6
Warnings and Precautions
•
Minimally invasive procedures should be performed only by persons having adequate training and
familiarity with minimally invasive techniques. consult medical literature relative to techniques,
complications, and hazards prior to performance of any minimally invasive procedure.
•
Minimally invasive instruments may vary in diameter from manufacturer to manufacturer. When
minimally invasive instruments and accessories from different manufacturers are employed together
in a procedure, verify compatibility prior to initiation of the procedure.
•
A thorough understanding of the principles and techniques involved in laser, electrosurgical, and
ultrasonic procedures is essential to avoid shock and burn hazards to both patient and medical
personnel and damage to the device or other medical instruments. Ensure that electrical insulation
or grounding is not compromised.
Do not
immerse electrosurgical instruments in liquid unless the
instruments are designed and labeled to be immersed.
•
Failure to properly follow the instructions may lead to serious surgical consequences, such as leakage
or disruption.
•
Before using, remove the staple retaining cap and observe the surface of the reload. The reload must
be replaced with another reload if any colored drivers are visible.
•
The instrument jaws must be closed to be introduced into the cavity through a trocar of the
appropriate size.
•
When placing the instrument through the trocar or incision, avoid advancing the firing trigger
accidentally as this action might activate the lockout. If this occurs, the instrument will not allow
the anvil release button to reopen the instrument jaws. To recover from this condition, remove the
instrument, pull the manual release lever; then press the anvil release button while slowly releasing
the closing trigger to open the instrument jaws and replace the cartridge.
•
When dividing major vascular structures, be sure to adhere to the basic surgical principle of proximal
and distal control.
•
Prior to positioning the instrument jaws on tissue, make sure the jaws are in the open position.
•
When positioning the stapler on the application site, ensure that no obstructions such as clips, stents,
guide wires, etc. are within the instrument jaws. Firing over an obstruction may result in incomplete
cutting action, improperly formed staples, and/or inability to open the instrument jaws.
•
Ensure that the tissue lies flat and is positioned properly between the jaws. Any “bunching” of tissue
along the reload, particularly in the crotch of the jaws, may result in an incomplete staple line. The
distal black lines on the anvil and cartridge channel designate the ends of the staple line. The line on
the cartridge channel that reads “cut” references the cut line on the device.
•
Ensure tissue has not extended (extruded) beyond the proximal black line on the instrument. Tissue
forced into the instrument beyond the black line may be transected without staples.
•
If the closing trigger (1) is difficult to lock,
reposition the instrument and take a smaller amount
of tissue
. (See
Contraindications
for appropriate reload selection.)
•
The Endoscopic Linear Cutter is a
multiple stroke firing device
. Three complete strokes of the firing
trigger will advance the staple line a full 45 mm and automatically return the knife blade. The manual
firing release lever will return the knife blade and end the staple line before the full 45 mm staple line
is applied.
•
Before removing the instrument, be sure tissue is cleared from the jaws and then close the jaws.
•
After removing the instrument, examine the staple lines for pneumostasis/hemostasis and proper
staple closure. Minor bleeding can be controlled with electrocautery, manual sutures or other
appropriate techniques.
•
The instrument may be reloaded during a single procedure. Do not load the instrument more than
12 times for a total of 12 firings per instrument.
•
The firing trigger (2) and closing trigger (1) must be in the open position during reloading.
•
Prior to reloading the instrument, hold the instrument in a vertical position, with anvil and cartridge
jaw completely submerged in sterile solution. Swish vigorously and then wipe the inside and outside
Summary of Contents for ECHELON ENDOPATH 45 Series
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