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1. The TruVue™ System is intended for use by patients who experience transient symptoms that may suggest cardiac arrhythmia. 2. Patients who require monitoring of effect of drugs to control ventricular rate in various atrial arrhythmias (e.g. atrial fibrillation) 3. Patients with symptoms that may be due to cardiac arrhythmias. These may include but are not limited to symptoms such as: a) dizziness or lightheadedness; b) syncope of unknown etiology in which arrhythmias are suspected or need to be excluded; and c) dyspnea (shortness of breath) 4. Patients recovering from cardiac surgery or interventional procedures who are indicated for outpatient arrhythmia monitoring 5. ECG data recorded by the device can be analyzed by other processing systems, such as the BMS Century Holter system to provide Holter style reports

The TruVue™ system is a continuous ECG monitor and Arrhythmia detector. The system is comprised of a body worn sensor that collects, stores and transmits 2 channels of ECG, a handheld communications device that transmits the ECG to an attended monitoring center and analysis software that continuously analyzes the ECG signal for arrhythmia. The sensor communicates with the handheld over a Bluetooth link, the handheld communicates with the data center over the cellular telephony network or a land line telephony network. Full disclosure ECG is available at the data center for use by the analysis algorithm or for review and further analysis by a monitoring technician or physician.

The Century Series Holter Scanner System, Model C3000/C2000/C1000 is intended for the replay and analysis of ECG data pre-recorded on compatible cassette tape or digital Holter recorders and is indicated for: - Cardiac evaluation of heart rate and rhythm in patients experiencing syncope, near syncope, dizziness, palpitations, shortness of breath, chest pain and transient arrhythmias. - To assess risk for future cardiac events in patients without symptoms from arrhythmia who have bee diagnosed with congestive heart failure, idiopathic hypertrophic cardiomyopathy, and post myocardial infarction with left ventricular dysfunction. - Assessment of drug response in patients taking antiarrhythmic medications. Baseline frequency of the arrhythmia should be characterized as reproducible and of sufficient frequency to permit evaluation. - ST segment analysis in patients with known coronary heart disease, chest pain, and suspected variant angina.

The Century Series Holter Scanner System, Model C3000/C2000/C1000 is a Holter ECG analysis software application that allows evaluation of Holter recordings obtained using solid-state digital Holter recorders or standard cassette tape Holter recorders. It is the successor to the Century Color Trace Holter Analyzer, 510(k) # K884152. The analysis is based on the WPI algorithm, as was the Century Color Trace. The unit features arrhythmia analysis, ST deviation analysis, pacemaker beat detection, and determination of beat types, in both an automatic and interactive mode.