Clive Buckberry, Nicholas Hoenich, Paul Komenda, Mark Wallace, John E Milad
Journal: Expert review of medical devices 2020;17(8):835-843
PMID: 32700578
BACKGROUND
Fluid management is integral to hemodialysis, both to correct abnormalities in a patient's plasma composition and to maintain fluid balance. Consequently, accurate net fluid removal during treatment is a critical design element of hemodialysis machines. As dialyzers have evolved, with increased ranges of ultrafiltration coefficients available, it has become more challenging for dialysis machines to minimize errors in flow balance and net fluid removal.
RESEARCH DESIGN AND METHODS
This paper describes the design, evaluation and experimental performance of the flow balance and ultrafiltration module of the SC+ system to deliver clinically specified fluid removal with both passive and active control measures, in laboratory conditions designed to simulate a wide range of therapies.
RESULTS
The use of passive and active control allows the errors to be minimized across a wider dynamic range of conditions. For the SC+ system, the average flow balance error was 1 mL/hr with an SD of 19 mL/hr and with ultrafiltration it was 13 mL/hr and an SD of 20 ml/hr across all conditions.
CONCLUSIONS
This paper demonstrates that the SC+ hemodialysis system, a small, simple and versatile CE marked device, operates within the limits required by international standards across a wide range of experimental conditions.
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