The system is an ultrasonic surgical aspirator system that allows a surgeon to remove tissue efficiently and selectively. It performs three functions:

fragmentation, irrigation, and aspiration.

2.1.1 Fragmentation

The console supplies the high-frequency handpiece with an alternating voltage signal at 36,000 cycles per second (36 kHz). This voltage moves to

opposite poles of a stack of piezoelectric ceramic discs fastened to the metallic body inside the handpiece. The resulting oscillating electric field causes

the discs to vibrate. This vibration transitions down the length of the metallic body and into the surgical tip. The slender, tapered shape of the surgical

tip focuses the vibrational energy at the tip of the handpiece. Fragmentation occurs when the vibrating tip meets the tissue, causing the tissue to break

apart.

Note

All three functions may occur at the same time.

2.1.2 Irrigation

The system transfers irrigation fluid from a user-supplied IV saline or Lactated Ringer's solution to the distal tip of the handpiece. Sterile irrigation fluid flows

from an IV set (bottle or bag and IV administration tubing) to a variable speed peristaltic pump.

The pump:

• Moves fluid at 2 to 20 mL/min; default flow is 3 mL/min. Use the adjustment slider (move the slider up/down on the Irrigation column on the touch

screen) to increase or decrease the irrigation flow in 1 mL/min increments.

• Accelerates to a Fast Flush speed, pumping at 25 mL/min ± 0.5 mL/min. The Fast Flush pedal on the system footswitch activates the Fast Flush feature.

The pump pushes the fluid through the manifold irrigation tubing to a flue, a sleeve surrounding the vibrating tip. As the irrigation fluid passes through the flue,

it cools the tip.

When the fluid reaches the distal end of the tip, as much as 99% of it passes through two pre-aspiration holes in the tip, preventing fluid pooling in the sterile

field and continually clearing the suction system. Fluid that does not pass through the pre-aspiration holes irrigates the surgical site and suspends fragmented

tissue.

2.1.3 Aspiration (Suction)

Aspiration enables Constant Tissue Contact, the consistent, tangible contact between tip and tissue, which is essential in efficient tissue resection. A

vacuum pump in the console provides nominally 640mmHg maximum dead head vacuum at sea level. Use the adjustment buttons (move the slider up/

down on the Aspiration column on the touchscreen display) to increase or decrease the suction from 10 to 100% in 5% increments; default is 60%.

The suction, which produces an air stream moving toward the vacuum pump, pulls irrigation fluid, fragmented tissue, and other materials through the

distal end of the surgical tip. From the tip, the aspirated materials pass through the handpiece and manifold suction tubing into the suction canister. From

the suction canister, the air stream continues to flow through a contamination guard that filters any remaining particulate matter or moisture, preventing

them from entering the vacuum pump.

The accuracy of the vacuum level in the aspiration tubing at the port of the handpiece is ± 66 mmHg and never less than 30 mmHg.

A suction pinch valve on the front of the console opens when the system is on, and closes to stop suction when:

• Priming the irrigation system

• Pressing the Fast Flush pedal

• Releasing the amplitude pedal in Run Status (in this case, the pinch valve closes for approximately one second, then re-opens).

• Releasing the amplitude pedal in the on demand aspiration mode, this suction stoppage prevents depletion of the pneumoperitoneum.

When powered off, the system's suction pump remains off and the suction pinch valve remains closed. Use the pinch value button on the front of the

suction pinch valve to open the valve manually

CAUTION

High frequency surgical equipment can affect the function of medical electrical devices such as ultrasonic aspirators. When using monopolar high

frequency surgical equipment simultaneously with the CUSA Clarity system, contact between the activated monopolar electrosurgery instrument