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 custom 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 the RenalGuard System to achieve a net fluid gain over and above matched hydration or to achieve a net fluid loss. RenalGuard System allows infusion of a bolus of fluid at the user's request. In addition, RenalGuard System is capable of adjusting matched hydration to take into account other fluid sources.
The RenalGuard System is CE-marked for the intended use of temporary (up to 14 days) replacement of urine output by infusion of a matched volume of sterile replacement solution to maintain a patient’s intravascular fluid volume, and has demonstrated accurate matched replacement and an appropriate safety profile with normal saline in limited human use.