[product name] disposable endotracheal intubation assembly。
【 specification 】 models: Ⅰ type (normal), Ⅱ type (reinforced) specification: 2.0 # # #, # 2.5, 2.5, 2.5, 4.0, # # #, # 4.5, 4.5, 4.5, 6.0, # # #, # 6.5, 6.5, 6.5, 8.0, # # #, # 8.5, 8.5, 8.5, 10.0, # #, # 10.5 and 10.5
[name of registrant] henan jianqi medical equipment co. LTD.
Residence: the dingluan industrial zone, changyuan county, henan province.
湖北11选5开奖[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。
湖北11选5开奖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.] yu ordnance mark 20152660194.
[execution standard number] YZB/ yu0218-2014.
The product consists of basic configuration and selection configuration. Type I basic configuration: endotracheal intubation, medical dental pad, disposable sputum suction tube, one-time use of suction connection tube, mouth pad, disposable mouth pharyngeal airway, medical absorbent gauze block; Type II basic configuration: reinforced endotracheal intubation, medical teeth pad, disposable sputum suction tube, disposable attract connection tube, mouth pad, one-time use of oropharyngeal airway, medical absorbent gauze pieces; Type I and type II choose configuration: disposable medical rubber examination gloves, adhesive wound care, medical infusion posts, one-time use laryngoscope, disposable sterilized rubber surgical gloves, disposable dispensing with syringes, trachea cannula holder, cloth bags, trays, medical paraffin tampon. Products should be sterile. After the sterilization of ethylene oxide, the residual amount of ethylene oxide should not be greater than 10 mu g/g. Disposable use
[product performance] : 1. The appearance should be clean and without foreign body. The surface of each group is smooth, without burrs, impurities, no foreign body and neat edges. Type 2, Ⅰ normal endotracheal intubation should be accord with the requirement of YY0337.1-2002. Ⅱ type reinforced tracheal intubation should comply with the YZB/prepare the requirements of 3.1, 3.2, 0178-2008. 3. Connection firmness: the connection between the drainage connections and the pipe joints shall be strong. Under the tensile force of 15N, they shall not be separated. Suction pipe body and joint connection should be strong, under the tension of 15N, the two cannot be separated. 4. Negative pressure resistance: the suction pipe should be under the negative pressure of 17Kpa, and it should be continuous with 15s. The drainage connection tube is under 20Kpa negative pressure and lasts for 15s. 5. Gloves should comply with the requirements of gb7543-2006, 6.2, 6.3.2, 6.3.3 and 6.3.4, which should meet the requirements of YY/ t0821-2010. 7 gauze blocks should be folded neatly, without any rough edges, odorless, mildew, impurities, stains, holes and so on. 8, wrap cloth used in nonwovens specifications shall be not less than 18 g / ㎡. 9. Oropharyngeal airway should conform to the requirements of YZB/ yu 0033-2012 standard: 4.1, 4.3 and 4.4. 10. The pads should meet the requirements of YZB/ yu 0350-2014 standard of 4.1 and 4.3. 11. Intubation components should be sterile. 12. If the intubation component is sterilized by ethylene oxide, the residual amount of ethylene oxide should not be greater than 10 g/g. 13. Cytotoxicity should be no greater than 2. 14 and very mild skin irritation, P Ⅱ value 0 ~ 0.4. 15. There should be no delayed hypersensitivity reaction.
[scope] for the establishment of artificial airway in clinical anesthesia or first aid。
1。 This product is a disposable product, which is damaged in packaging and is strictly prohibited to be used and destroyed after use。
2. The production batch number and the expiry date can be seen in the packing seal, and the sterilization date is shown in the packing box.
3。 This product is sterilized by ethylene oxide and is sterile for two years。
1. Before use, check the integrity of the packaging.
2. Open the package to see if the parts inside are intact.
3。 Prepare before intubation (such as the equipment before the intubation, the path to determine the intubation, the anesthesia before intubation, and the specification of the tracheal intubation)。
4。 After the preparation of the intubation, intubation is performed according to the corresponding intubation procedure (via mouth or nose)。
5. Confirm that the intubation is inserted into the trachea.
6. Fix the intubation with a tube holder or tape.
7. Pull out the endotracheal intubation according to the operation procedure of tube drawing tube.
[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。
湖北11选5开奖[production date] see the packing seal.
Expiry date: see the packing seal.
[label, package logo]