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medical macromolecule series non woven series medical kits series civilian products

two way endotracheal tube

  • product description
  • performance and use

【 product name 】 double lumen bronchial cannula.

[specifications] fr26, fr28, fr31, fr32, fr33, fr35, fr37, fr39, fr41.

[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 card no.] yu ordnance note 20162660347.

[technical requirements no.] yu ordnance note 20162660347.


[structure and composition] consists of a jacket, indicator capsule, one-way valve, inflatable tube, joint and tube body.

[product performance] 1. the head of the guide core inserted into the tube should be blunt and smooth; there should be no visible mechanical impurities or forming defects in all components of the double lumen tube; the end and ramp of the patients with double lumen should be smooth. murphy hole should have no burr; the printing of the double lumen tube should be clear, indicating that the airbag should be consistent with the printing on the tube body. type 2, the right side of the double lumen tube: big cavity cutting face of double lumen side 70 mm / - 0.5 mm, machine end curve radian is 135 ° / - 5 °; there should be murphy hole on the double lumen tube, and the distance between the front end of murphy hole is 25mm 0.5mm; double lumen of the first balloon sac sleeve edge from patients with double cavity end end slope near the machine part of the distance of 1 mm / - 0.5 mm, the second the effective part of the edge distance of spherical capsule murphy hole along the shall not be more than 1 mm / - 0.1 mm, cylindrical sac sac sleeve edge distance from slope near the end part of the machine for 1.5 mm / - 0.5 mm. type double lumen tube: on the left side of the cavity block is apart from the double lumen tube the patient end face 60 mm / - 0.5 mm machine is 135 ° 5 ° curve radian; the distal end of the sleeve is 1.5mm plus or minus 0.5mm, and the end of the sleeve is 1.5mm or 0.5mm from the edge of the end of the sleeve. 3. the capsule (spherical capsule, cylindrical capsule, indicating balloon) should be able to withstand the positive pressure of 3kpa 0.2kpa. 4. the color of pvc soft connector shall be consistent with the color of the bag in the closed system; the joint length is 80mm plus or minus 2mm. 5. the length of the inflatable tube shall be greater than 250mm or 2mm. 6. the air valve injection port shall comply with the requirements of the semi-rigid conical joint provided in gb1962.1-2001; the air valve must not leak. 7. the machine end of the connecting pipe shall be a taper joint with a small outer diameter of 15mm. 8. the four-way and soft joint of the double-lumen tube should be combined firmly. 9. the air-filled system should be well sealed, and the two parts (the inflatable pipe and the double cavity pipe, the valve capsule and the inflatable tube, the sleeve and the double cavity pipe) shall not leak. 10. the total metal content and cadmium content in the test solution of the double-chamber tube shall not exceed the product standard requirements. 11. the ph value of the product shall be 6.5 ~ 7.5. 12. the residual amount of ethylene oxide should not be greater than 10ug/g. 13. products should be sterile.

[scope of application] applicable to thoracic and vascular surgery, when the critical patient is single lung independent, synchronous or non-synchronous ventilation is used.

[contraindications] 1. laryngeal edema, acute laryngitis, edema in laryngeal mucosa, and severe bleeding caused by intubation trauma.

2. respiratory tract obstruction, and hemorrhagic hematopathy, aortic aneurysm pressure trachea.

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 can be seen in the packing seal or certificate, 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, make sure the outer packing is in good condition and open the package and take out the catheter.

2. lie on the back of the patient, check the oral cavity, (remove foreign body and active teeth, and fall without tongue).

3. use the laryngoscope to provoke the patient's epiglottis to expose the glottis, and insert the organ intubation on the side of the laryngoscope.

4. it can be used to test whether the intubation is successful by means of auscultation, sputum aspiration, and fiberoptic bronchoscopy.

5. 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 the packing seal or certificate.

[expiry date] see the packing seal or certificate.

[label, package logo]

[date of instructions] april 19, 2016.


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