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The Biotres is indicated for use on adult patients 18 years or older who may be asymptomatic or who suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light headedness, pre-syncope, syncope, fatigue, chest pain and/or anxiety and may require cardiac recording on a continuous basis for up to 30 days. The signal acquired by the Biotres is not intended and should not be used for automated or semi-automated analysis.

The Biotres system consists of 1) the Biotres Recorder, 2) a dedicated Biotres AC wall charger, 3) Biotres Gateway application for use on mobile devices using Android or iOS, and 4) Biotres Configured Secure Server. The Biotres Recorder is an ECG recording only device and does not include ECG analysis, alarms and is not a real time ECG monitor. The Biotres recorder is a small, lightweight, ambulatory, reusable 3 channel ECG recorder that is placed on the center of the chest. The Biotres Recorder has two buttons: 1) power button and 2) patient event marking button. There is an LED "status indicator light" in the middle of the patient event marking button that provides recorder status indications. The Biotres Recorder attaches to the patient's chest through three standard commercially available ECG electrodes. Biotres includes a Bluetooth modem to communicate with the Biotres Configured Secure Server through the Biotres Gateway Application. The Biotres Recorder integrated memory can store up to 30-days of ECG data. This data can be uploaded by the clinician to the Biotres Configured Secure Server. The dedicated Biotres AC Wall charger is used to charge the Biotres Recorder daily when disconnected from the patient. The ECG recorded data is transferred via the Biotres Gateway App via a Bluetooth connection and subsequently to the Biotres Configured Secure Server. Clinicians can use the Biotres Gateway Application using their privileged login credentials to connect Biotres Recorders to the Biotres Configured Secure Server so that patient studies may be started and completed. The Biotres Gateway Application can be used by the patient once registered (nonprivileged login credentials) and the patient can use the application to monitor the status indicators of the Biotres Recorder and to enter symptoms if the Event Marking Button is pressed on the recorder. The ECG recorded data from the Biotres Recorder can be transferred, by the clinician, from the Biotres Configured Secure Server when the recorder is connected to the Biotres Gateway App at the end of a patient study. The Biotres Configured Secure Server is an SFTP server that is configured to work with the Biotres System. The server enables the Clinician, through secured login, to command the Biotres Recorder (e.g. initiate ECG data collection) and to access uploaded MIT16 ECG data recordings when the ECG data collection is complete. Biotres does not provide the patient or clinician with diagnostic or interpretive statements based on the ECG data. Biotres ECG recordings can be viewed through the Bioflux Software II (K201040) by qualified medical personnel.

The Biotres is indicated for use on adult patients 18 years or older who may be asymptomatic or who suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light headedness, pre-syncope, fatigue, chest pain and/or anxiety and may require cardiac recording on a continuous basis for up to 30 days. The signal acquired by the Biotres is not intended and should not be used for automated or semi-automated analysis.

The Biotres system consists of 1) the Biotres Recorder, 2) a dedicated Biotres AC wall charger, 3) Biotres Gateway application for use on mobile devices using Android or iOS, and 4) Biotres Configured Secure Server. Biotres Recorder: The Biotres Recorder is an ECG recording only device and does not include ECG analysis, an ECG viewer/EGG display, alarms and is not a real time ECG monitor. The Biotres recorder is a small, lightweight, ambulatory, reusable 3 channel ECG recorder that is placed on the center of the chest. Biotres AC Wall Charger: The dedicated Biotres AC Wall charger is used to charge the Biotres Recorder daily when disconnected from the patient. Biotres Gateway Application: The ECG recorded data is transferred via the Biotres Gateway App (Downloaded from the app store for iOS or Android respectively) via a Bluetooth connection and subsequently to the Biotres Configured Secure Server. Biotres Secure Server: The Biotres Configured Secure Server is an SFTP server that is configured to work with the Biotres System. The server enables the Clinician, through secured login, to command the Biotres Recorder (e.g. initiate ECG data collection) and to access uploaded MIT16 ECG data recordings when the ECG data collection is complete.

Bioflux Software II is intended to be used to view and annotate data acquired from diagnostic ECG sources of 1 to 3leads. Bioflux Software II is operated in a web browser and data is accessed via the users' credentials on the hardware platform running the web browser. It will be used by cardiologists, general practitioners, cardiac, ECG technicians, nurses, monitoring service technicians, and other cardiac related institutions. Bioflux Software II will be used in independent clinical testing facilities. clinics, hospitals, physician's offices, or anywhere a physician or qualified practitioners deem appropriate. Bioflux Software II does not offer diagnosis, or medical alarms. It is intended that competent human intervention be involved before any impact on health occurs. Clinical judgement and experience are used to check and interpret the data.

Bioflux Software II is a browser based ECG viewer software that displays ECG records and provides tools for trained clinicians to annotate (store, retrieve and report) those ECG recordings. It is utilized by manually opening ECG files of supported formats or through an API that allows for third parties to integrate their devices and directly push ECG files into the viewer. Bioflux Software II fulfills all of the following: - 1. It is a cardiology software product, running locally in a browser. - 2. Bioflux Software II operates on 2018 or later versions of Chrome and Firefox browsers. - 3. The data can be opened manually or entered via keyboard, mouse or touchscreen where upon it gets opened in the browser for viewing and storage. - 4. Information can be displayed on the computer monitor or printed on paper using the web browser.

The bioflux Device is intended for use by patients who either have or are at risk of having cardiac disease and those that demonstrate intermittent symptoms indicative of cardiac disease and require cardiac monitoring on a continuing basis for up to 30 days. The device continuously records ECG data and upon detection by an ECG analysis algorithm or manually initiated by the patient, automatically delivers the recorded cardiac activity to the server where it is presented and can be reviewed by a medical professional. The data received from the bioflux device can be used by another device for arrhythmia analysis, reporting and signal measurements. The bioflux device is not intended to sound any alarms. The device does not deliver any therapy, administer any drugs, provide interpretive or diagnostic statements or provide for any life support. bioflux is for prescription use only.

The bioflux system consists of the bioflux device and the server. The bioflux device is a portable, battery-powered, wireless cardiac monitor which may be worn by a patient to record ECG and activity level data for up to 30 consecutive days. The device can capture patient activated and auto-triggered events such as Bradycardia, pause and Atrial Fibrillation as identified by an embedded arrhythmia detection algorithm. The device is designed to automatically deliver the data to the server. The data is delivered to the server wirelessly via mobile cellular dedicated network connection. A medical professional, using the server, can adjust and program the device configuration and autotriggering parameters. bioflux device is not a life-supporting or life-sustaining system. Clinical judgment and experience are used to check and interpret the data.

Bioflux software is intended to be used to analyze, view, and report ECG data acquired from a variety of ECG sources including single and 3-lead ECG devices. Bioflux software is operated locally in a browser and data is accessed via the users' credentials on the hardware platform running the browser. It will be used by cardiologists, general practitioners, cardiac, or ECG technicians, nurses, monitoring service technicians, and other cardiac related institutions, or care givers, in independent clinical testing facilities, clinics, hospitals, physician's offices, or anywhere a physician or qualified non-physician practitioners deems appropriate Bioflux software does not offer diagnosis, or medical alarms. It is intended that competent human intervention be involved before any impact on health occurs. Clinical judgement and experience are used to check and interpret the data.

Bioflux software is an API based ECG viewer software that can display ECG records and provide tools for trained clinicians to analyze those ECG recordings. It is utilized by manually opening up ECG files of supported formats into the viewer. Bioflux software fulfills all of the following: - It is a cardiology software product, delivered on disk using the Single Page Application model. - It operates on 2015 or later versions of Chrome and Firefox browsers. - The data can be opened manually or entered via keyboard, mouse or touchscreen whereupon it gets sent to the browser for viewing analysis and storage. - Information can be displayed on the display or printed via the browser. Bioflux software is not a life-supporting or life-sustaining system. Clinical judgment and experience are used to check and interpret the data.