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INDICATIONS FOR USE:
The NxStage® System OneTM is indicated for the treatment of acute and chronic renal failure, or fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration, in an acute or chronic care facility. The NxStage System One is also indicated for Therapeutic Plasma Exchange in a clinical environment. All treatments must be administered under a physician’s prescription, and must be observed by a trained and qualified person, considered to be competent in the use of this device by the prescribing physician. NxView is a computer-based touch screen user interface that provides online instructions for use, summarized system information, and remote access. NxView TM is contraindicated as the sole method of monitoring a patient during treatment.2
Renal replacement therapy, as with any medical therapy, is not without risks. The decision of which therapy to use should be made by the physician, based on previous experience and on the individual facts and circumstances of the patient. There is no literature demonstrating one therapy is clinically better than another.3
1. Michael S. Anger, Claudy Mullon, Linda H. Ficociello, David Thompson, Michael A. Kraus, Pete Newcomb, and Robert J. Kossmann, Kidney360, February 2021, 2 (2) 350-354, https://kidney360.asnjournals.org/content/2/2/350
2. NxStage System One User Guide, NC4921 Rev. H 2020-01.
3. Kraus MA. Selection of Dialysate and Replacement Fluids and Management of Electrolyte and Acid-Base Disturbances. Seminars in Dialysis; Vol 22, No 2 (March-April) 2009 pp. 137-140.
CAUTION: Federal law restricts this device to sale by or on the order of a physician.
© 2021 Fresenius Medical Care. All Rights Reserved. Fresenius Medical Care, the triangle logo, NxStage, NxView, and System One are trademarks of Fresenius Medical Care Holdings, Inc. or its affiliated companies. All other trademarks are the property of their respective owners.
P/N 104735-01 Rev A 05/2021 / APM3428 Rev A