Instructions For Use – neXus Ultrasonic Surgical Aspirator
Doc #: 100-10-1000 rev A
p 18
2.
Indications and Contraindications
2.1.
Indications for Use
The Misonix Inc.
neXus®
Ultrasonic Surgical Aspirator System is intended for the fragmentation, emulsification and aspiration
of both soft and hard (i.e.bone) tissue. The indications for use for the Standard Handpiece in combination with BoneScalpel®
and SonicOne® OR probe kit accessory configurations and the indications for the SonaStar® long and short handpiece in
combination with SonaStar® probe kit accessory configurations are charted below.
NEXUS INDICATIONS FOR USE BY HANDPIECE AND PROBE KIT ACCESSORY COMBINATION
Standard Handpiece
for use with BoneScalpel® and Sonic One®
Long and Short Handpiece
for use with SonaStar®
Indications for Use
BoneScalpel ®
Indications for Use
SonicOne ®
Indications for Use
SonaStar®
Indicated for use in the fragmentation and
aspiration of soft and hard (e.g.: bone) tissue in
the following surgical specialties:
Neurosurgery
Gastrointestinal and Affiliated Organ
Surgery
Urological Surgery
Plastic and Reconstructive Surgery
General Surgery
Orthopedic Surgery
Gynecology
External genitalia
- condyloma - benign
tumors (lipomas, fibromas, and leiomyomas)
- malignant primary and metastatic tumors
of all types and the following cystic lesions:
Bartholin's cysts, Vestibular adenitis,
Inclusion cysts, Sebaceous cysts
Abdominal area
- any abnormal growth,
cystic or solid, benign or malignant, involving
the ovary, fallopian tube, uterus, or the
supporting structures of the uterus except as
contraindicated for uterine fibroids.
Thoracic Surgery
Limited pulmonary reception such as
segmetectomies, nonanatomical
subsegmentectomies and metastatectomies.
Wound Care
The neXus Ultrasonic Surgical Aspirator is
also indicated for use in the debridement of
wounds, such as, but not limited to, burn
wounds, diabetic ulcers, bedsores and
vaginal ulcers, soft tissue debridement and
cleansing of the surgical site in applications
in which, in the physician's judgment would
require the use of an ultrasonic aspirator
with sharp debridement.
Indicated for use in the fragmentation and
aspiration of soft and hard tissue (i.e. bone) in
the following surgical specialty:
Wound Care
The neXus Ultrasonic Surgical Aspirator is
also indicated for use in the debridement of
wounds, such as, but not limited to, burn
wounds, diabetic ulcers, bedsores and
vaginal ulcers, soft tissue debridement and
cleansing of the surgical site in applications
in which, in the physician's judgment would
require the use of an ultrasonic aspirator
with sharp debridement.
Plastic and Reconstructive Surgery
Indicated for use in the fragmentation, emulsification
and aspiration of both soft and hard (i.e. bone) tissue in
the following surgical specialties:
Neurosurgery
Gastrointestinal and Affiliated Organ Surgery
Urological Surgery
Plastic and Reconstructive Surgery General
Surgery
Orthopedic Surgery
Gynecological Surgery except as contraindicated
for uterine fibroids.
Thoracic Surgery
Laparoscopic Surgery
Thoracoscopic Surgery
The system may also be combined with electrosurgery
using optional RF surgery interface components.
