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1. Indications for Use
This product is indicated for autologous blood recovery during surgical procedures, as well as for postoperative drainage of exudate, pus, and other bodily fluids, thereby creating favourable conditions for wound healing.
2. Contraindications
1.Hypersensitivity to polyvinyl chloride (PVC) material.
2.Severe coagulation disorders or obvious bleeding tendencies.
3.Skin or soft tissue infection at the drainage site that may lead to spread of infection.
4.Severe intra‑abdominal adhesions where placement of a drainage tube may cause organ damage or intestinal fistula.
5.Patients who are unconscious or unable to cooperate with treatment, which may result in accidental dislodgement or premature removal of the drainage tube (use with caution).
3. Specifications and Models
Inner Diameter | Outer Diameter | Catheter Length | Applications |
[Model 1]4.76 | [Size]7.75 | [Size]383-6022 |
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[Model 2]6.35 | [Size]9.9 | [Size]383-6022 |
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[Model 3]7.14 | [Size]10.9 | [Size]383-6022 |
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（Note: Dimensions are in mm. For detailed specifications, please refer to the product packaging label.）
4. Instructions for Use
(1) Preparation Before Use
1.Check that the product packaging is intact. Verify the date of manufacture, expiry date, and sterilization indicator. Do not use if the packaging is damaged, the expiry date has passed, or the sterilization indicator is compromised.
2.Confirm that the patient has no relevant contraindications. Explain the intended use and precautions to the patient or their family members.
3.Prepare the negative pressure source, drainage bag, and other ancillary devices, ensuring that all devices are sterile and in proper working condition.
(2) Operating Procedure
1.In a sterile environment, open the inner packaging and remove the drainage tube and its accompanying accessories.
2.According to surgical requirements and the drainage site, select an appropriate puncture point or surgical incision, and gently insert the drainage tube to the predetermined position.
3.Secure the extracorporeal portion of the drainage tube with a medical fixation dressing to prevent displacement, dislodgement, or kinking.
4.Following clinical practice, connect the drainage tube securely to the negative pressure
(2) Operating Procedure
1.In a sterile environment, open the inner packaging and remove the drainage tube and its accompanying accessories.
2.According to surgical requirements and the drainage site, select an appropriate puncture point or surgical incision, and gently insert the drainage tube to the predetermined position.
3.Secure the extracorporeal portion of the drainage tube with a medical fixation dressing to prevent displacement, dislodgement, or kinking.
4.Following clinical practice, connect the drainage tube securely to the negative pressure
5. Sterilization Method
The product is sterilized with ethylene oxide (EO). The sterilization process complies with the requirements of ISO 11135:2014 and ISO 11138‑7. The sterility assurance level (SAL) reaches 10⁻⁶. Once the sterile packaging is damaged, the product is considered contaminated and must not be used.
6. Storage and Transport
1. Storage Conditions
The product should be stored in a cool, dry, well‑ventilated, and clean environment, protected from direct sunlight, high temperature, and moisture. Keep away from fire sources and corrosive gases.
2. Transport Requirements
During transport, the product should be handled with care to avoid violent impact, compression, or packaging damage. The transport environment should meet the above storage conditions.
7. Shelf Life
The shelf life of this product is [Please specify the shelf life period]. It is calculated from the date of manufacture. Products exceeding the shelf life must not be used.
8. Accessories List
Medical PVC negative pressure drainage tube × 1
Connecting connectors × 2
Product certificate × 1
(Note: The actual accessories supplied are subject to the product packaging.)
9. Waste Disposal
After use, this product becomes medical waste. It shall be collected separately and disposed of harmlessly in accordance with the Regulations on the Management of Medical Wastes and other relevant regulations. It is strictly prohibited to discard it carelessly to avoid environmental contamination or cross‑infection.
10. Warnings and Precautions
This product is intended for use only in qualified medical institutions by trained healthcare professionals in accordance with standard clinical procedures.
Strict aseptic technique must be observed during operation to prevent the risk of infection.
If the patient experiences discomfort, allergic reactions, or other abnormal conditions during use, the procedure should be stopped immediately and appropriate medical measures should be taken.
The product is manufactured in compliance with GB 10010‑2009 and YY/T 0489‑2023 Sterile single‑use drainage catheters and auxiliary devices.
11. Date of Compilation/Revision of Instructions for Use
Date of Compilation: ________
12. Important Notice
The contents of this instruction manual are intended solely as a guide for product use and are not a substitute for the clinical judgment of qualified healthcare professionals.
In clinical practice, the selection and use of this product should be based on the patient’s specific condition, the surgical circumstances, and the professional experience of the medical staff. If you have any questions regarding the use of this product, please contact the manufacturer promptly.
