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
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
INLINE steam sterilization – purity ensured
No chemical residuals. Low rinsing volumes. Lower costs.
INLINE steam sterilisation process
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 – 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 dialyzers | FX 5 | FX 8 | FX 10 | |||
---|---|---|---|---|---|---|
Ultrafiltration coefficient (ml/h x mmHg) | 8 | 12 | 14 | |||
Clearance: QB: (200ml/min) | ||||||
Urea | 180 | 191 | 193 | |||
Creatinine | 165 | 178 | 181 | |||
Phosphate | 141 | 160 | 170 | |||
Vitamin B12 | 88 | 107 | 121 | |||
Clearance: QB: (300ml/min) | ||||||
Urea | 228 | 254 | 261 | |||
Creatinine | 200 | 225 | 231 | |||
Phosphate | 164 | 194 | 210 | |||
Vitamin B12 | 94 | 120 | 138 | |||
Clearance: QB: (400ml/min) | ||||||
Urea | 293 | 303 | ||||
Creatinine | 252 | 260 | ||||
Phosphate | 213 | 233 | ||||
Vitamin B12 | 126 | 146 | ||||
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) | 1.0 | 1.4 | 1.8 | |||
Blood filling volume (ml) | 54 | 74 | 95 | |||
Membrane material | Helixone® | |||||
Housing material | Polypropylene | |||||
Potting compound | Polyurethane | |||||
Sterilization method | INLINE steam | |||||
Application | HD |
FX high-flux dialyzers
FX high-flux dialyzers | FX 40 | FX 50 | FX 60 | FX 80 | FX 100 | |
---|---|---|---|---|---|---|
Ultrafiltration coefficient (ml/h x mmHg) | 20 | 33 | 46 | 59 | 73 | |
Clearance: QB: (200ml/min) | ||||||
Urea | 170 | 189 | 193 | 197 | ||
Creatinine | 144 | 170 | 182 | 189 | ||
Phosphate | 138 | 165 | 177 | 185 | ||
Vitamin B12 | 84 | 115 | 135 | 148 | ||
Inulin | 54 | 76 | 95 | 112 | ||
Clearance: QB: (300ml/min) | ||||||
Urea | 250 | 261 | 276 | 278 | ||
Creatinine | 210 | 230 | 250 | 261 | ||
Phosphate | 201 | 220 | 239 | 248 | ||
Vitamin B12 | 130 | 155 | 175 | 192 | ||
Inulin | 81 | 104 | 125 | 142 | ||
Clearance: QB: (400ml/min) | ||||||
Urea | 303 | 362 | 331 | |||
Creatinine | 262 | 287 | 304 | |||
Phosphate | 248 | 272 | 284 | |||
Vitamin B12 | 167 | 190 | 213 | |||
Inulin | 109 | 133 | 152 | |||
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) | 0.6 | 1.0 | 1.4 | 1.8 | 2.2 | |
Blood filling volume (ml) | 32 | 53 | 74 | 95 | 116 | |
Membrane material | Helixone® | |||||
Housing material | Polypropylene | |||||
Potting compound | Polyurethane | |||||
Sterilization method | INLINE steam | |||||
Application | HD/HDF/HF |
FX hemodiafilters
FX hemodiafilters | FX 600 | FX 800 | FX 1000 | |||
---|---|---|---|---|---|---|
Ultrafiltration coefficient (ml/h x mmHg) | 52 | 63 | 75 | |||
Clearance: QB: (200ml/min)QF: (0ml/min) | ||||||
Urea | 196 | 198 | ||||
Creatinine | 184 | 190 | ||||
Phosphate | 180 | 184 | ||||
Vitamin B12 | 141 | 149 | ||||
Inulin | 101 | 110 | ||||
Clearance: QB: (300ml/min) QF: (75ml/min) | ||||||
Urea | 284 | 289 | 290 | |||
Creatinine | 262 | 271 | 280 | |||
Phosphate | 254 | 262 | 269 | |||
Vitamin B12 | 199 | 209 | 211 | |||
Inulin | 150 | 161 | 164 | |||
Clearance: QB: (400ml/min) QF: (100ml/min) | ||||||
Urea | 351 | 361 | 364 | |||
Creatinine | 313 | 328 | 343 | |||
Phosphate | 301 | 313 | 325 | |||
Vitamin B12 | 229 | 241 | 244 | |||
Inulin | 172 | 185 | 188 | |||
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) | 1.5 | 1.8 | 2.2 | |||
Wall thickness / inner diameter (µm) | 35/210 | |||||
Blood filling volume (ml) | 97 | 118 | 138 | |||
Membrane material | Helixone® | |||||
Housing material | Polypropylene | |||||
Potting compound | Polyurethane | |||||
Sterilization method | INLINE steam | |||||
Application | HD/HDF |
1 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)
2 Ronco, C., Nissenson, A.R.: Does nanotechnology apply to dialysis? Blood Purification 19: 347-352 (2001)