Changing: Your Partner For
Changing: Your Partner For
life
changing
dialysis
3,700
Clinics
37
Production sites
114,000
Employees
Intuitive
touch screen
Patient monitoring
DIASAFE®plus
Battery
back up
4008A
following the same color coding philosophy
as the 5008S and 6008 devices
20 min.
power reserve
Reduced risk
of contamination
Dimensions:
– Height: 149 cm
– Width: approx. 63 cm
– Depth: approx. 80 cm
Maximum total weight of 100 kg
Compact design
DIASAFE® plus
DIASAFE®plus enables the safe production of
ultrapure dialysis fluid for all treatments:
* ISO 11663: Quality of dialysis fluid for haemodialysis and related therapies
1. W eber C et al. Novel Online Infusate-Assisted Dialysis System Performs
Microbiologically Safely. Artificial Organs 2000; 24(5): 323–328.
4008A
Medical Care: Application training, technical
training and clinical support
Residual Renal Function (RRF) is the ability “Residual renal function has been shown
of native kidneys to eliminate water and uremic to influence adequacy of hemodialysis,
toxins in patients with ESRD quality of life and mortality of hemodialysis
Even in small amounts, preserving RRF lowers patients”1
mortality and may improve quality of life 1, 2, 3
Ultrapure dialysis fluid as a standard in all
treatments may contribute to the preservation
of RRF 4
(1.6)a
clearance (ml/min)
6 4.3 4.3
(1.5)a (1.8)
4
2.5
(1.8)a
2
0
Daily urine
volume
0 6 12 24 months
Medical Benefits
a
p < 0.05 vs corresponding value in patients treated with ultrapure dialysis fluid.
Study design:
30 patients starting hemodialysis were randomly assigned to ultrapure or conventional dialysis fluid.
During the 24-month study period, creatinine clearance, CRP and IL-6 levels, hydration status, number of hypotensive
episodes and blood pressure recordings were assessed every 6 months.
1. Shafi T., Jaar B., Plantinga L. Association of Residual Urine Output 3. Obi Y., Rhee C., Mathew A. Residual Kidney Function Decline
With Mortality, Quality of Life, and Inflammation in Incident and Mortality in Incident Hemodialysis Patients. J Am Soc Nephrol
Hemodialysis Patients: The Choices for Healthy Outcomes in 2016; 27: 3758–3768
Caring for End-Stage Renal Disease (CHOICE) Study. 4. Schiffl H et al. Ultrapure dialysis fluid slows loss of residual renal
Am J Kidney Dis 2010; 56:348-358 function in new dialysis patients. Nephrol Dial Transplant 2002;
2. Termorshuizen F., Dekker F.Van Manen J. Relative Contribution of 17: 1814–1818
Residual Renal Function and Different Measures of Adequacy
to Survival in Hemodialysis Patients: An analysis of the Netherlands
Cooperative Study on the Adequacy of Dialysis (NECOSAD)-2.
J Am Soc Nephrol 2004; 15: 1061–1070
Inflammation is an important risk factor for Elevated serum levels of inflammatory markers
dialysis patients 1–3
such as C-reactive protein pose a strong
Residual Renal Function has been shown to cardiovascular risk and contribute to EPO
influence quality of life and mortality of hemo hyporesponsiveness
dialysis patients 1
Establishing ultrapure dialysis fluid as a
standard could contribute to the reduction
of inflammation in dialysis patients2
In doing so it can contribute to lowering
cardiovascular risk & morbidity, and improving
response to EPO1, 2
40 %
of patients with conventional
(n = 15) dialysis fluid showed
CRP levels above the normal
range
7 %
of patients with ultrapure
dialysis fluid (n = 15)
a
p < 0.05 vs corresponding value in patients treated with ultrapure dialysis fluid.
Study design:
30 patients starting hemodialysis were randomly assigned to ultrapure or conventional dialysis fluid.
During the 24-month study period, creatinine clearance, CRP and IL-6 levels, hydration status, number of hypotensive
episodes and blood pressure recordings were assessed every 6 months.
Medical Benefits
Chart created from Schiffl H. 2002 data
1. Lederer SR, Schiffl H. Ultrapure Dialysis Fluid Lowers the Cardiova 3. Furuya R et al. Ultrapure Dialysate Reduces Plasma Levels of
scular Morbidity in Patients on Maintenance Hemodialysis by Redu- β2-Microglobulin and Pentosidine in Hemodialysis Patients. Blood
cing Continuous Microinflammation. Nephron 2002; 91: 452–455. Purif 2005; 23: 311–316.
2. Sitter Tet al. Dialysate related cytokine induction and response 4. Schiffl H et al. Ultrapure dialysis fluid slows loss of residual renal
to recombinant human erythropoietin in haemodialysis patients. function in new dialysis patients. Nephrol Dial Transplant 2002;
Nephrol Dial Transplant 2000; 15: 2107–1211. 17: 1814–1818.
Ultrapure dialysis fluid produced with DIASAFE® plus has been shown to contribute
to reducing plasma levels of β2-m which could contribute to delaying the onset and
reducing the risk of dialysis-related amyloidosis1, 5, 6
35
Ultrapure
(n = 16) dialysis fluid
β2-m (mg/l)
30
p < 0.05
p < 0.05
25
Study design:
16 patients undergoing hemodialysis had their dialysis fluid switched from a conventional to an ultrapure dialysis fluid.
Patients were followed for 6 months on ultrapure dialysis fluid, and then switched back to conventional dialysate.
Among others, the plasma level of β2-m was measured.
1. Furuya R et al. Ultrapure Dialysate Reduces Plasma Levels 4. Miyata T, Inagi R, Iida Y. Involvement of β2-microglobulin modified
of β2-Microglobulin and Pentosidine in Hemodialysis Patients. with advanced glycation end products in the pathogenesis
Blood Purif 2005; 23: 311–316. of hemodialysis-associated amyloidosis. J Clin Invest 1994; 93:
2. Gejyo F, Yamada T, Odani S. A new form of amyloid protein 521–528.
associated with chronic hemodialysis was identified as 5. Baz M, Durand C, Ragon A, Jaber K, Andrieu D, Merzouk T,
β2-microglobulin. Biochem Biophys Res Commun 1985; Purgus R, Olmer M, Reynier JP, Berland Y: Using ultrapure water
129:701–706. in hemodialysis delays carpal tunnel syndrome. Int J Artif Organs
3. Miyata T, Oda O, Inagi R. β2-Microglobulin modified with advanced 1991; 14: 681–685.
glycation end products is a major component of hemodialysis- 6. Schiffl H. Nephrol Dial Transplant. 2000; 15(6):840-5. Clinical
associated amyloidosis. J Clin Invest 1993; 92: 1243–1252. manifestations of AB-amyloidosis: Effects of biocompatibility
and flux
Renal
specialized staff
DUCT
PRO
Technical
support
After sales
support
Clinical
SE
E
applications Customer
PL
service
RV
EO
IC
E
P
Corporate Social
Responsibility
Water inlet pressure 1.5 to 6.0 bar Dialysis fluid acid component
Water inlet temperature 5 °C to 30 °C Mixing ratio Adjustable, e.g. 1+44, 1+34
Max. drain height 1 m Adjustment range 125 to 150 mmol/L
Electrical data Dialysis fluid bicarbonate component
Power supply 110 to 240 V AC, 50 to 60 Hz, 10 to 15 A Mixing ratio 1 + 27.6 (others possible)
Current consumption The consumption and energy data are Adjustment range – 8 to + 8 mmol/L
comprised of examples of average Endotoxin retention filter
values during typical operation:
Dialysis fluid DIASAFE® plus
Blood pump rate: 300 ml/min
filter system
Dialysate flow: 500 ml/min
Ultrafiltration: 0.5 l/h Balancing accuracy
Dialysate temperature: 36.5 °C Pressure holding tests ± 0.1 % relative to the total dialysate volume
Mixing ratio: 1+44 Event controlled
Ambient conditions: Water inlet
temperature 15 °C, Ultrafiltration
ambient temperature 22 °C. UF rate Selectable UF time:
0:01 h to 9:59 h (in 1 min increments)
Mean energy consumption Dialysis: Selectable UF goal:
approx. 0.59 kWh per hour 10 ml to 9,990 ml (in 10 ml increments)
Rinsing: approx. 0.26 kWh Pump volume accuracy ± 1 %
(program length of 16 minutes) Parameters displayed UF goal, UF time, UF rate
Heat disinfection: approx. 0.62 kWh
Blood leak detector
(program length of 41 minutes)
Degreasing: approx. 0.45 kWh Sensitivity Response threshold less than or equal to
(program length of 41 minutes) 0.35 ml blood loss per minute into the
dialysate for a haematocrit of 0.32
Extracorporeal circuit
Disinfection and cleaning programmes
Arterial pressure monitoring
Rinse
Display range – 300 to + 280 mmHg
Accuracy ± 10 mmHg Temperature / flow 37 °C/700 mL/min
Resolution 5 mmHg Heat disinfection
Venous pressure monitoring Temperature / flow 84 °C/700 ml/min
Display range – 60 to + 520 mmHg Degreasing
Accuracy ± 10 mmHg
Resolution 5 mmHg Temperature / flow 37 °C/700 mL/min
Fresenius Medical Care Asia-Pacific Ltd · 51/F, Sun Hung Kai Centre, 30 Harbour Road, Wanchai, Hong Kong
Telephone: (852) 2583 0888 · Fax: (852) 2583 0200 ·
www.freseniusmedicalcare.asia