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Examine the new reload for the presence of a staple retainer. If the retainer is not in place, discard the
reload. Do not remove the staple retainer until the reload cartridge is inserted into the device.
NOTE: The staple retainer cannot be removed until the cartridge is correctly loaded into the device.
The loaded device cannot be used until the staple retainer is removed.
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Insert the new reload into the metal housing and snap into position. (Illustration 9) The tracks on
each side of the reload should be used as guides to align the reload within the jaws of the instrument.
When the reload is properly aligned, push the reload into the instrument until it is fully seated.
(Illustration 10) Remove the staple retainer. (Illustration 11) Check that the reload is held firmly
within the jaws.
NOTE: If the cartridge is removed from the device, whether the cartridge is spent or not, and if the
staple retainer has already been removed from the cartridge, the cartridge cannot be reloaded into the
device.
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After reloading and after removing the staple retainer, observe the surface of the new reload. If
drivers protrude out of the reload, replace with another reload.
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The stapler is now reloaded and ready for use.
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
during a procedure, verify compatibility prior to initiation of 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.
•
Pre-operative radiotherapy may result in changes to tissue characteristics. These changes may, for
example, cause the tissue thickness to exceed the indicated range for the selected staple. Careful
consideration should be given to any pre-surgical treatment the patient may have undergone, which
may require alterations to surgical technique or alternative surgical procedures.
•
Do not fire device without a loaded cartridge.
•
Be sure to remove the staple retainer prior to inserting tissue and closing the device.
•
If the staple retainer is not in place in a cartridge module, discard the cartridge module and replace
with a new one. Do not remove the staple retainer from the cartridge until the reload cartridge has been
inserted into the instrument.
•
Before closing the instrument on tissue, observe the surface of the new reload where the staples will
emerge. If colored drivers protrude out of the reload, replace with another reload.
•
Make sure tissue to be stapled is properly positioned in the jaws before stapling. Bunching, stretching
or uneven loading of tissue could result in leakage, lack of hemostasis, or disruption of staple line.
•
Ensure that unintentional tissue is not cut.
•
Always ensure complete closing prior to firing.
•
Before firing, verify that the intended tissue is in the closed jaws of the instrument. If the pin is not
properly positioned, staples may not form properly, which may result in leakage or disruption of the
staple line.
•
When positioning the stapler on the application site, ensure that no obstructions such as clips, stents,
guide wires, etc., are incorporated into the instrument jaws. Firing over an obstruction may result in
incomplete cutting action and/or improperly formed staples.
•
Make sure that the release button is not pressed during firing as proper formation of staples and cut
line may be compromised.
•
Care should be taken not to fire this instrument when the resulting staple line will be in tension.
•
Before firing, check to ensure the retaining pin is seated in the anvil. If the pin is not properly
positioned, staples may not form properly, which may result in leakage or disruption of the staple line.
•
Do not fire the instrument unless the closure trigger is properly latched against the handle.
•
The firing trigger must be pulled back completely against the closure trigger to properly fire the
instrument. Do not partially fire the instrument.
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