1. What is Singclean® Adhension Barrier Gel?
This product is a biocompatible, absorbable, flowable gel composed of hyaluronic acid sodium salt and physiologically balanced salt. With no sulfate groups in its molecule and no covalent binding with the protein, it can exist as free chain in the body for lubrication, moisture preservation and mechanical isolation, preventing adhesions.
Singclean® Adhesion barrier Gel
2. When should consider Singclean® Adhesion barrier Gel?
Used for the prevention and reduction of the incidence, extent, and severity postoperative adhesions of the abdominal and pelvic surgery.
3. How to use Singclean® Adhesion barrier Gel:
4. Important Safety Information
5. Why should use Singclean® Adhesion barrier Gel?
6. Warnings and Precautions
- Confirm that the surgical site is free of excessive bleeding. Excessive bleeding should be controlled prior to Singclean® Adhesion barrier Gel instillation.
- Singclean® Adhesion barrier Gel does not have intrinsic bacteriostatic or bactericidal activity. It is not bacteriostatic toward pre-existing infections, nor does it prevent the occurrence of new infections. In the case of pre-existing infections, appropriate treatment should be instituted.
- The concomitant use of Singclean® Adhesion barrier Gel with other anti-adhesion device has not been evaluated.
- Singclean® Adhesion barrier Gel has not been evaluated with a dose of over 2 ml/kg of body weight. It is not recommended to use Singclean® Adhesion barrier Gel over a dose of 2 ml/kg of body weight unless at the discretion of the physician.
- Singclean® Adhesion barrier Gel has not been evaluated in patients affected by malignant tumors. Preclinical evidence has shown that the products have no influence on neoplastic diffusion.
- Data on the use of Singclean® Adhesion barrier Gel on pregnant women are not available. The use of the products is not recommended in this condition. It is also recommended to avoid pregnancy during the first complete menstrual cycle subsequent to the treatment.
- Do not inject intravascularly.
- Singclean® Adhesion barrier Gel is provided in single-use, pre-filled syringes. The syringe content only is provided sterile. The external surface of the syringe has a very low controlled bio-burden. The syringe is packaged into a protective blister tray or Tyvek pouch to prevent the contamination of its outer surface and to allow the use of the devices in the surgical theatre. Do not re-sterilize the syringe content.
- It is recommended to use the product immediately after opening the pouch.
- All the assembling operations of the device must be performed in the surgical theatre.
- The syringe is single-use; any non-used product must be discarded accordingly. The reuse of the product may cause serious infection.
- The empty containers have to be discarded accordingly.
- Keep out of reach of children.
- If the syringe and /or protective pouch or the blister is damaged, do not use the product and contact local distributor.
- Do not use the product after the expiration date.
- Singclean® Adhesion barrier Gel must be used according to the instruction for use. Read instructions prior to use.
9. Packaging & Shipping
Q: What is hyaluronic acid?
A: Hyaluronic acid (HA) is a unique linear macromolecular mucopolysaccharide. It consists of glucuronic acid and n-acetyl glucosamine disaccharide units alternately connected together, the molecular formula is (C14H21NO11)n. The molecular weight changes between 105~107 based on different tissue of origin. HA is widely distributed in animal and human connective tissue extracellular matrix, with higher concentration in vitreous, umbilical cord, skin, cartilage and synovial fluid. We use bacterial fermentation to product HA material to avoid the risk of carrying virus and media from animal tissues or organs. HA is different from other natural mucopolysaccharide; HA molecule does not contain sulfate groups. It is also not covalently bound protein, and can exist free in the body as freedom chain. It is high viscosity gel for the anti-adhesion treatment.
Q: Normally, how many methods for sterilizing? What is the application range for each method? Which method we use for our products?
A：The common sterilizing methods are moist heat sterilization, irradiation sterilization, eo sterilization (Ethylene oxide) and aseptic processing (Process control). Moist heat sterilization is used widely, Singclean anti-adhension Gel also use this method.
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