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 – 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
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
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