Cardioprotective Haemodialysis

5008S CorDiax
Product Overview

Cardioprotective Haemodialysis SP T
 Protect your Patient

5008S CorDiax
Beyond your expectations

Almost one in two patients with ESRD dies as a result

of cardiovascular disease. That is why Cardioprotective
Haemodialysis is a core principle of Fresenius Medical
Care, as we work and strive to solve the challenges of
modern dialysis. Each step we take is focused on
minimising cardiovascular risks and extending patients’
lives. For this reason the 5008S CorDiax is the
standard device for haemodialysis treatment in our
SPOT programme. It offers sophisticated therapy
options and excellent usability combined with the
optimal use of dialysis-relevant resources.
The 5008S CorDiax helps you to protect your patient
– day by day.

Best therapies
Advanced therapy options such as
HighVolumeHDF enable Cardioprotective
Haemodialysis – for best possible patient
outcomes

Best handling
Sophisticated design guarantees outstanding
usability and convenient handling for all users

Optimal use of resources

Efficient and sustainable use of dialysis-
relevant resources result in excellent cost-
effectiveness

PR
O
D
U
CT
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5008S CorDiax
Highlights

5008S CorDiax

Therapy highlights

HighVolumeHDF – pre- and post-dilution /

AutoSub plus – automatically maximising substitution volumes in a highly safe manner

HighVolumeHDF during Single Needle treatment

Blood Temperature Monitor (BTM) – regulation of temperature and recirculation measurement

Home Haemodyalisis – Advanced therapies for home patients

Safety features

Integrated Venous Access Monitor – increased probability of detection of venous needle dislodgement

Dynamic Pressure Monitoring – detection of paravasal bleeding (“infiltration”)

VenAcc external device for detection of venous needle disconnection

Basic features

Dialysis fluid ultrafilter system – sterile and non-pyrogenic fluid for ONLINE use

ONLINE Priming, bolus and reinfusion in HD / HDF / SN – no saline required in all treatment modes* / /

OCM® Kt/V Measurement with transfer of V from BCM-Body Composition Monitor in HD / HDF /

Single-needle double-pump

PatientCard – prescription and documentation of treatment parameters

Interface heat disinfection – fulfilling all requirements of ISO 23500

Advanced service tools for fast diagnostics and maintenance with interactive hydraulic and pneumatic flow charts and remote access

Compliance with latest requirements of IEC 60601

Timer function for setting a reminder of a definable task

Eco-friendly features

High efficiency heat exchanger

AutoFlow – automatic adaptation of dialysate flow for optimal balance of dialysate consumption and treatment efficiency

EcoFlow – water and energy saving during standby conditions

(For more details please refer to the Technical Data) = standard, = optional

* Safety advice: It is recommended that you stock sodium chloride in

case it might be required.

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 Protect your Patient

5008S CorDiax
Technical Data

General data Dialysis fluid conductivity

Range 12.8 to 15.7 mS/cm
Dimensions 5008S CorDiax 1,680 x 350 x 780 mm (H x W x D) at dialysis Accuracy ± 0.1 mS/cm
chair/bed level (width at base: 520 mm, depth with Resolution 0.1 mS/cm
Weight canister holder: 900 mm)
Dialysis fluid acid component
approx. 114 kg
Mixing ratio Adjustable, e.g. 1+44, 1+34
Water supply Adjustment range 125 to 151 mmol/L, depending on the concentrate
Water inlet pressure 1.5 to 6.0 bar used ± 10 % of the base value
Water inlet temperature 5 to 30 °C; for “integrated hot rinse” 85 to 95 °C
Max. drain height 1m Dialysis fluid bicarbonate component
Flush (optional) Rinsing of the water supply area Default mixing ratio 1+27.6 (others possible)
Adjustment range 20.0 to 40.0 mmol/L (depending on the concen-
Concentrate supply
trate used; steps of 0.5 mmol/L)
Supply pressure 0 to 100 mbar; 1 m max. suction height with
Central Delivery System (CDS): 0.05 to 2.0 bar OCM® Online Clearance Monitoring
Central supply 2 central acid concentrates (optional) Accurate Clearance K ±6%
Electrical data Bicarbonate dry concentrate bibag®
Power supply 100 to 240 V AC ± 10%, 50 to 60 Hz
ONLINEplus
Current consumption Approx. 6 A (at 230 V) at a water inlet
Dialysis fluid filter system DIASAFE®plus
temperature of 17 °C, dialysate temperature 37 °C,
Online Haemo(dia)filtration 25 to 600 mL/min
Dialysate flow: 500 mL/min
Substitution rate Accuracy ± 10%
External connections Alarm output: potential free alarm outlet Balancing accuracy ± 0.1 % related to the total dialysate volume
(alternating contact max. 24 V/24 W). Pressure holding tests Event controlled
LAN (RJ 45) port for data exchange with
Therapy Data Management System (optional) Ultrafiltration
UF rate 0 to 4000 mL/h (in steps of 10 mL)
Extracorporeal circuit Pump volume accuracy ±1%
Parameters displayed UF goal, UF time, UF rate, UF volume
Arterial pressure monitoring
Display range -300 mmHg to + 300 mmHg Blood leak detector
Accuracy ± 7 mmHg Sensitivity ≤ 0.5 mL blood/min (Hct = 25 %)
Resolution 5 mmHg flow rate 100 mL/min to 1000 mL/min
Alarm reaction dynamic, static, immediate BTM (optional)
Venous pressure monitoring Temperature measurement Accuracy ± 0.2 °C
Display range -100 mmHg to + 500 mmHg Body temperature control Allowed change rate ± 0.5 °C/h
Accuracy ± 7 mmHg Recirculation measurement Accuracy ± 2 %
Resolution 5 mmHg BPM (optional)
Arterial blood pump Display range Systole: 30 mmHg to 280 mmHg
Blood flow range 30 to 600 mL/min Diastole: 10 mmHg to 240 mmHg
Accuracy ± 10 % MAP: 20 mmHg to 255 mmHg
Resolution 10 mL/min Pulse: 20 to 245 1/min
Accuracy ± 3 mmHg
Single needle system With 2 blood pumps, internal pressure/pressure Resolution 1 mmHg
(optional) control with variable stroke volume (max. 60 mL/min)
Disinfection and cleaning programmes*
Air bubble detector Ultrasound transmission measurement on blood
line, additional capacitive level and infrared optical Rinse
monitoring Temperature/flow 37 °C / 600 to 700 mL/min (adjustable)
Heparin pump Delivery range: 0.5 to 10 mL/h Hot rinse (recirculation)
Bolus function: 1.0 to 20.0 mL Temperature/flow 85 °C / max. 600 mL/min
Syringe size: 20 mL, 30 mL Flow for cool down rinse 600 to 700 mL/min (adjustable)
Cleaning Sporotal® 100 (recirculation)
Dialysis fluid circuit Temperature/flow 37 °C / 600 to 700 mL/min (adjustable)
Heat disinfection Diasteril®/Citrosteril® (recirculation)
Dialysis fluid flow range
Temperature/flow 85 °C / 600 to 700 mL/min (adjustable)
Selectable 0 to 1000 mL/min (steps of 100 mL/min)
AutoFlow (selectable) Automatic adaptation of the dialysate flow Cold disinfection Puristeril® 340/plus (recirculation)
to the effective blood flow Temperature/flow 37 °C / 600 to 700 mL/min (adjustable)
EcoFlow Stand-by flow during preparation and after reinfusion
Dialysis fluid temperature 34 to 39 °C

4 * Various programme combinations selectable.

Technical changes reserved.
5008S CorDiax
Accessories

PatientCard
Individualised
  therapy prescription and
documentation “Offline”
 Also for use with BCM measurements

Type For use with Units per treatment Units per box Art. No.

PatientCard 5008 / 5008S 1 1 M357651

BCM

VenAcc
Special
  wetness detector for detection of
venous needle disconnection
 External device for 5008 CorDiax and


5008S CorDiax with single-use patches

Type For use with Units per treatment Units per box Art. No.

VenAcc patch 5008 / 5008S 1 40 F00003229

BCM-Body Composition Monitor

Stand-alone
  device for the continuous monitoring of
the patient’s dry weight with single use electrodes
 Uses whole-body bioimpedance spectroscopy (BIS)
 Transfer of measurement results via PatientCard to


5008S CorDiax

Type For use with Units per treatment Units per box Art. No.

BCM single use electrodes BCM 4 10 x 4 M351431

BCM single use electrodes Paediatric Dialysis BCM 4 10 x 4 M416561

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 Protect your Patient

5008S CorDiax
Bloodlines

 Optimal compatibility between bloodline and machine

 Beta sterilised
 Phthalate free

Type For use with Tube length to patient Filling volume Units per box Art. No.

Arterial line Venous line SafeLine

AV-Sets
5008 / 5008S Arterial: Venous:
AV-Set ONLINEplus 5008-R 132 ml 24 F00000384
HD / HDF 1982 mm 1900 mm

5008S Arterial: Venous:

AV-Set ONLINE Priming 5008S-R 132 ml 24 F00000700
HD 1979 mm 1900 mm

F00000386_2

D E 8252082
8253058

8253059
6809 6812

6967811
2±3

8252011
C (RED)

300±3

DS
CONFEZIONAMENTO:
BLISTERATURA = 2 OPERATORI
CONFEZIONAMENTO = 1 OPERATORE

F00000700
SN-Sets
ATTENTION:
THE COMPONENTS HAVE TO BE ORIENTED
ACCORDING TO THE FOLLOWING PATTERN

I L

5008 / 5008S Arterial: Venous:

8252083
6968531
8253059

6811 6812
SN-Set ONLINEplus 5008-R 166 ml 20 F00000386
HD / HDF 1979 mm 1900 mm
7811 1114
2047/060
1674
6781

5008_5018441

6912071
6995271

Description
AV-Set ONLINEplus 5008-R
Sterilization type Machine Type
Code
5018441 F00000700
R Fresenius Medical Care 5008
Pump segment [mm] Drip chamber [mm] Priming volume [ml] Weight [gr] Quantity/box Quantity/pallet
8,0 22 132 382 24 480
Scale Tollerance Material Page N?

Date Drawn by Checked by Rev. N? Revision date Drawing N? Pr. N?

07/04/2004 MMR RR 9/6 08/01/2007 24
closure thereof may be made without its written permission and approval.

F00000386 F00000386_2

6 Technical changes reserved.

5008S CorDiax
Concentrates

bibag®
 Online dry bicarbonate concentrate 8.4%
 Fully collapsible bag made of PA/PE, 100% PVC-free

Boxes per
Type For use with Weight per bag Units per box Art. No.
pallet
bibag 5008
®
5008 / 5008S 650 g 56 16 506 078 1

bibag® 5008 5008 / 5008S 900 g 56 12 506 080 1

smartbag®
 Liquid acid concentrate (dilution ratio 1+ 44)
 Fully collapsible bag made of PP/PE, 100% PVC-free
 Compositions of ready to use dialysis fluid (after mixing


with bicarbonate concentrate 8.4% and purified water)

Na+ K+ Ca2+ Mg2+ Cl – HCO –3 Acetate Glucose Osmolarity Art. No. 4.7 L Art. No. 4.7 L
Type For use with
mmol/L mmol/L mmol/L mmol/L mmol/L mmol/L mmol/L g/L mosm/L Box of 60 Box of 2
smartbag® 111.5 5008 / 5008S 138 1.00 1.50 0.5 108.00 32.00 3.00 1.00 289.55 F000 000 64 F000 006 4D

smartbag 211.25
®
5008 / 5008S 138 2.00 1.25 0.5 108.50 32.00 3.00 1.00 290.80 F000 000 65 F000 006 5D

smartbag® 211.5 5008 / 5008S 138 2.00 1.50 0.5 109.00 32.00 3.00 1.00 291.55 F000 000 66 F000 006 6D

smartbag® 211.75 5008 / 5008S 138 2.00 1.75 0.5 109.50 32.00 3.00 1.00 292.30 F000 002 32 F000 023 2D

smartbag® 311.25 5008 / 5008S 138 3.00 1.25 0.5 109.50 32.00 3.00 1.00 292.80 F000 000 67 F000 006 7D

smartbag® 311.5 5008 / 5008S 138 3.00 1.50 0.5 110.00 32.00 3.00 1.00 293.55 F000 000 68 F000 006 8D

Acid concentrate per pallet 564 L 564 L

Bags/box - boxes/pallet 60 - 2 2 - 60

Code message: e.g. smartbag® 111.5 (1xx.x = K+ in mmol/L) (x1x.x = Glucose in g/L) (xx1.5 = Ca2+ in mmol/L)

Type For use with Art. No.

Concentrate platform* 5008S M423591

*Tray fixed onto the machine to improve the stability of the concentrates (e.g. smartbags).

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 Protect your Patient

5008S CorDiax
Dialysis Fluid Filter

DIASAFE ® plus
 Production of ultrapure dialysis fluid
Safe
  production of sterile and non-pyrogenic
­substitution fluid with two filters in series
 In accordance with ISO 23500:2011 and
ISO 11663:2009
 Membrane type: Fresenius Polysulfone®
 Material: housing/potting PP/PU, sealing silicone

Disinfection
Type For use with Effective surface Operating time Units per machine Units per box Art. No.
cycles
Max. 12 weeks
Max. 11 times
DIASAFE® plus 5008 / 5008S 2,2 m2 or 100 2 24 B 500 820 1
Sporotal
treatments
Max. 12 weeks
Max. 11 times
DIASAFE® plus 5008 / 5008S 2,2 m2 or 100 2 1 500 820 1
Sporotal
treatments

8 Technical changes reserved.

Protect your Patient

5008S CorDiax
Disinfectants

Machine Disinfectants
 For the disinfection, cleaning and decalcification of the hydraulic system
 All disinfectants are bactericidal and virucidal
 Cold disinfectants and cleaner at a process temperature of 37 °C
 Heat disinfectants at a process temperature of 85 °C

Filing volume/
Type For use with Specification Units per box Art. No.
Items per unit

For decalcification and disinfection

Puristeril ® 340
Contains:
Peracetic acid, acetic acid, hydrogen peroxide, water.

5008 / 5008S
Puristeril ® 340 multilingual 5 kg (4.4 L) 1 508 562 1
cold

For decalcification and disinfection

Puristeril plus
Contains:
Peracetic acid, acetic acid, hydrogen peroxide, water.

5008 / 5008S
Puristeril plus D-NL-F-GB-S-DK 5 kg (4.9 L) 1 508 570 1
cold
5008 / 5008S
Puristeril plus I-E-P-H-HR-GR 5 kg (4.9 L) 1 508 571 1
cold
5008 / 5008S
Puristeril plus RUS-SK-RO-PL-SLO-SRB 5 kg (4.9 L) 1 508 572 1
cold

For decalcification and disinfection

Citrosteril
Contains:
Citric acid 1-hydrate; lactic acid, malic acid

5008 / 5008S
Citrosteril multilingual 5L 1 F00005157
heat
5008 / 5008S
Citrosteril multilingual 5L 2 F00005158
heat

For decalcification and disinfection

Diasteril
Contains:
hydroxyacetic acid

5008 / 5008S
Diasteril GB-I-E-P-F-GR 6L 1 508 565 1
heat
5008 / 5008S
Diasteril D-NL-F-I-SK-CZ 6L 1 508 564 1
heat
5008 / 5008S
Diasteril RU-SK-RO-PL-CZ-SLO 6L 1 508 566 1
heat
For degreasing and disinfection

Sporotal 100 Contains:

Sodium hypochlorite (releases chlorine);
potassium hydroxide, corrosion inhibitors.
5008 / 5008S
Sporotal 100 multilingual 1L 6 508 516 1
cold
Accessories

Bottle Sporotal
Canister opener - - 1 M418491
100, 1 L

Canister opener 5 kg canisters - - 1 M305191

Puristeril 340,
Potassium iodide starch paper Puristeril plus, Residual test 100 1 508 521 1
Sporotal 100

pH-Fix 3.6-6.1 Diasteril Residual test 100 1 6288161

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 Protect your Patient

Surface Disinfectants
Bactericidal
  (incl. MRSA), yeasticidal, inactivating enveloped viruses
(Vaccinia virus and BVDV as surrogate viruses for e.g. HBV/HCV/HIV)
and noroviruses (MNV), tuberculocidal activity

Filing volume/
Type For use with Specification Units per box Art. No.
Items per unit

100 g Freka-NOL contains 45.0 g ethanol as active ingredient.

Freka-NOL
To be used undiluted. Contact time 1 min.

Freka-NOL 5008/5008S D-GB-F-I-NL 2L 6 F00001165

100 g ClearSurf contains: 16 g quaternary ammonium

compounds (benzyl-C12-16-alkyl-dimethyl, chlorides), additives,
ClearSurf
fragrance.
To be used in a 1% dilution. Contact time 15 min.

ClearSurf 5008/5008S D-F-I-NL 2L 6 508 569 1

ClearSurf 5008/5008S GB-E-P-SLO 2L 6 508 573 1

ClearSurf 5008/5008S S-DK-CZ-SK 2L 6 508 577 1

ClearSurf 5008/5008S GR-H-HR-TK 2L 6 508 578 1

ClearSurf 5008/5008S RUS-PL-RO-BG 2L 6 508 579 1

Dosing pump 5008/5008S - - 1 603 063 1

Measuring cup 5008/5008S - - 1 603 062 1

Canister opener 5008/5008S - - 1 M305191

Soaked with a 1% ClearSurf solution. Soaking solution

ClearSurf WIPES contains quaternary ammonium compounds
(benzyl-C12-16-alkyldimethyl, chlorides), additives, fragrance

ClearSurf WIPES 5008/5008S D-F-NL-I 30 wipes 14 603 071 1

ClearSurf WIPES 5008/5008S GB-DK-S-N 30 wipes 14 603 072 1

ClearSurf WIPES 5008/5008S BG-FIN-RUS-TR 30 wipes 14 603 073 1

ClearSurf WIPES 5008/5008S E-EST-LT-P 30 wipes 14 603 074 1

ClearSurf WIPES 5008/5008S H-HR-BIH-SRB-SK 30 wipes 14 603 075 1

Material: High grade, lint-free spunlace non-woven material.

Freka-WIPES 100% synthetic fibre mixture, 40 g/m2. Cross-linked and
tear-proof

multilingual
Freka-WIPES Dispenser 5008/5008S 1 F00000891
Blue dispenser, equipped with 1 roll Freka-WIPES

Freka-WIPES 5008/5008S multilingual 100 wipes 6 F00000892

10 Technical changes reserved.

Head office: Fresenius Medical Care Deutschland GmbH · 61346 Bad Homburg · Germany
Phone: +49 (0) 6172-609-0 · Fax: +49 (0) 6172-609-2191
www.fmc-ag.com