Ethicon Enseal X1 Manual De Instrucciones página 7

The generator gives audible feedback (Activation Tone) as energy is delivered to the clamped tissue.
Continue to depress the blue SEAL button or MIN foot pedal until the activation cycle is complete, and
a second tone (End Tone) is heard, indicating energy has been stopped.
WARNING: Avoid placing tension on the tissue when sealing or cutting to ensure adequate
hemostasis.
Release the SEAL button.
8
WARNING: 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.
Cutting
Fully press the CUT button against the grip housing (Illustration 7). The knife will advance to the end
9
of the knife slot.
WARNING: The knife is sharp. Take care to avoid injury from the knife.
WARNING: 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.
After the transection cycle is complete, squeeze the closing handle until it unlocks (Illustration 8). If
10
the desired cut is longer than the stroke of the blade, transection can be accomplished by repeating
Steps 5- 10.
Caution: 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.
Close the jaws by squeezing the closing handle, then remove the device from the trocar or incision.
11
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.
Cleaning the Device
For optimal performance and to avoid tissue sticking, clean the instrument jaws and distal end of the shaft
with a sterile, moist gauze sponge throughout the procedure.
Caution: Do not immerse distal tip in liquid, including saline solution, to clean (Illustration 9). This may
result in damage to the instrument.
WARNING: 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 (Illustration 10).
Caution: Do not activate the instrument while cleaning to avoid inadvertent user injury.
Post Procedure
Disconnect the instrument from the generator.
1
2 Dispose of the instrument and its integrated power cord in an appropriate "Sharps" container. Do not
reuse instrument.
Pre-Clinical Study
Product performance of the device was established in acute and chronic in-vivo porcine models. The results
showed that no animals studied experienced any hemostatic complications related to the device during
the acute and 30-day survival period. A variety of tissue types and vessels were evaluated to demonstrate
effective sealing in arteries and veins up to and including 7 mm.
This device has been tested and evaluated in preclinical animal studies only and has not been evaluated
in humans. There is no animal model predictive of how the device functions when used to seal vessels
containing atherosclerotic plaque.
Serious Incident Reporting
For a patient/user/third party in the European Union and in countries with identical regulatory regime
(Regulation EU 2017/745), if, during the use of this device or as a result of its use, a serious incident has
occurred, please report it to the manufacturer and/or its authorized representative and to your national
authority.
4