BIOSIG TECHNOLOGIES, INC. AE-0001-412 Pure EP

PURE EP™ is a system consists of two main parts: the amplifier,and the personal computer (PC), which are connected over a highspeedfiber optic cable. The patient is connected to the amplifier viaa set of supplied ECG cables and commercially availableintracardiac (IC) catheters. The amplifier includes hardware andembedded software necessary for acquiring ECG and IC signalsfrom patients. The device is not intended for active patientmonitoring. It consists of one ECG and seven IC modules designedto acquire 12-lead ECG and 56 IC signals and send the digitizeddata to the PC. The PC has preinstalled PURE-EP software and isconnected to display monitors. The pre-installed software providesvisualization of received data from the amplifier on real-time andreview screens. It also includes a signal processing module thatprovides various filter options for real-time and review screens.