P1516DEMONSTRATION OF FLUID REMOVAL ACCURACY USING THE SC+ HAEMODIALYSIS SYSTEM

Abstract

Abstract Background and Aims Fluid management is an integral component for managing patients to correct abnormalities in plasma composition and maintain fluid balance. Consequently, accurate fluid removal during treatment is a critical design element of haemodialysis machines. The SC+ haemodialysis system developed by Quanta Dialysis Technologies, is a small, simple-to-use dialysis system designed to improve patient access to self-care and home haemodialysis. This paper describes the design, evaluation and performance of the flow balance and ultrafiltration module of SC+ to deliver specified fluid removal in accordance with the international technical standards for haemodialysis defined in IEC 60601-2-16 using a number of unique proprietary technologies. Method SC+ uses volumetric flow balancing chambers which are contained within a single use disposable cartridge. During normal operation of SC+, dialysis fluid flows through the cartridge in discrete packets. This is achieved by the application of pneumatic pressure and vacuum to manipulate a flexible PVC membrane that, in turn, opens and closes a sequential series of valves and pump cavities that constitute the flow balance chambers. Proof of system performance was undertaken using a range of dialysers and venous pressures, with and without ultrafiltration, to quantify the net fluid removal error, in order to simulate a range of patient conditions in typical clinical practice. Results In total, the tests comprised 22 separate runs on multiple machines, with 88 individual 30-minute measurement samples, taken over a range of environmental conditions, dialyser types (with differing KuF), dialysate flowrates, and venous pressures. Across all results, there was a mean error of 7.4g/hour rate error, (max allowed is 100g/hr) of positive flow from the blood to the dialysate side with a standard deviation of 19.88g/hr. The maximum permissible rate stated in IEC 60601-2-16 is +/-100g/hr. In specific detail, without ultrafiltration the flow balance error was measured as 2.2g/hr with a deviation of 19.0g/hr, and with ultrafiltration the mean error was 12.8g/hr with a standard deviation of 19.5g/hr. Conclusion It has been demonstrated that flow balance error and fluid removal attainable with the SC+ haemodialysis system lies well within the acceptable standards permitted for haemodialysis machines. This essential performance parameter as defined within IEC 60601-2-16 has been demonstrated across a range of clinically relevant parameters at dialysate flow rates of up to 500ml/min