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The ZOLL Arrhythmia Management System (AMS) is intended to continuously record, store, and transmit ECG, Heart Rate, Respiration Rate, Activity and Posture. The data provided will aid medical professionals as they diagnose and identify various clinical conditions, events, and/or trends. AMS is intended for use in clinic and home settings. AMS is indicated for patients who are 21 years of age or older who require monitoring for the detection of non-lethal cardiac arrhythmias, such as, but not limited to, atrial flutter, ventricular ectopy, and bradyarrhythmias.

The ZOLL Arrhythmia Management System (AMS) noninvasively monitors patients' clinical parameters (ECG, Heart Rate, Respiration Rate, Activity, and Posture). These raw data are transmitted wirelessly to a remote Server for processing into the clinical parameters. The ZOLL Arrhythmia Management System is for prescription use only. It is intended for use in outpatient clinic and home settings. The ZOLL Arrhythmia Management System consists of the following components: - Sensor - a patient worn device for signal acquisition. - Patch – a single use, disposable adhesive piece adhered to the patient's body and allow for Sensor attachment. - Charger – the Charger recharges the Sensor and the Gateway. The Sensor typically requires recharging after 5 days. The Gateway typically requires recharging every day. - Gateway – An off-the-shelf item, the Gateway is essentially a cellphone that relays data and passes commands between the Sensor and the Server. - Server – Server refers to the hardware and the processing software, and resides in a cyber-secure location. The software analyzes the raw data received from the Sensor and processes the data into clinical values for eventual presentation to the physicians via an independent monitoring center (IDTF) that is regulated under 42 CFR 410.33. Raw data from the Sensor to the Gateway is transmitted via Bluetooth; the Gateway then transmits this data to the Server via TCP/IP over WiFi or cellular network for data processing and analysis. The ZOLL Arrhythmia Management System Patch and Sensor will be placed on the upper left chest ("front" location).

The ZOLL ECG Analysis Software is intended for use by qualified medical professionals for the assessment of arrhythmias. The ECG Analysis Software supports reading and analysis of ECG data recorded in compatible formats. The ECG Analysis Software is intended for use with ECG management software through an electronic interface. The ECG Analysis Software provides ECG signal processing and analysis on a beat by beat basis, QRS and Ectopic Beat detection, heart rate measurement, and rhythm analysis. The ECG Analysis Software is not for use in life supporting or sustaining systems or ECG monitoring and Alarm devices.

The ZOLL ECG Analysis Software is a SaMD (Software as a Medical Device) which is of Moderate Level of Concern. It is a software library consists of callable functions that are accessible through an Application Programming Interface (API). The ZOLL ECG Analysis Software provides ECG signal processing, QRS detection, classification of normal/VEB/SVEB, heart rate measurement, and the following rhythm interpretation for up to 3 leads (any combination of the standard 12 leads) of captured ECG data: Bradycardia, Tachycardia, Atrial Fibrillation, Pause, Ventricular Runs, Ventricular Bigeminy / Ventricular Trigeminy, Ventricular Tachycardia, Supraventricular Tachycardia, 2nd Degree Atrioventricular (AV) Block, 3rd Degree Atrioventricular (AV) Block. The ZOLL ECG Analysis Software is made up of: An ECG analysis engine that is responsible for ECG analysis and interpretation, An API to access the ECG analysis engine. The functions of the ZOLL ECG Analysis Software are intended to be called by a Windows application program written in C++, C# or MATLAB using the Microsoft .NET architecture. Furthermore, the ZOLL ECG Analysis Software requires the installation of MATLAB Runtime R2015B for execution. The ZOLL ECG Analysis Software has only been tested and validated to be used with MATLAB R2015B.

The uCor Heart Failure and Arrhythmia Management System is intended to periodically record, store, and transmit Thoracic Fluid Index. The uCor Heart Failure and Arrhythmia Management System is also intended to continuously record and store, and periodically transmit ECG, Heart Rate, Respiration Rate, Activity and Posture. The data provided will aid medical professionals as they diagnose and identify various clinical conditions, events, and/or trends. The uCor Heart Failure and Arrhythmia Management System is intended for use in clinical and home settings and is indicated for patients who are 21 years of age or older: - i) Who require monitoring for the detection of non-lethal cardiac arrhythmias, such as, but not limited to, atrial fibrillation, atrial flutter, ventricular ectopy, and bradyarrhythmias; or - ii) requiring fluid management.

The µCor Heart Failure and Arrhythmia Management System noninvasively monitors patients' clinical parameters (Thoracic Fluid Index, ECG, Heart Rate, Respiration Rate, Activity, and Posture). It acquires radiofrequency, ECG and accelerometer signals via the patient-worn device; these raw date are transmitted wirelessly to a remote Server for processing into the clinical parameters. The uCor Heart Failure and Arrhythmia Management System is for prescription use only. It is intended for use in outpatient clinic and home settings, with a monitoring period for up to 30 days. The µCor Heart Failure and Arrhythmia Management System consists of the following components: - . Sensor - a patient worn device for signal acquisition. - . Patch – a single use, disposable adhesive piece adhered to the patient's body and allow for Sensor attachment. - . Charger – the Charger recharges the Sensor and the Gateway. The Sensor typically requires recharging after 5 days. The Gateway typically requires recharging every day. - Gateway – An off-the-shelf item, the Gateway is essentially a cellphone that relays data and passes commands between the Sensor and the Server. - Server – Server refers to the hardware and the processing software, and resides in a cyber-secure location. The software analyzes the raw data received from the Sensor and processes the data into clinical values for eventual presentation to the physicians via an independent monitoring center (IDTF) that is regulated under 42 CFR 410.33. Raw data from the Sensor to the Gateway is transmitted via Bluetooth; the Gateway then transmits this data to the Server via TCP/IP over WiFi or cellular network for data processing and analysis.