Indications, Safety and Warnings
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.
For safe and proper use of these devices refer to the device’s Instructions for Use. See full package labeling for a complete description of hazards, contraindications, side effects and precautions in the [email protected] User’s Guide.