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Use caution during surgical cases in which patients have connective tissue disorder or exhibit certain
types of pathology (e.g., Atherosclerosis, Crohn's, etc.). For best results, apply the seal to unaffected
vasculature.
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Avoid contact with metal and plastic when instrument is active. Avoid cutting over metal or plastic as
damage to the knife may occur.
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Use surgical gloves specifically designed by their manufacturer for electrosurgical procedures. The use
of other gloves can result in burns or shocks.
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In case of system failure, ensure the availability of the appropriate back-up equipment relevant to the
specific procedure.
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During and following activation in tissue, the jaws and shaft may be hot. Avoid unintended contact with
patient, tissue, drapes, surgical gowns, or other unintended sites at all times. The surface of the active
electrode may remain hot enough to cause burns after the RF current is deactivated.
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To avoid user or patient injury in the event that inadvertent activation occurs while not in use, the
device jaws and shaft should not be in contact with the patient, drapes, or flammable materials.
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During energy activation in tissue, heat will be produced which may lead to the conversion of
water into steam. This may lead to unintended tissue effects in close proximity to the jaws, and it is
recommended that precautions be taken to protect surrounding tissue. This effect is more likely to
occur when operating in confined spaces.
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After utilizing the instrument to seal and 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 internal structures, proceed slowly and do not attempt to clamp/
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.
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Products manufactured or distributed by companies not authorized by Ethicon Endo-Surgery may not
be compatible with the ENSEAL instrument. Use of such products may lead to unanticipated results
and possible injury to the user or patient.
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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 open procedures.
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Do not connect wet accessories to the generator, due to the risk of electric shock.
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Do not use in the presence of flammable anesthetics or oxidizing gases (such as nitrous oxide (N2O)
and oxygen) or in close proximity to volatile solvents (such as methanol or alcohol), as an explosion
may occur.
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Do not use this device on vessels in excess of 7 mm in diameter. This may lead to improper sealing and
hemostasis.
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Do not use energy-based devices to transect seals, such as electrosurgical pencils or ultrasonic scalpels.
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Do not use the device beyond the labeled shelf life. This may lead to improper sealing and hemostasis.
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Device has not been evaluated in main vessels of the central circulatory system and is not intended
for use in the following named vessels: arteriae pulmonales, aorta ascendens, arcus aortae, aorta
descendens to the bifurcatio aortae, arteriae coronariae, arteria carotis communis, arteria carotis
externa, arteria carotis interna, arteriae cerebrales, truncus brachiocephalicus, venae cordis, venae
pulmonales, vena cava superior and vena cava inferior.
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Instruments or devices that come into contact with bodily fluids may require special disposal handling
to prevent biological contamination.
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Dispose of the instrument and its integrated power cord in an appropriate "Sharps" container.
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Dispose of all opened instruments whether used or unused. This device is packaged and sterilized for
single use only.
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Reuse and improper reprocessing or resterilization of single-use devices 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.
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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.
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