Ethicon Enseal X1 Manual De Instrucciones página 4

Indications
The ENSEAL X1 Tissue Sealers are bipolar electrosurgical instruments for use with an electrosurgical
generator. They are intended for use during open or laparoscopic surgical procedures to cut and seal vessels,
and to cut, grasp and dissect tissue during surgery.
Indications for use include open and laparoscopic general, gynecological, urologic, thoracic, and ENT
surgical procedures or any procedure where vessel ligation (cutting and sealing), tissue grasping, dissection,
and division of vessels, lymphatics, and tissue bundles is performed (e.g. bowel resections, hysterectomies,
gall bladder procedures, Nissen Fundoplication, adhesiolysis, and oophorectomies). The devices can be used
on vessels up to and including 7 mm and bundles as large as will fit in the jaws of the instruments.
The ENSEAL X1 Tissue Sealers have not been shown to be effective for tubal sterilization or tubal
coagulation for sterilization procedures. Do not use this system for these procedures.
Contraindications
The efficacy of the ENSEAL X1 Tissue Sealers for the indication of contraceptive tubal coagulation
(permanent female sterilization) has not been evaluated and is unknown. The design of the
ENSEAL X1 Tissue Sealers is significantly different from bipolar designs that are marketed for the
indication of contraceptive tubal coagulation. The design differences may affect the efficacy of the
procedure and failure rates may not be comparable.
Undesirable Side Effects/Residual Risks
Undesirable side effects and risks associated with ENSEAL bipolar electrosurgical devices include the
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potential for bleeding, tissue injury via mechanical or thermal damage, introduction of non-sterile surfaces
or pathogen transfer, inflammatory or unintended tissue reaction, electrical shock, foreign body or magnetic
resonance incompatibility, and property or environmental damage. Also, unintended harm, extended surgery,
or altered surgical approach may result from issues related to device activation, damaged devices, or
electromagnetic interference.
Device Description
The ENSEAL X1 Tissue Sealer instrument is a sterile, single patient use surgical instrument to coagulate
and transect vessels up to and including 7 mm in diameter, tissue and/or vascular bundles. This device is for
soft tissue only. The instrument consists of a grip housing assembly, a rotating shaft, a moveable jaw, and a
knife. The instrument shaft can be rotated 360° to facilitate visualization and enable easy access to targeted
tissue. The jaws are in a normally-opened position and can be partially or fully closed by squeezing the
closing handle. The jaws are designed for grasping and holding targeted tissue when clamped. The
ENSEAL X1 Tissue Sealer has separate seal and cut capabilities. The lower jaw of the
ENSEAL X1 Tissue Sealer can be used in the open or closed position to deliver energy based on the
electrode configuration and jaw design. Bipolar energy is delivered when the SEAL button or the MIN foot
pedal is pressed. Pressing the CUT button advances the knife the length of the jaws to cut the targeted tissue.
The power cord is permanently attached to the device and connects the instrument to the generator. The
ENSEAL X1 Tissue Sealer instrument is designed for use exclusively with the Ethicon
Generator G11 (GEN11) software version 2016-1 or later, packaged separately.
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