Integra CUSA NXT, Operator'S Manual

Page: 8 / 113

Chapter 1 • Patient and Operating Room Safety •
1
C
HAPTER
1 P
ATIENT AND
O
PERATING
R
OOM
S
AFETY
System Overview ............................................................................................. 1
Intended Users................................................................................................. 2
Warnings, Cautions and Notices.................................................................... 3
Classification and System Symbols ............................................................ 10
System Overview
The CUSA
®
NXT Ultrasonic Surgical Aspirator System facilitates the removal
of tissue. The system provides selective tissue disintegration with
simultaneous irrigation and aspiration.
Intended Use
The CUSA NXT Ultrasonic Surgical Aspirator System is indicated for use in
surgical procedures where fragmentation, emulsification and aspiration of
soft and hard (e.g. bone) tissue is desirable, including Neurosurgery,
Gastrointestinal and affiliated organ surgery, Urological surgery, Plastic and
Reconstructive surgery, General surgery, Orthopedic surgery, Gynecological
surgery, Thoracic surgery, Laparoscopic surgery and Thoracoscopic surgery.
Using this System in Ultrasonic Surgery
The basic operating principle of ultrasonic surgery involves the longitudinal
vibration of the hollow handpiece tip at ultrasonic frequency against tissue.
The mechanical action of the tip is similar to a tiny “surgical hammer” that
breaks off cellular material. When the tip contacts the fluid filled tissue, the
resulting slurry of emulsified material from the tissue is aspirated through the
center of the handpiece. A slow flow of irrigant around the tip assists in the
removal of waste tissue.
The selective action of the instrument arises from the disruption of fluid
containing cellular material while fibrous and elastic tissue such as nerves
and blood vessels remain relatively unaffected at the ultrasonic frequencies
used.
Contraindications
This device is not indicated for and should not be used for the removal of
uterine fibroids.
Warning
No modification of this equipment is allowed.