Synthetic Hollow Fiber Dialyzer

The synthetic hollow fiber dialyzer is designed for single use in acute and chronic renal failure hemodialysis and hemodiafiltration treatment.

There is no absolute contraindication, but it should be used with caution in the following cases: allergy to materials; severe intracranial hemorrhage; severe shock which is difficult to be corrected by drugs; severe myocardial disease with refractory heart failure; severe active bleeding; mental disorders cannot be treated with hemodialysis.

(1) The intended users are patients with acute and chronic renal failure, the use of the product must comply with the requirements of relevant operation instructions, laws and regulations of the medical department, and should only be used by trained doctors or nurses.

(2) After connecting to the bloodline, the dialyzer should be aseptic operation and used as soon as possible.

(3) The Maximum trans-membrane pressure is 66.5kpa (500mmhg), and unnecessary pressure should be avoiding to the bloodline and dialyzer to prevent leakage and falling off of the connecting parts.

(4) The operator should strictly obey the manufacturer's recommended procedures, warnings and precautions.

(5) Intended patient population: recommend for adults only. The safety and efficacy of the Polyethersulfone hollow fiber hemodialyzer for pregnant patients have not been established.

(6) When the flow rate of the synthetic hollow fiber dialyzer is lower than the recommended rate or the product is not used in accordance with the instructions, the performance will be reduced.

(7) It is suggested to test blood routine, renal function, blood electrolyte and other indicators once a month.

(8) The product should be used together with dialyzer machine, bloodline and dialysate. These equipment and consumables must meet the national and international standards. In case of complications affecting the stability of the patient's condition, the treatment should be stopped.

(9) The duration of device life use is 4h.

(10) The dialysate should meet the be ISO13485 and MDD/MDR.

Components & Materials

Membrane: Polyethersulfone (PES)

Sealing compound: Polyurethane (PUR)

Housing; End Cap: Polycarbonate (PC) or Polypropylene (PP)

Sealing ring: Silicon rubber (SIR)

Blood compartment connections: ISO 8637

Dialysis fluid connections: ISO 8637
Sterilization Method: Gamma ray

Store in a dry place with ventilated, clean, non-corrosive air within the temperature of 0~40℃.

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