MONITORED THERAPEUTICS, INC. 45-90058 GoSpiro

Device Description:The GoSpiro® is intended to be used by adults and children over 5 years old in physician’s offices, clinicsand home settings to conduct basic lung function and spirometry testing. It is a single-patient, use device.The GoSpiro spirometer transmits real-time lung function data to computers, tablets or smartphones over aBluetooth connection for tele-healthcare applications. The GoSpiro performs full flow-volume loopsincluding inspiratory and expiratory data. The internal program performs all of the calculations formeasurements to meet American Thoracic Society and European Respiratory Society requirements. It hasbuilt-in quality control measurements and transmits indices of measurement quality including time to peakflow, back-extrapolated volume, total expiratory time, and end-expiratory flow detection.It is used with the GoSpiro App display and communications software on a smartphone or tablet.The GoSpiro is powered by an internal rechargeable Lithium battery and is charged via its USB chargingstation connected to a USB power source. The device complies with ES 60601-1, IEC 60601-1-2, and IEC60601-1-11.The fundamental technology to measure flow is a vertical turbine volume sensor. The turbine transducermeasures expired air directly at B.T.P.S. (body temperature and pressure with saturated water vapor) thusavoiding the requirement for temperature correction on exhalation. An electronic temperature sensor on thedevice PCB measures atmospheric temperature, thus enabling correction of inspired volumes and flows. Thistransducer is insensitive to the effects of condensation and temperature and avoids the need for individualcalibration prior to performing a test.Indications for Use:The GoSpiro® is intended to be used by adults and children over 5 years old in physician’s offices, clinicsand home settings to conduct basic lung function and spirometry testing. It is a single-patient use device.