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Caution: Attempting to force the trigger to complete the closing stroke with too much
tissue or thickened tissue may result in poor staple line integrity with possible leakage or disruption.
In addition, instrument damage or failure may result.
Caution: The firing stroke must be completed. Do not partially fire the instrument. Incomplete firing
can result in malformed staples, incomplete cut line, bleeding, and leakage from the staple line and/or
difficulty removing the device.
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After firing the instrument, open the jaws of the instrument by squeezing the closure trigger and
pushing the release button with the thumb. For controlled release, while holding the release button
down, open your hand to release the closure trigger. (Illustration 6) The cartridge drivers are exposed
as a spent cartridge indicator. If the instrument becomes locked onto tissue and will not open by
pressing the release button, the device can be opened by depressing the release button and pulling the
closure trigger simultaneously.
Caution: Examine the staple line for hemostasis and proper staple formation. If hemostasis is not
present, appropriate techniques should be used to achieve hemostasis.
Caution: Following a division of the rectum, it is recommended that a leak test is performed prior to
the creation of the anastomosis.
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Retract the retaining pin manually. Ensure that the staple line and the cut line are complete. Remove
the instrument. (Illustration 7)
Muscle Stapling Instructions for Use
Verify compatibility of all instruments and accessories prior to using the instrument.
(Refer to Warnings and Precautions.)
1
Using sterile technique, remove the instrument from the package. To avoid damage, do not flip the
instrument into the sterile field.
2
Remove the staple retainer from the instrument by pushing on the pad labeled "Push to Remove".
(Illustration 2). Hold the cartridge when removing the retainer. Check that the cartridge is fully
loaded into the instrument (press down) after the retainer has been removed. Discard the staple
retainer.
3
Grasp the instrument handle in the palm of the hand with the fingers around the closure trigger.
Position tissue to be cut and stapled between the anvil and the cartridge.
NOTE: Any tissue covering the hole in the anvil will be pierced by the retaining pin. Reposition the
tissue if necessary.
4
Recommended operation, in skeletal muscle, is to manually advance the Push Rod using the
Retaining Pin Actuator. Squeeze the closure trigger (Illustration 3B). Note that there is an audible
click halfway through the closure stroke indicating that the device is in the intermediate position.
In the intermediate position, the pin is fully seated in the anvil capturing the tissue, and the jaws are
partially open. Reposition tissue within the instrument if desired. The closure trigger can be released
at this point, and the instrument will maintain its jaw opening to allow for final positioning of the
tissue to be cut and stapled. The retaining pin is fully engaged.
Caution: Make sure tissue to be stapled is properly positioned in the jaws before closing the jaws
or stapling. Bunching, tension, stretching or uneven loading of tissue could result in leakage, lack of
hemostasis, or disruption of staple line.
NOTE: In thick skeletal muscle tissue, two approaches are recommended for device closure:
•
A single slow, controlled and continuous squeeze of the Closure Trigger
•
Progressively squeezing and relaxing (pumping) the Closure Trigger
NOTE: Do not grasp the firing trigger before the instrument is to be fired.
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Squeeze the closure trigger and handle together until the closure trigger is latched. Listen for an
audible click. When the closure trigger is latched, the firing trigger moves to the ready-to-fire
position (Illustration 4). The cartridge is clamped onto the tissue, which is ready to be stapled and
cut. Ensure that the closing stroke is completed. All fingers should be completely removed from the
closing trigger to ensure that the closing system holds.
NOTE: If the closure trigger is difficult to lock, reposition the instrument and take a smaller amount
of tissue.
NOTE: Do not use excessive force to close the instrument. Forcing the instrument to fully close, with
excess tissue, may result in the closure trigger breaking.
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