• Disposable Linear Cutter Stapler (CE mark)

Disposable Linear Cutter Stapler (CE mark)

Application: Abdominal
Material: ABS Engineering Plastics;12cr18ni9 Stainless Steel
Feature: Disposable
Medical Device Regulatory Type: Type 2
Medical Devices Reg./Record No.: Syzz2012 2080462
Outside Diameter: 0.2
Customization:
Gold Member Since 2010

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Manufacturer/Factory

Basic Info.

Model NO.
Model A
Staple Height
H3.8±0.15; H4.8±0.15
Color
H Blue; H Green
Transport Package
Pet Box, Tyvek Paper
Specification
ISO/CE
Trademark
changsheng
Origin
Changzhou
HS Code
90189090
Production Capacity
100, 000PCS/Year

Product Description

Disposable Linear Cutter Stapler Model A
 
I.     Product Performance 
The disposable linear cutter stapler and its assembly put four rows of suturing staples staggered in a line into the tissue to replace manual suture. This instrument can save operation time and reduce bleeding. Besides, it is convenient for suturing and incision.

 
II.   Scope of Application
It is applicable to mutilation, excision and suture in the operation of alimentary canal such as stomach and intestines.

III. 
Name of Parts


IV. Graphic Symbols and Definition


V.  Contraindication 
1.    Serious mucous edema.
2.    Never use the stapler with staple height of 4.5mm for any tissue whose compressed thickness is less than 2.0mm, because the stapler staple cannot fully tighten up to stop bleeding in this case.
3.    Never use the stapler with staple height of 4.5mm for any tissue which fails to be compressed easily to be 2.0mm thick, because the tissue thickness is beyond the suturing specification in this case.
4.    Never use the stapler with staple height of 3.85mm for any tissue whose compressed thickness is less than 1.5mm, because the stapler staple cannot fully tighten up to stop bleeding in this case.
5.    Never use the stapler with staple height of 3.85mm for any tissue which fails to be compressed easily to be 1.5mm thick, because the tissue thickness is beyond the suturing specification in this case.
6.    Never use the instrument for any tissue whose compressed thickness is less than 1mm, because the stapler staple cannot fully tighten up to stop bleeding in this case.
7.    The instrument shall not be used for livers or spleens, because closing the instrument may cause destructive effect due to their compression characteristics.



VI. Instructions for Operation

1.    Take the instrument out of the package in the sterile purifying area. To avoid any damage, the instrument shall be handled gently.
2.    Open the free handle cover, separate the cutter assembly from the anvil, and then remove the cartridge cover.
3.    Clamp the tissue to be cut and sutured between the cartridge and the anvil support, and then press the free handle cover to the locking position (Note: The free handle cover must be pressed to its place).
4.    Hold the cutter stapler in one hand and push the ejector pad with the thumb and forefinger of the other hand to the firing position (as the cutting knife still does not start cutting, the hand feel is light), and then continue pushing the ejector pad uniformly forwards to the front end (the hand feel is heavy, indicating that the cutting knife starts cutting the tissue and suturing the tissue at both sides).
5.    Reset the ejector pad (there is red indication on the instrument, as shown in figure 1). Pay attention that the stapler cannot be lifted immediately. The free handle cover must be first released and the cartridge and anvil support shall be separated; after that, the instrument shall be removed, and then the operation is completed.

Removable assembly:
Usage of removable assembly of disposable linear cutter stapler and cartridge (Model A):
Be sure that the ejector pad returns to its original position, and then pull the free handle cover open to remove the used assembly and replace it with a new one; put the new assembly in the assembly holder and fix it, and then remove the cover; the assembly can be used in the same operation according to the usage.

VII.   Storage
The product shall be stored in a well-ventilated room where no corrosive gases exist and relative humidity is not more than 80%.
 
VIII.   Manufacturer and Its Address and Contact Number
Manufacturer: Changzhou Medical Bioengineering Co., Ltd.
Registered (Manufacturing) Address: Tianzhutang, Dongqing, Zhenglu Town, Wujin District 213114 Changzhou City China
Tel: 0519-88966750
Fax: 0519-88964890                                  Zip Code: 213114
Model & Specification
Cutting Length

Suture Length
Staple Height Number of Staples
Green Blue  
CSYQ(A)-55(H/h) 55 57 4.5 3.8 60
CSYQ(A)-60(H/h) 60 62 64
CSYQ(A)-75(H/h) 75 77 78
CSYQ(A)-80(H/h) 80 82 84
CSYQ(A)-90(H/h) 90 92 88
CSYQ(A)-100(H/h) 100 102 104
 

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