Reprocessed LigaSure Impact™ Curved, Large Jaw, Open Sealer/Dividers Page 6 of 16
Check for clips / Regrasp tissue – Avoid grasping objects such as staples, clips, or encapsulated sutures in the jaws of the
instrument.
Clean electrode tips – Use a sterile, water- or saline-soaked gauze pad to clean surfaces and edges of instrument jaws.
Remove excess fluids – Minimize or remove excess fluids that pool around the instrument tip.
Reactivate/Seal Cycle Incomplete Alert
A Reactivate/Seal Cycle Incomplete alert condition produces a sequence of pulsed tones and an alert will be displayed on the
generator.
If the Reactivate/Seal Cycle Incomplete alert appears, the user should:
1. Release the footswitch pedal or activation button.
2. Reactivate the seal cycle without removing or repositioning the jaws from their original position.
Reasons:
• Maximum seal cycle time has been reached. The system needs more time and energy to complete the seal.
• Seal cycle/endpoint was interrupted before the cycle was complete. The footswitch or activation button was released
before the seal cycle was complete.
After Surgery
• Discard the LF4318 instrument after use according to hospital policy for biohazards and sharps.
Pre-Clinical Study
Notice
There is no animal data qualified to predict the effectiveness of this device in sealing vessels containing atherosclerotic plaque.
Product performance of the device was established in a chronic in-vivo porcine model. The results showed that no animals
studied experienced any hemostatic complications related to the device during the 21-day survival period. In addition, there
was no evidence of thermal injury or other device-related damage to adjacent tissue. A variety of tissue types and vessels
were evaluated to demonstrate effective sealing in arteries and veins up to and including 7mm.
The United States clearance of this device was not based on human clinical testing.
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