Ethicon Enseal X1 Manual De Instrucciones página 6

Warning and Caution Statements
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 alerts the user of a potentially hazardous situation which, if not avoided, may
result in minor or moderate injury to the user or patient or damage to the equipment or other property. It
may also be used to alert against unsafe practices. This includes the special care necessary for the safe and
effective use of the device and the care necessary to avoid damage to a device that may occur as a result of
use or misuse.
Instructions for Use
Verify compatibility of all instruments and accessories prior to using the instrument (refer to Warnings
and Precautions).
Positioning the Instrument
Using sterile technique, remove the instrument from the package. To avoid damage, do not flip the
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instrument into the sterile field. Do not use a damaged product.
WARNING: 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 and turn the generator power on.
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WARNING: 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.
Close the jaws by squeezing the closing handle, and insert the shaft through a trocar or incision
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(Illustration 2).
WARNING: 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.
4 Once the instrument is inside the patient, squeeze the closing handle until it unlocks to open the jaws
(Illustration 3).
Turn the rotation knob to move the shaft around to the desired position. Position the vessel or tissue in
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the center of the jaws (Illustration 4).
Caution: 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.
Caution: 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.
Squeeze closing handle until it latches to clamp targeted tissue between the jaws (Illustration 5). Relax
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grip on closing handle once it is latched. Once the handle is latched, it will remain latched until it is
squeezed again.
WARNING: 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.
WARNING: If the closing handle is not fully latched, this may result in improper sealing and thermal
spread.
Caution: Do not turn the rotation knob when the closing handle is latched. This may damage the
device.
Sealing
WARNING: This instrument contains a surgically sharp knife. THIS DEVICE CUTS!
WARNING: 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).
Press the blue SEAL button or MIN foot pedal to energize the jaws and begin coagulation of the
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targeted tissue (Illustration 6).
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