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The FLOCAP is to provide a semi-quantitative visualization of the CO2 in the patient airway. It is an adjunct in patient assessment, to be used in conjunction with other methods to determine clinical signs and symptoms by or on the order of a physician. The FLOCAP has a visual indicator to visually detect the end of exhalation. For use up to 24 hours. For patients greater than 15 kg (33 lbs.) Environment of use - hospital, sub-acute, pre-hospital, transport

The proposed FLOCAP is comprised of several components: - Housing with standard 15 mm / 22 mm fittings to connect to ventilatory assist devices and a face . mask or endotracheal tube - . Colorimetric litmus media which has been treated with chemical to detect the presence of CO2 by a change in pH - . A spinner / vane which spins when there is expiratory flow. It is to detect presence of expiratory flow

The MaxMixing Block is designed to provide intermittent or continuous controlled flows of an air/oxygen gas mixture to infant, pediatric, and adult patients. The MaxMixing Block is intended to be used with a Maxtec Oxygen Analyzer device. The MaxMixing Block is a restricted medical device intended for use by qualified trained personnel under the direction of a physician in institutional environments where delivery and monitoring of air/oxygen mixtures is required.

The MaxMixing Block uses the well known technology of two compensated thorpe tube flowmeter to control and measure medical grade air and oxygen at an accurate flow rate as per a calibrated reference pressure (50 psig +/- 5 psig). The two gases are then mixing block for continuous air/oxygen delivery at oxygen concentrations of 21 - 100% as prescribed. There are no new technological characteristics introduced with respect to design, materials, chemical composition or energy source for the MaxMixing Block from those of flowmeters currently sold for medical use. There are differences with respect to mixers, in that the subject device has a wider pressure differential tolerance requirement since Oxygen concentration is much less affected by pressure differential as compared to the blender predicate devices. The blender predicate devices have a single gas failure alarm which is intended to indicate narrow pressure differential between air and Oxygen gas sources and failure of a single gas source, either air or Oxygen. The subject device also has a single gas failure alam which indicates a broader pressure differential between air and Oxygen gas sources and failure of a single gas source, either air or Oxygen.

The MaxO2 CU is a continuous use monitor of oxygen concentration in a patient breathing environment. It may be provided with an oxygen concentration dilution method which could be of a flowmeter, manifold or venturi design, which can deliver a set or adjustable FiO2 oxygen concentrations and flow rates to the patient. It is not intended for use with life supporting systems.

The MaxO2 CU is a combination of a continuous use oxygen monitor and a venturi oxygen dilution system in one device. An analogous device could be assembled by attaching a wall mount oxygen flow meter to a commercially available venturi and attaching the venturity a standard in-line oxygen analyzer. The MaxO2 CU offers this set-up to the clinician in one package. There are two models, one with adjustable flow and adjustable FiO2. The other has fixed flow and adjustable FiO. The flow adjustment is accomplished by adjusting the flow of oxygen through the venturi orifice. The adjustable oxygen % is accomplished by adjusting the flow of oxygen into the region surrounding the venturi orifice. This oxygen is drawn into the venturi stream in place of room air, increasing oxygen content in the mixture. The oxygen analyzer electronics, sensor, and programming are identical to the MaxQ+ predicate K040484.

The MAXO2+ is intended as a tool for use by qualified personnel to spot-check or measure oxygen concentration of a delivered air/ oxygen mixture. The MAXO2+ is not intended for use in continuous monitoring of oxygen delivery to a patient.

The MAXO2+ A(E) oxygen analyzer is a member of Maxtec's MAXO2 analyzer line of oxygen analyzers and monitors. It utilizes the MAX-250 oxygen sensor and is engineered for long life, maximum reliability and stable performance.