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The 5008Xâ„¢ CAREsystem With
High-Volume Hemodiafiltration

The 5008X CAREsystem enablesÌýadvanced, in-center hemodialysis care by providing both online hemodialysis (HD) and high-volume hemodiafiltration (HighVolumeHDF or HVHDF).

The 5008X CAREsystemÄ¢¹½´«Ã½˜s intelligent automationÌýempowers clinicians to focus on what matters most: the patient.

HVHDF offers patients an extraordinary treatment option. Clinical evidence (CONVINCE Trial) has shown aÌý23% reductionÌýin relative risk of mortality compared to High-Flux HD.1*

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*CONVINCE Trial Disclaimer: The CONVINCE Trial was an international pragmatic, randomized, controlled trial that compared all-cause mortality in European dialysis patients randomized to high-flux hemodialysis or high-dose (≥23 ± 1 L convection volume / session) hemodiafiltration.

The impact of high-dose hemodiafiltration on the dialysis patients in the United States has not been evaluated and the results of this trial may not reflect outcomes with this therapy in the United States.

The suitability of high-dose hemodiafiltration for a given patient should be based on each patientÄ¢¹½´«Ã½˜s individual characteristics and is the sole responsibility of the attending physician.

The CONVINCE Trial and other clinical studies supporting HighVolumeHDF were conducted outside of the US and did not involve the 5008X CAREsystem.

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Introducing HighVolumeHDF

HighVolumeHDFÌýhas demonstrated a positive impact on all-cause and cardiovascular mortality.2,3ÌýHVHDFÌýhas also shown the potential to reduce hospitalization rates and hypotensive episodes.4,5ÌýIn addition,ÌýHVHDF has been associated with improved quality of life, including: better preservation of cognitive function, extended ability for social participation, and a trend for reduced interference of daily activities due to pain.6

Delivering Next-Generation Intelligent Technology

Intelligent features of the 5008X CAREsystem are designed to deliver advanced therapies and empower efficient workflow, including:

  • AutoSub plus, a fully automatedÌýsubstitution technology for delivering HighVolumeHDF therapy
  • 5008X CAREset bloodline safely delivers sterile non-pyrogenic substitution fluidÌýgenerated with the 5008X CAREsystem
  • FX CorAL®Ìýdialyzers with Ä¢¹½´«Ã½Ä¢¹½´«Ã½™s most advanced high-flux membrane are designed for better uremic toxin clearance and albumin preservation during every treatment
  • Crit-Line® fluid monitoring enables appropriate volume management that has been associated with direct improvement of patient outcomes7,8*

With the 5008X CAREsystem, HVHDF is as easy to deliver as HD with just ONE-TOUCH of a button.

*Referenced studies were not conducted with the 5008X CAREsystem.

Empowering Clinicians to Enhance Care

The 5008X CAREsystem is designed to simplify workflow, limit nuisance alarms, and enhance the clinician experienceÄ¢¹½´«Ã½”allowing for more focus on patient care.ÌýIts advanced automation technology is leading the way to next-generation therapy delivery.

  • With ONE-TOUCHÄ¢¹½´«Ã½¦Prime the extracorporeal circuit
  • With ONE-TOUCH...Deliver fluid boluses
  • With ONE-TOUCH...Perform HighVolumeHDF therapy
  • With ONE-TOUCH...Access an EMR system at chairside
  • With ONE-TOUCH...Initiate hydraulic disinfection

These advancements not only simplify clinical workflow, but, along with the 5008X ONLINEplusâ„¢ technology, eliminate the need for costly saline bags* and mitigate the impact of disruptions in the saline bag supply chain.

*In certain troubleshooting procedures, saline is required.

Extreme close-up image of the 5008X CAREsystem fluid delivery features

Driving Efficiency

  • Once-A-DayÌýhydraulic disinfectionÌý(no disinfection between treatments required under normal conditions)
  • ONLINEplus technology produces ONLINE sterile, non-pyrogenic solution to help improve workflow and eliminate the expense for saline in normal operations*
  • HighVolumeHDF with AutoFlow may reduce dialysate consumption, saving on water and acid concentrate usage (when delivering HVHDF with autoflow factor 1.2 or less vs. HF-HD with autoflow factor 1.5 or more)9Ä¢¹½´«Ã½ 
  • Interactive diagnostic tools save biomedical technicians valuable time by enabling intelligent hydraulic troubleshooting through on-screen controls

*In certain troubleshooting procedures, saline is required.
Ä¢¹½´«Ã½ Potential savings may vary. Treatment modality and dialysate flow rate for a patient should be based on each patient's characteristics and treatment goals and are the responsibility of the attending physician.

Close-up image of the 5008X CAREsystem, highlighting its monitor

Workflow Efficiency

ONE-TOUCH reducesÌýdisinfection handling steps by 97%10,11*

Compare the difference

5008X CAREsystem

  • 0 weekly interactions (0 CitraSureâ„¢ changes and 0 bleach)
  • 3 quarterly interactions (2 CitraSureâ„¢ changes and 1 bleach)
  • 12 annual interactions (8 CitraSureâ„¢ changes and 4 bleach)

Conventional US dialysis

  • 7 weekly Interactions (6 heat disinfection/acid flush and 1 bleach)
  • 91 quarterly interactions (78 heat disinfection/acid flush and13 bleach)
  • 364 annual interactions (312 heat disinfection/acid flush and 52 bleach)

*Data on File (Instructions for Use comparison 2008T BlueStarâ„¢ vs 5008X CAREsystem.)

Side-view image of the 5008X CAREsystem and its features

Safety Features

Dynamic monitoring resets the standard for safety

  • Venous Access Monitor (VAM): Highly sensitive venous pressure monitoring thatÌýallows early detection of needle dislodgements*Ìý
  • Extracorporeal leakage sensor can detect leaks in the blood circuit

With ONE-TOUCH ofÌýthe emergency button, four critical functions can be activated to:

  • Reduce blood flow
  • Measure blood pressure
  • Pause fluid removal
  • Infuse bolus volume

These advanced automated featuresÌýhelp mitigate patient risk and assist nursing staff during critical moments,Ìýreducing the chance of delayed responses and possible human error.

*Not every needle dislodgement can be detected. The user is still responsible for the patientÄ¢¹½´«Ã½˜s safety.Ìý

Front image of the 5008X CAREsystem and its features

Value Impact

The 5008X CAREsystemÌýis designed to drive measurable economic value.

Key value features:

  • Produces its own sterile, nonpyrogenic substitution fluid for priming, online bolus, and reinfusionÄ¢¹½´«Ã½”eliminating the need for bags of saline and associated costs*
  • Only requires preventive maintenance every 2 years versus a conventional system, which is recommended every 6 months
  • Potential for start-of-day and end-of-day labor savings, by reducing workflow steps
  • Reduces the need and cost for external diagnostic equipment, such as the Genius meter

*In normal operations.

Image of a clinician and a patient during a hemodialysis session with the 5008X CAREsystem

Experienced Team

Standing behind the 5008X CAREsystem is a dependable Ä¢¹½´«Ã½ team that offers the best product customer service in the industry.12 Our staff of experts cover these critical areas:

  • Customer Support
  • Technical Service
  • Clinical Education
  • Medical ScienceÌýLiaisons
  • Supply Chain and Logistics
Image of the 5008X CAREsystem and copy that states how it transforms the standard of kidney care

The 5008X CAREsystem is here to support healthcare professionals, clinicians, and clinics in providing the highest quality care for patients requiring hemodialysis therapy. WithÌýONE-TOUCH of a button, the 5008X CAREsystem provides the flexibility to deliver online hemodialysis orÌýHighVolumeHDF. The 5008X CAREsystem helps to streamline workflow, while providing important safety features for peace of mind.

Disclaimer

The information in this document is provided as is and no guarantee or warranty is given that the information is fit for any particular purpose. The user thereof uses the information at its sole risk and liability. The opinions expressed in the document are of the authors only and in no way reflect the European Commission's opinions.

Andorra Flag In Rectangle Square And Circle

Funded by the European Union

The CONVINCE study was exclusively supported by the European Commission Research & Innovation, Horizon 2020, Call H2020-SC1-2016-2017 under the topic SC1-PM-10-2017: Comparing the effectiveness of existing healthcare interventions in the adult population (grant no 754803).

Please note:Ìýreferences 1-6 and 9 are based on studies outside the United States.ÌýThe clinical studies supportingÌýHighVolumeHDF were conducted outside of the US and did not involve the 5008X CAREsystem.ÌýResults may differ.

References:

1. Blankestijn PJ, Vernooij RWM, Hockman C, et al; on behalf of the CONVINCE Scientific Committee Investigators. Effect of hemodiafiltration or hemodialysis on mortality in kidney failure. N Engl J Med. 2023;389(8):700-709.

2.ÌýVernooij RWM, Hockham C, Strippoli G, et al. Haemodiafiltration versus haemodialysis for kidney failure: an individual patient data meta-analysis of randomised controlled trials. Lancet. Published online October 25, 2024. doi:10.1016/S0140-6736(24)01859-2

3. Mostovaya IM, Blankestijn PJ, Bots ML, et al; on behalf of EUDIAL 1, an ERA-EDTA Working Group. Clinical evidence on hemodiafiltration: a systematic review and a meta-analysis. Semin Dial. 2014;27(2):119-127.

4. Maduell F, Moreso F, Pons M, et al; on behalf of the ESHOL Study Group. High-efficiency postdilution online hemodiafiltration reduces all-cause mortality in hemodialysis patients. J Am Soc Nephrol. 2013;24(3):487-497.

5.ÌýRootjes PA, Chaara S, de Roij van Zuijdewijn CLM, Nubé MJ, Wijngaarden G, Grooteman MPC. High-volume hemodiafiltration and cool hemodialysis have a beneficial effect on Intradialytic hemodynamics: a randomized cross-over trial of four intermittent dialysis strategies. Kidney Int Rep. 2022;7(9):1980-1990.

6.ÌýRose M, Fischer FH, Liegl G, et al. The CONVINCE randomized trial found positive effects on quality of life for patients with chronic kidney disease treated with hemodiafiltration.ÌýKidney Int.Ìý2024;106(5):961-971.

7. Balter P, Ficociello LH, Taylor PB, et al. A year-long quality improvement project on fluid management using blood volume monitoring during hemodialysis. Curr Med Res Opin. 2015;31(7):1323-1331.

8.ÌýPreciado P, Zhang H, Thijssen S, Kooman JP, van der Sande FM, Kotanko P. All-cause mortality in relation to changes in relative blood volume during hemodialysis. Nephrol Dial Transplant. 2019;34(8):1401-1408. doi:10.1093/ndt/gfy286

9. Canaud B, Gagel A, Peters A, Maierhofer A, Stuard S. Does online high-volume hemodiafiltration offer greater efficiency and sustainability compared with high-flux hemodialysis? A detailed simulation analysis anchored in real-world data. Clin Kidney J. 2024;17(6):sfae147.

10.Ìý5008X Hemodialysis system, Instructions for Use, Software version: 4.82, Edition: 04A, Date of issue: 2025-07, Part no.: F50047166.

11. 5008X Hemodialysis system, Instructions for Use, Software version: 4.80, Edition: 03A-2022, Date of issue: 2024-10, Part no.: F50029506, 2008T Hemodialysis Machine OperatorÄ¢¹½´«Ã½™s Manual, Part no.: 490122 Rev AB.

12. Data On File: IPSOS Preference Drivers Qualitative Research Report, March 2024.

Ìý

Indications for Use:

Machine:

The 5008Xâ„¢Ìýsystem isÌýindicatedÌýfor intermittent hemodialysis treatment for patients with acute and chronic renal failure in a healthcare facility. Therapy options for patients weighing more than 40 kg include: Hemodiafiltration (HDF), Hemodialysis (HD), Hemofiltration (HF)Ìýand Isolated Ultrafiltration.ÌýÌý

The 5008X Machine is equipped with aÌýbibag® system, but it may also be used with liquid bicarbonate using the connector included with the machine.ÌýÌý

TheÌýbibagÌýSystem isÌýindicatedÌýfor use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure. TheÌýbibagÌýSystem is intended to be used as oneÌýcomponentÌýin the preparation of dialysate according to a physician's prescription in a 3-stream proportioning hemodialysis machine equipped with theÌýbibagÌýmodule.ÌýÌý

The 5008X Machine is available equipped with a Crit-Line® Clip (CLiC) Monitor System.ÌýÌý

The optionalÌýCLiCÌýsystem is used to non-invasively measure hematocrit, oxygenÌýsaturationÌýand percent change in blood volume 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 dialysis technician. 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 symptoms of dialysis which include nausea, cramping and vomiting.ÌýÌý

DIASAFEPlusUSÌýFilter:ÌýÌý

TheÌýDIASAFE®plusUSÌýis intended for the preparation of ultrapure dialysate and sterile, non-pyrogenic substitution fluid from pretreated water and is not intended to provide primary purification. Attention must still be given to the chemical and microbiological quality of water andÌýconcentratesÌýand the maintenance of supply systemsÌý(e.g.ÌýRO system, central delivery system).ÌýÌý

The microbiological quality (microbial count [CFU/mL] and endotoxin measurement [EU/mL]) of the incoming water should be < 200 CFU/mL and < 2 EU/mL, respectively.ÌýÌý

TheÌýDIASAFE®plusUSÌýcan only be used with Ä¢¹½´«Ã½ dialysis machines fitted for use withÌýDIASAFE®plusUS.ÌýÌý

5008X Tubing Set:Ìý

The blood tubing sets are intended to be used only with the Ä¢¹½´«Ã½ 5008X Hemodialysis Device, which isÌýindicatedÌýfor intermittent hemodialysis treatment for patients with acute kidney injury or chronic kidney disease in a healthcare facility. Therapy options include: hemodiafiltration (HDF), hemodialysis (HD), hemofiltration (HF), and isolated ultrafiltration.ÌýÌý

The HDF blood tubing sets areÌýindicatedÌýfor use with a prescribed dialyzer. For use with a compatible dialyzer, as per the labeling.ÌýÌý

Additional Indications for Use for the blood tubing set equipped with Twister AFRCÌýÌý

The Fresenius Twister Access Flow Reversing Connector (AFRC) is indicated for use during hemodialysis to reverse the blood flow to and from the arterial and venous vascular access devicesÌýin order toÌýobtain an access flow measurement.ÌýÌý

Additional Indications for Use for the blood tubing set equipped withÌýCLiCÌýÌý

The blood tubing set is intended to be used with the Crit-Line Clip Monitor System (CLiC) on the 5008X Hemodialysis Device.ÌýÌý

TheÌýCLiCÌýis used to non-invasively measure hematocrit, oxygen saturation, and percent change in blood volume 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 dialysis technician. Based on the data that the monitor provides, the clinician/nurse,Ìýunder physician direction,Ìýintervenes (i.e.,Ìýincreases or decreases the rate at whichÌýfluidÌýis removed from the blood)ÌýinÌýorder to remove the maximum amount of fluid from the dialysis patient without the patient experiencing the common symptoms of dialysis which include nausea, cramping and vomiting.ÌýÌý

CitraSureÌýDisinfectant:ÌýÌý

CitraSureÌýis intended for thermal disinfection of the Ä¢¹½´«Ã½ 5008X Hemodialysis System when delivered and diluted per the 5008X heat disinfection program.Ìý

Caution:ÌýFederal (US) law restricts these devices to sale by or on the order of a physician.

© 2025 Ä¢¹½´«Ã½. All Rights Reserved. Ä¢¹½´«Ã½, the triangle logo, 5008X, bibag, Crit-Line, CLiC, and FX CorAL dialyzers are trademarks for which Ä¢¹½´«Ã½ AG holds rights. All other trademarks are the property of their respective owners.
D/N US-5008X-000022 Rev A 10/2025

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