• Tissue selective ultrasonic debridement
• Consistently maximizes wound bed preparation
• Removes bioburden
• Reduces blood loss

The SonicOne® O.R is indicated for use in debridement of wounds such as, but not limited to, burn wounds, diabetic ulcers, bed sores 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 is contraindicated for cardiac surgery and any procedure in the proximity of the heart. The irrigation pump is contraindicated for the administration of parenteral fluids, infusion of drugs or for any life sustaining purposes.

Special Skill and Training requirements: Federal law restricts this device to sale by or on the order of a licensed health care practitioner. The SonicOne® O.R. is to be used by an appropriately trained and licensed health care practitioner. The SonicOne® O.R system is an electro-mechanical device, which under certain circumstances could present an electrical shock hazard to the operator and/or patient. Please read manual thoroughly and follow directions stated herein to assure maximum safety during operation. The manual shall be kept in close proximity to the system for easy referral when needed.

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. 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. The SonicOne® O.R system and its accessories may emit harmful acoustic pressure if exposure exceeds recommended limits. For the Wide Hatch Probe: Less than 50" (127cm) tall patients to wear ear protection during debridement. All other patients to wear ear protection only for upper body debridement.

Temperature: -4°F-122°F (-20°C-50°C)
Relative humidity: 15%-90% (non condensing)
Ambient pressure extremes: 40,000ft (12,192m)