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The MouthLab Vital Signs Monitoring System is a hand-held, wireless device intended to record, transfer, store and display single lead electrocardiography (ECG), heart rate variability (HRV), functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), respiration rate (RR), respiration pattern (RP), oral temperature (TEMP) and basic lung function measurements: peak expiratory flow (PEF) and forced expiratory volume in one second (FEV1). This system is for spot checking and does not have continuous monitoring capability or any alarm features. The device comes in contact with the user for approximately 60 seconds at each use and the captured medical parameters shall be displayed on a mobile application. It is intended for use by adults in the home environment and in healthcare facilities. This system makes no specific diagnosis. Respiration rate is not intended for adults with underlying or suspected medical conditions. The device is for single user use. It is intended for use with users who are well perfused and during no motion condition. Users with implanted pacemakers and/or implanted cardioverter-defibrillators (ICDs) are not recommended to use the device.

The MouthLab Vital Signs Monitoring System is a non-invasive, battery-powered, handheld, wireless, personalized single-user, vital sign measuring apparatus. The device is intended to intermittently monitor the user vitals through the use of an integrated SpO2 sensor, ECG electrodes, microphones and thermistor, which measures the users' functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), oral temperature (TEMP), ECG, heart rate (HR) and heart rate variability (HRV). The users' respiration rate (RR) measurements, respiration pattern (RP) and the basic lung functions (FEV1 and PEF) measurements are obtained are obtained through the acoustic measurement of air turbulence. The vital signs data are transferred to the Aidar Cloud™ Application via a cellular network for processing and storage. This processed data is then displayed on the Aidar Care™ Mobile Application.