[Scope of Application]
It is used for construction of
anastomotic stoma and the closure of stumps or incisions in digestive tract
reconstruction and other organ resection operations.
[Contraindications]
1. Do not use this device on severely mucosal edematous,
ischemic or necrotic tissue.
2. This product should not be used on
liver, spleen and other tissues, because the closure of the instrument may have
destructive effects due to the compressibility of such tissues.
[Usage]
1. Linear cutting stapler (stitcher):
During surgery, first unpack the sterile packaging of the stapler, pull open
the locking lever of the movable handle, and separate the device to take out
the staple bin protection cover.
2. Clamp the tissue to be cut and
sutured into the middle of the staple bin and the nail holder, put the locating
pin at the tail of the fixing handle into the locating slot at the tail of the
movable handle, and put the locating protrusion of the nail holder into the
locating slot of the staple bin. Close the movable handle until you hear a
"snap" locking sound from the movable handle.
3. Push the firing button of cutting
stapler from the bottom of the device until it cannot be pushed. There will be
obvious resistance during the pushing process, which is necessary for the
device to complete the surgery and is a normal situation.
4. Return the firing button to the
initial position, press the locking button of the fixing handle, and separate
the device so as to complete the operation. If the same patient needs the same
surgery at different parts, that is, withdraw the staple bin and replace it
with a new staple bin (see the staple bin replacement method for details),
repeat the above surgical process.
Replacement method of staple bin
1. Remove
the inner and outer packages, take out staple bin assemblies, and remove the
protection cover.
2. Check
whether the red limit button of staple bin assemblies is in the correct
position (the limit button should be perpendicular to the axial line of the
staple bin, as shown in the figure below). If not vertical, dial the limit
button to make it perpendicular to the axial line of the staple bin;![]()
3. Install staple bin assemblies into the lower splint
of the disposable linear cutting stapler (stitcher), which should be assembled
tightly;
4. Perform surgical procedures.
[Precautions]
1. When using this product, aseptic
operation specifications should be strictly followed;
2. The instructions cannot be used as
the basis for the guidance of clinical surgical anastomosis. Please refer to
the professional literature or consult the company and its designated agents
for the guidance on clinical surgical anastomosis techniques.
3. Physicians should read the
instructions carefully before use.
4. The product is single-use and is
sterilized by ethylene oxide with a validity period of two years.
5. It is strictly prohibited to use
if the inner packaging is damaged or expired.
6. Please destroy it as required
after use;
7. This product can only be used on
the same patient in the same operation. Multiple staple bin (up to 6) can be
used in one operation.
[Product Packaging]
1. When the product leaves the
factory, each Disposable Linear Cutter should be put into a small packaging
with a blister housing. The packaging form should be sealed packaging, and the
product should be ensured to be sterile until it is opened. The product is then
packed in a cardboard packaging box with instructions for use and a product
certificate. The large packaging of this product should be able to ensure no
damage under normal transportation and storage conditions, and the delivery
inspection report should be attached with the goods.
2. There must be the following
warning signs on the outer packaging of each handful of products.