Reprocessed Ultrasonic Focus™ Curved Shears
Device Description
The reprocessed Ultrasonic FOCUS™ Curved Shears (hereinafter Ultrasonic Curved Shears) is an instrument consisting
of a scissor handle housing assembly with hand control buttons (MIN for minimum power level and MAX for maximum
power level). The instrument has a working length of 9cm, an active blade length of 16mm, and utilizes a curved blade
and clamp arm. The Ultrasonic Curved Shears device allows for the cutting and coagulation of vessels up to and including
5mm in diameter.
The Reprocessed Ultrasonic Curved Shears with torque wrench and grip assist are compatible with the Harmonic
TM
Generator 300 (GEN04) and Harmonic™ Blue Hand Piece (HPBLUE), packaged separately. Refer to the Harmonic™
Generator 300 Operator’s Manual before using this instrument and the Instructions for Use of the Harmonic™ Blue Hand
Piece and Test Tip (TTBLUE).
Use only the Blue Torque Wrench (TWBLUE) or equivalent torque wrench and Blue Grip Assist (GABLUE) or equivalent
grip assist.
The Blue Torque Wrench and Blue Grip Assist should not be discarded until the completion of a surgical case. In the
event the Blue Torque Wrench falls out of sterile field, replace with a sterile Blue Torque Wrench (TWBLUE). Do not
attempt to sterilize the Blue Torque Wrench. Replace the Blue Grip Assist (GABLUE) if it happens to fall out of the sterile
field with a sterile Blue Grip Assist.
Indications for Use
The Reprocessed Ultrasonic Curved Shears is indicated for soft tissue incisions when bleeding control and minimal
thermal injury is desired. The device 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 and other open procedures.
Contraindications for Use
Reprocessed Ultrasonic Curved Shears are contraindicated for the following uses:
•
Incising bone
•
Contraceptive tubal occlusion
Warnings and Precautions
•
These instruments are only intended for use by individuals with adequate training and familiarity with techniques
associated with the surgical procedure employed. For further information about techniques, complications and hazards,
consult the medical literature.
•
Prior to the initiation of the procedure, verify compatibility of minimally invasive instruments and accessories when they
will be used together since there may be variations from manufacturer to manufacturer.
•
The use of these instruments requires a thorough understanding of the techniques and principles of laser,
electrosurgical, and ultrasonic procedures. Inappropriate use may result in shock and burn hazards to both patient and
medical personnel or damage to the device or other medical instruments. Check and ensure electrical insulation or
grounding is not compromised. Do not immerse instruments in liquid unless it is designed and stated.
•
The Reprocessed Ultrasonic Curved Shears are only compatible with the Harmonic
TM
Generator 300 (GEN04)
•
Use the Harmonic
TM
foot switch, Blue Hand Piece, and the Blue Grip Assist to ensure compatibility with the generator.
•
In case of system failure, arrange for the availability of 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, and may result in abnormally high shaft temperatures and user or
patient injury.
•
High temperatures at the distal end of the shaft can occur due to blood and tissue buildup between the blade and shaft.
Remove any visible tissue to prevent burn injury.
•
Measures such as protective eyewear, filtration masks, and effective smoke evacuation equipment should be used in
both open and laparoscopic procedures to address the concerns with the carcinogenic and infectious potential of the by-
products (tissue smoke plume and aerosols) of electrosurgery, laser and ultrasound energy sources.
•
Do not sharpen, bend, or alter the shape of the blade as it can result in blade failure and user or patient injury.
•
While not in use, the instrument’s blade should be kept out of contact with the patient, drapes, or flammable materials in
the case that accidental activation occurs.
•
During prolonged activation, the blade, the clamp arm, and the distal end of the shaft may become hot. At all times
avoid unintended contact with tissue, drapes, surgical gowns, or other unintended sites.
