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The Hexoskin Medical System (HMS) is intended for use at home, or at a healthcare facility, on the order of a licensed medical professional, to record, display and store the following physiological data: a) 3 leads of electrocardiogram; b) heart rate; c) respiratory rate; and d) activity. The device is intended for use when the clinician decides to evaluate the physiologic signals of adult patients as an aid to diagnosis and treatment. The HMS ECG recordings are indicated for the manual assessment of cardiac rhythm disturbances. The device does not produce alarms and is not intended for active patient monitoring (real-time). The device is not intended for use as life supporting equipment on high-risk patients such as critical care patients. The device is not intended for use in the presence of a pacemaker.

The HMS consists of four main components - three physical components and one software user interface (UI) component. The physical components are the HMS Recorder, the HMS Shirt, and the Cable. The Recorder is a rechargeable data acquisition module that connects to the Shirt. The Shirt is available in a wide range of configurations, catering to diverse patient body types and builds. The Cable is a USB to micro-USB cable that connects to the Recorder for data transfer and charging. The UI component is a PC-based, stand-alone software that displays the recordings stored on the Recorder.

This device is not an apnea monitor. Users should not rely on its respiration monitoring for detecting cessation of breathing. The Hexoskin Medical System does not provide any automatic analysis or diagnosis.

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