Skip to content

Menu

trigger trigger

Attention

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

Not all products are cleared or available for sale in all Asia Pacific countries.

By clicking on the button "Accepted and Confirmed" you assure that you have taken note of this information and that you are a healthcare professional.

F-Series

Not all polysulfones are like Fresenius Polysulfone®

  • Proven quality and efficiency of Fresenius Polysulfone®
  • The original benchmark for biocompatibility
  • INLINE steam sterilized
  • Available in both low-flux and high-flux ranges
csm_SPE001_F-Series_8f57fa749b

Key features

Fresenius Polysulfone® — A synonym for biocompatibility

  • Adverse interactions between blood and material arising during the dialysis treatment have been related to a variety of clinical symptoms
  • It has become increasingly evident that not all dialysis membranes are the same with respect to their ability to activate blood cell components1
  • Ever since its introduction, Fresenius Polysulfone® has been recognized for its biocompatibility and was an established benchmark for all membrane improvements and developments 2,3,4,5 

Safety during each and every treatment

  • All Fresenius Medical Care dialyzers provide a high degree of safety during each and every treatment
  • The high endotoxin retention capabilities of the Fresenius Polysulfone® are attributed to the chemical composition and structure of the membrane

Enhanced design for maximum efficiency

  • The special undulating structure of the hollow fibers delivers an excellent performance profile
  • Spacing between the wavy fiber structures keeps the individual fibers apart, preventing dialyzate channeling and facilitating a uniform flow of dialyzate within the fiber bundle
  • The consistent dialyzate flow around each fiber ensures every single performs at maximum efficiency, resulting in enhanced solute transport
The endotoxin permeability profiles of different synthetic low-flux membranes6
The endotoxin permeability profiles of different synthetic low-flux membranes6
The wavy structure of the hollow fibres reduces dialysate channelling and enhances solute transport.
The wavy structure of the hollow fibres reduces dialysate channelling and enhances solute transport. 

Technology

INLINE steam sterilization – purity enhanced

No chemical residuals. Low rinsing volumes. Lower costs.

INLINE steam
The INLINE steam sterilization process of F-Series dialyzers. Diagram shows example use with FX dialyzers.

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 at or above 121°C for 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

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

Quality from start to finish

  • Fresenius Polysulfone® dialyzers are produced to meet international safety regulations
  • Fresenius Medical Care’s core competency is the complete production from membranes to the finished dialyzers, providing the highest quality during every step of production 
Quality from start to finish

Performance data

Low Flux Dialysers – High Performance Steam (HPS)

Low Flux Dialysers – High Performance Steam (HPS) F4 HPS  F5 HPS  F6 HPS  F7 HPS F8 HPS   F10 HPS
Ultrafiltration coefficient (ml/h x mmHg) 8 10 13 16 18 21
Clearance: QB: (200ml/min)            
Urea 170 179 186 188    
Creatinine 149 162 173 175    
Phosphate 123 139 148 155    
Vitamin B12 75 84 92 102    
Clearance: QB: (300ml/min)             
Urea   227 243 247 252 259
Creatinine   196 215 220 224 230
Phosphate   162 175 186 193 208
Vitamin B12   91 100 113 118 131
Clearance: QB: (400ml/min)             
Urea         290 300
Creatinine         251 259
Phosphate         212 231
Vitamin B12         124 139
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) 0.8 1.0 1.3 1.6 1.8 2.2
Blood priming volume (ml) 51 63 78 96 113 132
Membrane material Fresenius Polysulfone®
Housing material Polycarbonate
Potting compound Polyurethane
Sterilization method Inline Steam
Form of treatment HD
Art. No. 5007041 5007051 5007061 5007071 5007081 5007201

High Flux Dialysers

High Flux Dialysers F40S F50S F60S F70S HF80S  HdF100S
Ultrafiltration coefficient (ml/h x mmHg) 20 30 40 50 55 60
Clearance: QB: (200ml/min)            
Urea 165 178 185 190    
Creatinine 140 160 172 177    
Phosphate 138 158 170 174    
Vitamin B12 80 100 118 127    
Inulin 54 75 88 98    
Clearance: QB: (300ml/min)             
Urea 200 225 242 245 248 271
Creatinine 165 195 215 220 225 252
Phosphate 158 190 210 216 220 240
Vitamin B12 86 112 134 145 155 190
Inulin 58 83 97 109 120 145
Clearance: QB: (400ml/min)             
Urea 222 252 276 281 285 285
Creatinine 178 215 238 254 250 272
Phosphate 170 206 230 241 245 260
Vitamin B12 90 118 144 159 170 215
Inulin 60 87 103 118 126 170
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) 0.7 1.0 1.3 1.6 1.8 2.3
Blood priming volume (ml) 42 63 82 98 110 132
Membrane material Fresenius Polysulfone®
Housing material Polycarbonate
Potting compound Polyurethane
Sterilization method Inline Steam
Art. No. 5007141 5008151 5007161 5007171 5007181 5007191

Related Content

csm_SPE001_FXCorDiax100_755996ce32

FX CorDiax dialyzers

Designed to dialyze. Built for cardioprotection.

SPE001_4008S-Classix

4008S classix

Quality treatment to suit your budget.

1 Krieter DH, Sauer N, Stanic D, Reinhardt B, Lemke HD, Tetta C, Kliem V: Biocompatibility of the new DIAPES LF 100 low flux dialysis membrane. Blood Purification 20: 498-520, 2002.

2 Schäfer RM, Hörl WH, Gilge U, Konrad G, Heidland A : Biocompatibility profile of the Polysulfone 400 membrane. In: Contributions to Nephrology, Karger, Basel, 74: 43-51, 1989.

3 Hakim R: Clinical implications of hemodialysis membrane biocompatibility. Kidney International 44: 484-494, 1993.

4 Debrand-Passard A, Lajous-Petter A, Schmidt R, Herbst R, von Baeyer M, Krause AA, Schiffl M: Thrombogenicity of dialyser membranes as assessed by residual blood volume and surface morphology at different heparin dosages. In: Contributions to Nephrology, Karger, Basel, 74: 2-9, 1989.

5 Hoenich NA, Woffindin C, Cox PJ, Goldfinch M, Roberts SJ: Clinical characterisation of DICEA a new cellulose membrane for haemodialysis. Clinical Nephrology 48: 253-259, 1997.

6 Weber V, Linsberger I, Rossmanith E, Falkenhagen D. Pyrogen transfer across high- and low-flux hemodialysis membranes. Nephrology Dialysis Transplantation 18, Suppl. 4 : T451, 2003.