Description

The Philips 12-Lead Algorithm

The PageWriter Trim Cardiograph software uses the Philips 12-Lead Algorithm. The algorithm in the software analyzes the morphology and rhythm on each of the 12 leads and summarizes the results. The set of summarized measurements is then analyzed by the clinically-proven ECG Analysis Program.

12-lead Reports may include or exclude ECG measurements, reasons, or analysis statements.

Intended Use

The intended use of the Philips 12-Lead Algorithm is to analyze multi-channel ECG signals from adult and pediatric patients with algorithms that provide measurements, data presentations, graphical presentations, and interpretations for review by the user. 

The interpreted ECG with measurements and interpretive statements is offered to the clinician on an advisory basis only. It is to be used in conjunction with the clinician’s knowledge of the patient, the results of the physical examination, the ECG tracings, and other clinical findings. A qualified physician is asked to overread and validate (or change) the computer-generated ECG interpretation.

Indications for Use

The Philips 12-Lead Algorithm is to be used where the clinician decides to evaluate the electrocardiogram of adult and pediatric patients as part of decisions regarding possible diagnosis, potential treatment, effectiveness of treatment, or to rule out causes for symptoms.

Patient Interface Module (PIM)

The Patient Interface Module (PIM) is a hand-held device that connects to the cardiograph. The lead wires on the PIM attach to the electrodes placed on the patient. The exterior of the PIM is labeled and color-coded for quick and easy lead identification.