[product name] simple respirator

[specification and model] adult type, child type and neonatal type

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

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

[Tel.] 0373-8690789

[after sales service 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 20182080494

[structure and composition] this product is composed of breathing ball, air inlet valve, one-way fish mouth valve, oxygen mask, oxygen connecting pipe, respiratory sac, emergency opener and disposable oropharyngeal airway assembly.

[product performance]: 1. the contact part between the mask and the face of oxygen inhalation anesthesia shall be soft and smooth; the surface of respiratory valve and breathing ball components shall be smooth and clean without damage; no visible impurities and foreign matters; 2. the air inlet valve of respirator shall be one-way air inlet device; 3 Strength: respirator shall be able to withstand two 1200mm high natural drop tests, and one-way fish mouth valve and air inlet valve shall be free from rupture; 4. oxygen connecting pipe: the length of oxygen connecting pipe shall not be less than 1.3m; after connecting oxygen connecting pipe and respirator, it shall be well sealed, and the connection shall not leak when the respirator is in normal use; 5. the spiral end of the opener shall bear 50N ± 5N Under pressure, it shall not break or break within 30s; 6. the breathing bag shall have good sealing performance after connecting with the intake valve, and the connection and the respiratory capsule shall not leak during normal use of respirator. 7. Connection firmness: the connection between components shall be firm and shall not be separated or loosened. 8. Simple respirators should be sterile. 9. If the simple respirator is sterilized with ethylene oxide, the residual amount of ethylene oxide shall not be more than 10 μ g / g. 10. The toxicity of the mask and disposable oropharyngeal airway should not be greater than grade 2. The skin irritation was very mild, P Ⅱ was 0-0.4. Hypersensitivity should be developed without delay.

[scope of application] for mixed air and oxygen gas for one-way intermittent positive pressure artificial respiration first aid and auxiliary respiration.

[contraindications] 1. Patients with sober or shallow anesthesia (except for short-term application).

2. The first 4 teeth are highly dangerous patients with broken or detached teeth.

[precautions] 1. This product is disposable, the package is damaged, and it is forbidden to use it. It is destroyed after use.

2. See the packing seal for the production batch number and expiration date, and see the external packing box for sterilization date.

3. The product is sterilized by ethylene oxide, and the sterile period is two years.

[usage] L. choose a suitable disposable oral and pharyngeal airway, and put the bed flat so that the patient head is inverted.

2. Open the patient's mouth, put the disposable oropharyngeal airway into the airway until the end protrudes 1-2cm from the incisor tooth

3. Hold the jaw with both hands, place the thumb of both hands on the flange, push down at least 2cm until the flange of the oropharyngeal airway reaches the upper part of the lip.

4. Check mouth: lip and tongue.

5. Reverse insertion: that is, the pharyngeal curved surface of disposable oropharyngeal airway is inserted into the mouth towards the palatal part.

[storage method] 1. The product shall be loaded and transported in covered carriage and cabin, and kept clean, and it shall not be heavy pressed, directly exposed to sunlight and soaked in rain and snow.

2. Handle and handle it gently during handling to avoid severe collision;

3. The product shall be stored in a well ventilated and clean environment, which is far away from the fire source, with a relative humidity of no more than 80%.