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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.
®
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Simple Green D Pro 3
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10% Bleach (sodium hypochlorite solution)
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70% Isopropyl alcohol
Standard Conventions Used
Information relative to the completion of a task in a safe and thorough manner will be supplied in the form of a WARNING, a Caution, 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
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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.
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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.
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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.
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Failure to properly follow the instructions may lead to serious surgical consequences, such as leakage or disruption.
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Inspect the package for shipping damage. Do not use an instrument, battery pack, or reload that has shipping damage.
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When selecting an instrument and reload, careful consideration should be given to existing pathologic conditions as well as any
pre-surgical treatment, such as radiotherapy, that the patient may have undergone. Certain conditions or preoperative treatments may
cause change in tissue thickness that would exceed the indicated range of tissue thickness for the standard choice of reload.
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Do not modify this equipment without authorization from the manufacturer.
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Instruments or devices which come into contact with bodily fluids may require special disposal handling to prevent biological
contamination.
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Federal (USA) law restricts this device to sale by or on the order of a physician.
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Do not load the instrument more than 12 times for a maximum of 12 firings per instrument.
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The ECHELON FLEX Powered Vascular Stapler instrument may only be used with ENDOPATH ECHELON Vascular White Reload
for Advanced Placement Tip, (35mm, 4 Row).
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Tissue thickness should be carefully evaluated prior to using the instrument. Refer to the Reload Product Code Chart for proper
reload selection.
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After removing the staple retaining cap, observe the surface of the new reload. The reload must be replaced with another reload if
any blue-colored drivers are visible. (If blue-colored drivers are visible, the reload may not contain staples.)
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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.
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When placing the instrument through the trocar or incision, avoid inadvertently pulling the red firing trigger lock and the firing
trigger. The instrument may be partially or completely fired and will need to be reloaded before using on tissue. If the instrument is
partially fired, 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 button on either side of the instrument
(Illustration 8a). While pressure is still on the anvil release button, slowly release the closing trigger (Illustration 8b). Remove the
reload and insert a new one (see Reloading the Instrument). If the instrument is fired completely, the knife will return to home
position automatically. Remove the instrument and insert a new reload (see Reloading the Instrument).
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Do not attempt to articulate by pressing the front of the jaws against the grounding surfaces as device damage or tissue trauma may
occur.
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The instrument can only achieve a maximum articulation of angle of 50º. When the maximum angle is reached, the articulation lever
force will increase, indicating the maximum angle has been reached.
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Attempting to articulate beyond the stop in either direction, or while the instrument jaws are within the trocar, may result in
instrument damage.
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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.
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Do not use the instrument on the parenchyma of the liver, pancreas, kidney, or spleen, or other tissues which cannot comfortably
compress to the closed staple height.
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Do not use the instrument if upon closing, the tissue extends beyond the cut line marking, which represents the minimum cut
distance, such as in creating an anastomosis (Illustration 13). If this occurs, open and reposition the instrument. Firing with tissue
in the tip of the jaws may result in incomplete cutting action, and/or improperly formed staples.
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