Country websites

Attention

The medical device and therapy related information on this website is aimed exclusively at healthcare professionals.

The product related information on the websites covers – unless explicitly stated otherwise – only CE marked products which are marketable in the European Union. Please be aware that not all products and services described on the following website are cleared or available for sale in all countries. Please check the relevant country web site for details.

By clicking the button “Accepted and Confirmed” you assure that you have taken note of this information.

FX high-flux and FX low-flux dialyzers

Innovation at all levels

  • State-of-the art FX-class design
  • Efficient removal of uraemic toxins with the Helixone® membrane
  • INLINE steam sterilized
  • Available in both low-flux and high-flux ranges

Key features

FX dialyzers

    Several state-of-the-art technologies have been combined to create the distinctive functional features of the FX dialyzers. The fibre bundle geometry, the membrane nanostructure, the flow port and the housing design all provide advantages in terms of performance, hemodynamics, dialyzate flow, as well as safety and handling.

    Improved design and refined hemodynamics

    • The lateral blood-inlet port provides a homogenous blood-flow path, avoiding low velocity stagnation zones in the header region
    • The risk of accidental kinking of bloodlines is very low


    Lateral blood-inlet ports provide a homogenous blood-flow path

    Improved design and refined hemodynamics

    • The lateral blood-inlet port provides a homogenous blood-flow path, avoiding low velocity stagnation zones in the header region
    • The risk of accidental kinking of bloodlines is very low

    Radial dialyzate flow

    • The pinnacle structure of the polypropylene housing ensures a uniform dialyzate flow around the entire fiber bundle
    • A high packing density of the fiber bundle and a special wavy fiber structure to avoid dialyzate channeling
    • Combined these features enable the constant performance of all FX dialyzers

    Optimum fiber dimensions

    • The reduced inner diameter and wall thickness of the fiber increase the internal filtration and minimize diffusive resistance
    • A significant increase of both the diffusive and convective clearances is therefore achieved, allowing the efficient removal of a broad spectrum of uraemic toxins

    Dialyzer weight

      • Dialyzer weight is a crucial factor not only in logistics but also in waste management
      • The housing of FX dialyzers is made of polypropylene. In comparison to the widely used polycarbonate it is much lighter
      • The result: FX dialyzers weigh around half as much as most dialyzers.
      • FX60 = 105g

      Technology

      Helixone® — the advanced polysulfone membrane

      • Nanotechnology membrane fabrication procedures (Nano Controlled Spinning Technology, NCS) provide Helixone® with a highly-defined pore structure and distribution at the innermost, separating region of the membrane1,2
      • Unlike conventional pores which were rugged and uneven in shape, the pores at the inner layer of the Helixone® membrane are smooth and cylindrical
      • This reduces the resistance of the molecules when travelling through the pores and allows for enhanced removal

      Conventional pores

      Helixone® pores

      Helixone® has been specially designed to meet the demands of both low-flux and high-flux therapies:

      • More even distribution of pores
      • Estimated increased average pore size of 1.8 nm (low-flux) and 3.3 nm (high-flux)
      • Increased performance per unit of surface area

      NCSTM results in optimized pore size distribution and larger average pore size

      Performance (K0) per m² surface area

      INLINE steam sterilization – purity ensured

      No chemical residuals. Low rinsing volumes. Lower costs.

      INLINE steam sterilisation process

      INLINE steam sterilization – how it works

      1. Both the blood and the dialysate compartment of the dialyzers are rinsed continuously with steam at a temperature of 121°C for a minimum of 15 minutes, or a higher temperature for a shorter time, to ensure sterility. 
      2. The dialyzer is rinsed with sterile water
      3. Every dialyzer is tested for fiber integrity using a bubble-point test
      4. The dialyzers are dried with warm, sterile air
      5. Finally, after drying the blood inlet and outlet ports are closed

      INLINE steam sterilization – the benefits

      • Highly pure, sterile and pyrogen-free dialyzers without any potentially harmful residuals from sterilization
      • Biocompatibility of membranes remains unaffected from sterilization
      • Optimized use of resources due to low rinsing volumes: only 500 mL is required
      • Dry dialyzers with minimized risk of contamination due to microbial growth

      Fibre integrity testing

          • All dialyzers have to pass the bubble point test as part of the INLINE steam sterilization process
          • Sterile air is pressed into the dialyzate compartment while the blood compartment contains sterile water
          • If any leakages were present in the membrane, air would pass through the membrane and create bubbles
          • Dialyzers failing the integrity test are discarded
          • This integrity test minimizes the risk of fibre ruptures and the risk of blood leakages

          Performance data

          FX low-flux dialyzers

          FX low-flux dialyzersFX 5FX 8FX 10
          Ultrafiltration coefficient (ml/h x mmHg)81214
          Clearance: QB: (200ml/min)   
          Urea180191193
          Creatinine165178181
          Phosphate141160170
          Vitamin B1288107121
          Clearance: QB: (300ml/min)    
          Urea228254261
          Creatinine200225231
          Phosphate164194210
          Vitamin B1294120138
          Clearance: QB: (400ml/min)    
          Urea 293303
          Creatinine 252260
          Phosphate 213233
          Vitamin B12 126146
          The in vitro performance data were obtained with QD = 500ml/min:
          QF = 0ml/min; T=37°C (ISO8637)
          The ultrafiltration coefficients were maintained using human blood,
          Hct = 32%, protein content 6%
           
          Effective surface area (m²)1.01.41.8
          Blood filling volume (ml)547495
          Membrane materialHelixone® 
          Housing materialPolypropylene
          Potting compoundPolyurethane
          Sterilization methodINLINE steam
          ApplicationHD

          FX high-flux dialyzers

          FX high-flux dialyzersFX 40FX 50FX 60FX 80FX 100
          Ultrafiltration coefficient (ml/h x mmHg)2033465973
          Clearance: QB: (200ml/min)     
          Urea170189193197 
          Creatinine144170182189 
          Phosphate138165177185 
          Vitamin B1284115135148 
          Inulin547695112 
          Clearance: QB: (300ml/min)      
          Urea 250261276278
          Creatinine 210230250261
          Phosphate 201220239248
          Vitamin B12 130155175192
          Inulin 81104125142
          Clearance: QB: (400ml/min)      
          Urea  303362331
          Creatinine  262287304
          Phosphate  248272284
          Vitamin B12  167190213
          Inulin  109133152
          The in vitro performance data were obtained with QD = 500ml/min:
          QF = 0ml/min; T=37°C (ISO8637)
          The ultrafiltration coefficients were maintained using human blood,
          Hct = 32%, protein content 6%
           
          Effective surface area (m²)0.61.01.41.82.2
          Blood filling volume (ml)32537495116
          Membrane materialHelixone® 
          Housing materialPolypropylene
          Potting compoundPolyurethane
          Sterilization methodINLINE steam
          ApplicationHD/HDF/HF

          FX hemodiafilters

          FX hemodiafiltersFX 600FX 800FX 1000
          Ultrafiltration coefficient (ml/h x mmHg)526375
          Clearance: QB: (200ml/min)QF: (0ml/min)   
          Urea196198 
          Creatinine184190 
          Phosphate180184 
          Vitamin B12141149 
          Inulin101110 
          Clearance: QB: (300ml/min) QF: (75ml/min)     
          Urea284289290
          Creatinine262271280
          Phosphate254262269
          Vitamin B12199209211
          Inulin150161164
          Clearance: QB: (400ml/min) QF: (100ml/min)   
          Urea351361364
          Creatinine313328343
          Phosphate301313325
          Vitamin B12229241244
          Inulin172185188
          The in vitro performance data were obtained with QD = 500ml/min:
          T=37°C (ISO8637)
          The ultrafiltration coefficients were maintained using human blood,
          Hct = 32%, protein content 6%
           
          Effective surface area (m²)1.51.82.2
          Wall thickness / inner diameter (µm)35/210  
          Blood filling volume (ml)97118138
          Membrane materialHelixone® 
          Housing materialPolypropylene
          Potting compoundPolyurethane
          Sterilization methodINLINE steam
          ApplicationHD/HDF

          Related content

          Bowry, S.K.: Nano-controlled membrane spinning technology: Regulation of pore size, distribution and morphology of a new polysulfone dialysis membrane. In Hemodialysis Technology (eds: Ronco, C., La Greca, G.) Contributions to Nephrology, Vol. 137: 85-94 (2002)

          Ronco, C., Nissenson, A.R.: Does nanotechnology apply to dialysis? Blood Purification 19: 347-352 (2001)