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The PowerCube+ Series is indicated for use in the measurement and data collection of lung function parameters. The system performs cooperation-dependent pulmonary function tests which include Spirometry/Flow-Volume measurement, Body Plethysmography measurement, Lung Diffusion measurement, Occlusive Resistance measurement and Respiratory Muscle Strength measurement. The device provides information that aids in a diagnosis by a clinician. The PowerCube+ Series is indicated for use by a clinician in a professional healthcare setting on adult and pediatric patients who are 5 years and older that can cooperate in the testing.

The GANSHORN PowerCube+ Series is a device that performs cooperation-dependent pulmonary function tests, including Spirometry, Body Plethysmography, Lung Diffusion measurement, Occlusive Resistance measurement and Respiratory Muscle Strength measurement. The device provides information that aids in a diagnosis by a clinician. Spirometry is a set of non-invasive pulmonary function tests where the flow of inhaled/exhaled air is measured to determine physiological parameters such as Peak Expiratory Flow and Forced Vital Capacity. The patient's breathing flow is measured with ultrasound technology inside a breathing insert. Two ultrasound transducers measure the difference in ultrasound wave transit time to calculate breathing flow direction, speed, and volume. Body Plethysmography provides for the measurement of physiological parameters such as Functional Residual Capacity and Specific Airway Resistance. The patient is seated in an air-tight chamber which has a fixed shape and volume. Pressure sensors measure the chamber pressure and the pressure close to the mouth, which is used as a proxy for alveolar pressure when measured under a zero-flow condition. Boyle's Law is used to infer the volume in the lungs from changes in chamber pressure. Lung Diffusion testing is a non-invasive process for measuring diffusion capacity and lung volume. The patient inhales a test gas with known concentrations of helium and carbon monoxide. The patient's breath is held for 10 seconds during which time the helium dilutes into the lungs and the carbon monoxide diffuses through the alveoli into the blood. After 10 seconds of breath-hold time, the patient exhales and the difference between inhaled and exhaled gas concentrations is measured with a gas analyzer. The differences in gas concentration are used to determine physiological parameters such as DLCO (diffusing capacity of the lungs for carbon monoxide) and Alveolar Volume. Occlusive Resistance measurement is an established method for measuring airway resistance during tidal breathing, using a shutter and mouth pressure sensor. Respiratory Muscle Strength measurement is an established method for measuring the maximal strength of respiratory muscles, using a shutter and mouth pressure sensor. The PowerCube+ Series has the following product model configurations: - . PowerCube Body+ includes Spirometry and Body Plethysmography measurement - . PowerCube Diffusion+ includes Spirometry and Lung Diffusion measurement - . PowerCube Body+ / Diffusion+ includes Spirometry, Body Plethysmography, and Lung Diffusion measurement All product model configurations support Occlusive Resistance measurement and Respiratory Muscle Strength measurement. The PowerCube+ Series is mains-powered and not intended for mobile/transportable use.

The Model 9160 VitaloQUB is a whole-body plethysmograph device, when used with the Vitalograph Model 9100, is designed for lung function testing on adults and pediatrics, 6 years and older, by trained medical healthcare professionals in a variety of professional healthcare environments e.g., primary care, hospitals, and pharmaceutical research centers.

The proposed Model 9160 VitaloQUB incorporates the cleared Model 9100 (K221030) with integrated LCD display and ComPAS2 software (K213872). The ComPAS2 software controls valves and reads unprocessed data from the sensors in the Model 9100 and from Model 9160. The ComPAS2 software then determines respiratory parameters including the 2 new parameters. The ComPAS2 software is unchanged from K213872. The Model 9160 and Model 9100 firmware does not determine any respiratory parameters. The Model 9160 is adding 2 additional parameters: - TVG – Thoracic Gas Volume - Raw Airway resistance

The Masterscreen PFT Body is intended to be used for measurement and data collection of lung function parameters. The system performs cooperation-dependent pulmonary function tests which include Spirometry/Flow-Volume/Resistance measurements, lung diffusion measurements and bodyplethysmography measurement. The device provides data / information and supports help for a diagnosis. MasterScreen PFT (Clinical Trial version) includes Spirometry/Flow-Volume/Resistance measurements and lung diffusion measurements with individual access rights defined for different user roles (e.g. Investigator, doctor, study nurse, trainer and service personnel). MasterScreen PFT includes Spirometry/Flow-Volume/Resistance and lung diffusion measurements.

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The Body Box 5500 when used in conjunction with a computer and the ComPAS pulmonary function software is intended to perform plethysmography, diffusion and spirometry to provide pulmonary function testing in adult and pediatric patients.

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