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The Biosensor CMS Holter Analysis system is intended for patients requiring anbulatory monitoring is most frequently used for the indications below. 1. Evaluation of symptoms suggesting arrhythmia or myocardial ischemia. 2. Evaluation of Symptoms suggesting army announce of the works 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. Evaluation of patients with pacemakers 7. Reporting of time and frequency domain heart rate variability 8. Reporting of QT Interval.

Holter analysis systems contain software, which must perform effectively, accurately, and reliably.

The Biosensor Frequency Domain Heart Rate Variability (FD HRV), analysis option is being incorporated into the Biosensor Holter Monitor System for quantification and graphical displays of heart rate changes over a specific monitoring period as an aid to other clinical diagnostic techniques. The FD HRV graph is modeled after the recommendations of the Task Force of the European Society of Cardiology (Circulation. 1996;93: 1042-1065). FD HRV is intended to provide HRV spectra for any selected time segment of 5 minutes of duration or longer, at the physician's discretion.

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The Biosensor Holter Monitor System is intended for patients requiring ambulatory (Hotter) monitoring from 1 to 24 hours. Such monitoring is most frequently used for the indications below, (Portions from Ambulatory Electrocardiograph Recording, Wegner NK, Mock MB, and Reingquist I, Year Book Medical Publishers, 1981.) 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 patient's response after resuming occupational or recreational activities (e.g., after M.I. or cardiac surgery.) 5. Evaluation of clinical syndromes or situations where arrhythmia may increase the risk of sudden death. 6. Clinical and epidemiological research studies.

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Stress and ECG systems contain digital and analog hardware, associated firmware and software, which must perform effectively, accurately, and reliably.