Medtronic Affinity Pixie Gebrauchsanweisung Seite 23

Affinity Pixie™
Oxygenation System with Cortiva™ BioActive Surface
1. Model
CBP211
CBP241
Accessories available separately
ATP210
AUH2093
AUH2070
AMH2014
2. Description
This product is a single-use device, which is nontoxic, nonpyrogenic, and supplied STERILE in individual
packaging. It is sterilized by ethylene oxide.
2.1. Hollow fiber oxygenator
The Affinity Pixie hollow fiber oxygenator with Cortiva bioactive surface is a single-use, microporous, hollow-
fiber, gas-exchange device with plasma-resistant fiber and integrated heat exchanger. Products coated with
Cortiva bioactive surface include a "CB" prefix in the model number. Additional information regarding Cortiva
bioactive surface is available in Section 9.
The following accessories are packaged for use with the oxygenator (Figure 3):
■
Two 0.5 cm (3/16 in) adapters for blood inlet and outlet ports
■
One recirculation line — 0.5 cm (3/16 in)
2.2. Cardiotomy/venous reservoir
The Affinity Pixie cardiotomy/venous reservoir (CVR) with Cortiva bioactive surface is a single-use device
designed to collect and store blood during extracorporeal circulation. Cardiotomy blood is collected, filtered, and
defoamed before mixing with the venous blood, which is filtered. Products coated with Cortiva bioactive surface
include a "CB" prefix in the model number. Additional information regarding Cortiva bioactive surface is available
in Section 9. Coverage is verified on all primary blood-contacting surfaces and bioactivity is verified on the
venous flow path surfaces.
The following accessories are packaged for use with the CVR (Figure 3):
■
Two 0.5 cm (3/16 in) adapters for venous return inlet and outlet ports
■
Two 1.0 cm (3/8 in) adapters for venous return inlet and outlet ports
■
Two flexible luer lock adapters
■
One sampling manifold assembly
3. Specifications
Oxygenator
Oxygenator membrane type
Maximum gas:blood ratio
Heat exchanger
Oxygenator membrane surface area
Static priming volume
Recommended blood flow range
Maximum water pressure
Maximum rated blood pressure
Maximum transit temperature
Store the product at room temperature.
Cardiotomy/venous reservoir
Reservoir volume capacity
Recommended blood flow range
Maximum cardiotomy flow rate
Minimum operating level
Cardiotomy filter
Venous inlet screen
Maximum rated pressure
Hollow fiber oxygenator with Cortiva bioactive surface
Hollow fiber oxygenator and cardiotomy/venous reservoir with Cortiva bioactive surface
Affinity™ temperature probe
Affinity Orbit™ holder system
Affinity Orbit™ oxygenator arm replacement
Affinity™ manifold holder
Microporous polypropylene hollow fiber
2:1
Polyethylene terephthalate (PET)
0.67 m 2
48 mL
0.1 to 2.0 L/min
206 kPa (1550 mmHg)
100 kPa (750 mmHg)
40°C (104°F)
1200 mL
0.1 to 2.0 L/min
2.0 L/min
20 mL
30 μm nominal polyester depth filter
64 μm
+20 mmHg / –100 mmHg
Instructions for Use English 21