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    Key features

    Optimized blood flow conditions

    • The lateral blood-inlet port provides a homogenous blood flow in the dialyzer header, preventing stagnation zones. The design minimizes the risk of kinking, contributing to improved safety
    • A high capillary density leads to a more even distribution of the fibers. This enables a homogenous distribution of the incoming blood flow into each fiber in the bundle

    Homogeneous dialysate flow for better clearances

    • The pinnacle structure at both ends of the polypropylene housing together with the potting technology provides an even, radial flow of the dialysate around the individual fibers of the bundle
    • The undulation of the hollow fibers prevents dialysate channeling and, thus, enhances the performance of the dialyzer. The higher packing density of the fiber bundle together with the undulation of the hollow fibers enables a uniform dialysate flow within the whole cross-section of fiber bundle

    The FX-class® housing design

    The FX-class housing design
    The FX-class® housing design was optimized for efficient blood flow conditions

    The FX-class® design

    The FX-class design
    The FX-class® design affects dialysate flow and hence dialyser performance

    Dialyzer weight

    Dialyzer weight is a crucial factor not only in logistics but also in waste management. The housing of FX-class® dialyzers is made of polypropylene. In comparison to the widely used polycarbonate it is much lighter with the result that FX-class® dialyzers weigh around half as much as most dialyzers.
    FX 60 classix 107g
    FX CorDiax 60 107g

    The benefits of INLINE steam sterilization
    No chemical residuals No need for gamma sterilization – high energy ionizing radiation can degrade and alter the material chemistry. 
    Low rinsing volumes Minimal preparation time – since dialyzers are clean on arrival, rinsing times prior to use are substantially reduced.  
    Lower costs Lower rinsing volumes mean reduced preparation times and costs.

    Technology

    Better clearance through nanotechnology

    Conventional pores
    Conventional pores
    The removal of uraemic toxins is enhanced by smooth and cylindrical pores
    Helixone® pores
    Helixone pores
     The removal of uraemic toxins is enhanced by smooth and cylindrical pores

    When FX-class® dialyzers were introduced into the market, an innovative spinning technology had been developed to produce its Helixone® membrane. The so called Nano Controlled Spinning (NCSTM) technology allowed the production of highly-defined pore structures. Opposed to the previously produced 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 therewith allow for enhanced removal.

    Optimized pore spectrum through nanotechnology

    All Helixone® membranes offer optimized sieving properties as the pore size distribution has been tightened compared to previously produced membranes as used e.g. in the F-series. The average pore size is larger compared to F-series dialyzers and the variance in pore sizes is smaller. This results in a better selective permeability for middle molecules, i.e. a more favorable β2-m / albumin sieving proportion.

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

    INLINE steam sterilisation

    INLINE Steam
    The INLINE steam sterilisation process

    Purity enhanced — with steam

    All FX-class® dialyzers are sterilized by the unique INLINE steam sterilization process:  

    1. Both the blood and the dialysate compartment of the dialyzers are rinsed continuously with steam at a temperature of or above 121°C for more a minimum of 15 minutes. Rinsing with hot steam and without chemicals results in extremely low levels of residuals in the dialyzer
    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

    Benefits of the INLINE steam sterilization process

    • 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
    • Minimized risk of blood leakages and fiber ruptures due to 100% fiber integrity testing
    • Dry dialyzers with minimized risk of contamination due to microbial growth

    Fibre integrity testing

    Weber et al. (2003) compared endotoxin adsorption capacity of different dialyzers.

     

    The Helixone® membrane of a FX 60 dialyzer had a higher endotoxin adsorption capacity compared to:
    Gambro‘s Polyflux® 140H - Polyethersulfone (Polyamid S)
    Gambro‘s Nephral® ST 400 - Polyacrylonitrile (AN69ST)
    B.Braun‘s Diacap® HI PS 18 - Alpha- Polysulfone
    Endotoxin Retention weber
    Endotoxin adsorption per cm2 membrane surface area after 120 min in-vitro dialysis with contaminated dialysate1

    Performance data

    FX classix High-Flux dialysers   FX 50 classix FX 60 classix FX 80 classix FX 100 classix
    Clearance (QB = 300 mL/min) Molecular weight (Dalton)        
    Cytochrome c 12,230 55 74 89 100
    Inulin 5,200 72 95 113 122
    Vitamin B12 1,355 137 162 185 201
    Phosphate 132 204 225 244 253
    Creatinine 113 224 243 259 264
    Urea 60 253 266 279 280
    Clearance (QB = 400 mL/min)          
    Cytochrome c 12,230 - 76 92 105
    Inulin 5,200 - 99 119 129
    Vitamin B12 1,355 - 175 202 222
    Phosphate 132 - 252 279 291
    Creatinine 113 - 277 300 309
    Urea 60 - 312 334 336
    Ultrafiltration coeff. (mL/h x mm Hg)   27 38 53 68
    Sieving coefficients          
    Albumin 66,500 < 0.001
    Myoglobin 17,053 0.1
    β2-microglobulin 11,731 0.7
    Inulin 5,200 1
    In vitro performance: QD = 500 mL/min, QF = 0 mL/min, T = 37°C (ISO8637). Ultrafiltration coefficients: human blood, Hct 32 %, protein content 6 %.
    Membrane material Helixone®
    Sterilisation method INLINE steam
    Housing material Polypropylene
    Potting compound Polyurethane
    Units per box 24
    Effective surface (m²)   1.0 1.4 1.8 2.2
    K0A Urea   866 1,068 1,394 1,429
    Priming volume (mL)   53 74 95 116
    Article number   F00002385
    		 F00002386
    		 F00002387
    		 F00002388

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    1 Weber V. et al., Blood Purification (2003); 21: 365.

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