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For patients with cardiac pacemakers or other active implants, a possible hazard exists because
interference with the action of the pacemaker may occur, or the pacemaker may be damaged. In case of
doubt, approved qualified advice should be obtained.
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This instrument contains a surgically sharp edge. THIS DEVICE CUTS!
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The ENSEAL
®
G2 Articulating Tissue Sealer has not been shown to be effective for sealing large
vessels without fully advancing the I-BLADE
®
. Do not attempt to seal large vessels by only clamping
the tissue and applying energy.
•
Do not use this device on vessels in excess of 7mm in diameter.
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Do not use excessive force on the closing handle to close the jaws; grasp only as much tissue as will fit
between the jaws where the current will pass. Greater amounts of tissue require more closing handle
force. Excessive force could damage the device.
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Avoid contact with metal and plastic when instrument is active.
•
Use surgical gloves specifically designed by their manufacturer for electrosurgical procedures. The use
of other gloves can result in burns or shocks.
•
In case of system failure, ensure the availability of the appropriate back-up equipment relevant to the
specific procedure.
•
During and following activation in tissue, the jaws and shaft may be hot. Avoid unintended contact with
tissue, drapes, surgical gowns, or other unintended sites at all times.
•
After using the instrument to seal and/or transect, always examine the tissue for hemostasis.
If hemostasis is not present, appropriate techniques should be used to achieve hemostasis.
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Due to the difficulty of visualizing obscured structures, proceed slowly and do not attempt to transect
large masses of tissue in one activation. Avoid the division of large tissue and/or vascular bundles when
using the instrument under these conditions.
•
Products manufactured or distributed by companies not authorized by Ethicon Endo-Surgery may not
be compatible with the ENSEAL
G2 Articulating Tissue Sealer instrument. Use of such products may
®
lead to unanticipated results and possible injury to the user or patient.
•
Discontinue use and replace device if excessive smoke or sparking is observed.
•
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 eyewear, filtration masks, and effective smoke evacuation
equipment should be used in laparoscopic or open procedures.
•
Instruments or devices which come into contact with bodily fluids may require special disposal
handling to prevent biological contamination.
•
To ensure effective sealing and transection of large vessels, always completely advance the I-BLADE
and wait for Tone 3.
•
Do not stop squeezing the closing handle with the I-BLADE
•
Transection without power application can lead to bleeding in vascular tissue.
•
Do NOT immerse distal tip in liquid, including saline solution, to clean.
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Do not clean the instrument with abrasives.
•
To avoid inadvertent user injury, do not activate the instrument while cleaning.
Prior to inserting or removing the device from the trocar, ensure that the device is in the straight, non-
articulated position by confirming that the indicator arrow on the articulation wheel is aligned with the
top of the instrument.
•
Removing the device from a trocar while the device is articulated could result in unintentionally
removing the trocar from the incision site, a loss of insufflation, or damage to the black shaft covering.
•
If the black shaft covering is damaged, discontinue use.
•
Prior to articulating the shaft, ensure that the jaw and the articulation joint are fully inserted through the
trocar.
•
The ENSEAL
G2 Articulating Tissue Sealer is not a passive articulation device. Do not force the
®
articulation angle by pressing the shaft against a solid body. Use the articulation wheel to achieve the
desired articulation angle.
•
If the rotation force of the articulation wheel seems excessive, discontinue rotation of the wheel. Using
excessive force could damage the device.
•
Do not use the top jaw alone to perform tissue dissection.
•
To reduce the possibility of an accidental activation, do not place your finger on the activation button
until the jaws are in the desired position and activation is intended.
•
Dispose of all opened instruments whether used or unused. This device is packaged and sterilized for
single use only.
only partially advanced.
®
3
•
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.
Instructions for Use
1
Using sterile technique, remove the
instrument from the package. To avoid
damage, do not flip the instrument into the
sterile field. Do not use a damaged product.
2
Connect the instrument power cord to the
generator.
3
Before inserting the instrument through the
trocar, make certain that the instrument is in
the straight (non-articulated) position and the
jaws are closed. (Illustration 2) Insert the
instrument into the trocar before articulating
the device.
To rotate the device, turn the rotation knob in
the desired direction. (Illustration 2a)
To articulate the device, turn the articulation
wheel. (Illustration 2b) The illustration
provided shows the direction the shaft
®
articulates when the rotation knob arrow is
aligned on top.
The articulation wheel may be turned even
if the rotation knob indicator arrow is NOT
aligned on top. The articulation wheel and
rotation knob may be used independently.
4
Position targeted tissue within open jaws.
(Illustration 3).
5
Squeeze the closing handle to grasp targeted
tissue between the jaws (Illustration 4).
6
Press the energy activation button to energize
the jaws and begin coagulation of the
targeted tissue. The generator gives audible
feedback (Tone 1) as energy is delivered to
the grasped tissue. Affirm tissue effects prior
to advancing the I-BLADE
Illustrations & Notes
•
NOTE: The instrument is straight when the
indicator arrow on the articulation wheel is
aligned with the top of the instrument.
2
2a
2b
2
3
4
3
•
NOTE: Tissue between the jaws may be
further compressed by squeezing the closing
through tissue.
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handle to the first stop. Applying additional
pressure at the first stop does not increase
tissue compression.
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