Indications, Safety, and Warnings

Indications, Safety, and Warnings

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 a physician. 2008K@home 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 2008K@homehemodialysis 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 System full package labeling.

The WetAlert wireless wetness detector is indicated for use with the 2008K@homehemodialysis 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.

Note: Every HD patient’s level of risk for venous needle dislodgement should be assessed before beginning treatment.  The most important precaution patients, caregivers and HD professionals can take against VND is to monitor the access site, keeping it visible at all times during dialysis.  WetAlert full package label.

The CombiSet blood tubing is indicated for use with a prescribed hemodialyzer. The suitability of a particular configuration is the responsibility of the physician. CombiSet full package labeling.

The Optiflux dialyzers are designed for single-use acute and chronic hemodialysis. Optiflux dialyzers full package labeling.

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