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Haemodialysis

5008S
The Pragmatic Approach to ONLINE HDF
Extending Experience

Offering ONLINE HDF to All Patients the sole purpose of enabling ONLINE HDF in a
Around the World pragmatic manner – taking into account the needs
of the nursing staff  –  and of course, the patients.
ONLINE Haemodiafiltration ( ONLINE  HDF ) is
increasingly being recognised as the most advanced Thus, the cornerstones of the 5008S philosophy are
haemodialysis treatment modality that improves the provision of:
patient outcomes through a number of clinical
advantages. These benefits indicate that ONLINE • Best therapy for your patients
HDF induces less endothelial dysfunction, thereby • Best handling for all users
facilitating Cardioprotective Haemodialysis. • Optimal use of resources

We at Fresenius Medical Care strive to continuously The 5008S Dialysis System has been extensively tried
refine and develop new dialysis therapies and and tested around the world. With the confidence
products to improve clinical outcomes of dialysis of this elaborate clinical experience, the recognised
patients. The innovative 5008S system combines superiority of ONLINE HDF can now be offered to all
our technological and dialysis provider expertise patients around the world.
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
Best Therapy for your Patients

ONLINE HDF – The Therapy of Choice Recent studies demonstrate that the ONLINE HDF
therapy offers a significant reduction of the risk for
Despite significant advances in the quality and efficacy mortality for ESRD patients compared to standard
of haemodialysis therapy in recent years, morbidity haemodialysis therapy (7). 41

and mortality among haemodialysis patients are still


unacceptably high. There are numerous reasons for ONLINE HDF, particularly with large volumes of
this poor patient outcome as current renal replacement sterile replacement fluid, offers not only the most
therapies are only partially able to replace the natural physiological and efficient elimination of a broad
kidney’s filtering functions. The continuous improvement range of small, medium-sized and large uremic toxins,
of the efficiency of renal replacement therapies should but also improves patient outcome and Quality-of-Life
therefore represent the central point in the care of through:
End Stage Renal Disease (ESRD) patients.
• Better elimination of middle molecules (1)
One of the major goals of Fresenius Medical Care’s • Greater haemodynamic stability (2)
Cardioprotective Haemodialysis programme is the • Less side-effects and intradialytic symptoms (2)
continuous development and implementation of • Reduced Calcium-Phosphate-Product (3)
innovative therapy systems and concepts, further • Better anaemia control and reduced EPO
improving the cardiovascular prognosis of dialysis requirements (4)
patients. • Reduced inflammation and oxidative stress (5, 6)

1.2

1.00 1.03
1.0
0.93

0.8
0.65
Relative risk

0.6

0.4

0.2 Ref P = 0.83 P = 0.68 P = 0.01

0
Low-Flux High-Flux Low-efficiency High-efficiency
HD HD HDF HDF

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
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. 5. Merello Godino JI, Rentero R, Orlandini G, Marcelli D, Ronco C. Results
Artif Organs 1998; 22: 20-25 from EuCliD (European Clinical Dialysis Database): impact of shifting treat-
ment modality. Int. J Artif Organs 2002; 25(11): 1049-1060
2. Altieri P, Sorba GB, Bolasco PG et al.: Online predilution hemofiltration
versus ultrapure High-Flux haemodialysis, a multicentre prospective study in 6. Vaslaki L, Major L, Berta K, Karatson A, Misz M, Ladanyi E, Arkossi O,
23 patients. Blood Purif 1997; 15: 169-181 Pethoe F, Fodor B, Descamps-Latscha B, Stein G, Wojke R, Passlick-Deetjen J.
The Impact of Convection in Online Haemodiafiltration on Blood Concentra-
3. Lornoy W, De Meester J, Because I et al.: Impact of convective flow on tion of Advanced Glycation End Products. Nephrol Dial Transplant 2002;17
phosphorus removal in maintenance haemodialysis patients. Journal of Renal (Suppl.1) (M383): 154
Nutrition 2006; 16: 47-53
7. Canaud B, Bragg-Gresham JL, Marshall MR et al.: Mortality risk for patients
4. Bonforte G, Grillo P, Zerbi S, Surian M. Improvement of anemia in haemo- receiving haemodiafiltration versus haemodialysis: European results from the
dialysis patients treated by haemodiafiltration with high-volume on-line-pre- DOPPS. Kid Int 2006; 69: 2087-2093
pared substitution fluid. Blood Purif 2002; 20(4): 357-363
5008S
Best Handling for all Users

5008S – Facilitating ONLINE HDF Hence the 5008S facilitates ONLINE HDF in a
Therapies surprisingly easy manner by applying sophisticated
technologies and innovative operation concepts.
Haemodialysis involves a large number of intensive Based on the experience gathered as the leading
manual operations centred around the haemodialysis service provider in dialysis care and the feedback
machine. from numerous users, the 5008S has been specifically
designed to simplify and safeguard all work-intensive
The 5008S Dialysis System and all its individual and manual operation steps in daily routine through
components have been created to minimise and fully automated and matured procedures.
facilitate these routine procedures as much as
possible. This gives the nursing personnel much- The 5008S not only provides unlimited quantities of
needed time for the adequate care of a growing sterile substitution fluid for a highly efficient ONLINE
number of patients who additionally and increasingly HDF therapy, but also applies intelligently the ONLINE
suffer from multiple comorbidities. concept to ease the labour-intensive priming and
post-processing steps:
• Centralised operation and information via a
spacious touch screen interface. 41 • ONLINE Priming
• “Intuitively correct” user guidance philosophy. • ONLINE Bolus
• Ergonomic handling, e. g. one-handed • ONLINE Reinfusion
connection of bibag®.
• Seamless work-flow including multiple 5008S – The Pragmatic Approach to ONLINE HDF.
machine-assisted procedures.
• Easy, rapid and safe data management via
PatientCard or network (Therapy Data Management
System – TDMS).

4Ergonomically designed handling 41: Touch screen interface


Optimal Use of Resources

Efficient and Sustainable The automatic adjustment and optimal adaptation


of dialysate flow to the effective blood flow with
As a provider of dialysis products and services, “AutoFlow”  (8) and the minimised consumption during
Fresenius Medical Care is constantly aware of the stand-by conditions with “EcoFlow”, economise the
fact that restricted health care resources require use of dialysate and energy. 42

novel solutions to perform the most superior dialysis


therapy. The innovative and highly automated work-flow in
all routine procedures, the easy data input and
It is therefore one of our firm commitments to provide documentation, as well as novel approaches in
premium haemodialysis systems and therapies that serviceability save valuable time for personal patient
facilitate and promote the efficient and sustainable care and ensure highest availability and reliability.
use of these limited resources available for an
increasing patient number. The 5008S offers a highly pragmatic approach
towards the provision of ONLINE HDF – currently,
With the acknowledged benefits of the online the best possible therapy – using sophisticated
production of large quantities of sterile dialysis modern technologies while maintaining an awareness
fluid, the complex handling procedures involving of the limited resources available in dialysis units.
rinse solutions from bags and bottles have become
obsolete. Thus, the ONLINE Priming, ONLINE Bolus 5008S – Making a Premium Therapy
and ONLINE Reinfusion not only simplify standard Become Standard!
handling procedures but save the need for ready-
made rinse solutions. 41
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

FX 60
Hct. = 35 %
Rec. = 5 %
Keff (mL/min)
Blood flow

AutoFlow e. g. Reduction QD


QD = 1.2 x QB

Dialysate (mL/min)

Keff at QD = 500 mL/min


Keff at QD = 360 mL/min
Keff 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
5008S
5008S – Extending Experience

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 Product Range
Product Art. No.

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



Technical Data 5008S

General data EcoFlow Stand-by flow of 100/150 mL/min (HD/HDF)


during preparation and reinfusion
Dimensions 5008S 1,680 x 350 x 780 mm (H x W x D) at bed/dialysis
Dialysis fluid
chair level (width at base: 520 mm, depth with temperature 34 – 39 °C
canister holder: 900 mm)
Dialysis fluid conductivity
Weight approx. 100 kg Range 12.8 – 15.7 mS/cm
Accuracy ± 0.1 mS/cm
Monitor/Screen 15" high-resolution TFT LCD with touch screen user
interface. Monitor rotatable around the 3 axes Sodium concentration dialysis fluid
Mixing ratio Freely adjustable e.g. 1 + 44, 1 + 34
Card reader Smart card (ICC) for Patient, User and ServiceCard Adjustment range 125 to 151 mmol/L, depending on the
concentrate used ± 10 % of the base value
Water supply
Water inlet pressure 1.5 – 6.0 bar Bicarbonate concentration dialysis fluid
Water inlet temperature 5 – 30 °C; for “integrated hot rinse” 85 – 95 °C Default mixing ratio 1 + 27.6 (others possible)
Max. drain height 1m Adjustment range 24.0 – 40.0 mmol/L (steps of 0.5 mmol/L)
Flush Rinse of water supply area (option)
Bicarbonate dry concentrate bibag®
Concentrate supply
Supply pressure 0 to 100 mbar; 1 m suction height with Balancing accuracy ± 0.1 % related to the total dialysate volume
Central Delivery System: 0.05 to 2.0 bar Pressure holding test Event controlled
Central supply 1 central acid concentrate (option)
Ultrafiltration
Electrical data UF rate 0 – 4,000 mL/h (in steps of 10 mL)
Power supply 100 to 240 V AC ± 10 %, 47 – 63 Hz Pump volume accuracy ± 1%
Current consumption Approx. 6 A (at 230 V) at a water inlet Parameters displayed UF goal, UF time, UF rate, UF volume
temperature of 17 °C, Dialysate temperature 37 °C
Dialysate flow: 500 mL/min Blood leak detector
Sensitivity <_ 0.5 mL blood/min (Hct = 25 %)
External connections Alarm output: potential free alarm outlet flow rate 100 mL/min – 1,000 mL/min
(alternating contact max. 24 V/24 W).
LAN (RJ 45) port for data exchange with Dialysis fluid filter system DIASAFE®plus
Therapy Data Management System/Finesse®
ONLINEplus ONLINE Haemo(dia)filtration
Substitution rate 25 – 600 mL/min
Extracorporeal circuit Accuracy ± 10 %
AutoSub Substitution ideally matched to
Arterial pressure monitoring effective blood flow
Display range - 300 mmHg to + 300 mmHg
Accuracy ± 7 mmHg OCM® Online Clearance Monitoring
Resolution 5 mmHg Accuracy Clearance K ± 6%

Venous pressure monitoring BPM (Option)


Display range - 100 mmHg to + 500 mmHg Display range Systole: 30 mmHg – 280 mmHg
Accuracy ± 7 mmHg Diastole: 10 mmHg – 240 mmHg
Resolution 5 mmHg MAP: 20 mmHg – 255 mmHg
Accuracy ± 3 mmHg
Transmembrane pressure monitoring
Display range - 100 mmHg to + 400 mmHg BTM (Option)
Resolution 5 mmHg Temperature measurement Accuracy ± 0.2 °C
Body temperature control Allowed change rate ± 0.5 °C/h
Arterial blood pump Recirculation measurement Accuracy ± 2 %
Blood flow range (effective) 30 to 600 mL/min
Accuracy ± 10 %
Disinfection and cleaning programmes*
Single-Needle system 2 blood pumps. Internal pressure/pressure
(Option) control with variable stroke volume (max. 50 mL) Rinse
Temperature/flow 37 °C/600 – 800 mL/min (adjustable)
Air bubble detector Ultrasound transmission measurement on blood line,
additional capacitive level and optical monitoring Hot rinse (recirculation)
Temperature/flow 85 °C/600 – 800 mL/min (adjustable)
Heparin pump Delivery range: 0.5 to 10 mL/h
Bolus function: 1.0 up to 20.0 mL Cleaning Sporotal® 100 (recirculation)
Syringe size: 30 mL Temperature/flow 37 °C/600 – 800 mL/min (adjustable)

Heat disinfection Diasteril®/Citrosteril® (recirculation)


Dialysis fluid circuit Temperature/flow 85 °C/600 – 800 mL/min (adjustable)

Dialysis fluid flow range Disinfection Puristeril® 340/plus (recirculation)


Selectable 0 – 1,000 mL/min (steps of 100 mL/min) Temperature/flow 37 °C/600 – 800 mL/min (adjustable)
AutoFlow (selectable) Automatic adaptation of the dialysate flow to
the effective blood flow (factors adjustable) * Various programme combinations selectable. Technical changes reserved.
© Copyright 2008 Fresenius Medical Care Deutschland GmbH
736 425 1/1 GB (4,0 V&B 04.08)

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

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