[product name] disposable linear cutter stapler kit

[specification and model] model: type A, type B; specification: jqqa-55, jqqa-75, jqqa-100; jqqb-60, jqqb-80, jqqb-100

[name of registrant] Henan Jianqi medical device Co., Ltd

[residence] dingluan Industrial Zone, Changyuan County

[Tel.] 0373-8690789

[after sales unit] Henan Jianqi medical equipment sales Co., Ltd

[name of manufacturer] Henan Jianqi Medical Equipment Co., Ltd

[residence] dingluan Industrial Zone, Changyuan County

[production address] dingluan Industrial Zone, Changyuan County

[contact information] 0373-8690789

[production license] ysyjx production license No. 20080036

[Registration Certificate No.] yxzz 20162080719

[technical requirements No.] yxzz 20162080719

Disposable linear cutting stapler and components.jpg

[structure and composition] the disposable linear cutting stapler and its components (type A) are composed of nail bin, nail holder bracket, nail holder, bracket cover, movable handle cover, pushing block, stapling nail, cutting knife and nail bin cover. (type b) is composed of bulkhead, nail holder, locking rod, locking rod shell, nail bin, shell, nail bin frame and anastomotic nail.

[product performance] 1. The linear cutting stapler and its components have smooth appearance, clear outline, no burr and scratch; the scale value or mark on the body is clear without dislocation, skew and other defects; the stapler shell is firmly bonded without cracks and obvious accumulation; the outer surface of metal parts is bright without burr and dent. 2. Application performance: the stapler head is sharp, and the stapler is in "B" shape after suturing, and the cutting knife has no curling edge or chipping edge; the cutting edge after anastomosis is neat and has no burr; the length of the anastomosis line is 1.5 times longer than that of the cutting line; the linear cutting stapler has the safety protection device for the empty nail warehouse, which increases the safety of the equipment; the nail warehouse and the device are in good condition The body frame can be assembled and disassembled smoothly, the replacement is convenient, and the positioning is reliable. The rear of the nail bin loader should be firm; the staples should be stable in the nail bin, and there will be no falling off after swinging; the moving parts can be pushed easily, and the opening and closing are flexible, and there is no jamming and loosening phenomenon; the spring has enough elasticity, which can quickly reset when the handle is released. 3. The hardness of the ring cutter is not less than 377hv0.2; 4. The surface roughness of the metal parts of the linear cutting stapler is RA ≤ 0.8 μ M. 5. The peel strength of the packaging seal is 0.1n/mm ~ 0.5n/mm. The two contact surfaces are smooth, continuous and uniform without delamination or tearing. 6. The cutting edge of the cutting blade shall be sharp, and the cutting force shall not be greater than 0.8N. 7. After anastomosis, the suture should be able to withstand a pressure of not less than 3.6kPa, and there should be no water leakage and tear. 8. The linear stapler should be sterile. 9. After sterilization with ethylene oxide, the residual amount of ethylene oxide should not be more than 10ug / g. 10. There are slight corrosive marks on the surface of metal parts of linear cutting stapler, which can be removed by wiping.

[scope of application] it is applicable to the creation of anastomotic stoma and the closure of stump or incision in digestive tract reconstruction and other organ resection operations.

[contraindications] 1;

2. It is forbidden for patients with coagulation disorders;

3. It is forbidden for those allergic to product materials.

[precautions] 1. This product is disposable and its package is damaged. It is forbidden to use it and destroy it after use;

2. The production batch number and expiration date are shown on the seal or label of the package, and the sterilization date is shown in the outer packing box;

3. Ensure the package is in good condition before use;

4. This product is used by doctors and personnel who have been trained in stapler knowledge and technology;

[warning] 1. Any person who falls to the ground or is damaged or suspected to be damaged due to improper handling shall not be used clinically.

2. The device should not be used on liver or spleen tissues because of the compression properties of such tissues, the closure of the device may have a destructive effect;

[tips] 1. Please carefully check the hemostasis of suture thread after each firing and withdrawing from the instrument. If there is bleeding, appropriate methods must be used to stop bleeding;

2. If the first mechanical suture fails, it is not suitable for mechanical suture in principle;

3. When the instrument is fired, the movable handle must be pressed to close tightly with the bracket of the nail holder. When a click is heard, the instrument is closed. If the movable handle is not closed tightly with the support of the nail holder, the staples may not be fully formed. The incompletely formed staples may affect the integrity of the suture, resulting in leakage or rupture of the suture;

4. If the first mechanical suture fails, it is not suitable for mechanical suture in principle;

[usage] the disposable linear cutting stapler and its components (type A and type b) are used

1. Select the applicable model and specification, and take the instrument out of the package in the sterile operating room environment. In order to avoid damage, the equipment should be handled with care to avoid collision or falling to the ground;

2. Open the movable handle outward, separate the cutting component and the nail holder, and then remove the nail bin cover;

3. Clip the tissue to be cut and sutured between the nail bin and the nail holder bracket, and press the movable handle to the locking part (pay attention to the movable handle must be pressed in place);

4. Hold the stapler firmly with one hand, press the thumb and index finger of the other hand on the pushing block and gently push it forward to the excitation position (at this time, the cutting knife has not started cutting, the hand feeling is light), and then push forward evenly to the front end (at this time, the hand feeling is obviously increased)