Ethicon ENSEAL G2 Super Jaw, Быстрый старт

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Indications
The ENSEAL
®
Tissue Sealing Device is indicated for bipolar coagulation and mechanical transection of
tissue during open procedures.
It is a bipolar instrument for use with an electrosurgical generator. It is intended for use during open general
and gynecological surgery to cut and seal vessels, cut, grasp and dissect during surgery.
Indications for use include open general, gynecological surgical procedures (including urologic, thoracic,
plastic and reconstructive, bowel resections, hysterectomies, cholecystectomies, gall bladder procedures,
Nissen fundoplication, adhesiolysis, oophorectomies, etc.), or any procedure where vessel ligation (cutting
and sealing), tissue grasping and dissection is performed. 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.
Contraindications
The ENSEAL
®
Tissue Sealing Device has not been shown to be effective for tubal sterilization or tubal
coagulation for sterilization procedures. Do not use this system for these procedures.
The efficacy of the ENSEAL
®
Tissue Sealing Device for the indication of contraceptive tubal coagulation
(permanent female sterilization) has not been evaluated and is unknown. The design of the ENSEAL
®
Tissue Sealing Device 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.
Device Description
The Ethicon Endo-Surgery ENSEAL
®
Tissue Sealer G2, Super Jaw device is a sterile, single patient use
surgical instrument to coagulate and transect vessels up to and including 7 mm in diameter and 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 an I-BLADE
®
knife in the rounded tip. The instrument shaft can be
rotated 360˚ to facilitate visualization and enable easy access to targeted tissue. The curved jaws are in a
normally opened position and can be partially or fully closed by squeezing the Closing Handle. The jaws
have atraumatic teeth for grasping and holding targeted tissue when clamped. Bipolar energy is delivered
to the clamped tissue when the Energy Activation Button is pressed. Full activation of the Closing Handle
advances the I-BLADE
®
the length of the jaws, and the targeted tissue is compressed, coagulated, and
transected. The I-BLADE
®
knife cannot be advanced to transect tissue without fully pressing the Energy
Activation Button. The power cord is permanently attached to the device and connects the instrument to the
generator. The Ethicon Endo-Surgery ENSEAL ® Tissue Sealer G2, Super Jaw instrument is designed for use
exclusively with an ENSEAL
®
-compatible generator, packaged separately.
Dimensions:
• Jaw length: 40 mm
• Jaw width: 6.7 mm
• Shaft length: 22 cm from Jaw tip to Rotation Knob
• Shaft diameter: 12 mm
• Power cord length: 3.1 m
Illustration and Nomenclature
(Illustration 1)
1. Jaws
2. Atraumatic teeth
3. I-BLADE® knife (not visible)
4. Shaft
5. 360
˚
Rotation Knob
6. Energy Activation Button
7. Closing Handle
8. Grip Housing
9. Attached Power Cord
Transport and Storage Conditions
Temperature: −22°C to 60°C
Relative Humidity: 10–80%
How Supplied
The ENSEAL
®
Tissue Sealer G2, Super Jaw with integrated power cord is supplied sterile for single patient
use. Discard after use.
Instructions for Use
Verify compatibility of all instruments and accessories prior to using the instrument (refer to Warnings
and Precautions).
1
Using sterile technique, remove the instrument from the package. To avoid damage, do not flip the
instrument into the sterile field. Do not use a damaged product.
2
Connect the instrument power cord to the generator.
3
Turn the rotation knob to move the shaft around to the desired position. Position targeted tissue within
open jaws. (Illustration 2)
4
Squeeze Closing Handle to grasp targeted tissue between the jaws. (Illustration 3)
Note: Tissue between the jaws may be further compressed by squeezing the Closing Handle to the first
stop.
5
Press the Energy Activation Button to energize the jaws and begin coagulation of the targeted tissue.
The generator gives audible feedback (Tone 1) as energy is delivered to the grasped tissue. Affirm
tissue effects prior to advancing the I-BLADE
®
through tissue.
6
Complete the instrument firing cycle. (Illustration 4)
a. Fully depressing the Energy Activation Button unlocks the I-BLADE
®
knife as energy continues to
be delivered to the tissue.
b. Continue to hold down the Energy Activation Button. Continued squeezing of the Closing Handle
increases compression on the grasped tissue and advances the I-BLADE
®
knife.
Note: For larger vascular bundles, it is recommended to advance the I-BLADE
®
slowly (gradually).
c. The tissue is transected as it collapses during coagulation. Audible feedback from the generator
changes tone (Tone 2) when the tissue impedance threshold is reached, and the I-BLADE ® knife
is ready to be fully advanced. It is recommended to maintain a consistent speed throughout the
I-BLADE
®
advancement during Tone 1 and Tone 2. In cases where the I-BLADE
®
knife has already
been advanced, Tone 2 may not be heard.
Note: Ensure that the Closing Handle is squeezed to the fully closed position until it stops against the
grip housing.
d. Once the Closing Handle is fully closed, the I-BLADE
®
knife is fully advanced, and the tissue
impedance threshold has been reached, the generator provides audible feedback (Tone 3) that the cycle
is complete and automatically stops delivery of energy.
Generator Audible Indicators
Refer to the following table for generator audible feedback tones.
Tone Description Action
Tone 1 Continuous steady beeping Generator On: Device is active.
Tone 2 Continuous steady beeping at
increased pitch
Intermediate: Tissue impedance threshold is reached.
Tone 3 One short beep End of cycle: I-BLADE
®
knife fully advanced. Energy
is stopped.