The ABLE® Disposable Haemodialyser is mainly used for haemodialysis treatment of acute and chronic renal failure.
Intended Use
Contraindications
Order Information
Advertising Review Filing Number
Warnings and Precautions
A-40, A60, A-80, A-200
Yue Guang Shen Zhun Xu Zi [2025] No. 007000
Warnings:
1. Use this product according to instructions of a physician who is well familiar with the patient's condition.
2. Do not use for any other purposes than dialysis.
3. If any abnormalities such as foam generation or mixture, blood leakage, blood coagulation and hemolysis occur during the use of this product, take appropriate measures according to a physician's instructions.
4. In case drugs including an anticoagulant are administered before or during use of this product, follow a physician's instructions about the administration and dose and the administration time of the drugs.
5. Do not reuse this product, as it is intended FOR SINGLE-USE ONLY. Potential risks associated with reuse included:
- Life-threatening infections due to microbial contamination,6. Keep the product away from chemical solvents, such as bleach and alcohols. Residual disinfectant in product may cause adverse patient reactions.
- Deterioration of solute removal performance and ultrafiltration performance,
- Exposure of patients and/or technicians to residual disinfectants and/or adverse reactions, and
- Damage to hollow fibers and/or potential leakage.
7. If the patient experiences abnormal symptoms during treatment with this product, such as discomfort, pruritus, urticaria, peripheral and facial edema, respiratory arrest, facial flush, erythema, asthmatic reaction, hypertension, hypotension and/or cardiac arrhythmia, initiate appropriate interventions as directed by the treating physician.
8. Adverse reactions (e.g., hypotension, hypertension, headache and nausea which are sometimes with hypovolemia or hypervolemia) may occur. Optimize fluid/electrolyte balance and dialysis parameters (blood flow rate and UF rate) to minimize who.
9. During dialysis, constantly monitor the patients who:
- have a history of hypotension with hemodialysis,
- have inflammatory reaction, allergic reaction, hypersensitivity, or increase in the immunity by infections,
- take hypotensive drugs such as inhibitor of angiotensin converting enzyme and calcium antagonist,
- use this product for the first time.
Precautions:
1. The Disposable Haemodialyser must be used under the supervision of qualified healthcare professionals. To prevent bacterial and pyrogenic contamination, it must be used in conjunction with a hemodialysis machine, dialysate, water, and concentrated solution that comply with applicable standards.
2. The maximum dialysate flow rate is 800 mL/min.
3. During treatment, the transmembrane pressure (TMP) must not exceed 66.5 kPa (500 mmHg).
4. The blood flow rate must be maintained between 150 mL/min and 500 mL/min.
5. Do not use if expired. Check the expiry date printed on the packaging before use.
6. Do not use if the outer packaging is damaged, torn, or shows signs of tampering, or if protective caps on the connectors are missing or loose.
7. This product is FOR SINGLE-USE ONLY; reuse is strictly prohibited. Reprocessing may cause patient harm, device failure, or cross-contamination. After use, dispose of it as infectious medical waste in accordance with local regulations to prevent infection risks.
8. The product is provided sterile and non-pyrogenic. Store in original packaging to maintain sterility until use.
9. Color-coding for connectors:
- Arterial line (blood inlet): Red-coded connector10. Any incident (e.g., device malfunction, patient injury) related to the use of this dialyser must be reported immediately to both the manufacturer and the competent regulatory authority in the user’s country/region.
- Venous line (blood outlet): Blue-coded connector
