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The SphygmoCor® Cardiovascular Management System (CvMS) provides a derived ascending aortic blood pressure waveform and a range of central arterial indices. The CvMS is used with a tonometer over a radial artery calibrated with a standard cuff blood pressure measurement. It is to be used on those patients where information related to ascending aortic blood pressure is desired but in the opinion of the physician, the risks of cardiac catheterization procedure or other invasive monitoring may outweigh the benefits. The CvMS Heart Rate Variability (HRV) option is intended for use in obtaining HRV measurements in response to controlled exercises.

The CvMS is a modified version of the SphygmoCor Px (K012487). Like its predecessor, the CvMS is a computerized tool for the assessment of a range of central vascular parameters, including blood pressure, by peripheral pulse wave detection, callbration, and analysis that can be derived from the calibrated peripheral pressure waveform. The CvMS is used with a tonometer over the radial artery, and is calibrated with a standard blood pressure cuff measurement. The CyMS is intended for use on those patients where information related to ascending aortic blood pressure is desired but in the opinion of the physician, the risks of cardiac catheterization procedure or other invasive monitoring may outweigh the benefits. In addition, the CvMS incorporates an option to enable users to measure Heart Rate Variability (HRV) in response to controlled exercises. The CvMS is made up of three primary components: 1) a proprietary signal processing electronics module; 2) proprietary software; and 3) a Millar Micro-Tip Pulse Transducer tonometer (Millar tonometer). One notable new feature incorporated into the CvMS is the addition of the capability to noninvasively measure Heart Rate Variability (HRV) data. The CvMS measures the variability in intervals between R waves ("R-R intervals") on a continuous beat-to-beat basis for a period of time to provide HRV data and to use standard analysis procedures to provide stable and evoked measures of HRV in response to certain controlled exercises. The CvMS is also capable of providing Central Blood Pressure (PWA) and Pulse Wave Velocity (PWV) measurements. The CvMS system is available in three different configuration options based upon these measurement capabilities. These options allow the user to select a measurement system that suits their particular clinical needs. These configuration options include: 1. SphygmoCor Px Pulse Wave Analysis (PWA) System (Px); 2. SphygmoCor Vx Pulse Wave Velocity (PWV) System (Vx); and 3. SphygmoCor Hx Heart Rate Variability (HRV) System (Hx). All measurements may be stored and viewed on an attached computer which is attached to the CvMS's signal processing electronics module via a standard USB cable. The patient study reports are displayed on an attached computer.

The SphygmoCor Px is indicated for use in those patients where information related to the ascending aortic pressure is desired, but in the opinion of the physician, the risks of the intra-arterial radial artery pressure recording procedure may outweigh the benefits of using the SphygmoCor Mx system with an invasive radial pressure input. The SphygmoCor Px provides a derived ascending aortic blood pressure waveform and a range of central arterial indices. The SphygmoCor is used with a tonometer over the radial artery calibrated with a standard cuff blood pressure measurement. It is to be used in those patients where information related to the ascending aortic pressure is desired but in the opinion of the physician, the risks of the cardiac catheterization procedure or other invasive monitoring may outweigh the benefits.

The SphygmoCor SCOR-Px is a computerized tool for the assessment of blood pressure. The SphygmoCor can calculate the calibrated ascending aortic pressure probater - 110 g the radial artery pressure waveform recorded non-invasively from a radial artery tonometer and a brachial cuff measurement. An eight-second segment of the radial artery pressure signal is processed in the SphygmoCor electronics module to derive the calibrated ascending aorta pressure waveform and to derive central pressure waveform parameters. The signal processing electronics module is attached to a PC computer through a serial RS-232C port. The patient's study report appears on the PC computer and displays the measured (radial) and calculated (central) waveforms, allows input of patient information, and provides the operator with instructions. It uses an IBM-compatible computer (notebook or desktop) to run the SphygmoCor computer software suite.