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The Melys Atrial Fibrillation Monitor is indicated for self-testing by patients who have been diagnosed with, or are susceptible to developing, atrial fibrillation and who would like to monitor and record their heart rhythms on an intermittent basis.

The Melys Atrial Fibrillation Monitor is a lightweight portable device for measuring and displaying heart irregularity and pulse rate. The device consists of the following - 1) Atrial Fibrillation Monitor, 2) Finger Sensor (K101692), 3) Power Supply and 4) Instruction Manual. The Melys Atrial Fibrillation Monitor device receives physiological data relating to heart rhythm from a finger sensor (K101692) attached to the patient's finger. The device captures, processes and records this data. Once sufficient data has been captured the device will run a mathematical analysis on the data and presents an indicative result of the patient's likelihood of suffering from atrial fibrillation or other heart irregularity. The monitor contains a rechargeable battery, and a power supply is provided with the monitor for charging the monitor's battery. The finger sensor is connected to the monitor and with the pressing of the start button is ready to deliver trace measurements within 10 seconds. Each measurement is shown in a large display with a light and a number (the Arrhythmia Index Result). A history results bar at the bottom of the monitor will show the results of the previous 8 analyses with each light indicating each separate result by a green, amber, or red light. In the upper right corner of the display is an indication of the input signal strength and the level of battery charge.