1. No category

Haemodialysis
Dialysers and Filters
Product Range
Contents
Cardioprotective
Haemodialysis
Fresenius Polysulfone® and
Helixone® Dialysis Membranes
Cardioprotective
Haemodialysis
2
3
Dialysers and Haemofilters
FX-class Haemodiafilters
4
FX-class High-Flux Dialysers
5
FX-class Low-Flux Dialysers
6
Fresenius Polysulfone®
High-Flux Dialysers
and Haemodiafilters
7
Fresenius Polysulfone®
Low-Flux Dialysers (HPS)
8
Fresenius Polysulfone®
Low-Flux Dialysers
9
Despite significant improvements in the quality and
efficacy of haemodialysis therapy in recent years,
cardiovascular disease (CVD) remains the leading
every other dialysis patient dies from cardiovascular
Paediatric Filters
Paediatric Filters FX paed, FX 40
cause of death for dialysis patients. Today, almost
complications.
10
Fresenius Medical Care is supporting nephrologists
worldwide in reducing their patients’ risks for cardio-
Dialysis Fluid Filters
Dialysis Fluid Filter DIASAFE®plus
vascular morbidity and mortality.
11
Innovative membranes like Fresenius Polysulfone® or
Helixone®, modern monitoring devices like the Blood
Volume Monitor, the Blood Temperature Monitor
and Online Clearance Monitoring (OCM®), ultra-pure
dialysis fluid prepared with DIASAFE®plus and
modern ONLINE haemodiafiltration systems support
the reduction of CVD risk factors.
Moreover, one of our major goals in coming years
is the development and implementation of innovative
new therapies and products that further improve
the cardiovascular prognosis of dialysis patients.
2
Fresenius Polysulfone® and
Helixone® Dialysis Membranes
With over thirty years of experience in the development and manufacturing of dialysis membranes, Fresenius
Medical Care offers a broad spectrum of dialysers to meet the specific demands of the different therapy
modalities and the individual needs of every patient.
Commonly regarded as the “gold standard” for dialysis
membranes, Fresenius Polysulfone® stands for
performance and safety in haemodialysis since three
decades.
Numerous scientific publications and millions of treatments reflect the good experiences and satisfaction
with this synthetic membrane among clinical staff
and patients.
The Fresenius Polysulfone® membrane is available in
the F-series low-flux and high-flux dialysers and
invests these dialysers with a high performance, a
good endotoxin retention and an excellent haemocompatibility.
Continuing to set the standard for novel dialysis
products, Fresenius Medical Care developed an
advanced, Fresenius Polysulfone®-based dialysis
membrane – the Helixone® membrane.
Manufacturing of the Helixone® membrane employs
a new process of membrane making – the Nano
Controlled Spinning (NCS™) Technology.
By means of this technology it is possible to create a
defined pore structure and pore distribution profile
of the inner membrane layer according to the desired
application.
Helixone® is the membrane of the FX-class of dialysers.
3
FX-class Haemodiafilters
INLINE Steam sterilised
This series of haemodiafilters has particularly been
developed for high-volume HDF treatments with
fluid exchange rates above 15 liters per treatment.
Together with the modern housing design, the
advanced variant of the Helixone® membrane used
in these types of haemodiafilters allows for:
• An enhanced removal of low molecular-weight
substances, in particular phosphate
• An improved middle-molecule removal
• Higher fluid exchange rates during haemodiafiltration (> 15 L / treatment)
In vitro performance data/technical data
FX 600
Ultrafiltration coeff. (mL/h x mmHg)
52
Clearance QB = 300 mL/min, QD = 500 mL/min, QF = 0 mL/min
Urea
268
Creatinine
238
Phosphate
228
Vitamin B12
165
Inulin
111
Clearance QB = 300 mL/min, QD = 500 mL/min, QF = 75 mL/min
Urea
284
Creatinine
262
Phosphate
254
Vitamin B12
199
Inulin
150
FX 800
63
FX 1000
75
276
250
238
176
123
278
262
248
178
126
289
271
262
209
161
290
280
269
211
164
1.8
200 – 500
35/210
118
Helixone®
Polypropylene
Polyurethane
INLINE Steam
HDF/HF
20
500 814 1
2.2
250 – 600
35/210
138
In vitro performance: T = 37°C (EN 1283, ISO 8638).
Ultrafiltration coefficients: human blood, Hct 32 %, protein content 6 %.
Effective surface (m2)
Blood flow range (mL/min)
Wall thickness / lumen (µm)
Priming volume (mL)
Membrane material
Housing material
Potting compound
Sterilisation method
Form of treatment
Units per box
Art.-No.
4
1.5
150 – 400
35/210
97
20
500 813 1
20
500 972 1
FX-class High-Flux Dialysers
INLINE Steam sterilised
A completely new concept of dialysers has led to
the improved performance profile of the FX-class of
dialysers achieved by various technical improvements to all components of the dialyser including the
membrane Helixone®.
•
•
•
•
•
Improved diffusive and convective clearances
Refined haemodynamics
Increased patient safety
Simplified handling and priming
Reduction of waste
In vitro performance data/technical data
Ultrafiltration coeff. (mL/h x mmHg)
Clearance QB = 200 mL/min
Urea
Creatinine
Phosphate
Vitamin B12
Inulin
Clearance QB = 300 mL/min
Urea
Creatinine
Phosphate
Vitamin B12
Inulin
FX 40
20
FX 50
33
FX 60
46
FX 80
59
170
144
138
84
54
189
170
165
115
76
193
182
177
135
95
197
189
185
148
112
250
210
201
130
81
261
230
220
155
104
276
250
239
175
125
–*
–
–
–
–
In vitro performance: QD = 500 mL/min, QF = 0 mL/min, T = 37 °C (EN 1283. ISO 8637).
Ultrafiltration coefficients: human blood, Hct 32 %, protein content 6 %.
Effective surface (m2)
Blood flow range (mL/min)
Wall thickness / lumen (µm)
Priming volume (mL)
Membrane material
Housing material
Potting compound
Sterilisation method
Form of treatment
Units per box
Art.-No.
FX 100
73
–*
–
–
–
–
278
261
248
192
142
* refer to recommended blood flow range
0.6
50 – 200
35/185
32
1.0
100 – 300
35/185
53
HD
20
500 884 1
HD
20
500 885 1
1.4
150 – 400
35/185
74
Helixone®
Polypropylene
Polyurethane
INLINE Steam
HD
20
500 886 1
1.8
200 – 500
35/185
95
2.2
250 – 600
35/185
116
HD/HDF/HF
20
500 888 1
HD/HDF/HF
20
500 890 1
5
FX-class Low-Flux Dialysers
INLINE Steam sterilised
A modulation of the Helixone® membrane at the
nanoscale level targeting the elimination of low
molecular weight solutes led to a new generation of
low-flux dialysers with an optimal diffusive clearance.
The new low-flux Helixone® membrane offers the
following advantages:
• An increased pore size of 1.8 nm
• More even distribution of the pores
• Increased performance per unit surface area
In vitro performance data/technical data
Ultrafiltration coeff. (mL/h x mmHg)
Clearance QB = 200 mL/min
Urea
Creatinine
Phosphate
Vitamin B12
Clearance QB = 300 mL/min
Urea
Creatinine
Phosphate
Vitamin B12
FX 5
8
FX 8
12
FX 10
14
180
165
141
88
191
178
160
107
193
181
170
121
228
200
164
94
254
225
194
120
261
231
210
138
1.4
150 – 400
35/185
74
Helixone®
Polypropylene
Polyurethane
INLINE Steam
HD
20
500 473 1
1.8
200 – 500
35/185
95
In vitro performance: QD = 500 mL/min, QF = 0 mL/min, T = 37 °C (EN 1283, ISO 8637).
Ultrafiltration coefficients: human blood, Hct 32 %, protein content 6 %.
Effective surface (m2)
Blood flow range (mL/min)
Wall thickness / lumen (µm)
Priming volume (mL)
Membrane material
Housing material
Potting compound
Sterilisation method
Form of treatment
Units per box
Art.-No.
6
1.0
100 – 300
35/185
54
20
500 483 1
20
500 474 1
Fresenius Polysulfone®
High-Flux Dialysers and Haemodia filters
INLINE Steam sterilised
The Fresenius Polysulfone® High-Flux Steam dialyser
range combines the advantages of a blood compatible
membrane with a safe sterilisation procedure.
•
•
•
•
•
Excellent blood compatibility
Optimal performance
Wide product range (0,7 – 2,4 m2)
Suitable for HD, HF, HDF treatments
Effective ␤2-microglobulin removal
• High endotoxin retention capacity
• Unique INLINE Steam Sterilisation – no sterilisation
by-products or residues – dry
• No pretreatment rinsing procedures required
(time saving)
In vitro performance data/technical data
Ultrafiltration coeff. (mL/h x mmHg)
Clearance QB = 200 mL/min
Urea
Creatinine
Phosphate
Vitamin B12
Inulin
Clearance QB = 300 mL/min
Urea
Creatinine
Phosphate
Vitamin B12
Inulin
F40S
20
F50S
30
F60S
40
F70S
50
HF80S
55
165
140
138
80
54
178
160
158
100
75
185
172
170
118
88
190
177
174
127
98
192
180
177
135
110
225
195
190
112
83
242
215
210
134
97
245
220
216
145
109
248
225
220
155
120
–*
–
–
–
–
HdF100S
60
–*
–
–
–
–
271
252
240
190
145
In vitro performance: QD = 500 mL/min, QF = 0 mL/min, T = 37 °C (EN 1283, ISO 8637).
Ultrafiltration coefficients: human blood, Hct 32 %, protein content 6 %. Use only on machines with controlled ultrafiltration!
* refer to recommended blood flow range
Effective surface (m2)
Blood flow range (mL/min)
Wall thickness / lumen (µm)
Priming volume (mL)
Membrane material
Housing material
Potting compound
Sterilisation method
Form of treatment
Units per box
Art.-No.
1.8
200 – 600
40/200
110
2.4
250 – 600
35/185
138
HDF/HF
12
500 718 1
HDF/HF
12
500 719 1
0.7
50 – 200
40/200
42
1.0
100 – 300
40/200
63
HD
12
500 714 1
HD
12
500 815 1
1.3
1.6
150 – 400
200 – 500
40/200
40/200
82
98
Fresenius Polysulfone®
Polycarbonate
Polyurethane
INLINE Steam
HD/HDF
HD/HDF
12
12
500 716 1
500 717 1
7
Fresenius Polysulfone® Low-Flux Dialysers (HPS)
IINLINE Steam sterilised
High performance dialysers in the Low-Flux range
combined with the advantages of steam sterilisation.
• Higher clearances by a new design
• Microundulation ensures efficient dialysate flow
• Excellent blood compatibility
• Wide product range (0.8 – 2.2 m2)
• High endotoxin retention capacity
• Unique INLINE Steam Sterilisation, no sterilisation
residues or by-products – dry
In vitro performance data/technical data
Ultrafiltration coeff. (mL/h x mmHg)
Clearance QB = 200 mL/min
Urea
Creatinine
Phosphate
Vitamin B12
Clearance QB = 300 mL/min
Urea
Creatinine
Phosphate
Vitamin B12
8
F4HPS
8
F5HPS
10
F6HPS
13
F7HPS
16
F8HPS
18
170
149
123
75
179
162
139
84
186
173
148
92
188
175
155
102
190
177
159
106
227
196
162
91
243
215
175
100
247
220
186
113
252
224
193
118
–*
–
–
–
F10HPS
21
–*
–
–
–
259
230
208
131
In vitro performance: QD = 500 mL/min, QF = 0 mL/min, T = 37 °C (EN 1283, ISO 8637).
Ultrafiltration coefficients: human blood, Hct 32 %, protein content 6 %. Use only on machines with controlled ultrafiltration!
* refer to recommended blood flow range
Effective surface (m2)
Blood flow range (mL/min)
Wall thickness / lumen (µm)
Priming volume (mL)
Membrane material
Housing material
Potting compound
Sterilisation method
Form of treatment
Units per box
Art.-No.
1.8
250 – 600
40/200
113
2.2
300 – 600
40/200
132
12
500 708 1
12
500 720 1
0.8
50 – 200
40/200
51
1.0
100 – 300
40/200
63
12
500 704 1
12
500 705 1
1.3
1.6
150 – 400
200 – 500
40/200
40/200
78
96
Fresenius Polysulfone®
Polycarbonate
Polyurethane
INLINE Steam
HD
12
12
500 706 1
500 707 1
Fresenius Polysulfone® Low-Flux Dialysers
ETO sterilised
• Excellent blood compatibility
• Wide product range (0.4 – 1.8 m2)
• High endotoxin retention capacity
The wide product range is tailored to meet the
requirements of the individual patient.
In vitro performance data/technical data
Ultrafiltration coeff. (mL/h x mmHg)
Clearance QB = 200 mL/min
Urea
Creatinine
Phosphate
Vitamin B12
Clearance QB = 300 mL/min
Urea
Creatinine
Phosphate
Vitamin B12
F3
1.7
F4
2.8
F5
4.0
F6
5.5
F7
6.4
F8
7.5
125
95
50
20
155
128
78
32
170
149
103
45
180
164
123
60
184
169
132
68
186
172
138
76
206
175
115
47
222
194
145
62
236
210
155
72
240
216
165
82
–*
–
–
–
In vitro performance: QD = 500 ml/min, QF = 0 ml/min, T = 37 °C (EN 1283. ISO 8637).
Ultrafiltration coefficients: human blood, Hct 32 %, protein content 6 %.
Effective surface (m2)
Blood flow range (mL/min)
Wall thickness / lumen (µm)
Priming volume (mL)
Membrane material
Housing material
Potting compound
Sterilisation method
Form of treatment
Units per box
Art.-No.
0.4
50 – 200
40/200
28
0.7
50 – 200
40/200
42
12
500 165 1
12
500 161 1
* refer to recommended blood flow range
1.0
1.3
100 – 300
150 – 400
40/200
40/200
63
82
Fresenius Polysulfone®
Polycarbonate
Polyurethane
ETO
HD
12
12
500 162 1
500 145 1
1.6
200 – 500
40/200
98
1.8
250 – 600
40/200
110
12
500 163 1
12
500 164 1
9
Paediatric Filters FX paed, FX 40
INLINE Steam sterilisation
As members of the FX-class of dialysers, both
the FX paed and the FX 40 dialyser deliver the high
expectations on dialysers for application in paediatric
dialysis.
• State-of-the-art housing and membrane technology
• Low effective surface areas and low blood filling
volumes
• No kinking of blood lines through lateral blood
inlet ports
• Fast and easy preparation
• High-flux dialysis membrane with
high middle-molecule removal rate
In vitro performance data/technical data
FX paed
Ultrafiltration coeff. (mL/h x mmHg)
7
Clearance QB = 100 mL/min, QD = 300 mL/min
Urea
76
Creatinine
64
Phosphate
57
Vitamin B12
34
Inulin
20
Clearance QB = 200 mL/min QD = 500 mL/min
Urea
–
Creatinine
–
Phosphate
–
Vitamin B12
–
Inulin
–
FX 40
20
–
–
–
–
–
170
144
138
84
54
In vitro performance: QF = 0 mL/min, T = 37 °C (EN 1283, ISO 8637).
Ultrafiltration coefficients: human blood, Hct 32 %, protein content 6 %.
Effective surface (m2)
Blood flow range (mL/min)
Wall thickness / lumen (µm)
Priming volume (mL)
Membrane material
Housing material
Potting compound
Sterilisation method
Form of treatment
Units per box
Art.-No.
10
0.2
0.6
30 – 100
50 – 200
35/220
35/185
18
32
Helixone®
Polypropylene
Polyurethane
INLINE Steam
HD
20
20
500 822 1
500 884 1
Dialysis Fluid Filter DIASAFE®plus
The dialysis fluid filter DIASAFE®plus is a further
development of the successful DIASAFE® filter by
Fresenius Medical Care.
• Preparation of ultra pure dialysis fluid
(endotoxins < 0.03 IU/mL, microbial contaminations
< 0.1 CFU/mL)
• ONLINE preparation of substitution fluid for
HF and HDF treatments
• Microbiological safety through redundant double
filtration of the substitution fluid using two
DIASAFE®plus filters in series
• Checking of filter function in automatic integrity
tests
• High resistance to disinfection agents, such as
Puristeril® 340 and Diasteril®, Citrosteril®,
Sporotal® 100
Technical data
Membrane material
Effective surface (m2)
Housing material
Potting compound
Sealings
Filtration rate
Operating time
Disinfection
Units per box
Art.-No.
DIASAFE®plus
Fresenius Polysulfone®
2.2
Polypropylene
Polyurethane
Silicone
5 mL/min mmHg (3.75 L/min bar; max. 2 bar)
Standard HD: max. 12 weeks
ONLINE HF/HDF, ONLINE priming/rinsing:
max. 12 weeks or 100 treatments
Puristeril® 340 (peracetic acid);
Diasteril® (hydroxyacetic acid) or Citrosteril® (citric acid);
Sporotal® 100 (sodium hypochlorite) max. 11 times
12
500 820 1
Accessories
Safe line™
Units per box
Art.-No.
100
504 580 1
Residual test
(Puristeril® 340)
100
629 916 1
pH Indicator test
(Diasteril®)
100
628 816 1
11
© Copyright 2007 Fresenius Medical Care Deutschland GmbH
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Fresenius Medical Care Deutschland GmbH · 61346 Bad Homburg v. d. H. · Germany · Phone: +49 (0) 6172-609-0 · Fax: +49 (0) 6172-609-2191
Head office: Else-Kröner-Straße 1 · 61352 Bad Homburg v. d. H.
www.fmc-ag.com