7
GEN04
Chapter 2 - General Description
System Description
The H
ARMONIC
™ Generator 300 System utilizes ultrasonic energy to enable hemostatic cutting and/or
coagulation of soft tissue. The system consists of an ultrasonic generator, a foot switch, an optional hand
switching adaptor, a hand piece, and a variety of open and minimally invasive instruments.
Note: Throughout this manual “instrument(s)” refers to The H
ARMONIC
™ Generator 300 System blades, ball
coagulators, or coagulating shears.
The H
ARMONIC
™ instruments vibrate longitudinally at 55.5 kilohertz. This ultrasonic vibration at the blade
enhances its cutting ability. The same vibration seals small vessels with coagulated blood and tissue proteins.
Hemostasis occurs when tissue couples with the instrument. This coupling causes collagen molecules within
the tissue to vibrate and become denatured, forming a coagulum.
Indications
The H
ARMONIC
™ Generator 300 System is indicated for soft tissue incisions when bleeding control and
minimal thermal injury are desired. The H
ARMONIC
™ Generator 300 System instruments can be used as an
adjunct to or substitute for electrosurgery, lasers, and steel scalpels.
Contraindications
•
The instruments are not indicated for incising bone.
•
The instruments are not intended for contraceptive tubal occlusion.
System Components
Generator 300
The generator supplies the hand piece with electrical energy and facilitates selection of power levels, system
monitoring, and system diagnostics.
Power is delivered by activating the foot switch or hand switching adaptor.
Hand Piece
The hand piece contains an acoustic transducer that converts the electrical energy supplied by the generator to
mechanical motion. The transducer is connected to an ultrasonic wave guide/amplifier which amplifies the
motion produced by the transducer and relays it to the instrument.
Instrument
The mechanical motion from the hand piece advances to the instrument, transmitting ultrasonic energy which
enables hemostatic cutting and/or coagulation of tissue.
Power Levels
The generator delivers two power levels: minimum (MIN) and maximum (MAX). The minimum power level
may be adjusted by the user from Level 1 to 5. The maximum power level is always Level 5. With all
instruments except the ball coagulator, use a higher generator power level for greater tissue cutting speed and
a lower generator power level for greater coagulation. For the ball coagulator, higher generator power levels
will provide greater coagulation. The amount of energy delivered to the tissue and resultant tissue effects are
a function of many factors including the power level selected, instrument characteristics, grip force (when
applicable), tissue tension, tissue type, pathology, and surgical technique.
Note: Refer to the instruments’ package inserts for additional power level information.
Summary of Contents for ETHICON ENDO-SURGERY HARMONIC 300
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