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Breezing Med™ Metabolism Analyzer measures metabolic functions including resting energy expenditure and respiratory quotient during resting conditions via direct measurement of oxygen uptake and carbon dioxide production to provide nutritional assessment, to optimize nutritional supplements, and to quantify substrate utilization. The nutritional assessment enables the healthcare professional to further assess energy expenditure and caloric intake for weight management, and to aid in the diagnosis of diseases related to abnormal metabolic parameters. Breezing Med is intended for use with adults breathing normally on their own in a sitting position in a healthcare environment. Since the device is designed for the patient to breathe ambient air, it is not intended for patients where supplementary oxygen is being provided. Breezing Med is not intended to use as sole means for any diagnosis, and ultimately will provide data for evaluation by the professional.

Breezing Med™ Metabolism Analyzer is a resting metabolic rate measurement system with an application installed on mobile devices that provides measurements of exhalation rate, oxygen uptake and carbon dioxide production. It is used to determine resting metabolic rates, teach energy balance, and pinpoint accurate caloric intake for weight management. Breezing Med™ is a stand-alone and fully integrated mask-like wearable metabolic analyzer based on the principle of indirect calorimetry, which is a gold standard for energy expenditure measurement. Breezing Med is designed for metabolic rate and respiratory quotient measurement and the main outputs include Resting Energy Expenditure (REE), Respiratory Quotient (RQ), Volume of Oxygen consumption (VO2), and Volume of Carbon Dioxide production (VCO2), where REE and RQ are calculated from measured parameters VO2 and VC02. Breezing Med measures the expiratory volume similar to the predicate device Medical Graphics Express® Series. Breezing Med consists of five components: 1) a device body; 2) a mask; 3) headgear; 4) a sensor cartridge; and 5) an application.

The device is indicated for use in mechanically ventilated neonate, infant and pediatic patients where the precise and direct measurement of oxygen uptake (VO2), carbon dioxide excretion (VCO2), resting energy expenditure (REE) and respiratory quotient (RQ) will allow the attending physician to plan and monitor an optimal nutrition regime for the patient in terms of substrate composition and utilization.

The NICU V'O2 device is an indirect calorimeter that allows accurate and precise quantification of oxygen consumption (V'O2), carbon dioxide excretion (V'CO2), resting energy expenditure (REE, the number of calories consumed per day) and respiratory quotient (RQ, the ratio of V'CO2 to V'O2) in mechanically ventilated patients. Patients include neonate, infant and pediatric patients with a body weight from 0.5 kg, low minute ventilation, high respiratory rate, and receiving fluctuating and/or elevated inspiratory oxygen concentrations. The device functions by measuring oxygen concentration (using laser diode sensor technology) and carbon dioxide concentration (using NDIR infrared sensor technology) in inspired and expired gas as well as inspiratory flow. The inspiratory flowmeter (differential pressure type pneumotach) is attached at the patient inspiratory outlet of the ventilator. An inspiratory gas sample line is connected to the inspiratory limb of the patient breathing circuit, and an expiratory gas sample line is connected to the ventilator exhaust. The device automatically alternates between these two sample points. Oxygen consumption is determined by comparing the amounts of oxygen in inspired and expired gas, and carbon dioxide excretion is determined by comparing the amounts of carbon dioxide in expired and inspired gas, respectively, per unit of time. These amounts are calculated from the primary measurements of oxygen and carbon dioxide concentrations and gas flow. The resting energy expenditure (or resting metabolic rate), which is defined as the number of calories the body expends daily during resting conditions, is calculated from the values of oxygen consumption and carbon dioxide excretion using the modified Weir equation: REE = (V'O2 x 3.941 + V'CO2 x 1.106) x 1440 kcal min / day L Respiratory Quotient is calculated as the ratio of carbon dioxide produced by the patient to oxygen consumed by the patient. The duration of measurement can be from tens of minutes to 24 hours, partly because the inspiratory flowmeter only sees dry gas and therefore does not significantly change calibration over time. The device consists of two main components. An analyzer unit to which the patient is connected via gas sample and flowmeter pressure lines, and a computer running the dedicated software application under the Windows operating system. The software application works in conjunction with the hardware, and the computer presents in real time measured signals and computed physiological parameters, both as numeric and graphical data. The computer is the main control interface for the ICU staff using the device and offers options for offline data management. The device is powered through an external medical AC/DC power supply.

The Anascient™ Breath Monitor is intended for use in clinical and research applications to measure oxygen uptake.

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The Metaphor uses the direct measurement of Oxygen uptake (VO2) and Carbon Dioxide production (VCO2) to objectively and noninvasively assess breath by breath metabolic function during rest or exercise. The Metaphor can assess energy expenditure to support nutritional assessment. Optional measurement of Nitrous Oxide (N2O) is available for enhanced accuracy of the CO2 measurement in the presence of N2O. The Metaphor is a comprehensive pulmonary mechanics monitor which can display graphic and numeric data in patients who are mechanically ventilated or breathing spontaneously. The Metaphor pulse oximetry function provides continuous SpO2 and pulse rate measurements in neonatal through adult populations with appropriate probes. The Metaphor provides adjustable visible and audible alarms. The device is not intended for use as a transport monitor.

The Metaphor Metabolic Monitor integrates the functions of a sidestream respiratory gas monitor (CO2, O2, N2O), and pulmonary mechanics monitor (pressure, flow, and volume). These features allow the Metaphor to measure Oxygen uptake (VO2) and Carbon Dioxide production (VCO2) to objectively and noninvasively assess breath by breath metabolic function during rest or exercise. The system is comprised of two main elements: - Metaphor PC software host application running on a dedicated touch screen computer terminal, which presents computed physiological monitoring parameters, including metabolic measurements, as graphic and numeric data. This application manages the user interface, including alarms, and it interfaces to the BXB_DAS. - The BXB DAS embedded measurement platform this subsystem contains the sensor technology to perform the gas, pressure, and flow measurements, and integrates a 510(k) cleared third party pulse oximeter module. The BXB DAS subsystem interfaces with single patient use EZ-Flow sensors and SpO2 sensors.

This device is intended for use in clinical and research application to measure oxygen uptake. Fitmate and Fitmate Pro are designed for the measurement of Resting Metabolic Rate only. Fitmate Pro also measures maximal oxygen uptake (VO2max) that is used for assessing basic pulmonary function.

Fitmate is designed for measuring oxygen uptake at rest and during exercise (VO2max). The device is a metabolic monitor measuring Resting Metabolic Rate (RMR) and Exercise Capacity - VO2max (maximal oxygen uptake), during a sub-maximal or maximal exercise protocol. Fitmate series family includes Fitmate and Fitmate Pro. Fitmate is specifically designed for the measurement of Resting Metabolic Rate only, and Fitmate Pro includes also the measurement of maximal oxygen uptake (VO2max).

The Express Series uses the direct measurement of oxygen uptake to objectively and noninvasively assess cardiac and pulmonary function during exercise. The system can be used to screen for early signs of cardiac and pulmonary dysfunction; differentiate heart and lung disease; assess dyspnea complaints; classify patients according to severity of disease as a guide for patient management; establish an optimal exercise prescription and training program; evaluate the efficiency of prescribed therapy. The Express Series uses the direct measurement of oxygen uptake and carbon dioxide production to provide nutritional assessment, to optimize nutritional supplements and quantify substrate utilization. The Express Series can also provide direct Fick determination of cardiac output using real time oxygen uptake measurements.

The Express Series is a cardiopulmonary exercise or resting metabolic measurement system with an integrated touch screen computer that provides breath by breath measurements of flow, oxygen uptake and carbon dioxide production.

The Ultima system uses the direct measurement of oxygen uptake to objectively and noninvasively assess cardiac and pulmonary function during exercise. The system can be used to screen for early signs of cardiac and pulmonary dysfunction; differentiate heart and lung disease; assess dyspnea complaints; classify patients according to severity of disease as a guide for patient management; establish an optimal exercise prescription and training program; evaluate the efficiency of prescribed therapy. The Ultima system uses the direct measurement of oxygen uptake and carbon dioxide production to provide nutritional assessment, to optimize nutritional supplements and quantify substrate utilization. The Ultima system can also provide direct Fick determination of cardiac output using real time oxygen uptake measurements.

The Ultima system is a cardiopulmonary exercise system that provides breath by breath measurements of flow, oxygen uptake and carbon dioxide production.

The device is intended for use in clinical and research applications to measure oxygen uptake.

The REEVUE is an indirect calorimeter. The REEVUE device measures oxygen consumption (VO2) and estimates Resting Metabolic Rate (RMR) based on the measured VO2 using an assumed respiratory quotient (RQ=0.83). Resting metabolic rate can also be referred to as Resting Energy Expenditure (REE). Measurement of energy requirements can be used for nutritional assessment. A typical application would be for counseling obese patients on their caloric intake requirements. During a test the patient breathes through a mouthpiece with unidirectional breathing valves. These valves allow the patient to breath in ambient air and then direct the expiratory gas down a hose to the device. The flow rate of the expiratory gas is measured and the patient's tidal volume and respiratory rate is calculated. The expiratory gas passes through a mixing chamber so that the mixed expiratory oxygen concentration can be found. The oxygen concentration of the mixed expiratory gas is measured. Oxygen consumption can be expressed as the volume of oxygen breathed in minus the volume of oxygen breathed out. This can be described as: [VO2 - VI|IO2 - VE|E O2] (1) where VO2 is the oxygen consumption, VI is the inspiratory volume, FIO2 is the inspiratory oxygen fraction, VE is the expiratory volume, and FEO2 is the expiratory oxygen fraction. Since the REEVUE only measures the expiratory volume of gas breathed out, the inspired volume must be estimated. This is similar to other legally marketed medical devices. When measuring both CO2 and O2 this is often referred as the Haldane method. To estimate the inspired volume, the components of the expiratory and inspiratory volumes need to be accounted for. In estimating the inspiratory volume the REEVUE requires an estimate of the Respiratory Quotient (Ro). The REEVUE uses an assumed RO of 0.83. The RO is defined as: RQ = VCO2 / VO2 (2) where VCO2 is the carbon dioxide eliminated by the patient's breathing. An estimate of Resting Energy Expenditure (REE) is calculated using the Weir Equation with the assumed RO value of 0.83. Substituting for the VCO2 using the RO and the VO2 the Weir Equation can be expressed as: Calories = { 3.941 VO2-STPD + 1.106 RQ VO2-STPD } x { 1 - 0.082 PF } (3) Where Calories .......... is the calories burned per liter of oxygen consumed. PF ......................is the fraction of total energy production due to protein oxidation. Typical values for Pr range from 0.08 to 0.2, corresponding to 8 to 20% protein. We selected a default value of 0.125 for our calculations. In reporting (REE) in Kcal/day, this simplifies to: RMRKcal/day = 6.925 x VO2-ml/min-STPD (4)

The MedGem is intended for use in clinical and research applications to measure oxygen uptake.

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