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Biofourmis Everion+ (G2) provides continuous monitoring of the following vital signs in adults, 18 years of age or older, when at rest: - · Pulse rate - · Respiration rate - · Movement - · Skin temperature Biofourmis Everion+ (G2) also provides Blood oxygen saturation (SpO2) as a vital for continuous data collection in adults, 18 years of age or older, when at rest. Biofourmis Everion+ (G2) is intended for use in a hospital or home environment to support monitoring of wearers under the care of a trained healthcare professional. Biofourmis Everion+ (G2) is not intended for use in a critical care environment such as an ICU or operating room. The device information should not be the sole basis for clinical decisions.

The Biofourmis Everion+ (G2) is a wireless multi-parameter vital-signs monitoring system. The Everion+ was includes an Application Programming Interface (API), which is intended to allow development of user interface applications that enable clinicians and medically-qualified personnel to access recorded vital signs information for patient monitoring. The system is comprised of the following components: - . Wearable device with multiple sensors - . Secure cloud environment with an API - Charger with accessories - . Armband The Everion+ G2 wearable is battery-operated with integrated sensors and wireless transceiver. The device is reusable and considered multi-patient use. After a healthcare professional (HCP) prescribes a device to a patient, they can clean the device according to the accompanying documentation for normal expected wear and buildup on the device. When the patient no longer needs the device for remote monitoring, the device can be returned to the HCP and undergo a low-level disinfection process, so it can be prescribed to a new patient. The wearable is worn on the upper arm via the adjustable armband that snaps to it. The armband is made of a stretchy material and has an adjustable clip to enable fitting to most adults. The patient contacting components primarily involved in permanent contact are the bottom device housing and the armband. The wearable continuously gathers multiparameter vital signs data from the person being monitored and securely transmits the data to the server component of the system, via cellular communication, when in range of a third-party receiver. When not in range, the collected data is stored on the Everion+ G2 wearable and transmitted when connection has been restored. Through APIs of the cloud environment, the data may be accessed from the cloud storage or integrated into a third-party application for monitoring.

RhythmAnalytics is a software application for the assessment of cardiac arrhythmias using single-lead ECG data in subjects over 18 years of age. It is intended for use by a healthcare solution integrator to build web or mobile applications to let qualified healthcare professionals review and confirm the analytic result. The product supports downloading and analysing data recorded in compatible formats from any FDA cleared device used for the arrhythmia diagnostics such as Holter, event recorder, or other similar devices when of the rhythm is necessary. RhythmAnalytics can also be electronically interfaced, and perform analysis with data transferred from other computer based ECG systems, such as an ECG management system. RhythmAnalytics provides ECG signal processing and analysis, QRS and Ventricular Ectopic Beat detection, QRS feature extraction, interval measurement, heart rate measurement, and rhythm analysis. RhythmAnalytics is not for use in life supporting or sustaining systems or ECG monitor and Alarm devices. The product can be integrated into medical devices. In this case, the medical device manufacturer will identify the indication for use depending on the application of their device. RhythmAnalytics interpretation results are not intended to be the sole means of diagnosis. It is offered to physicians and clinicians on an advisory basis only in conjunction with the physician's knowledge of ECG patterns, patient background, clinical history, symptoms, and other diagnostic information.

RhythmAnalytics consists of (1) A web application programming interface (API) which an authentic user to upload single-lead ECG data and reports ECG interpretation results, and (2) An automated proprietary algorithm, i.e., cardiac beats/arrhythmias detection which measures and analyzes ECG data to provide qualified healthcare professional supportive information for review. RhythmAnalytics is only intended to analyze recordings performed on adults (over the age of 18). RhythmAnalytics works in the following sequence: - Accept uploading digital ECG files via secure API; - Analyse the uploaded ECG using RhythmAnalytics proprietary algorithm, which detects cardiac beats/arrhythmias and intervals including: - Heart rate determination - RR Interval measurements - ORS - Non-paced arrhythmias - Non-paced ventricular arrhythmia calls - Ventricular ectopic beats - RhythmAnalytics returns the interpretation result to be reviewed by a qualified healthcare professional.