[Product Name] Disposable Ozone Rectal Drug Delivery Kit [Models] YH-50-A, YH-50-B, YH-50-C, YH-50-D, YH-100-E, YH-100-F, YH-100-G, YH-100-H.
The specific model descriptions are shown in the table below

Model	Bolus syringe volume	Rectal tube diameter	Model	Bolus syringe volume	Rectal tube diameter
YH-50-A	50ml	1.9mm	YH-100-E	100ml	4.4mm
YH-50-B		2.0mm	YH-100-F		4.5mm
YH-50-C		2.05mm	YH-100-G		4.55mm
YH-50-D		2.1mm	YH-100-H		4.6mm

[Scope of Application] This product is designed to be used in conjunction with various medical ozone generators or medical ozone therapy devices for rectal administration to patients. It is not suitable for subcutaneous or intravenous administration, nor for vaginal administration. The bolus syringe is intended for local administration to the body surface and natural orifices, excluding vaginal administration; the rectal tube is used for intestinal cleaning (irrigation, evacuation, or infusion) or exhausting; the medical thin film gloves are designed to be worn on the hands or fingers of doctors for examination or palpation of patients' conditions; the medical pad is a hygienic nursing product used on hospital beds or examination tables; and the medical catheter clamp is used to clamp medical plastic catheters and control the flow of liquid in the catheter.
[Structural Composition] The disposable ozone rectal medication delivery kit consists of a push-injection applicator (14-07-03), a rectal tube (14-05-04), a medical thin film glove (14-14-04), a medical pad (14-15-05), and a medical catheter clamp (14-16-12). It is provided non-sterile and intended for single use. It does not contain medication and does not have a dose control function. All components within the kit belong to Class I medical devices. The push-injection applicator consists of an outer sleeve, a core rod, and a piston, made of polymer materials, provided non-sterile, does not contain medication, and does not have a dose control function; the rectal tube consists of a catheter and a connector, made of medical polyvinyl chloride plastic, with catheter tips available in both perforated and non-perforated versions, and one or more side holes on both sides, provided non-sterile; the medical thin film glove is made of polyethylene material, with sufficient strength and barrier properties, provided non-sterile and intended for single use; the medical pad is made of a composite of nonwoven fabric and plastic film, provided non-sterile and intended for single use; the medical catheter clamp is made of plastic material, does not come into contact with the liquid in the catheter, provided non-sterile, and is reusable.
[Product Performance] Push-injection Drug Applicator: When inspected with normal or corrected vision, the surface should be smooth, free of burrs, cracks, and deformations, with uniform color and luster, and must not have obvious scratches or stains; the connections of each part of the push-injection drug applicator should be secure. After placing the piston and core rod into the outer sleeve, when the tail of the core rod is normally pushed and pulled, the piston should not loosen or fall off; the piston and outer sleeve should fit tightly, and the irrigation fluid should not leak when the core rod moves up and down. Rectal Tube: When inspecting the tube in standby mode with normal or corrected vision, the pipeline, tip, and holes should be free of foreign substances; under a force not exceeding 15N, the tube should not break, and the tube and connector should not separate; place the tube with the hole blocked in a water bath at a temperature of (37±2)℃ until the temperature reaches equilibrium; apply a pressure of -10kPa to one end of the tube for 15s, and the tube should not collapse, obstructing the flow of the tube. Block the hole of the tube, apply a pressure of 10kPa to the tube, and the connection between the tube and connector should not leak. Medical Thin Film Gloves: After filling the glove with water, hang it for 4 minutes, and there should be no leakage; apply a force of ≥4.8N, and the glove should not break. Medical Pad: When inspected with normal or corrected vision, it should be flat, clean, and free of defects such as stains, holes, and wrinkles; the cut edges should be neat and straight. The surface should be clean, free of stains, impurities, and holes; the mass per unit area of the nonwoven fabric used should not be less than 25g/m2; the longitudinal breaking strength of the nonwoven fabric used should be greater than or equal to 17N, and the transverse breaking strength should be greater than or equal to 3N. Medical Tube Clamp: When inspected with normal or corrected vision, the surface of the medical tube clamp should be smooth, undamaged, and free of dirt; when the medical tube clamp is in the closed state, it should be able to close the pipeline passage.
[Usage] 1. Confirm that the product is within its expiration date before opening the packaging bag; 2. Take out the thin film gloves and put them on; 3. Place the pad under the patient's body; 4. Slowly insert the rectal tube into the patient's rectum (silicone oil or vaseline lubricant can be applied to reduce the resistance of the rectal tube); 5. Connect the medication applicator to a medical ozone generator or medical ozone therapy device, and take an appropriate amount of ozone gas; 6. Connect the medication applicator to the rectal tube, push the core rod, and inject ozone into the patient's rectum; 7. Close the tube clamp.
[Precautions] 1. Strict inspection should be conducted before use. If the packaging is damaged or leaking, use is strictly prohibited; 2. This product is for single use only and must not be reused; 3. After use, this product should be disposed of in accordance with the "Regulations on the Management of Medical Waste"; 4. Do not use the product if it has expired; 5. This product requires professional medical personnel for operation. Before use, please read the instruction manual carefully.

[Storage and transportation conditions] This product should be stored in a clean, dry, ventilated, and shaded place, away from heat sources, and isolated from toxic, harmful, and corrosive substances.
[Expiration Date] Under the conditions of storage and transportation, the product is valid for 2 years. [Medical Device Registration Certificate Number] JLXB 20260004