Johnson & Johnson EC45A, Instructions Manual

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Reloading the Instrument:
21
Using sterile technique, remove the reload from the package. To avoid damage, do not flip the reload into the sterile field.
22 Prior to reloading, ensure the instrument is in the open position. (Illustration )
23
Push upward (toward the anvil) to unsnap the reload from the cartridge jaw. Discard the used reload. (Illustration 1)
WARNING: Prior to reloading the instrument, rinse the anvil and cartridge jaw in sterile solution and then wipe the anvil and
cartridge jaw to clear any formed but unused staples from the instrument. Do not use the instrument until it has been visually
inspected to confirm there are no staples on the anvil and cartridge jaw.
24
Examine the new reload for the presence of a staple retaining cap. If the retaining cap is not in place, discard the reload.
Caution: Selection of the appropriate staple cartridge should be based upon the combined thicknesses of both the tissue
and the staple line reinforcement material. The use of staple line reinforcement material with the instrument may require an
increased force to fire and may reduce the number of times the device may be fired. When using staple line reinforcement
material, the instructions of the manufacturer of the material should be followed.
WARNING: Loading the incorrect reload for the instrument size or model may result in transecting the tissue without sealing
(e.g. loading a 60 mm reload into a mm instrument).
25 Insert the new reload by sliding it against the bottom of the cartridge jaw until the cartridge alignment tab stops in the
reload alignment slot. Snap the reload securely in place. Remove the staple retaining cap and discard. The instrument is now
reloaded and ready for use. (Illustration 1)
Caution: After removing the staple retaining cap, observe the surface of the new reload. The reload must be replaced with
another reload if any colored drivers are visible. (If colored drivers are visible, the reload may not contain staples.)
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.
• When using other technologies (e.g., electrocautery) in the procedure, observe the precautions suggested by the original
equipment manufacturer to avoid the hazards associated with their use.
• Loading the incorrect reload for the instrument size or model may result in transecting the tissue without sealing (e.g. loading
a 60 mm reload into a mm instrument).
• Do not attempt to articulate by pressing the front of the jaws against the grounding surface as tissue damage or tissue trauma
may occur.
• Prior to reloading the instrument, rinse the anvil and cartridge jaw in sterile solution and then wipe the anvil and cartridge jaw
to clear any formed but unused staples from the instrument. Do not use the instrument until it has been visually inspected to
confirm there are no staples on the anvil and cartridge jaw.
• 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. (If colored drivers are visible, the reload may not contain staples.)
• When placing the instrument through the trocar or incision, avoid advancing the firing trigger () accidentally. If this occurs,
the instrument will lockout and the stroke indicator will display a lock symbol; in this state, the instrument will not allow the
anvil release button to reopen the instrument jaws.
• The instrument can only achieve a maximum articulation angle of º. When using body structures or organs as a grounding
surface, particular attention should be placed to the visual cues and tactile feedback received from the instrument. When the
maximum angle is reached, the force will increase indicating the maximum angle has been reached. Avoid applying excessive
pressure to the tissue as tissue damage or tissue trauma may occur.
• When dividing major vascular structures, be sure to adhere to the basic surgical principle of proximal and distal control.
• 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.
• 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 tissue has not extended (extruded) proximal to the proximal black line on the instrument. Tissue forced into the
instrument proximal to 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. Ensure that the
proper reload selection has been made. (Refer to the ECHELON Reload Product Codes table.)
• Selection of the appropriate staple cartridge should be based upon the combined thicknesses of both the tissue and the staple
line reinforcement material. The use of staple line reinforcement material with the instrument may require an increased force
to fire and may reduce the number of times the device may be fired. When using staple line reinforcement material, the
instructions of the manufacturer of the material should be followed.
• Attempting to force the trigger to complete the firing stroke with too much tissue between the jaws, or with dense/thick tissue
between the jaws, may result in increased forced to fire or instrument failure.
• If the instrument locks out, the stroke count indicator will display a lockout symbol. Stop and push the red manual knife
reverse switch downward to reverse the knife motion; the knife direction indicator will display an arrow pointing towards the
proximal end of the instrument to indicate the knife is in the return mode. Squeeze firing trigger () completely until it rests
on the closing trigger. The stroke count indicator will display “0” to indicate the knife has returned to its home position. Then
press the anvil release button to release the jaws from the tissue. Close the instrument jaws by pressing the closing trigger (1),
remove the instrument, and replace the cartridge. Firing through the lockout mechanism will break the instrument.
• If the jaws do not automatically open after the anvil release button is pressed, first ensure that the knife is in the retracted
position by verifying that the stroke count indicator displays “0” and knife direction indicator points towards the proximal
side of the instrument, or that the knife blade indicator is in the home position. If the stroke count indicator or knife blade
indicator is not in the home position, push the red manual knife reverse switch downward to reverse the knife motion and
squeeze the firing trigger () completely until it rests on the closing trigger (1). Press the anvil release button. If the jaws do
not open at this point, then gently pull the closing trigger (1) upward (away from the handle) until both firing and closing
triggers return to their original positions
• If the firing mechanism becomes inoperative, do not continue to use the instrument.
• If the clamping mechanism becomes inoperative and the jaws do not clamp on tissue, do not fire the instrument. Remove and
do not continue to use the instrument.