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The SensiCardiac Mobi 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 Mobi are only significant when used in conjunction with physician over-read as well as consideration of all other relevant patient data.

The SensiCardiac Mobi Diagnostic Heart Murmur Application 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 application comprising Sensi Diagnostic Heart Murmur Algorithm that runs on a hosted server environment with Linux operating system, a hand held device to capture patient data, instructions for use and the electronic stethoscope that captures the acoustic heart signals. The user must provide a compatible electronic stethoscope. SensiCardiac Mobi is a decision support software package intended to assist medical examiners in heart auscultation. The SensiCardiac Mobi system consists of the following components: - 1. The Sensi Diagnostic Heart Murmur Algorithm running within a hosted environment with TCP/IP interfaces to: - o a hand held mobile device (iPhone 4S or later) - o A database with patient and health worker information - 2. A hand held mobile device (iPhone 4S or later) with the following uses: - o electronic transfer of the medical device data (TCP/IP interface) - o the electronic interfacing and conversion of the electronic stethoscope audio signal. - o The electronic display of medical device data. - o Capturing of basic patient information. - 3. 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 - Recording Time: o minimum 10 sec, maximum 30 sec - o Electronic stethoscope: compatible model: ThinkLabs Medical ds32a+ - Number of Sensors: o 1 The Sensi Diagnostic Heart Murmur Algorithm 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 hear 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. The Sensi Diagnostic Heart Murmur Algorithm or the application running on the hand held mobile device does not control the medical device (electronic stethoscope) or actively monitoring the patient.

The Sensi device consisting of the Sensi Diagnostic Heart Murmur Software, the WelchAllyn Master Elite Stethoscope and WelchAllyn USB Analyzer is a decision support device intended to be used on a single patient to assist the medical examiner in analyzing cardiac sounds for the identification and classification of suspected murmurs. It is used to distinguish between normal/physiological and pathological heart murmurs by recording the acoustic signal of the heart and the ECG signal simultaneously and analyze these signals. The acoustic heart signal is analyzed to identify specific heart sounds that may be present. Identified sounds include S1, S2, and suspected systolic murmurs. Sensi indicates whether or not a recorded heart sound contains a suspected heart murmur and the confidence with which the analysis was made The device must be used in a clinical setting by trained personnel with the prescribed accessories and all relevant patient information must be taken into consideration before a diagnosis is made. The interpretations of heart sounds offered by the Sensi device are only significant when used in conjunction with physician over-read as well as consideration of all other relevant patient data. Sensi is not intended to be a diagnostic device. It does not supersede the judgment of the qualified medical personnel. The device is intended to aid the physician in the evaluation of heart sounds. The physicians responsible for reviewing and interpreting the results, along with the auscultatory findings and medical history, in making a referral decision.

The Sensi with Diagnostic Heart Murmur Software is a decision support device intended to acquire, record, and analyze heart sounds. It is used to distinguish between normal/physiological and pathological heart murmurs by recording the acoustic signal of the heart and the ECG signal simultaneously and analyzing these signal. The complete system is a CD comprising Sensi Diagnostic Heart Murmur Software that runs on a computer with Windows operating system, instructions for use, the WelchAllyn Master Elite Stethoscope and the WelchAllyn Meditron Analyzer that captures the acoustic heart and ECG signals. The Sensi Diagnostic Heart Murmur Software distinguishes between normal/ physiological and pathological heart murmurs by analyzing the acoustic heart and ECG signals captured with the WelchAllyn Meditron Analyzer. The device will record the acoustic sound of the heart at the four main auscultation positions and a three lead ECG signal. The ECG signal is not intended for diagnostic use, only to synchronize with the beginning of each heart cycle. The acoustic heart signal is analyzed to identify heart sounds that may be present, identified sounds include S1, S2 and suspected systolic murmurs.