Dual chamber aDulT oxygenaTor - EUROSETSRobert F. Brooker et al. Cardiotomy Suction: a Major Source...
2
*REFERENCES • The diffuse brain damage (DBD) after cardiac operation is reported as a frequency within a range of between 20% and 80%. karl Gunnar Engstrom. The embolic potential of liquid fat in pericaldial suction blood, and its elimination. Perfusion 2003; 18:69-74 • The scavenging ofpericardial suction blood is a potential mayor source of lipid emboli during cardiopulmonary by pass. Robert F. Brooker et al. Cardiotomy Suction: a Major Source of Brain Lipid Emboli during Cardiopulmonary bypass. Ann Thorac Surg 1998; 65: 1651-5 • Lipid particles in the side range of 10 μm to were characterized in shed mediastinal blood, until 300,000 particles per milliliter of blood were found. Atli Eyjolfsson, Henrik Jonsson et al. Charatcterization of Lipid Particles in Shed Mediastinal Blood. Ann Thorac Surg 2008; 85: 978-81 • Embolization of lipids is not a phenomenon restricted to the brain, but affected other organs which kidneys1, spleen1 and lung2. 1 Henrik Jonsson et al. Differential Distribution of Lipid Microemboli After Cardiac Surgery. Ann Thorac Surgery 2006; 81: 643-9 2 AJ de Vries et al. The rationale for fat filtration during cardiac surgery. Perfusion 2002; 17: 29-33 • Activation of the systemic inflammatory response during CPB has been a mayor problem for clinicians because of the potenzial deleterious effect on organs such as the heart, brain, lung, kidneys. one strategy may be the use of leukocyte-depleting filters. Oliver Warren et al. The effect of various leukocyte fitration strategyes in cardiac surgery. Eur J Cardiothorac Surg 2007; 31: 665-676 Shalini Boodram et al. Use of Leukocyte-depleting Filters During Cardiac Surgery with Cardiopulmonary bypass: A Review. JECT 2008; 40: 27-42 *REMOWELL PUBBLICATIONS • Quantification of Lipid Filtration and the Effects on Cerebral Injury During Cardiopulmonary Bypass Richard W. Issitt, FCCP, Ian Harvey, LCCP, Bronagh Walsh, PhD, and David Voegeli, PhD Perfusion Department, Great Ormond Street Hospital for Children, London; Faculty of Health Sciences, University of Southampton, Southampton; and Perfusion Department, John Radcliffe Hospital, Oxford, United Kingdom (Ann Thorac Surg 2017) ©2017 by The Society of Thoracic Surgeons • Do lipid microemboli induce acute kidney injury during cardiopulmonary bypass? Richard Issitt, Tim James, Bronagh Walsh and David Voegeli Perfusion 1–8 © The Author(s) 2017 • The use of RemoweLL oxygenatorintegrated device in the prevention of the complications related to aortic valve surgery in the elderly patient: Preliminary results Alberto Molardi, Bruno Borrello - Department of General and Specialized Surgery, Cardiac Surgery Unit, University Hospital of Parma, Italy Maria V. Di Chicco, Davide Carino, Matteo Goldoni, Matteo Ricci, Florida Gripshi, Tiziano Gherli and Francesco Nicolini - Department of Medicine and Surgery, University Medical School, University of Parma, Italy European Journal of Preventive Cardiology 2018, Vol. 25(1S) 59–65 DUAL CHAMBER ADULT OXYGENATOR WITH LIPIDS AND LEUKOCYTES REDUCTION © Copyright 2018 by Eurosets S.r.l. - Catalogue, products, pictures may differentiate from the actual product appearance. Specifications are subject to change without prior notice. Distribuito da Distributed by Distribuè par Vertrieb Distribuido por Prodotto da Manufactured by Fabriquè par Hersteller Fabricado por Eurosets s.r.l. Strada Statale 12, n°143 41036 Medolla (MO) Italy Tel: +39 0535 660311 Fax: +39 0535 51248 E-mail: [email protected] eurosets.com Rev. 2018/08 Helicoidal internal conveyor to reduce GME and dedicated lypids and leukocytes reduction* Curved TOP venous inlet port Angled venous outlet port for reduced vortex Improved internal surface profile to create laminar flow avoiding the “water-fall” effect of blood CODE DESCRIPTION N°/PACK EU2331 Holder for REMOWELL2 1 EU2147/P Holder for CVR REMOWELL2 1 EU2054/P Holder for Oxygenator Module 1 ORDERING GUIDE RESERVOIR OXYGENATOR MODULE A.L.ONE AF Plus (1.65 m 2 ) code AG5204 (N° 4 pcs/pack) REMOWELL2 AF Plus (1.65 m 2 ) code AG5301 (N° 1 pcs/pack) CVR REMOWELL2 code AG5074 (N° 1 pcs/pack) A.L.ONE (1.35 m 2 ) code AG5000 (N° 4 pcs/pack) REMOWELL2 A.L.ONE (1.35 m 2 ) code AG5101 (N° 1 pcs/pack) INTEGRATED A.L.ONE AF Plus MODULE and REMOWELL2 CVR INTEGRATED A.L.ONE MODULE and REMOWELL2 CVR INTEGRATED AMG MODULE and REMOWELL2 CVR AMG (1.81 m 2 ) code AG5012 (N° 4 pcs/pack) REMOWELL2 AMG (1.81 m 2 ) code AG5103 (N° 1 pcs/pack)
Transcript of Dual chamber aDulT oxygenaTor - EUROSETSRobert F. Brooker et al. Cardiotomy Suction: a Major Source...
*REFERENCES• The diffuse brain damage (DBD) after cardiac operation is reported as a frequency within a range of between 20% and 80%.karl Gunnar Engstrom. The embolic potential of liquid fat in pericaldial suction blood, and its elimination. Perfusion 2003; 18:69-74• The scavenging ofpericardial suction blood is a potential mayor source of lipid emboli during cardiopulmonary by pass. Robert F. Brooker et al. Cardiotomy Suction: a Major Source of Brain Lipid Emboli during Cardiopulmonary bypass. Ann Thorac Surg 1998; 65: 1651-5• Lipid particles in the side range of 10 μm to were characterized in shed mediastinal blood, until 300,000 particles per milliliter of blood were found.Atli Eyjolfsson, Henrik Jonsson et al. Charatcterization of Lipid Particles in Shed Mediastinal Blood. Ann Thorac Surg 2008; 85: 978-81• Embolization of lipids is not a phenomenon restricted to the brain, but affected other organs which kidneys1, spleen1 and lung2.1 Henrik Jonsson et al. Differential Distribution of Lipid Microemboli After Cardiac Surgery. Ann Thorac Surgery 2006; 81: 643-9 2 AJ de Vries et al. The rationale for fat filtration during cardiac surgery. Perfusion 2002; 17: 29-33• Activation of the systemic inflammatory response during CPB has been a mayor problem for clinicians because of the potenzial deleterious effect on organs such as the heart, brain, lung, kidneys. one strategy may be the use of leukocyte-depleting filters. Oliver Warren et al. The effect of various leukocyte fitration strategyes in cardiac surgery. Eur J Cardiothorac Surg 2007; 31: 665-676 Shalini Boodram et al. Use of Leukocyte-depleting Filters During Cardiac Surgery with Cardiopulmonary bypass: A Review. JECT 2008; 40: 27-42
*REMOWELL PUBBLICATIONS• Quantification of Lipid Filtration and the Effects on Cerebral Injury During Cardiopulmonary BypassRichard W. Issitt, FCCP, Ian Harvey, LCCP, Bronagh Walsh, PhD, and David Voegeli, PhDPerfusion Department, Great Ormond Street Hospital for Children, London; Faculty of Health Sciences, University of Southampton, Southampton; and Perfusion Department, John Radcliffe Hospital, Oxford, United Kingdom (Ann Thorac Surg 2017) ©2017 by The Society of Thoracic Surgeons• Do lipid microemboli induce acute kidney injury during cardiopulmonary bypass?Richard Issitt, Tim James, Bronagh Walsh and David VoegeliPerfusion 1–8 © The Author(s) 2017• The use of RemoweLL oxygenatorintegrated device in the prevention of the complications related to aortic valve surgery in the elderly patient:Preliminary resultsAlberto Molardi, Bruno Borrello - Department of General and Specialized Surgery, Cardiac Surgery Unit, University Hospital of Parma, Italy Maria V. Di Chicco, Davide Carino, Matteo Goldoni, Matteo Ricci, Florida Gripshi, Tiziano Gherli and Francesco Nicolini - Department of Medicine and Surgery, University Medical School, University of Parma, ItalyEuropean Journal of Preventive Cardiology 2018, Vol. 25(1S) 59–65
Dual chamber aDulT oxygenaTorwiTh lipiDs anD leukocyTes reDucTion
© Copyright 2018 by Eurosets S.r.l. - Catalogue, products, pictures may differentiate from the actual product appearance. Specifications are subject to change without prior notice.
Distribuito daDistributed byDistribuè parVertriebDistribuido por
Prodotto daManufactured byFabriquè parHerstellerFabricado por
Eurosets s.r.l.Strada Statale 12, n°14341036 Medolla (MO) ItalyTel: +39 0535 660311Fax: +39 0535 51248E-mail: [email protected]
Rev. 2018/08
Helicoidal internal conveyor
to reduce GME and dedicated lypids and
leukocytes reduction*
Curved TOP venous inlet port
Angled venous outlet port for reduced vortex
Improved internal surface profile to create
laminar flow avoiding the “water-fall” effect of blood
CODE DESCRIPTION N°/PaCk
EU2331 Holder for REMOWELL2 1
EU2147/P Holder for CVR REMOWELL2 1
EU2054/P Holder for Oxygenator Module 1
ORDERING GUIDE
RESERVOIR OXY
GEN
ATO
R M
OD
ULE
a.L.ONE aF Plus (1.65 m2)code AG5204 (N° 4 pcs/pack)
REMOWELL2 aF Plus (1.65 m2)
code AG5301(N° 1 pcs/pack)
CVR REMOWELL2code AG5074 (N° 1 pcs/pack)
a.L.ONE (1.35 m2)code AG5000 (N° 4 pcs/pack)
REMOWELL2 a.L.ONE (1.35 m2)
code AG5101(N° 1 pcs/pack)
INTEGRATEDA.L.ONE AF Plus MODULE
and REMOWELL2 CVR
INTEGRATEDA.L.ONE MODULE
and REMOWELL2 CVR
INTEGRATEDAMG MODULE
and REMOWELL2 CVR
aMG (1.81 m2)code AG5012 (N° 4 pcs/pack)
REMOWELL2 aMG (1.81 m2)
code AG5103(N° 1 pcs/pack)
Cardiotomy Capacity 800 ml
PHOSPHORYLCHOLINE COATING
Phosphorylcoline or PC is the predominant lipid headgroup found in the outer layer of cell membranes.
PC has a natural affinity for water and binds water tightly around itself. As a result, the outer layer of the cell membrane does not promote clots formation (thrombosis).
• low thrombogenic• low inflammatory response• stable• resistant to bacterial adhesion• resistant to protein deposition
FOREIGN SURFACE
FOREIGN SURFACE
PHOSPHORYLCHOLINE COATINGalkaline chains spread across
the surface yelding a stable
coating through hydrophobic
interactions
layer of hydratation around pc - with a coated substratethe blood therefore “sees” a layer of water
zwitterionic pc groups expressed outwards from the surface
blood\body fluid contact layer
LIPIDS AND LEUkOCYTES REDUCER
CVR REMOWELL2 MAIN FEATURES
• Despite improvements in cardiopulmonary bypass (CPB) brain injury remains a significant sequela of cardiac surgery.• Cardiopulmonary bypass is associated with an inflammatory reaction that involves activation of plasma proteins and cells. • Activation of leukocytes, in particular neutrophils, directly contributes to issue and organ injury.
CARDIOTOMY FEATURES• Capacity 800 ml• Two steps lipid-leukocytes depletion:• Multilayer cascade filtration (for lipids and leukocytes) • Supernatant separator (lipids only)
LIPI
DS
RED
UC
TIO
N [%
]
00
10
20
30
40
50
60
70
5 10 15 20 25 30 35 40 45 50 55 60 65
LAB
TEST
TIME (min)
00
10
20
30
40
50
60
70
5 10 15 20 25 30 35 40 45 50 55 60 65
WBC
s RE
DU
CTI
ON
[%]
LAB
TEST
TIME (min)
ALONE OXYGENATOR MODULE TECHNICAL CHARACTERISTICSPriming volume: 190 mlContact surface area: 1,35 m2
Max blood flow rate: 7,0 l/minInnovative Heat Exchanger Heat Exchanger surface area: 0.08 m2
H.E. Performance Factor η = 0.64 (@ 4 l/min)Coating: PC phosphorylcholine
AMG OXYGENATOR MODULE TECHNICAL CHARACTERISTICSPriming volume: 220 mlContact surface area: 1,81 m2
Max blood flow rate: 8,0 l/minInnovative Heat Exchanger Heat Exchanger surface area: 0.08 m2
H.E. Performance Factor: η = 0.64 (@ 4 l/min)Coating: PC phosphorylcholine
dPB vs Qb
O2T vs Qb
100,0
200,0
150,0
0,0
50,0
300,0
250,0
400,0
350,0
1 2 3 4 5 6 70,50,0
Qb (lpm)
Qb (lpm)
O2T
(cc/
min
)
*ISO
719
9 co
nd
itio
n
CO2T vs Qb
100,0
200,0
150,0
0,0
50,0
300,0
250,0
400,0
350,0
1 2 3 4 5 6 70,50,0
*ISO
719
9 co
nd
itio
n
CO2T
(cc/
min
)
dPB
(mm
Hg)
Qb (lpm)
100,0
200,0
150,0
0,0
50,0
300,0
250,0
350,0
1 2 3 4 5 6 70,50,0
*ISO
719
9 co
nd
itio
n
H.E. Performance Factor vs Qb(Water Flow 10 l/min)
Qb (lpm)
0,20
0,40
0,30
0,0
0,10
0,60
0,90
1,00
0,50
0,80
0,70
1 2 3 4 5 6 7 80,50,0
*ISO
719
9 co
nd
itio
n
Perf
orm
ance
Fac
tor
dPB vs Qb
O2T vs Qb
100,0
200,0
150,0
0,0
50,0
300,0
450,0
250,0
400,0
350,0
1 2 3 4 5 6 7 80,50,0
Qb (lpm)
Qb (lpm)
O2T
(cc/
min
)
*ISO
719
9 co
nd
itio
n
CO2T vs Qb
100,0
200,0
150,0
0,0
50,0
300,0
250,0
400,0
350,0
1 2 3 4 5 6 7 80,50,0
*ISO
719
9 co
nd
itio
n
CO2T
(cc/
min
)
dPB
(mm
Hg)
Qb (lpm)
100,0
200,0
150,0
0,0
50,0
300,0
250,0
350,0
1 2 3 4 5 6 7 80,50,0
*ISO
719
9 co
nd
itio
n
H.E. Performance Factor vs Qb(Water Flow 10 l/min)
Qb (lpm)
0,20
0,40
0,30
0,0
0,10
0,60
0,90
1,00
0,50
0,80
0,70
1 2 3 4 5 6 7 80,50,0
*ISO
719
9 co
nd
itio
n
Perf
orm
ance
Fac
tor
sample ramp
Tven
Connection to cell separator
Extracavitary suckers with dedicated
lypids and leukocytes reduction*
Venous inlet1/2” - 3/8”
over-under safety valve vent/vacuum port
Intracavitary suckers with helicoidal internal conveyor to reduce GME**
• 4500 ml total reservoir capacity• 800 ml cardiotomy capacity• 3 different filtration systems: - Venous inlet (80µm) - Intracavitary inlet (40µm) - Extracavitary inlet · Two steps lipid-leukocytes depletion: · Multilayer cascade filtration (for lipids and leukocytes) · Supernatant separator (lipids only)• Fully PC coated• Suitable for VAVD
CONNECTIONS
• venous inlet, 360° rotatable 1/2” with 3/8” adapter• venous reservoir outlet 3/8”• vented/vacuum port 1/4”• 4 filtered ports 1/4” , 1 of those with 1/4” - luer lock adapter• 2 filtered port 3/8”, 1 of those with 3/8 - 1/4” adapter 1 of those with 3/8” - luer lock adapter• 2 filtered luer lock ports• 2 filtered post lock - luer lock• 1 non filtered luer lock
3/8” - 1/4” (1 pc)1/4” - Luer (1 pcs)3/8” - Luer (1 pcs)
1/2” - 3/8” (1 pc)
ADAPTERS
** Laboratory Data
arterialbloodoutlet
cardioplegiablood outlet
venous blood inlet
H.E. water in/out
purgingline
80 μm
38 μm
CascadeArterialFilter
CARDIOPLEGIA ADAPTERPoslock - 1/4” M (1 pc)
H.E. Performance Factor vs Qb (in vitro)(Water Flow 10 l/min)
1 2 3 4 5 6 70,5
Qb (lpm)
0,00
0,10
0,20
0,30
0,40
0,50
0,60
0,70
0,80
0,90
1,00
*ISO
719
9 co
nd
itio
n
O2T vs Qb (in vitro)
100,0
150,0
0,0
50,0
200,0
250,0
300,0
350,0
400,0
1 2 3 4 5 6 70,5
Qb (lpm)
O2T
(ml/
min
)
*ISO
719
9 co
nd
itio
n
CO2T vs Qb (in vitro)
100,0
150,0
0,0
50,0
200,0
250,0
300,0
350,0
400,0
1 2 3 4 5 6 70,5
Qb (lpm)
CO2T
(m
l/m
in)
*ISO
719
9 co
nd
itio
n
dPB vs Qb (in vitro)
100,0
150,0
0,0
50,0
200,0
250,0
300,0
1 2 3 4 5 6 70,5
Qb (lpm)
Pres
sure
dro
p (m
mH
g)
*ISO
719
9 co
nd
itio
n
Perf
orm
ance
Fac
tor
* ISO 7199 conditionBovine bloodHb = 12 ± 1g/dLSVO2 = 65 ± 5%PVCO2 = 45 ± 5 mmHg
B.E. = 0 ± 5 mEq/LTemp = 37 ± 1°CQb/Qg = 1FiO2 = 100%
A.L.ONE AF PLUS OPTIMIZED PRESSURE RESISTANCE OXYGENATOR MODULE WITH INTEGRATED CASCADE ARTERIAL FILTER
TECHNICAL CHARACTERISTICS
Priming volume: 225 mlContact surface area: 1.65 m2
Max blood flow rate: 7.0 l/minCascade Arterial Filter pore size: 80 μm + 38 μm
Heat Exchanger surface area: 0.08 m2
H.E. Performance Factor: η = 0.64 (@ 4 l/min)Material: stainless steelCoating: PC phosphorylcholine
* ISO 7199 conditionBovine bloodHb = 12 ± 1g/dLSVO2 = 65 ± 5%
PVCO2 = 45 ± 5 mmHg B.E. = 0 ± 5 mEq/LTemp = 37 ± 1°C
Qb/Qg = 1FiO2 = 100%
