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Healthcare Professionals

Affinity Pixie™

Oxygenation System

  

AFFINITY PIXIE™ OXYGENATION system

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/minute. Its comprehensive system design offers ease of setup, ease of use, and minimised 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:

Cortiva™ BioActive Surface

  • Durable, Non-leaching End Point Attached Heparin
  • Provides thromboresistance and enhanced blood compatibility 

Balance™ Biosurface*

  • A hydrophilic biosurface option without heparin
  • Reduces platelet activation
  • Reduces platelet adhesion
  • Preserves platelet function1

AFFINITY PIXIE™ OXYGENATOR

Advanced Affinity™ Oxygenator Technology in a compact, low-prime design

This paediatric oxygenator features:

  • 2.0 L/min maximum flow rate with just 48 mL prime
  • The Medtronic proprietary graduated fiber bundle density technology, together with a radial-radial flow path, which create a uniform blood flow distribution through the bundle, enhance gas transfer, reduce pressure drop, and decrease fiber bundle prime volume
  • Cortiva and Balance Biosurface*
  • Device and accessories do not contain DEHP.

 

AFFINITY PIXIE™ CARDIOTOMY/VENOUS RESERVOIR

Ergonomic, easy-to-use design. Minimised blood contact with antifoam

This paediatric cardiotomy/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
  • Cortiva and Balance Biosurface*
  • Device and accessories do not contain DEHP.

HOLDERS FOR USE WITH THE AFFINITY PIXIE™ OXYGENATION SYSTEM

Affinity Orbit™ Holder System

Quick setup. Custom device positioning and orientation

  • Quick and easy device attachment
  • Adapts to any pump setup
  • 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

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
Horizontal

Affinity™ Manifold Holder System

This is an image of the Affinity Orbit™ holder system for use with the Affinity Pixie™ oxygenation system.

  vertical

Affinity Manifold™ Holder System

Caution: For a complete listing of indications, contraindications, precautions and warnings, please refer to the Instructions for Use which accompany each product.

ORDERING INFORMATION

OXYGENATION SYSTEMS

Order Number Description # of Units
CBP211 Hollow Fiber Oxygenator with Cortiva™ BioActive Surface Tubing packs only
BBP211 Hollow Fiber Oxygenator with Balance™ Biosurface Tubing packs only
CBP241 Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir with Cortiva BioActive Surface Tubing packs only
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

*

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

References

1

See chart below.

Functional_Platelets

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: For a complete listing of indications, contraindications, precautions and warnings, please refer to the Instructions for Use which accompany each product.