Ethicon Enseal X1 Manual De Instrucciones página 8

Warnings and Precautions
• Federal (USA) law restricts this device to sale by or on the order of a physician.
• Examine the shipping carton and instrument for signs of shipping damage. Note any shortages,
breakage, or apparent damage, retain the evidence, notify Ethicon Endo-Surgery Customer Service
immediately and replace with a new instrument. Do not use a damaged product.
• 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.
• 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.
• If the instrument shaft is visibly bent, replace the instrument. A bent shaft may cause decreased device
performance.
• Connect the instrument power cord to the generator when the energy is off. Failure to do so may result
in an injury or electrical shock to the patient or operating room personnel.
• Prior to squeezing the closing handle, check for objects such as surgical drapes, gowns, and/or patient
tissue that could get caught between the closing handle and the grip housing of the device. Failure to do
so may result in patient injury, loss of sterility, and/or impaired device functionality.
• Do not grasp tissue beyond the electrode surface, in the hinge of the jaws. Do not overfill the jaws of
the instrument with tissue. This could result in difficulty opening the jaws, partially cutting tissue, and
unintended injury.
• To reduce the possibility of an inadvertent activation of the sealing mechanism, do not place your
finger on the blue SEAL button until the jaws are in the desired position and activation is intended.
• If the closing handle is not fully latched, this may result in improper sealing and thermal spread.
• Do not turn the rotation knob when the closing handle is latched. This may damage the device.
• This instrument contains a surgically sharp knife. THIS DEVICE CUTS!
• Do not press the CUT button unless transection is desired. There may be situations where cutting tissue
prior to energy activation is desired (i.e. avascular tissue).
• Avoid placing tension on the tissue when sealing or cutting to ensure adequate hemostasis.
• If transection of tissue is desired after sealing, wait for the end tone before pressing the CUT button
and transecting the tissue. If the knife is advanced prior to hearing the end tone, this may result in an
incomplete sealing and lack of hemostasis.
• The knife is sharp. Take care to avoid injury from the knife.
• Prior to cutting, inspect the vessel or tissue to ensure proper sealing. If the instrument is removed from
the tissue for inspection, create a second seal adjacent and distal to the first seal, then cut tissue.
• If the CUT button does not automatically return, open the closing handle to manually return the CUT
button, retract the knife, and open the jaws.
• Do not immerse distal tip in liquid, including saline solution, to clean. This may result in damage to the
instrument.
• Do not clean the instrument with abrasives. It can be wiped with a sterile, moist gauze sponge to
remove tissue, if necessary. If tissue is still visible in the jaws, use forceps to remove residue, taking
care not to actuate the instrument.
• Do not activate the instrument while cleaning to avoid inadvertent user injury.
• Pools of conductive fluids (e.g. blood, saline) in direct contact with the instrument jaws may affect
device performance. Remove pooled fluid from around the instrument jaws before activating the
instrument.
• Verify compatibility with generators. Use device only with the Ethicon Generator G11 (GEN11)
software version 2016-1 or later.
• The device is at high voltage whenever the generator is active. Activate this device only when the jaws
are under direct visual observation to avoid unintended tissue coagulation or necrosis.
• Check if patient has a pacemaker or implanted cardioverter/defibrillator. Consult pacemaker
manufacturer for information about the effects of RF energy on these devices.
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