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SonicOne® O.R. Ultrasonic Wound Care System
SonicOne® O.R. is an ultrasonic wound care system that provides thorough wound cleansing and debridement with minimal pain sensation and excellent preservation of healthy, soft tissue.
Bioventus
Bioventus
Bioventus, formerly Misonix, designs, develops and manufactures an array of therapeutic ultrasonic medical devices. Devices combine precision with power, utilizing state-of-the-art technology.
System or individual components.
• 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)
The console produces an electrical signal that is fed into the handpiece and its piezoelectric transducer. The transducer converts the electrical signal into mechanical vibrations. The vibratory motion is amplified all the way down to the tip's distal end. Various tip shapes and sizes are available to achieve desired tissue effects.
Debridement probes are typically used for contact wound debridement. Tissue excision and fragmentation are achieved through cavitation and other mechanical and hydrodynamic effects.
TECHNICAL SPECIFICATIONS:
Dimensions: 7"x16"x19" (180mmx410mmx485mm)
Weight: 25.6lb (11.6kg)
Mode of Operation: Continuous Wave and Pulse Wave
Operating Frequency: 22.5kHz
The ultrasonic tip engages the target area in linear strokes at a rate of approximately 22,500 cycles per second. During each cycle the tip elongates from resting to maximum position, contracts back over resting and to minimum position and elongates back to its resting point. The peak-to-peak amplitude or stroke distance can be adjusted by changing the amplitude from setting 1-10. This is the main parameter to control the rate of tissue removal. A high amplitude setting results in more aggressive tissue removal, a low setting in less aggressive tissue removal. Amplitude and thus removal rate may alter with size and geometry of the ultrasonic tip.
Proper system grounding can only be ensured when an approved, hospital-grade receptacle and matching power cord are used. To avoid the risk of electric shock, this equipment must only be connected to a supply with protective earth. Install plug and receptacles as per local regulations before operating the unit. Power cord, plug and receptacle should be examined to verify that they are in good working condition before connecting the console. Never pull on the power cord to remove it from the receptacle.
Connecting the console to a power outlet with inadequate voltage or frequency may cause the unit to malfunction or to create a shock or fire hazard. Confirm that the voltage selector switch in the console rear is set to the local voltage setting and ensure that the correct fuses are being used. Refer to section 12 on fuse replacement.
