[product name] chitosan umbilical protection package

[specification and model] pure cotton and Nonwovens

[name of registrant] Henan Jianqi medical device Co., Ltd

[residence] dingluan Industrial Zone, Changyuan County

[Tel.] 0373-8690789

[after sales service unit] Henan Jianqi medical equipment sales Co., Ltd

[name of manufacturer] Henan Jianqi Medical Equipment Co., Ltd

[residence] dingluan Industrial Zone, Changyuan County

[production address] dingluan Industrial Zone, Changyuan County

[contact information] 0373-8690789

[production license] ysyjx production license No. 20080036

[Registration Certificate No.] yxzz 20182140542

It is mainly composed of chitosan and medical umbilical cord protector.

[product performance]: 1. The appearance of the navel protector should be soft with no damage and disconnection, and the components should be free of stains and odor, and the surface should be clean; 2 Umbilical cord protection: the breaking strength of spunlaced nonwovens used shall comply with the relevant provisions of class B in 3.3 of FZ / t64012.2-2001 standard. The pure cotton cloth used shall not break under a tensile force of 30n, and the saturated water absorption capacity of umbilical cord protection shall not be less than 8 times of its fixed weight. The formaldehyde content of cotton cloth is less than or equal to 20 mg / kg. The pH value of cotton cloth is 4.0-7.5; 3. The umbilical cord does not break under 30n static tension. 4. The medical rubber ring does not break when it is stretched twice. 5. Chitosan dressing should meet the requirements of yzb / yu0214-2014 standard or provide supplier qualification, inspection report and supply contract. 6. When the adhesion of adhesive tape is tested according to Appendix B of YY / T 0148-2006, during the test in oven, the top sliding of adhesive tape pasted on stainless steel plate shall not exceed 2.5 mm. When the peel strength is tested according to Appendix B of YY / T 0148-2006, the average force required to paste the adhesive tape per 1 cm width should not be less than 1.0N; 4. The chitosan umbilical protector should be sterile; 6. If the chitosan umbilical protector is sterilized by ethylene oxide, the residual ethylene oxide should not be more than 10 μ g / g; 7. The cytotoxicity should not be less than grade 2, the pH value of skin stimulation should be 0-0.4, and there should be no delayed hypersensitivity reaction.

[scope of application] it can be used to protect the umbilical cord of newborn.

[contraindications] it is forbidden for those allergic to chitosan raw materials

[precautions] 1. This product is disposable and its package is damaged. It is forbidden to use it and destroy it after use. 2. The production batch number and expiration date are shown in the seal of the package, and the sterilization date is shown in the outer packing box. 3. This product is sterilized by ethylene oxide and has a sterility validity of two years.

[method of use] 1. Open the package before use, and cover one end of navel protector containing chitosan dressing piece on the navel of newborn; 2. Wrap the other end around the abdomen for one week, and fasten the buckle or paste firmly according to the waist circumference; 3. It is recommended to replace it every 24 hours.

[storage method] 1. The product should be loaded and transported in covered carriage and cabin, and kept clean. It should not be under heavy pressure, direct sunlight, rain or snow. 2. In the process of handling, it should be handled with care to avoid violent collision; 3. The product should be stored away from the fire source, the relative humidity is not more than 80%, there is no corrosive gas, and there is good ventilation and clean environment.