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The SensiCardiac is an electronic auscultatory device, intended to provide support to the physician in the evaluation of patients' heart sounds. The product acquires and records the acoustic signals of the heart and analyzes these signals. The analysis procedure will identify specific heart sounds that may be present. Identified sounds include S1, S2, and suspected murmurs. The device is indicated for use in a clinical setting, by a physician or by trained personnel who are acting on the orders of a licensed physician. It is not intended as a sole means of diagnosis. The interpretations of heart sounds offered by the SensiCardiac are only significant when used in conjunction with physician over-read as well as consideration of all other relevant patient data.

The Sensi Diagnostic Heart Murmur Software is a decision support device intended to acquire, record, and anlyze heart sounds. It is used to distinguish between normal/ physiological and pathological heart murmurs by recording the acoustic signal of the heart by means of an electronic stethoscope. The complete system is a software package comprising Sensi Diagnostic Heart Murmur Software that runs on a computer with Windows operating system, instructions for use and the electronic stethoscope that captures the acoustic heart signals. The user must provide a compatible electronic stethoscope. The Sensi system consists of the following components: 1. The Sensi Diagnostic Heart Murmur Software program running on a personal computer (PC) with interfaces to: o a compatible electronic stethoscope o A database with patient and health worker information o Functions to record, display, analyze, save and playback heart sounds. 2. A compatible electronic stethoscope with characteristics o Recording Frequency Range: 20 Hz to 10,000 Hz o Sampling Frequency: > 4,000 Hz o Data Recording: Standard .wav files at resolution of 16bit, mono o Recording Time: minimum 10 sec, maximum 30 sec o Acoustic Sensors: Electronic stethoscope; compatible models include: ThinkLabs Medical ds32a+, Meditron Master Elite, RNK PCP/PC Stethoscope. Number of Sensors: 0 The Sensi Diagnostic Heart Murmur Software distinguishes between normal/ physiological and pathological heart murmurs by analyzing the acoustic heart signals captured with an electronic stethoscope. The device will record the acoustic sound of the heart at the four main auscultation positions. The acoustic heart signal is analyzed to identify heart sounds that may be present, identified sounds include S1, S2 and suspected murmurs.