Indications, Safety, and Warnings
Indications, Safety, and Warnings
The 2008T hemodialysis machine is indicated for acute and chronic dialysis therapy in a healthcare facility. 2008T hemodialysis machine full package labeling.
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 ≥ 20kg 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. 2008T BlueStar hemodialysis machine full package labeling.
bibag On-line Bicarbonate Concentrate is used with three stream proportioning hemodialysis systems equipped with the bibag module such as the 2008T Hemodialysis Machine and is 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. bibag On-line Bicarbonate Concentrate full package labeling.
Crit-Line Clip Monitor (CLiC) (Optional): The Crit-Line Clip Monitor is used with the 2008T 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. Crit-Line Clip Monitor full package labeling.
Citrasate hemodialysate concentrate solution is formulated to be used with a three stream hemodialysis machine which is calibrated for acid and bicarbonate dialysate concentrates.
DIASAFE Plus filter is intended for the preparation of ultrapure dialysis fluid for use in hemodialysis. Attention must still be given to the chemical and microbiological quality of water and concentrate and the maintenance of supply systems (e.g., RO system, water delivery system, etc.). DIASAFE Plus filter full package labeling.
OnLine Clearance Monitor is intended to be used as a module with the Fresenius Renal Technologies 2008 series hemodialysis machines for determination of dialysis treatment urea clearance and for access flow estimation for those patients undergoing acute or chronic hemodialysis. OnLine Clearance Monitor full package labeling available within Fresenius Renal Technologies hemodialysis machine manual.
Caution: Frequency, duration, and parameters of treatment are to be determined by the prescribing physician.
Note: Not all features are available in all regions.
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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 available at www.fmcna.com.
© 2013, 2018, Fresenius Medical Care, All Rights Reserved. Fresenius Medical Care, the triangle logo, Fresenius Renal Technologies, 2008, 2008K@home, BlueStar, bibag, DIASAFE, Crit-Line, CLiC, and Clinical Data eXchange (CDX) are trademarks of Fresenius Medical Care Holdings, Inc. or its affiliated companies. Citrasate is a registered trademark of Advanced Renal Technologies, Inc. in the United States and is used under license from Advanced Renal Technologies. All other trademarks are the property of their respective owners. P/N 102054-01 Rev D 10/2018