[product name] disposable anorectal stapler and components。
[specification model] jqgc-32, jqgc-34, jqgc-36.
[name of registrant] henan jianqi medical equipment co. LTD.
The dingluan industrial zone in changyuan county.
[contact number] 0373-8690789.
【 after-sales unit 】 henan jianqi medical equipment sales co。 LTD。
[name of production enterprise] henan jianqi medical equipment co。, LTD。
The dingluan industrial zone in changyuan county。
[production address] dingluan industrial zone, changyuan county。
[contact information] 0373-8690789.
[production license] the food and drug regulatory apparatus is permitted to be made in 20080036。
[registration certificate no.] yu ordnance registration 20162080720.
[technical requirements no。] the ordnance mark 20162080720。
[structure and composition] disposable anal stapler and components are made up of nailing seat, body, kiss cutting component and accessories (optional accessories)。 The body is made up of adjusting nut, fixed handle, window, insurance lock and movable handle。 The cutting component is composed of ring knife, nailing, pushing, anastomosing nail, and packing ring。 The attachment consists of four parts: the anal mirror, the enlarged anus, the stitching part and the crochet。
[product performance] 1. The shape of the anal stapler is smooth, smooth, without front edge, burr and crack, and the scale and mark of the device are clear; The adhesion (or welding) of the anal stapler shell is firm, without cracks and obvious accumulation; The head end is sharp, there are no dents, scratches and other defects. 2. Performance: the components of the anorectal stapler can be assembled and disassembled smoothly; The mobile parts can be pushed smoothly, without jamming or loosening; The component loader is firmly behind and the matching pin does not fall off; The anastomosed nail head is sharp, the ring blade is sharp, and there is no rolling blade. The insurance mechanism of anorectal stapler is flexible and safe to use. The spring is elastic enough to reposition quickly when releasing the handle; 3. The hardness of the ring knife should be no less than 377hv0. 2. 4. The surface roughness of the metal parts of the anorectal stapler is less than 0.8m; 5. The anastomosis after anastomosis can withstand the pressure of no less than 3.6kPa without leakage or tearing; 6. The peel strength of the packing seal is 0.1n /mm ~ 0.5n /mm, and the two contact surfaces that are torn are smooth and continuous, without layering or tearing. 7. Sterilization of anorectal stapler; 8. The residual amount of ethylene oxide is not greater than 10ug/g. 9. The surface of the metal parts of the anorectal stapler is slightly corroded and can be removed after wiping.
[scope of application] suitable for selective resection of the mucosal and submucosal tissues of the rectal dentate line, and to restore normal anatomical structure of the lower rectum, for selective resection of the dentate line.
[contraindications] 1. Severe mucosal edema, gangrene, anal stenosis, total rectal prolapse, and hemorrhoid tissues are severely fibrosis; 2. Repeated injection of hardener in the hemorrhoid tissue; 3. For pregnant women, children, intractable constipation, pelvic tumor, portal hypertension, but-card syndrome or intolerance to surgery; 4. Allergic to product materials; 5. Disabled people with coagulation mechanism.
1. This product is a disposable product, which is damaged in packaging and is strictly prohibited to be used and destroyed after use.
2. If the production batch number and expiry date are shown in the packing seal or label, the sterilization date will be in the outer packing box;
3. Ensure the packaging is in good condition before use;
4。 The product is used by doctors and personnel after the knowledge and technical training of the stapler;
Any falling to the ground or being damaged or suspected of damage due to improper disposal shall not be used in clinical practice.
1. Please check the hemostatic condition of the stitching thread after each breakdown and exit. If there is blood seepage, appropriate methods must be used to stop the bleeding.
2。 The first mechanical suture fails, and the mechanical suture is not suitable in principle;
[use method] disposable anorectal stapler and group usage:
Select the applicable model specifications, and remove the equipment from the packaging in the sterile operating room environment。 In order to avoid damage, it is necessary to gently remove the equipment to avoid collision or falling land;
1. Insert the stitching part into the anus and then pull out the joint.
2。 To insert the anal mirror piece into the anus to be imported into the anus, which can make the hemorrhoid prolapse or anal mucosal prolapse partially reposition, and then the fixation of the anal lens can be sewn with thread。
3。 After fixation of the anus, the mucous membrane of the prolapse is falling into the sleeve of the anal mirror。
5. In the case of anus, the expansion of the anus was introduced, and the opening of the enlarged anus exposed the prolapse mucosa, and the distance between the suture line and the tooth line was selected according to the prolapse degree, generally 3 to 4cm above. Rotate the threading device to complete the suture of the whole anal canal.
6。 The adjusting nut to spin counterclockwise motionless, to import the anus nail seat, make over nail seat depth and the pouch is the upper line, and then suture knot forming pockets should make organization even bandage on the piercing shaft。
7。 Use a crochet hook to separate the seams of the stitches and tie the seams, and tie the ends to the length of the fingers。
8。 Tighten the stapler, and pull the tissue properly。 (by pulling the thread through the fingers, the tissue can enter the cavity of the instrument at a constant speed。 Note: keep the head end position and close the device forward。 Turn the adjusting nut clockwise to allow the red pointer to enter the indicator window to stop pulling and hold。
9. Continue to rotate the adjusting nut. After the red pointer enters the green range of the indicator window, the location of the firing is determined according to the thickness of the mucosal tissue.
10. Open the insurance block, press the active handle to hit the hair, hear the click, and feel the loss at the same time, indicating that the shooting is completed, and keep the device static for at least 30 seconds to help stop the bleeding.
11. Finish the breakdown, reset the handle and restore the safety button.
12. Rotate the nut 3/4-1 by counter-clockwise, and gently shake the equipment gently and slowly exit. Do not use force or force out of equipment.
13. Exit the anal mirror, that is, to complete the stapler.
[storage method] 1. The product is used in the carriage and hold of the cabins, and is kept clean, without pressure, sunshine and rain or snow;
2. Handle gently in handling and avoid violent collision;
3. The product shall be stored away from the fire source, and the relative humidity shall not exceed 80%, without corrosive gas and well-ventilated and clean environment;
[production date] see the packing seal or label.
Expiry date: see the packing seal or label.
[label, package logo]
[specification preparation date] November 21, 2016.