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 below.
The Fresenius Renal Technologies 2008T hemodialysis machine is indicated for acute and chronic dialysis therapy.
2008T hemodialysis machine full package labeling.
The 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.
The Fresenius Renal Technologies bibag® system is used with Fresenius Medical Care 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. bibag bicarbonate concentrate is intended for extracorporeal bicarbonate hemodialysis according
to a physician’s prescription. bibag machine module full package labeling. bibag disposable full package labeling.
The CLiC device 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. The CLiC blood chamber is a sterile, single use, disposable, optical cuvette designed for use with the CLiC monitor’s sensor clip during acute and chronic hemodialysis therapy to non-invasively measure hematocrit, percent change in blood volume and oxygen saturation. The blood chamber is connected between the arterial bloodline and the dialyzer within the extracorporeal circuit during the hemodialysis treatment. Crit-Line Technology.
The Fresenius Renal Technologies 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 FMCNA
hemodialysis machine manual.
The CombiSet® with Twister® device is for use during hemodialysis to reverse the blood flow to and from the arterial and venous
vascular access devices in order to obtain an access flow measurement. CombiSet with Twister 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.