System Overview - Abbott Ultiri 1015082 Operation Manual

System Overview

The Ultiri™ Measurement System is a diagnostic computer designed to record,
compute, display, and store data from the PressureWire™ X Guidewire and the
Wi-Box™ AO Transmitter. The information is displayed as graphs as well as
numerical values on the screen. Data includes, but is not limited to: systolic,
diastolic, and mean blood pressure; heart rate; Fractional Flow Reserve (FFR);
and Resting Full-Cycle Ratio (RFR).
FFR is the ratio of distal coronary arterial pressure (Pd) to aortic pressure (Pa),
measured during hyperemia. It provides the maximal blood flow in the presence
of a stenosis as a fraction of the achievable blood flow that would exist in the
hypothetical situation that the stenosis was not present. Pd / Pa at rest is the
ratio of distal coronary arterial pressure to aortic pressure measured at resting
conditions.
RFR is a moving average ratio of Pd to Pa taken at a point in the cardiac cycle
where the Pd / Pa ratio reaches a minimum for the whole cycle. RFR is designed
to be used at rest.
The physician may use the FFR, Pd / Pa at rest, and RFR parameters, along
with knowledge of patient history, medical expertise, and clinical judgment, to
determine if therapeutic intervention is indicated.
CAUTION: The components listed in "System Components" on page 19 are
integral parts of the Ultiri Measurement System. The hardware and software
must not be modified in any way by the customer. Making such modifications
may interfere with correct operation and will void system warranties. Contact an
Abbott Technical Service representative for more information.
CAUTION: Medical personnel who use the Ultiri Measurement System and the
installed software must be aware of the system's limitations. Only medical
personnel who are knowledgeable in physiological procedures can determine if
use of the Ultiri Measurement System and the installed software is appropriate.
Be sure to read Safety Information before operating the Ultiri Measurement
System and the installed software for the first time.
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Ultiri™ Measurement System Operation Manual – 600327583 Rev. A