Nipro Europe Headquarters Weihoek 3H

1930 ZaventemBelgium

T +32-(0)2-7255533F +32-(0)2-7257041

www.nipro-europe.com

Nipro Europe - FranceBiôpole Clermont-Limagne

63360 GerzatFrance

T +33 (0)473 33 41 00F +33 (0)473 33 41 09

Nipro Europe - NetherlandsRegus Business Center

Verlengde Poolseweg 34-36NL-4818 CL Breda

NetherlandsT: +31-(0)76-524 50 99F: +31-(0)76-524 46 66

Nipro Europe - TurkeyAkasyali Sok. Mine Palas Apt.No.10/4

Bostanci34744 Istanbul

Turkey T +90 (0)216 445 16 88F +90 (0)216 445 41 27

Nipro Europe - UKGround Floor - Unit 7

The Forum - Minerva Business ParkLynchwood

Peterborough PE2 6FTUnited Kingdom

T: +44-(0)173-322 4300F: +44-(0)173-323 4310

Nipro Europe - PolandUl. Aleja Jana Paw a II, 2300-854 WarsawPolandT +48 (0)22 653 85 98T +48 (0)22 653 85 06

Nipro Europe - ItalyCentro Direnzionale MilanafioriStrada 1 - Palazza F/1I-20090 AssagoItalyT: +39-02-575 000 57F: +39-02-575 181 11

Nipro Europe - SpainAvda. Castilla 2San Fernando HenaresSP-28830 MadridSpainT: +34-91-672 1834F: +34-91-672 1917

Nipro Europe - Russia12 KrasnopresnenskayaNab. Office nr. 101710th Floor - entrance nr. 6World Trade CenterRF-123610 MoscowRussiaT: +7-495 258 1364F: +7-495 258 1367

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Back To Basics

When we designed this dialyser, we once againreviewed the human kidney function. Thehuman kidney is an assembly of nephron ele-ments. Therefore, as a starting point, welooked at a single nephron before designing asingle hollow fibre. From there, we focused onthe overall human kidney functions byredesigning the dialyser housing and its insidestructure.

ELISIO™

Mat

eria

ls

Specifications

90H 110H 130H 150H 170H 190H 210H 250H

Effective Surface Area (m2) 1,1 1,3 1,5 1,7 1,9 2,1

Priming Volume (ml) 70 85 95 105 115 130

Effective Length (mm) 228 245 259 271 281 290

Inner Diameter (µm) 200 200 200 200 200 200

Membrane Thickness (µm) 40 40 40 40 40 40

Maximum TMP (mmHg) 500 500 500 500 500 500

Membrane PolynephronTM

Housing Polycarbonate

Header Polycarbonate

Potting Compound Polyurethane

Sterilization Method Dry Gamma

Package 24 pcs/box

The redesigned housing and its inside structure improvesremoval of small molecules as well as low molecular weightproteins, while conserving such essential proteins as albumin. The ELISIO™ dialyser might look similar to competing pro-ducts. Our exclusive POLYNEPHRON™ membrane and theother dialyser elements have been finely tuned based onyears of experience and expertise, and this distinguishes ourproduct. The ultra-smooth PU cut surface and the finely-finished inner lumen of hollow fibres will not damage bloodcells. The inner design of the fibre ensures smooth blood flow.Consequently, the return of blood is easier and there will beminimum residual blood in the dialyser.

The ELISIO™ dialyser with its POLYNEPHRON™ membraneis state of the art and unique dialyser ready for the current dia-lysis demands.

Dialyser DesignPolynephronTMinside

Treatmentfor all patients

Optimized use of mOptimized dialysa

Perfect d

Weight reduction

This dialyser uses less priming solutionthan other dialysers currently

on the market.

The ELISIOTM dialysers are availablefrom 0,9 -2,5 m2.

During the development of the ELISIOTM dialyserwe also looked at the environmental impact.

This resulted in a significant weight reduction.

Ultra-smoothPU-cut surface

Improvedheadershape

membrane quantityate flow dynamicsdegassing

Competitor

During the production of the dialyserthe cutting of the potting is done

in such away that the surface is mirror-like,making it smoother and less damaging for blood cells.

The caps have been redesignedto reduce channeling

at the blood side.

ELISIOTM

CompetitorELISIOTM

Improved fibres withPOLYNEPHRONTM membrane

The new rippled structure of the membrane fibresmakes spacer yarns unnecessary, resulting in a more

homogeneous dialysate flow and a slimmer dialyser design.

3D-structure of the membraneThe well-balanced mix of hydrophobic (reddish) and

hydrophilic (bluish) domains reduces membrane fouling.

Improved mechanical strengthof the fibresReduces the risk of fibre leakage

Better contact between dialysateand blood compartmentand higher package densityResulting in higher performances .

Uniform distribution of pore sizesPore sizes are optimized to have the highest possible clearancesfor low molecular weight proteins, like ß2m, whilst avoiding albuminloss.

Optimised asymmetric structureand wall thickness

In-vitroClearances

Urea

Phosphate ELISIO HPolyflux H

Fx-seriesHI-PS

White Blood Cell count C5a generation

Best ß2m Clearances in HD and HDFIndependently of the treatment mode, the Nipro ELISIO™ 190H dialyser demonstratedmuch better performances than the reference filters, with regard to ß2 microglobulinRemarks : Qb400/Qd700 /Qs 80 mL/min

Excellent biocompatibilityThe POLYNEPHRONTM membrane showed an excellent biocompatibility (WBC, C5a) andthrombogenicity (Platelet count, TAT) as could be expected from a synthetic membrane.

Clinical data obtained in Germany, 8 patients, Jan 2008

In-vivoClearances

ELISIO™

1 In Vitro Test Condition(EN1283) : Qf 0mL/min2 KUF (EN1283) : Bovine Blood (Hct 32±2%, Protein 60g/L, 37°C), Qb 300mL/min3 SC(EN1283) : Qb 300mL/min, Qf 60mL/min

Clearances (mL/min)1 Qb/Qd(mL/min) 90H 110H 130H 150H 170H 190H 210H 250H

Urea 200/500 189 192 195 197 198 199 200 200300/500 243 253 263 270 275 280 284 293400/500 274 291 311 323 332 343 346 361400/800 300 325 344 357 362 370 377 385500/800 332 363 388 406 417 427 432 457

Creatinine 200/500 175 183 191 194 196 197 198 200300/500 213 228 240 252 259 268 269 282400/500 237 252 273 288 299 309 319 337400/800 265 294 316 331 342 349 355 375500/800 282 320 346 363 383 404 410 426

Phosphate 200/500 160 164 170 176 179 183 188 193300/500 195 209 224 233 245 251 256 274400/500 220 240 255 271 288 296 304 322400/800 235 254 280 298 313 325 330 346500/800 254 282 315 333 352 368 373 400

Vitamin B12 200/500 114 125 137 148 156 162 165 177300/500 128 145 161 173 185 195 198 219400/500 132 153 174 188 202 215 219 242400/800 141 171 193 209 227 240 250 270500/800 151 178 204 223 242 259 264 291

Inulin 200/500 77 82 90 97 105 115 120 149300/500 84 86 97 109 117 127 138 166400/500 86 90 100 116 126 137 145 176400/800 91 92 106 120 128 140 150 185500/800 94 97 112 122 135 148 158 203

Myoglobin 200/500 55 61 70 78 88 94 98 112300/500 58 64 78 89 96 101 103 123400/500 61 70 82 92 104 110 113 132400/800 64 71 84 95 106 111 116 137500/800 65 81 90 104 110 117 124 141

KUF (mL/hr/mmHg)2 53 59 64 67 74 76 82 93

Sieving Coefficient3 Vitamin B12 0,989Inulin 0,926

Myoglobin 0,223Albumin 0,002

Performance Qf=0

SERIES

Back To Basics

When we designed this dialyser, we once againreviewed the human kidney function. Thehuman kidney is an assembly of nephron ele-ments. Therefore, as a starting point, welooked at a single nephron before designing asingle hollow fibre. From there, we focused onthe overall human kidney functions byredesigning the dialyser housing and its insidestructure.

ELISIO™

Mat

eria

ls

Specifications

90H 110H 130H 150H 170H 190H 210H 250H

Effective Surface Area (m2) 0,9 1,1 1,3 1,5 1,7 1,9 2,1 2,5

Priming Volume (ml) 62 70 85 95 105 115 130 149

Effective Length (mm) 210 228 245 259 271 281 290 302

Inner Diameter (µm) 200 200 200 200 200 200 200 200

Membrane Thickness (µm) 40 40 40 40 40 40 40 40

Maximum TMP (mmHg) 500 500 500 500 500 500 500 500

Membrane PolynephronTM

Housing Polycarbonate

Header Polycarbonate

Potting Compound Polyurethane

Sterilization Method Dry Gamma

Package 24 pcs/box

Nipro Europe Headquarters Weihoek 3H

1930 ZaventemBelgium

T +32-(0)2-7255533F +32-(0)2-7257041

www.nipro-europe.com

Nipro Europe - FranceBiôpole Clermont-Limagne

63360 GerzatFrance

T +33 (0)473 33 41 00F +33 (0)473 33 41 09

Nipro Europe - NetherlandsRegus Business Center

Verlengde Poolseweg 34-36NL-4818 CL Breda

NetherlandsT: +31-(0)76-524 50 99F: +31-(0)76-524 46 66

Nipro Europe - TurkeyAkasyali Sok. Mine Palas Apt.No.10/4

Bostanci34744 Istanbul

Turkey T +90 (0)216 445 16 88F +90 (0)216 445 41 27

Nipro Europe - UKGround Floor - Unit 7

The Forum - Minerva Business ParkLynchwood

Peterborough PE2 6FTUnited Kingdom

T: +44-(0)173-322 4300F: +44-(0)173-323 4310

Nipro Europe - PolandUl. Aleja Jana Paw a II, 2300-854 WarsawPolandT +48 (0)22 653 85 98T +48 (0)22 653 85 06

Nipro Europe - ItalyCentro Direnzionale MilanafioriStrada 1 - Palazza F/1I-20090 AssagoItalyT: +39-02-575 000 57F: +39-02-575 181 11

Nipro Europe - SpainAvda. Castilla 2San Fernando HenaresSP-28830 MadridSpainT: +34-91-672 1834F: +34-91-672 1917

Nipro Europe - Russia12 KrasnopresnenskayaNab. Office nr. 101710th Floor - entrance nr. 6World Trade CenterRF-123610 MoscowRussiaT: +7-495 258 1364F: +7-495 258 1367

ł