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Copyright ©2012 Asahi Kasei Medical Europe GmbH Printed in Germany No. 2014.1-1007 LEOceed Dialyser, Light, Ecological design with the highest regard for Optimal performance. Manufacturer: 350 Merrimack Street, Lawrence, MA 01843 USA European authorized representative: Herriotstrasse 1, 60528 Frankfurt am Main, Germany TEL: +49 (0) 69 66 37 15 00 FAX: +49 (0) 69 6 66 51 93 High Flux Low Flux Conditions: Leoceed-16H/N Leoceed-18H/N Leoceed-16H Leoceed-18H Leoceed-21H Notes: High permeability devices. Use only with ultrafiltration controlling equipment. ISO 8637:2010 1) Clearances: Qd=500mL/min, Qf=0mL/min 2) KoA: Qb=300mL/min, Qd=500mL/min, Qf=0mL/min 3) KUF: bovine blood, TP=60±5g/L, Hct=32±2%, Qb=300=mL/min 4) Sieving Coefficient: bovine plasma, TP=60±5g/L; ISO 8637:2010 196 192 186 146 271 254 241 173 1167 68 (508) 1,6 0,8 < 0.001 Sieving Coefficient - ß 2 -MG Sieving Coefficient - Albumin Blood Flow (mL/min) Clearances (mL/min) Urea Creatinine Phosphate Vitamin B12 KoA (Urea) (mL/min) KUF (mL/hr/mmHg (mL/hr/kPa)) Effective Surface Area (m 2 ) Blood Flow (mL/min) Clearances (mL/min) Urea Creatinine Phosphate Vitamin B12 KoA (Urea) (mL/min) KUF (mL/hr/mmHg (mL/hr/kPa)) Effective Surface Area (m 2 ) Membrane Internal Diameter of Hollow Fiber (μm) Wall Thickness of Hollow Fiber (μm) Priming Volume (mL) Maximum TMP (mmHg (kPa)) Maximum Blood Flow (mL/min) Maximum Dialysate Flow (mL/min) Dimensions (mm [L] x mm [D]) Weight (g) Sterilization 1239 76 (568) 1,8 1351 88 (658) 2,1 902 14 (106) 1,6 961 15 (114) 1,8 1010 17 (126) 2,1 86 240 x 41 130 96 270 x 41 140 Leoceed-21H/N 108 300 x 41 150 317 297 272 191 198 195 189 155 274 260 247 185 322 304 283 204 192 185 162 110 256 238 196 120 292 270 219 131 194 188 166 114 260 245 202 126 298 278 227 138 200 300 400 200 300 400 199 197 193 166 200 278 268 254 200 300 328 311 296 221 400 Leoceed-16N Leoceed-18N Leoceed-21N 200 300 400 200 300 400 195 192 170 117 200 263 253 209 133 300 303 287 236 145 400 1) 2) 3) 4) 4) 1) 2) 3) Performance (in vitro) Specifications Asahi Polysulfone 185 35 600 (80) 500 800 Gamma-Ray

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Copyright ©2012Asahi Kasei Medical Europe GmbHPrinted in Germany No. 2014.1-1007

LEOceed Dialyser, Light, Ecological designwith the highest regard for Optimal performance.

Manufacturer:

350 Merrimack Street, Lawrence, MA 01843 USA

European authorized representative:

Herriotstrasse 1, 60528 Frankfurt am Main, GermanyTEL: +49 (0) 69 66 37 15 00 FAX: +49 (0) 69 6 66 51 93

High Flux

Low Flux

Conditions:

Leoceed-16H/N Leoceed-18H/N

Leoceed-16H Leoceed-18H Leoceed-21H

Notes: High permeability devices. Use only with ultrafiltration controlling equipment. ISO 8637:2010

1) Clearances: Qd=500mL/min, Qf=0mL/min 2) KoA: Qb=300mL/min, Qd=500mL/min, Qf=0mL/min3) KUF: bovine blood, TP=60±5g/L, Hct=32±2%, Qb=300=mL/min 4) Sieving Coefficient: bovine plasma, TP=60±5g/L; ISO 8637:2010

196

192

186

146

271

254

241

173

1167

68 (508)

1,6

0,8

< 0.001

Sieving Coefficient - ß2 -MG

Sieving Coefficient - Albumin

Blood Flow (mL/min)

Clearances (mL/min)

Urea

Creatinine

Phosphate

Vitamin B12

KoA (Urea) (mL/min)

KUF (mL/hr/mmHg (mL/hr/kPa))

Effective Surface Area (m2)

Blood Flow (mL/min)

Clearances (mL/min)

Urea

Creatinine

Phosphate

Vitamin B12

KoA (Urea) (mL/min)

KUF (mL/hr/mmHg (mL/hr/kPa))

Effective Surface Area (m2)

Membrane

Internal Diameter of Hollow Fiber (µm)

Wall Thickness of Hollow Fiber (µm)

Priming Volume (mL)

Maximum TMP (mmHg (kPa)) Maximum Blood Flow (mL/min)

Maximum Dialysate Flow (mL/min)

Dimensions (mm [L] x mm [D])

Weight (g)

Sterilization

1239

76 (568)

1,8

1351

88 (658)

2,1

902

14 (106)

1,6

961

15 (114)

1,8

1010

17 (126)

2,1

86

240 x 41

130

96

270 x 41

140

Leoceed-21H/N

108

300 x 41

150

317

297

272

191

198

195

189

155

274

260

247

185

322

304

283

204

192

185

162

110

256

238

196

120

292

270

219

131

194

188

166

114

260

245

202

126

298

278

227

138

200 300 400 200 300 400

199

197

193

166

200

278

268

254

200

300

328

311

296

221

400

Leoceed-16N Leoceed-18N Leoceed-21N200 300 400 200 300 400

195

192

170

117

200

263

253

209

133

300

303

287

236

145

400

1)

2)

3)

4)

4)

1)

2)

3)

Performance (in vitro)

Specifications

Asahi Polysulfone

185

35

600 (80)

500

800

Gamma-Ray

Leoceed was designed to achieve optimal performance by combining a new housing design with the proven Asahi Polysulfone membrane.

Outstanding biocompatibilityThe hydrophilic gel layer formed on the inner surface of the membrane helps to alleviate the blood-membrane interaction. Futhermore, the membrane has a low backfiltration of endotoxins reducing the risk of inflammatory responses.

The newly developed housing design features a lateral blood port. This makes Leoceed easy to handle when connecting the blood line to the dialyser.

In addition, the new inlet port design ensures a homogenous blood circulation inside the arterial header and throughout the fiber bundle.

With regard to small molecule clearance, Leoceed demonstrates the highest level of performance compared to other synthetic membrane dialysers.

The superior membrane technology and the original housing design contribute to the exceptional clearance performance.

In-vitro test conditions: Qb: 500 ml/min, Qd: 300 ml/min, Qf: 0ml/minAll data are as per the manufacturers’ specifications for in-vitro procedures. Source: Manufacturers’ brochures

Excellent Clearance

Urea

Creatinine

Phosphate

2.1 m2

2.2 m2

278

278

1.8 m2

Leoceed-21H

FX100

FX80 276

2.1 m2

2.1 m2

254

249

2.2 m2

Leoceed-21H

Polyflux 210H

FX100 248

2.1 m2

2.2 m2

268

261

2.1 m2

Leoceed-21H

FX100

Polyflux 210H 259

Ecological

Optimal

Light

Source: in-house data

Dialyser weight (g)

Polyflux 210HLeoceed-21H

300

250

200

150

100

50

0

Innovative Housing Design

Leoceed – CO2 reduction equivalent to 3.8 beech trees per year.

Using Leoceed for one patient for one year instead of a conventional product can save up to 41 kg CO2 emissions during incineration. This CO2 reduction is equal to the CO2

absorption by 3.8 beech trees.1

Also, thanks to Leoceed’s low weight, transportation emissions are significantly reduced.

Due to a new production technology and an innovative housing design, Leoceed is considerably lighter than many other dialysers. The low weight makes it easy to handle for medical staff.

1Beech tree absorption was calculated by the Forestry and Forest Products Research Institute Japan Basis: Amount of CO2 absorption is 11 kg/year (Beech tree age: 100 years, height: 20-30 m, diameter 20-30 cm)