3
Illustration and Nomenclature
(Illustration 1)
1. Jaws (curved or straight)
6. Rotation knob
2. Atraumatic teeth
7. Articulation wheel
3. I-BLADE
®
knife (not visible)
8. Energy activation button
4. Articulation joint
9. Closing handle
5. Shaft
10. Grip
housing
11.
Power
cord
1
11
2
3
3
4
5
6
7
8
9
10
Transport and Storage Conditions
Temperature: -22° C to +60° C
Relative Humidity: 10% - 80%
How Supplied
The ENSEAL
®
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
®
G2 Articulating Tissue Sealer should be
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.
•
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.
•
Check if patient has a pacemaker or implanted cardioverter/defibrillator. Consult the manufacturers for
information about the effects of RF energy on these devices.
•
This instrument contains a surgically sharp edge. THIS DEVICE CUTS!
• The
ENSEAL
®
G2 Articulating Tissue Sealer has not been shown to be effective for sealing large
vessels without fully advancing the I-BLADE
®
. Do not attempt to seal large vessels by only clamping
the tissue and applying energy.
•
Do not use this device on vessels in excess of 7mm in diameter.
