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Intradialytic Hypoxemia on Hemodialysis Disclosure

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References:

1 Moissl U, et al., Hemodial Int. 2022 Apr;26(2):264-273.
2 Zoccali C et al., JASN August 2017, 28 (8) 2491-2497.
3 Wabel, P. et al., Blood Purif. 2009;27(1):75-80.
4 Hussein W, et al., Am J Kidney Dis. 2016; 67(1):166-8.
5 Agarwal R, Hypertension. 2010;56(3):512-7.
6 Balter P, et al.,Curr Med Res Opin. 2015;31(7):1323-31.
7 Sibbel S., et al., Blood Purif 2014;37:249–25.
8 Ho W., et al., Nephrol Dial Transplant (2010) 25: 2710–2714.

Indications for Use:

2008T BlueStar™ Hemodialysis Machine:
The 2008T BlueStar Hemodialysis Machine is indicated for acute and chronic dialysis therapy in a healthcare facility.
Additional therapy options for patients receiving hemodialysis include: Isolated Ultrafiltration, Sustained Low Efficiency Dialysis (SLED), and low volume hemodialysis (patients weighing ≥20 kg and ≤40 kg). This machine accommodates the use of both low flux and high flux dialyzers. The SLED therapy option is not to be used for patients weighing ≤40 kg. The 2008T BlueStar Hemodialysis Machine is not to be used for plasma replacement therapies, for patients weighing less than 20 kg, or for renal therapies using substitution fluid.
bibag^® System (Optional):
The bibag system is used with three stream proportioning Hemodialysis Machines equipped with the bibag module such as the 2008T BlueStar Hemodialysis Machine and intended for use in bicarbonate hemodialysis for acute and chronic renal failure. The bibag is intended for extracorporeal bicarbonate hemodialysis according to a physician‘s prescription.
Crit-Line^® Clip Monitor (CLiC™) (Optional):
The Crit-Line Clip Monitor is used with the 2008T BlueStar Hemodialysis Machine to non-invasively measure hematocrit, oxygen saturation and percent change in blood volume. The CLiC device measures hematocrit, percent change in blood volume and oxygen saturation in real time for application in the treatment of dialysis patients with the intended purpose of providing a more effective treatment for both the dialysis patient and the clinician. Based on the data that the monitor provides, the clinician/nurse, under physician direction, intervenes (i.e., increases or decreases the rate at which fluid is removed from the blood) in order to remove the maximum amount of fluid from the dialysis patient without the patient experiencing the common complications of dialysis which include nausea, cramping and vomiting.
Caution: Federal (US) law restricts these devices to sale by or on the order of a physician.
Note: Read the Instructions for Use for safe and proper use of these devices. For a complete description of hazards, contraindications, side effects, and precautions, see full package labeling at fmcna.com.

© 2023, 2024 Fresenius Medical Care. All Rights Reserved. Fresenius Medical Care, the triangle logo, 2008T BlueStar, bibag, Crit-Line, and CLiC are trademarks of Fresenius Medical Care Holdings, Inc., or its affiliated companies. All other trademarks are the property of their respective owners.
D/N US-CLM-000001 Rev A 04/2024

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