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The Intelesens Aingeal Activity is used to monitor and transmit physiological data to a remote application for display or analysis by a clinician. The device can be worn by ambulatory or non-ambulatory adult patients in a healthcare environment to support clinical staff when they are carrying out their routine observations or when a patient would otherwise be in an unmonitored or unobserved situation. This re-usable device is intended to be used on the patient for short term periods only. The device is intended to be used on adult patients for monitoring of ECG, respiration, heart rate, skin temperature and activity levels in a healthcare setting. The device can be used where information on ECG, respiration, heart rate, skin temperature, and activity levels would be useful. The device uses on-board ECG arrhythmia detection algorithms to automatically record and send ECG data if the user is suspected to be experiencing an arrhythmia event. The device also detects and records respiration, skin temperature and activity. The device transmits the data to the remote application at user defined intervals or upon the detection of an arrhythmia event (arrhythmia or threshold breach).

The Aingeal Activity System is a modification of the Intelesens Aingeal (VS200) 510(k) cleared under 510(k) K110015. Details of the modifications can be found in Section 11. The Aingeal Activity system includes the following components: - Aingeal Activity Monitor a wireless (Wi-Fi) monitoring device with a rechargeable lithium polymer battery - Adherent electrode array - Battery charger - Compatible monitoring software such as CPC Bernoulli (FDA 510(k) clearance # K130208) The Aingeal Activity device is battery powered. The battery is removed from the device prior to charging in the standalone battery charger station. Charging does not occur when the Aingeal Activity device is connected to a patient. Aingeal Activity is a reusable, nonsterile device to be used with a single use disposable electrode. The battery is charged in a separate charger, charging does not / cannot occur when the Aingeal Activity Device is connected to a patient The Aingeal Activity monitor clips on the adherent electrode array and is worn on-body. In conjunction with the array it collects, stores and transmits user physiological data. The electrode array and device, when enabled and applied to the user's torso will measure ECG, heart rate, respiration rate, skin temperature and activity levels with on board software algorithms. This data is transmitted periodically to the compatible third party server for display such as the CPC Bernoulli software (server). ECG signals recorded by the electrode array and device will also be transmitted on a heart rate trigger basis with thresholds adjustable by the user, or arrhythmia. Respiration signals recorded by the electrode array and device will also be transmitted on a respiration rate trigger basis with thresholds adjustable by the user. Skin temperature is recorded by the electrode array and device will also be transmitted on a temperature level trigger basis with thresholds adjustable by the user. The ECG, respiration signals, skin temperature value and activity metrics are also transmitted periodically and can be displayed via the server. The device also contains on-board ECG arrhythmia recognition to automatically record and send ECG data on detection of one or more of the following arrhythmias: - 1. asystole, - 2. ventricular fibrillation, (VF) - 3. bradycardia - tachycardia (Ventricular or Supraventricular 4.