BIOSIG TECHNOLOGIES, INC. PE-002-006-000 Pure EP - Catheter Input Module

The Catheter Input Module - IC1 J-Box Unipolar/Bipolar Cable Assembly (3m) is an accessory to the PURE EP™ System. The catheter input modules are used for connecting the IC catheters to the amplifier (aka MSU - Main System Unit).The PURE EP™ is a system that consists of two main parts: the amplifier (aka MSU - Main System Unit),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.