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The Philips ST80i Stress Test System is a PC-based diagnostic tool intended to acquire, process, and store ECG data of patients undergoing stress exercise testing. The software records ECG, heart rate, and ST data, creates summary tables, trends, and produces a final report regarding a variety of cardiac data indices. The cardiac data provided by the Stress system is intended to be reviewed, confirmed, and used by trained medical personnel to assist in the evaluation of the patient's cardiovascular condition and the patient's physiological condition during stress exercise testing. The arrhythmia detection portion of the ST80i Stress Exercise System is provided to the user for the convenience of automatic detection of arrhythmias but does not provide alarms.

The Philips ST80i Stress Test System is indicated for use in exercise ECG testing where the clinician decides to evaluate the electrocardiogram of patients at 10 years or older, as part of decisions regarding possible diagnosis, potential treatment, effectiveness of treatment or to rule out causes for symptoms of cardiovascular disease. The Philips ST80i Stress Test System is not intended to be used as a physiological monitor.

The ST80i Stress Test System is a PC-based diagnostic tool intended to acquire, process, and store ECG data (resting and physiologic) of patients undergoing stress exercise testing and acquire data from ancillary devices (such as SpO2 and Ambulatory Blood Pressure). The software records ECG, heart rate, and ST data, creates summary tables, trends, and produces a final report regarding a variety of cardiac data indices. The arrhythmia detection portion of ST80i Stress Testing System is provided to the user for the convenience of automatic detection of arrhythmias but does not provide alarms. The cardiac data provided by the stress system is intended to be reviewed, confirmed and used for diagnostic purposes by trained medical personnel to assist in the diagnosis of coronary artery disease (CAD) and the patient's physiological condition during stress exercise testing. The ST80i Stress Test System will be offered in two versions which are a complete turnkey system which includes an ECG data acquisition module, trolley with a PC loaded with the application software and optional thermal printer or a minimal system with the application software and data acquisition module only.

The Philips ST80i Stress Test System is a PC-based diagnostic tool designed to acquire, process, and store ECG data during stress exercise testing. It records ECG, heart rate, and ST data, generates summary tables, trends, and reports for cardiac data indices. The system's arrhythmia detection offers convenience but does not provide alarms. It is intended to assist trained medical personnel in evaluating cardiovascular conditions, diagnosing coronary artery disease (CAD), and assessing physiological conditions during stress exercise testing for patients 10 years or older. It is not intended as a physiological monitor.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the ST80i Stress Test System are largely demonstrated through its equivalence to the predicate devices, CASE V6.6 and CS V6.6 Cardiac Testing Systems. The provided documentation presents a comparison of specifications and features rather than explicit acceptance criteria with numerical targets. The "Comparison" column indicates whether the ST80i's performance is "Same," "Similar," or "Different" to the predicate.

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