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Close the clamp arm and insert the instrument through the incision. Use the H
Curved Shears for dissection, grasping, coagulation, and cutting between the blade and clamp arm. Use
the top of the blade for backcutting.
CAUTION: Do not use finger ring rests to extend reach during procedure, as this could result in poor
vessel sealing and unstable positioning of the instrument. (Illustration 9)
Note: Keep the clamp arm open when backcutting or while the blade is active without tissue
between the blade and tissue pad, to avoid damage to the tissue pad.
Disassembly
1
Turn the generator OFF at the power switch, or enter Standby mode.
2
Close the clamp arm and place the purple torque wrench over the distal end of the instrument.
3
While holding the Hand Piece, loosen the instrument by turning the torque wrench counterclockwise.
Continue to loosen by turning the instrument manually to completely unscrew it from the Hand Piece.
4
Remove the torque wrench from the instrument. Dispose of the instrument, grip assist, and the torque
wrench in an appropriate container.
NOTE: Take care to avoid injury from the blade tip while positioning or removing the torque wrench.
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 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. The H
armonic
with the u c Generator (GEN01/GEN32).
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• Audible high-pitched tones resonating from the blade or Hand Piece during activation 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.
• In case of system failure, ensure the availability of the appropriate back-up equipment relevant to the
specific procedure.
• 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.
• During and following activation in tissue, the instrument blade, clamp arm and distal portion of the
shaft may be hot. Avoid unintended contact with tissue, drapes, surgical gowns, or other unintended
sites at all times.
• 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.
F Long
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F Long Curved Shears are not compatible
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instruments in fatty
armonic
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• 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 H
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 button is depressed.
• 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
• Keep the clamp arm open when backcutting or 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.
• Do not use finger ring rests to extend reach during procedure, as this could result in poor vessel sealing
and unstable positioning of the instrument.
• Use only the H Foot Switch, the Blue Hand Piece, and the blue grip assist with the H
armonic
F Long Curved Shears instrument to ensure that they are compatible with the Generator.
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• After removing the instrument, examine the tissue for hemostasis. If hemostasis is not present,
appropriate techniques should be used to achieve hemostasis.
• Minimum starting power level defaults to power level 3.
• Successful hemostasis may require adjunct measures when H
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 instrument under these conditions.
• Products manufactured or distributed by companies not authorized by Ethicon Endo-Surgery may not
be compatible with the H F instrument. Use of such products may lead to unanticipated
armonic ocus
results and 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 instrument is packaged and sterilized for single use only. Do not reuse, reprocess or resterilize.
Reuse, reprocessing, or resterilization may compromise the structural integrity of the instrument
and/or lead to instrument failure that in turn may result in patient injury, illness or death. Also,
reprocessing or resterilization of single use instruments may create a risk of contamination and/or
cause patient infection or cross-infection, including, but not limited to, the transmission of infectious
disease(s) from one patient to another. Contamination of the instrument may lead to injury, illness, or
death of the patient.
How Supplied
The H F Long Curved Shears, purple torque wrench, and grip assist are supplied sterile for
armonic ocus
single patient use. Discard after use.
F blade and tissue pad without
armonic ocus
F instrument.
armonic ocus
armonic
and H F instruments
armonic armonic ocus
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