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Disposable Endoscopic Cutter Stapler and Cartridge

1. Application
This surgical tool is widely used in the tissue transaction, resection and anastomosis of endoscopic surgery for visiting surgeon, gynecology, pediatrics, and chest surgery.

2. Working Principle
The disposable endoscopic cutter stapler is a single patient use medical instrument. The special kit has three rows of titanium elastic nails with a surgical knife between the first two rows of titanium elastic nails. The nails are arranged in 3 staggered rows in the soft tissue, allowing the knife to cut the tissue between the staple lines. This has led to its common usage as a sewing and cutting surgical tool.

3. Material
The staple material is pure titanium, which comply with the ISO 5832-2:1999(E) Surgical Implants--pure titanium material standards. The anvil and blades are made of stainless steel. The cartridge and the handle are made of ABS, reinforced nylon or Makrolon.

4. Description
ECS series endoscopic cutter stapler, short ECS series endoscopic cutter stapler and extra-long ECS series endoscopic cutter stapler, are sterilized instruments for single patient. The instrument inserts the staples and cross cuts the tissue between the staples together. The ECS series endoscopic cutter stapler’s cartridges are white, blue, gold and green, and can insert two sets of three-row cross staples. The locking function avoids accidental shooting of used cartridges.  The 45 instrument has a 45mm suture line and the cutting length is 43mm. The 60 instrument has a 60mm suture line and the cutting length is 58mm. In the cartridges, there is a protective plate to protect staples during transportation.

The cartridge should be installed before use by the surgeons. It will not be shipped together with the stapler together. ECS series endoscopic cutter staplers should only be used with the matching cartridge, though the cartridge can be used with all types of ECS series endoscopic cutter staplers. Please do not use the ECS series cartridge with other instrument series.
The maximum number of shootings is 12, with a reloading time of no more than 12 as well. Using this instrument together with a linear suture support material may decrease the shooting times.

5. Directions for use

Before using, please check the compatibility of all instruments and accessories (please review Considerations and precautions)
1. Please follow the aseptic techniques and take the instrument out of the package。Prevent damage caused by throwing the instrument into unsterilized areas.  
2. Loading the cartridge。
3. Pull the flexible handle (light gray and marked with no. “1”) and close the clamp to closed position. A “click” can be heard when the close is locked (picture 2).
Caution:Please do not pull the shooting handle in this step (dark grey and marked with no. “2”)
4. With a suitable trocar or incision, insert the instrument into the body cavity (picture 3)
Caution:The clamp must be closed when the instrument is inserted into the body cavity with suitable trocar.
Caution:When the instrument is rotated through the trocar or incision, please avoid accidentally pushing the shooting handle because it is possible to activate the lock. If this happens, the clamp can’t be reopened through a reset function. The surgeon will have to take out the instrument, pull the release button, then press a reset button and change the cartridge.
5. Once the instrument is in the body cavity, please press the reset button to open the clamp, and return the flexible handle (1) back to the original position (picture 4)
6. Make sure the instrument surrounds the tissue that requires suturing.
Caution:Make sure the tissue in the clamp is flat. If there is fascicle tissue along the cartridge, especially along the crotch, suturing lines will be incomplete.
The black line at the end of anvil and cartridge holder indicates the end of the suture line, and the cutting indicatrix on the cartridge holder indicates the cutting line of the instrument.
Caution: make sure the tissue does not extend past the proximal black line. The tissue beyond the black line will be cross cut without any staples.
7. Put the clamp surround the tissue that needs to be sutured, pull the flexible handle (1) to lock position and close the clamp. It is closed when there is a click. (picture 5)
Caution: when placing the stapler in the application place, please make sure there is are no staple clamps, trash, or guide wires, as that can lead to incomplete cutting, unsuitable suturing line, or the inability to open the clamp due to the foreign material
Caution:If the flexible handle (1) cannot lock, the instrument needs to be placed again and less tissue should be included. (Refers to Contraindication and choose suitable cartridge)
Caution: If the tissue or suturing line support material is used in the operation, more power needs to be used to close the clamp.
Caution: When it shoots through thick tissue, the clamp should not be moved, and remain in place for 15 seconds after closing to improve the extrusion and seam formation effects.
8. Use the continuous, smooth, and same power to pull and loosen the firing handle (2), until it stops at the flexible handle (1), to fire the instrument (picture 6).
Caution: The endoscopic cutter stapler needs 3 times to fire the instrument. 3 complete shoots can create a 45mm suture line (Size 45) or a 60mm suture line (Size 60).

9. The 3-shoots indicatrix on the fixed handle or bottom of cartridge holder will move forward together with suturing line and cutting line. Making sure 3 complete shoots in reference with 3-shoots indicatrix or blade indicatrix. After 3 complete shoots, the blade will return automatically.
Caution: The whole firing process should be finished once the firing process is begun. Do not fire an incomplete instrument.  
Caution: In the firing process, if there is too much tissue, or intensive/ thick tissue in the clamp, it may lead to the instrument malfunctioning.
Caution: A manual release button can stop the firing process, return the blade and stop the suturing line when it does not reach 45mm or 60mm.
Caution: Once the blade returns to the initial position automatically or manually, it means the cartridge is finished. The cartridge should then be thrown away. Trying to fire the finished cartridge will lead to the instrument locking up, indicative by the feeling of instrument resistance. Once the instrument locked, please stop the operation, take out the instrument, pull the manual release button, and press the reset button to change the cartridge. Not doing so may lead to instrument breakage through the locking device.  
Caution; Suturing support material used together with this instrument will lead to using more power to fire and lead to fewer firing times.
Caution: When several cartridges are used in the operation, it may cut the previous staples. The useful life of the instrument may be reduced.
10. Press the reset button to open the clamp, return the flexible handle and firing handle back to the initial position (picture 7). Make sure to remove the clamp from the tissue before taking out the instrument.
Caution: After taking out the instrument, please check the bleeding situation around the suture position and the strictness of the staples. Tiny bleeding can be controlled by electrocautery, suturing manually, or other suitable methods.
Caution: If the clamp does not open after pressing the reset button, please check if the 3-shooting indicatrix or blade indicatrix are back to the initial position, as well as the blade back in the initial position. If the clamp still does not open, push the flexible handle to return the indicatrixes to the initial positions
Caution: If the firing device is not functional, please do not fire the instrument. (take out the instrument and throw it away)
11. For taking out the instrument, the flexible handle (1) needs to be pulled to the locking position to close the clamp.
12. Take out the instrument in the closed position.
6 .Considerations and precautions
1. The general principle should be complied with when this product is used.
2.The blister packaging should be checked before use. If the package is damaged, the instrument should not be used.
3. The instrument only can be used within the sterilization period of 3 years.
4.In the same operation the stapler can be reused no more than 12 times through cartridge reloading/
5.The cartridge should be covered well before use. Otherwise, the quantity of the staples should be checked.
6. After removal of the instrument, please check the surrounding tissue for bleeding. If there is bleeding, the corresponding area should be fulgerized or sutured more.
7. The instrument only can be used in one operation. It should be thrown away after use

Contraindication
Do not use the white cartridge on any tissue that requires excessive force to compress to 1.0mm or on any tissue that is below 1.0mm
Do not use the blue cartridge on any tissue that requires excessive force to compress to 1.5mm or on any tissue that is below 1.5mm
Do not use the gold cartridge on any tissue that requires excessive force to compress to 1.8mm or on any tissue that is below 1.8mm
Do not use the green cartridge on any tissue that requires excessive force to compress to 2.0mm or on any tissue that is below 2.0mm
Do not use the instruments on severe mucous edema, ischemic or necrotic tissue
Do not use the instruments on the aorta.
Do not use the instruments on the great vessels if there is no proximal or distal preventive measure.
Do not use the instruments on solid organs, such as the liver or spleen, where attempted compression would be destructive.
These instruments are not intended for use when surgical stapling is contraindicated.

Precaution
1. The product is for disposable use and comes in a sterilized, sealed package that ensures a valid sterilization for 3 years.
2. Before use, please check if the product is within the three-year expiration date and the package.  Do not use if the package is damaged or the tool is past the expiration date.
3. The sterilized product should be stored in the place where the relative humidity is no more than 80%, ventilated and features no corrosive gas, all indoors.
4. Discard as stipulated after use.
7Packaging
The package of endoscopic cutter device is a blister box and dialysis bag. The outer package is paper box, and there is one device in each box.  Within COC and instructions, the device can be used directly after opening the package.
8. Storage
The instrument should not be extruded, impacted or have any wear. It should be placed in a ventilated, dry, non-corrosive gas indoor environment.  

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