Transcript Folie 1 - Lmb Europa

Lmb Technologie GmbH
ADVANCED TECHNOLOGY IN BLOOD SEPARATION
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 )
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
UK Blood Banks
Spain Blood Banks
Bulgaria Blood Banks
Greece Blood Banks
Chech Blood Banks
Slovakia Blood Banks
Belgium Blood Banks
Turkish Blood Banks
Russia Blood Banks
Indonesia Blood Banks
Malaysia Blood Banks
Myanmar Blood Banks
Taiwan Blood Banks
Philippines Blood Banks
Egypt Blood Banks
Yemen Blood Banks
Jordan Blood Banks
Saudi Blood Banks
• All results meets with European Blood Components Standard
• Guide to the preparation, use and quality assurance of blood components - 15th Edition
(2009)
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
• Expert can obtain specific demanded
quantity
• ErySep can answer night time demand
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
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 <1 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.
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.
Datas from Hospital Prag Dr. Bohaniek
Time
Day 0
Day 42
pH Average value
7.2348
57
6.8932
86
LDH (µkat/l) Average value
0.9592
86
4.9578
57
K (mmol/l) Average value
1.2542
86
39.250
71
P (mmol/l) Average value
0.9692
86
3.6607
14
NH3 (µmol/l) Average value
10.207
71
153.69
29
Osmolality (mOsm/l) Average value
333.42
86
352.85
71
ATP (µmol/g Hb) Average value
2.6214
29
0.7185
71
DPG (µmol/g Hb) Average value
12.165
43
0.3636
43
Hemolysis Average value
0.1407
14
0.7205
Rating and Validation of ErySepe..aıood 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.
RBC Results German Studies ( n=15 )
Value
Avarage volume unit
346 ml
Hb
17,4 g/dl
Haematocrit
54%
Leucocytes in unit on day 1
0,03x10
Protein / unit
3,3 g/unit
K+ in RBC on day 1
0,28mmol/l
Free Hb on day 1
all<0,03 g/l
6
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 ( n=15 )
Plasma volume
232 ml
Protein concentration
53,5 g/l
Leukocytes per unit
0,02 WBC/unit
Fibrinogen
191 mg/dl
Units were sterile as tested with BacT/Alert Culture System of BioMerieux
ATIII
82% of normal
vWF-antigen
82% of normal
F VIII
82% of normal
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;
RBC’s 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.
Cord Blood separation for obtaining fetal erithrocytes.Preliminar
results. / December 2009.
Marta Torrabadella
Spain / Cord Blood Bank. Banc de Sang i Teixits. Barcelona
BACKGROUND: 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
RBC concentration
Value
Mean fetal Hb
67,8%
76- 58,6
Median Hb obtained in RBC concentrate
5,5
1,8-10,6
Percentage hemolysis
0,26%
LDH (U/L) : Basal (n= 3 )
143
Range
0,13 –
0,48
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