Johnson & Johnson ECHELON FLEX + Manual De Instrucciones página 7

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.
• Inspect the package for shipping damage. Do not use an instrument, battery pack, or reload that has shipping damage.
• Do not load the instrument more than 12 times for a maximum of 12 firings per instrument. The use of the instrument with staple line
reinforcement material may reduce the number of firings.
• The ECHELON FLEX 60 mm Powered Plus instruments may only be used with ECHELON 60 mm 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 fired. 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 difficult 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 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.
• 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 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 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 Chart).
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• 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.
• 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 cartridge jaw (Illustration 11).
Discard the instrument.
• 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 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.
If the firing mechanism becomes inoperative, do not continue to use the instrument.
•
• 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. 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 switch. 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 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.
• Before removing the instrument, be sure tissue is cleared from the jaws and then close the jaws.
• When selecting the cartridge, 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 cartridge.
• 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 60 mm Powered Plus Articulating Endoscopic Linear Cutter.
• Portable radio and mobile RF communications equipment can affect medical devices. Follow the directions of the following tables when
using the ECHELON FLEX 60 mm Powered Plus Articulating Endoscopic Linear Cutter.
• Avoid use of the ECHELON FLEX 60 mm Powered Plus Articulating Endoscopic Linear Cutter adjacent to or stacked with other
equipment. If adjacent or stacked use is necessary, monitor the ECHELON FLEX 60 mm Powered Plus Articulating Endoscopic Linear
Cutter 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 instruments whether used or unused. This device is packaged and sterilized for single use only. Multiple patient use
may compromise the device integrity or create a risk of contamination that, in turn, may result in patient injury or illness.
Specifications
The ECHELON FLEX 60 mm Powered Plus Articulating Endoscopic Linear Cutter has a power rating of 40 W.
The ECHELON FLEX 60 mm Powered Plus Articulating Endoscopic Linear Cutter is resistant to water ingress and is classified per IEC 60601-1
as IPX0.
The ECHELON FLEX 60 mm Powered Plus Articulating Endoscopic Linear Cutter needs special precautions regarding EMC and needs to be
installed and put into service according to the EMC information provided in this document. Portable and mobile RF communications equipment
can affect Medical Electrical Equipment.
WARNING: 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 60 mm Powered Plus Articulating Endoscopic Linear Cutter.
WARNING: Portable radio and mobile RF communications equipment can affect Medical Electrical Equipment. Follow the directions of the
following tables when using the ECHELON FLEX 60 mm Powered Plus Articulating Endoscopic Linear Cutter.
WARNING: Avoid use of the ECHELON FLEX 60 mm Powered Plus Articulating Endoscopic Linear Cutter adjacent to or stacked with other
equipment. If adjacent or stacked use is necessary, monitor the ECHELON FLEX 60 mm Powered Plus Articulating Endoscopic Linear Cutter
and the other equipment to ensure normal operation.
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