Ethicon Endo-Surgery ECHELON FLEX 45 Mode D'emploi page 6

Preparing the Instrument for Use
Using sterile technique, remove the instrument, battery pack, and reload from their respective packages. To avoid damage, do not fl ip the
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instrument, battery pack, or reload into the sterile fi eld.
Install the battery pack. The battery pack must be installed prior to use. Insert the battery pack by lining up the release tabs on the battery
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pack with the slots on the rear of the instrument. It can be inserted in either orientation; there is no up or down. (Illustration 3) Ensure
battery pack is fully inserted into the device. An audible click will be heard when the battery pack is fully inserted.
Note: The instrument must be used within 12 hours of inserting the battery pack. Refer to the Battery Pack Disposal section for battery
pack disposal instructions.
Prior to inserting the reload, ensure the instrument is in the open position (Illustration 1).
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Examine the reload for the presence of a staple retaining cap. If the retaining cap is not in place, discard the reload.
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Caution: Tissue thickness should be carefully evaluated prior to using the instrument. Refer to the Reload Product Codes Chart for
proper reload selection.
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 close and may
reduce the number of times the device may be fi red. When using staple line reinforcement material, the instructions of the manufacturer of
the material should be followed.
Insert the reload by sliding it against the bottom of the cartridge jaw until the cartridge alignment tab stops in the reload alignment slot.
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Snap the reload securely in place. Remove the staple retaining cap and discard. (Illustration 4) The instrument is now loaded and ready for
use.
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.)
Using the Instrument
Close the jaws of the instrument by squeezing the closing trigger until it locks in place (Illustration 5). An audible click indicates that
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the closing trigger and the jaws are locked. When the jaws of the instrument are closed, the red fi ring trigger lock and fi ring trigger are
exposed.
Note: Do not pull the red fi ring trigger lock or fi ring trigger at this time. The instrument may be partially or completely fi red and will need
to be reloaded before using on tissue.
Visually inspect the stapler to ensure proper cartridge seating. Introduce the instrument into the body cavity through a trocar of the
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appropriate size or through an incision (Illustration 6). When using a trocar, the instrument jaws must be visible past the trocar sleeve
before opening the jaws.
Caution: For insertion and removal of articulating instruments, the jaws of the instrument must be straight, parallel to the shaft of the
instrument. Failure to have the instrument jaws in the straight position will result in diffi cult insertion or withdrawal of the instrument and
may result in damage to the instrument.
Caution: When placing the instrument through the trocar or incision, avoid inadvertently pulling the red fi ring trigger lock and the fi ring
trigger. The instrument may be partially or completely fi red and will need to be reloaded before using on tissue. If the instrument is
partially fi red, remove the instrument and slide the knife reverse switch forward to return the knife to home position (Illustration 7). To
open the jaws, squeeze the closing trigger, then simultaneously press the anvil release switch on either side of the instrument (Illustration
8a). While pressure is still on the anvil release switch, slowly release the closing trigger (Illustration 8b). Remove the reload and insert a
new one (see Reloading the Instrument). If the instrument is fi red completely, the knife will return to home position automatically. Remove
the instrument and insert a new reload (see Reloading the Instrument).
Note: At any time, if the knife reverse switch does not return the knife to home position and the jaws will not open:
a. First, ensure the battery pack is securely installed and the instrument has power (Illustration 9); then, try the knife reverse
switch again (Illustration 7).
b. If the knife still does not return, use the manual override. After the manual override system is used, the instrument is disabled
and cannot be used for any subsequent fi rings. To use the manual override, remove the access panel labeled "Manual Override" on
the top of the instrument handle. The manual override lever will be exposed. Move the lever forward and backward until it can no
longer be moved. (Illustration 10) The knife will now be in the home position. This can be verifi ed by viewing the position of the
knife blade indicator on the underside of the cartridge jaw (Illustration 11). Discard the instrument.
Once in the cavity, squeeze the closing trigger, then simultaneously press the anvil release switch on either side of the instrument
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(Illustration 8a). While pressure is still on the anvil release switch, slowly release the closing trigger to reopen the jaws and return the
closing trigger to its original position (Illustration 8b).
If needed, rotate the jaws by pushing on the fi ns of the rotating knob with the index fi nger using a downward or upward pressure
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(Illustration 12). The instrument shaft will rotate freely in either direction.
To articulate the jaws inside the body cavity, select an appropriate surface (a body structure, organ, or another instrument) to use as a
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grounding surface to bend the jaws, ensuring that it stays within the fi eld of view. Rest the lateral side of the jaws that are opposite to the
desired direction of articulation against the grounding surface (the jaws must be open in order to articulate the instrument). (Illustration 13)
WARNING: Do not attempt to articulate by pressing the front of the jaws against the grounding surface as tissue damage or tissue trauma
may occur (Illustration 14).
Pull the fi ns of the rotating knob back with the index fi nger and apply a sweeping motion towards the side articulation is wanted while
gently pushing the instrument handle towards the grounding surface. Maintain the jaws pressed against the grounding surface during this
action. Once the desired articulation angle is reached, release the rotating knob to lock the angle (the instrument will only lock at pre-
determined angles – 15º, 30º and 45º).
Caution: The instrument can only achieve a maximum articulation angle of 45º. 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.
Position the instrument around the tissue to be stapled.
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Caution: 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. (Illustration 1)
A88091P00 AMP IFU_1_18_12.indd 10-11 A88091P00 AMP IFU_1_18_12.indd 10-11
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Caution: 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.
After positioning the instrument jaws, close the jaws by squeezing the closing trigger until it locks. (Illustration 5) An audible click
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indicates that the closing trigger and the jaws are locked. When the jaws of the instrument are closed, the red fi ring trigger lock and fi ring
trigger are exposed.
Caution: Ensure tissue has not extended (extruded) proximal to the proximal black line on the instrument (Illustration 1). Tissue forced
into the instrument proximal to the black line may be transected without staples.
Caution: If the closing trigger is diffi cult to lock, reposition the instrument and take a smaller amount of tissue. Ensure that the proper
reload selection has been made. (Refer to the Reload Product Codes Chart.)
Caution: If the clamping mechanism becomes inoperative and the jaws do not clamp on tissue, do not fi re the instrument. Remove and do
not continue to use instrument.
Caution: The use of staple line buttressing materials with the instrument may require an increased force to close. When using staple line
reinforcement material, the instructions of the manufacturer of the material should be followed.
Note: When fi ring across thick tissue, holding the jaws in place for 15 seconds after closing and prior to fi ring may result in better
compression and staple formation.
Pull back the red fi ring-trigger lock to enable the fi ring trigger to be pulled (Illustration 15).
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Fire the instrument by pulling the fi ring trigger; the motor will activate audibly (Illustration 16). Continue to depress the trigger until the
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motor stops (audible feedback), in order to reach the end of the transection.
Caution: Since the motor may stop if it stalls, it is important to do a visual check to ensure that the knife blade indicator, on the underside
of the cartridge jaw, has reached the end of the transection.
Caution: Attempting to force the device to complete the fi ring stroke with too much tissue between the jaws, or with dense/thick tissue
between the jaws, may result in motor stall and the knife will stop. If this happens, release the fi ring trigger, slide the knife reverse switch
forward, and remove and reload the instrument (Illustration 7). Then, position the instrument around a smaller tissue section or use a more
appropriate reload (refer to the Reload Product Codes Chart).
Note: The motor will slow down when device encounters more force.
To complete the fi ring sequence, release the fi ring trigger to activate the motor and automatically return the knife to home position where
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the motor will stop. In this position, the instrument is locked out until the jaws are opened and re-closed.
Note: If it is necessary to interrupt the fi ring sequence or it is interrupted inadvertently by releasing the trigger during the fi ring sequence,
pull the fi ring trigger again to continue. The status of the transection can be determined by observing the knife blade indicator on the
underside of the cartridge jaw throughout the fi ring action (Illustration 1). This can be done as often as necessary until the knife reaches its
end where releasing the trigger automatically returns the knife to home position.
Caution: If the instrument locks out, the motor will stop. Release the fi ring trigger and slide the knife reverse switch forward to return
the knife to the home position (Illustration 7). In this position, the instrument should be removed, opened, and reloaded in order to
continue. To open the jaws, squeeze the closing trigger, then simultaneously press the anvil release switch on either side of the instrument
(Illustration 8a). While pressure is still on the anvil release switch, slowly release the closing trigger (Illustration 8b). Follow the
instructions for Reloading the Instrument.
Note: At any time, if the knife reverse switch does not return the knife to home position and the jaws will not open:
a. First, ensure the battery pack is securely installed and the instrument has power (Illustration 9). Then, try the knife reverse
switch again (Illustration 7).
b. If the knife still does not return, use the manual override.
Caution: After the manual override system is used, the instrument is disabled and cannot be used for any subsequent fi rings.
To use the manual override, remove the access panel labeled "Manual Override" on the top of the instrument handle. The manual
override lever will be exposed. Move the lever forward and backward until it can no longer be moved. (Illustration 10) The knife
will now be in the home position. This can be verifi ed by viewing the position of the knife blade indicator on the underside of the
cartridge jaw (Illustration 11). Discard the instrument.
Caution: Incomplete fi ring may result in malformed staples, incomplete cut line, bleeding, and/or diffi culty removing the device.
Caution: The use of staple line reinforcement material with the instrument may reduce the number of times the device may be fi red. When
using staple line reinforcement material, the instructions of the manufacturer of the material should be followed.
Note: Crossing of staple lines may shorten the life of the instrument.
Caution: If the fi ring mechanism becomes inoperative, do not continue to use the instrument.
To open the jaws, squeeze the closing trigger, then simultaneously press the anvil release switch on either side of the instrument. While
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pressure is still on the anvil release switch, slowly release the closing trigger. (Illustration 8).
Caution: If the jaws do not automatically open after the anvil release switch is pressed, fi rst ensure that the knife is in the home position.
The position of the knife can be determined by observing the knife blade indicator under the cartridge jaw. (Illustration 11) If the knife
blade indicator is not in the home position or the position of the knife cannot be determined, slide the knife return switch to activate the
motor and return the knife to home position (Illustration 7). Try opening the jaws again using the anvil release switch. If the jaws do not
open at this point, then gently pull the closing trigger (1) upward (away from the handle) until both fi ring and closing triggers return to
their original positions.
Gently pull the instrument away from the transected tissue and ensure it is released from the jaws.
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Caution: Examine the staple lines for pneumostasis/hemostasis and proper staple closure. Minor bleeding can be controlled with manual
sutures or other appropriate techniques.
Before removing articulating instruments, move the jaws away from any obstruction inside the body cavity while keeping the jaws open
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and within the fi eld of view, and pull on the fi ns of the rotating knob. The jaws will return to the straight position automatically.
Caution: For insertion and removal of articulating instruments, the jaws of the instrument must be straight, parallel to the shaft of the
instrument. Failure to have the instrument jaws in the straight position will result in diffi cult insertion or withdrawal of the instrument and
may result in damage to the instrument.
To remove the instrument from the cavity, squeeze the closing trigger until it locks, closing the jaws (Illustration 5). Completely withdraw
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the instrument in the closed position.
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