Nasal oxygen tube

[Product name] Disposable humidified nasal oxygen cannula
[Model specification]

【Production license number】

[Medical device registration certificate number]
[Product technical requirements number]
[Main product performance]
1. Appearance: The color of the nasal oxygen tube should be uniform, the surface should be smooth, and there should be no obvious impurities, foreign matter, and bubble defects visible to the naked eye; there should be no obvious burrs, burrs, and sharp plastic flow defects.
2. Bonding and connection firmness
2.1 The bonding parts of the nasal oxygen tube should be firmly bonded, and each bonding point should be able to withstand an axial static tensile force of 30N for 15s without breaking.
2.2 Connection firmness: The bayonet-type bottle cap and the connecting tube connected to it should be firmly connected and should be able to withstand an axial static tensile force of 15N for 15s without falling off.
3. Airflow resistance: According to the different models of nasal oxygen tubes, the corresponding flow rate is selected to test the airflow resistance. The pressure increment per meter of pipeline length should not exceed 2.0kPa. The flow table corresponding to different types of nasal oxygen tubes is shown in Table 1:
Table 1 Flow table corresponding to different types of nasal oxygen tubes

4. Leakage
4.1 The nasal oxygen tube should not leak under the pressure of 100kPa. The oxygen loss during the oxygen delivery process is ≤5%.
4.2 The humidification bottle cap and the bottle body should be sealed after tightening, and there should be no liquid leakage.
5. Bending resistance: In an environment of 18℃～25℃, 60%RH±10%RH, the nasal oxygen tube is repeatedly bent 10 times, the catheter should not break, and the inner wall of the tube cavity should not stick.
6. Compressive strength
6.1 Under a working pressure of 200kPa, the nasal oxygen tube should not break.
6.2 The inside of the humidification bottle cavity should be able to withstand a pressure of 0.4MPa without damage.
7. Sterility
7.1 The nasal oxygen tube should be sterile after being sterilized with ethylene oxide; the residual amount of ethylene oxide should not be greater than 10μg/g.
7.2 The humidification bottle and humidification liquid should be sterile after Co60 irradiation.
[Main structure] This product consists of a nasal oxygen tube and a humidification bottle (pre-filled with humidification liquid).
[Scope of application] It is used for humidified oxygen transportation between the oxygen source and the oxygen inhaler during oxygen inhalation.
[Instructions for use]
1. How to use the screw cap type:
① Open the package and take out the product;
② Confirm that the oxygen supply equipment is in the flow closed state;
③ Open the cap of the humidification bottle and check whether there is water accumulation at the mouth of the humidification bottle and the top of the air inlet pipe; if so, gently press the bottle body to flow the water back into the bottle. Prevent water vapor from entering the patient's respiratory tract through the nasal oxygen tube;
④ Connect the humidifier bottle to the flow meter interface;
⑤ Insert the nasal oxygen tube into the oxygen outlet;
⑥ Turn on the oxygen and slowly adjust the oxygen flow rate to the range of use. Before use, check whether the oxygen output is unobstructed;
2. Bayonet type usage method:
① Open the package and take out the product;
② Confirm that the oxygen supply equipment is in the flow closed state;
③ Pull out the connecting tube (oxygen inlet tube) on the humidifier bottle cap and connect it to the oxygen source;
④ Turn on the oxygen and slowly adjust the oxygen flow rate to the range of use, drain the liquid in the connecting tube on the bottle cap and the oxygen outlet of the humidifier bottle, and use your hand to check whether there is still water vapor at the outlet to prevent water vapor from entering the patient's respiratory tract through the nasal oxygen tube;
⑤ Connect the nasal oxygen tube connector to the oxygen outlet of the humidifier bottle and use it after confirming that it is unobstructed.
3. According to different models of nasal oxygen tubes, the normal applicable flow range of this product should meet the requirements in Table 1.
[Contraindications] It is prohibited for those who are allergic to PVC materials.
【Precautions】
1. It is strictly forbidden to use if the inner packaging is damaged, leaking, there are foreign objects in the humidifying liquid, the humidifying bottle leaks or the properties change.
2. During oxygen inhalation, the humidifying bottle must be in a vertical state. It is strictly forbidden to place it flat or inverted to prevent the humidifying liquid from overflowing into the patient's respiratory tract and causing danger.
3. Keep the nasal oxygen tube unobstructed during use to prevent bending, squeezing, and winding.
4. Please confirm the expiration date before use. Do not use it after it expires.
5. When connecting oxygen and adjusting the flow meter, adjust it slowly; do not adjust the flow meter too much instantly to prevent the humidifying liquid from vaporizing in time due to excessive air pressure, and enter the patient's respiratory tract from the nasal oxygen tube and cause danger.
6. The applicable flow range of this product should meet the requirements in Table 1. If high-flow (6L/min-10L/min) oxygen inhalation is required, it is recommended to use the specification of 100ml liquid volume.
7. This product is only for single use by a single patient. Cross- or repeated use is strictly prohibited.
8. After the product is unpacked, it is recommended that the maximum usage time should not exceed 4 days.
9. It is strictly forbidden to use it for oxygen device nebulization inhalation treatment.
10. Keep away from fire sources during oxygen inhalation and prohibit open flames.
11. Dispose of it as medical waste after use.
12. If you encounter any problems during use, please contact us.
[Diagram and symbol definition]

[Storage and transportation conditions]
1. After packaging, this product should be stored at room temperature, away from light, without corrosive gases, in a dry, well-ventilated and clean room.
2. This product should be handled with care during transportation to prevent collision, extrusion, moisture, heat and direct sunlight.
[Production date] See the product packaging
[Expiration date] Two years from the date of sterilization
[Registrant/Manufacturer] Guangxi Yihe Medical Technology Co., Ltd.
[Residence/Manufacturer Address] Building 12, Changgui ASEAN Science and Technology Park, No. 146, Wuhua Avenue, Guangxi-ASEAN Economic and Technological Development Zone
[Contact number] 0771-6262566
[After-sales service unit] Guangxi Yihe Medical Technology Co., Ltd.
[Quality complaint phone number] 0771-6262566
[Instruction manual revision date] May 5, 2022
[Instruction manual version] A/1