Ethicon Endo-Surgery Endopath XCEL Manual De Instrucciones página 3

Indications
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The ENDOPATH XCEL™ Dilating Tip Trocar has applications in thoracic, gynecologic laparoscopy and
other abdominal procedures to establish a path of entry for endoscopic instruments.
Contraindications
This instrument is not intended for use when minimally invasive techniques are contraindicated.
Device Description
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The ENDOPATH XCEL Dilating Tip Trocar with OPTIVIEW™ Technology is a sterile, single patient
use instrument consisting of a radiolucent sleeve and obturator available in sizes 5 and 12 mm diameter.
The obturator has a sharp flat-bladed tip and a spring-loaded shield. The shield is designed to cover the flat-
bladed tip to protect internal structures from puncture or laceration once the abdominal or thoracic cavity
has been entered. OPTIVIEW™ Technology reduces the incidence of trocar-induced smudging during
camera reinsertion. The trocar sleeve contains two seals, an outer integrated removable self-adjusting seal
to accommodate instruments ranging from 5 mm to 12 mm in diameter where indicated and an internal
seal. Together, these seals minimize gas leakage when instruments are inserted or withdrawn through the
trocar. The 5 mm trocar sleeve does not contain an integrated removable seal and accommodates only 5 mm
instruments. A stopcock valve is compatible with standard luer lock fittings and provides attachment for gas
insufflation and desufflation. The stopcock is in the closed position when it is parallel to the sleeve.
Illustration and Nomenclature (Illustration 1)
1. Flat Bladed Tip
2. Retracted Shield
3. Obturator
4. Shield
5. Obturator Handle
6. Shield Reset Button
7. Obturator Locking Button (housed in obturator handle)
Instructions for Use
Verify compatibility of all minimally invasive instruments and accessories prior to using the instrument (refer
to Warnings and Precautions).
Prepare the patient in accordance with standard surgical techniques prior to insertion of the trocar.
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.
The trocar obturator and sleeve are packaged unassembled. To assemble, remove the protective
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tip covering from the obturator and trocar sleeve and discard. Assemble the trocar by inserting the
obturator into the trocar sleeve until they lock securely together.
NOTE: The trocar is packaged with the stopcock in the open position. Close the stopcock before use.
The stopcock is in the closed position when the stopcock lever is parallel to the sleeve.
Important: To allow retraction of the shield, push the reset button forward to the activated position
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until an audible click is heard. The trocar cannot be deactivated by forcing the reset button to the
original position (Illustration 2).
Create an incision using standard surgical procedure which allows the trocar to be introduced.
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NOTE: An inadequate incision may cause increased resistance to insertion, increasing the required
penetration force, and possibly resulting in a loss of control during entry.
Introduce the trocar through the skin incision, applying continuous but controlled downward pressure
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on the trocar. When this pressure is applied, the shield will begin to retract. As the shield retracts,
the sharp flat-bladed tip is exposed to create the passage through the abdominal or thoracic wall
(Illustration 3). Once the retracted shield has passed through the abdominal or thoracic wall, it will
advance forward and cover the exposed flat-bladed tip. As the shield retracts, the red shield reset
button will return to the original position (Illustration 4).
NOTE: Shield retraction is activated by tissue resistance. When there is insufficient tissue resistance,
the shield reset button will remain in the activated position and the shield will be free to retract when
pressure is applied.
When the trocar is in the abdominal or thoracic cavity, press the locking buttons to remove the
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obturator handle assembly, leaving the sleeve in place (Illustration 5). The internal seal in the sleeve
8. Trocar Stability Sleeve
9. Outer Seal
10. Outer Seal Release Lever
11. Stopcock
12. Dilating Tip Symbol
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automatically closes as the obturator is withdrawn. The seal system maintains insufflation in the
absence of an instrument in the sleeve. Instruments of appropriate size can be easily introduced
through the sleeve of the trocar.
Important: If entry into the abdominal or thoracic cavity is incomplete or the surgeon is uncertain
whether entry is complete, the instrument must be reactivated. In order to reactivate the instrument,
it should first be removed. After removing the instrument, push the red shield reset button forward
to the activated position (Illustration 6). The shield will again be free to retract when pressure is
applied. Reinsert the instrument to complete the entry.
WARNING: Since partial entry has been accomplished, very little pressure may be required to
complete entry. Excessive pressure could cause injury to intra-abdominal or intra-thoracic structures.
To insufflate, attach a gas line to the stopcock on the trocar sleeve and open the stopcock. The seal
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system maintains insufflation in the absence of an instrument in the sleeve.
For specimen removal during the procedure, with the exception of the 5 mm sleeve, the outer seal
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can be removed by pushing the outer seal release lever in a counterclockwise direction and lifting
off the outer seal. After removal of the specimen, use a sterile abdominal sponge to remove any
bodily fluid or debris that may have been deposited within the trocar's seal system (Illustration 7 and
Illustration 8). Replace the outer seal on the trocar. Orient the reducer cap so it is aligned correctly
with the top of the trocar. Position the seal latches over the corresponding holes in the top of the
trocar and press down to snap cap in place (Illustration 9).
Upon completion of the procedure, remove the gas line. Open the stopcock to rapidly deflate the
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abdominal cavity.
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ENDOPATH XCEL Dilating Tip Trocar with OPTIVIEW™ Technology Additional Sleeve Information
If using a dilating tip trocar with additional sleeves, follow steps 3 through 6 under Instructions for Use for
additional port insertions.
Warnings and Precautions
• 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. The presence
of the shield on the obturator is not a substitute for proper endoscopic techniques.
• 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. Do not immerse electrosurgical instruments in liquid unless the
instruments are designed and labeled to be immersed.
• Using minimally invasive instruments with a smaller diameter than specified for the dilating tip trocar
may result in desufflation of the abdominal cavity.
• The incorporation of the shield feature in the trocar design is intended to minimize the likelihood of
penetrating injury to intra-abdominal or intra-thoracic structures. However, because the trocar tip will
be briefly unprotected prior to shield advancement, the standard precautionary measures employed in
all trocar insertions must be observed.
• Adhesions, anatomical anomalies, or other obstructions, if present, may prevent or delay
advancement of the shield, leaving the tip uncovered, exposing internal structures to injury.
• Although the dilating tip trocar is designed with a shield, care must still be taken, as with all trocars, to
avoid damage to major vessels and other anatomic structures (such as bowel or mesentery).
To minimize the risk of such injury, be sure to:
- Establish adequate pneumoperitoneum, in order to secure enough space in the abdominal or
thoracic cavity;
- Properly position the patient to help displace organs out of the area of penetration;
- For the second and additional punctures of the trocar into the abdominal or thoracic cavity, inspect
the tip of trocar visually by monitor and note important anatomical landmarks each time;
- Direct the trocar tip away from major vessels and structures;
- Do not use excessive force.
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