Disposable Combination Suction Catheter Type A1

[Product Name] Disposable Combination Suction Catheter Type A1

[Model Specification] See Table 1

Table 1 Model Specifications and Classification Description

[Production License Number]

[Medical Device Registration Number]

[Product Technical Requirement Number]

[Product Performance]

1. When connecting the suction catheter and the negative pressure connecting tube to the vacuum source, block the patient end and the vacuum control device (if any), and apply a negative pressure of 40kPa (300mmHg) for 15 seconds at 23℃±2℃. The catheter body should not collapse.

2. Under a gas pressure of 20kPa for 30 seconds, there should be no gas leakage from the suction catheter and the negative pressure connecting tube.

3. After sterilization with ethylene oxide, the product should be sterile, and the residual amount of ethylene oxide should be ≤10μg/g.

[Main Structural Components]

[Accessory List] See Table 1.

[Scope of Application] The product is used for suctioning respiratory secretions or for clearing phlegm in the oral cavity.

[Instructions for Use]

(1) Type A Suction Catheter

1. Open the single packaging bag and take out the suction catheter.

2. Confirm that the pressure relief port (vacuum control device) of the machine end connector of the suction catheter is in the open position, and then connect the machine end connector of the suction catheter to the negative pressure device.

3. Insert the patient end of the suction catheter into the patient's trachea (the specific position is determined by professional medical personnel).

4. When starting suction, close the pressure relief port to create a sealed state in the catheter body, forming negative pressure.

5. After suctioning, first close the negative pressure, then withdraw the suction catheter.

(2) Type B Brush Head Suction Catheter

1. Open the single packaging bag and take out the suction catheter.

2. Connect the machine end connector of the suction catheter to the negative pressure device.

3. Place the patient end of the suction catheter into the patient's oral cavity, using the sponge brush head to clean the patient's mouth and between the teeth.

4. When starting suction, block the pressure relief port to create a sealed state in the catheter body, forming negative pressure.

5. After suctioning, first close the negative pressure, then withdraw the suction catheter.

(3) Type C Flush and Suction Suction Catheter

1. Open the single packaging bag and take out the suction catheter.

2. Connect the machine end of the handle to the negative pressure device, and then connect the flushing tube connector to the infusion device.

3. Place the patient end of the suction catheter into the patient's oral cavity, block the pressure relief port to create a sealed state in the catheter body, forming negative pressure, and start suction.

4. Slowly inject the cleaning liquid through the flushing tube into the patient's oral cavity, controlling the speed at about 80 drops/min.

5. Use the silicone brush head to clean the patient's mouth and between the teeth while flushing and brushing, simultaneously suctioning the cleaning liquid, phlegm, saliva, etc. During the operation, pay attention to control the input speed of the cleaning liquid and the negative pressure to avoid causing the patient to cough.

6. After the oral cavity is clean, first stop the input of the cleaning liquid, then close the negative pressure and remove the suction catheter.

[Contraindications, Precautions, Warnings, and Tips]

1. Be sure to connect a waste liquid collection bag between the negative pressure source and the suction catheter and clean it in a timely manner to avoid waste liquid directly entering the negative pressure source equipment, which could damage the equipment.

2. During oral care, the adjustment of the negative pressure source should be within an appropriate range to ensure that excessive negative pressure does not cause harm to the patient.

3. If the suction catheter cannot suction during use, please immediately remove the suction catheter and perform relevant checks and cleaning. If it cannot be restored, please replace it with a new suction catheter.

4. This product is a sterile product for single use only; dispose of it after use.

5. Before use, please confirm the expiration date and check whether the packaging and product are intact. Do not use if the product is damaged, expired, or the packaging is damaged.

6. When not in use for suction, the pressure relief port of the suction catheter should remain open.

7. When inserting the catheter body, pay attention to the adhesion of the catheter body to other instruments.

8. Avoid continuous suctioning at the same site for a long time.

9. The suction catheter is not suitable for restless, mentally symptomatic, or critically ill patients with oral ulcers during oral care. For patients with clenched jaws, use an opening device with two people if necessary.

10. When using Type B and Type C suction catheters for oral care, pay attention to observe the firmness of the connection between the brush head and the catheter body.

[Storage and Transportation Conditions]

1. After packaging, this product should be stored at room temperature, with a relative humidity not exceeding 80%, and in a clean, dry, well-ventilated indoor environment free of corrosive gases.

2. Prevent moisture, heat, and direct sunlight exposure during transportation and storage.

【Production Date】See product packaging

【Shelf Life】Two years from the date of sterilization.