Surgiclean_® Fibril Absorbable Hemostat （Oxidized Regenerated Cellulose）

Instruction For Use

[Product Name]

Fibril Absorbable Hemostat （Oxidized Regenerated Cellulose）

[Structure and Composition]

This product is a sterile and absorbable non-woven fabric prepared by oxidation of regenerated cellulose, which is composed of oxidized regenerated cellulose. The product is packaged by medical packaging paper and then sealed in an aluminum-plastic paper bag, The appearance of the product is white or yellowish, lumpy solid with a slight caramel taste. The product is sterilized by irradiation for single use.

[Indications]

This product is suitable for situations where conventional control methods are ineffective or impossible to apply, serving as auxiliary supplies for controlling bleeding in capillaries, veins, and small arteriolesOphthalmology, neurosurgery and urology are excluded.

[Use Method]

Open the aluminum-plastic paper bag and take out the fibril absorbable hemostat, According to the bleeding site and the amount of bleeding, using the fibril absorbable hemostat with appropriate thickness and place it on the bleeding site, and press until hemostasis. The part of product should be removed after use if it is not immersed in blood.

[Precautions]

1. This product is sterile, please treat the unused part as medical waste.

2. Do not use if the package is broken.

3. This product is a supplement to traditional hemostatic methods and cannot replace surgical procedures such as suture and ligation.

4. Avoid using this product on contaminated wounds without drainage to avoid inflammation. if the wound is still inflamed after drainage, a second operation is required to remove the implanted product and apply anti-inflammatory treatment.

5. This product has excellent water absorption, keep away from liquids before using.

6. This product has a low pH; do not mix/use with enzyme based hemostatic agents

7. Do not remove this product without complete hemostasis.

8. Remove any excess after hemostasis is achieved in order to minimize the possibility of tissue reaction.

9. Because the chemical burning area will affect the absorption of this product, this product should not be used after the use of silver nitrate or any other corrosive chemical.

10. This product must not be used in conjunction with a blood recovery system, as product fragments may pass through the filter causing blockages in the blood recovery system or the patient's vasculature.

11. The product must not be used in conjunction with a methyl methacrylate adhesive for prosthetic orthopedic devices, which may reduce the strength of the adhesive.

12. The safety and effectiveness of this product in children, people over 75 years of age, and pregnant and lactating women have not been verified, so it is not clear whether it is suitable for use.

13. This product is only used by persons with relevant professional physician qualifications in medical institutions officially approved by the authorities.

14. Be sure to read the instructions carefully before use and use according to the method as specified

15. Be sure to pay attention to whether this product is within the validity period before use.

16. The maximum use of this product in the human body is 24cm?, which has been fully verified and supported by clinical data.

[Contraindications]

1. The product should not be used in bone defects.

2. The product should not be in stuffing unless it is to be removed after hemostasis is achieved.

3. The product should not be used to control hemorrhage from large arteries.

4. The product should not be used on non-hemorrhagic serous oozing surfaces, since body fluids are different from whole blood.

5. The product should not be used to patients allergic to cellulose.

[Adverse Reactions]

1. Occasionally the use of oxidized regenerated cellulose products may cause fluid cysts or foreign body reactions.

2. There may be a“burning" and a“stinging" sensation.

3. Use of this product near large and medium vessels may lead to vascular embolism.

4. Excessive use may cause a thrombus at the site of application.

5. Oxidized regenerated cellulose is highly acidic, which may lead to aseptic inflammation at the implant site and may delay healing. The above adverse reactions have been reported for similar products, and these adverse reactions have not been found in clinical trials of this product. Any adverse reactions during use can be directly reported to the distributor or to the manufacturer viawww.Singclean.net.

[Specifications]

[Storage]:

It should be stored in normal temperature, dry environment, and keep away from sunlight.

[Shelf Life]:

2 years.

8.21.04.0202-A0             Issue date:2023-11-01