Ecmo Life

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THE MOST GENTLE,

SAFE AND VERSATILE


SOLUTION FOR
ECMO AND ECLS

1
The most gentle, safe and versatile solution for ECMO
(Extracorporeal Membrane Oxygenation)
and ECLS (Extracorporeal Life Support) enabling all healthcare professionals
to easily manage any situation in different environments

GENTLE SAFE VERSATILE


Features state of the art Designed for optimal Portable and flexible
technology for optimal patient safety to address a variety
biocompatibility of different practices
2021
Magnetic levitating pump technology Non invasive sensoring system Compact design for easy transport
GLOBAL EXTRACORPOREAL for minimized hemolysis for optimal patient monitoring
MEMBRANE OXYGENATION (ECMO) Optimized circuits
NEW PRODUCT INNOVATION AWARD Phosphorylcholine coated circuit Integrated back-up system for ECMO and ECLS
for reduced platelets consumption for extra safety in case of failure
Unique transport options
Up to 14 days disposable validation Auxiliary external battery for to address every therapeutic need
for long term procedures extra procedural time in case of emergency across different hospital facilities

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GENTLE
Features state of the art
technology for optimal
biocompatibility

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MAGNETIC LEVITATING MAGNETIC Technical Features
PUMP TECHNOLOGY FOR LEVITATION
TECHNOLOGY Limitations
MINIMIZED HEMOLYSIS1 Blood flow range: 0-10 l/min
Centrifugal pump speed: 0-5000 rpm PERFORMANCE GRAPH
The impeller’s contact-free Blood pathway volume: 39 ml
environment ensures: Max blood pathway pressure 800 mmHg (107 kPa) 700

Pressure drop (mm Hg)


Patient weight: ≥20 kg
650
Optimal flow dynamics
Ports 600

Reduced blood stagnation areas BLOOD


Blood inlet: 3/8” (9.53 mm) 550

PATHWAY
Blood outlet: 3/8” (9.53 mm) 500

Minimal friction and shear stress MAGNETIC


Pdrain pressure monitoring port
450 5000 RPM

FIELD (on dedicated configuration only): Female Luer Lock ISO 594-2
400
Materials in contact with blood 350
4500 RPM

Housing: Polycarbonate (PC)


300
Rotor: Polycarbonate (PC)
OUT

OUT
OUT

250
IN Luer cap: Polyethylene (PE) 4000 RPM

IN IN Biocompatible coating: Phosphorylcholine (PC) 200

150 3500 RPM


Hydraulic performance data: PERFORMANCE GRAPH
100
Pressure differential vs. flow rate (average of TIME 0 samples data).
3000 RPM
90% LEFT VERTICAL HORIZONTAL 90% RIGHT VERTICAL Data gathered from test in accordance with ISO 18242 standard. 50 1500 RPM
2000 RPM 2500 RPM
Conditions: Anticoagulated Bovine Blood, Hb = 12±1 g/dL, 0
0 1,0 2,0 3,0 4,0 5,0 6,0 7,0 8,0 9,0 10,0 11,0
Temp. 37±1°C.
Flow rate (l/min)
Precise rotor control and stability is guaranteed
by 32,000 controls every second.
1. Condello et al. Magnetic levitation pump versus constrained
vortex pump: a pilot study on the hemolysis effect during
minimal invasive extracorporeal circulation, Journal of
The magnetic field is automatically adjusted to
Cardiothoracic Surgery, 2021
compensate for external movements and bumps.
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PHOSPHORYLCHOLINE COATED CIRCUIT UP TO 14 DAYS DISPOSABLE
FOR REDUCED PLATELETS CONSUMPTION VALIDATION FOR LONG TERM
Phosphorylcoline is the predominant lipid headgroup found PROCEDURES
within the outer layer of cell membranes. The optimized circuits for ECMO and ECLS
Phosphorylcoline has a natural affinity for water and binds water tightly are validated for 14 days,
around itself. ensuring optimal performance
Reduces platelet consumption remarkably.1 throughout the entire period.
Phosphorylcoline coating is suitable for patients with acute HIT
(Heparine Induced Thrombocytopenia)2.
ALKALINE CHAINS SPREAD ACROSS THE SURFACE YIELDING LAYER OF HYDRATION AROUND PC ZWITTERIONIC PC GROUPS EXPRESSED
A STABLE COATING THROUGH HYDROPHOBIC INTERACTIONS - WITH A COATED SUBSTRATE THE BLOOD THEREFORE OUTWARDS FROM THE SURFACE
“SEES” A LAYER OF WATER
PHOSPHORYLCHOLINE COATING

FOREIGN FOREIGN
S U R FA C S U R FA C
E E

REFERENCES
1. R. Lorusso et al. Effects of phosphorylcholine coating on extracorporeal circulation management and postoperative outcome: a double-blind randomized study.
Interactive CardioVascular and Thoracic Surgery 8 (2009) 7–11.
2. F. Pappalardo et al. Bioline® heparin-coated ECMO with bivalirudin anticoagulation in a patient with acute heparin-induced thrombocytopenia: the immune reaction
appeared to continue unabated. Perfusion 2009; 24: 135–137

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SAFE
Designed for optimal
patient safety

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NON INVASIVE SENSORING SYSTEM FOR ECMOLife circuit can be connected to the LANDING
OPTIMAL PATIENT MONITORING ECMO adding an additional cuvette along the arterial line.
The ECMOLIFE system is equipped with 5 non invasive sensors ensuring continuous LANDING ECMO displays 18 parameters in real time for optimal patient monitoring.
monitoring of 10 parameters displayed simultaneously and in real time, providing the Thanks to these 18 parameters, HCPs can easily evaluate:
operator with full control of the procedure. Procedure efficacy Metabolic-hemodynamic Interdependency between the
patient’s pattern Membrane Lung and the Native Lung

10 Parameters displayed 3 Drainage pressure (PDRAIN)


Exhausted CO2% Membrane Lung Membrane Lung Native Lung Native Lung behaviour
Cardiac Output
4 Pre oxygenator pressure (PIN) Oxygen Contribution CO2 Contribution CO2 Contribution vs total CO2

5 Post oxygenator pressure (POUT)


1 Blood flow (LPM)
6 Oxygenator Pressure drop Sweep Gas Flow Total CO2
2 Pump speed (RPM)
7 Oxygen venous saturation (SVO2)

8 Hemoglobin (HB)

9 Blood venous temperature (TVEN) Arterial O2 Saturation Pressure


Drop

10 Air bubble detector

Pump Flow Negative Suction


Pressure

Arterial Venous O2 Hemoglobin Venous Pre-Membrane Post-Membrane


Temperature Saturation Temperature Pressure Pressure

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INTEGRATED BACK UP SYSTEM FOR AUXILIARY EXTERNAL BATTERY FOR
EXTRA SAFETY IN CASE OF FAILURE EXTRA PROCEDURAL TIME IN CASE OF EMERGENCY
The ECMOLIFE Pump is the only device available
on the market with an integrated back-up system
that acts as a perfectly functioning replacement
in case of failure, ensuring increased patient safety. PRIMARY

TOTAL 6 HOURS
BATTERY
Compared to standard manual hand cranks, 90 MIN 180
the integrated back-up system ensures superior +
comfort for HCPs. 90 MIN MIN
BACK UP

+
BATTERY

BATTERY 1
90 MIN 180
+
90 MIN MIN
BATTERY 2

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VERSATILE
Portable and flexible
to address a variety
of different practices

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COMPACT DESIGN OPTIMIZED CIRCUITS FOR EITHER
FOR EASY TRANSPORT ECMO OR MCS
The circuits for ECMO and ECLS come completely
pre-connected and assembled in a kit.
Oxygenator and pump are located on a
dedicated bracket assuring:
Easy and quick disposable set up
ECMOLife is approved for both Clear view of circuits integrity
intra and inter hospital transport.
The device not only meets
the existing mandatory regulations,
but also underwent testing according 14
to UNECE Regulation No.10 to
further confirm its
days
Dedicated ECMO validated
electromagnetic
compatibility. Oxygenator Module
The ECMO adult oxygenator
is clinically proven to be an efficient,
highly biocompatible, solution for prolonged
cardio-respiratory support1.

1. Pieri et al., A new phosphorylcholine-coated polymethylpentene oxygenator


for extracorporeal membrane oxygenation: a preliminary experience, Perfusion, 2013

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UNIQUE TRANSPORT OPTIONS TO ADDRESS EVERY THERAPEUTIC
NEED ACROSS DIFFERENT HOSPITAL FACILITIES FOIL
The Proprietary Leonardo Trolley, available in two different configurations,
is designed as a stable and compact workstation for ECMOLife.
• Leonardo Trolley features
the unique possibility that part of the FOIL is the only device in the market that is
trolley can be used as accessory certified and validated to carry ECLS devices
shelf adaptable to any stretchers. on a stretcher between the patient’s legs.

Trolley • Leonardo Slim is characterized High-quality carbon-fiber design for minimized weight
by a minimized footprint and a unique
Ergonomic tailored wings that increase comfort
and patented design that allow
for patients and operators
ECMOLife operations also
very narrow environments. Can be safely attached to any stretcher
Ensures convenient positioning of ECMOLife
during any type of transports

Intra-hospital Transport ECMO Transport

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REUSABLE SINGLE USE

A B CODE DESCRIPTION N°/PACK CODE DESCRIPTION N°/PACK

R229P01-010 MAX BLEND 0-15 LPM 1 * ECMOLIFE ECMO tubing set


14AG70232 1
Bracket, Pole mount, Includes: Oxy, pump, circuit, press. Transducers Metallux 3 to1
R100P26 gas blender 1 *

ECMOLIFE ECMO tubing set


ORDERING GUIDE R129P91

R129P94
Air Tube

Oxygen Tube
1 *

1 *
14AG70232/SM
Includes: Oxy, pump, circuit, press. Transducers Smith Medical
1

C D ECMOLIFE VAS tubing set


REUSABLE R219P31 3 in 1 single pack 1 * 14AG70231 1
(connector gas outlet) Includes pump, circuit, press. Transducers Smith Medical
CODE DESCRIPTION N°/PACK
EU3941 ECMOLIFE HEATER COOLER 1
ECMOLife 6 hrs Tubing Set
AG70232/PP 1
EU5086 ECMOLIFE SYSTEM 1 PP Oxy, pump, circuit, press. Transducers Smith Medical
includes: HC Unit 1
includes: Console 1 A
UK AND EU EU5083 ECMO ADULT console Sterile (Stand alone ECMO Oxy) 2
Motor driver 2 B Power Supply Cables 1
E F Hoses 1,5m 2
Clamp on transducer sct 3/8" x 3/32" 2 C
Hanses connection tube 1 AG5078 ECMOLIFE centrifugal pump (without luer port) 1
Air sensor 3/8" x 3/32" ecls 1 D
Water Discharge Hose
Bracket 1 E (Female) 1

Venous probe 1 F EU1589 Smith Medical single use pressure transducer 1 *


EU3943 Hoses 3m 2
ECMOLife pressure sensor cable 3 G
Logical pressure transducer 3 H
ECMOLIFE Ambulance
Holder for reusable pressure transducer 3 I H I EU3898 1
Plate holder
ECMOLife power cord EU 2
G
3 to 1 SM Holder Plate 1

EU5093 LEONARDO Trolley 1 EU3996 FOIL Transport System 1

includes: ECMOLIFE Cable Holder 1 L


REOMED 1000 isolating trans-formers 1000VA 1 M N ECMOLIFE Ambulance
EU3898 1
24V Power
REOMED Plug C13-C14 2
MX 263 3 to 1 SM Holder Plate 1 *
EU5094 LEONARDO Slim 1
EU10775 ECMOLIFE Power Cord GB 1 *
includes: ECMOLife Cable Holder 1 L
REOMED 1000 isolating trans-formers 1000VA 1 EU10996 ECMOLIFE Power Cord BR 1 *
REOMED Plug C13-14 2
L O 2M85274 Holder with BAR 25x10 mm 1M *

ECMOLIFE Auxiliary
EU3899 batteries Kit with 1 N
* Product not manufactured by EUROSETS S.r.l.
transport bag
• Products in bold are manufactured and certified by Eurosets S.r.l. ECMOLIFE
EU2511 1 O
• ECMOLife System, ECMOLife Heater Cooler and Single-use codes are CE0123 Certified Holder Motor Driver

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by Eurosets S.r.l. - Catalogue, products, pictures may differentiate from the actual product appearance. Specifications are subject to change without prior notice.
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