Ethicon Endo-Surgery ENSEAL G2 Mode D'emploi page 2

Indications
The ENSEAL G2 Tissue Sealers are indicated for bipolar coagulation and mechanical transection of tissue
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during laparoscopic and open procedures.
The devices are bipolar electrosurgical instruments for use with an electrosurgical generator. 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) 7 mm and bundles as large as will fit in the jaws of the instruments.
The ENSEAL G2 Tissue Sealers have not been shown to be effective for tubal sterilization or tubal
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coagulation for sterilization procedures. Do not use these devices for these procedures
Contraindications
The efficacy of the ENSEAL
(permanent female sterilization) has not been evaluated and is unknown. The design of the ENSEAL
Tissue Sealer 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 ENSEAL G2 Tissue Sealer is a sterile, single patient use surgical instrument used to coagulate and
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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 shaft, a moveable jaw and an
I-BLADE knife in the jaws. The instrument shaft can be rotated to facilitate visualization and enable easy
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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 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
tissue is compressed, coagulated, and transected. The I-BLADE
without fully pressing the energy activation button and then releasing the I-BLADE
is permanently attached to the device and connects the instrument to the generator. The ENSEAL
Tissue Sealer is designed for use exclusively with the Generator G11 (GEN11), packaged separately.
Dimensions: Jaw Length: 20mm, Shaft Length: 14, 25, 35 or 45 cm from Jaw Tip to Rotation Knob (varies
by product code), Shaft Diameter: 5 mm.
Generator Audible Indicators
Refer to the following table for generator audible feedback tones.
Tone
Tone 1 Continuous steady beeping
Tone 2 Continuous steady beeping at
increased pitch
Tone 3 One short beep
G2 Tissue Sealer for the indication of contraceptive tubal coagulation
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Description
knife the length of the jaws, and the targeted
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knife cannot be advanced to transect tissue
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Generator On: Device is active.
Intermediate: Tissue impedance threshold is reached.
End of cycle: I-BLADE
Energy is stopped.
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knife. The power cord
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Action
knife fully advanced.
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G2
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G2
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