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Indications, safety and 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.

2008K@home machine
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 Hemodialysis Machine with bibag System
The 2008K@home machine is indicated for acute and chronic dialysis therapy in and acute or chronic facility. The 2008K@home 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 three stream proportioning hemodialysis systems equipped with the bibag module, such as the 2008K@home hemodialysis machine and is intended for use in bicarbonate hemodialysis for acute and chronic renal failure. The bibag system intended for extracorporeal bicarbonate hemodialysis according to a physician’s prescription.

WetAlert Wireless Wetness Detector
The WetAlert wireless wetness detector is indicated for use with the 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.

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 a VND is to monitor the access site, keeping it visible at all times during dialysis.

DIASAFE Plus
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.).

2008 MeDS pump
The 2008 MeDS pump is an optional accessory for use with the Fresenius Medical Care 2008 series hemodialysis machines and is intended to administer Venofer (iron sucrose injection, USP) to treat iron deficiency anemia in patients with chronic kidney disease undergoing hemodialysis, where Venofer, in conjunction with hemodialysis, as prescribed by a physician.

2008T
The 2008T machine is indicated for acute and chronic dialysis therapy.

bibag
The 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.

Crit-Line
The Crit-Line monitor III (CLM III) is a non-invasive hematocrit, oxygen saturation and percent change in blood volume monitor used in the treatment of hemodialysis patients. In addition, the CLM III estimates access recirculation and access blood flow in hemodialysis patients.

CLiC
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.

OnLine Clearance Monitor
The OnLine Clearance Monitor is intended to be used as a module with the Fresenius Medical Care 2008H hemodialysis machine for determination of dialysis treatment urea clearance and for access flow estimation for those patients undergoing acute or chronic hemodialysis.

Twister Reverse Flow Device
The 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 during hemodialysis in order to obtain an access flow measurement.

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

Dialyzers
The Hemoflow F5, F6, F8, F60A & F80A dialyzers and Optiflux F200A, F200B, F180A and F180B are designed for acute and chronic hemodialysis and are appropriate for single and multiple use when reprocessed utilizing the methods described in package insert.

The Hemoflow F3, F4, F40S, F50NRe; Optiflux 16NRe, 18NRe, 20NRe, F160NR, F160NRe, F180NR, F180NRe, F200NR, F200NRe; and Ultraflux AV400S and AV600S are designed for single use acute and chronic hemodialysis.

The Optiflux 250NR is intended for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate.

iCare
The Fresenius Medical Care Monitoring System is a computer-based hemodialysis treatment monitoring system for adjunctive use with the 2008 series dialysate delivery system when the patient is attended by trained personnel. This monitoring system is contraindicated as the sole method of monitoring a patient during hemodialysis.

CombiSet with Twister
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.

Citrasate
Citrasate hemodialysate concentrate solution is formulated to be used with a three stream hemodialysis machine which is calibrated for acid and bicarbonate dialysate concentrates.

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.

Liberty cycler
The Liberty cycler is intended for acute and chronic peritoneal dialysis.

Newton IQ cycler
The Newton IQ cycler is intended for acute and chronic peritoneal dialysis.

stay·safe
The stay·safe patient connectors are intended for use with a peritoneal cycler for drainage and infusion of PD solution during peritoneal dialysis exchanges. The stay·safe patient connectors are indicated for acute and chronic peritoneal dialysis.

© 2015, 2017, Fresenius Medical Care, All Rights Reserved. Fresenius Medical Care, the triangle logo, Fresenius Renal Technologies, the @home logo, WetAlert, DIASAFE Plus, MeDS pump, 2008, bibag, Crit-Line, CLiC, Twister, CombiSet, Hemoflow, Optiflux, Liberty, Newton IQ, success@home and stay·safe are trademarks of Fresenius Medical Care Holdings, Inc or its affiliated companies. Citrasate is a registered trademark of Advanced Renal Technologies in the United States and is used under license from Advanced Renal Technologies. All other trademarks are the property of their respective owners.  P/N 102763-03 Rev B 10/2017

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