Johnson & Johnson ECHELON FLEX + Manual De Instrucciones página 6

11 Once in the cavity, 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 to reopen the jaws and return the
closing trigger to its original position (Illustration 8b).
12 If needed, rotate the jaws by pushing on the fins of the rotating knob with the index finger using a downward or upward pressure
(Illustration 12). The instrument shaft will rotate freely in either direction.
13 To articulate the jaws inside the body cavity, select an appropriate surface (a body structure, organ, or another instrument) to use as
a grounding surface to bend the jaws, ensuring that it stays within the field 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 fins of the rotating knob back with the index finger 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).
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.
15 After positioning the instrument jaws, close the jaws by squeezing the closing trigger until it locks (Illustration 5). An audible click
indicates that the closing trigger and the jaws are locked. When the jaws of the instrument are closed, the red firing trigger lock and
firing trigger are exposed. Holding the jaws in place for 15 seconds after closing and prior to firing may result in better compression
and staple formation.
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 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 Reload Product Codes Chart.)
Caution: 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 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.
Pull back the red firing-trigger lock to enable the firing trigger to be pulled (Illustration 15).
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17 Fire the instrument by pulling the firing trigger; the motor will activate audibly (Illustration 16). Continue to depress the trigger until
the motor stops (audible feedback). Alternatively, for enhanced tissue compression, the user may pulse the firing trigger throughout
the firing cycle until the transection is completed.
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 firing 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 firing 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.
18 To complete the firing sequence, release the firing trigger to activate the motor and automatically return the knife to home position
where 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 firing sequence or it is interrupted inadvertently by releasing the trigger during the firing
sequence, pull the firing 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 at the beginning and end of the firing (Illustration 1). Once the knife reaches the end
of the firing, releasing the trigger automatically returns the knife to home position.
Caution: If the instrument locks out, the motor will stop. Release the firing 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 firings.
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 verified by viewing the position of the knife blade
indicator on the underside of the cartridge jaw (Illustration 11). Discard the instrument.
Caution: Incomplete firing may result in malformed staples, incomplete cut line, bleeding, and/or difficulty removing the device.
Caution: The use of staple line reinforcement material with the instrument 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.
Note: Crossing of staple lines may shorten the life of the instrument.
Caution: If the firing mechanism becomes inoperative, do not continue to use the instrument.
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19 To open the jaws, squeeze the closing trigger, then simultaneously press the anvil release switch on either side of the instrument. While
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, first 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 firing and closing triggers return to
their original positions.
20 Gently pull the instrument away from the transected tissue and ensure it is released from the jaws.
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 field of view, and pull on the fins 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 difficult 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.
Reloading the Instrument
23 Using sterile technique, remove the reload from the package. To avoid damage, do not flip the reload into the sterile field.
Prior to reloading, ensure the instrument is in the open position (Illustration 1).
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25 Push upward (toward the anvil) to unsnap the reload from the cartridge jaw. Discard the used reload (Illustration 17).
WARNING: 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 surfaces of the anvil and cartridge jaw to clear any
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.
26 Examine the new reload for the presence of a staple retaining cap. If the retaining cap is not in place, discard the reload.
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 fired. When using staple line reinforcement material, the instructions of the manufacturer of
the material should be followed.
Insert the new reload by sliding it against the bottom of the cartridge jaw until the cartridge alignment tab stops in the reload alignment
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slot. Snap the reload securely in place. Remove the staple retaining cap and discard. The instrument is now reloaded and ready for use
(Illustration 4).
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.)
Battery Pack Disposal
The battery pack contains a built-in battery drain and must be installed into the instrument to trigger the automatic battery drain feature. The
battery pack does not need to remain in the instrument—the battery pack will continue to drain after it has been removed from the instrument.
Once removed, depending on your local regulations, it can be put directly into the battery recycling bin or normal waste stream.
Note: Batteries used in this device contain 1,2-dimethoxyethane.
Prior to Installation into the Instrument
If battery pack needs to be disposed of prior to installation into instrument (e.g. product is beyond expiration date indicated on the
package, battery pack is dropped), first install the battery pack into the instrument, then remove, to trigger built-in battery drain.
After Instrument Use
The battery pack must be removed from the instrument prior to disposal.
If battery pack requires decontamination prior to disposal, follow hospital protocol or the Battery Pack Cleaning and Disinfection instructions
below.
To remove the battery pack, squeeze the release tabs and pull the battery pack straight back (Illustration 18).
Note: It is not necessary to disassemble the battery pack.
Battery Pack Cleaning and Disinfection
WARNING: Do not use an autoclave, ethylene oxide, or radiation to sterilize or disinfect the battery pack.
Manual Cleaning
1 Remove the battery pack from the instrument before cleaning.
Note: Battery pack should not be submerged in water or cleaning solutions.
Clean the battery pack surfaces with a neutral pH detergent or neutral pH enzymatic detergent, prepared according to the manufacturer's
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instructions.
Use soft bristle brush to manually clean the battery pack with the cleaning solution.
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4 Ensure areas containing crevices are scrubbed thoroughly.
5 Wipe off detergent thoroughly with lukewarm tap water.
Perform visual inspection to determine if debris is removed.
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7 Repeat cleaning as necessary to obtain a visually clean battery pack.
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