【 product name 】 use the stomach check auxiliary bag once。
【 specification 】 Ⅰ type (check).
[name of registrant] henan jianqi medical equipment co. LTD.
The dingluan industrial zone in changyuan county.
[contact number] 0373-8690789.
[after-sales service unit] henan jianqi medical equipment sales co., LTD.
[name of production enterprise] henan jianqi medical equipment co., LTD.
The dingluan industrial zone in changyuan county.
[production address] dingluan industrial zone, changyuan county。
[contact information] 0373-8690789。
[production license] the food and drug regulatory apparatus is permitted to be made in 20080036.
[registration certificate no。]yu ordnance note 20142640017
[technical requirements no.]yu ordnance note 20142640017
[structure and composition] the product consists of basic configuration and selection configuration; Basic configuration: mouth pad, disposable therapeutic towel, medical absorbent gauze pad; Choose configuration by: disposable medical rubber examination gloves, medical cotton ball, cloth bags, trays, PE examination gloves, disposable medical cushion, medical nonwovens dressing blocks, apron, medical forceps, tissue paper.
[product performance] 1. The name, specification and quantity of items configured in the auxiliary bag of the stomach shall meet the requirements of the product technical requirements in table 1. 2. The auxiliary package of gastric inspection should be well sealed, with no gaps and no holes; All accessories in the bag should be free of damage, no stain, no impurities; Folded parts should be folded neatly. 3. The surface of the mouth cushion should be clean, smooth, without impurities, no burr, no injection flow; The specification and size shall conform to the requirements of table 2 in the technical requirements; The pressure resistance is not deformed, unbroken and not broken in 30s under tension of 50N. 4. Disposable therapeutic towels shall be qualified products to obtain registration certificate of medical devices. 5. Disposable rubber inspection gloves shall be qualified products for obtaining medical device registration certificate. 6. For the identification test of medical absorbent gauze, the cotton fiber should meet the requirements of the identification test A, B and C according to the test of YY 0331-2006. According to the test of YY 0331-2006, cotton fiber should meet the requirements of identification test A and C. The viscose fiber should meet the requirements of identification test B; The luster of the product shall meet the requirements of the identification test D; The solution should not be pink; The warp fiber should be all or almost all cotton, and the weft fiber should be all or almost all typical cotton fibers. Check the warp and weft fibers, occasionally a small number of isolated foreign fibers exist; Only the microscopic brown and purple fluorescence and a small amount of yellow particles should be used. In addition to a small amount of isolated fiber, should not show strong blue fluorescence; The yarn number of each 100mm shall meet the requirements of table 3 of the product technical requirements; The quality of each square metre (in grams) should meet the requirements of table 3 in the product technical requirements; The minimum breaking force per 50mm (in newtons) should meet the requirements of table 3. The sinking time shall be no more than 10S; The total amount of soluble in ether should not be greater than 0.50%; After 300S, the surface active substance foam should not exceed 2mm. The total amount of soluble in water should not be greater than 0.50%; The solution should not be blue, purple, light red or light brown; Get the color of the liquid should be deep in appendix A of regulations on the control of the liquid Y5, GY6 or reference solutions according to the following methods: 3.0 mL to primary blue solution with 7.0 mL of hydrochloric acid solution (mass concentration of 10 g/L hydrochloride), using hydrochloric acid solution (mass concentration hydrochloric acid of 10 g/L) 0.5 mL of the solution will be diluted to 10.0 mL. The quality loss of absorbent cotton gauze should not be greater than 8.0%; The total amount of sulphate ash should meet the requirements of table 4; X-ray detectable components (if any) X-ray detectable components shall be not less than 55% of barium sulfate content of material or other have the same X-ray permeability of the material, the material should not fall off fiber, should not affect the softness of dressing or provides the raw material inspection report; The X-ray detectable component can be detected from the gauze package, and its quality should meet the following requirements: single wire: not less than 0.5 g/m; Multifilament: no less than 0.28 g/m; The imaging of the samples should be significantly lighter than the background in accordance with the standard yy0594-2006 appendix B test. 7. The medical cotton ball shall be a qualified product for obtaining the medical device registration certificate. 8. If the package cloth is made of hot pressure, the hot pressing part should be firm and not cracked; The specification of non-woven fabric shall not be less than 20g/m2; The longitudinal fracture strength should be greater than or equal to 13N, and the transverse fracture strength should be greater than or equal to 8N. 9. The tray should be smooth, without burr, burr or injection flow; Thickness shall not be less than 0.01mm; PE examination gloves shall be eligible for medical device registration certificate. 10. Disposable medical MATS shall be qualified products with medical device registration certificate. 11. Medical non-woven dressings shall be qualified products for obtaining registration certificate of medical devices. 12. The apron and appearance should be free of stains, mildew stains and no damage; The thickness of the apron should not be less than 0.01mm and the gram weight should not be less than 20g/m2. 13. The medical tweezers should be symmetrical, and the appearance should be smooth, without front edge, burr, crack, pitting and trachoma. Tweezers should have good elasticity; The two pieces of tweezers should be strong enough to withstand the tension of 15N without breaking. The teeth should be clear and complete, should not be missing teeth, bad teeth defects; The guiding pin and positioning pin of tweezers should be firmly fixed. When the tweezers are open and closed, they should be flexible and should not be jammed. The handle of the tweezers should be clear and complete. There should be no flowers or flowers. 14. The paper towel should be wrinkled, the wrinkles should be even and delicate; Paper surface should be clean, no obvious dust, broken, sand, hard block or fade, powder, hair loss. 15. The auxiliary bag should be sterile. 16. The residual amount of epoxy ethane should not be greater than 10 g/g after the sterilization of the gastric test.
[scope of application] applicable to clinical assisted gastric examination.
Contraindication: no absolute contraindication.
1. This product is a disposable product, which is damaged in packaging and is strictly prohibited to be used and destroyed after use.
2。 See packaging seal or label on the production batch number, and the sterilization date is in the outer packing box。
3. This product is sterilized by ethylene oxide.
[use method] 1. Select the applicable patient's specifications and model, and then open the package after the outer packing is in good condition.
2。 Take out the accessories according to the surgical needs。
3。 After the product is finished, it should be treated with medical waste to avoid pollution。
[storage method] 1. This product is used in the carriage and hold of the cabins, and is kept clean, without pressure, sunshine and rain and snow.
2. Handle gently in handling and avoid violent collision;
3. The product shall be stored away from the fire source, and the relative humidity shall not exceed 80%, without corrosive gas and well-ventilated and clean environment.
[production date] see packaging seal or label.
Expiry date: see packaging seal or label.
[label, package logo]