Search Results

The intended use of the Quinton Electrophysiology Corporation's EPXpress System (Timberwolf Revision) is the acquisition, amplification, display, recording, and transmission of electrical signals of biological origin obtained during electrophysiology studies and related procedures. Such signals include ECG, intracardiac ECG, and blood pressure. Physiological parameters as diastolic, systolic, and mean blood pressure, heart rate, and cycle length may be derived from these signals and displayed numerically, recorded, and/or transmitted.

Additionally, the EPXpress System (Timberwolf Revision) may acquire, transpose, amplify, display, record and transmit measurement data received from other medical devices typically used during these procedures, such as oximeters, RF generators, or electronic thermometers.

The EPXpress System (Timberwolf Revision) is an integrated catheter switching amplification and display system that can be installed at the patient table in the electrophysiology lab or moved to other locations where particular procedures may require its use. The system is made up of the EPAmp, Real-Time Controller, and monitor that are usually mounted on a cart. The EPAmp unit amplifies and conditions electrical signals from intracardiac catheters and displays these signals on a real-time monitor and/or prints these results to a chart recorder. The Timberwolf Revision added the capability of numerically displaying diastolic, systolic and mean blood pressures, as well as heart rate, cycle length, and certain measurement data received from other instruments.

Here's a summary of the acceptance criteria and study details for the Quinton Electrophysiology Corporation's EPXpress System (Timberwolf Revision), based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Ask a specific question about this device