AFFINITY FUSION

Oxygenation System

OVERVIEW

Designed by Perfusionists. Engineered by Medtronic.

The Affinity Fusion™ oxygenation system’s design is based on input from more than 500 perfusionists worldwide. Thoughtfully engineered from inlet to outlet, the Affinity Fusion oxygenation system takes a fundamentally different design approach:

Proactive air handling
Hemocompatibility
Improved flexibility
Integrated arterial filter
Expanded heat exchanger and gas transfer capabilities

PRODUCT DETAILS: AFFINITY FUSION OXYGENATION SYSTEM

Both oxygenator and reservoir device 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

Oxygenator available in:

Balance™ biosurface coating
Cortiva™ bioactive surface

Cardiotomy/venous reservoir available in:

Balance™ biosurface coating

*Sampling manifold is not BPA free.

PET HEAT EXCHANGER

Safe. Effective. Environmentally Friendly.

The higher density structure of the Affinity Fusion polyethylene terephthalate (PET) heat exchanger provides improved chemical resistance with a low permeability factor when compared to lower density plastics such as polyurethane or TPU*.

PET heat exchanger features and benefits:

Resistant to chemical migration
Durable to withstand the surrounding environment
Small tube design of capillaries increases heat exchange performance
Decreases prime volume
Enables device incineration

*Testing performed at a water side concentration of 330 PPM over the course of 6 hours. Fusion N=10, Inspire N=3, Maquet N=3. All testing ran at 37C with blood side flow rate of 4.5 lpm. Medtronic data on file.

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Learn more about the PET Heat Exchanger.

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OUR COMMITMENT TO QUALITY

Commitment to quality is a way of life at Medtronic. See one patient’s story.

Oxygenator Features	Cardiotomy/Venous Reservoir Features
Oxygenator Features Integrated arterial filter 25 µm filtration 260 mL prime Enhanced gas transfer Plastic heat exchanger (PET) Recirculation and cardioplegia ports ½" quick-connect water ports Ambidextrous design BPA-free plastic Clear housing Volume-displacing leur caps Built-in temp probe sleeve 1-7 L/min flow Balance™ biosurface Cortiva™ BioActive surface	Cardiotomy/Venous Reservoir Features 4500 mL capacity 360-degree rotating venous inlet Curved venous inlet with 2 angled luer ports Built-in temperature probe sleeve 360-degree rotating cardiotomy inlet with 4 luer ports 2 nonfiltered luer ports Antifoam in venous and cardiotomy filters Pressure relief valve VAVD ready BPA-free plastic* Removable sampling manifold Clear housing 1-7 L/min flow 200 mL @7 L/min minimum operating level Balance™ biosurface

Oxygenator Features

Cardiotomy/Venous Reservoir Features

Oxygenator Features

Integrated arterial filter
25 µm filtration
260 mL prime
Enhanced gas transfer
Plastic heat exchanger (PET)
Recirculation and cardioplegia ports
½" quick-connect water ports
Ambidextrous design
BPA-free plastic
Clear housing
Volume-displacing leur caps
Built-in temp probe sleeve
1-7 L/min flow
Balance™ biosurface
Cortiva™ BioActive surface

Cardiotomy/Venous Reservoir Features

4500 mL capacity
360-degree rotating venous inlet
Curved venous inlet with 2 angled luer ports
Built-in temperature probe sleeve
360-degree rotating cardiotomy inlet
with 4 luer ports
2 nonfiltered luer ports
Antifoam in venous and cardiotomy filters
Pressure relief valve
VAVD ready
BPA-free plastic*
Removable sampling manifold
Clear housing
1-7 L/min flow
200 mL @7 L/min minimum operating level
Balance™ biosurface

*Sampling manifold is not BPA-free

AFFINITY FUSION OXYGENATION SYSTEM SPECIFICATIONS

Oxygenator

Membrane type	Microporous polypropylene hollow fiber
Membrane surface area	2.5m²
Heat exchange surface material	Polyethylene terephthalate (PET)
Static priming volume	260 mL
Recommended blood flow rate	1-7 L/min
Maximum water side pressure	30 psi
Maximum blood pressure	750 mm Hg
Arterial outlet port	3/8"
Venous inlet port	3/8"
Arterial sample port	Female luer port
Recirculation port	1/4"
Cardioplegia port	1/4"
Gas inlet port	1/4" nonbarbed
Gas outlet port	3/8" nonbarbed
Water ports	1/2" quick disconnects
Filtration	25 µm

Cardiotomy/Venous Reservoir

Reservoir volume capacity	4500 ml
Recommended blood flow rate	1-7 L/min
Maximum cardiotomy flow rate	6 L/min
Minimum operating level	200 mL at 7L/min
Cardiotomy filtration	30 µm
Venous screen	105 µm
Venous inlet, rotatable	1/2" with 3/8" adapter
Venous reservoir outlet	3/8"
Vent/VAVD port	1/4" nonbarbed
Cardiotomy port (4)	1/4"
Cardiotomy port (1)	3/8"
Prime port	1/4" nonbarbed
Recirculation port	1/4"
Filtered luer lock ports	4
Non-filtered luer lock ports	2
Venous luer lock ports	2
Positive pressure relief valve crack	<5 mm Hg
Vacuum pressure relief valve crack	>100 mm Hg average

ORDERING INFORMATION

Affinity Fusion Oxygenation Systems
Model#	Product Description	Units/case
CB841	Oxygenator with integrated arterial filter with Cortiva bioactive surface and cardiotomy/venous reservoir with Balance biosurface	1
BB841	Oxygenator with integrated arterial filter and cardiotomy/venous reservoir with Balance biosurface	1
CB811	Oxygenator with integrated arterial filter and Cortiva bioactive surface	1
BB811	Oxygenator with integrated arterial filter and Balance biosurface	1

Affinity Fusion Accessories and Holders
Model #	Product Description	Units/Case
AUH2093	Affinity orbit holder system	1
ATP210	Temperature probe	1
AMH2014	Affinity manifold holder	1
RCL841	Recirculation line	12

MANUALS AND TECHNICAL GUIDES

Instructions for Use

Find this technical manual in the product labeling supplied with each device or call Medtronic at 800-961-9055.

Balance is a trademark of Medtronic, Inc. Technology licensed under agreement from BioInteractions, United Kingdom.