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The X-Series System is intended for prescription use in the home, healthcare facility, or clinical research environment to acquire, transmit, display and store physiological signals from patients ages 6 and older. The X-Series system requires operation by a trained technician. The X-Series System acquires, transmits, displays and stores electroencephalogram (EEG), electrooculogram (EOG), electrocardiogram (ECG), and/or electromyogram (EMG), and accelerometer signals. The X-Series System only acquires and displays physiological signals, no claims are being made for analysis of the acquired signals with respect to the accuracy, precision and reliability.

The X-Series System is indicated for acquiring, transmitting, displaying and storing physiological data in patients. It can be used with ambulatory patients in the home, health care facility, or clinical research environment. The X-Series system requires operation by a trained technician. The X-Series System.is comprised the X10 and X24 Headsets and accessories, Synapse Cream, X-Series Basic Software and BT receiving unit. The X-Series Basic Software is also compatible with the Models X4-E, and X4-M (K130013) when used in wireless mode. The X-Series System combines hardware, firmware and software to acquire physiological signals. It acquires physiological data through a battery powered headset worn by the patient and provides a flexible platform for applying sensors using synapse cream and acquiring signals from multiple locations on the head or body, transmitting and recording the signals and providing visual indications to ensure high quality data are obtained. Model X24 provides for acquisition of twenty channels of electroencephalography (EEG) and four optional channels connected to two sensors via a dual-lead connector. Model X10 provides for acquisition of nine channels of electroencephalography (EEG) and an optional channel connected to two sensors via a dual-lead connector. Both models measure movement and position measured via a 3-D accelerometer. The device is designed so it can be affixed by a technician and displays the signals via a wireless connection during acquisition. The X-Series Basic software monitors signal quality to ensure that the sensors are properly applied and that high quality signals are being acquired. The X-Series Basic software provides a means to: a) initiate a study and track patient information, b) acquire and wirelessly transmit signals from the device, c) visually inspect the signal quality. The acquired signals are saved in a universal data format (European Data Format Plus, EDF+) that is intended to be analyzed by a Physician using FDA cleared third party software, i.e. Persyst Software (K011397).

The X4 System is intended for prescription use in the home, healthcare facility, or clinical research environment to acquire, record, transmit and display physiological signals from adult patients. The X4 System acquires, records, transmits and displays electroencephalogram (EEG), electrooculogram (EOG), electrocardiogram (ECG), and/or electromyogram (EMG), accelerometer, acoustical and photoplethesmographic signals. The X4 system only acquires and displays physiological signals, no claims are being made for analysis of the acquired signals with respect to the accuracy, precision and reliability.

The X4 system is used for configurable acquisition of physiological signals. Model X4-E provides for acquisition of three channels of electroencephalography (EEG) and one photoplethesmographic (PPG) signal from a head strip, with an optional channel connected to two sensors via a dual-lead connector with twice the gain. Model X4-M provides four channels of EEG with the dual-lead connector providing the input for reference sensors. Both models measure sound via an acoustic microphone, and movement and position measured via a 3-D accelerometer. The device is designed so it can be affixed by the patient and to record data. Alternatively, a technician can affix the device and display the signals via a wireless connection during acquisition. The X4 system firmware monitors signal quality to ensure that the sensors are properly applied and that high quality signals are being acquired. The X4 software provides a means to: a) initiate a study and track patient information, b) acquire and save signals to the memory of the device, c) acquire and wirelessly transmit signals from the device, d) upload data saved in the memory of the device to a PC, and e) visually inspect the signal quality. The acquired signals are saved in a universal data format (European Data Format - EDF). The study record, once saved on the PC, is available for analysis by Advanced Brain Monitoring's Sleep Profiler software application. The X4's downloaded study will reside on either or local PC or a cloud server, which can be a physical or virtual server. Software on the cloud server is accessed via web portal software.

The Apnea Risk Evaluation System (ARES™), Model 610 is indicated for use in the diagnostic evaluation by a physician of adult patients with possible sleep apnea. The ARES™ can record and score respiratory events during sleep (e.g., apneas, hypopneas, mixed apneas and flow limiting events). The device is designed for prescription use in home diagnosis of adults with possible sleep-related breathing disorders.

The Apnea Risk Evaluation System (ARES™) includes a device called a Unicorder which records oxygen saturation, pulse rate, snoring level, head movement and head position, airflow, and a physiological signal from the forehead used to stage sleep. The battery powered Unicorder provides sufficient capacity to record two nights of data. The device monitors signal quality during acquisition and notifies the user via voice messages when adjustments are required. A standard USB cable connects the Unicorder to a USB port on a host computer when patient data is to be uploaded or downloaded. The USB cable provides power to the Unicorder during recharging from the host computer or from a USB wall charger. The Unicorder cannot record nor can it be worn by the patient when connected to the host computer or the wall charger. Software controls the uploading and downloading of data to the Unicorder, processes the sleep study data and generates a sleep study report. The ARES can auto-detect positional and non-positional obstructive and mixed apneas and hypopneas similarly to polysomnography. It can detect sleep/wake and REM and non-REM. After the sleep study has been completed, data is transferred off the Unicorder is prepared for the next study. The downloaded sleep study record is then processed with the ARES™ Insight software to transform the raw signals and derive and assess changes in oxygen saturation (SpO2), pulse rate, head movement, head position, snoring sounds, airflow, and EEG. The red and IR signals are used to calculate the SpO2 and pulse rate. The actigraphy signals are transformed to obtain head movement and head position. ARES™ Screener can predict pre-test probability of obstructive sleep apnea (OSA). The ARES can assist the physician to identify patients who will likely have a successful OSA treatment outcome, including CPAP and oral appliance therapies. ARES™ can also help identify patients who would benefit from a laboratory PAP titration.