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The Natus Breath Analyzer is intended for non-invasive, quantitative measurement of respiratory rate, end tidal carbon dioxide concentration, and end tidal carbon monoxide (corrected for background carbon monoxide) concentration in the breath. The analyzer is intended for use with neonates, children, and adults breathing spontaneously. The analyzer measures the carbon monoxide concentration in end tidal breath, as an indicator of the blood level of COHb. The level of COHb (and consequently the concentration of carbon monoxide in the end tidal breath) can be affected by endogenous sources (for example the rate of hemolysis), exogenous sources (for example, combustion engine exhaust), or in some cases both. The COHb level, elevated or normal, can be used in the diagnosis of medical conditions in which the rate of hemolysis may be relevant, and in the monitoring of patient populations affected by the rate of hemolyzer is also indicated for use in respiratory status evaluation, whenever measurements of respiratory rate and end tidal carbon dioxide concentration are desired. The analyzer is intended for use under the direction of a physician in hospitals and a variety of health care settings.

The Natus Breath Analyzer system is a point-of-care test that consists of the instrument and a single-use patient sampler. The patient sampler incorporates a flexible nasal catheter with a filter cartridge that attaches to the device. An integral adhesive strip on the catheter aids in proper placement in the nostril. The computer-controlled instrument contains two gas analysis sensors: an infra-red carbon dioxide sensor and an electrochemical carbon monoxide sensor. The signal produced by the carbon dioxide sensor is analyzed to determine the end tidal carbon dioxide concentration and the respiratory rate. The signal produced by the carbon monoxide sensor is analyzed to determine the average carbon monoxide concentration. The end tidal carbon monoxide concentration is calculated by an algorithm using carbon monoxide and carbon dioxide concentrations. During the automated test procedure the device displays appropriate prompts. The user operates the instrument by selecting menu options from the display screen. During sampling, a small volume of the patient's breath is continuously drawn into the instrument for a short time. Results are displayed and printed at the end of the test. The Natus Breath Analyzer utilizes the same respiratory gas concentration measurement technology as the predicate devices.