Product
[Product name] Medical Glue
[Main ingredients] α-n-Butyl Cyanoacrylate, α-n-Octyl Cyanoacrylate
[Structural formula]
CN
∣
CH2=C–COOC4H9
CN
∣
CH2=C–COOC8H17
[Composition]
Ingredient name | Component proportion |
α-N-butyl cyanoacrylate (NBCA) | 20% |
α-N-octyl cyanoacrylate (NOCA) | 80% |
[Description] This product is a colorless or faint yellow transparent liquid. The curing and film-forming time of the medical glue on the surface of tap water is (2~6) s, and the cured film is transparent and able to be lifted and bent without breaking.
[Intended purpose] The device is intended used for spraying on the wound after debridement under direct vision or endoscope in human body for hemostasis of organ and tissue wounds.
[Indication] Spraying on the wound after debridement under direct vision or endoscope in human body for hemostasis of organ and tissue wounds. Can not be used for actively bleeding wound.
[Model] laparoscopic type
[Specification] 1.0 ml/piece, 1.2 ml/piece, 1.5 ml/piece, 1.8 ml/piece, 2.0ml/piece.
[Intended user] Medical staff
Mechanism of action
[Contraindications]
· Do not used for actively bleeding wounds, uncleaned wounds, and great vessels not effectively ligated.
· Do not use on any infected wound.
· Strictly prohibited for the nozzle of the convertible spray head and the extended nozzle under the endoscope to come into contact with blood or tissue fluid, which will result in the curing of glue, block the nozzle, and cause spray failure (at this time, spray shall not be implemented by force, otherwise non-intended sites may be sprayed).
· Patients with known preoperative systemic infections, patients with uncontrolled diabetes, or other diseases or conditions known to interfere with the wound healing process.
[Side effects]
The use of this product can cause a fever reaction. If applied too thick, the heat generated during the adhesive polymerization reaction can damage adjacent tissues.
Some other possible side effects includes wound separation, wound dehiscence, seroma or hematoma.
[Warnings]
1. This product is for single use only. Please check the sterile package of tools before use, and do not use it if damaged.
2. This product is for single use, it can not be re-used, re-use of the product can cause loss of product function, and infection or other hazards to the patient.
2. Keep the product away from children.
3. With fast curing speed, the medical glue can bond most human tissues and many other materials, such as surgical gloves and stainless steel. It is required to avoid accidental contact with any human tissues, surfaces of objects and equipment that are not disposable or cannot be easily cleaned with solvents such as acetone. Clear water or alcoholic liquid can speed up the polymerization speed of medical glue.
4. Do not put the medical glue in any procedure pack or surgical tray that should be sterilized before use. The medical glue will speed up curing when exposed to a hot environment (such as autoclave or ethylene oxide sterilization) or ray (such as gamma ray and electron beam), and lose adhesion properties.
5. One medical glue can only be used by one patient, and after each wound adhesion operation is completed, it is required to discard the opened residual medical glue and handle it as medical waste.
6. Do not re-sterilize the medical glue.
7. If intact skin is accidentally bonded together, it is required to remove the medical glue from the skin, without ripping the skin edges apart. Vaseline or acetone can help release the adhesion. Other agents (such as clear water, normal saline, or soapy water) cannot immediately release the adhesion.
8. Do not splash into the eyes.
9. Do not use in active infected wounds.
10. The medical glue has not been studied regarding the safety and effectiveness of the following wounds:
Wounds, burst stellate lacerated wounds, bite wounds of patients with peripheral angiopathy, insulin-dependent diabetes mellitus, coagulation disorders, or a personal or family history of keloid formation or hypertrophy.
11. Relevant studies have shown that α-Cyanoacrylate products have the following adverse reactions: acute inflammatory reactions; allergic reactions; possible tissue necrosis; nerve damage, contraindicated in nerve sites, possibly irreversible damage to nerve sites; especially when used in great amounts, the larger the polymer, the slower it is absorbed in the body and the more likely it is to become a foreign body.
12. If any serious incident that has occurred in relation to the device, it should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established.
13. EUH202 — ‘Cyanoacrylate. Danger. Bonds skin and eyes in seconds. Keep out of the reach of children’
[Lifetime]
The intended lifetime of the product is 6 months.