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FX classix

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Not all products and services are cleared or available for sale in all EU countries. Check your country web site for details.

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 ensures 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 design

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.

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

Weight of FX-class dialyzers

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.
Less rinsing – lower costs	Lower rinsing volumes mean reduced preparation times and costs.

Technology

Better clearance through nanotechnology

Conventional pores

Helixone 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.

INLINE steam sterilisation

Purity enhanced — with steam

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

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
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

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

All dialyzers have to pass the bubble point test. Here, 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. This integrity test minimizes the risk of fiber ruptures and therewith the risk of blood leakages.

High endotoxin retention capacity of Helixone

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

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

Attention

FX classix

DISCLAIMER