[product name] disposable sterile vaginal dilator.
Type: axial and push-pull type; Specifications: large, medium and small.
[name of registrant] henan jianqi medical equipment co. LTD.
Residence: the dingluan industrial zone, changyuan county, henan province.
[contact number] 0373-8690789.
【 after-sales unit 】 henan jianqi medical equipment sales co。 LTD。
[name of production enterprise] henan jianqi medical equipment co., LTD.
Residence: the dingluan industrial zone, changyuan county, henan province。
[production address] dingluan industrial zone, changyuan county, henan province。
[contact information] 0373-8690789。
[production license] the food and drug regulatory apparatus is permitted to be made in 20080036.
[registration certificate no。]
[product technical requirements no.]
[structure and composition] this product is mainly composed of upper lobe, lower lobe and handle.
[product performance] 1. The external surface of the expander is clean and free of impurities, without powder or watermark; 2. The area and surrounding area of the expander and the lower lobe are smooth, without frontal edge, without burr. The contact surface of the lower lobe close to the outer edge of the light; 3. When the expander is in a closed state, the upper and lower leaves basically match; 4. When the expander is used, each stall is adjusted and expanded flexibly, without the phenomenon of card resistance. When the force on the expander and the lower page is stressed, the use gear is stable; 5. The shaft pin and the shaft hole should be firm, reliable and flexible. The sliding pin and sliding groove of push-pull expander should be flexible when used and should not fall off. Shaft pin should be firm and should not break. 6. In any working state, any part of the dilator should not obstruct the view port; 7. When the expander expands to the maximum range, the force of 20N shall be applied, and the amount of deformation allowed shall not be greater than 30mm. 8. When the expander expands to the maximum file, the force of 30N is applied, and no part is broken. 9. The expander should be sterile; 10. The expander is sterilized by ethylene oxide, and the residual amount of ethylene oxide is not greater than 10ug/g.
[scope of application] for gynecology and obstetrics for vaginal examination.
【 taboo 】 the plastic product allergy is careful to use.
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 specifications and model, and then open the package after the outer packing is in good condition。
2. You can lubricate the expander first, then close the upper and lower leaves of the sterile vaginal expander once and gently into the vagina.
3. Press the handle or rotating position tip, and push pull handle to open the field of view.
4。 After the product is finished, it should be treated according to medical waste, so as not to cause 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]
[date of instruction] May 3, 2017.