DESIGNED BY

PERFUSIONISTS.
ENGINEERED BY
MEDTRONIC.

Affinity Fusion ™

Oxygenation System
THE PRODUCT
OF TRUE
COLLABORATION
The Affinity Fusion oxygenation system
Built on input from more than
500 perfusionists worldwide
Represents a unique fusion of clinical insight
and engineering expertise
Features 79 new design enhancements
Designed by perfusionists.
Engineered by Medtronic.
DESIGN,
SIMPLY ADVANCED.

Proactive Air Uniform Flow

Management Distribution
An entire oxygenation system designed Designed to reduce blood trauma, lower
to handle air upfront. rates of hemolysis and minimize exposure
Unique curved venous inlet reduces to foreign surfaces.
blood turbulence and GME generation  urved venous inlet for smooth, fluid
C
A pre-membrane bubble trap is pathways and low resistance to flow
designed to purge air before it enters
the fiber membrane  enous inlet tube’s flared design reduces
V
blood velocity and resistance to flow
An oxygenator with integrated arterial
filter removes particulates and air  ardiotomy cone shape design allows for
C
gentle blood flow

 xygenator’s radial flow design results in short

O
blood flow paths that avoid areas of stasis

Perfusion-practical Progressive Fiber

Ergonomics Filtration
Improved flexibility, ease of use and set-up, Gas exchange and particulate filtration occur
and enhanced customization capabilities. simultaneously, enabled by Medtronic’s proprietary
Graduated Fiber Bundle Density Technology.
Orbit holder system with 360 degrees
of flexibility A fully integrated oxygenator and arterial filter
Ambidextrous design A compact, low-prime design
Convenient port locations and spacing Radial flow for short, uniform blood
paths, minimizing blood’s contact with
Independent adjustment of the reservoir
foreign surfaces
and oxygenator
Low pressure drop

Finely tuned, carefully considered parameters, from inlet to outlet.

Designed to achieve the optimal blend of performance providing expanded heat exchange and oxygenation capability,
while maintaining low prime and low pressure drop.
INLET TO OUTLET Perfusion-practical Ergonomics

Affinity Orbit™
Holder System
Facilitates 180-degree
side-to-side movement
to further optimize device
positioning

MORE ROOM TO
Easy access, low-profile
SHORTEN LINES.
venous temperature port The Fusion system delivers Perfusion-practical Ergonomics,
providing improved flexibility, ease of use and set-up, and
enhanced customization capabilities.
The unique Affinity Orbit holder system allows 360-degree
positioning and placement flexibility
Ambidextrous design
Volume-displacing luer
caps to prevent areas of stasis Independent adjustment of the oxygenator and reservoir
Convenient port locations and spacing
Non-vented caps for ease of set-up for VAVD procedures
(except inlet, outlet and vent/vacuum port)
Totally clear design for unobstructed visibility of blood, gas
and water phases
Quick and easy set-up and tear down
THOUGHTFUL DESIGN,
FROM INLET TO OUTLET.
The Affinity Fusion oxygenation system takes
a fundamentally different design approach.
Proactive air handling
Uniquely designed for hemocompatibility
Improved flexibility and ease of use
Oxygenator with integrated arterial filter
Expanded heat exchanger and gas transfer capabilities

Both oxygenator and reservoir devices have:

Blood-contacting materials made from BPA*­­­­­­­­-
and DEHP-free polymers
1 to 7 L/min flow rate
Low system priming volume
Biocompatible surface coatings

Cardiotomy/Venous Reservoir available in:

Balance Biosurface1

Oxygenator available in two biocompatible

surface options:
Balance Biosurface
Cortiva BioActive Surface

Balance™ Biosurface
A hydrophilic biosurface option
without heparin
Reduces platelet activation
Lowers platelet adhesion
Preserves platelet function2
The Affinity Fusion oxygenation system is indicated for use
Cortiva™ BioActive Surface in an extracorporeal circulation circuit during cardiopulmonary
bypass procedures up to 6 hours in duration.
Durable, Non-leaching End
Point Attached Heparin Warning: A strict anticoagulation protocol should be followed
and anticoagulation should be routinely monitored during all
Provides thromboresistance procedures. The benefits of extracorporeal support must be
and enhanced blood weighed against the risk of systematic anticoagulation and
compatibility must be assessed by the prescribing physician.
For a complete listing of indications, contraindications,
precautions and warnings, please refer to the Instructions
for Use which accompany each product.

* Sampling manifold is not BPA-free. Made in U.S.A.

INLET TO OUTLET Cardiotomy/Venous Reservoir

THE AFFINITY FUSION ™

CARDIOTOMY/VENOUS
RESERVOIR
Curved venous inlet, flared walls of the venous inlet down
tube and gradual slope of the reservoir contribute to
Uniform Flow Distribution
Separate venous and cardiotomy filter chambers
Low minimum operating level
Low dynamic and static hold-up
Low resistance to flow
Proactive removal of GME and gross air
Vacuum Assisted Venous Drainage (VAVD) ready with built-in Venous
pressure relief valve and non-vented cardiotomy port covers Chamber
Removable sampling manifold
Cardiotomy
Indicated for use for chest drainage collection
Filter
Chamber

Angled Venous Luer Ports

Facilitate gentle merging of
peripheral blood flow
For reduced blood
turbulence that could create
gaseous micro emboli from
gross air

Curved Venous Inlet 1/2" to 3/8"

Adapter
Creates smooth, fluid blood pathways
For reduced blood turbulence that could
create gaseous micro emboli from gross air
Reduction in GME generation allows for
larger venous screen pore size, lowering
dynamic hold-up behind the screen
For reduced resistance to flow

Vacuum Port
VAVD ready
360º Rotation
For flexibility in
circuit set-up

Performance claims based on in vitro product validation test results.3

INLET TO OUTLET Cardiotomy/Venous Reservoir

DESIGNED FOR
CAREFUL BLOOD HANDLING
AND AIR MANAGEMENT.
Curved
Cardiotomy
Inlets

Vent/VAVD Port
Cardiotomy Defoamer
Recirculation
Full height to separate Port
air from blood
Pressure
Relief Valve
4500 mL Volume
VAVD ready
Capacity

Venous Defoamer
Cardiotomy Cone
Non-foaming
Enables smooth blood blood does not
flow to the bottom of contact antifoam at
the chamber normal operating
levels

30 Micron Depth Filter

Enables rapid prime and Venous Cage
blood breakthrough and Screen
Small diameter
Flow Diverter and larger screen
pore size for low
Directs blood toward dynamic hold-up
the back of the
reservoir for gentle flow
without obstructing
the warning track label
at low flow rates
Flared Venous Inlet
Down Tube
Cardiotomy
on Pedestal For reduced resistance to flow
Gently slows the blood velocity
Elevated cardiotomy Gradual Slope
Positioned at rear of reservoir
design to reduce to minimize stasis from inlet
For fluid level stability
venous blood contact to outlet
while minimizing blood
with cardiotomy
turbulence at the outlet
filtration media at low
operating levels
Blood Outlet
Caution: Federal law (USA) restricts these devices to sale by or on the
order of a physician. For a complete listing of indications, contraindications,
precautions and warnings, please refer to the Instructions for Use.

Performance claims based on in vitro product validation test results.3

INLET TO OUTLET Oxygenator

THE AFFINITY FUSION

OXYGENATOR Blood Inlet
260 mL prime volume
Enhanced gas transfer and heat
exchange performance
Recirculation Port
Indicated for use as both an oxygenator
With volume- displacing cap
and arterial filter
25µm filtration
Efficiently handles air and particulates
Cardioplegia Port
With volume- displacing cap

Temperature Port

Dual Outlet Port

Oxygenated blood exits the
device through a unique dual
outlet, minimizing areas of stasis,
shear or hemolysis
Provides good temperature and
sampling accuracy Sampling Port
With volume-displacing cap

Oxygenator
O Transfer Rate
Performance
O Transfer Rate Data3 2 2
CO2 Transfer Rate
CO2 Transfer Rate
400
Testing
400 performance per ISO 7199, 2009 standard 400
conditions.
400
Based on100%
in vitro
FiO data;
100%may
FiO not be indicative of clinical results. 100% FiO
2 2 2
100% FiO2
2:1
2:1
300 300 300 300
CO2 (mL/min)
CO2 (mL/min)
O2 (mL/min)
O2 (mL/min)

1:1
200
O2200
Transfer Rate
O2 Transfer Rate 200
CO2200 CO2 Transfer1:1
Transfer Rate Rate
400 400 400 400 0.5:1 0.5:1
100 100 100% FiO2 100% FiO2 100 100 100% FiO2 100% FiO2
2:1 2:1
300 300 300 300
CO2 (mL/min)

CO2 (mL/min)
O2 (mL/min)

O2 (mL/min)

0 0 0 0
0 1 2 03 14 25 36 47 58 6 7 8 0 1 2 03 14 25 36 47 1:1 58 6 7 1:1 8
200 200 200 200
Blood Flow Rate (L/min)
Blood Flow Rate (L/min) Blood Flow Rate
Blood Flow Rate (L/min) (L/min)
0.5:1 0.5:1
100 100 100 100

0 0 0 0
0 1 2 03 14 25 36 47 58 6 7 8 0 1 2 03 14 25 36 47 58 6 7 8
Blood Flow Rate (L/min)
Blood Flow Rate (L/min) Blood Flow Rate (L/min)
Blood Flow Rate (L/min)

Heat
Heat Exchanger Exchanger Performance
Performance Factor Factor Blood Side
Blood Side Pressure Pressure Drop
Drop
Drop (mm Hg)
Drop (mm Hg)

1.0 1.0 200 200

0.9 0.9
Performance FactorPerformance Factor
Performance FactorPerformance Factor

150 150
Multiple Gas Vents 0.8 0.8
Heat Exchanger
Heat
0.7 Performance
Exchanger Performance
Factor Factor Blood Side
100 Pressure
Blood Side
Drop
Pressure Drop
(mmPressure

Reduces the risk of gas

(mmPressure

0.7 100
Hg)

Hg)

pressure build-up in the 1.0

0.6 1.0
0.6 200 200
15.0 15.0 50
Drop Side

oxygenator chamber 50
DropSide

0.9
0.5 0.9
0.5
10.0 10.0 150 150
Blood Side PressureBlood
Blood Side PressureBlood

0.8
0.4 0.8
0.4 0
0
0.7 0 1 2 0.7 03 14 25 36 47 58 6 7 8 0 1 2 03 14 25 36 47 58 6 7 8
100 100
Blood Flow Rate (L/min)
Blood Flow Rate (L/min) Blood Flow Rate (L/min)
Blood Flow Rate (L/min)
0.6 0.6
15.0 15.0 50 50
0.5 0.5
10.0 10.0
Performance claims based on in
0.4vitro product
0.4 validation test results.3 0 0
0 1 2 03 14 25 36 47 58 6 7 8 0 1 2 03 14 25 36 47 58 6 7 8
Blood Flow Rate (L/min)
Blood Flow Rate (L/min) Blood Flow Rate (L/min)
Blood Flow Rate (L/min)
INLET TO OUTLET Oxygenator

A FULLY INTEGRATED Pre-membrane

OXYGENATOR AND Bubble Trap
ARTERIAL FILTER. Placed at top of oxygenator
to purge air before it reaches
the fiber membrane
Tangential flow creates
Electrical Shunt
centrifugal force that
Equilibrates voltage between moves air to the center
the blood and water pathways of device and removes
Reduces the potential for through purge line
electrostatic discharge that
may develop inside the blood Built-in, one-way valve
pathway due to rotation of
the roller pump heads

Radial Blood Flow Design

Plastic Heat Exchanger Facilitates a short, uniform
Small tube design of capillaries blood flow path that
increases heat exchange avoids areas of stasis
performance Minimizes blood’s contact
Decreases prime with foreign surfaces
volume
Proprietary Graduated
Minimizes blood-contacting
surfaces Fiber Bundle Density
Enables device incineration Technology
Optimized bundle efficiency
Manufacturing consistency
Progressive Fiber Filtration

Progressive
Fiber Filtration
Within the graduated fiber bundle
Blood
assembly, gas exchange and parti-
Gas
culate filtration occur simultaneously
Water
by means of Progressive Fiber
Filtration, which allows for:
Low pressure drop
Enhanced gas transfer
Short, uniform blood flow path Caution: Once an oxygenator is primed with
Efficient particulate filtration blood, adequate heparinization should be
maintained per institution cardiopulmonary
A compact, low-prime design bypass (CPB) protocol and the blood
Integrated arterial filter pathway should be constantly recirculated
within the recommended blood flow range.

Performance claims based on in vitro product validation test results.3

Affinity Fusion Oxygenation System
Affinity Fusion Oxygenation Systems Specifications
Oxygenator
Model# Product Description Units/case
Membrane Type Microporous polypropylene
BB841  xygenator with Integrated Arterial
O 1 hollow fiber
Filter and Cardiotomy/ Venous Reservoir Membrane Surface Area 2.5 m2
with Balance Biosurface Heat Exchange Material Polyethylene Terephthalate (PET)
Static Priming Volume 260 mL
CB841 Oxygenator with Integrated Arterial 1 Recommended Blood Flow Rate 1-7 L /min
Filter with Cortiva BioActive Surface Maximum Water Side Pressure 30 psi
and Cardiotomy/Venous Reservoir Maximum Blood Pressure 750 mmHg
with Balance Biosurface Arterial Outlet Port 3/8"
Venous Inlet Port 3/8"
BB811  xygenator with Integrated Arterial
O 1
Arterial Sample Port Female Luer Port
Filter and Balance Biosurface Recirculation Port 1/4"
Cardioplegia Port 1/4"
CB811 O
 xygenator with Integrated Arterial 1 Gas Inlet Port 1/4" Nonbarbed
Filter and Cortiva BioActive Surface Gas Outlet Port 3/8" Nonbarbed
Water Ports 1/2" Quick Disconnects
Affinity Fusion Accessories and Holders Filtration 25 µm

Model# Product Description Units/case Cardiotomy/Venous Reservoir

AUH2093 Affinity Orbit Holder System 1 Reservoir Volume Capacity 4500 ml
Recommended Blood Flow Rate 1-7 L /min
ATP210 Temperature Probe 1 Maximum Cardiotomy Flow Rate 6 L /min
AMH2014 Affinity Manifold Holder 1 Minimum Operating Level 200 at 7 L /min
Cardiotomy Filtration 30 µm
RCL841 Recirculation Line 12 Venous Screen 105 µm
AUH4014 Affinity Orbit Arterial Filter Arm 1 Venous Inlet, Rotatable 1/2" with 3/8" adapter
Venous Reservoir Outlet 3/8"
Vent/VAVD Port 1/4" Nonbarbed
References Cardiotomy Port (4) 1/4"
1. Technology licensed under agreement from Biointeractions, Limited, Cardiotomy Port (1) 3/8"
United Kingdom.
Prime Port 1/4" Nonbarbed
2. % Functional Platelets Over Time. Recirculation Port 1/4"
% Functional Platelets Over Time
Filtered Luer Lock Ports 4
100
98
Non-filtered Luer Lock Ports 2
96 Venous Luer Lock Ports 2
Functional Platelets

94
92 Positive Pressure Relief Valve Crack <5 mmHg
90
88
Vacuum Pressure Relief Valve Crack >100 mmHg average
86
84
82
80
78
0 1 min 10 min 30 min 60 min 120 min

Uncoated Balance-Coated For information on Affinity Fusion visit: www.fusionoxygenator.com

Comparison between Balance-coated and uncoated in vitro bench test
circuits of percentage of platelets that are activated with adenosine For information on other Medtronic technologies for
diphosophate (ADP @20 μM) in circulating heparinized human blood
over time. Error bars represent standard deviation. († indicates p<0.05)
extracorporeal circulation, blood processing and diagnostics,
visit: www.perfusion.medtronic.com
3. Data on file at Medtronic.

710 Medtronic Parkway LifeLine ©2013, 2016, 2017 Medtronic.

Minneapolis, MN 55432-5604 CardioVascular Technical Support All rights reserved.
USA Tel: (877) 526-7890 Medtronic, Medtronic logo
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Tel: (763) 514-4000 Tel: (763) 526-7890 are trademarks of Medtronic.
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12/2017