Instruction manual for disposable medicine bag
[product name]: disposable medicine change bag
[specification / model]: type I II
[name of registrant]: Xinxiang Hongda sanitary materials Co., Ltd
Residence: dingluan Town, Changyuan County
[contact information]: Tel: 0373-8996070 Fax: 0373-8996966
[after sales service unit]: Xinxiang Hongda sanitary materials Co., Ltd
[name of manufacturer]: Xinxiang Hongda sanitary materials Co., Ltd
Residence: dingluan Town, Changyuan County
[production address]: dingluan Town, Changyuan County
[contact information]: Tel: 0373-8996070 Fax: 0373-8996966
Email: xxshd@126.com Postcode: 453412 website: www.xxshongda.com
[production license No.]: ysyjx production license No. 20150111
[Registration Certificate No.: yxzz 20172640722
[technical requirement No.]: yxzz 20172640722
[product performance]: 1. See Table 1 for the configuration and quantity of disposable medicine change kit. 2. The change package should be clean and free from defects such as stain and damage. The surface of tweezers in the medicine changing bag should be smooth and without burr; the gauze block surface should be clean and folded neatly. 3. The inner wrapping cloth and hole towel of the charge changing bag are made of thin bonded nonwovens with a thickness of 25-35g / m2, and the performance shall meet the requirements of FZ / t64004-1993. 4. The maximum closing size of forceps in the charge changing bag should not be less than 15mm. When the middle part of forceps is stressed, the tweezers heads should be consistent with each other. 5. The performance of the medical gauze block in the charge change bag should meet the requirements of yy0331-2006; the performance of the absorbent cotton used in the cotton ball should meet the requirements of YY0330-2002. 6. The performance of rubber inspection gloves in the charge change bag shall meet the requirements of gb10213-2006.
7. The performance of suture needle used in the charge change package should meet the requirements of yy0043-2005. The linear performance of non absorbable surgical suture in the cartridge should meet the requirements of yy0167-2005.
8. Change the package should be sterile.
9. The residual amount of ethylene oxide should not be greater than 10 ˊ g / G after sterilization with ethylene oxide.
[main structure composition]: the product is divided into type I and type II. Type I is composed of wrapping cloth, hole towel, tweezers, gauze block, inspection gloves, cotton ball and tray; type II is composed of wrapping cloth, hole towel, tweezers, gauze block, inspection gloves, cotton ball, suture needle, non absorbable surgical suture and tray. The product should be sterile. After sterilization with ethylene oxide, the residual amount of ethylene oxide should not be more than 10 μ g / g. Disposable use.
[scope of application]: it is applicable to medical institutions when changing dressing or suturing patients.
[contraindications]: none
[precautions]: 1. This product is disposable and should be destroyed after use. 2. The package is damaged. Do not use it.
3. Confirm the validity period of the product before use, use it within the validity period and prohibit repeated use.
[storage]: the product should be stored in a cool, dry and well ventilated warehouse with relative humidity no more than 80%, no corrosive gas.
[production date]: see the certificate or seal of package
[service life]; two years
[expiration date]: see the certificate or seal of package
[package identification]:
[preparation of instructions]: the instruction manual of this product is compiled and formulated in accordance with the regulations on the management of instructions and labels of medical devices.