DEVICE: Vapotherm (00841737105787)

An electrically-powered unit designed to be connected to a pulse oximeter sensor and used during the administration of oxygen (O2) to a spontaneously breathing patient, for: 1) continuous monitoring of physiologic parameters, especially haemoglobin oxygen saturation (SpO2); and 2) dynamic regulation of the amount of O2 delivered to the patient based on physiological parameter measurements. It is a computerized unit designed to interface between the O2 source and the patient and includes monitoring functionality, a graphic display, alarm(s), electronic gas valve, and integrated software.

An electrically-powered device designed to interface between a pulse oximeter probe and an electronic medical gas regulating unit during oxygen (O2) therapy, to continuously monitor haemoglobin oxygen saturation (SpO2), calculate the appropriate volume of O2 needed to be delivered to the patient based on SpO2 values, and transmit an electronic signal to the electronic O2 regulating unit. It includes a display, alarm(s), and integrated software; it does not come into direct contact with medical gases (i.e., does not include a gas regulator or tubing).

An electrically-powered device designed to deliver high-flow (exceeding peak inspiratory flow) heated and humidified ambient air or air/oxygen, at a manually set oxygen concentration (FiO2), to a spontaneously breathing patient. It is intended for use by a healthcare provider as part of noninvasive ventilation (NIV), in a peri-anaesthesia environment, or for a patient experiencing a respiratory disorder [e.g., chronic obstructive pulmonary disease (COPD)]. It typically consists of a gas flow generator, a heating element, and humidification chamber.