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FDA Clears Cardiac Output Measurements with HD Monitor
Oct. 6, 1998 — The FDA today cleared the Transonic HD01 Cardiac Output
Hemodialysis Monitor for "assessment of a patient's hemodynamic condition through estimation of cardiac output while undergoing hemodialysis in a non-critical care
setting." Through this action the FDA enables better care for hemodialysis patients. Until now, a cardiac output measurement would require a separate scheduled visit
to the hospital for a costly ultrasound scan or cardiac catherization. Now, this breakthrough Transonic technology brings monitoring of this vital sign into the dialysis
clinic.
How Does It Work?
The measurement uses time-proven Transonic
ultrasound indicator dilution technology to measure cardiac output right during hemodialysis when the patient is already under observation. With the HD01 Monitor connected
to the dialysis tubing, a nurse injects a measured amount of saline into the tubing, first to calibrate the sensitivity of the measurement device and then to make a
cardiac output measurement. A computer automatically calculates and displays cardiac output. The computer screen also displays, as an added quality assurance, the
indicator dilution signals for review by the nurse.
What Is Its Clinical Significance?
Transonic Systems expects
dialysis staff to use these on-site cardiac measurements to proactively monitor and mange their patient's total well being. The measurements offer a nephrologist greater
control and a quicker response in patient diagnosis and management. American patients can now receive the diagnostic benefit long enjoyed by their European counterparts.
What Equipment Do I Need for this Measurement?
Current customers
of the Transonic Flow-QC Monitoring system can upgrade their system by purchasing dedicated cardiac output software. New customers can purchase the Transonic HD01 Flow-QC
Monitoring System with its full complement of diagnostic capabilities: Cardiac Output Measurement, Access Flow/Access Patency Monitoring and Dialysis Adequacy Monitoring.
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