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The CardioSleeve System consisting of the CardioSleeve Front-End stethoscope with integrated ECG device. mobile heart sound and ECG recording application and the remote diagnostic heart murmur software is a decision support device intended to be used on a single patient to assist the qualified clinician in analyzing cardiac sounds and electrical signals for the identification and classification including 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 analyzing these signals. The acoustic heart signal is analyzed to identify specific heart sounds that may be present. Identified sounds include S1, S2, and suspected murmurs. CardioSleeve indicates whether or not a recorded heart sound contains a suspected heart murmur. 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 CardioSleeve device are only significant when used in conjunction with physician over-read as well as consideration of all other relevant patient data. CardioSleeve is not intended to be a diagnostic device. It does not supersede the judgment of the clinician. The device is intended to aid the physician in the evaluation of heart sounds. The clinicians are responsible for reviewing and interpreting the results, along with the auscultatory findings and medical history, when making a referral decision. Caution: Federal (USA) law restricts this device to sale by or on the order of a clinician

The CardioSleeve with Diagnostic Heart Murmur Application, (application identical to the FDA cleared Sensi with Diagnostic Heart Murmur Software-K110704), is a decision support device intended to acquire, record, and analyze heart sounds. It is used to distinguish between normal and pathological heart murmurs by recording the acoustic signal of the heart and the ECG signal simultaneously and analyzing these signals, and to acquire, record and display 3 Lead ECG signals for diagnostic support. The complete system comprises of: a) Diagnostic Heart Murmur Algorithm (algorithm identical to the FDA cleared Diagnostic Heart Murmur Algorithm in K110704), that runs on a hosted server environment with Linux operating system, b) a mobile device software application that captures patient data, displays patient data and instructions for use and c) a stethoscope front-end recorder device with integrated ECG to acquire the acoustic and electrical heart signals. The CardioSleeve Front-end recorder device will interface via Bluetooth with the clinician's hand held mobile device.