Indications, Safety and Warnings
Note: Read the Instructions for Use for safe and proper use of this device. For a complete description of hazards, contraindications, side effects and precautions, see full package labeling.
Indications for Use: The [email protected] machine is indicated for acute and chronic dialysis therapy in an acute or chronic facility. The [email protected] machine is also indicated for hemodialysis in the home and must be observed by a trained and qualified person as prescribed by a physician.
The bibag® system is used with Fresenius Renal Technologies three stream proportioning hemodialysis systems equipped with the bibag module, such as the [email protected] 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.
The WetAlert wireless wetness detector is indicated for use with the [email protected] 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.
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.
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 Optiflux dialyzers are designed for single-use acute and chronic hemodialysis.
Caution: Federal (US) law restricts these devices to sale by or on the order of a physician.
Warning: Acid concentrate products are used as one component in mixing dialysate bath. These acid products contain chemical compounds that, after mixing, yield acetate (and citrate in certain products) in the dialysate. (Please refer to the acid concentrate product labeling for specific acetate/citrate amounts.) After diffusion across the dialyzer membrane, acetate (and citrate when present) is metabolized by the liver to serum bicarbonate and adds to the serum bicarbonate that separately results from the diffusion of dialysate bicarbonate across the dialyzer membrane. During dialysis, the dynamic of diffusion and concentration gradients prevent serum bicarbonate concentration from exceeding the dialysate bicarbonate concentration. The bicarbonate concentration of the dialysate is the “bicarbonate” setting on the dialysis machine, and is the bicarbonate dose prescribed by the physician. On 2008 series hemodialysis machines, the bicarbonate dose may be set in a range between 20 and 40 milliequivalents per liter, but may be set in different ranges in other machines.
When the dialysis session terminates, acetate (and citrate when present) that has not yet metabolized may remain in the blood and will be converted to serum bicarbonate after diffusion ceases, without possibility of diffusion out of the blood. The post dialysis metabolism of acetate (and citrate when present) could thus briefly increase serum bicarbonate concentration above the prescribed bicarbonate concentration of the dialysate. Physicians should consider this possibility in prescribing bicarbonate dose.
Prescription of insufficient bicarbonate may contribute to metabolic acidosis; excessive bicarbonate may contribute to metabolic alkalosis. Both conditions are associated with poor patient outcomes, including increased mortality risk.