[product name] disposable anorectal stapler and components

[specification and model] jqgc-32, jqgc-34, jqgc-36

[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 20162080720

[technical requirements No.] yxzz 20162080720

[structure and composition] the disposable anorectal stapler and its components are composed of nail holder, body, cutting component and accessories (optional accessories). The body is composed of adjusting nut, fixed handle, window, safety brake and movable handle; the kissing component is composed of annular knife, nail bin, pushing piece, anastomotic nail and knife pad ring; the accessories are composed of anal mirror parts, anal expansion parts, sewing and binding parts and crochet parts.

[product performance] 1. The shape of anorectal stapler is flat and smooth without sharp edge, burr and crack, and the scale value and mark on the body are clear; the adhesion (or welding) of anorectal stapler shell is firm, without cracks and obvious accumulation; the head end of stapler is sharp, and there are no defects such as dents and scratches on the surface; the annular blade is sharp, and there is no edge collapse. 2. Application performance: the components and body frame of anorectal stapler can be assembled and disassembled smoothly; all moving parts can be pushed smoothly without jamming and loosening; the components are firmly installed behind the device, and the staples do not fall off; the head end of the stapler is sharp, the annular blade is sharp, and there is no roll edge collapse phenomenon; the safety mechanism of anorectal stapler is flexible and safe to use. The spring has enough elasticity, and it can return quickly when the handle is released; 3. The hardness of the annular knife should not be lower than 377hv0.2; 4. The surface roughness of the metal parts of the anorectal stapler RA ≤ 0.8 μ m; 5. The anastomotic stoma after anastomotic with the anorectal stapler can withstand a pressure of not less than 3.6kPa without water leakage and tearing; 6. The peel strength of the packaging seal is 0.1n/mm ~ 0.5n/mm, and the two contact surfaces torn off are smooth, continuous and uniform without delamination or tearing; 7 The stapler is sterile; 8. The residual ethylene oxide is not more than 10ug / g. 9. There are slight corrosive marks on the surface of the metal parts of the anorectal stapler, which can be removed by wiping.

[scope of application] it is suitable for selective resection of the mucosa and submucosal tissue on the dentate line of the rectum and restore the normal anatomical structure of the lower rectal segment.

[contraindications] 1. Severe mucosal edema, gangrene, anal stenosis, full-thickness rectal prolapse, and severe fibrosis of hemorrhoids; 2. Repeated injection of sclerosing agent into hemorrhoids; 3. Pregnant women, children, patients with intractable constipation, pelvic tumor, portal hypertension, Budd Chiari syndrome or intolerance of surgery; 4. Allergic to product materials; 5. Blood coagulation mechanism disorders are prohibited.

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

[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;

[method of use] the disposable anorectal stapler and its group were used

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;

1. Guide the suture and ligation piece into the anus, and then pull out the suture piece.

2. The anal mirror piece can be inserted into the anus outside the suture piece, so that the hemorrhoids prolapse or anal mucosa prolapse can be partially reset, and then the fixed anal mirror can be sutured with thread.

3. After fixing the anal mirror piece and pulling out the suture piece, the prolapsed mucosa falls into the sleeve of the anal mirror piece.

5. Introduce the anal dilation part into the anal mirror, and the prolapse mucosa is exposed at the opening of the anal dilation piece. According to the degree of prolapse, the distance between suture and tooth line is generally more than 3-4cm. Rotate the threading device to complete the purse string suture around the whole anal canal.

6. Rotate the adjusting nut anticlockwise until it can't be rotated, lead the buttress into the anus, make the nail holder go deep into the upper end of the purse string, and then knot the suture to form a purse bag, so that the tissue is evenly wrapped on the puncture shaft.

7. Use Crochet to lead out the sutures from the holes on both sides of the suture, and tie the suture. The length that the finger can hook is appropriate.

8. Tighten the stapler, and at the same time, pull the tissue properly, (pull the suture through the fingers to make the tissue enter into the instrument cavity at a uniform speed, and do not pull by force. Note: keep the head end position and move the instrument forward when closing). First, turn the adjusting nut clockwise to make the red pointer enter the indicator window, stop pulling and keep it.

9. Continue to rotate the adjusting nut. After the red pointer enters the green range of the indicator window, determine the firing position according to the thickness of mucosal tissue.

10. Open the safety block, press the movable handle to fire. When a click is heard, the sense of strength is lost, which indicates that the firing is completed, and keep the instrument static for at least 30 seconds to help stop bleeding.

11. Complete the firing, reset the firing handle and restore the safety button.

12. Loosen the adjusting nut by 3 / 4-1 turn anticlockwise, shake the instrument to the left and right gently, and exit slowly. Do not use violence or forcibly withdraw the device.

13. Withdraw the anal mirror, that is to complete the use of stapler.

[storage method] 1. The product shall be loaded and transported in the covered carriage and cabin, and kept clean, and shall not be exposed to heavy pressure, direct sunlight or rain and snow;

2. Handling should be handled with care to avoid drama