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The ASSURE Wearable ECG is indicated for adult patients who have been prescribed this device by a medical professional, who were previously prescribed the ASSURE WCD system, and who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light-headedness, presyncope, syncope, fatigue, or anxiety. The signal acquired by the ASSURE Wearable ECG is not intended and should not be used for automated or semi-automated analysis. The device does not deliver any therapy, administer any drugs, provide interpretive or diagnostic statements or provide for any life support. The ASSURE Wearable ECG is contraindicated for use in patients with an active implantable pacemaker or defibrillator.

The ASSURE Wearable ECG is a reusable, ambulatory electrocardiography-based, cardiac- and physiologicmonitoring, medical-electrical system whose intended purpose is to inform clinical management of options for diagnosing, monitoring and/or mitigating cardiac conditions after patient's improvement following ASSURE® Wearable Cardioverter Defibrillator (WCD) prescriptive use. The system utilizes the same five-electrode SensorFit™ Garment worn previously with the WCD prescription. The system continuously records ECG data and upon detection, it identifies and records episodes as high and low heart rate, as well as patient-triggered events. The system utilizes the same algorithm detection and episode reporting software marketed in the ASSURE WCD with high (Tachy) and low (Brady) capture for later transmission to the medical professional for interpretation. The system captures and stores ECG episodes, and non-ECG patient activity and wear information to be displayed and reported in counters and trends. Recorded events include ECG waveforms and reports identifying high and low heart rates, as well as patient-triggered events. The system uses a 3axis accelerometer to monitor non-ECG patient activity (steps and wear time). The ASSURE Wearable ECG event reports do not contain diagnostic interpretation. The reported events are provided for review by the prescriber to assist in diagnosis of the recently transitioned WCD patient and to assess care options based on the healthcare professional's judgment and experience. The ASSURE Wearable Cardiac ECG is a prescription use device. The ASSURE Wearable ECG is intended for use by a patient during their normal daily activities primarily in the home or community setting, but also hospitals, medical clinics, healthcare facilities and transport. The device is non-invasive, and intended to be used on one patient at a time. The Wearable Cardiac ECG System is comprised of the following reusable patient-worn components: - Monitor Cable Assembly - Hub - Alert Button - Battery Pack - SensorFit™ Garment - Charger