Haemodialysis

4008SVisually the best dialysis results

Through continuous optimisationof the treatment modalities Fresenius Medical Care alwaysaims to offer patients the bestrenal replacement therapy toincrease their well being and quality of life.

Our haemodialysis system 4008Sensures safety and efficiency of allimportant treatment modalitieswithin the scope of renal replace-ment therapies, such as:

• Bicarbonate dialysis

• Single-Needle or SN Click-Clack

• Ultrafiltration and Sodium profiles

• ISO-UF programme

• ONLINE Haemo(dia)filtration

Therapy

Ultrafiltration and Sodium Profiles

ONLINEplus System – ONLINE Haemo(dia)filtration

DIASAFE®plus – Dialysis fluid filter

bibag® – Dry bicarbonate concentrate

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The 4008S can be customised bya modular combination of variousmonitoring and control functions.

The automated acquisition, monitoring and control of specificpatient and machine parametersprovide the operator with continu-ous and precise assessment ofthe current treatment situation.

The 4008S is available with 5 functional slots for slide-in mod-ules.

FINESSE® / TDMSDialysis Data Acquisition andManagement Systems

Monitoring

OCM® – ONLINE Clearance Monitoring

BVM – Blood Volume Management

BTM – Blood Temperature Management

BPM – Blood Pressure Monitoring

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System

BalancingChamber

RetentateValve Bypass

Valve

RinsingPort

SubstitutionPort

DIASAFE®plusSystem Pump

Predilution

SafeLINE

Postdilution

VenousBubbleTrap

PatientBlood PumpArterial

FlowChamber

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OptionONLINEplus

UF Pump

The ergonomical and logical operating structure with clear allocation of operating functionsseen in only seven menu screens,permits the user easy program-ming of the treatment parameterson the high-resolution colourscreen.

Additional information of the treat-ment is provided by the graphicalrepresentations of treatmentparameters and measured values scaled to time. Warningmessages give support and easethe operation. The automatedsetting of alarm limits and their

intelligent monitoring ensures astraight forward treatment almostfree from false alarms.

The preparation of the dialysisfluid occurs in a closed, media-separated and volumetric balanc-ing system with volumetricallycontrolled ultrafiltration. TheAdvanced Dialysis Fluid Circuit isthe basis to perform the highlyeffective ONLINE H(D)F therapy(ONLINEplus System) and the precise ONLINE Clearance Monitoring (OCM®).

Adjustable dialysate parametersinclude:

• Sodium and Bicarbonate content

• flow: 0 – 300 – 500 – 800 mL/min

The concentrate can be suppliedin various mixing ratios using:

• canisters• central concentrate delivery

systems (CDS)• dry bicarbonate concentrate

bibag®.

Advanced Dialysis Fluid Circuit

Operation

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OCM® – Impulses to improve quality of life!

Based on the precise ultrasoundmeasuring technology the BloodVolume Monitor BVM permits theexact and continuous acquisitionof the:

• relative changes in the bloodvolume (RBV)

• Haematocrit value (Hct) • Haemoglobin value (Hb)

as well as an:

• individualised, blood volumedependent control of the ultra-filtration rate during thehaemodialysis treatment

With the clinically evaluated algo-rithms of this option, symptomatichypotension due to excessivefluid removal can now be prevent-ed, without the need of an addi-tional sodium load for the patient.

An effective modality to reduceintradialytic complications and tostabilise haemodynamic parame-ters is the monitoring and controlof the blood temperature usingthe BTM:

• stabilisation of the intradialyticbody temperature

• control of thermal energy bal-ance

Additionally, the BTM facilitates:• the assessment of the fistula

function by measuring therecirculation during the treat-ment using a thermodilutiontechnique

Thanks to the automated meas-uring procedure, the informationon the total recirculation isobtained within a few minutes.

Monitoring

The „online Clearance monitoring“ enables the continuous monitoring of:

• the effective in-vivo urea clearance (K)

• the accumulated cleared plasma (Kt) or

• the current dialysis dose administered (Kt/V)

• and the plasma sodium con-centration, during treatment.

OCM® can also be combined withONLINEplus Haemodiafiltration inpre- or postdilution. The user can

specify the prescribed therapygoal and detect immediately pos-sible deviations during the courseof the treatment and perform thenecessary corrections.

The measuring technique is:

• non-invasive • runs completely automated• causes no additional treatment

costs and • requires no additional dispos-

able, laboratory or staff effort.

BVM – Blood Volume Management

BTM – Blood Temperature Management

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Monitoring

The BPM is a fully automated and non-invasive blood pressuremonitor, operating on the principles of oscillometry.

In addition to the manual proce-dure for blood pressure measure-ment, it is also possible to perform measurements in prese-lected intervals:

• interval modes of 5 - 15 - 30 - 60 minutes

• quick mode for individual measurements approx. every30 seconds over a period of 5 minutes

The following obtained values willbe recorded:

• Systolic blood pressure• Diastolic blood pressure• Mean Arterial Pressure (MAP)• Pulse

FINESSE® / TDMS are DialysisData Acquisition and Manage-ment Systems for continuousquality improvement and processanalysis providing the basis for aneffective and efficient organisationof the dialysis practice:

• providing valuable clinical and therapy information in aneasy-to-use format

• support in planning and organi-sation of day to day activities ina dialysis unit

• supporting the increase in effi-ciency in a modern dialysis unitby automating work-intensiveand time-consuming activities(e.g. manual pre-setting of dialysis machines, filling in dialysis protocols etc.)

• easy, fast and targeted onlineaccess for all users to all relevant treatment data e.g. for further data processing

• automated pre-setting of our dialysis machines via thedownload

• easy and safe performance of patient individualised dialysistreatments

• online data acquisition from ourdialysis machines as well asfrom connected scales and/oronline lab analysers via a com-puter network offers valuabletreatment documentation,which is automatically stored inthe connected clinical manage-ment system

• data is accessible at any timeproviding a comprehensiveoverview of relevant data foranalytical and organisationalpurposes

• modular designed and flexiblesystem for easy and unlimitedgrowth

FINESSE® / TDMS – Dialysis Data Acquisition and Management Systems

BPM – Blood Pressure Monitoring

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Recent studies show that ONLINEHaemodiafiltration proceduresimproves the patient’s quality oflife and outcome.

The high microbiological qualityrequirements stipulated for dialy-sis fluid and substituation solutionare met by the filtration of dialysatethrough two DIASAFE®plus filters.

• Haemodiafiltration in pre orpost-dilution, also in com-bination with Single-Needleprocedure

• Haemofiltration in pre or post-dilution, also in combinationwith Single-Needle procedure

• Haemodialysis with ultrapuredialysis fluid

• bolus programme / also in HD• priming and infinite rinsing of

the extracorporeal circuit / alsoin HD

• reinfusion without additionalsaline solution / also in HD.

Profiles counteract actively againstintra and post-dialytic complica-tions by targeted influence on thefluid and electrolyte balance.

Sodium profiles can achieve:

• a temporary increase of theplasma sodium concentration

• a support of the intradialyticrefilling

• stabilisation of the circulation

The increase in the plasma sodi-um concentration is phased

out completely at the end of thetreatment (neutral balancing) anddoes not cause a problematicincrease in the post-dialytic plasmasodium.

The UF profiles adapt the fluidremoval to the intradialytic changein the UF tolerance of the patientsand are designed in such a waythat an adequate refilling can takeplace in the intravascular space.Sodium and UF profiles can be combined, but can also beused individually.

Due to its high retention propertiesfor microbiological contaminantsthe Fresenius Polysulfone® dialysisfluid filter DIASAFE®plus preventsthe passage of microbial sub-stances and assures ultrapuredialysis fluid, independent fromthe type of dialyser and treatmentmodality selected:

• maximum safety due to anautomated filter integrity testprior to each treatment

• automatic control of the filterlife time

• automated programme forexchanging the filter

• aseptic connection technologydeveloped for the hygienic,easy and fast installation of theDIASAFE®plus.

Therapy

Ultrafiltration and Sodium Profiles

DIASAFE®plus – Dialysis Fluid Filter

The ONLINEplus System

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Therapy

The supply of the bicarbonatebuffer as a dry substance avoidsthe risk of a potential, microbio-logical contamination of the liquidbicarbonate concentrate. Furtheradvantages of the bibag® are:

• high hygienic safety• easy handling

• minimum storage/space required

• ecologically beneficial, reduced waste volume

The bibag® is available in threesizes:

• 650 g• 700 g • 950 g

bibag® – Bicarbonate Dry Concentrate

Hygiene/Service

The disinfection and cleaning pro-cedures used in the 4008S are:

• validated, user-friendly• environmental friendly and

economical.

Thanks to their:

• disinfecting• decalcifying and• cleaning effect

we recommend the use of theheat disinfectant Diasteril® basedon hydroxyacetic acid or the cold

disinfectant Puristeril® 340 basedon peracetic acid:

• wide range of action: sporocidal, bactericidal, virucidal, Hepatitis B/C andHIV inactivating

• non-offensive odour and non-volatile

• biodegradable

Controlled volumes of the disin-fectant are aspirated from a firmlyconnected canister. Dependingon the disinfection regime thecontents of the canister will lastfor several weeks.

Disinfection Procedures

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The technical servicing of the4008S haemodialysis machines is optimised by an innovative,computer-supported service tool.

This system features:

• an automated test for the dialysis fluid circuit

• real time flow chart• display, printing and memory

of device specific data• individual configuration of the

set-up menu

The single patient reverse osmo-sis device AquaUNO is especiallydesigned for the operation of ourhaemodialysis machines in homedialysis and intensive care units.The AquaUNO is intended formobile stand-alone use, togetherwith the 4008S dialysis machines.

The system features:

• automated circulating rinsewith pre-selected rinse cycles

• optimised cleaning and disin-fection programmes includingthe permeate supply lines

• Initial self-test of essential components

• improved safety feature• recovery of excess permeate

and concentrate• monitoring of cleaning cycles

to protect the membrane.

Hygiene/Service

The quality of the dialysis fluidand its contamination with organ-isms is taking an important role inhaemodialysis. A critical pointunder the aspects of hygiene isthe risk of fluid within the treatedwater supply line deterioratingduring the interdialytic interval.

A potential microbiological con-tamination of the disinfected dial-ysis fluid circuit of the machine isprevented by:

• flushing the treated water sup-ply line using the optional flushvalve every time the machine is switched on

• bypassing the dialysis machineand discarding the entire con-tents of the supply line directlyinto the drain, via the hygienicflush adapter.

Flush – Complete Rinsing of the Treated Water Supply Line

AquaUNO

Service Programme 4008S

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4008S – The ideal partner for home haemodialysis

• The compact size of the dialysismachine, the offer of a remotecontrol unit with all main func-tions and the integrated bloodpressure module (BPM) makeit easy for the patient to operatethe dialysis machine and monitor the treatment processfrom chair or bed.

• Easy, step-by-step user-guidance on a clear andcolour-coded display.

• Pre-setting of all the therapyparameters facilitates thepreparation process andensures that the parametersare maintained by the patientas prescribed.

• Adjustable settings of bloodflow rate and dialysate flowrate allow a variety of treat-ment modalities, from conven-tional dialysis to short daily dialysis or nocturnal dialysis –depending on patient’s life style and the doctor’s prescription.

• Additional assistance in alarmhandling gives the patient theconfidence needed to dialyseat home.

Important operation and safety features

The haemodialysis system 4008S ensures safety and ease-of-use for the patient when dialysing at home withor without the assistance of a family member or spouse / partner.

The FINESSE® / TDMS DialysisData Acquisition and Manage-ment Systems allows a remote

patient monitoring with an immediate alarm reporting.

Patient monitoring:

• A special training manual tailored to the needs of thehome haemodialysis patientsupports the training and education.

• Our experienced and dedicatedtechnical service installs andmaintains the dialysis equip-ment.

• The reliable and punctual delivery and disposal service is part and parcel of our customer service.

Excellent “Home” Services

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General Data

Dimensions 1330 x 495 x 340 mm (H x W x D)(depth of pedestal 630 mm)

Weight approx. 80 kgWater supply

Water inlet pressure 1.5 – 6.0 barWater inlet temperature 5 °C – 30 °CMax. drain height 1 mConcentrate supply

Supply pressure 1 m suction heightElectrical data

Power supply 230 V – 10 % to + 6 %, 50 Hz, 16 ACurrent consumption max. 9 AExternal connections

“Alarm in”: zero potential alarm inlet“Alarm out”: zero potential alarm outletSerial Port RS 232 for data transmission to TDMS (optional)

Extracorporeal circuit

Arterial pressure monitoring

Display range – 300 mmHg to + 280 mmHgAccuracy ± 10 mmHgResolution 20 mmHgVenous pressure monitoring

Display range – 60 mmHg to + 520 mmHgAccuracy ± 10 mmHgResolution 20 mmHgTransmembrane pressure monitoring

Display range – 60 mmHg to + 520 mmHgResolution 20 mmHgArterial blood pump

Blood flow range 10 to 600 mL/minAccuracy ± 10 %Single-Needle system

with 2 blood pumps. Internal pressure/ pressure control with variable stroke volume

Air bubble detector

by ultrasound transmission, additional optical monitoring in venous clamp

Heparin pump

Delivery range 0 to 10 mL/hBolus function max. 5 mL per bolusSyringe size 20 mL, 30 mL

Dialysis fluid circuit

Dialysis fluid flow range

Selectable 0 – 300 – 500 – 800 mL/minDialysis fluid temperature

Selectable 35 °C to 39 °CDialysis fluid conductivity

Range 12.8 to 15.7 mS/cm (25 °C)Accuracy ± 0.1 mS/cmSodium concentration dialysis fluid

Default mixing ratio 1 + 34 (others possible)Range –13 to +13 mmol/l sodiumBicarbonate concentration dialysis fluid

Default mixing ratio 1 + 27.6 (others possible)Range – 8 to + 8 mmol/l bicarbonateBicarbonate dry concentrate

bibag®

Dialysis fluid filter system DIASAFE®plus

Balancing accuracy

± 0.1 % of dialysate flowUltrafiltration

UF rate 0 to 4.00 l/hAccuracy ± 0.5 %Allowed dialyser UF factor unlimitedParameters displayed UF goal, UF time, UF rate, UF volumeBlood leak detector

Sensitivity ≤0.5 mL blood/min (Hct = 25)at max. flow 800 mL/min

Disinfection and cleaning programmes*

Rinse

Temperature/flow 37 °C / 600 mL/minHot rinse (recirculation)

Temperature/flow 85 °C / 450 mL/minCleaning Sporotal® (recirculation)

Temperature/flow 37 °C / 600 mL/minHot disinfection Diasteril® (recirculation)

Temperature/flow 85 °C / 450 mL/minDisinfection Puristeril® 340 (recirculation)

Temperature/flow 37 °C / 600 mL/min

*Various programme combinations selectable

Technical Data Sheet Haemodialysis Machine 4008S

Technical changes reserved

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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