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Disposable tissue closure clamp
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Disposable tissue closure clamp

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Product description
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[Product name]Organization folder

[Production License Number]Su Food and Drug Administration Apparatus Production License No. 20090084

[Product Registration Certificate Number] National Machinery Note 20203020002

[Technical Requirement Number] National Machinery Note 20203020002

[Product Model Specifications] According to the ligation range of the ligation lock, the tissue clip can be divided into three types: L, M, and S. The basic dimensions are shown in Table 1. The range of L-type ligation is 9mm~16mm; the range of M-type ligation is 5mm~10mm; the range of S-type ligation is 3mm~6mm.

[Product performance, main structure]

1. Structure: The tissue clip is composed of a ligation lock, a fixed cover, and a base. The type is shown in the figure below. Up to six ligature locks can be installed in a base.

 

a

Name Model Name Model
L M S L M S
Ligature lock
Size
(mm)
a 2.0±0.3 1.3±0.2 1.1±0.2 Fixed cover
Size
(mm)
e 31.8±1.5 31±1.5 30.1±1.5
b 16.8±1.0 12.3±1.0 8.8±0.5 f 26.3±1.5 24.5±1.5 23.6±1.5
c 1.3±0.2 1.4±0.2 0.9±0.2 Base
Size
(mm)
g 28.7±1.5 26.9±1.5 26.8±1.5
d 17.8±1.0 12.6±1.0 9.5±0.5 h 16.9±1.0 16.9±1.0 14.4±1.0
        j 34.1±1.5 32.3±1.5 32.6±1.5

2. Material: The material of the ligation lock is acetaldehyde diethyl acetal, the material of the fixing cover is polypropylene (PP), and the material of the base is acrylonitrile-butadiene-styrene (ABS).

3. Main performance: The surface of the ligation lock should be smooth and flat, free of flashes, burrs and other defects. The anti-skid teeth on the ligation lock should be clear, complete, and evenly distributed. The surface of the base should be smooth and free of impurities and foreign matter, and the card slot should be intact and free of defects or deformation. The fixed cover should be clean and smooth. The ligation lock shall not appear cracks and breaks when it is completely clamped. When the ligation lock is fully clamped, a 5N weight is hung in the opening direction of the middle of the ligation lock for 30 seconds without deformation, loosening, or breaking. The ligation lock shall not fall off after being installed in the base. The tissue clip should be sterile after sterilization with ethylene oxide and be used for one time.

[Scope of Application]

This product is suitable for the ligation and closure of blood vessels and body cavity tissues during human surgery.

[How to use]

1. Choose a suitable organization folder according to the size of the organization structure.

2. Place the tissue forceps, grasp the tissue forceps, and accurately place the head of the tissue forceps into the base of the tissue clamp. Make sure that the head is perpendicular to the base, and gently press the tissue forceps until you hear a click. Do not force the tissue forceps into the base or the upper part of the ligation lock.

3. Remove the tissue forceps from the base to ensure that the ligation lock is securely clamped in the occlusal surface of the tissue forceps (as shown in Figure 1). At this time, the base must be held to ensure that the ligation lock can be smoothly removed from the base.

4. During use, as shown in Figure 1, locate the single tooth of the ligation lock. At this time, the operator can confirm the ligated structure with the naked eye.

5. Position the ligation lock around the ligated body cavity tissue bundle (as shown in Figure 2), and apply sufficient force on the handle of the tissue forceps to close the occlusal surface, thereby locking the ligation lock (as shown in Figure 3) , Loosen the handle of the tissue forceps and return the occlusal surface of the tissue forceps to a large enough position.

6. If the body cavity tissue is peeled off (as shown in Figure 4), leave the end edge about 2-3mm away from the ligation lock, and do not use one end of the ligation lock as an incision guide.

 

a

7. The distal tissue should be removed after clipping.

[Notes]

1. Before using the tissue clamp, please effectively simplify the structure of the ligated tissue so that the ligated tissue is clear. Do not use the ligation lock and tissue forceps as dissecting tools;

2. Do not use the ligature lock as a stop marker;

3. This product is for one-time use only and is destroyed after use;

4. If the package is found to be damaged or the expiration date has passed before use, please do not use it;

5. This product has been sterilized by ethylene oxide before leaving the factory;

6. In order to avoid undesirable consequences, please read the instruction manual carefully before use. ;

7. Under the specified storage conditions, the validity period is 3 years.

8. At the end of the operation, before closing the abdominal wall or chest wall, make sure that the ligation lock is in a normal closed state.

[Contraindications]

1. The tissue clip cannot be used as an occlusion device for the contraceptive fallopian tube;

2. Those who are allergic to the ingredients of this product, and those who have diffuse mucosal hemorrhage;

3. The tissue at the lesion site is fragile or the tissue is severely necrotic, and the ligation lock is easy to fall off;

4. The diameter of the tissue bundle is too large for patients who use tissue clamp devices;

5. Patients with late-stage distant metastasis of malignant tumors, immunosuppression or immunodeficiency.

[Product Packaging]

1. When the product leaves the factory, the inner packaging is a blister box dialysis paper packaging, the middle packaging is a carton with a product label and product instruction manual inside, and the outer packaging is a corrugated carton, accompanied by a factory inspection report.

2. The following warning signs must be displayed on the outer packaging of the product:

a

[Product Save]

It should be protected from impact and squeezing, and placed in a ventilated, dry and non-corrosive gas room.

The product is valid for three years.

Please refer to the product label for the production date and expiration date of the product.

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Precision(changzhou)medical Instruments Co.,ltd

Address: 5 floor, B2 block, Hutang science and Technology Industrial Park, Hutang Town, Wujin District, Changzhou.

Whatsapp/Phone number:+86-519-86538970

Fax: +86-519-86533357

Email: oliver@precision-stapler.com  

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