Precision Disposable Endoscopic Cutter Stapler

【Application Scope】

Applies to excision, transection and suturing of tissues in the operation of abdominal surgery, gynecology, pediatrics and thoracic endoscopy.

【Precautions and preventive measures】

1. Follow the specification of sterile operation strictly when using the Product.

2. Minimal invasive surgery should be performed by those who are fully trained and familiar with minimal invasive surgery. Make sure to query the medical literature related to the operation, complications and hazards prior to minimal invasive surgery.

3. Check if the cartridge is matched with the Stapler prior to use and select the puncture outfit properly, for the size of stapler varies along with the manufacturer. Check if the stapler and cartridge are matched prior to operation if they are produced by different manufacturers.

4. The radiation treatment prior to operation may lead to tissue changes; for example, the changes may lead to increase of tissue thickness and violation of staple. The treatment prior to operation of patient must be considered carefully and it may be required to change the operation technique or mode.

5. The product should be used according to the general rules of stapler.

6. Check if blister package is damaged prior to use and it is forbidden to use if there’s damage.

7. The Stapler must be used within 2-year warranty period.

8. The cartridge can be replaced for not over 10 times if it needs repeat use in the same operation.

9. Make sure protective cover is well sealed prior to use of cartridge; otherwise, check if the nail slot of cartridge is lack of nails.

10. Once the Stapler is removed, check if the tissue has blooding after suturing; if so, perform fulguration or suturing at the corresponding position.

11. Make sure the tissue thickness is within the specified range and tissue is distributed evenly in the Stapler; otherwise, it may lead to poor suturing and leakage of anastomotic astium.

12. For any excessive or thick tissue, it may lead to incomplete suturing line, crack or penetration of anastomotic astium if trying to trigger the Stapler by force. Besides, it may lead to mechanical damage or trigging failure.

13. Trigging must be finished in one time. Do not trigger the Stapler partially; otherwise, it may lead to abnormal forming of nail, incomplete cutting line, blooding, penetration of suturing line, and/or difficulty of removing the Stapler.

14. MRI magnetic resonance compatibility and limited use condition: Static field strength is less than or equal to 3T and space magnetic field gradient is not above 720-Gauss/cm. The max. mean energy absorption rate of body (SAR) is not over 3.0W/kg. The max. temperature rise of staple due to radio frequency should not exceed 1.6℃ at the 1.5T magnetic field environment, or not exceed 1.9℃ at the 3T magnetic field environment.

15. The Stapler should be used in single operation only and be abandoned immediately after use.

16. The Stapler or products with contact to body liquids should be handled as wastes according to the public rules of hospital.

【Contraindications】

1. Do not apply the Stapler to severe mucosal edema.

2. Do not apply the Stapler to aorta.

3. Do not apply the Stapler to great vessels unless rear-end or far-end prevention measures are adopted.

4. Do not apply the Stapler to ischemia or necrotic tissue.

5. Do not apply the Stapler to liver or spleen tissue, for they can be injured by the Stapler’s closing due to the compression of such tissues.

6. Do not apply the Stapler to tissues where bleeding stop cannot be observed.

7. Do not apply the Stapler to suturing in surgical operation.

8. Evaluate the tissue thickness before triggering the Stapler. The tissue does not apply to the Stapler (due to improper thickness) if the tissue can be hardly or easily pressed to the closing height of the Stapler. The reference height of the Stapler is as follows:

● Do not apply the Stapler with white cartridge (W) to the tissue of which closing thickness can be compressed to 1.0mm by force, or the tissues which can be compressed to the thickness below 1.0mm.

● Do not apply the Stapler with blue cartridge (B) to the tissue of which closing thickness can be compressed to 1.5mm by force, or the tissues which can be compressed to the thickness below 1.5mm.

● Do not apply the Stapler with golden cartridge (D) to the tissue of which closing thickness can be compressed to 1.8mm by force, or the tissues which can be compressed to the thickness below 1.8mm.

● Do not apply the Stapler with green cartridge (G) to the tissue of which closing thickness can be compressed to 2.0mm by force, or the tissues which can be compressed to the thickness below 2.0mm.

● Do not apply the Stapler with black cartridge (T) to the tissue of which closing thickness can be compressed to 2.3mm by force, or the tissues which can be compressed to the thickness below 2.3mm.

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