5008SThe Pragmatic Approach to ONLINE HDF

Haemodialysis

Offering ONLINE HDF to All Patients Around the World

ONLINE Haemodiafiltration ( ONLINE HDF ) is

increasingly being recognised as the most advanced

haemodialysis treatment modality that improves

patient outcomes through a number of clinical

advantages. These benefits indicate that ONLINE

HDF induces less endothelial dysfunction, thereby

facilitating Cardioprotective Haemodialysis.

We at Fresenius Medical Care strive to continuously

refine and develop new dialysis therapies and

products to improve clinical outcomes of dialysis

patients. The innovative 5008S system combines

our technological and dialysis provider expertise

and allows you to utilise the full benefits of

Cardioprotective Haemodialysis.

While focussing on a more widespread implementation

of the most advanced treatment modality for dialysis

patients, the 5008S has been conceived with

the sole purpose of enabling ONLINE HDF in a

pragmatic manner – taking into account the needs

of the nursing staff – and of course, the patients.

Thus, the cornerstones of the 5008S philosophy are

the provision of:

• Best therapy for your patients

• Best handling for all users

• Optimal use of resources

The 5008S Dialysis System has been extensively tried

and tested around the world. With the confidence

of this elaborate clinical experience, the recognised

superiority of ONLINE HDF can now be offered to all

patients around the world.

Extending Experience

Best Therapy for your Patients

ONLINE HDF – The Therapy of Choice

Despite significant advances in the quality and efficacy

of haemodialysis therapy in recent years, morbidity

and mortality among haemodialysis patients are still

unacceptably high. There are numerous reasons for

this poor patient outcome as current renal replacement

therapies are only partially able to replace the natural

kidney’s filtering functions. The continuous improvement

of the efficiency of renal replacement therapies should

therefore represent the central point in the care of

End Stage Renal Disease (ESRD) patients.

One of the major goals of Fresenius Medical Care’s

Cardioprotective Haemodialysis programme is the

continuous development and implementation of

innovative therapy systems and concepts, further

improving the cardiovascular prognosis of dialysis

patients.

Recent studies demonstrate that the ONLINE HDF

therapy offers a significant reduction of the risk for

mortality for ESRD patients compared to standard

haemodialysis therapy (7). 41

ONLINE HDF, particularly with large volumes of

sterile replacement fluid, offers not only the most

physiological and efficient elimination of a broad

range of small, medium-sized and large uremic toxins,

but also improves patient outcome and Quality-of-Life

through:

• Better elimination of middle molecules (1)

• Greater haemodynamic stability (2)

• Less side-effects and intradialytic symptoms (2)

• Reduced Calcium-Phosphate-Product (3)

• Better anaemia control and reduced EPO

requirements (4)

• Reduced inflammation and oxidative stress (5, 6)

4ONLINE HDF Pump 41: Relative risk of mortality by dialysis type (Adjusted for age, sex, time on dialysis, 14 summary comorbid conditions, weight, catheter use, haemoglobin, albumin, normalized protein catabolic rate, cholesterol, triglycerides, Kt/V, erythropoietin, MCS and PCS). Canaud B et al., Kid Int 2006; 69: 2087-2093

Low-Flux HD

High-Flux HD

Low-efficiency HDF

High-efficiency HDF

1.00 1.03

0.93

0.65

Ref P = 0.83 P = 0.68 P = 0.01

1.2

1.0

0.8

0.6

0.4

0.2

0

Rel

ativ

e ri

sk

Although convective therapies are prescribed to

efficiently remove larger solutes, the continuous

monitoring of the clearance of small solutes is

essential towards evaluating the overall efficiency

of the treatment. The Online Clearance Monitor

(OCM®) of the 5008S provides completely automated

dialysis efficiency control without incurring additional

expenses and assures compliance of dialysis dose

targets.

Additionally, the therapy option Blood Temperature

Monitor (BTM) offers the possibility to further increase

the quality of treatment: regulation of the core body

temperature significantly improves the haemodynamic

stability and effective recirculation measurements

can be undertaken.

Furthermore, numerous novel technology safety

systems of the 5008S (e. g. various leakage sensors

and integrity tests) help to minimise undesirable

incidences, assure the highest patient safety and

provide full confidence for the entire dialysis team.

5008S – Offering ONLINE HDF to All Patients

Around the World.

1. Ledebo I: Principles & Practice of Haemofiltration and Haemodiafiltration. Artif Organs 1998; 22: 20-25

2. Altieri P, Sorba GB, Bolasco PG et al.: Online predilution hemofiltration versus ultrapure High-Flux haemodialysis, a multicentre prospective study in 23 patients. Blood Purif 1997; 15: 169-181

3. Lornoy W, De Meester J, Because I et al.: Impact of convective flow on phosphorus removal in maintenance haemodialysis patients. Journal of Renal Nutrition 2006; 16: 47-53

4. Bonforte G, Grillo P, Zerbi S, Surian M. Improvement of anemia in haemo-dialysis patients treated by haemodiafiltration with high-volume on-line-pre-pared substitution fluid. Blood Purif 2002; 20(4): 357-363

5. Merello Godino JI, Rentero R, Orlandini G, Marcelli D, Ronco C. Results from EuCliD (European Clinical Dialysis Database): impact of shifting treat-ment modality. Int. J Artif Organs 2002; 25(11): 1049-1060

6. Vaslaki L, Major L, Berta K, Karatson A, Misz M, Ladanyi E, Arkossi O, Pethoe F, Fodor B, Descamps-Latscha B, Stein G, Wojke R, Passlick-Deetjen J.The Impact of Convection in Online Haemodiafiltration on Blood Concentra-tion of Advanced Glycation End Products. Nephrol Dial Transplant 2002;17 (Suppl.1) (M383): 154

7. Canaud B, Bragg-Gresham JL, Marshall MR et al.: Mortality risk for patients receiving haemodiafiltration versus haemodialysis: European results from the DOPPS. Kid Int 2006; 69: 2087-2093

5008S

5008S – Facilitating ONLINE HDF Therapies

Haemodialysis involves a large number of intensive

manual operations centred around the haemodialysis

machine.

The 5008S Dialysis System and all its individual

components have been created to minimise and

facilitate these routine procedures as much as

possible. This gives the nursing personnel much-

needed time for the adequate care of a growing

number of patients who additionally and increasingly

suffer from multiple comorbidities.

• Centralised operation and information via a

spacious touch screen interface. 41

• “Intuitively correct” user guidance philosophy.

• Ergonomic handling, e. g. one-handed

connection of bibag®.

• Seamless work-flow including multiple

machine-assisted procedures.

• Easy, rapid and safe data management via

PatientCard or network (Therapy Data Management

System – TDMS).

Hence the 5008S facilitates ONLINE HDF in a

surprisingly easy manner by applying sophisticated

technologies and innovative operation concepts.

Based on the experience gathered as the leading

service provider in dialysis care and the feedback

from numerous users, the 5008S has been specifically

designed to simplify and safeguard all work-intensive

and manual operation steps in daily routine through

fully automated and matured procedures.

The 5008S not only provides unlimited quantities of

sterile substitution fluid for a highly efficient ONLINE

HDF therapy, but also applies intelligently the ONLINE

concept to ease the labour-intensive priming and

post-processing steps:

• ONLINE Priming

• ONLINE Bolus

• ONLINE Reinfusion

5008S – The Pragmatic Approach to ONLINE HDF.

Best Handling for all Users

4Ergonomically designed handling 41: Touch screen interface

Optimal Use of Resources

Efficient and Sustainable

As a provider of dialysis products and services,

Fresenius Medical Care is constantly aware of the

fact that restricted health care resources require

novel solutions to perform the most superior dialysis

therapy.

It is therefore one of our firm commitments to provide

premium haemodialysis systems and therapies that

facilitate and promote the efficient and sustainable

use of these limited resources available for an

increasing patient number.

With the acknowledged benefits of the online

production of large quantities of sterile dialysis

fluid, the complex handling procedures involving

rinse solutions from bags and bottles have become

obsolete. Thus, the ONLINE Priming, ONLINE Bolus

and ONLINE Reinfusion not only simplify standard

handling procedures but save the need for ready-

made rinse solutions. 41

The automatic adjustment and optimal adaptation

of dialysate flow to the effective blood flow with

“AutoFlow” (8) and the minimised consumption during

stand-by conditions with “EcoFlow”, economise the

use of dialysate and energy. 42

The innovative and highly automated work-flow in

all routine procedures, the easy data input and

documentation, as well as novel approaches in

serviceability save valuable time for personal patient

care and ensure highest availability and reliability.

The 5008S offers a highly pragmatic approach

towards the provision of ONLINE HDF – currently,

the best possible therapy – using sophisticated

modern technologies while maintaining an awareness

of the limited resources available in dialysis units.

5008S – Making a Premium Therapy

Become Standard!

Blo

od

flo

w

FX 60Hct. = 35 %Rec. = 5 %

Reduction QDAutoFlow e. g.QD = 1.2 x QB

Kef

f (m

L/m

in)

Dialysate (mL/min)

Keff at QD = 500 mL/minKeff at QD = 360 mL/minKeff at QD = 360 mL/min + ONLINE HDF (AutoSub)

41: ONLINE Priming makes saline rinse solution obsolete 42: AutoFlow: matching dialysate best to blood flow thus reducing dialysate and energy consumption

8. Kult J, Stapf E. Changing emphasis in modern hemodialysis therapies: Cost-effectiveness of delivering higher doses of dialysis. Int. J Artif Organs 2007; 30(7): 577-582

5008S

The new 5008S Dialysis System allows ONLINE HDF

therapy to be accomplished as the standard treatment

modality in a remarkably easy and convenient

manner. The simplification of this traditionally very

elaborate and complex therapy into a highly safe

modality is significantly facilitated by the application

of fully-automated, easy-to-operate and ergonomic

design features of the new 5008S System.

With a clear emphasis on the essentials of the

superior ONLINE HDF therapy for routine clinical

practice as well as a consideration of optimal usage

of all available resources, this extremely sleek

dialysis system will contribute towards establishing

ONLINE HDF as the treatment of choice in renal

replacement care around the world.

5008S – The Pragmatic Approach to ONLINE HDF.

5008S – Extending Experience

Haemodialysis system 5008S ONLINEplus M20 121 1

Bloodline systems AV Set ONLINEplus 5008 (Filling vol. 132 mL) 501 844 1

AV SN Set ONLINEplus 5008 (Filling vol. 167 mL) 501 851 1

Dry concentrates bibag® 5008 650 g 506 078 1

bibag® 5008 900 g 506 080 1

Dialysis fluid filter DIASAFE® plus 500 820 1

Disinfectants Diasteril® 508 564 1

Citrosteril® 508 535 1

Puristeril® 340 508 551 1

Puristeril® plus e. g. 508 570 1

Sporotal® 100 508 542 1

Surface disinfectant ClearSurf® e. g. 508 569 1

Accessories Heparin syringe 30 mL 503 032 1

Product Art. No.

5008S Product Range

General data

Dimensions 5008S 1,680 x 350 x 780 mm (H x W x D) at bed/dialysis

chair level (width at base: 520 mm, depth with

canister holder: 900 mm)

Weight approx. 100 kg

Monitor/Screen 15" high-resolution TFT LCD with touch screen user interface. Monitor rotatable around the 3 axes

Card reader Smart card (ICC) for Patient, User and ServiceCard

Water supplyWater inlet pressure 1.5 – 6.0 barWater inlet temperature 5 – 30 °C; for “integrated hot rinse” 85 – 95 °CMax. drain height 1 mFlush Rinse of water supply area (option)

Concentrate supplySupply pressure 0 to 100 mbar; 1 m suction height with Central Delivery System: 0.05 to 2.0 barCentral supply 1 central acid concentrate (option)

Electrical dataPower supply 100 to 240 V AC ± 10 %, 47 – 63 HzCurrent consumption Approx. 6 A (at 230 V) at a water inlet temperature of 17 °C, Dialysate temperature 37 °C Dialysate flow: 500 mL/min

External connections Alarm output: potential free alarm outlet (alternating contact max. 24 V/24 W). LAN (RJ 45) port for data exchange with Therapy Data Management System/Finesse®

Extracorporeal circuit

Arterial pressure monitoringDisplay range - 300 mmHg to + 300 mmHgAccuracy ± 7 mmHgResolution 5 mmHg

Venous pressure monitoringDisplay range - 100 mmHg to + 500 mmHgAccuracy ± 7 mmHgResolution 5 mmHg

Transmembrane pressure monitoringDisplay range - 100 mmHg to + 400 mmHgResolution 5 mmHg

Arterial blood pumpBlood flow range (effective) 30 to 600 mL/minAccuracy ± 10 %

Single-Needle system 2 blood pumps. Internal pressure/pressure (Option) control with variable stroke volume (max. 50 mL)

Air bubble detector Ultrasound transmission measurement on blood line, additional capacitive level and optical monitoring

Heparin pump Delivery range: 0.5 to 10 mL/h Bolus function: 1.0 up to 20.0 mL Syringe size: 30 mL

Dialysis fluid circuit

Dialysis fluid flow rangeSelectable 0 – 1,000 mL/min (steps of 100 mL/min)AutoFlow (selectable) Automatic adaptation of the dialysate flow to the effective blood flow (factors adjustable)

EcoFlow Stand-by flow of 100/150 mL/min (HD/HDF) during preparation and reinfusion

Dialysis fluid temperature 34 – 39 °C

Dialysis fluid conductivityRange 12.8 – 15.7 mS/cmAccuracy ± 0.1 mS/cm

Sodium concentration dialysis fluidMixing ratio Freely adjustable e.g. 1 + 44, 1 + 34Adjustment range 125 to 151 mmol/L, depending on the concentrate used ± 10 % of the base value

Bicarbonate concentration dialysis fluidDefault mixing ratio 1 + 27.6 (others possible)Adjustment range 24.0 – 40.0 mmol/L (steps of 0.5 mmol/L)

Bicarbonate dry concentrate bibag®

Balancing accuracy ± 0.1 % related to the total dialysate volumePressure holding test Event controlled

UltrafiltrationUF rate 0 – 4,000 mL/h (in steps of 10 mL)Pump volume accuracy ± 1 %Parameters displayed UF goal, UF time, UF rate, UF volume

Blood leak detectorSensitivity <_ 0.5 mL blood/min (Hct = 25 %) flow rate 100 mL/min – 1,000 mL/min

Dialysis fluid filter system DIASAFE®plus

ONLINEplus ONLINE Haemo(dia)filtrationSubstitution rate 25 – 600 mL/minAccuracy ± 10 %AutoSub Substitution ideally matched to effective blood flow

OCM® Online Clearance MonitoringAccuracy Clearance K ± 6 %

BPM (Option)Display range Systole: 30 mmHg – 280 mmHg Diastole: 10 mmHg – 240 mmHg MAP: 20 mmHg – 255 mmHgAccuracy ± 3 mmHg

BTM (Option)Temperature measurement Accuracy ± 0.2 °CBody temperature control Allowed change rate ± 0.5 °C/hRecirculation measurement Accuracy ± 2 %

Disinfection and cleaning programmes*

RinseTemperature/flow 37 °C/600 – 800 mL/min (adjustable)

Hot rinse (recirculation)Temperature/flow 85 °C/600 – 800 mL/min (adjustable)

Cleaning Sporotal® 100 (recirculation)Temperature/flow 37 °C/600 – 800 mL/min (adjustable)

Heat disinfection Diasteril®/Citrosteril® (recirculation)Temperature/flow 85 °C/600 – 800 mL/min (adjustable)

Disinfection Puristeril® 340/plus (recirculation)Temperature/flow 37 °C/600 – 800 mL/min (adjustable)

* Various programme combinations selectable. Technical changes reserved.

Technical Data 5008S

Fresenius Medical Care Deutschland GmbH · 61346 Bad Homburg v. d. H. · Germany · Phone: +49 (0) 6172-609-0 · Fax: +49 (0) 6172-609-2191Head office: Else-Kröner-Straße 1 · 61352 Bad Homburg v. d. H.

www.fmc-ag.com

736

425

1/1

GB

(4,0

V&

B 0

4.08

) ©

Cop

yrig

ht 2

008

Fres

eniu

s M

edic

al C

are

Deu

tsch

land

Gm

bH