Composition of the extracorporeal circulation circuit of a blood purification device
2024-06-11
[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 extracorporeal circulation tubing of the blood purification device (hereinafter referred to as the "blood circuit") consists of an arterial line, a venous line, an infusion line (optional), and a waste fluid collection bag (optional). The red connector is the arterial end, and the blue connector is the venous end.
KBXL-1 Model: The arterial line includes a connecting hub, a sliding hub, a clamp switch, a catheter, a sampling hub, a three-way connector, a locking hub, a locking hub cap, a two-way connector (pump hub), a pump tubing, a pressure sensor protective cover, a drip chamber bottle, and a dialysis hub. The venous line includes a connecting hub, a sliding hub, a clamp switch, a catheter, a sampling hub, a locking hub, a locking hub cap, a drip chamber bottle, a dialysis hub, and a filter mesh.
KBXL-2 Model: The arterial line includes a connecting joint, a sliding joint, a switch clamp, a catheter, a sampling connector, a three-way valve, an insertion needle, a protective sheath, a locking joint, a locking joint cap, a two-way valve (pump connector), a pump tubing, a pressure sensor protective cover, a drip chamber bottle, and a dialysis connector. The venous line includes a connecting joint, a sliding joint, a switch clamp, a catheter, a sampling connector, a locking joint, a locking joint cap, a drip chamber bottle, a dialysis connector, and a filter mesh.
Waste fluid collection bag (optional): switch clip, dialysis connector, waste fluid bag.
Fluid infusion tubing (optional): Type A consists of a catheter, T-connector, injection port, injection port protective cap, injection tip, injection tip protective cap,调节 clamp, pump tubing, pump tubing connector, conversion connector, and conversion connector protective cap.
Type B consists of a catheter, a T-shaped connector, an injection port, an injection-port protective cap, an injection tip, an injection-tip protective cap, an adjustment clamp, a pump tube, and a pump-tube connector.
The Type C consists of a catheter, an injection nozzle, an injection nozzle protective cap, an adjustment clamp, a pump tube, and a pump tube connector.
The Type D consists of a catheter, a T-shaped connector, an injection port, an injection-port protective cap, an injection head, an injection-head protective cap, an adjustment clamp, a pump tube, a pump-tube connector, and an injection component.
The E-type consists of a catheter, an injection interface, an injection-interface protective cap, a sensor protector, an injection head, an injection-head protective cap, an adjustment clamp, a pump tube, a pump-tube connector, and an air trap.
The F-type assembly consists of a catheter, a T-shaped connector, an injection port, an injection-port protective cap, an injection needle, an injection-needle protective cap, an adjustment clamp, a pump tubing, a pump-tubing connector, an air trap, a bottle-seal puncturer, a protective sleeve for the bottle-seal puncturer, a pressure-measuring block, a sensor protector, a dialysis-connector, a dialysis-connector cap, a conversion connector, a conversion-connector protective cap, and an infusion component.
The product is supplied in a sterile condition, sterilized by ethylene oxide, and intended for single-use only.
[Material]
Table 1: Material Distribution of Each Component 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 connector cap |
PP |
YY/T 0242-2007 |
|
2 |
Sliding joint |
PP |
YY/T 0242-2007 |
11 |
Two-way (pump connector) |
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 |
/ |
|
5 |
Sampling connector |
PP |
YY/T 0242-2007 |
14 |
Drip bottle |
PVC |
GB/T15593-2020 |
|
6 |
Three-way joint |
PVC |
GB/T15593-2020 |
15 |
Dialysis connector |
PVC |
GB/T15593-2020 |
|
7 |
Insert needle |
ABS |
/ |
16 |
Waste liquid bag |
PVC |
GB/T15593-2020 |
|
8 |
Sheath |
PP |
YY/T 0242-2007 |
17 |
Filter mesh |
PP |
YY/T 0242-2007 |
|
9 |
Locking connector |
PP |
GB/T15593-2020 |
|
|
|
|
Note 1: All medical-grade PVC used contains DEHP plasticizer (except for waste fluid bags).
Table 2: Material Distribution of Each Component in the Fluid Infusion Pipeline
|
Component Name |
Material Name |
According to the standard |
|
Catheter, dialyzer interface, injection interface, injection head, injection device, air trap, pump tubing, pump tubing connector, T-shaped interface, conversion connector, pressure measurement block, sensor protector |
PVC |
GB/T15593-2020 |
|
Injection head protector, dialyzer interface cap, vial puncture protector, injection interface cap, adapter connector protective cap, adjustment clamp |
PP |
YY/T 0242-2007 |
|
Note item |
Silicone |
YY/T 0031-2008 |
|
Bottle stopper puncture device |
ABS |
/ |
Note 2: The PVC used to manufacture catheters, pump tubing, pressure-measuring blocks, and adapter fittings contains DEHP as a plasticizer.
[Main Performance Parameters]
1) Structural Integrity: The blood pathway shall be able to withstand a test pressure of 1.5 times the maximum positive pressure specified by the manufacturer (66.7 kPa, or 100 kPa, or 750 mmHg) and 1.5 times the maximum negative pressure specified by the manufacturer (62.2 kPa, or 93.3 kPa, or 700 mmHg), without leakage or rupture.
2) Performance of pump tubing
Within the specified inlet pressure range of 0 to 33.3 kPa (0 to 250 mmHg), the relative deviation in flow rate should not exceed 10%.
【Scope of Application】
This product is intended for use as a blood conduit during hemodialysis, hemodiafiltration, and hemoperfusion combined with hemodialysis treatments. It is suitable only for adult patients.
【Applicable Models】
When using this product for blood purification therapy, please ensure that the model and specifications of this product are compatible with your blood purification equipment.
