Fresenius Low Flux Dialyser – FX 8

FRESENIUS LOW FLUX DIAYSER – FX 8
 
The Fresenius Low Flux Dialyzer is an artificial filter containing fine hollow fibers with microscopic pores in the wall to remove toxins during hemodialysis, a special dialysis-fluid flows through this filter, and bathes the fibers from the outside, while the blood flows through the hollow fiber. Due to the semi-permeable dialysis membrane, toxins, urea and other small particles can pass through the membrane.

TECHNICAL SPECIFICATIONS
 
– Ultrafiltration Coefficient: 12 ml/h X mmHg

– Effective Surface Area: 1.4 m²

– Blood Filling Volume: 74 ml

– Membrane Material: Helixone

– Housing Material: Polypropylene

– Potting Compound: Polyurethane

– Sterilization Method: INLINE Steam

– Application: HD
 
KEY FEATURES
 
– State of the Art Technology: Several state-of-the-art technologies have been combined to create the distinctive functional features of the FX dialyzers. The fiber bundle geometry, the membrane nanostructure, the flow port and the housing design all provide advantages in terms of performance, hemodynamics, dialysate flow, as well as safety and handling
 

– Improved Design & 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 Dialysate Flow: The pinnacle structure of the polypropylene housing ensures a uniform dialysate flow around the entire fiber bundle. A high packing density of the fiber bundle and a special wavy fiber structure to avoid dialysate 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 urinemic 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.

 
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 membrane 1 & 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

– 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
 

INLINE Steam Sterilization – Purity Ensured
 

 
– No chemical residuals

– Low rinsing volumes

– Lower costs

 
INLINE Steam Sterilization – HOW IT WORKS
 
– 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

– The dialyzer is rinsed with sterile water

– Every dialyzer is tested for fiber integrity using a bubble-point test

– The dialyzers are dried with warm, sterile air

– Finally, after drying the blood inlet and outlet ports are closed
 
INLINE Steam Sterilization – 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
 
INLINE Steam Sterilization – FIBRE TESTING INTEGRITY
 

 
– All dialyzers have to pass the bubble point test as part of the INLINE steam sterilization process

– Sterile air is pressed into the dialysate 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 fiber ruptures and the risk of blood leakages