[product name] disposable sterile vaginal dilator

[specification and model] model: rotary type, push-pull type; specification: large, medium and small size.

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

[address] dingluan Industrial Zone, Changyuan County, Henan Province

[Tel.] 0373-8690789

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

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

[address] dingluan Industrial Zone, Changyuan County, Henan Province

[production address] dingluan Industrial Zone, Changyuan County, Henan Province

[contact information] 0373-8690789

[production license] ysyjx production license No. 20080036

[Registration Certificate No.] yxzz 20172660188

[product technical requirements No.] yxzz 20172660188

[structure and composition] this product is mainly composed of upper leaf, lower leaf and handle.

[product performance] 1. The outer surface of the expander is smooth and smooth, without impurities, powder or watermark traces; 2. The upper and lower leaves of the expander and their surrounding areas are smooth without sharp edges and burrs. When the expander is in the closed state, the upper and lower lobes are basically identical; 4. When the expander is in use, each gear can be adjusted and expanded flexibly without jamming. When the upper and lower pages of the expander are stressed, each gear should be stable; 5. The shaft pin and shaft hole of the axial rotary expander should match firmly and reliably, and the rotation should be flexible. The sliding pin and chute of the push-pull expander should be flexible and should not fall off, and the shaft pin should be firm without fracture; 6. Under any working condition, any part of the expander should not block the field of view; 7. When the expander is extended to the gear, the allowable deformation should not be greater than 30mm when the force of 20n is applied. 8. When the expander is extended to the gear, the force of 30n is applied, and no part will break. 9. The expander should be sterile; 10. The ethylene oxide residue should not be more than 10ug / G after the expander is sterilized with ethylene oxide.

[scope of application] it is used for vaginal examination in obstetrics and gynecology.

[contraindications] plastic allergy should be used with caution.

[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 applicable specification and model, and open the package after confirming that the outer package is in good condition.

2. The expander can be lubricated first, and then the upper and lower leaves of disposable sterile vaginal dilator can be closed and gently sent into the vagina.

3. Press and press the handle or rotate the gear pin, and the push-pull push-pull handle can open the field of vision.

4. 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.