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The Oxycon Pro is a software-driven, medical device for exercise measurements, including ECG ST Segment Analysis and/or ECG Stress Analysis. It measures the human response to increasing workloads with emphasis on the gas exchange parameters. Measurements include ventilation, oxygen uptake, carbon dioxide excretion, heart rate and derived parameters. The results of the tests, including the ECG wave forms, can be viewed on the computer screen and can be printed during the test. The test results can be saved on the computer hard disk for further referral or report generation purposes. The Oxycon Pro interfaces to a testsubject via a mouthpiece or a face mask and ECG electrodes. The Oxycon Pro interfaces to a peripheral ergometer or treadmill. The patient population is 4 age and older. The Oxycon Pro is capable of performing computerized ECG interpretation during resting condition. The intended use locations are either in a physician office, hospital exercise rehabilitation facilities, or similar areas. It is intended to be used by or on the order of a physician or similar qualified health care professional. This device is intended for use in the hospital environment, physician's office, or similar settings. This device is not intended for home use.

The Oxycon Pro is a software-driven, medical device for exercise measurements, including ECG ST Segment Analysis and/or ECG Stress Analysis. It measures the human response to increasing workloads with emphasis on the gas exchange parameters. Measurements include ventilation, oxygen uptake, carbon dioxide excretion, heart rate and derived parameters. The results of the tests, including the ECG wave forms, can be viewed on the computer screen and can be printed during the test. The test results can be saved on the computer hard disk for further referral or report generation purposes. The Oxycon Pro interfaces to a testsubject via a mouthpiece or a face mask and ECG electrodes. The Oxycon Pro interfaces to a peripheral ergometer or treadmill.

The OxyconAlpha with option ECG is a software-driven, medical device for exercise measurements, including ECG ST Segment Analysis and/or ECG Stress Analysis. It measures the human response to increasing workloads with emphasis on the gas exchange parameters. Measurements include ventilation, oxygen uptake, carbon dioxide excretion, heart rate and derived parameters. The results of the tests, including the ECG wave forms, can be viewed on the computer screen and can be printed during the test. The test results can be saved on the computer hard disk for further referral or report generation purposes. The OxyconAlpha with option ECG interfaces to a testsubject via a mouthpiece or a face mask and ECG electrodes. The OxyconAlpha with option ECG interfaces to a peripheral ergometer or treadmill. The patient population is 4 age and older, The OxyconAlpha with option ECG is capable of performing computerized ECG interpretation during resting condition. The intended use locations are either in a physician office, hospital exercise rehabilitation facilities, or similar areas. It is intended to be used by or on the order of a physician or similar qualified health care professional. This device is intended for use in the hospital environment, physician's office, or similar settings. This device is not intended for home use.

The OxyconAlpha with option ECG is a software-driven, medical device for exercise measurements, including ECG ST Segment Analysis and/or ECG Stress Analysis. It measures the human response to increasing workloads with emphasis on the gas exchange parameters. Measurements include ventilation, oxygen uptake, carbon dioxide excretion, heart rate and derived parameters. The results of the tests, including the ECG wave forms, can be viewed on the computer screen and can be printed during the test. The test results can be saved on the computer hard disk for further referral or report generation purposes. The OxyconAlpha with option ECG interfaces to a testsubject via a mouthpiece or a face mask and ECG electrodes. The OxyconAlpha with option ECG interfaces to a peripheral ergometer or treadmill.

The OxyconAlpha is used as a predictive pulmonary function value calculator (Product code BTY). It is a software-driven, active medical device for investigational exercise measurements. It measures the human response to increasing workloads with emphasis on the gas exchange parameters. Measurements include ventilation, oxygen uptake, carbon dioxide production and derived parameters. It is the intention to determine on patients a cardiopulmonary limitation and to test on sport athlets their training level. The different load levels for both groups can be generated over a bicycle ergometer or over a treadmill. The patient population is age 4 and older. The environment of use is indoor. The OxyconAlpha interfaces to a testsubject via mouthpiece or a face mask. The OxyconAlpha interfaces to peripheral equipment and is therefore available in a variety of configurations from a standard controlled ergospirometry unit to a fully expandable laboratory system with blood pressure monitor, treadmill and ergometer. The OxyconAlpha interacts with the ECG signal (recorded by another device) only to the extent of extracting the patient's heart rate from the ECG signal. Other uses such as displaying or further analyzing the ECG waveforms are not included in the present submittal. The device is not intended for use as a diagnostic pulmonary-function interpretation calculator.

The OxyconAlpha is a software-driven, active medical device for investigational exercise measurements. It measures the human response to increasing workloads with emphasis on the gas exchange parameters. Measurements include ventilation, oxygen uptake, carbon dioxide production and derived parameters. It interfaces to a testsubject via mouthpiece or a face mask and to peripheral equipment such as a bicycle ergometer or treadmill. It can interact with an ECG signal (recorded by another device) to extract the patient's heart rate.