Screw cap humidification bottle

[Product Name] Disposable Humidified Nasal Oxygen Tube
[Model Specification]

[Production License Number]
[Medical Device Registration Number]
[Product Technical Requirement Number]
[Main Performance of the Product]
1. Appearance: The color of the nasal oxygen tube should be uniform, the surface should be smooth, with no visible impurities, foreign objects, or bubble defects; no obvious burrs, sharp edges, or plastic flow defects.
2. Adhesion and Connection Firmness
2.1 The adhesive parts of the nasal oxygen tube should be firmly bonded, and each adhesive point should withstand an axial static tensile force of 30N for 15 seconds without breaking.
2.2 Connection firmness: The snap-on bottle cap and the connecting tube should be firmly connected, able to withstand an axial static tensile force of 15N for 15 seconds without falling off.
3. Airflow Resistance: Select the corresponding flow rate to test airflow resistance based on different models of nasal oxygen tubes, and the pressure increase per meter of pipeline should not exceed 2.0kPa. The corresponding flow rate table for different models of nasal oxygen tubes is shown in Table 1:
Table 1 Corresponding Flow Rate Table for Different Models of Nasal Oxygen Tubes

4. Leakage
4.1 Under a pressure of 100kPa, the nasal oxygen tube should not leak. The loss of oxygen during the oxygen delivery process should be ≤5%.
4.2 After tightening the humidifying bottle cap with the bottle body, it should be sealed without liquid leakage.
5. Bend Resistance: In an environment of 18℃～25℃, 60%RH±10%RH, the nasal oxygen tube should not break after being bent 10 times, and the inner wall of the lumen should not stick.
6. Pressure Strength
6.1 At a working pressure of 200kPa, the nasal oxygen tube should not break.
6.2 The internal cavity of the humidifying bottle should withstand a pressure of 0.4MPa without damage.
7. Sterility
7.1 After ethylene oxide sterilization, the nasal oxygen tube should be sterile; the residual amount of ethylene oxide should not exceed 10μg/g.
7.2 After Co60 ray irradiation, the humidifying bottle and humidifying liquid should be sterile.
[Main Structural Composition] This product consists of a nasal oxygen tube and a humidifying bottle (pre-filled with humidifying liquid).
[Scope of Application] Used for delivering humidified oxygen from the oxygen source to the oxygen user.
[Instructions for Use]
1. Screw Cap Type Usage Method:
① Open the package and take out the product;
② Confirm that the oxygen supply device is in the closed flow state;
③ Open the cap of the humidifying bottle and check if there is water accumulation at the top of the inlet tube; if so, gently press the bottle body to return the water to the bottle. Prevent water vapor from entering the patient's respiratory tract through the nasal oxygen tube;
④ Connect the humidifying bottle to the flow meter interface;
⑤ Insert the nasal oxygen tube into the oxygen outlet;
⑥ Open the oxygen and slowly adjust to the oxygen flow rate within the usage range, and check that the oxygen output is unobstructed before use;
2. Snap-on Type Usage Method:
① Open the package and take out the product;
② Confirm that the oxygen supply device is in the closed flow state;
③ Pull out the connecting tube (inlet tube) on the humidifying bottle cap and connect it to the oxygen source;
④ Open the oxygen and slowly adjust to the oxygen flow rate within the usage range, drain the liquid from the connecting tube on the bottle cap and the oxygen outlet of the humidifying bottle, and use your hand to check if 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 joint to the oxygen outlet of the humidifying bottle, and confirm that it is unobstructed before use.
3. This product's normal applicable flow range should meet the requirements in Table 1 for different models of nasal oxygen tubes.
[Contraindications] Prohibited for those allergic to PVC materials.
[Precautions]
1. It is strictly prohibited to use if the inner packaging is damaged, leaking, the humidifying liquid has foreign objects, or the humidifying bottle shows leakage or changes in properties.
2. During oxygen inhalation, the humidifying bottle must be in a vertical position, and it is strictly prohibited to lay flat or invert it to prevent the humidifying liquid from spilling into the patient.
This poses a risk to the respiratory tract.
3. Keep the nasal oxygen tube unobstructed during use to prevent bending, squeezing, or entanglement.
4. Please confirm the expiration date before use; do not use if expired.
5. When connecting oxygen and adjusting the flow meter, adjustments should be made slowly; do not suddenly adjust the flow meter to a large value to avoid the humidifying liquid being unable to vaporize due to excessive air pressure, which may pose a risk of entering the patient's respiratory tract through the nasal oxygen tube.
6. The applicable flow range of this product should meet the requirements in Table 1. If high flow (6L/min-10L/min) oxygen is needed, it is recommended to use the specification with a liquid volume of 100ml.
7. This product is for single use by a single patient only, and cross-use or reuse is strictly prohibited.
8. After opening, it is recommended that the maximum usage time does not exceed 4 days.
9. It is strictly prohibited for use in oxygen device nebulization therapy.
10. During oxygen inhalation, keep away from fire sources and do not use open flames.
11. Dispose of as medical waste after use.
12. If you encounter any problems during use, please contact us.
【Illustration and Symbol Definitions】

【Storage and Transportation Conditions】
1. This product should be stored in a clean, dry, well-ventilated indoor environment at room temperature, away from light and corrosive gases.
2. This product should be handled with care during transportation to prevent collision, compression, moisture, heat, and direct sunlight.
【Production Date】See product individual packaging
【Shelf Life】Two years from the date of sterilization
【Registrant/Manufacturer】Guangxi Yihe Medical Technology Co., Ltd.
【Address/Production Address】No. 146 Wuhua Avenue, Dongmeng Economic and Technological Development Zone, Guangxi - Changgui Dongmeng Science and Technology Park, Building 12
【Contact Number】0771-6262566
【After-Sales Service Unit】Guangxi Yihe Medical Technology Co., Ltd.
【Quality Complaint Phone】0771-6262566
【Instruction Manual Revision Date】May 5, 2022
【Instruction Manual Version】A/1