【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.
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