Why do we need purified water for dialysis?
Because the patient’s blood and dialysate are separated only by a thin semi-permeable membrane, the quality of dialysis water and the dialysate is very important. The average person drinks approximately 14 liters of water a week. On average, dialysis patients are subjected to 360 liters of water per week.
What is dialysate?
Dialysate is a mixture of purified water, acetate and bicarbonate. The dialysate is approximately 95% purified water.
What is Hemodialysis?
During hemodialysis, blood from the dialysis patient flows through one compartment of an artificial kidney (dialyser), while an isotonic salt solution (dialysate) flows in a countercurrent manner through another compartment. A thin semi-permeable membrane separates the two compartments, allowing metabolic waste products in the patient’s blood to diffuse across the membrane into the dialysate and to be discarded with the dialysate to drain.
What does 510(k) mean?
Any manufacturer that wants to market a new medical device or obtain premarket clearance of a substantial equivalent device must submit a 510(K) premarket notification to the FDA (Food and Drug Administration). Total Water Treatment Systems 510(K) number is K002045.