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
- Haemocompatibility
- 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.
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 |
|---|---|
|
|
*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.