The MoMe ARC® device consists of a Sensor Pod, Leads, Gateway, and Charging Cradle withaccessories. The body worn Sensor Pod acquires, stores and forwards electrocardiogram(ECG) data from Leads in a Wired Lead-Set or in a Patch to the Gateway using a 2.4GHz BLEwireless link. The Gateway consists of an OTS mobile device running the MoMe ARC® GatewayMobile App. The Gateway is a Medical Device Data System (MDDS) which stores and forwardsthe ECG signal data to the MoMe Software Platform (K152491) via a wireless cellular link.The MoMe ARC® communicates with the MoMe Software Platform (K152491), a web-basedremote server software with proprietary algorithms for analysis, using the MoMe DeviceCommunications Protocol. The MoMe Software System (K152491) analyzes the data via theembedded algorithm and, when indicated, data identified by the algorithm is flagged forphysician review.Once activated and operating normally, the system requires no patient intervention to capture oranalyze data. However, the MoMe ARC® has an optional patient triggered event feature thatallows for manual selection and recording of patient symptoms, if and when desired.The device is intended for use under prescription only (Rx only) for monitoring patients withsuspected cardiac arrhythmias.
A small unit dedicated for the receipt of wireless electrocardiogram (ECG) signals sent from an ambulatory patient so that the electrical activity of the patient's heart can be monitored when the patient is remote to the patient monitoring system. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device or a connected module rack. The parent device operates as a mainframe computer displaying the ECG signal information received and provided by this module.
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