E-SOUM-PLUS Rev E
15
2.
Indications And Contra Indications
2.1.
Indications
The SonicOne CLINIC® is 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
o
External genitalia - condyloma - benign tumors (lipomas, fibromas, and leiomyoma) - malignant primary and metastatic
tumors of all types and the following cystic lesions: Bartholin's cysts, Vestibular adenitis, Inclusion cysts, Sebaceous cysts
o
Abdominal area - any abnormal growth, cystic or solid, benign or malignant, involving the ovary, fallopian tube, uterus, or the
supporting structures of the uterus.
•
Thoracic Surgery
o
Limited pulmonary reception such as segmetectomies, nonanatomical subsegmentectomies and metastatectomies.
•
Wound Care
o
The SonicOne CLINIC® 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.
The SonicOne CLINIC system to be operated by medical professionals justified to practice in the fields covered by the stated
indications for use.
CAUTION 1.1
Special Skill and Training requirements. Federal law restricts this device to sale by or on the order of a licensed
healthcare practitioner. The SonicOne CLINIC is to be used by an appropriately trained and licensed healthcare
practitioner.
2.2.
Contra Indications
The SonicOne CLINIC ultrasonic surgical aspirator system is not indicated for and should not be used for cardiac surgery and
any procedure in the proximity of the heart.
The irrigation pump is not indicated for and should not be used for the administration of parenteral fluids, infusion of drugs,
or for any life sustaining purposes.
This SonicOne CLINIC ultrasonic surgical aspirator device is not indicated for and should not be used for the fragmentation,
emulsification, and aspiration of uterine fibroids.
3.
Adverse Effects
WARNING 3.1 Tip and irrigant temperatures may exceed the tissue necrosis point if insufficient irrigation flow rates are
used. For hard tissue removal, set the irrigation flowrate to a setting no less than the comparable
vibration setting. For example, if the vibration setting is 7, a minimum flow setting of 70% should be used.
Additional external irrigation, e.g. by administering sterile saline with a syringe over the distal tip portion,
may be necessary for removal of very dense, hard osseous structures.
WARNING 3.2 Tissue necrosis may result if tip is not moved relative to tissue. A continuous, lateral sweeping motion is
recommended in order to minimize contact duration with the ultrasonic tip and minimize heat build-up.
When lateral motion is not possible withdraw and re-insert tip frequently.
WARNING 3.3
The SonicOne CLINIC system and its accessories may emit harmful acoustic pressure if exposure
exceeds recommended limits. Refer to the table below for limits for airborne acoustic exposure.
Wear hearing protection or protect patient hearing if not within the exposure limits.
