Pre Advanced Disposable reloadable linear stapler

【Scope of application】

     The product is suitable for stump or incision closure in surgeries of digestive tract reconstruction and organ resection.

【Contraindications】

1) Severe mucosal edema.

2) The device shall not be used on the liver or spleen; due to the compression characteristics of this kind of tissues, the closure of the device may cause destructive effect.

3) 2.0mm high staples cannot be used for tissues with thickness less than 0.6mm after compression, or tissues and aorta that cannot be appropriately compressed to 1.0mm thickness.

4) 2.5mm high staples cannot be used for tissues with thickness less than 1mm after compression, or tissues and aorta that cannot be appropriately compressed to 1.5mm thickness.

5) 3.5mm high staples cannot be used for tissues with thickness less than 1.5mm after compression, or tissues and aorta that cannot be appropriately compressed to 2mm thickness.

6) 4.5mm high staples cannot be used for tissues with thickness less than 2mm after compression, or tissues and aorta that cannot be appropriately compressed to 2.5mm thickness.

【Instructions For Use】

1.      Take the sterilized instrument out of the package, remove the protection cover. Place the intended tissue between the cartridge and the anvil; push the feed handle and make the position setting pin come into the anvil. 

2.      Grasp the handles and move backward the active handle to about half of the movable range and release the active handle and keep it. Adjust the tissue between the cartridge and the anvil to make the tissue suitable and no overlapping. Further press the active handle to the end until the click sound can be heard. At this time, the tissue is frapped between the cartridge and the anvil. Release the active handle to the original place automatically.

3.      Grasp the handle again and press the active handle to the end. At this time, the active handle is locked and completes suturing.

4.      Cut the excessive tissue by scalpel. Press release button and the active handle will be automatically opened. Withdraw the retaining pin thumb button and remove the instrument.

【Precautions】

The product is sterilized with radiation, and the sterilized product is provided for clinical use.

 When using the product, the sterile operation procedure shall be executed strictly.

1) Please check the package of the product carefully before use, and it is forbidden to use if the package is damaged;

2) Please check the indicator on the sterilization package box of the product; “yellow” indicates that the product is not sterilized with radiation, and cannot be used directly; “red” indicates that the product has been sterilized with radiation, and can be directly used for clinical application;

3) The product is disposable and cannot be sterilized again after use;

4) Prior to use, please check whether the product is within the validity period; the sterilization validity period is two years, and it is forbidden to use if the product is beyond the validity period;

5) After taking out the stapler, check the hemostasis situation of the suture, and a slight bit of bleeding can be handled through manual suturing;

6) The manual only provides general introduction to the operation of the stapler and assembly, and is not used as a surgery guidance; refer to other relevant medical literatures and surgical atlas at the time of surgery.

【Warning】

The product is intended for use by physicians provided with professional knowledge and technical training and (or) use under the guidance of the personnel with relevant experience.

Please do not try to operate the product before reading the instruction manual thoroughly, and any imprudent operation may bring risks to the success of the surgery.

After use, dispose of the device in accordance with recognized hospital rules.