[product name] disposable oral package

[specification and model] type I (inspection type).

[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 20142660134

[technical requirements No.] yxzz 20142660134

Oral bag (water mark). Jpg

[structure and composition] the product is composed of basic configuration and optional configuration; basic configuration: tooth probe and tray; optional configuration: Medical tweezers, medical cotton ball, medical degreasing gauze block, oral mirror, apron, disposable medical rubber inspection gloves, disposable treatment towel, medical cotton swab, disposable hole towel, medical nonwoven dressing block, disposable medical bag , tissue paper, hemostatic forceps, tongue depressor, small bowl, straw.

[product performance] 1. The configuration, item name, specification and quantity of the oral package shall meet the requirements of Table 1 in the product technical requirements. 2. Oral packaging should be well sealed, no gaps, no holes; the accessories in the oral bag should be free from damage, stains and impurities; folding parts should be folded neatly. 3. The surface of dental probe should be free of pores, cracks, grinding marks, peeling residues, acid stains, oil stains and grinding and polishing residues; satin finishing should be uniform and smooth, and can reduce the reflective effect; if the tooth probe has a mirror, its surface should be free of defects and grinding marks, and should have a surface with good reflection; the hardness of the working tip should not be less than 480hv1 The tensile strength of the working tip should be 1700mngmm2; there should be no corrosion; except for the serrated martensitic stainless steel handle, any defect will be considered as evidence of corrosion of the instrument; the physical appearance of the heat-resistant instrument should not be changed; the connection of the instrument should not be loose; the total length should be less than or equal to 178mm, with a tolerance of ± 10%. 4. The medical tweezers should be symmetrical, smooth in appearance and free from sharp edges, burrs, cracks, pockmarks and trachoma; the tweezers should have good elasticity; the two pieces of tweezers should be firmly connected, which should be able to withstand 15N tension without fracture; the lip teeth should be clear and complete, without missing teeth or rotten teeth; the guide pin and positioning pin of forceps should be fixed firmly, and when the tweezers are opened and closed, they should be fixed firmly The handle of forceps should be clear and complete without missing or rotten flowers. 5. The appearance shall be free of stain, mildew and damage; the thickness of apron shall not be less than 0.01mm, and the weight of apron shall not be less than 20g / m2. 6. Medical cotton ball should be a qualified product with medical device registration certificate. 7. The pallet appearance should be smooth, without burr and injection flow; the thickness should not be less than 0.1 mm. 8. The mirror surface of the oral mirror should have bubbles, ripples, sand particles, pockmarks, scratches, lines and stains; the mirror should be regular in shape, and there should be no damage or debris on the mirror edge; the mirror should have good reflection and can bear its own weight without falling off; the handle should be free from flash, burr, stain, crack and obvious bending; if there is handle flower, it should be clearly visible. 9. Oral package should be sterile. 10. After sterilization with ethylene oxide, the residual amount of ethylene oxide should not be more than 10ug / g.

[scope of application] for clinical oral examination and treatment.

[contraindications] no contraindications.

[precautions] 1. This product is disposable and its package is damaged. It is forbidden to use it and destroy it after use.

2. See the seal or label of the package for the batch number and the outer packing box for the sterilization date.

3. The product was sterilized by ethylene oxide.

[usage] 1. Select the specifications and models of the patients, and open the package after confirming that the outer package is in good condition.

2. According to the needs of surgery, the accessories can be used.

3. After the end of use, the product should be treated as medical waste to avoid pollution.

[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. Handle 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%, no corrosive gas and well ventilated and clean environment.