Affinity Pixie
Oxygenation System
This addition to the Affinity family is part of Medtronic’s commitment to providing more options for pediatric patients undergoing cardiopulmonary bypass.
Overview
The Affinity Pixie® Oxygenation System delivers performance and versatility for neonates, infants and small children requiring cardiopulmonary bypass at flow rates up to 2.0 L/min. Its comprehensive system design offers ease of setup, ease of use and minimized prime volumes.
The system features the Affinity Orbit® Holder System, which provides even greater device positioning flexibility to adapt to your preferred circuit setup.
Two biocompatible surface options are provided for the oxygenator and cardiotomy/venous reservoir:
- Durable, Non-leaching End Point Attached Heparin
- Provides thromboresistance and enhanced blood compatibility
- A hydrophilic biosurface option without heparin
- Reduces platelet activation
- Reduces platelet adhesion
- Preserves platelet function1
Affinity Pixie Oxygenation System Brochure (PDF, 3.0 MB)
For Affinity Pixie Oxygenation System product images, visit our Image Gallery
References
1 Carmeda is a trademark of Carmeda AB. Products are coated with Carmeda® BIoActive Surface, which is licensed from Carmeda AB for use only as part of an extracorporeal blood circulation system circuit that includes an oxygenator or blood pump.
2Balance® is a registered trademark of Medtronic, Inc. Technology licensed under agreement from BioInteractions, Limited, United Kingdom
3 See Chart Below.
Comparison between Balance-coated and uncoated in vitro bench test circuits of percentage of platelets that are activated with adenosine diphosphate (ADP @20 μM) in circulating heparinized human blood over time. Error bars represent standard deviation. († indicates p<0.05)
Warnings: A strict anticoagulation protocol should be followed and anticoagulation should be routinely monitored during all procedures. The benefits of extracorporeal support must be weighed against the risk of systematic anticoagulation and must be assessed by the prescribing physician.
Caution: Federal law (USA) restricts devices coated with Carmeda BioActive Surface and Balance Biosurface to sale by or on the order of a physician. For a complete listing of indicatons, contraindications, precautions and warnings, please refer to the Instructions for Use which accompany each product.
Affinity Pixie Oxygenator
Advanced Affinity® Oxygenator Technology in a compact, low-prime design
This pediatric oxygenator features:
- 2.0 L/min maximum flow rate with just 48 mL prime
- Medtronic proprietary graduated fiber bundle density technology, together with radial-radial flow path, design with the objective to:
- Enhance gas transfer
- Reduce pressure drop
- Decrease fiber bundle prime volume
- Create uniform blood flow distribution through the bundle
- Carmeda® BioActive Surface1 and Balance® Biosurface2
- Device and accessories do not contain DEHP
For more information, including product specifications and ordering information, download our product brochure:
Affinity Pixie Oxygenation System Brochure (PDF, 3.0 MB)
For Affinity Pixie Oxygenation System product images, visit our Image Gallery
References
1 Carmeda is a trademark of Carmeda AB. Products are coated with Carmeda® BIoActive Surface, which is licensed from Carmeda AB for use only as part of an extracorporeal blood circulation system circuit that includes an oxygenator or blood pump.
2 Balance® is a registered trademark of Medtronic, Inc. Technology licensed under agreement from BioInteractions, Limited, United Kingdom
Warnings: A strict anticoagulation protocol should be followed and anticoagulation should be routinely monitored during all procedures. The benefits of extracorporeal support must be weighed against the risk of systematic anticoagulation and must be assessed by the prescribing physician.
Caution: Federal law (USA) restricts devices coated with Carmeda BioActive Surface and Balance Biosurface to sale by or on the order of a physician. For a complete listing of indicatons, contraindications, precautions and warnings, please refer to the Instructions for Use which accompany each product.
Affinity Pixie Cardiotomy/Venous Reservoir
Ergonomic, easy to use design. Minimized blood contact with antifoam
This pediatric venous reservoir features:
- 2.0 L/min maximum flow rate
- 1200 mL volume capacity
- 20 mL minimum operating volume without vortex formation
- Non-foaming blood does not contact antifoam at typical reservoir operating levels
- Independent rotation of venous inlet and cardiotomy turret
- Vacuum assisted venous drainage-ready design
- Carmeda® BioActive Surface1 and Balance® Biosurface2
- Device and accessories do not contain DEHP
For more information, including product specifications and ordering information, download our product brochure:
Affinity Pixie® Oxygenation System Brochure (PDF, 3.0 MB)
For Affinity Pixie Oxygenation System product images, visit our Image Gallery
References
1 Carmeda is a trademark of Carmeda AB. Products are coated with Carmeda® BioActive Surface, which is licensed from Carmeda AB for use only as part of an extracorporeal blood circulation system circuit that includes an oxygenator or blood pump.
2 Balance® is a registered trademark of Medtronic, Inc. Technology licensed under agreement from BioInteractions, Limited, United Kingdom
Warnings: A strict anticoagulation protocol should be followed and anticoagulation should be routinely monitored during all procedures. The benefits of extracorporeal support must be weighed against the risk of systematic anticoagulation and must be assessed by the prescribing physician.
Caution: Federal law (USA) restricts devices coated with Carmeda BioActive Surface and Balance Biosurface to sale by or on the order of a physician. For a complete listing of indicatons, contraindications, precautions and warnings, please refer to the Instructions for Use which accompany each product.
Holders for Use with the Affinity Pixie Oxegenation System
Affinity Orbit® Holder System
Quick set-up. Custom device positioning and orientation
- Quick and easy device attachment
- Adapts to any pump set-up
- Versatile device positioning and port orientation
- Holder arm, oxygenator arm and cardiotomy/venous reservoir pivot for custom device positioning
- Oxygenator rotates 360° for desired port orientation
- Facilitates reductions in circuit tubing length and associated prime volume
- Designed for use with future Medtronic perfusion technologies
Affinity® Manifold Holder
- Holds a standard flat-plate stopcock manifold in either horizontal or vertical orientation
- C-clamp for easy and stable attachment to both IV poles and larger diameter pump masts
For more information, including product specifications and ordering information, download our product brochure:
Affinity Pixie® Oxygenation System Brochure (PDF, 3.0 MB)
For Affinity Pixie Oxygenation System product images, visit our Image Gallery
Caution: For a complete listing of indications, contraindications, precautions and warnings, please refer to the Instructions for Use which accompany each product.
Ordering Information
| Oxegenation Systems | ||
|---|---|---|
| Order Number | Description | # of Units |
| CBP211 | Hollow Fiber Oxygenator with Carmeda® BioActive Surface | 4 per case |
| BBP211 | Hollow Fiber Oxygenator with Balance® Biosurface | 4 per case |
| CBP241 | Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir with Carmeda® BioActive Surface | 4 per case |
| BBP241 | Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir with Balance® Biosurface | 4 per case |
| Accessories and Holders | ||
|---|---|---|
| Order Number | Description | # of Units |
| ATP210 | Affinity® Temperature Probe | 1 per case |
| AUH2093 | Affinity Orbit® Holder System | 1 per case |
| AMH2014 | Affinity® Manifold Holder | 1 per case |
For more information, including product specifications and ordering information, download our product brochure:
Affinity Pixie Oxygenation System Brochure (PDF, 3.0 MB)
For Affinity Pixie Oxygenation System product images, visit our Image Gallery
References
1 Carmeda is a trademark of Carmeda AB. Products are coated with Carmeda® BioActive Surface, which is licensed from Carmeda AB for use only as part of an extracorporeal blood circulation system circuit that includes an oxygenator or blood pump.
2 Balance® is a registered trademark of Medtronic, Inc. Technology licensed under agreement from BioInteractions, Limited, United Kingdom
Warnings: A strict anticoagulation protocol should be followed and anticoagulation should be routinely monitored during all procedures. The benefits of extracorporeal support must be weighed against the risk of systematic anticoagulation and must be assessed by the prescribing physician.
Caution: Federal law (USA) restricts devices coated with Carmeda BioActive Surface and Balance Biosurface to sale by or on the order of a physician. For a complete listing of indicatons, contraindications, precautions and warnings, please refer to the Instructions for Use which accompany each product.
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