[product name] disposable tube stapler and components.
[specifications] jqga-17, jqga-19, jqga-21, jqga-24, jqga-26, jqga-29, jqga-32, jqga-34。
[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 note 20162080718.
[technical requirements no.] yu ordnance note 20162080718.
Disposable tube type structure and composition 】 【 stapling and components are: to nail, osculating components, casing, fixed joystick, insurance button, activity, the regulating handle, pad knife ring, circular knives, and consistent with nails.
[product performance] 1. The shape of pipe type stapler is smooth, smooth, without front edge, burr and crack, and the scale value and mark of the device are clear; The bonding (or welding) of tube type stapler shell and components is firm, without cracks and obvious accumulation; The head end is sharp, there are no dents, scratches and other defects. 2. Performance: the offset assembly of the pipe type stapler can be successfully assembled and disassembled, and the moving parts can be pushed smoothly without jamming or loosening. The component loader is firmly behind and the anastomosis is not falling off; The insurance mechanism of tube type stapler and component is open and closed, and should be safe. The spring is elastic enough to reposition quickly when releasing the handle; The anastomosed nail head is sharp, the ring blade is sharp, and there is no roll blade or collapse. 3. The hardness of the ring knife should be no less than 377hv0. 2. 4. The surface roughness of the metal parts of the pipe type stapler is less than 0.8mm; 5. The metal parts of pipe type stapler shall have good corrosion resistance; 6. The peel strength of the packing seal is 0.1n /mm ~ 0.5n /mm. The two contact surfaces that are torn should be smooth and continuous, without layering or tearing. 7. The anastomosis after the anastomosis can withstand the pressure of no less than 3.6kPa, no leakage or tearing phenomenon, and the sterilization of the tube type stapler; 9. The tube type stapler is sterilized by ethylene oxide, and the residual amount of ethylene oxide is not greater than 10ug/g. 10. The surface of the metal part of the pipe type stapler is slightly corroded and can be removed after wiping.
[scope of application] applicable to the end, end and side of digestive tract reconstruction surgery.
1. The mucous membrane of gastrointestinal wall esophagus has inflammation, edema, and the tumor is forbidden.
2。 It is forbidden to have a thin or thin tube wall muscle layer (less than 1。0mm);
3. The tissue is too thick, (it is estimated that the total thickness of the two layers of gastrointestinal wall is more than 2.5~3mm in thickness);
4。 Disabled people with coagulation mechanism。
5. Disable product material allergy.
1. This product belongs to disposable products, which 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 tube stapler and component usage:
1. Select the applicable model specifications and take out 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;
2. Counterclockwise rotary adjusting nut, holding the fixed handle firmly to the other hand with one hand and holding the fixed handle to the opposite direction, so as to separate the holder from the stapler and remove the protective cover;
3. The sleeve is inserted on the puncture shaft, and it is inserted into the tissue that is ready to be sutured, tightening the purse, and showing the tip of the puncture shaft from the pocket center. If double anastomosis is required, please ensure that the puncture shaft is worn from the center of the stitching line to avoid excessive tissue accumulation around the puncture axis.
4。 The long pull rod is extended to the nail block and can be assisted into the tissue to be sutured, then it can be replaced with a puncture head to assist with the production of the bag;
5. Tighten the load on the spring tube of the nail seat, and show it from the center of the pocket, and then insert the spring tube of the nail seat into the puncture shaft of the stapler;
6. At this time, turn the adjusting nut clockwise to the green area of the indicator window, according to the thickness of the mucosal tissue, to determine the firing position;
7。 Open the insurance block, press the active handle to hit the hair, hear the click, and feel the sense of loss at the same time, indicating the completion of the shooting;
8。 Finish the breakdown, reset the handle and restore the safety button;
9. Turn the adjusting nut 3/4-1 in the counterclockwise and slowly exit, that is, to complete the use of the stapler; Do not use force or force out of equipment.
[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。