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The intended use of the Prucka Engineering, Inc. CardioLab EP 4.2 System is to acquire, filter, digitize, amplify, display, and record electrical signals obtained during electrophysiological studies and related procedures conducted in an electrophysiological laboratory. Signal types acquired include ECG signals, direct cardiac signals, and pressure recordings. Physiological parameters such as diastolic, systolic, and mean blood pressure, heart rate, and cycle length may be derived from the signal data, displayed and recorded. The system allows the user to monitor the acquisition of data, review the data, store the data, perform elementary caliper-type measurements of the data, and generate reports on the data. Additionally, the system may acquire, amplify, display, and record data received from other medical devices typically used during these procedures, such as imaging devices and RF generators. The CardioLab EP system does not control the delivery of energy, administer drugs, perform any life-supporting or life-sustaining functions, or analyze physiological data or other data acquired during an EP procedure. It does not transmit alarms or arrhythmias, and does not have arrhythmia detection capabilities.

The CardioLab EP System is a microprocessor based data acquisition system used during electrophysiology procedures to accquire ECG, intracardiac, pressure, and digital data from other devices such as RF generators and fluoro video systems. The ECG, intracardiac and pressure data are acquired by an amplifier that is connected to the patient by third-party devices such as ECG leadwires and catheters. The amplifier filters, amplifies, digitizes and transmits the data to the computer. The computer stores the data on optical disks, displays the data on the video monitors, allows the user to perform basic signal measurements, and prints out waveforms on a laser printer or continuous paper recorder. The software has three major functions: data acquisition and display, data storage, and reporting of data. The system is able to acquire signal data in the presence of pacing pulses. In addition to signal waveform display and basic caliper-type measurement, the system allows the user to create isopotential and isochronal activation maps of waveform timing information. The system can also be used to accept video input from a fluoroscopy system for either single frame capture or full motion video display. The system can also acquire data from an RF generator via standard computer RS-232 serial port. The CardioLab EP system does not control the delivery of energy, administer drugs, perform any life-supporting or life-sustaining functions, or analyze physiological data or other data acquired during an EP procedure. It does not transmit alarms or arrhythmias, and does not have arrhythmia detection capabilities.

The system is used in a cardiac catheterization laboratory where ECG, intracardiac signals, and pressure recordings need to be recorded from a patient.

The CardioCath system is a multi-channel pressure and electrocardiograph system that digitizes, and stores pressure and electrical signal information on magnetic media. The CardioCath system is a data acquisition unit which connects to the patient to collect both electrical ECG and intracardiac signals as well as pressure waveforms acquired by various pressure transducers. The data is digitized and stored in a computer which displays the data on video monitors. The system allows the user to archive, perform signal measurements and to print out signals on both continuous paper recorder or on a laser printer. The system provides isolation of biopotential signals from the patient to ground, high impedance inputs, high gain and variable filtering capabilities required for measuring bioelectric potentials. The system provides isolation, conditioning and amplifications of electrical signals from strain gage blood pressure transducers. The system is microprocessor based and feature graphical user interfaces. The system allows the user to acquire, display, measure and printout various biopotential waveforms.