Ethicon Endo-Surgery ECHELON FLEX 45 Mode D'emploi page 7

Reloading the Instrument
Using sterile technique, remove the reload from the package. To avoid damage, do not fl ip the reload into the sterile fi eld.
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Prior to reloading, ensure the instrument is in the open position (Illustration 1).
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Push upward (toward the anvil) to unsnap the reload from the cartridge jaw. Discard the used reload. (Illustration 17)
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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 clean any
unused staples from the instrument. Do not use the instrument until it has been visually inspected to confi rm there are no staples on the
anvil and cartridge jaw.
Examine the new 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 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. It does
not need to remain in the instrument – it 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.
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), fi rst 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 hospital autoclaves to sterilize or disinfect battery pack.
Manual Cleaning
Remove the battery pack from the instrument before cleaning.
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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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Ensure areas containing crevices are scrubbed thoroughly.
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Wipe off detergent thoroughly with lukewarm tap water.
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Perform visual inspection to determine if debris is removed.
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Repeat cleaning as necessary to obtain a visually clean battery pack.
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A88091P00 AMP IFU_1_18_12.indd 12-13 A88091P00 AMP IFU_1_18_12.indd 12-13
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Chemical Disinfection
Disinfectants should be prepared and used according to the manufacturer's recommendations. It is recommended that the chemical disinfectant
be wiped off with tap water.
®
• Simple Green D Pro 3
• 10% Bleach (sodium hypochlorite solution)
• 70% Isopropyl alcohol
Standard Conventions Used
The Use of Caution, Warning, and Note Statements
Information relative to the completion of a task in a safe and thorough manner will be supplied in the form of a Caution, a Warning, or a Note
statement. These statements are found throughout the documentation.
These statements should be read before continuing to the next step in a procedure.
WARNING: A Warning statement indicates an operating or maintenance procedure, practice, or condition that, if not strictly observed, could
result in personal injury or loss of life.
Caution: A Caution statement indicates an operating or maintenance procedure, practice, or condition that, if not strictly observed, could result in
damage to or destruction of the equipment.
Note: A Note statement indicates an operating or maintenance problem, practice, or condition that is necessary to accomplish a task efficiently.
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.
• Failure to properly follow the instructions may lead to serious surgical consequences, such as leakage or disruption.
• Do not load the instrument more than 12 times for a maximum of 12 fi rings per instrument. The use of the instrument with staple line
reinforcement material may reduce the number of fi rings.
• The ECHELON FLEX instruments may only be used with the ECHELON reloads.
• Tissue thickness should be carefully evaluated prior to using the instrument. Refer to the Reload Product Codes Chart for proper reload
selection.
• 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.
• 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.)
• 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.
• 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.
• Do not attempt to articulate by pressing the front of the jaws against the grounding surface as tissue damage or tissue trauma may occur.
• 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.
• 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 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.)
• 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.
• 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.
• Attempting to force the trigger 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.
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