FX high and low-flux dialyzers (2024)

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 FXdialyzers. 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 hom*ogenous 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 efficientremoval 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 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

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

NCS^TM results in optimized pore size distribution and larger average pore size

Performance (K₀) per m² 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

FX classix dialyzers

Proven Fresenius quality for standard hemodialysis.

References

¹Bowry, 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)

²Ronco, C., Nissenson, A.R.: Does nanotechnology apply to dialysis? Blood Purification 19: 347-352 (2001)