The 2008® Series of Hemodialysis Machines. Take a Closer Look to Discover Which is Right for You.

Indications, Safety, & Warnings

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 2008T hemodialysis machine is indicated for acute and chronic dialysis therapy. 2008T hemodialysis machine full package labeling.

The 2008K2 Hemodialysis Machine is indicated for acute and chronic hemodialysis 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 =40kg). 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 =40kg.The 2008K2 hemodialysis machine is not to be used for plasma replacement therapies, for patients weighing less than 20kg, or for renal therapies using substitution fluid. 2008K2 hemodialyis full package labeling.

The 2008K@home machine is indicated for acute and chronic dialysis therapy in an acute or chronic facility. The 2008K@home machine is also indicated for hemodialysis in the home and must be observed by a trained and qualified person as prescribed by their physician. 2008K@home 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 bibag® system is used with Fresenius Renal Technologies 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 Crit-Line III monitor is a non-invasive hematocrit, oxygen saturation and percent change in blood volume monitor used in the treatment of hemodialysis patients. In addition, the Crit-Line III monitor estimates access recirculation and access blood flow in hemodialysis patients. The blood chamber is connected between the arterial bloodline and the dialyzer within the extracorporeal circuit during the hemodialysis treatment.
Crit-Line monitor full package labeling.

The Crit-Line IV monitor is used to non-invasively measure hematocrit, oxygen saturation and percent change in blood volume. The sensor clip 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 Crit-Line blood chamber is a sterile, single use, disposable, optical cuvette designed for use with the Crit-Line 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.

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.

The 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.

The CombiSet blood tubing is indicated for use with a prescribed hemodialyzer. The suitability of a particular configuration is the responsibility of the physician. The Twister Access Flow Reversing Connector (AFRC) is intended 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.

The WetAlert™ wireless wetness detector is indicated for use with the Fresenius Renal Technologies 2008K@home hemodialysis machine and is an optional accessory to aid in the detection of blood and water leaks during hemodialysis. Home hemodialysis using the detector must be observed by a trained and qualified person as prescribed by their physician. WetAlert wireless wetness detector 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.