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The Rubicon screening device is a small battery-powered device designed to assess and record nasal and oral airflow in adult patient during sleep in the home setting. The device is intended as a screening device to determine the need for clinical diagnosis and evaluation by polysomnography (PSG) based on the patient's test data.

The Rubicon Screening Device is comprised of 3 components and software. For the physical device. Rubicon is comprised of an Airflow sensor, cable connecting air flow sensor and a single inline module (SIM) as described below: Airflow sensor: The airflow sensor is placed under the user's nose where it converts temperature and pressure changes to a voltage signal. Polarized Polyvinylidene Fluoride (PVDF) is a temperature-sensing material. PVDF generates a small electrical charge in response to temperature change. The sensor is permanently connected to the SIM via two lead wires. The temperature difference between patient exhaled air and ambient air, as well as airflow pressure on the sensor generates a small voltage signal, which can be recorded as airflow by recording equipment. The vibration of breath sounds (snoring) produces a small voltage signal, which can be recorded as snoring by recording equipment. As integrated into the Rubicon, the airflow sensor provides two channels of output data from the same PVDF sensor. One channel focuses on sinusoidal airflow waveforms for identification of airflow events, and the second channel provides snore data. Cable: The lead wires are a typical cable pair. The lead wires were reviewed as part of the IEC 60601-1 safety evaluation. The lead wires transmit signals from the airflow sensor to the SIM and are permanently attached to the airflow sensor and the SIM. SIM (Housing and PCB): The SIM's primary function is to collect raw electrical signals from the airflow sensor. These signals include airflow and snore analog data. These analog signals are filtered and acquired by the SIM's A/D converter, then transmitted in real time to a nearby Smartphone, which must be running the Rubicon companion app. The SIM PCB is powered by a small coin cell battery. Software: The basic purpose of the software is to: Collect data from the sensor device by transmitting the data to a collection hub, which is a Smartphone + a mobile software application (app). Transmit data to a remote data center, which is accomplished via the cellular network. Store, process, and display data to a health care professional or end user via the Rubicon Analysis Software PC application and its report. The system consists of three major components: Sim Software (firmware), Rubicon App and Rubicon Desktop Software

The Disposable Gold Cup EEG Electrodes are intended for non-invasive use with recording and monitoring equipment, (active and reference), of Electroencephalograph (EEG), electromyography (EMG), and Evoked Potentials (EP).

The EEG electrodes are provided to the healthcare provider in either a set of 10 which are typically used for sleep studies or a set of 15 which are used for EEG monitoring. Each set of electrodes are the same length, however, sets can be ordered in lengths varying from 1.0 to 3.0 meters. Each electrode within a set has a different color to aid in placement.