Product Description
The super high flux dialyzer is a sterile, single-use device designed for use with hemodialysis machines and extracorporeal circulation tubes. It is intended for hemodialysis therapy in patients with acute or chronic renal failure. This dialyzer effectively purifies blood by removing small molecule toxins and metabolic wastes (such as urea, creatinine, phosphate, vitamin B12), as well as middle and large molecule toxins (such as β2-microglobulin) and excess water. Additionally, it helps regulate the patient's water, electrolyte, and acid-base balance.


Indications
The Polyethersulfone Hollow Fiber Hemodialyzer is designed for single use in acute and chronic renal failure hemodialysis and hemodiafiltration treatment.
Contraindications
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.
Components Of The Product
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

Precautions
1. Intended Users:
The product is designed for patients with acute and chronic renal failure.
Use must comply with relevant operational instructions, laws, and regulations of the medical department.
Only trained doctors or nurses should use this product.
2. Aseptic Operation:
After connecting to the bloodline, ensure the dialyzer is operated aseptically and used as soon as possible.
3. Pressure Limitations:
The maximum trans-membrane pressure is 66.5 kPa (500 mmHg).
Avoid unnecessary pressure on the bloodline and dialyzer to prevent leakage and disconnection of parts.
4. Adherence to Procedures:
Operators must strictly follow the our recommended procedures, warnings, and precautions.
5. Patient Population:
Recommended for adult use only.
The safety and efficacy for pregnant patients have not been established.
6. Flow Rate Compliance:
Using the product below the recommended flow rate or not following the instructions will reduce performance.
7. Routine Testing:
It is suggested to test blood routine, renal function, blood electrolyte, and other indicators once a month.
8. Compatibility with Equipment:
The product should be used with a dialyzer machine, bloodline, and dialysate meeting national and international standards.
Treatment should be stopped if complications affecting the patient's condition arise.
9. Device Life:
The device's usage duration is 4 hours.
10. Dialysate Standards:
The dialysate should comply with ISO 13485 and MDD/MDR standards.
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