Ethicon Echelon Flex PCEE45A Manual Del Usuario página 13

• 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 difficult to lock, reposition the instrument and take a smaller amount of tissue. Ensure that the proper reload
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selection has been made. (Refer to the Reload Product Codes Table.)
• 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.
• 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 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 Table).
• 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
reload jaw, has reached the end of the transection.
• 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. In this position, the instrument should be removed, opened, and reloaded in order to continue.
• 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 reload jaw (Illustration 11).
Discard the instrument.
• Selection of the appropriate staple reload 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 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.
• Incomplete firing may result in malformed staples, incomplete cut line, bleeding, and/or difficulty removing the device.
• Crossing of staple lines may shorten the life of the instrument.
If the firing mechanism becomes inoperative, do not continue to use the instrument.
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• If the jaws do not automatically open after the anvil release button 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 reload jaw. 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. Try opening the jaws again using the anvil release button. If the jaws do not open at this point, then gently pull the closing
trigger upward (away from the handle) until both firing and closing triggers return to their original positions.
• Examine the staple lines for pneumostasis/hemostasis and proper staple closure. Minor bleeding can be controlled with manual sutures or
other appropriate techniques.
• Prior to reloading the instrument, hold the instrument in a vertical position, with anvil and reload jaw completely submerged in sterile
solution. Swish vigorously and then wipe the inside and outside surfaces of the anvil and reload jaw to clean 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 reload jaw.
• Before removing the instrument, be sure tissue is cleared from the jaws and then close the jaws.
• When selecting the 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.
• When dividing major vascular structures, be sure to adhere to the basic surgical principle of proximal and distal control.
• Do not use an autoclave, ethylene oxide, or radiation to sterilize or disinfect the battery pack.
• The battery may present a fire hazard if mistreated. Do not disassemble, heat above 100 ºC, autoclave, crush, puncture, short external contacts or
recharge.
• Use of any other type of battery other than the battery supplied with the device may result in increased EMISSIONS or decreased
IMMUNITY of the ECHELON FLEX™ Powered Plus Articulating Endoscopic Linear Cutters.
• Portable radio and mobile RF communications equipment can affect medical devices. Follow the directions of the following tables when
using the ECHELON FLEX™ Powered Plus Articulating Endoscopic Linear Cutters.
• Avoid use of the ECHELON FLEX™ Powered Plus Articulating Endoscopic Linear Cutters adjacent to or stacked with other equipment.
If adjacent or stacked use is necessary, monitor the ECHELON FLEX™ Powered Plus Articulating Endoscopic Linear Cutters and the
other equipment to ensure normal operation.
• Do not modify this equipment without authorization from the manufacturer.
• Instruments or devices which come into contact with bodily fluids may require special disposal handling to prevent biological
contamination.
• Dispose of all opened devices whether used or unused. This device is packaged and sterilized for single use only.
• Reuse and improper reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure that
in turn may result in patient injury, illness, or death.
• Reuse and improper reprocessing or resterilization of single use devices may create a risk of contamination and/or cause infection or cross-
infection, including but not limited to, the transmission of infectious diseases. Contamination may lead to injury, illness, or death.
• Federal (USA) law restricts this device to sale by or on the order of a licensed healthcare practitioner.
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