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The PRIME ECG® with enhanced Diagnostic Algorithm is intended to be used for the recording of electrocardiographic signals. The PRIME ECG® with enhanced Diagnostic Algorithm is indicated for the recording of electrocardiographic signals on the body surface

The device consists of the following components and accessories: PRIME ECG Cart, PRIME ECG Algorithm, PRIME ECG Single-Use Patient Vest. Data recording and analysis is contained within a durable medical device that is used to record, analyze and display electrocardiographic signals from the body surface. The system features a power supply with battery back-up, signal acquisitioning and processing hardware and firmware, a computer and a software, including automated analysis software, a flat panel color display and a color printer. The PRIME ECG System incorporates computer processing that can present conventional ECG waveforms as color images displayed on a simulated torso. Each PRIME ECG recording captures body surface potentials for analysis. The PRIME ECG System translates the segments of the ECG waveform into ranges of color based on measured values. The range from vellow to red is assigned to positive values, with deep red assigned to the highest value. Green is assigned to neutral values and shades of blue are assigned to negative values with deep blue assigned to the highest negative value. This information allows physicians to identify areas of abnormality for interrogation. The PRIME Diagnostic Algorithm is an adjunct to the color displays of the underlying ECG waveforms to assist the physician in coming to a conclusion on the patient's cardiac status. The Diagnostic Algorithm uses multiple parameters of ECG potentials and ECG morphology to make a recommendation on whether the patient has a Normal, Abnormal or Acute MI condition. An explanation window describes to the physician the basis of the Diagnostic Algorithm conclusion. Thus, the physician is at liberty to interrogate the recommendation and agree to or override it. The PRIME ECG data recording and analysis system is attached to a single-patient electrode array (vest) that is placed on the patient in two parts consisting of a 64 lead anterior and a 16 lead posterior segment. Electrodes and signal conduction pathways are screen-printed onto a clear plastic substrate. The vest is secured to the patient with a pre-applied conductive adhesive gel. The vest is a single use device and cannot be re-used.