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ECG is intended to disclose either normal condition or patterns of arrhythmia, myocardial ischemia, rate abnormalities, or features of prognostic value in patients: 1) suspected of cardiac abnormalities, or 2) in populations of patients at an age or period in which a routine baseline evaluation of ECG characteristics are desired. 3) QT Analysis is useful in the assessment of long QT syndrome (LQTS). In some instances, LQTS can be corrected by pharmacologic therapy. QT analysis is also used to measure QT dispersion, the difference between maximal and minimal QT values. QT dispersion is a measure of the inhomogeneity of ventricular repolarization. 4) The PCECG-1200 System With MEANS has been tested to measure Heart Rate Variability within 1 millisecond tolerance. The clinical significance of HRV measures should be determined by a physician. 5) The PCECG-1200 System With MEANS has been tested to measure Late Potential within 1 millisecond tolerance in the time domain, and 1 microvolt tolerance in voltage. The clinical significance of Heart Rate Variability measures should be determined by a physician. Stress testing intended use: Angina pectoris (chest pain) is a clinical syndrome resulting from myocardial ischemia, indicative of a reduced blood supply to the cardiac muscle. The electrocardiogram may establish the diagnosis of ischemic heart disease if characteristic changes are present. Stress testing is the most widely used method to decide whether this chest pain is related to myocardial ischemia, and thereby coronary artery disease. In stress testing, the contractile capability of the heart muscle is monitored via ECG during patient exercise. Patients are exercised by bicycle, treadmill, or other means while continuously monitoring the ECG. Exercise loads are determined by predefined protocols. The ECG signals are recorded for the resting, exercise and recovery portions of the exercise protocol. The changes in ECG waveforms are compared to the resting ECG records. Although not necessary, most of the commercial stress test systems control the bicycle or treadmill automatically according to the requirements of the chosen protocol. ST segment monitoring is intended as an aid in the evaluation of myocardial ischemia in patients with known or suspected coronary artery disease. The ST segment algorithm has been tested for accuracy of the ST segment data, and a database has been used as a tool for performance testing. The significance of the ST segment changes must be determined by a physician.

The PCECG-1200 System With Modular ECG Analysis System (MEANS) is designed to disclose either normal condition or patterns of arrhythmia, myocardial ischemia, rate abnormalities, or features of prognostic value. The System comprises: - · Data Acquisition Unit - · RF transceiver - · USB communications cable - · Software application - · Software access security lock (dongle), optional The system acquires ECG data and displays it on the color monitor, calculates and controls some parameters of ECG display such as sweep speed, filters line interference and muscle noises introduced during monitoring, makes necessary outputs, handles the user interface, and controls the flow of operations. Acquired data is stored, and subsequently transferred to the PC for display. Up to 12 channels of real time ECG display are possible. The available commands, calculation of results and status messages are also displayed. All commands are initiated via keyboard. ECG is analyzed by the Modular ECG Analysis System (MEANS), which is a cleared O.E.M. SW Application obtained by Norav from the producer: the Department of Medical Informatics Erasmus University Medical Center Rotterdam, the Netherlands.

ECG is intended to disclose either normal condition or patterns of arrhythmia, myocardial ischemia, rate abnormalities, or features of prognostic value in patients: l ) suspected of cardiac abnormalities, or 2) in populations of patients at an age or period in which a routine baseline evaluation of ECG characteristics are desired. 3) OT Analysis is useful in the assessment of long QT syndrome (LQTS). In some instances, LQTS can be corrected by pharmacologic therary. QT analysis is also used to measure QT dispersion, the difference between maximal and minimal QT values. QT dispersion is a measure of the inhomogeneity of ventricular repolarization. 4) The PC ECG 1200W System has been tested to measure Heart Rate Variability within 1 millisecond tolcrance. The clinical significance of Heart Rate Variability measures should be determined by a physician. 5) The PC ECG 1200W System has been tested to measure Latc Potential within 1 millisecond tolerance in the time domain, and I microvolt tolerance in voltage. The clinical significance of Heart Rate Variability measures should be determined by a physician. Stress testing intended use: Angina pectoris (chest pain) is a clinical syndrome resulting from myocardial ischemia, indicative of a reduced blood supply to the cardiac muscle. The electrocardiogram may establish the diagnosis of ischemic heart disease if characteristic changes are present. Stress testing is the most widely used method to decide whether this chest pain is related to myocardial ischemia, and thereby coronary artery disease. In stress testing, the contractile capability of the heart muscle is monitored via ECG during patient exercise. Patients are exercised by bicycle, treadmill, or other means while continuously monitoring the ECG. Exercise loads are determined by predefined protocols. The ECG signals are recorded for the resting, exercise and recovery portions of the exercise protocol. The changes in ECG waveforms are compared to the resting ECG records. Although not necessary, most of the commercial stress test systems control the bicycle or treadmill automatically according to the requirements of the chosen protocol. ST segment monitoring is intended as an aid in the evaluation of myocardial ischemia in patients with known or suspected coronary artery disease. The ST segment algorithm has been tested for accuracy of the ST segment data, and a database has been used as a tool for performance testing. The significance of the ST segment changes must be determined by a physician.

The PC ECG 1200W System is designed to disclose either normal condition or patterns of arrhythmia, myocardial ischemia, rate abnormalities, or features of prognostic value. The System comprises: - · PCECG 1200W data acquisition unit - · PCECG 1200WR RF transceiver - · USB communications cable - · Software application - · Software security lock (dongle) for access to stress testing functions (optional)

The Norav Holter Analysis System is intended for patients requiring ambulatory (Holter) monitoring from 1 to 48 hours. Such monitoring is most frequently used for the indications below: 1) Evaluation of symptoms suggesting arrhythmia or myocardial ischemia. 2 ) Evaluation of ECG documenting therapeutic interventions in individual patients or groups of patients. 3) Evaluation of patients for ST segment changes. 4) Evaluation of a patient's response after resuming occupational or recreational activities (e.g. after M.I. or cardiac surgery.) 5) Clinical and epidemiological Research Studies 6) Norav Holter Systems containing Heart Rate Variability (HRV) software have been of Tronor Heart Rate Variability within 4 ms tolerance. The clinical significance of Heart Rate Variability measures should be determined by a physician. 7) Evaluation of patients with pacemakers.

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