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The PSI TEC III Peristaltic Infiltration Pump indications for use are lipoplasty general tumescent infiltration to include body contouring. The PSI TEC III Peristaltic Infiltration Pump is not intended for intravenous use.

The principles of operation and technology incorporated in the PT-PINF III pump are equivalent to peristaltic irrigation systems, which use peristalsis-type action to move fluid through a tube by alternating mechanical squeezing of fluid-filled tubing with a roller. The PT-PINF III uses a single-cam roller and a grooved channel to squeeze and hold tubing and assist in moving fluid from an I.V. fluid bag to the infiltration site. As with all peristaltic pumps, the PT-PINF III contacts only the tubing/tractor and never directly contacts the fluid, thus fluid sterility cannot be compromised by the pumping action.

The Accelerator Reciprocating Cannula indications for use are the removal of tissue or fluid from the body during general surgical procedures including suction lipoplasty for the purpose of aesthetic body contouring.

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The PSI-TEC Liposuction Aspirator(s) indications for use is for esthetic body contouring.

Powered Suction Pump(s)/Aspirator(s) which use an electrically (AC) driven vacuum pump generating a negative pressure for the removal of fat/adipose, soft tissue, and general surgical waste. The Psi-Tec Aspirator 2 also has the capability to capture the waste air "exhaust" (that creates the negative pressure) in an enclosed container. This now, contained and pressurized air, can then be utilized for driving other devices requiring the use of pressurized air.

The Aspiration and Infusion Cannulae and Needles indications for use are for Aesthetic Body Contouring.

The principles of operation and technology incorporated in the Cannulae and Needles are equivalent to fluid, soft tissue, and exudate removal and infusion instruments generally used for aspiration and infusion, utilizing a hollow Stainless Steal tube with multiple tip, handle and attachment connectors that are in a reusable and disposable configuration.

General surgical fluid irrigation and infiltration. The Psi-Tec Syringe Infusion Pump and accessories indications for use are for General Fluid Irrigation/Infiltration.

The principles of operation and technology incorporated in the Psi-Tec Svringe Infusion Pump and accessories are to provide controlled fluid delivery by utilizing a disposable, pneumatically driven syringe cartridge attached to tubing, that can propel and monitor fluid volumes delivered into a surgical site by the system.

General surgical fluids, exudate, soft tissue, and general tissue removal from surgical sites.

General aspirator(s), which use an electrically (AC) driven vacuum pump generating a negative pressure for evacuating surgical waste. The Psi-Tec Aspirator 2 also has the capability to capture the waste air "exhaust" (that creates the negative pressure) in an enclosed container. This now, contained and pressurized air, can then be utilized for driving other devices requiring the use of pressurized air.

The Tubing Indications for use are general surgical fluid, exudate, rne Tubing me aspiration and general surgical fluid irrigation/infiltration.

The principles of operation and technology incorporated in the Tubing are equivalent to other standard surgical tubing that acts as a pathway between the operative site and either an aspiration or irrigation source for fluid or soft tissue removal and fluid delivery.

The Big Bag 3000 Pressure Infusor indications for use are general surgical fluid irrigation and infiltration.

The principles of operation and technology incorporated in the Big Bag 3000 Pressure Infusor are equivalent to pressurized irrigation systems, which use compressed nonflammable gases within a closed bladder (inflatable cuff) to apply direct pressure externally to a bag of fluid for infusion of fluids.