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9
Close the clamp arm by closing the trigger and finger ring together and insert the shaft through
the incision.
Note: Optimum instrument performance is achieved with full trigger closure (Illustration 8).
An audible/tactile click indicates full trigger closure. A second click is heard/felt when full trigger
closure is lost due to a decreased grip force. (Illustration 9) If full trigger closure is released prior to
or during activation on tissue, increase grip force until full trigger closure is achieved.
10 The WaVE Shears can be used for dissection, grasping, coagulation, and cutting between the blade and
clamp arm.
Note: Refer to Warnings and Precautions for proper use.
Disassembly
1
Turn the generator OFF at the power switch or enter Standby mode.
2
Close the clamp arm and slide the torque wrench over the distal end and up the shaft until the wrench
aligns with the ribs on the internal knob.
Note: Take care to avoid injury from the blade tip while sliding the torque wrench onto or off of
the shaft.
3
Loosen the instrument by turning the wrench counterclockwise. Continue to loosen by turning the
instrument manually to completely remove the instrument from the hand piece.
4
Remove the torque wrench by pulling it straight back over the blade.
Note: Hold only the gray hand piece and not the shears handle while using the torque wrench
(Illustration 2).
Note: Take care to avoid damage to the blade and clamp arm by closing the trigger while sliding
the torque wrench onto or off of the shaft.
5
Dispose of the instrument and the torque wrench in an appropriate container.
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.
•
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 instruments in liquid unless the instruments are designed and labeled
to be immersed.
•
Verify compatibility with generators. H
armonic
U
c
Generator (GEN01/GEN32).
ltra
ision
®
•
In case of system failure, ensure the availability of the appropriate back up equipment relevant to the
specific procedure.
•
Audible high-pitched tones, resonating from the blade or hand piece, are an abnormal condition and an
indicator that the blade or hand piece is not operating properly. The tones may be an indicator that the
hand piece is beyond its useful life or that the blade has not been attached properly, which may result in
abnormally high shaft temperatures and user or patient injury.
•
Blood and tissue buildup between the blade and shaft may result in abnormally high temperatures at
the distal end of the shaft. To prevent burn injury, remove any visible tissue buildup at the distal end of
the shaft.
•
As with all energy sources (Electrosurgery, Laser, or Ultrasound), there are concerns about the
carcinogenic and infectious potential of the by-products, such as tissue smoke plume and aerosols.
Appropriate measures such as protective eyewear, filtration masks, and effective smoke evacuation
equipment should be used in both open and laparoscopic procedures.
•
Do not attempt to bend, sharpen, or otherwise alter the shape of the blade. Doing so may cause blade
failure and user or patient injury.
•
To avoid user or patient injury in the event that accidental activation occurs, the instrument blade, clamp
arm, and distal end of the shaft should not be in contact with the patient, drapes, or flammable materials
while not in use.
WaVE instruments are not compatible with the
3
•
During and following activation in tissue, the instrument blade, clamp arm, and distal 7 cm of the shaft
may become hot. Avoid unintended contact with tissue, drapes, surgical gowns, or other unintended
sites at all times.
•
Incidental and prolonged activation against solid surfaces, such as bone, may result in blade heating and
subsequent blade failure, and should be avoided.
•
Avoid contact with any and all metal or plastic instruments or objects when the instrument is activated.
Contact with staples, clips or other instruments while the instrument is activated may result in cracked
or broken blades, which may be identified by generator solid tone or instrument error.
•
Care should be taken not to apply pressure between the instrument blade and tissue pad without having
tissue between them. Clamping the tissue pad against the active blade without tissue on the full length of
the blade will result in higher blade, clamp arm and distal shaft temperatures and can result in possible
damage to the instrument. If this happens, there may be a system failure signaled by a continuous tone
or Error Code when either of the foot pedals or hand control buttons is depressed.
•
Keep the clamp arm open while the blade is active without tissue between the blade and tissue pad to
avoid damage to the tissue pad and increased blade, clamp arm and distal shaft temperatures.
•
To avoid user or patient injury, do not activate an electrosurgical device in close proximity to the
H
instruments. The aerosols created by the activation of the H
armonic
tissue are potentially flammable.
•
The entire exposed blade tip and any exposed blade shaft is active and will cut/coagulate tissue when the
instrument blade is activated. Be careful to avoid inadvertent contact between all exposed blade surfaces
and surrounding tissue when using the H
armonic
•
Use only the H
Foot Switch, Hand Piece, Instruments and power cord to ensure that they are
armonic
compatible with the Generator.
•
Adjust MIN power to level 2 or lower for optimal hemostasis on vessels greater than 3 mm.
•
After removing the instrument, examine the tissue for hemostasis. If hemostasis is not present,
appropriate techniques should be used to achieve hemostasis.
•
Successful hemostasis may require adjunct measures when H
instruments are used on solid organs. Due to the difficulty of visualizing internal structures, proceed
slowly and do not attempt to transect large masses of tissue in one activation. Avoid the division of large
vascular/biliary bundles when using the H
armonic
•
Products manufactured or distributed by companies not authorized by Ethicon Endo-Surgery may not
be compatible with the H
System. Use of such products may lead to unanticipated results and
armonic
possible injury to the user or patient.
•
Instruments or devices which come into contact with bodily fluids may require special disposal handling
to prevent biological contamination.
•
Dispose of all opened instruments whether used or unused.
•
This device is packaged and sterilized for single use only. Multiple patient use may compromise the
device integrity or create a risk of contamination that, in turn, may result in patient injury or illness.
How Supplied
The H
WaVE Coagulating Shears with Scissor Handle and Hand Control is supplied sterile for
armonic
single patient use. Each H
WaVE instrument is shipped with one sterile, single patient use, green
armonic
disposable torque wrench. Discard the instrument and torque wrench after use.
instruments in fatty
armonic
WaVE.
and H
WaVE
armonic
armonic
instrument under these conditions.
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