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AUDICOR CA300/CC100 Analyzer with SDB is a software-only system intended to be used to analyze recordings from AUDICOR-compatible recording devices. AUDICOR CA300/CC100 Analyzer with SDB is capable of analyzing, editing, storing and reporting ECG, heart sound, sleep-disordered breathing (SDB), snoring detection, body position and activity level. An interpretation of the analysis results is produced in an integrated report for consideration by physicians. The AUDICOR CA300/CC100 Analyzer with SDB software is intended for use on adults 18 years of age and older. The SDB analysis and reporting is intended for use on adult patients as a screening device for obstructive or mixed apnea to determine the need for evaluation by polysomnography based on the patient's screened for SDB should have periods of sleep of at least 4 hours duration. AUDICOR CA300/CC100 Analyzer with SDB is intended to be used by trained operators under the direct supervision of a physician in a hospital or clinic environment.

AUDICOR CA300/CC100 Analyzer is a software-only system for the analysis of physiologic signals acquired through AUDICOR-compatible recording devices. Analysis results from ECG, heart sound, sleep-disordered breathing, snoring sounds, body position and activity levels are automatically interpreted. The AUDICOR CA300/CC100 software system allows for the review, edit, and storage of the analysis results. Reporting of analysis results is provided, together with patient data and notable events for review by the clinician. The AUDICOR Analyzer software analyzes and reports the following parameters: - Heart rate including bradycardia and tachycardia events . - Atrial fibrillation ● - ECG beat classification and morphology grouping with user-editing ● - Heart rate variability ● - Snoring detection ● - Sleep disordered breathing events - Sleep disordered breathing score - Activity level ● - Body Position - Heart sound and combined ECG/heart sound measurements - Heart rate distributions of heart sound parameters ●

The AUDICOR System when used with AUDICOR Sensors on the chest wall and properly attached Holter unit, is intended for use on adults 18 years of age and older in acquiring, analyzing and reporting ECG, heart sound, Sleep Disordered Breathing (SDB) and snoring detection and to provide interpretation of the data in an integrated report for consideration by physicians. The SDB analysis and reporting is intended for use on adult patients only as a screening device for obstructive or mixed apnea to determine the need for evaluation by polysomnography based on the patient's score. Patients screened for SDB should have periods of sleep of at least 4 hours duration during which the ECG is predominantly sinus rhythm in nature. The AUDICOR recording may be obtained at any location specified by a physician including home, hospital or clinic. The device is intended for use only under the direct supervision of a physician.

The AUDICOR System employs the AUDICOR AM (Home) ambulatory recording device to capture 10-second snapshots or up to 48 continuous hours of physiologic data. ECG, heart sound, sleep-disordered breathing, snoring sounds, and activity level are interpreted from the physiologic signals captured. The AUDICOR System includes software to analyze recorded data, then display and present a summary of patient data over time in a trended format. Notable events are detected and displayed for review by the clinician. The AUDICOR System analyzes and reports the following parameters: - Heart rate including bradycardia and tachycardia events . - Atrial fibrillation . - ECG beat classification and morphology grouping with user-editing . - Heart rate variability . - . Snoring detection - . Sleep disordered breathing (apnea/hypopnea) events - . Sleep disordered breathing score - Activity level . - Heart sound and combined ECG/heart sound measurements . - Heart rate distributions of heart sound parameters . The clinician can review automatically detected events and measurements, and modify them as well as modify the interpretative statements generated.

The AUDICOR System when used with an AUDICOR Sensor on the chest wall and properly attached Holter unit, is intended for use on adults 18 years of age and older in acquiring, analyzing and reporting ECG, heart sound, body position, Sleep Disordered Breathing (SDB) and snoring detection and to provide interpretation of the data in an integrated report for consideration by physicians. The SDB analysis and reporting is intended for use on adult patients only as a screening device for obstructive or mixed apnea to determine the need for evaluation by polysomnography based on the patient's score. Patients screened for SDB should have periods of sleep of at least 4 hours duration during which the ECG is predominantly sinus rhythm in nature. The AUDICOR recording may be obtained at any location specified by a physician including home, hospital or clinic. The device is intended for use only under the direct supervision of a physician.

The AUDICOR System employs the Hemo ambulatory recording device to capture 10-second snapshots or up to 48 continuous hours of physiologic data. ECG, heart sounds, body position, sleep disordered breathing, snoring sounds, and activity level are interpreted from the physiologic signals captured. The AUDICOR System includes software to analyze recorded data, then display and present a summary of patient data over time in a trended format. Notable events are detected and displayed for review by the clinician. The AUDICOR System analyzes and reports the following parameters: - Heart rate including bradycardia and tachycardia events . - Atrial fibrillation . - ECG beat classification and morphology grouping with user-editing l - . Heart rate variability - Snoring detection . - Sleep disordered breathing (apnealhypopnea) events - . Sleep disordered breathing score - Activity level . - . Body position - Heart sound and combined ECG/heart sound measurements . - Heart rate distributions of heart sound parameters The clinician can review automatically detected events and measurements, and modify them as well as modify the interpretative statements generated.

The AUDICOR System when used with AUDICOR Sensors on the chest wall and properly attached Holter unit, is intended for use on adults 18 years of age and older in acquiring, analyzing and reporting ECG, heart sound, sleep disordered breathing and snoring detection and to provide interpretation of the data in an integrated report for consideration by physicians. The sleep disordered breathing analysis and reporting is intended for use on adult patients only as a screening device for obstructive or mixed apnea to determine the need for evaluation by polysomnography based on the patient's score. Subjects screened for sleep disordered breathing should have periods of sleep of at least 4 hours duration during which the ECG is predominantly sinus rhythm in nature. The AUDICOR recording may be obtained at any location specified by a physician including home, hospital or clinic. The device is intended for use only under the direct supervision of a physician.

The Audicor CPAM with SDB (Cardiopulmonary Holter with Sleep Disordered Breathing detection) is an ambulatory device that can be used to capture 10second snapshots or up to 48 hours of continuous data from ECG, heart sounds, sleep disordered breathing and snoring detection, and activity level, particularly in patients suspected of heart failure or acute coronary syndrome. The Audicor CPAM with SDB includes software to display, analyze and provide a summary of patient data over time in a trended format. Notable events are detected and displayed for review by the clinician. The Audicor System analyzes and reports the following parameters: Heart rate including bradycardia and tachycardia events . Atrial fibrillation . ECG beat classification and morphology grouping with user-editing . . Heart rate variability . Snoring detection Sleep disordered breathing (apnea/hypopnea) events . Sleep disordered breathing score . Activity level - Heart sound and combined ECG/heart sound measurements - Heart rate distributions of heart sound parameters ● The clinician can review automatically detected events and measurements, and modify them as well as modify the interpretative statements generated.

The Audicor® System, when used with AUDICOR Sensors on the chest wall and properly attached Holter unit, is intended for use on adults 18 years of age and older in acquiring, analyzing and reporting ECG and heart sound data and to provide interpretation of the data in an integrated report for consideration by physicians. The Audicor recording may be obtained at any location specified by a physician including home, hospital or clinic. The measurements provided and interpretations of ECG and heart sound data offered by the device are only significant when used in conjunction with physician over-read as well as consideration of other relevant patient data. The device is intended for use only under the direct supervision of a physician.

The Audicor System is an ambulatory device that can be used to capture up to 48 hours of continuous data or 10-second snapshots of ECG and heart sounds data. The Audicor System includes software to display, analyze and provide a summary of patient data over time in a trended format. Notable events are detected and displayed for review by the clinician. The analysis package includes heart rate variability and performs ECG beat classification, editing and reporting of arrhythmias. The Audicor System analyzes and reports the following parameters: Heart rate distributions of heart sound parameters Heart rate and associated events Atrial fibrillation ECG beat classification and morphology grouping Ventricular and atrial ectopic beat arrhythmias Heart rate variability

The Audicor ™ Sensors with Adapters are a family of dual-function transducers for use on patients where combined ECG/heart sounds data are needed for the evaluation of patient status, to aid in diagnosis and determine effects of treatment on ECG and hemodynamics. Audicor Sensors with Adapters may be used only with a compatible Audicor System. There are disposable and reusable versions of the Audicor Sensor component. Both can be used in the recording of resting ECG / heart sound reports. The disposable Audicor Sensor is also intended for longer term monitoring applications of up to 48 hours.

The Audicor sensors/adapters included in this submission are a group of devices that are intended for use with Audicor-enabled ECG/heart sounds detections systems. Sensors are designed with conductive patient-contact surfaces to enable capture of ECG data. The mating cable adapter for Sensor 4.0 includes an accelerometer for detection of heart sounds. The sensor and adapter devices are intended for use on the chest wall in the V3 and V4 positions. Audicor sensors are available in two versions: 1) Single-use disposable sensors, for use up to 48 hours (Sensor 2.0 and Sensor 4.0) 2) Reusable sensors (Sensor 3.0)

The Audicor® Sensors are a family of dual-function sensors for use on adult patients (≥ 18 years) for acquisition of both heart sounds and ECG electrical signals and to transmit these signals to a compatible Audicor system to allow for the evaluation of patient status, to aid in diagnosis, and to determine effects of treatment on ECG and hemodynamics. There are disposable and reusable versions of the Audicor Sensor. Both can be used in the collection of resting ECG reports. The disposable Audicor Sensor is also intended for longer term monitoring applications of up to 48 hours.

The Audicor Sensors are a group of devices that are intended for use with Audicor-enabled ECG/heart sounds detections systems. Sensors are designed with conductive patient-contact surfaces to enable capture of ECG data, and include a microphone for detection of heart sounds. The devices are intended for use on the chest wall in the V3 and/or V4 positions. Audicor sensors are available in two versions: 1) Single-use disposable sensors, for use up to 48 hours 2) Durable reusable sensors

The Audicor® System, when used with AUDICOR Sensors on the chest wall, is intended for use in acquiring, analyzing and reporting ECG and heart sound data and to provide interpretation of the data in an integrated ACG (acoustic cardiograph) report for consideration by physicians. Audicor systems allow detection, reporting and interpretation of standard ECG data as well as advanced parameters such as EMAT, LVST, S3 strength, S4 strength, and SDI. Data may be reported in a single snapshot report and in a trended report format where multiple data points are trended over time. The Audicor system also accepts and analyzes downloads of up to 48 hours of patient data from an optional ambulatory ECG/heart sounds collection device. ECG and heart sound data offered by the device are only significant when used in conjunction with physician over read as well as consideration of other relevant patient data. The device is intended for use only under the direct supervision of a physician and is for use on adults (≥ 18 years).

The Audicor 200 is a stand-alone device that can be used to capture 10-second snapshots of ECG and heart sounds in patients suspected of heart failure or acute coronary syndrome. The Audicor TS system, a combination of the Audicor 200 with an Audicor-enabled laptop computer, is used to display and analyze patient data over time in a trended format. The trending system can be used in monitoring patient changes during therapeutic treatment or during CRT studies. The Audicor system, when used with either a 10 wire or 4 wire patient cable analyzes and reports the following advanced parameters and a systolic dysfunction index (SDI) calculated from advanced parameters: LVST ( Left Ventricular Systolic Time ) LVDT (Left Ventricular Diastolic Time) PADT (Pre-atrial Diastolic Filling Time) AAFT (Accelerated Atrial Filling Time ) EMAT (QS1, Electromechanical Activation Time) QS2 R-R Interval S3 Strength S4 Strenth SDI (Systolic Dysfunction Index) The Audicor-enabled laptop computer also accepts, analyzes and displays trended data from an optional ambulatory data collection harness for trend and event analysis.

The Audicor 200 System, when used with AUDICOR Sensors on the chest wall, is intended for use in acquiring, analyzing and reporting ECG and heart sound data and to provide interpretation of the data in an integrated report for consideration by physicians. In addition, the Audicor 200 System can be used with an add-on laptop computer that allows data to be presented in the format of real-time and trended display of advanced parameters derived from simultaneous ECG data and heart sounds data. The interpretations of ECG and heart sound data offered by the device are only significant when used in conjunction with physician over read as well as consideration of other relevant patient data. The device is intended for use only under the direct supervision of a physician, and is for use on adults (>= 18 years).

The Audicor 200 is a stand-alone device that can be used to capture 10-second evaluations of ECG and heart sounds in patients suspected of heart failure or acute coronary syndrome. In addition the system can be connected to a compatible laptop computer and used to display and analyze patient data over time in a trended format. The trending system can be used in monitoring patient changes during therapeutic treatment or during CRT studies.

The Extended Measurements System, when used with AUDICOR Sensors on the chest wall, is intended for use in acquiring, analyzing and reporting ECG and heart sound data and to provide interpretation of the data in an integrated COR report for consideration by physicians. In addition the data can be presented in the format of real-time and trended display of cardiac indices derived from simultaneous ECG data and heart sounds data. The Extended Measurements System can be used as an add-on device to work in conjunction with an AUDICOR-enabled device, or as a stand-alone electrocardiograph. The interpretations of ECG and heart sound data offered by the device are only significant when used in conjunction with physician over read as well as consideration of other relevant patient data. The device is intended for use only under the direct supervision of a physician, and is for use on adults (≥ 18 years).

The Extended Measurements System is a software-based device that that can be installed into a compatible computer to communicate with an AUDICOR-capable device via a Blue tooth interface. The Extended Measurements system will also be offered as a stand-alone electrocardiograph/ monitoring device.