog signals from the headset sensors and provides a digital data stream via Ethernet cable to the computer. The computer is loaded with software that allows for the user to initiate and end recordings and to manage saved data files. The BrainPulse software is not capable of displaying the recorded data from the headset; rather the data are saved in multiple file formats that can be readily displayed using other third-party software for post-hoc review.