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IM007 is intended for use by qualified healthcare professionals for the assessment of arrhythmias in Insertable Cardiac Monitor (ICM) ECG data. IM007 supports downloading and analyzing data recorded in compatible formats from ICMs. This version of the IM007 only supports ECG data from Medtronic ICMs. IM007 is intended to be electronically interfaced with other computer systems (remote monitoring platform) that supply the ECG data to IM007, and receive the output of IM007 (analysis) for viewing by the healthcare professionals. IM007 provides ECG signal processing and analysis, to detect asystole, bradycardia, atrial tachycardia or atrial fibrillation, ventricular tachycardia, normal rhythm and artifact. IM007 is not for use in life supporting or sustaining systems or ECG monitor and Alarm devices. IM007 interpretation results are not intended to be the sole means of diagnosis. It is offered to physicians on an advisory basis only in conjunction with the physician's knowledge of ECG patterns, patient background, clinical history, symptoms, and other diagnostic information.

IM007 is a software medical device for the analysis of ECG signals from Insertable Cardiac Monitor (ICM) devices and confirms the presence or absence of arrhythmias. When it is interfaced with a compatible remote monitoring platform, IM007 provides additional data to healthcare professionals to support the analysis of abnormal episodes detected by ICM devices. IM007 receives as input an ECG data signal via the Implicity remote monitoring platform, then processes the signal with a proprietary algorithm designed to detect arrhythmias and generates as output the result of the analysis to a remote monitoring platform. IM007 comprises: - . An algorithm (the Algorithm) that analyzes ECG files in order to detect cardiac rhythm abnormalities. - A communication interface to external applications with the Algorithm and processing of ECG files. The API consists of 2 messaging queues (an input and an output). IM007 works as follows: - . IM007 receives input data (an ECG file and device parameters) from the remote monitoring platform using the input queue. - . The file is processed by the Algorithm which delineates zones with abnormal waveforms (ECG signals not defined as normal sinus rhythm). The output format is a sequence of waveform labels/start time/end time. - . IM007 sends a response to the Remote Monitoring Platform using the output queue.