•The generator emits one of the audible tones listed in the table below to indicate when the instrument
blade is first activated.
Tone
Button
Repeating
Energy Button
single tone
3 repeating,
Energy Button with Advanced
ascending
Hemostasis
tones
•
The generator changes to a second audible tone as Adaptive Tissue Technology regulates the delivery
of energy. Thermal influences such as fluids or minimal to no tissue in the jaws may affect the presence
or timing of the tone change. The tone change does not provide confirmation of tissue effect. When the
second tone is heard, the situation should be assessed and the intended surgical action completed, such
as gradual application of tension to facilitate transection. The secondary audible tone change is not a
substitute for surgical experience.
Tone
Button
High pitched,
Applies to both buttons
repeating
single tone
WARNING: Avoid contact with any and all metal or plastic instruments or objects when the instrument
is activated (Illustration 4). Contact with staples, clips or other instruments while the instrument is
activated may result in scratches on the blade, cracked or broken blades and premature blade failure.
WARNING: Do not use the Energy button with Advanced Hemostasis when energy application is
desired prior to full closure of the jaws. Energy is not delivered using the Energy button with Advanced
Hemostasis until the jaws are completely closed. Using the Energy button with Advanced Hemostasis
without full trigger closure may result in lack of hemostasis.
WARNING: If activation is unintentionally stopped while sealing, maintain jaw closure and reactivate.
Releasing the trigger while sealing may result in lack of hemostasis.
Caution: Keep the clamp arm open when backcutting or while the blade is active without tissue
between the blade and tissue pad to avoid damage to the tissue pad and increased blade, clamp arm and
distal shaft temperatures (Illustration 5).
WARNING: During benchtop testing of vessels >5 mm, the strongest vessel seals were achieved by
allowing the Advanced Hemostasis mode to completely transect the targeted vessel.
For optimal performance and to avoid tissue sticking, clean the instrument blade, clamp arm, and distal
end of the shaft throughout the procedure by activating the instrument tip in saline. (Illustration 6)
WARNING: Do not clean the blade tip with abrasives. It can be wiped with a moist gauze sponge to
remove tissue, if necessary. If tissue is still visible in the clamp arm, use hemostats to remove residue,
taking care not to actuate the instrument (Illustration 7). Do not touch the instrument to the hemostats
while activated. Scratches on the blade may lead to cracked or broken blades and premature blade
failure.
Close the clamp arm by closing the trigger and remove the shaft from the trocar or incision.
8
Unplug the instrument from the generator.
9
10 Turn the generator OFF at the power switch.
11 Dispose of the instrument and cable in an appropriate container. No disassembly is required.
Warnings and Precautions
•
Federal (USA) law restricts this device to sale by or on the order of a physician.
•
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.
Action
Generator On: Device is active
Generator On: Device is active and in Advanced Hemostasis
mode
Action
Adaptive Tissue Technology is active
3
•
A thorough understanding of the principles and techniques involved in laser, electrosurgical, and
ultrasonic procedures is essential to avoid shock and burn hazards to both patient and medical
personnel and damage to the device or other medical instruments. Ensure that electrical insulation
or grounding is not compromised. Do not immerse instruments in liquid unless the instruments are
designed and labeled to be immersed.
•
Verify compatibility with generators. Use device only with Ethicon Endo-Surgery Generator G11
(GEN11) software version 2016-1 or later. Software revision can be found under "System Information"
in the Generator G11 (GEN11) "Settings" menu. Refer to the Generator G11 (GEN11) Operator's
Manual for more information.
•
Avoid contact with any and all metal or plastic instruments or objects when the instrument is activated.
Contact with staples, clips or other instruments while the instrument is activated may result in scratches
on the blade, cracked or broken blades and premature blade failure.
•
Do not use the Energy button with Advanced Hemostasis when energy application is desired prior to
full closure of the jaws. Energy is not delivered using the Energy button with Advanced Hemostasis
until the jaws are completely closed. Using the Energy button with Advanced Hemostasis without full
trigger closure may result in lack of hemostasis.
•
If activation is unintentionally stopped while sealing, maintain jaw closure and reactivate. Releasing
the trigger while sealing may result in lack of hemostasis.
•
Keep the clamp arm open when backcutting or while the blade is active without tissue between the
blade and tissue pad to avoid damage to the tissue pad and increased blade, clamp arm and distal shaft
temperatures.
•
During benchtop testing of vessels >5 mm, the strongest vessel seals were achieved by allowing the
Advanced Hemostasis mode to completely transect the targeted vessel.
•
Do not clean the blade tip with abrasives. It can be wiped with a moist gauze sponge to remove tissue,
if necessary. If tissue is still visible in the clamp arm, use hemostats to remove residue, taking care not
to actuate the instrument. Do not touch the instrument to the hemostats while activated. Scratches on
the blade may lead to cracked or broken blades and premature blade failure.
•
In case of system failure, ensure the availability of the appropriate back up equipment relevant to the
specific procedure.
•
Audible high-pitched ringing, resonating from the blade, is an abnormal condition and an indicator that
the blade is not operating properly. This may result in abnormally high shaft temperatures and user or
patient injury.
•
The instruments allow for the coagulation of vessels up to and including 7 mm in diameter, using
the Energy button with Advanced Hemostasis. Do not attempt to seal vessels in excess of 7 mm in
diameter.
•
Blood and tissue buildup between the blade and shaft may result in abnormally high temperatures at
the distal end of the shaft. To prevent burn injury, remove any visible tissue buildup at the distal end
of the shaft.
•
As with all energy sources (Electrosurgery, Laser, or Ultrasound), there are concerns about the
carcinogenic and infectious potential of the by-products, such as tissue smoke plume and aerosols.
Appropriate measures such as protective eye wear, filtration masks, and effective smoke evacuation
equipment should be used in both open and laparoscopic procedures.
•
Do not attempt to bend, sharpen, or otherwise alter the shape of the blade. Doing so may cause
blade failure and user or patient injury.
•
To avoid user or patient injury in the event that accidental activation occurs, the instrument blade,
clamp arm, and distal end of the shaft should not be in contact with the patient, drapes, or flammable
materials while not in use.
•
During and following activation in tissue, the instrument blade, clamp arm, and distal 7 cm of the shaft
may be hot. Avoid unintended contact with tissue, drapes, surgical gowns, at all times.
•
Do not introduce or withdraw the instrument with the jaws open through a trocar sleeve as this may
damage the instrument.
•
Care should be taken not to apply pressure between the instrument blade and tissue pad without having
tissue between them. Clamping the tissue pad against the active blade without tissue on the full length
of the blade will result in higher blade, clamp arm and distal shaft temperatures and can result in
possible damage to the instrument. If this occurs, there may be an instrument failure, and the generator
touchscreen displays a troubleshooting message.
4
