Warning For Locking The Guidewire

INSTRUCTIONS

USA: CAUTION: Federal law restricts this device to sale by or on the order of a physician.

WARNING FOR LOCKING THE GUIDEWIRE

TJF-Q180V

The TJF-Q180V is designed to lock the guidewire in place during wire-guided type EndoTherapy accessory withdrawal or insertion, such as when a guidewire has been placed through a cannulation device into the biliary or pancreatic duct and this device must be removed from the endoscope and exchanged for a different EndoTherapy accessory. When locking or replacing the guidewire, follow the warnings below. •

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Do not use a guidewire when its outer surface is damaged. This could allow leakage current to flow from the guidewire to the endoscope and/or the patient, and it could cause burns to the patient, operator, and/or assistant. Also, it could damage the endoscope, equipment, and/or Endo Therapy accessory. Manipulate the elevator control lever and the insertion section of the endoscope slowly while viewing the papilla when locking the guidewire at the distal end of the endoscope. Otherwise, patient injury, bleeding, and/or perforation may result. Do not manipulate the elevator control lever and the insertion section abruptly while the guidewire is being locked. Otherwise, patient pain, injury, bleeding, and/or perforation may result. If the patient reports pain while the guidewire is being locked at the distal end of the endoscope, stop locking the guidewire and ensure patient safety. Lock the guidewire at the distal end of the endoscope after making the insertion section of the endoscope as straight as possible. Confirm the insertion section with the X-ray image as required. If the guidewire is locked with the insertion section excessively bent, the distal end of the endoscope moves suddenly and patient pain, injury, bleeding, and/or perforation may result. Insert the guidewire into the biliary/pancreatic duct sufficiently when the guidewire is retained there. If the guidewire is not locked at the distal end of the endoscope with sufficient insertion, the guidewire can be withdrawn from the biliary/pancreatic duct. This may cause patient injury, bleeding, and/or perforation. Insert and withdraw a wire-guided type EndoTherapy accessory slowly and carefully when the guidewire is locked in the guidewire-locking groove at the distal end of the endoscope. If the EndoTherapy accessory is withdrawn or inserted along the guidewire with excessive force or rapidly while the guidewire is locked, or the guidewire is moved while it is locked at the distal end of the endoscope, the following may occur:  The guidewire comes off the guidewire-locking groove and cannot be locked at the distal end of the endoscope.  The guidewire penetrates deep inside the patient’s body and patient injury, bleeding, and/or perforation can result.  The outer surface of the guidewire becomes damaged, ripped or torn, and pieces of the outer surface might fall into the patient’s body.  The outer surface of the guidewire is damaged, ripped or torn, and leakage current can be discharged from damaged parts of the guidewire, which could cause burns to the patient, operator and/or assistant, and damage the endoscope, equipment and/or EndoTherapy accessory. Observe the endoscopic image and/or X-ray image to confirm that the guidewire is locked at the distal end of the endoscope when withdrawing or inserting a wire-guided type EndoTherapy accessory. Otherwise, patient injury, bleeding, and/or perforation can result. Do not withdraw the endoscope if the guidewire is stuck in the guidewire-locking groove at the distal end. Doing so may result in patient injury, bleeding, and/or perforation. In this case, insert a wire-guided type EndoTherapy accessory over the guidewire from its proximal end while observing the endoscopic image to confirm that the guidewire does not penetrate patient tissue. When the EndoTherapy accessory passes through the groove, it removes the guidewire from the groove. If the guidewire is still stuck in the guidewire-locking groove, contact Olympus without changing the position of the instrument.

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