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Lmb Technologie GmbH ADVANCED TECHNOLOGY IN BLOOD SEPARATION ErySep ! Unique and New Blood Separation Technology Blood Separation without mechanical devices Without ... – PowerPoint PPT presentation

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Title: Folie 1


1
Lmb Technologie GmbH
ADVANCED TECHNOLOGY IN BLOOD SEPARATION
2
ErySep ! Unique and New Blood Separation
Technology
  • Blood Separation without mechanical devices
  • Without Centrifuge
  • Without Separation Press
  • Without Power Supply
  • Blood Separation by gravity force
  • ErySep separates whole blood into two components
    ( RED CELL and PLASMA ) by itself without any
    other instruments
  • Separated Blood Components in perfect quality
  • Cells Free PLASMA
  • Leukocyte Free RED CELL
  • Concentrated RED CELL ( 55-60 HTC )

3
ErySep ! Unique and New Blood Separation
Technology
  • Approved Clinical Results
  • Studying on different parameters such as pH,
    LDH, K, P, NH3, Osmolality, 2,3-DPG, Total
    protein, Hemoglobin in TU (g/unit), Loss of Hb,
    Haemolysis, Leucocytes, F VIII activity,
    Platelets,
  • the results have been published in international
    scientific magazines.
  • Validation in different Country Blood Banks
  • German Blood Banks Indonesia Blood Banks
  • UK Blood Banks Malaysia Blood Banks
  • Spain Blood Banks Myanmar Blood Banks
  • Bulgaria Blood Banks Taiwan Blood Banks
  • Greece Blood Banks Philippines Blood Banks
  • Chech Blood Banks Egypt Blood Banks
  • Slovakia Blood Banks Yemen Blood Banks
  • Belgium Blood Banks Jordan Blood Banks
  • Turkish Blood Banks Saudi Blood Banks
  • Russia Blood Banks
  • All results meets with European Blood Components
    Standard
  • Guide to the preparation, use and quality
    assurance of blood components - 15th Edition
    (2009)

4
ErySep ! Unique and New Blood Separation
Technology
  • WHY ERYSEP?
  • ErySep is user friendly
  • No necessary special education
  • Work in all kind of environment
  • (outdoor/indoor)
  • It is activated in 5 minute, and no need extra
    efforts
  • Staff can do their other daily work
  • ErySep complete process by itself within 75
    minutes.
  • ErySep is a Closed Sterile System
  • It can not effect outside conditions
  • Cost Reduction
  • No centrifuge extractor investment
  • No maintainance cost in routine usage
  • No power supply
  • Easy Handling
  • 24 month shelflife in room condition
  • Easy Product exchange replacement
  • Portable ready work wherever needed
  • Ready to use any time for any amount

5
ErySep ! Unique and New Blood Separation
Technology
  • ErySep is a disposable system
  • has standard triple blood bag
  • whole blood bag
  • red cell bag
  • plasma bag with an integrated air drainage bag
  • has standard leukocyte filter
  • has test bag with vacu-container port
  • has membrane filter embedded into separation
    chamber unit

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ErySep ! Unique and New Blood Separation
Technology
  • HOW ErySep WORKS?
  • Donor Blood is taken into Mother bag by using an
    integrated needle on the system.
  • ErySep works by gravity force, does not need any
    other instruments or power supply.
  • System can activate just by breaking internal
    plastic valves, after hanging to a infusion
    stand.
  • Tubular membrane with a diameter of lt1 mm and
    hollows (pores) 0,2 µm make physical separation
    Red Cells are pushed into Red Cell Bag, Plasma
    are pushed into Plasma Bag through the membrane
    filter.

7
ErySep ! Unique and New Blood Separation
Technology
  • Medical ADVANTAGES of ErySep
  • ErySep supplies Leuko-depleted Red Cell Plasma
  • Erysep supplies high HTC level into the Packed
    Red Cell Bag.
  • ErySep supplies plasma, which is ready for FFP
  • ErySep supplies Packed Red Cell Bag, which can be
    store 42 days.
  • Leuko-depleted components are precious for
    Oncology and Hematology Patients
  • Make available the fresh components at hospital
    for surgical operation purposes.
  • Make available the fresh components for the
    patients need routine transfusion at hinterland.

8

Datas from Hospital Prag Dr. Bohaniek
Time Day 0 Day 42
pH Average value 7.234857 6.893286
LDH (µkat/l) Average value 0.959286 4.957857
K (mmol/l) Average value 1.254286 39.25071
P (mmol/l) Average value 0.969286 3.660714
NH3 (µmol/l) Average value 10.20771 153.6929
Osmolality (mOsm/l) Average value 333.4286 352.8571
ATP (µmol/g Hb) Average value 2.621429 0.718571
DPG (µmol/g Hb) Average value 12.16543 0.363643
Hemolysis Average value 0.140714 0.7205
9
Rating and Validation of ErySepe..aiood donation
and Blood separation device Dr. med.Dr.rer.nat
Kurt Mannemann-Pohl Germany Hamburg - Pohl
Fachaat fOr Laboratoriumsmedizin Facharzt fOr
Transfusionsmedizin DipL. Chem. BACKGROUND
ErySep Blood Donation and Blood separation device
has been validated in Hamburg at Marien
Krankenhaus Blood bank. Whole results have been
reported as clinical study. STUDY DESIGN AND
METHODS The used analysis methods performed in
the laboratory of the Marienkrankenhaus Hamburg
and are listed below. All analysers and reagents
were CE certified. All analysis methods were
under permanent supervision of our quality
control system with permant internal and four
external controls per year.
10
RBC Results German Studies ( n15 ) Value
Avarage volume unit 346 ml
Hb 17,4 g/dl
Haematocrit 54
Leucocytes in unit on day 1 0,03x10 6
Protein / unit 3,3 g/unit
K in RBC on day 1 0,28mmol/l
Free Hb on day 1 alllt0,03 g/l
Free Hb on day 42 1,5 g/l
Units were sterile as tested with BacT/Alert
Culture System of BioMerieux Plasma Results
German Studies ( n15 )
Plasma volume 232 ml
Protein concentration 53,5 g/l
Leukocytes per unit 0,02 WBC/unit
Fibrinogen 191 mg/dl
ATIII 82 of normal
vWF-antigen 82 of normal
F VIII 82 of normal
Units were sterile as tested with BacT/Alert
Culture System of BioMerieux
11
CONCLUSION Easy to perform blood separation
without the need for centrifuge, separator or
even electricity For donor and patient the
procedure do not change Plasma has a very good
quality and is better than the standard blood
bank quality RBCs are better compared to
standard blood bank quality. Remarkable is the
very low WBC contect of far less than 1 WBC/µl (
effect of the hollow fibres ) Variation of
measured parameters were all within the accepted
limits for blood bank routine. The ErySep-Device
is a ready to use blood donation and separation
system. It is allowing, to produce leukocyte
depleted erythrocyte concentrate and a cell free
plasma with an elegant and save procedure with
less equipment and limited manpower. In one of
the last validations of ErySep (09.01.2009). we
can say, that the results of the related labor
tests are identical with the standards of the
European Guidelines. The ErySep is separating
the donor blood only by earth gravitation,
without electricity or using of centrifuges etc.
12
Cord Blood separation for obtaining fetal
erithrocytes.Preliminar results. / December
2009. Marta Torrabadella Spain / Cord Blood
Bank. Banc de Sang i Teixits. Barcelona BACKGROUN
D Cord blood separation with membrane filter
technology is totally new and available in 2009
commercially. The first clinical study made by Dr
Brune in Germany. This is 2nd study, which was
perfomed in December 2009. STUDY DESIGN AND
METHODS The aim of the study is to show
characterization of cord blood components after
separation with ErySep system. ErySep system
offers the possibility of blood separation of
plasma and erythrocyte concentrate by gravity
13
RBC concentration Value Range
Mean fetal Hb 67,8 76- 58,6
Median Hb obtained in RBC concentrate 5,5 1,8-10,6
Percentage hemolysis 0,26 0,13 0,48
LDH (U/L) Basal (n 3 ) 143 114 - 186
K (mmol/l) Basal (n 3) 1,63 1,54 - 1,76
Plasma Value Range
Plasma Volume (ml) (n 11) 31.36 5 - 85
Platelet concentration (CellDyn) in Plasma (n 13) 77.30 0 - 490
Protein (g/L) in Plasma (n 12) 2,45 2- 3,3
K mmol/l in Plasma (n 7) 4,38 3,13- 5,96
LDH (UI) in Plasma (n 7) 370,85 206- 612
Free Hb (n 12) 0.022 0,00- 0,06
WBC/µL (n 13) 0.076 0- 1
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