Indications For Use; Contraindications - Medtronic Affinity NT Gebrauchsanweisung

Affinity NT™
Oxygenator with Cortiva™ BioActive Surface
1. Model
CB511
2. Description
The Affinity NT™ oxygenator with Cortiva bioactive surface is a single-use gas exchange device with blood
outside the fiber design and includes an integral 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 8.
2.1. Specifications
Oxygenator
Membrane type
Membrane surface area
Static priming volume
Residual blood volume
Minimum gas:blood ratio
Maximum gas:blood ratio
Recommended blood flow rate
Maximum water side pressure
Arterial outlet port
Venous inlet port
Access port
Arterial sample port
Recirculation port
Gas inlet port
Gas outlet port
Water ports
Size
Maximum transit temperature
Tested with saline
a
Store the product at room temperature.
Upon written request, a list of all materials used in the construction of the oxygenator will be made available.
2.2. Accessories available separately
Model number
TP
61399401072

3. Indications for use

The Affinity NT oxygenator with Cortiva bioactive surface is intended to be used in an extracorporeal perfusion
circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine
cardiopulmonary bypass (CPB) procedures up to 6 hours in duration.

4. Contraindications

Use the device only as indicated.
5. Warnings
Read all warnings, precautions, and instructions for use carefully prior to use. Failure to read and follow all
instructions, or failure to observe all stated warnings, could cause serious injury or death to the patient.
■
The fluid pathway is sterile and nonpyrogenic. Inspect each package and device prior to use. Do not use the
device if the package is opened or damaged, the device is damaged, or the protective caps are not in place.
■
If air bubbles and/or leaks are observed during priming and/or operation, these conditions may result in air
embolism to the patient and/or fluid loss. The extracorporeal circuit must be continually monitored. Do not
use the device if these conditions are observed.
■
Clear all gas emboli from the extracorporeal circuit before initiating bypass. Gas emboli are hazardous to the
patient.
■
In any extracorporeal circuit, the use of a prebypass and arterial line filter should be considered.
a
Description
Temperature probe
Affinity™ oxygenator holder
Microporous polypropylene hollow fibers
2.5 m 2
270 mL
144 mL
0.5:1
2:1
1 to 7 L/min
206.8 kPa (30 psi)
1.0 cm (3/8 in)
1.0 cm (3/8 in)
Female luer port
Female luer port
0.6 cm (1/4 in)
0.6 cm (1/4 in)
1.0 cm (3/8 in) nonbarbed
1.3 cm (1/2 in) quick disconnects
Adult
40°C (104°F)
Instructions for Use English 7