E-SOUM-OR Rev M
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2.
Indications And Contra Indications
2.1.
Indications
The SonicOne O.R® is indicated for use in debridement of wounds, such as, but not limited to burn wounds, diabetic ul-
cers, bedsores and vaginal ulcers, soft tissue debridement and cleansing of the surgical site in application, in which, in the
physician’s
judgement would require the use of an ultrasonic aspirator with sharp debridement.
It is also indicated for use in the fragmentation and aspiration of both soft and hard (e.g.: bone) tissue as used in the following
surgical specialties. Wound Care, Orthopedic Surgery, Plastic and Reconstructive Surgery, Thoracic Surgery, NeuroSurgery and
General Surgery.
The SonicOne O.R. 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 O.R is to be used by an appropriately trained and licensed healthcare
practitioner.
2.2.
Contra Indications
The SonicOne O.R. 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 O.R. 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
Limits For Airborn Acoustic Exposure
Distance from operator’s
or patient’s ear
Maximum Exposure Period
Within a 24 hour period
3”
-
24”
8 cm
–
60 cm
28 minutes
> 24”
> 60 cm
287 minutes
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 O.R system and its accessories may emit harmful acoustic pressure if exposure exceeds recommended limits.
Wear
hearing protection or protect patient hearing if not within the exporsure limits.
WARNING 3.4
For the Wide Hatch Probe: Less than
50”
(127 cm) tall patients to wear ear protection during debridement. All other patients
