Surgiclean_® Absorbable Collagen Hemostotic Sponge

Product Name

Absorbable collagen hemostatic sponge

Structure and Properties

Surgiclean® is a white or light yellow sponge which is composed of bovine-origin collagen. This product has good absorbability of liquid; the absorption weight of water is more than 30 times the weight of this product. This product is sterilized by radiation and can be used once only.

Principe of action

On contact with blood, collagen is known to cause aggregation of platelets. Platelets deposit in large numbers on the collagen structure, degranulate, and release coagulation factors. together with plasma factors, enable the formation of fibrin.

Indications

This product is suitable for non-pulsatile arteriole, venule and capillary hemostasis in surgery when pressure, ligation, electrocoagulation or other traditional methods of hemostasis are ineffective.

Instructions for Use

1. When this product is used on the body surface, the wound can be routinely disinfected

2. Then cut the product into a suitable size, cover the wound with its rough side.

3. Finally fix it with medical gauze, medical cotton or other dressings

4. If dressing change or wound care is needed, it is not necessary to remove this product that originally covered the wound. Continue to cover the original surface directly with this product.

5. When the product is used in vivo, it should be cut into a suitable size according to the wound, press lightly for 1 to 2 minutes, Finally, sutured and fixed as needed.

Contraindications

1. Do not use this product in blood vessels to prevent thrombosis

2. Do not use this product in patients with a history of allergy to bovine origin materials or collagen.

3. Do not use this product in patients with autoimmune diseases.

4. This product should not be used in department of ophthalmology, neurosurgery and urology.

5. Do not use this product on skin incisions, otherwise it may affect the repair and healing of skin and tissue at the edge of the incision due to the physical characteristics of dry collagen.

Precautions

1. This product can only be used by personnel with relevant professional qualifications in medical institutions officially approved by local authority.

2. This product is forbidden to be used if its packaging is damaged

3. When the product is used to stop bleeding inside the tissue, the minimum amount of this product should be used to meet the needs of hemostasis. Once the hemostasis is effective, the residual product should be removed as much as possible

4. This product should not be used to stop bleeding in infected areas, and should be used with care in contaminated areas. lf there are obvious signs of infection or abscess expansion at the application site after application of the product, a second operation is required to remove the implanted product and drain it.

5. Do not repeat sterilization, unsealed and unused product should be discarded and treated as medical waste.

6. This product should not be used for cavity filling to stop bleeding.

7. This product cannot be used for active arterial bleeding (or bleeding point immersed by blood or other liquid, or bleeding point which cannot find the location).

8. This product can not be used to replace fine hemostasis surgery, ligation and other conventional methods of hemostasis.

9. This product should not be used for hemostasis of postpartum hemorrhage or menorrhagia

10. This product is not suitable for the treatment of patients with coagulation disorders

11. Data on the safety and efficiency of the product in children and pregnant women are not available

12. The safety and efficacy of the product in combination with other agents, such as topical thrombin, antibiotic solution or antibiotic powder, have not been established.

Warning

1. The product should not be used with the blood recovery system because product fragments may block the blood recovery system.

2. The product should not be used together with the methyl methacrylate adhesive used for the fixation of artificial limb orthopedic instruments.

Adverse reactions

The product has good biocompatibility, absorbability and safety in clinical application. No adverse reactions have been reported so far, but doctors should be aware of the potential allergic reactions when using any natural biological material. Any adverse reactions in the process of use can be directly feedback to the distributor or login to Web: www.singclean.net and feedback to the manufacturer.

Storage

The product should be stored in dry and room temperature conditions. 

Date of production

See the small box for details.

Specification

10x10x5mm、25x10x5mm、25x25x5mm、50x50x5mm、50x100x5mm、100x100x5mm

8.33.04.0150-A0            Issued date:2024-06-25