[Production License Number] Sujiang Medical Device Production License No. 20240191

【Medical Device Registration Certificate Number】 National Medical Device Registration No. 20253102526

[Product Technical Requirements Number] National Medical Device Registration No. 20253102526

【Model Specifications】

KBXL-1, KBXL-2

Waste Liquid Collection Bag (Optional): Type I

Fluid infusion tubing (optional): Type A, Type B, Type C, Type D, Type E, Type F

【Structural Composition】

The single-use hemodialysis tubing set consists of an arterial line, a venous line, and an optional waste fluid collection bag. The red connector is the arterial end, and the blue connector is the venous end. Model KBXL-1: The arterial line includes a connecting adapter, a sliding connector, a clamp, a catheter, a sampling port, a three-way connector, a locking connector, a locking connector cap, a three-way (pump tubing) connector, pump tubing, a pressure sensor protective cover, a drip chamber bottle, and dialysis connectors; the venous line includes a connecting adapter, a sliding connector, a clamp, a catheter, a sampling port, a locking connector, a locking connector cap, a drip chamber bottle, dialysis connectors, and a filter screen. Model KBXL-2: The arterial line includes a connecting adapter, a sliding connector, a clamp, a catheter, a sampling port, a three-way connector, a needle-piercing device for the bottle stopper, a protective sheath, a locking connector, a locking connector cap, a three-way (pump tubing) connector, pump tubing, a pressure sensor protective cover, a drip chamber bottle, and dialysis connectors; the venous line includes a connecting adapter, a sliding connector, a clamp, a catheter, a sampling port, a locking connector, a locking connector cap, a drip chamber bottle, dialysis connectors, and a filter screen; the optional waste fluid collection bag includes a clamp, dialysis connectors, and a waste fluid collection bag. The product is supplied in a sterile condition, sterilized with ethylene oxide, and intended for single use only.

【Material】

Table 1: Material Distribution of Components in the Arterial Line, Venous Line, and Waste Collection Bag

Serial Number	Accessory Name	Material	Meets the standard	Serial Number	Accessory Name	Material	Meets the standard
1	Connecting joint	PP	YY/T 0242-2007	10	Locking Joint Cap	PP	YY/T 0242-2007
2	Sliding joint	PP	YY/T 0242-2007	11	Three-way (pump pipe fitting)	PVC	GB/T15593-2020
3	Switch clip	PP	YY/T 0242-2007	12	Pump pipe	PVC	GB/T15593-2020
4	Catheter	PVC	GB/T15593-2020	13	Pressure sensor protective cover	ABS (Grade: TR557) PP	/ YY/T 0242-2007
5	Sampling connector	PP Silicone	YY/T 0242-2007 /	14	Drip bottle	PVC	GB/T15593-2020
6	Three-way connector	PVC	GB/T15593-2020	15	Dialysis connector	PVC	GB/T15593-2020
7	Bottle stopper puncture device	ABS (Grade: TR557)	/	16	Waste liquid collection bag	PVC	GB/T15593-2020
8	Sheath	PP	YY/T 0242-2007	17	Filter screen	PP	YY/T 0242-2007
9	Locking joint	PP	YY/T 0242-2007

Note 1: All medical-grade PVC used contains DEHP as a plasticizer (except for waste fluid collection bags).

【Main Performance Parameters】

1) Structural Integrity: Arterial and venous tubing shall be capable of withstanding a test pressure of 1.5 times the manufacturer’s specified maximum positive pressure (66.7 kPa), i.e., 100 kPa (750 mmHg), and 1.5 times the manufacturer’s specified maximum negative pressure (62.2 kPa), i.e., 93.3 kPa (700 mmHg), without leakage or rupture.

2) Performance of pump pipes

Within the specified inlet pressure range of 0 to 33.3 kPa (0 to 250 mmHg), the relative deviation of the flow rate shall not exceed 10%.

3) The maximum blood flow rate shall not exceed 400 mL/min.

【Scope of Application】

This product is intended for use as a blood line during hemodialysis, hemodiafiltration, and hemoperfusion combined with hemodialysis, and is indicated only for adult patients.

【Applicable Models】

When using this product for blood purification therapy, ensure that the model and specifications of this product are compatible with the blood purification equipment.

[Installation and Usage Instructions or Diagrams]

1. Remove the extracorporeal blood circuit from the packaging, and connect the arterial port and venous port of the circuit to the dialyzer’s arterial and venous ports, respectively.

2. Pre-flush with normal saline to remove all air from the tubing and the dialyzer.

3. Before completing the saline priming, connect the heparinized saline to the infusion branch of the arterial blood circuit. Use the heparinized saline to prime the entire extracorporeal circuit and dialyzer; once the circuit is completely filled with heparinized saline, stop the blood pump and clamp all inlet, outlet, and infusion ports of the extracorporeal circuit. After priming is complete, collect the saline in the waste fluid bag.

4. Recheck that all connections in the extracorporeal circulation circuit are correct and secure.

5. Please read the dialyzer instruction manual before starting treatment.

6. Discontinue treatment.

6.1 Prepare 500 mL of normal saline.

6.2 Adjust the blood flow to 50–100 mL/min and then stop the blood pump.

6.3 Connect the saline solution, start the blood pump, and perform continuous priming with saline throughout the entire extracorporeal circuit, ensuring that no air enters the circuit. Intermittently clamp the venous line to maximize the return of blood to the patient’s circulation.

6.4 After the blood reinfusion volume meets the requirements, shut down the blood pump and simultaneously disconnect the venous line connected to the patient.

 

The single-use hemodialysis tubing set consists of an arterial line, a venous line, and an optional waste fluid collection bag. The red connector is the arterial end, and the blue connector is the venous end. KBXL-1 model: The arterial line includes a connecting adapter, a sliding connector, a clamp, a catheter, a sampling connector, a three-way connector, a locking connector, a locking connector cap, a three-way (pump tubing) connector, pump tubing, a pressure sensor protective cover, a drip chamber bottle, and a dialysis connector; the venous line includes a connecting adapter, a sliding connector, a clamp, a catheter, a sampling connector, a locking connector, a locking connector cap, a drip chamber bottle, a dialysis connector, and a filter screen. KBXL-2 model: The arterial line includes a connecting adapter, a sliding connector, a clamp, a catheter, a sampling connector, a three-way connector, a needle-piercing device for the bottle stopper, a protective sleeve, a locking connector, a locking connector cap, a three-way (pump tubing) connector, pump tubing, a pressure sensor protective cover, a drip chamber bottle, and a dialysis connector; the venous line includes a connecting adapter, a sliding connector, a clamp, a catheter, a sampling connector, a locking connector, a locking connector cap, a drip chamber bottle, a dialysis connector, and a filter screen. Optional waste fluid collection bag: clamp, dialysis connector, and waste fluid collection bag. The product is supplied in a sterile condition, sterilized with ethylene oxide, and intended for single use only.