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UK/HEMA/FME/0922/0005 Date of Preparation: November 2022

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FX high-flux and FX low-flux dialysers

Key features

FX dialysers

A dialyser is often referred to as an “artificial kidney" in dialysis treatment. Its function is to remove any excess wastes and fluid from the blood, when the patient's kidneys can no longer perform that task.

Several state-of-the-art technologies have been combined to create the distinctive, functional features of the FX dialysers. The fibre bundle geometry, the membrane nanostructure, the flow port and the housing design all provide advantages in terms of performance, haemodynamics, dialysate flow and safety and handling.

Improved design and refined haemodynamics

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

Lateral blood inlet ports provide a homogenous blood flow path

Improved design and refined haemodynamics

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 fibre bundle
A high packing density of the fibre bundle and a special wavy fiber structure avoid dialysate channeling
Combined, these features enable the constant performance of all FX dialysers

Optimum fibre dimensions

The reduced inner diameter and wall thickness of the fibre increase the internal filtration and minimise diffusive resistance
A significant increase of both the diffusive and convective clearances is therefore achieved, allowing for the efficient removal of a broad spectrum of uraemic toxins

Dialyser weight

Dialyser weight is a crucial factor not only in logistics, but also in waste management
The housing of FX dialysers is made of polypropylene. In comparison with the widely used polycarbonate, it is much lighter
The result: FX dialysers weigh around half as much as most dialysers.
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 rough and uneven in shape, the pores in the inner layer of the Helixone^®membrane are smooth and cylindrical
This reduces the molecules' resistance 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 sterilisation – purity ensured

No chemical residuals. Low rinsing volumes. Lower costs.

INLINE steam sterilisation – how it works

Both the blood and the dialysate compartment of the dialysers 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 dialyser is rinsed with sterile water
Every dialyser is tested for fibre integrity using a bubble-point test
The dialysers are dried with warm, sterile air
Finally, after drying the blood inlet and outlet, ports are closed

INLINE steam sterilisation: the benefits

Highly pure, sterile and pyrogen-free dialysers without any potentially harmful residues from sterilisation
The biocompatibility of membranes remains unaffected by sterilisation
The optimised use of resources due to low rinsing volumes: only 500 ml is required
Dry dialysers with minimised risk of contamination due to microbial growth

Performance data

FX low-flux dialysers

FX low-flux dialysers	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
Sterilisation method	INLINE steam
Application	HD

FX high-flux dialysers

FX high-flux dialysers	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
Sterilisation 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
Sterilisation method	INLINE steam
Application	HD/HDF

If you would like to order this product via the NHS Supply Chain Catalogue, please visit the following link: NHS Supply Chain Online Catalogue

Additional information relating to multiBic or Calrecia can be found in the critical care section of our product information page.

Adverse Events Reporting

Adverse events should be reported. Reporting forms and information can be found at

https://yellowcard.mhra.gov.uk/ or search for MHRA Yellowcard in the Google Play or Apple app store. Adverse events should also be reported to Fresenius Medical Care on 01623 445100.

UK/HEMA/FME/0922/0005 Date of Preparation: November 2022

Attention

FX high-flux and FX low-flux dialysers