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Instructions for use, ERGO 300 - BOWA- IFU-12930- ERG0300-S0-EN-20210701
6.2 Execution
Risk of death or serious injury!
Unsupervised cutting may injure the abdominal wall and organs and cause the death of the patient.
Remedy:
• Before every procedure make sure that an endoscopic procedure is preferable to a conventional procedure.
• Use only the products described in this manual.
• During the procedure use the protective tube or Trocar Cannula as a precautionary measure.
Follow “Option 1: Morcellation with protective tube” and “Option 2: Morcellation with Trocar Cannula” in Chapter 5.
• Use Morcellator under visual control (endoscope) only.
• Use Morcellator only for morcellation of tissue that has been fully prepared and is clearly visible. Nouvag AG accepts
no liability for any other applications.
• Nouvag also recommends the use of a second gripper or a similar retaining device to prevent uncontrolled movement
of large Morcellator pieces of tissue. This will require an additional percutaneous access.
• Fix the Morcellator in a ventrolateral position to prevent movements inside the uterus.
• Prevent movement of the lateral blood vessels, kidneys and retroperitoneum.
• Pull the tissue towards the rotating blade for morcellation with the gripper.
Risk of injury due to gas loss!
Gas may be lost during the procedure. This may result in the abdominal wall dropping.
• Select an Insufflator with adequate flow to prevent the abdominal wall from dropping.
• Use the Morcellator with protective tube as in option 1: when removing or replacing instruments, immediately close
the proximal opening of the seal unit with the thumbs.
• Use with Trocar Cannula as in option 2: pull the Morcellator with cutting tube out of the Trocar Cannula. The Trocar
Cannula valve closes to prevent gas loss.
• After removal of the morcellated tissue, insert the Morcellator into the Trocar Cannula and repeat the process.
Risk of injury!
The Morcellator system is designed for removing tissue with the greatest possible safety. For this purpose the protective
tube and the Trocar Cannula are both fitted with a valve flap.
Morcellation without protective tube or Trocar Cannula is prohibited!
Tissue escapes the gripper!
Tissue may escape the gripper during the procedure and fall into the abdominal cavity.
Causes:
• The tissue is not gripped tightly enough.
Remedy:
• Grip the tissue at a different position
• Press the jaws of the gripper together as tightly as possible.
