Consistently high dialysis quality Tested in practice and proven in studies

Haemodialysis

Hollow fiber dialyser for efficient high-flux and low-flux dialysis

Intro allg. + Filter

Approved quality - made by B. Braun

The excellent performance and high patient compatibility of a dialyser depend on optimal membrane properties, a perfect dialyser design and a safe sterilisation method. Based on its many years of experience in the development and production of dialysers, B. Braun has the comprehensive knowhow and competence that are required for the production of high-quality and efficient dialysers. B. Braun dialysers provide optimum treatment quality for individuals suffering from a renal disease, thus improving their quality of life.

Constant reliability and efficient dialysis

Our Diacap Polysulfone dialysers are high-flux and low-flux dialysers of high quality, each available in five different sizes. The high biocompatibility of the Polysulfone membrane and excellent performance of the Diacap dialysers have already been proven by studies in the past.1,2,3 A current clinical comparative study has confirmed that the efficiency and quality of a dialysis procedure with Diacap Polysulfone dialysers remain constant and comparable over a long treatment period.4

In addition to the Diacap Polysulfone dialysers, the new

Diacap Polysulfone+ HiFlo dialyser provides a highly efficient haemodiafilter for high-flux dialysis and haemodiafiltration.

Continuous performance to achieve consistently high dialysis quality High endotoxin retention capabilities and low activation of blood coagulation Efficient removal of uremic toxins in the low- and mediummolecular ranges Optimum biocompatibility Easy and safe handling with high mechanical stability Available in 5 low-flux and 5 high-flux versions

Technical specifications

Diacap Polysulfone high-flux dialysers

In vitro performance Ultrafiltration coefficient (ml/h/mmHg) Clearances: QB = 200 ml/min Urea Creatinine Phosphate Vitamin B12 Inulin Clearances: QB = 300 ml/min Urea Creatinine Phosphate Vitamin B12 Inulin Clearances: QB = 400 ml/min Urea Creatinine Phosphate Vitamin B12 Inulin Sieving coefficients Inulin 2-microglobulin Albumin HI PS 10 34 180 162 160 100 76 223 195 192 112 84 250 213 208 120 90 HI PS 12 42 186 173 171 115 89 238 213 210 131 97 271 239 235 136 104 HI PS 15 50 190 178 176 127 99 245 224 220 148 111 288 262 259 160 120 1 0.8 0.005 HI PS 18 55 192 182 180 137 109 250 228 224 160 120 292 270 267 181 132 HI PS 20 58 194 184 183 143 114 253 232 229 168 127 296 275 273 189 139

Indication Surface (m2) Wall thickness / internal diameter (m) Priming volume (ml) bloodside Membrane material Housing Potting compound Sterilisation Units per box Art-No

HD / HDF 1.0 58 1.2 68

HD / HDF / HF 1.5 1.8 40/200 90 110 High-flux Polysulfone Polycarbonate Polyurethane Gamma 20 720 3649 720 3657

2.0 121

720 3622

720 3630

720 3665

In vitro performance and physical data acc to EN 1283 UF-coefficient: human blood, Hct 32%, total protein 6%, T = 37C Clearances: QD = 500 ml/min, QF = 0 ml/min Sieving coefficient: QB = 300 ml/min, QF = 60 ml/min

Samtleben W. et al.: Comparative evaluation of oxidative and antioxidative capacity during high-flux hemodialysis using two different membranes, Clin Nephrol. 2006; 66 (357-363). Mann H. et al.: Diacap polysulfone HI PS: A new dialysis membrane with optimum 2-microglobulin elimination, Artif Organs. 2003; 26: 461-466. Ronco C. et al.: Effects of novel manufacturing technology on blood and dialysate flow distribution in a low flux " Polysulfone" hemodialyzer, Artif Organs. 2003; 26: 105-112. Cano R, Bonilla B, et al. (2008), data on file.

2 3

Haemodialysis
Diacap Polysulfone low-flux dialysers
In vitro performance Ultrafiltration coefficient (ml/h/mmHg) Clearances: QB = 200 ml/min Urea Creatinine Phosphate Vitamin B12 Clearances: QB = 300 ml/min Urea Creatinine Phosphate Vitamin B12 Clearances: QB = 400 ml/min Urea Creatinine Phosphate Vitamin B12 LO PS 10 6.8 176 157 126 68 LO PS 12 7.9 183 166 139 77 LO PS 15 9.8 189 173 146 83 LO PS 18 12.3 192 180 157 100 LO PS 20 13.7 194 183 164 110

217 181 147 73

233 200 162 82

246 213 172 91

253 225 188 112

258 234 198 125

242 198 159 75

261 220 175 86

285 239 190 95

294 256 207 123

302 264 220 136

Indication Surface (m2) Wall thickness / internal diameter (m) Priming volume (ml) bloodside Membrane material Housing Potting compound Sterilisation Units per box Art-No

1.0 58

1.2 68

HD 1.5 40/200 90 Low-flux Polysulfone Polycarbonate Polyurethane Gamma 20 720 3541

1.8 110

2.0 121

720 3525

720 3533

720 3550

720 3568

In vitro performance and physical data acc to EN 1283 UF-coefficient: human blood, Hct 32%, total protein 6%, T = 37C Clearances: QD = 500 ml/min, QF = 0 ml/min Subject to modification

Proven in clinical applications

Haemodialysis
Description of the study High-flux dialysers Data of 55 patients (25 female, 30 male) was collected over a period of 8 months. Mean age was 62.5 years, whereas mean body weight and height were 68 kg and 164.0 cm respectively. Data was collected at three dialysis centres. During the first 3 months, the patients were treated with the FX 80 high-flux (surface 1.8 m2) dialyser by Fresenius Medical Care. As of the first week of the fourth month of treatment, the patients were converted to the Diacap Polysulfone HI PS 18 (surface 1.8 m2) dialyser by B. Braun Avitum. Administered heparin
I.U./kg 52.0

FX 80

FX 10

HI PS 18

LO PS 18

49.0

46.0

43.0 1 2 3 4 5 6 7 8 month Administered heparin doses remain stable throughout the study. No significant changes occur following the change in dialyser, and heparin requirements remain constant.

Erythropoietin (EPO) and haemoglobin (Hb)

I.U./week (EPO)

High-flux dialysers FX 80 HI PS 18

g/dl (Hb)
12.5

10,500

Hb 12.0
11.5 11.0

Low-flux dialysers Data of 45 patients (18 female, 27 male) was collected over a period of 8 months. Mean age was 73.6 years, whereas mean body weight and height were 60.6 kg and 159.5 cm respectively. Data was collected at three dialysis centres. During the first 3 months, the patients were treated with the FX 10 low-flux (surface 1.8 m2) dialyser by Fresenius Medical Care. As of the first week of the fourth month of treatment, the patients were converted to the Diacap Polysulfone LO PS 18 (surface 1.8 m2) dialyser by B. Braun Avitum.

9,500

EPO
8,500

10.5 10.0

1 I.U./week (EPO)

8 g/dl (Hb)
13.25 12.5

Low-flux dialysers FX 10 LO PS 18

9,500

EPO
7,500

Hb 11.75
11.0 10.25

5,500

9.5

1 2 3 4 5 6 7 8 For the high-flux dialysers, both haemoglobin and erythropoietin values yield a continuous curve throughout the study. The conversion from FX to Diacap did not result in any significant changes. The curve confirms that it is not necessary to administer additional EPO if the haemoglobin is stable. This in turn confirms the high dialysis quality. If low-flux dialysers are used, slightly lower EPO doses result in the expected correspondingly slight decrease in haemoglobin. This relationship is illustrated by the EPO resistance index shown below.

Administered dialysis dose (eKt/V)

eKt/V eKt/V

EPO resistance index (ERI)

ERI ERI

1.40

1.40

12.5

HI PS 18

FX 80 FX 10 LO PS 18

12.5

1.20

HI PS 18

FX 10 FX 80 LO PS 18
1.20 11.0 11.0

1.00

1.00

9.5

9.5

0.80

High-flux dialysers

Low-flux dialysers

0.80

8.0

High-flux dialysers

Low-flux dialysers

8.0

eKt/V: equilibrated Kt/V Values are mean values over a period of four months each.

ERI calculation: EPO dose per week / kg of body weight / haemoglobin in g/dl Values are mean values over a period of four months each.

B. Braun Avitum AG Schwarzenberger Weg 7379 D-34212 Melsungen Germany Tel +49 (0)56 61 71-26 24 Fax +49 (0)56 61 75-26 24
W. 03.01.09/1 Nr. 708 0138A Edition: 01/2009

e-mail: dialysis@bbraun.com www.bbraun-dialysis.com