Johnson & Johnson Harmonic Focus Guia De Inicio Rapido página 3

Indications
The H F ® shears are indicated for soft tissue incisions when bleeding control and minimal
armonic ocus
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
• The instrument is not indicated for incising bone.
• The instrument is not intended for contraceptive tubal occlusion.
Device Description
The H F Long Curved Shears are a sterile, single patient use instrument consisting of a soft
armonic ocus
grip scissor handle housing assembly with two hand controls (MIN for minimum power level and MAX for
maximum power level). The instrument has a curved blade and clamp arm with teflon tissue pad. Measured
from the blade tip to the MAX hand control power button, the instrument is 17 cm in length with a 16 mm
active blade length. The H F instrument allows for the cutting and coagulation of vessels up to
armonic ocus
and including 5 mm in diameter.
Each H F Long Curved Shears is packaged with one sterile, single patient use, disposable
armonic ocus
purple torque wrench and blue grip assist. Use only the purple torque wrench and blue grip assist with the
H F Long Curved Shears.
armonic ocus
The H F instrument is designed for use exclusively with a compatible H
armonic ocus
H Blue Hand Piece, packaged separately. Refer to a compatible H
armonic
before using this instrument. Refer to the Instructions for Use of the H
Illustration and Nomenclature
(Illustration 1)
1. Torque Wrench
2. Blade
3. Clamp Arm and Tissue Pad
4. Handle Housing
5. Finger Rings
6. Finger Ring Rests
7. MIN Hand Control (proximal)
8. MAX Hand Control (distal)
9. Grip Assist
10. Hand Piece (not included)
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 and Test Tip, packaged separately, are shipped non-sterile and must be sterilized per the
insert instructions prior to each use.
Assembly
1
Using sterile technique, remove the instrument from the package. To avoid damage, do not flip the
instrument into the sterile field.
2
While holding the Hand Piece, attach the instrument by rotating it onto the Hand Piece in a clockwise
rotation as viewed from the distal end of the instrument (finger tight only). (Illustration 2)
Note: The blue grip assist is provided and may be positioned onto the Hand Piece to more easily grip
the Hand Piece for proper assembly.
Generator and
®
armonic
Generator User Manual
armonic
Blue Hand Piece and Test Tip.
armonic
1
3
Use the purple torque wrench to tighten the instrument onto the Hand Piece. Turn the wrench clockwise
while holding the Hand Piece until it clicks twice, indicating that sufficient torque has been applied
to secure the instrument. (Illustration 3) In the event that the torque wrench must be re-positioned on
the instrument, ensure that the torque wrench is re-positioned correctly, as shown in Illustration 3.
When properly aligned, the short side of the torque wrench should be aligned with the instrument hand
controls, handle housing, and the Hand Piece, and the dispose of properly icon on the torque wrench is
on top.
NOTE: Do not torque the instrument by hand or damage may occur to the Hand Piece.
NOTE: Do not grip the instrument handle while applying torque with the torque wrench. If necessary,
utilize the grip assist to hold on to the Hand Piece.
NOTE: Do not use any means other than the torque wrench to attach or detach the instrument from the
Hand Piece. If necessary, utilize the grip assist to hold on to the Hand Piece.
4
Remove the torque wrench from the instrument, and remove the grip assist from the Hand Piece.
Do not discard the disposable torque wrench and grip assist until the completion of the surgical
case. The torque wrench is used for removal of the instrument from the Hand Piece following the
procedure. (Illustration 4) In the event the torque wrench falls out of the sterile field, replace with
a sterile purple torque wrench. In the event the grip assist falls out of the sterile field, replace with
a sterile grip assist. Do not re-sterilize the disposable torque wrench or the disposable grip assist.
NOTE: Take care to avoid damage to the shears when removing the torque wrench from the instrument.
NOTE: Take care to avoid injury from the blade tip while removing the torque wrench from
the instrument.
Operation
Refer to a compatible H Generator User Manual for Hand Piece attachment and system operation
armonic
instructions.
1
Connect the assembled Hand Piece and instrument to the generator and turn the generator power on.
NOTE: Do not turn the generator power on before the Hand Piece and instrument are connected
to the generator.
2
Select the desired variable or minimum power level using the INCREASE and DECREASE buttons
on the generator.
NOTE: Minimum starting power level defaults to power level 3. (Illustration 5) 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.
3
The H F Long Curved Shears instrument may be operated with either the foot switch or
armonic ocus
hand control. For foot switch or hand control function, refer to a compatible H
Manual for further detail and system operation instructions.
4
Remove the generator from Standby mode by depressing the stand-by button on the generator.
5
For optimal performance, clean the instrument blade and clamp arm throughout the procedure by
activating the instrument tip in sterile saline (Illustration 6).
NOTE: Do not touch the instrument to metal while activated (Illustration 7).
NOTE: Do not clean the instrument with abrasives. The instrument can be wiped with a sterile moist
gauze sponge to remove tissue, if necessary.
6
If tissue is still visible in the clamp arm, use hemostats to remove residue with the generator in Standby
mode (Illustration 8). To return the instrument into use, the generator must be taken off Standby mode
by depressing the stand-by button on the generator.
7
The blade is ultrasonically energized when either the foot switch pedal is depressed or one of the
hand controls is depressed. Pressing either the left foot pedal of the footswitch or the proximal
hand control (MIN) on the instrument activates the selected minimum power level. Pressing either
the right foot pedal of the footswitch or distal hand control (MAX) on the instrument activates the
maximum power level.
NOTE: Scratches on the blade may lead to premature blade failure.
- Avoid accidental contact with other instruments during use.
- Do not use any means other than the torque wrench to attach or detach the instrument from the
Hand Piece.
Generator User
armonic
2