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Indications
The H
WaVE Coagulating Shears with Scissor Handle and Hand Control is indicated for
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soft tissue incisions when bleeding control and minimal thermal injury are desired. The instrument can
be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic,
pediatric, gynecologic, urologic, exposure to orthopedic structures (such as spine and joint space) and other
open procedures.
Contraindications
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The instrument is not indicated for incising bone.
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The instrument is not intended for contraceptive tubal occlusion.
Device Description
The H
WaVE Coagulating Shears with Scissor Handle and Hand Control is a sterile, single
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patient use instrument consisting of a scissor handle housing assembly with hand control buttons (MIN
for minimum power level and MAX for maximum power level). The handle housing has an integrated
audible/tactile mechanism for indicating full closure. The instrument has a straight blade and clamp arm and
is designed to function through an incision without the use of a trocar. The instrument is 18 cm long with a
shaft diameter of 8.5 mm and an active blade length of 18 mm.
The H
WaVE instrument allows for the cutting and coagulation of vessels up to and including
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5 mm in diameter.
H
WaVE instruments are designed for use exclusively with a compatible H
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and Hand Piece. Refer to a compatible H
Generator User Manual before using this instrument.
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Each H
WaVE instrument is shipped with one sterile, single patient use, green disposable torque
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wrench. Use only the green torque wrench with the H
should not be discarded until the completion of the surgical case. In the event the torque wrench falls out
of the sterile field, replace with a sterile torque wrench. Do not attempt to sterilize the disposable torque
wrench.
Note: Use of H
torque wrenches other than the green H
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in damage to the device.
Illustration and Nomenclature (Illustration 1)
1. Clamp Arm and Tissue Pad
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2. Blade and Shaft
7.
3. Tip Protector
8.
4. MAX Hand Control Button
9.
5. MIN Hand Control Button
10. Torque Wrench
Transport and Storage Conditions
Temperature: -22°C to +60°C
Relative Humidity: 10–80%
Instructions for Use
Verify compatibility of all instruments and accessories prior to using the instrument (refer to Warnings
and Precautions).
The Hand Piece is shipped non-sterile and must be sterilized per the insert instructions prior to each use.
Using sterile technique, remove the instrument from the package. To avoid damage, do not flip the
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instrument into the sterile field.
Assembly
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While holding the Hand Piece in a vertical orientation, attach the Hand Piece to the instrument by
rotating the instrument onto the Hand Piece in a clockwise rotation as viewed from the distal end of the
instrument (finger tight only).
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Use the torque wrench (already mounted to the shaft) to tighten the blade onto the Hand Piece. Slide the
torque wrench up the shaft, rotating as necessary to engage ribs on the internal knob on the shaft. Turn
Generator
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®
WaVE instrument. The torque wrench
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torque wrench may result
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Hand Piece
Handle Housing
Trigger
Finger Ring
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the torque wrench clockwise by holding only the gray Hand Piece until it clicks twice indicating that
sufficient torque has been applied to secure the blade.
Note: Do not use any other means than the torque wrench to attach or detach the instrument from
the hand piece.
Note: Do not torque the instrument by hand or damage may occur to the hand piece.
Note: Hold only the gray hand piece and not the shears handle while applying the torque wrench
(Illustration 2).
Remove the tip protector and discard. Remove the torque wrench by sliding it off the shaft. Do
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not dispose of the torque wrench until completion of the procedure as it is used for removal of the
instrument from the hand piece following the procedure. (Illustration 3) Dispose of the torque wrench
only after completing the procedure.
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.
Note: Take care to avoid injury from the blade tip while sliding the torque wrench onto or off of
the shaft.
Operation
Refer to a compatible H
Generator User Manual for hand piece attachment and system operation
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instructions.
Connect the assembled hand piece and instrument to the generator and turn the generator power on.
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Note: Do not turn the generator power on before the hand piece and instrument are connected to
the generator.
Note: MAX power is defaulted at power level 5 and cannot be adjusted.
Select the desired MIN power level using the INCREASE and DECREASE buttons on the generator.
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Note: MIN power is defaulted at power level 3.
Caution: Adjust MIN power to level 2 or lower for optimal hemostasis on vessels greater than
3 mm. (Illustration 4)
For greater tissue cutting speed use a higher generator power level, and for greater coagulation use a
lower generator power level. The amount of energy delivered to the tissue and resultant tissue effects are
a function of many factors, including the power level selected, blade characteristics, grip force, tissue
tension, tissue type, pathology, and surgical technique.
For hand control function, refer to a compatible H
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and setup and operation instructions.
Remove the generator from stand-by by depressing the stand-by button on the generator.
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System check and activation: Each time the generator is activated after exiting Standby, hold the
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instrument in air with the clamp arm open and depress the MIN or MAX power level on the foot switch
or hand control button. "TEST IN PROGRESS" will appear on the graphic display and a rapid two-
pulse will sound while the test is occurring. During this five-second period, a system check is being
performed.
Note: Failure to have the jaws open during activation may generate a false error message from the
generator.
For optimal performance and to avoid tissue sticking, clean the instrument blade, clamp arm, and distal
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end of the shaft throughout the procedure by activating the instrument tip in sterile saline (Illustration 5).
Note: Do not touch the instrument to metal while activated (Illustration 6).
Note: Do not clean the blade tip with abrasives. If necessary, wipe the blade tip with a sterile moist
gauze sponge to remove tissue.
If tissue is still visible in the clamp arm, use hemostats to remove residue with the generator in standby
mode (Illustration 7).
The blade is ultrasonically energized when either the foot switch pedal is depressed or one of the hand
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control buttons is depressed. Pressing the left foot pedal of the footswitch or the proximal hand control
button (MIN) on the Coagulating Shears activates the selected minimum power level. Pressing the right
foot pedal of the footswitch or distal hand control button (MAX) on the Coagulating Shears activates the
maximum power level.
Note: Scratches on the blade may lead to premature blade failure.
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- Avoid accidental contact with other instruments during use.
- Do not use any other means than the torque wrench to attach or detach the instrument or the hand
piece.
Generator User Manual for further detail
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