[product name] disposable arc-type stapler and components.
[specifications] jqha-45, jqhb-45。
[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 20162080717.
[product technical requirements no.]
Structure and composition of the disposable use 】 arc stapling and component (type A) by the arrival of the screw, screw, components, plywood, locating pin, positioning push button, the reset button, handle, closing the handle, the cocking handle, cutting knife, nail anastomosis; One-time use of arc stapling and component (type B) by the arrival of the screw, screw, components, plywood, locating pin, positioning button and reset button, fixed, activity, joystick, cutting knife, nail anastomosis。
[product performance] 1。 The shape of arc type stapler is smooth, without front edge, without burrs and cracks。 The marks on the body are clear; The bond of arc type stapler shell is firm, without cracks and obvious accumulation, the outer surface of metal parts is bright, without the defects such as burrs and dents。 2。 Performance: the moving parts of arc type stapler can be easily pushed, without jamming or loosening。 The component loader is firmly behind and the matching pin does not fall off; The anastomosed nail has a sharp head, and after the anastomosis, it has a "B" shape, cutting edge of the blade, and the cutting blade does not have the blade or blade。 The reposition spring of arc type stapler has sufficient elasticity。 When the anastomosis is completed, the moving handle of the reset button can be reset quickly。 3。 The hardness of ring knife is not less than 377hv0。2。 4。 The surface roughness of the metal parts of arc type stapler is less than 0。8mm; 5。 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。 6。 After the anastomosis, the suture can withstand the pressure not less than 3。6KPa, without leakage or tear。 7。 Sterile products; 8。 The product is sterilized by ethylene oxide, and the residual amount of ethylene oxide should not be greater than 10ug/g。 9。 The surface of metal parts of arc type stapler is slightly corroded and can be removed by wiping。
[scope of application] applicable to the reconstruction of the digestive tract and the closure of the stump or incision in the reconstruction of the digestive tract with difficulty in the surgical field.
[contraindication] 1。 The tissue has inflammation, edema or tumor site;
2. The tissue is too thick, and the total thickness of the two layers of gastrointestinal wall is more than 2.5~3mm.
3. The tissue is too thin to prevent tissue tearing when the stapler is inserted;
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 professional 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] use of arc-type stapler and component (type A) at one time:
1. Remove the equipment from the packaging in the sterile operating room environment. To avoid collision or falling land impact on the performance of products;
2. Remove the stitching cap and place the tissue that needs to be stitched into the nailing seat and the kiss cutting component. After pressing the closing handle, click the click to indicate that the positioning needle has entered the positioning hole to lock the position; At this point, the distance between the jaws is reduced to facilitate the adjustment of the tissue to the desired slot.
3. After the ideal seam cutting position is organized, press the closed handle clamp again to close, and then wait for the seam to be cut.
4. When the tissue is fixed, press the hit handle with force.
5. Press the reset button after the seam cutting, and then push the positioning button to return the positioning pin. Slowly exit the stapler to complete the use of the stapler. Do not use force or force out of equipment.
Use of arc-type stapler and component (type B) :
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, remove the screw cover, will need to stitch in the arrival of the nail seat and kiss cut between components, gently press after handle release activity, handle back 2 cm or less will not rebound, hear clicks said positioning needle has entered the location hole in the lock position; At this point, the distance between the jaws is reduced to facilitate the adjustment of the tissue to the desired slot.
3, organizations, to the ideal sewing and cutting position, press activities make activity joystick press again to handle fixed jaw will be closed at this moment, gently loosen the grip handle will rebound to the front, at this time to sew cutting seam organization fixed waiting for cutting;
4. After the organization is fixed, press the active handle again to press the activity handle to the fixed handle. When the structure is finished, the handle will not rebound.
5。 Press the reset button after the seam cutting, and then push the positioning button to return the positioning pin。 Slowly exit the stapler to complete the use of the stapler。 Do not use force or force out of equipment。
1. The product shall be carried in a covered carriage and cabin, and shall be 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.