Haemodialysis. Bloodlines, Tubing Systems, Accessories Product Range. Product name / Headline Subline

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Haemodialysis Bloodlines, Tubing Systems, Accessories Product Range Product name / Headline Subline

Ensuring safety with the authentic Fresenius Medical Care Original Bloodlines e Com ac G u ibility at p Inte rf Quality and reliability characterise the Fresenius bloodlines in function and use. ar ant ee Handling Safety Clearly colour-coded components Excellent safety and performance with our Ergonomic components and layout * and 5008 machines Transducer protector with integrated inspection * We guarantee that all our bloodlines are compatible with all software and hardware versions of our respective therapy systems. 2 windows Injection port with enlarged finger-protection shield

developed to meet your needs Quality Biocompatibility Certified quality systems for development, Use of plasticisers with high haemocompatibility production and sales Perfect compatibility to machine interfaces and low cytotoxic reaction Free of DEHP 3

5008 Therapy System Beyond your expectations Enabling the application of HighVolumeHDF in the most practical way. ONLINE Priming / HighVolumeHDF Saline free priming of extracorporeal circuit HighVolumeHDF treatment as standard Enabled by the SafeLine included in every bloodline set Reliable Precision Convenience Exact measurement of arterial pressure via Clear layout and optimised tube lengths pressure dome Trouble-free air detection directly on system tube 4 Machine assisted set-up and disassembling Reduced filling volume and less blood-air contact

Product Range 5008 e fre DEHPLifeLineBeta Phtalate free Beta-sterilisation by accelerated electrons (e-beam) Fewer material alterations in comparison to gamma-irradiation No radioactive source of radiation Adult Bloodlines Beta sterilisation DEHP free Type To be used with Filling volume Units per box Art.-No. AV-Set ONLINEplus 5008-R 5008/5008S 132 ml F00000384 AV-Set ONLINEplus BVM 5008-R 5008 136 ml F00000385 AV-Set ONLINE Priming 5008S-R 5008S 132 ml F00000700 AV-Set 5008 CorDiax post-r 5008/5008S 132 ml F00003267 SN-Set ONLINEplus 5008-R 5008/5008S 193 ml 14 F00000386 SN-Set ONLINEplus BVM 5008-R 5008 196 ml 14 F00000387 To be used with Filling volume Units per box Art.-No. 5008 114 ml F00001068 5008 169 ml 14 F00001069 AV-Sets SN-Sets Paediatric Bloodlines Beta sterilisation DEHP free Type AV-Sets AV-Set ONLINEplus BVM Paed 5008-R SN-Sets SN-Set ONLINEplus BVM Paed 5008-R BVM: Blood Volume Monitor -R: Beta Sterilisation (Radiation) Inner diameter of pump segment: 8 mm Diameter of venous chamber: 22 mm 5

Sustained dependability Reliability established over several years and millions of treatments. Superior quality and safety Consistent and validated manufacturing Rigorous testing of bloodline performance Highly compatible interface between bloodlines and machine Reliable therapy Meeting diverse needs Matured technology recognised worldwide Appropriate sterilisation to suit varying demands Extensive experience in the production of Broad product range to meet all requirements bloodlines ensuring consistent product quality 6

Product Range ee fr DEHPLifeLineBeta Phtalate free Sterilisation by accelerated electrons (e-beam) Less material alterations in comparison to gamma-irradiation No radioactive source of radiation Adult Bloodlines Beta sterilisation DEHP free Type To be used with Inner diameter pump segment Filling volume Units per box Art.-No. AV-Set B-R 8 mm 161 ml F00001124 AV-Set SRB-R 8 mm 161 ml F00000257 AV-Set SRB BVM-R 8 mm 172 ml F00000258 AV-Set FMC (FA 4 C/ FV 4 C)-R 8 mm 161 ml F00004757 8 mm 211 ml 14 F00000259 To be used with Inner diameter pump segment Filling volume Units per box Art.-No. AV-Set-FMC Paed R 6.4 mm 117 ml F00001064 AV-Set-FMC BVM Paed R 6.4 mm 126 ml F00001065 AV-Set-FMC Paed/Baby R 6.4 mm 56 ml 26 F00001063 AV-SN-Set-FMC Paed R 6.4 mm 155 ml F00001067 AV-SN-Set-FMC Paed/Baby R 6.4 mm 88 ml F00001066 AV-Sets SN-Sets SN-Set SRB L-R Paediatric Bloodlines Beta sterilisation DEHP free Type AV-Sets SN-Sets All paediatric bloodlines are equipped with spike, waste bag and recirculation connector. S: Spike R: Recirculation connector B: Waste bag L: Long tubes to SN expansion chamber (needed for SN-treatment with S) BVM: Blood Volume Monitor -R: Beta Sterilisation (Radiation) Diameter of venous chamber: 22 mm 7

Components Patient connectors Line clamps Optimal handling and safety: Colour coding Optimal ergonomics for easy and Ergonomic grip on the rotating part ensures secure connection reliable handling No additional clamps required Easy to remove protective caps Injection ports Transducer protectors Latex-free septum Inspection windows Colour coding Colour coding Large finger-protection shield Pump segment Perfect fit to the Fresenius Medical Care dialysis machines (geometry, shore hardness, occlusion performance) Heparin line Luer-Lock female Adapter with protecting cap Easy to remove paper tape Qualified for the effective blood flow measurement Allows achievement of prescribed dialysis dose 8

Components Correct filling level Arterial bubble catcher Dialyser connector Dynamic blood flow due to special geometry Soft material allows safe connection to dialyser Safe and effective air separation Easy to remove protective caps Single Needle chamber Pressure dome Optimised design Precise pressure measurement Dynamic, controlled bloodflow Reduced filling volume Easy handling and protection No blood-air contact Traps of the pressure line Correct filling level Venous drip chamber BVM cuvette Inlet distributor reduces activation of clotting Precise BVM measurement - Directed blood flow Easy handling - No free fall of blood Allows an easy and correct positioning in the air detector due to the special shape of venous bubble trap (22 mm ) 9

Technical drawings 5008 AV-Set ONLINEplus 5008-R (F00000384) Arterial line Venous line 6781 11 15/700 1741 (700) SafeLine D E 8253058 82541 82582 3000002 8253059 B 8253069 8253068 6812 82511 (RED) C 82528 6809 6967811 82±3 RTERIAL LINE F E TAPE Cod.3000002 ATTENTOIN: TO BE GLUED IN HORIZONTAL POSITION WITH THE MEMBRANE TURNED DOWNWARDS : PAPER STRIP Cod.6913271 300±3 CONFEZIONAMENTO: BLISTERATURA = 2 OPERATORI CONFEZIONAMENTO = 1 OPERATORE Variants 1114 47/060 1674 6781 6968911 ATTENTION: THE COMPONENTS HAVE TO BE ORIENTED ACCORDING TO THE FOLLOWING PATTERN (Venous line and SafeLine M TOTM TUBE G 69921 I 8253058 unchanged) 1114 47/060 1674 6781 H L 6968531 8253059 6967811 82583 6811 1114 47/060 1674 6781 6812 5008_5018441 SN-Set ONLINEplus 5008-R 6995221 N (TRANSPARENT) 82531 (F00000386) P 6917531 69171 6995271 Description Code AV-Set ONLINEplus 5008-R O Sterilization type R 300±3 8,0 Fresenius Medical Care 5018441 Machine Type Fresenius Medical Care 5008 Pump segment [mm] Scale Drip chamber [mm] Priming volume [ml] 22 132 Tollerance Quantity/box Weight [gr] 382 Quantity/pallet 24 480 Page N? Material Date Drawn by Checked by Rev. N? Revision date 07/04/04 MMR RR 9/6 08/01/07 Drawing N? Pr. N? 24 This drawing is propriety of FMC. No use or disclosure thereof may be made without its written permission and approval. AV-Set ONLINEplus BVM 5008-R (F00000385) 5008_5018511 SN-Set ONLINEplus BVM 5008-R (F00000387) 10 5008_5018451

Technical drawings AV-Set SRB-R (F00000257) Arterial line Venous line* Variants (Venous lines unchanged)* _7010011 AV-Set SRB BVM-R (F00000258) SN-Set SRB LR (F00000259) _7010031 _5017441 _70001 * Delivered with a drainage bag 11

Technical drawings paediatric lines 5008 AV-Set ONLINEplus BVM Paed 5008-R (F00001068) Arterial line Venous line SafeLine AV-Set-FMC Paed R (F00001064) Kind_5018601 Kind_5018601 Arterial line Kind_5018601 Venous line * AV-Set-FMC Paed/Baby R (F00001063) Kind_6014611 Arterial line Kind_6014611 Venous line * * Delivered with a drainage bag 12

Important handling aspects Pressure line Connect the pressure transducer protector to the machine ensuring it is straight and secure (do not overtighten!). If the membrane is wet, replace either the bloodline or the pressure line with a new one. Arterial bubble catcher Correct filling level For level setting release the cap, raise the level slowly to the filling line. Make sure that the caps are secure Correct filling level and the clamps closed. Venous bubble catcher () Rest the shoulder of the chamber on the top of the level detector holder, so the filter of the chamber is 1 cm below the level of the door. 1 cm Make sure that the caps are secure and the clamps closed. Pump segment () Insert the pump segment with the red colour coding on the left hand side. SN-pump segment () Make sure that all air has been removed during the priming of the pump segment. Injection port Clean the septum by using a disinfectant. Hold the injection port by the finger grips underneath the protection shield. Insert the needle directly into the septum (90 ). SN-chamber Place the chamber into the holder. Connect the pressure line (see above). Make sure that the caps are secure and the clamps closed. Do not invert the chamber. During priming, the filling level will be set automatically (do not raise the level manually). 13

Accessories Type To be used with Steril isation Description /5008 Beta Frekaflex infusion set Dialysis accessories Connectors Units per box Art.-No. ONLINEplus HDF 5008 12 7030031 Steam ONLINEplus, pump segment 6.4 mm 100 5046801 Infusion set Luer-Lock male / Luer-Lock male with roller clamp 150 2889011 Infusion set with spike, vented spike, Luer-Lock male, drip chamber and recirculation connector 130 5017151 Rinsing of extracorporeal circuit 100 5015091 Transducer protector Luer-Lock male /female 100 5015911 Pressure line 30 cm /5008 Complete pressure line 30 cm, Luer-Lock male /female 100 5014631 Heparin syringe 30 ml 5008 Luer-Lock male, separate closure cap, latex-free plug 100 5030321 Heparin syringe ml /5008 Luer-Lock male, latex-free plug 1 F00001255 SN-adapter Luer-Lock /5008 Y-adapter, 2 x Luer-Lock female, 1 x Luer-Lock male 100 5027851 Scissor clamp /5008 --- For clamping tubes 5 2845241 Recirculation connector /5008 Beta For short-circuit of A/V-set, Luer-Lock female / Luer-Lock female 100 5015971 Spike /5008 Beta Spike/Luer-Lock female 100 5015921 Dialyser exchange set /5008 Tubing system for exchange of dialyser during treatment, short-circuit AV-set 75 5018001 5008 Beta Set with drainage connector and pre-connected sampling bag of 1L 15 F00006222 HF / HDF Drainage connector Safeline Infusion sets Waste bags Waste bag 2,000 ml Transducer protectors Various accessories Fluid sampling set 14

Accessories Type Steril isation Description Units per box Art.-No. HD Connection-Disconnection Set prohd Set S All components for connection and disconnection of fistula patients (AVF/AVG), including drape, nitrile gloves, non-woven gauzes, adhesive tapes, haemostatic plasters 1 F00001621 prohd Set M All components for connection and disconnection of fistula patients (AVF/AVG), including drape, nitrile gloves, non-woven gauzes, adhesive tapes, haemostatic plasters 1 F00001622 prohd Set L All components for connection and disconnection of fistula patients (AVF/AVG), including drape, nitrile gloves, non-woven gauzes, adhesive tapes, haemostatic plasters 1 F00001623 prohd CVC Set S Connection Set All components for connection of CVC patients, including gloves, masks, drapes, swabs, syringes, tape strips 40 TMD000081 prohd CVC Set M Connection Set All components for connection of CVC patients, including gloves, masks, drapes, swabs, syringes, tape strips 40 TMD000091 prohd CVC Set L Connection Set All components for connection of CVC patients, including gloves, masks, drapes, swabs, syringes, tape strips 40 TMD000101 prohd CVC Set S Disconnection Set All components for disconnection of CVC patients, including gloves, masks, drapes, swabs, syringes, caps, tape strips 44 TMD000111 prohd CVC Set M Disconnection Set All components for disconnection of CVC patients, including gloves, masks, drapes, swabs, syringes, caps, tape strips 44 TMD000121 prohd CVC Set L Disconnection Set All components for disconnection of CVC patients, including gloves, masks, drapes, swabs, syringes, caps, tape strips 44 TMD000131 CVC Connection Set* CVC Disconnection Set* * For one treatment 1 connection and 1 disconnection set needed. The letters S, M and L in the name of the prohd Sets and prohd CVC Set indicate the glove size. 15

Copyright 17 Fresenius Medical Care Deutschland GmbH www.freseniusmedicalcare.com F00006846 MT-EN (BG 08.17) Head office: Fresenius Medical Care Deutschland GmbH 61346 Bad Homburg v. d. H. Germany Phone: +49 (0) 6172-609-0 Fax: +49 (0) 6172-609-2191