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RenalGuard System is comprised of a Console and a RenalGuard Single Use Set for infusion and urine collection. The Single Use Set contains a urine collection set which connects to a patient's Foley catheter and an infusion set which connects to a standard IV catheter. The Console measures the volume of urine in the collection set and infuses an equal volume of hydration fluid to match the patient's urine output. The Console relies on proprietary, patented software and electronic weight measurements to control the rate at which fluid is infused and to monitor urine volume.

The Console is mounted on a standard IV pole and is equipped with an internal battery that allows operation while the patient is being transported within a hospital.

In addition to urine volume replacement, a user can set RenalGuard System to achieve a net fluid gain over and above matched hydration. RenalGuard System also allows infusion of a bolus of fluid at the user's request.

In a clinical setting, it is important that the device is straightforward and flexible. RenalGuard System achieves this in a number of ways:

Straightforward hospital integration

  • Automatic priming and operating features allow existing staff to operate the console
  • Familiar operational features minimize staff learning curve and user errors
  • Connections mate with standard hospital catheters.

Flexible, software-controlled fluid management

  • Accurate measurement system is designed for reliable matched fluid replacement
  • Clinically relevant safety modes and sensors increase confidence in patient welfare
  • Simple displays and function support implementation of RenalGuard Therapy™

 

Clinical Investigations are planned to establish the safety and effectiveness of RenalGuard Therapy in reducing the incidence of Contrast-Induced Nephropathy (CIN) in high-risk patients.  RenalGuard System is not intended for the infusion of blood, blood components, medications, or nutritional fluids, nor have any investigations been carried out on patients with congestive heart failure (CHF) or acute cardiac instability.