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

The principles of operation and technology incorporated in the Infiltration Pump are equivalent to peristaltic infiltration/irrigation devices, which use peristalsis-type action to move fluid through a tube by alternating mechanical squeezing of fluid-filled tubing with a roller. The Infiltration Pump uses a multiple roller pump and a mechanical tubing clamp to squeeze and hold tubing and assist in moving fluid from an IV fluid bag to the infiltration site. As with all peristaltic pumps, the Infiltration Pump contacts only the tubing and never directly contacts the fluid, thus fluid sterility cannot be compromised by the pumping action.

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Transrectal (B and M mode of operation)

PR3 Ultrasound System with 6.5 R11 Endocavity Probe