Healthcare Professionals

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

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.}

Our commitment to quality

Commitment to quality is a way of life at Medtronic.

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.

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