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Indications
The ENSEAL
G2 Articulating Tissue Sealers are indicated for bipolar coagulation and mechanical
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transection of tissue during laparoscopic and open procedures.
The devices are bipolar electrosurgical instruments for use with the Generator G11 (GEN11). They are
intended for use during open or laparoscopic, general and gynecological surgery to cut and seal vessels, and
to cut, grasp and dissect tissue during surgery.
Indications for use include open and laparoscopic, general and 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) 7mm and tissue and/or vascular bundles as large as will fit in the jaws of
the instruments.
The ENSEAL
G2 Articulating Tissue Sealers have not been shown to be effective for tubal sterilization or
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tubal coagulation for sterilization procedures. Do not use these devices for these procedures.
Contraindications
The efficacy of the ENSEAL
G2 Articulating Tissue Sealer for the indication of contraceptive tubal
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coagulation (permanent female sterilization) has not been evaluated and is unknown. The design of the
ENSEAL
G2 Articulating Tissue Sealer is significantly different from bipolar designs that are marketed
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for the indication of contraceptive tubal coagulation. The design differences may affect the efficacy of the
procedure and failure rates may not be comparable.
Residual Risk:
Undesirable side effects and risks associated with ENSEAL
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
G2 Articulating Tissue Sealer is a sterile, single patient use surgical instrument used to
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coagulate and transect vessels up to and including 7mm 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 and articulating
shaft either 35cm or 45cm in length, a moveable jaw and an I-BLADE
can be rotated to facilitate visualization and enable easy access to targeted tissue. The instrument shaft,
normally in the straight position, can be articulated using the articulation wheel to gain additional access to
tissue and facilitate additional angles across tissue and/or vascular bundles.
The 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. Fully squeezing
the closing handle advances the I-BLADE
the length of the jaws, and the targeted tissue is compressed,
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coagulated, and transected. The I-BLADE
cannot be advanced to transect tissue without first fully
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depressing the energy activation button. The power cord is permanently attached to the device and connects
the instrument to the generator. The ENSEAL
G2 Articulating Tissue Sealer is designed for use exclusively
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with the Generator G11 (GEN11), packaged separately. Dimensions: Jaw Length, Straight: 20mm, Jaw
Length, Curved: 19mm, Shaft Length: 35cm from Jaw Tip to Shaft Rotation Knob or 45cm from Jaw Tip to
Shaft Rotation Knob, Shaft Diameter: 5mm.
bipolar electrosurgical devices include the
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in the jaws. The instrument shaft
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1
Generator Audible Indicators
Refer to the following table for generator audible feedback tones.
Tone
Description
Tone 1
Continuous steady beeping
Generator On: Device is active.
Tone 2
Continuous steady beeping at
Intermediate: Tissue impedance threshold is reached.
increased pitch
Tone 3
One short beep
End of cycle: I-BLADE
Energy is stopped.
Illustration and Nomenclature (Illustration 1)
1. Jaws (curved or straight)
6. Rotation knob
2. Atraumatic teeth
7. Articulation wheel
3. I-BLADE
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knife (not visible)
8. Energy activation button
4. Articulation joint
9. Closing handle
5. Shaft
10. Grip housing
11. Power cord
3
2
5
1
4
3
Transport and Storage Conditions
Temperature: -22° C to +60° C
Relative Humidity: 10% - 80%
How Supplied
The ENSEAL
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G2 Articulating Tissue Sealer with integrated power cord is supplied sterile for single patient
use. Discard after use.
Warnings and Precautions
•
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
•
Examine the shipping carton and instrument for signs of shipping damage. Note any shortages,
breakage, or apparent damage, retain the evidence, and notify Ethicon Endo-Surgery Customer Service
immediately and replace with a new instrument. Do not use a damaged product.
•
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.
•
Laparoscopic surgical procedures with the ENSEAL
performed only by persons with adequate training and preparation. Consult the medical literature
regarding techniques, complications, and hazards prior to any surgical procedure.
•
Do not immerse the ENSEAL
G2 Articulating Tissue Sealer in liquid.
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•
Pools of conductive fluids (e.g. blood, saline) in direct contact with the instrument jaws may affect
device performance. Remove pooled fluid from around the instrument jaws before activating the
instrument.
•
Verify compatibility with generators. Use device only with Ethicon Endo-Surgery Generator G11
(GEN11) software version X or later. Refer to the Generator G11 (GEN11) Operator's Manual to
confirm software versions.
•
The device is at high voltage whenever the generator is active. Activate this device only when the jaws
are under direct visual observation to avoid unintended tissue coagulation or necrosis.
Action
fully advanced.
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7
6
11
8
9
10
G2 Articulating Tissue Sealer should be
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2
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