The SonaStar Ultrasonic Surgical Aspiration System is a microprocessor-based control system and handpiece designed for the fragmentation, emulsification, and aspiration of both soft and hard tissues, including bone, in various surgical specialties. It is a self-contained console with integrated irrigation, aspiration, and vibration systems, and can also perform electrosurgery functions when combined with an approved electrosurgical unit.
Function Description:
The system operates by high-frequency vibration of a titanium tip connected to the handpiece, causing tissue rupture through vacuum effects and cavitation. The tip oscillates longitudinally at approximately 23,000 cycles per second. The vibration level or amplitude can be preset to a single fixed level or linearly varied up to a selected level when the footswitch is pressed.
Irrigating solution (sterile IV solution) is supplied to the distal end of the tip to suspend fragmented particles, prevent clogging of the aspiration system, and cool the tip, excision site, and handpiece transducer. The flow rate can be adjusted from approximately 2cc/min to 10cc/min. A minimum setting of 25 (approx. 2.5cc/min) is recommended for optimal cooling and clog prevention. When vibration is activated, irrigation fluid flows at the preset level. After the footswitch is released, irrigation continues for two minutes at a minimal flow rate of 2cc/min to clear the aspiration line and keep the handpiece cool. During COAG, irrigation fluid is supplied at a rate greater than 15cc/min to cool the tip and prevent eschar buildup.
A self-contained vacuum pump provides continuous aspiration of irrigation fluid and fragmented tissue particles through the hollow titanium tip and handpiece aspiration canal, into a collection canister. Aspiration level is controlled at the front panel, with a maximum setting of '100' corresponding to approximately 23 inches Hg (585 mmHg) at sea level. A minimum vacuum of approximately 1 inch Hg (25 mmHg) is maintained in Standby mode. When vibration is activated, suction increases to the preset level. A pinch-off feature momentarily cuts off suction for 1/2 second when the foot pedal is released, or continuously during flush mode, to maximize irrigation delivery to the surgical site.
The system features a wireless multi-pedal footswitch that communicates via infrared beams to two integrated IR receivers on the console and an optional remote IR receiver. The footswitch enables remote activation and control of VIBRATION, VIBRATION+COAG, COAG, and FLUSH functions. Four coded wireless frequencies (0, 1, 2, 3) are available to prevent interference between multiple systems.
Important Technical Specifications:
- Physical Dimensions: Height: 40" (102cm), Width: 25" (63.5cm), Depth: 19" (48cm).
- Weight: 120 pounds (54.5 kg) for the bare console.
- Shelf Safe Working Load: 35lbs (15.9kg).
- Environmental Protection: IPX0.
- Operating Conditions: Temperature: 55-86°F (13-30°C), Relative humidity: 15-90% (non-condensing), Altitude maximum: 13,125ft. | 4,000m (custom calibration may be required above 5000ft).
- Shipping/Storage Conditions: Temperature: -4-122°F (-20-50°C), Relative humidity: 15-90% (non-condensing), Ambient pressure extremes: 40,000ft. | 12,000m.
- Power Requirements:
- Line Voltages: 100/110/115/120 VAC, 50/60 Hz. or 200/220/230/240 VAC, 50/60 Hz.
- Current Draw: 4 Amps max at 100/110/115/120 VAC, 2 Amps max at 200/220/230/240 VAC.
- Vibration Frequency: 23 kHz.
- Stroke Maximum Amplitude: Approximately 300 microns for Curved Extended (CE) handpiece, 200 microns for Short Straight (SS) handpiece.
- Irrigation Flow Rates (approximate): 2-10 cc/min (standard), >25 cc/min (fast flush), >15 cc/min (COAG with or without Vibration), 2 cc/min (2 minutes following deactivation of vibration).
- Aspiration Vacuum Level: Approximately 23" (585mm) Hg at sea level.
- Footswitch: Wireless, Infrared 870nm, 360 degree transmission, Range: Typically 40 feet, Latency: 200 milliseconds, Battery Operated: 3 AA alkaline cells, Battery Life: 150 hours @ 50% Duty cycle typical, Current Consumption (Stand-By): 250ua. Certification: IEC/UL 60601-1 2nd and 3rd Edition Safety, EN60601-1-2: 2007 EMC, EN60529 Degree of Protection IP68. Size: 14.0in x 10.0in x 3.0in, Weight: 5.5 lbs w/batteries.
- Remote IR Receiver: Redundant infrared receiver. Certification: IEC/UL 60601-1 2nd and 3rd Edition Safety, EN60601-1-2: 2007 EMC, EN60529 Degree of Protection IP68. Size: 5.0 in diameter, Weight: 2.0 lbs. Cable Length: 18 feet (5.5 m).
- Handpieces: Piezoelectric transducer – 23kHz, Autoclavable.
- Short Straight: Length w/o probe 4.8" (13 cm), Diameter .8" (2.0 cm), Weight w/ tip 3.2 oz. (91 g).
- Curved Extended: Length w/o probe 9.5" (24.1 cm), Diameter .8" (2.0 cm), Weight w/ tip 4.16 oz. (118 g).
- Cable length (for both): 17′ (5.2 m).
- Fuses (100/110/115/120 VAC Systems): F1 & F2: 5x20 mm Fast-Acting, 6.3A, 250V (LITTLEFUSE Part Number 021706.3, Bottom). F3: 3AG Fast-Acting, 5A, 250V (LITTLEFUSE Part Number 312005, Top).
- Fuses (200/220/230/240 VAC Systems): F1 & F2: 5x20 mm Time Delay, 3.0A, 250V (LITTLEFUSE Part Number 0239003, Bottom). F3: 3AG Fast-Acting, 5A, 250V (LITTLEFUSE Part Number 312005, Top).
- UL (IEC) 60601-1 Classification: Class I Equipment, Type B Equipment, Ordinary Equipment.
Usage Features:
- Color Coding: Blue for vibration, Green for aspiration, Yellow for irrigation. COAG is also designated by blue on the electrosurgery unit and footswitch pedal.
- Front Panel Controls: Power on/off, Setup, Linear, Preset keys, Amplitude adjustment, Aspiration vacuum level adjustment, Irrigation flow rate adjustment.
- Displays: LED displays for irrigation flow, vacuum level, and vibration percentage. Digital LED display for accumulated vibration time or error codes.
- Setup Key: Initiates system self-testing, including handpiece vibration test and aspiration/irrigation system tests.
- Preset/Linear Keys: Toggle functions for controlling vibration level. Preset mode activates vibration at a selected fixed level. Linear mode allows variable vibration level proportional to footswitch depression.
- Fault Indicator: Illuminates with an error code on the digital display if a system malfunction is detected. Faults can be cleared by pressing Preset or Linear keys, or overridden for non-critical E4 errors.
- Low Footswitch Battery Indicator: Red LED on the console top illuminates when footswitch batteries are low.
- Footswitch Activation Indicator: Blinking blue LED on the console top indicates signal reception from the wireless footswitch.
- Electrosurgery Integration: Approved electrosurgical units (e.g., Valleylab ForceFX, Force2, Erbe ICC 300, ConMed Sabre 2400, ConMed 7500) can be connected for monopolar COAG. CUT MODE is disabled for use with the SonaStar.
- Handpiece Types: Two configurations: Curved Extended (CE) and Short Straight (SS), both electrosurgery compatible.
- Procedure Trays: Contain disposable titanium tip (probe), wire stylet, O-rings, and silicone sleeve/tip or rigid sleeve. OsteoSculpt™ bone shaver probes are for Short Straight (SS) handpieces only.
- Handpiece Assembly: Requires proper tightening of the tip with a torque wrench and counter wrench.
- Safety: Warnings against touching the tip during activation, operating without proper irrigation, and using in flammable atmospheres. Recommendations for proper grounding and use of specified sterilization cycles.
- Airborne Acoustic Exposure Limits: Guidelines for maximum exposure time based on distance from the tip to the patient's or operator's ear. Hearing protection is recommended if limits are exceeded.
Maintenance Features:
- Cleaning Procedures: Detailed manual and automated cleaning procedures for handpieces, front housing, wrenches, and silicone connectors using enzymatic detergents and hot water.
- Console, Footswitch, IR Receiver Cleaning: External surfaces can be cleaned with surface disinfectant wipes. The console is not sealed against liquids, and internal cleaning should only be performed by authorized personnel.
- Sterilization: Steam autoclave methods are specified for handpieces, components, and wrenches. Sterilization cycles are provided for both disassembled and assembled handpieces, with specific temperature, exposure, and dry times.
- Filter Replacement: External and internal aspiration filters should be changed at 6-month intervals or when soiled/clogged.
- Torque Wrench Recalibration: Recommended every 12 months.
- Footswitch Battery Replacement: Three AA alkaline batteries when the low battery indicator illuminates.
- Service & Repair: Contact Misonix, LLC for repairs or maintenance. No user-serviceable parts within the console.
- Environmental Protection: All equipment should be disposed of according to local requirements at the end of its life, following WEEE Directive guidelines for users within the European Economic Area.
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