Indications For Use; Contraindications - Medtronic Affinity Pixie Gebrauchsanweisung

Cardiotomy/venous reservoir
Positive/negative pressure relief valve
Maximum transit temperature
Store the product at room temperature.

4. Indications for use

The Affinity Pixie hollow fiber oxygenator and cardiotomy/venous reservoir with Cortiva bioactive surface are
indicated for use for neonate, infant, and small pediatric patients undergoing cardiopulmonary bypass (CPB)
procedures requiring a blood flow rate up to 2.0 L/min.
The Affinity Pixie hollow fiber oxygenator 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 CPB
procedures up to 6 hours in duration. The Affinity Pixie hollow fiber oxygenator is suitable for transfer of the
volatile anesthetics isoflurane, sevoflurane, desflurane, and enflurane by administration through the oxygenator
gas inlet by means of a suitable gas vaporizer.
The Affinity Pixie cardiotomy/venous reservoir is intended to be used in an extracorporeal perfusion circuit to
collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures up to 6 hours in
duration. The CVR is also intended for use during vacuum-assisted venous drainage (VAVD) procedures.

5. Contraindications

Use the device only as indicated.
6. Warnings
■
Read all warnings, precautions, and instructions for use carefully before use. Failure to read and follow all
instructions, or failure to observe all stated warnings, could cause serious injury or death to the
patient.
■
Only persons thoroughly trained in CPB procedures should use this device. Operation of each device
requires constant supervision by qualified personnel for patient safety.
■
The fluid pathway is sterile and nonpyrogenic. Inspect each package and device before 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.
Note: The oxygenator water inlet, water outlet, and gas outlet ports do not have protective caps.
■
Clear all gas emboli from the extracorporeal circuit before initiating bypass. Gas emboli are hazardous to the
patient.
■
If air leaks are observed during priming or operation, this may result in air embolism to the patient or fluid
loss. The extracorporeal circuit must be continually monitored. Do not use the device if these conditions are
observed.
■
In any extracorporeal circuit, the use of a prebypass and arterial line filter is recommended.
■
Monitoring of circuit pressure is recommended.
■
The blood phase pressure should be greater than the gas phase pressure at all times in the oxygenator.
■
The oxygenator and CVR should not be operated outside the recommended parameter ranges.
■ Total combined flow into the cardiotomy filter should not exceed 2.0 L/min.
■
Do not exceed blood pressure of 100 kPa (750 mmHg) in the blood pathway.
■
Once an oxygenator is primed with blood, adequate anticoagulation should be maintained per institution
CPB protocol and the blood pathway should be constantly recirculated at a low flow rate.
■ After initiation of bypass, blood flow should circulate through oxygenator and CVR at all times within the
recommended blood flow range during CPB, except during emergency oxygenator replacement.
■
Heat exchanger temperature should not exceed 42°C (107°F).
■
Follow institution CPB protocol when using disinfectants in the heater/cooler during bypass. The integrity of
the water path has been verified with hydrogen peroxide (330 ppm). Contact Medtronic for information
regarding the use of additional disinfectants.
■
Band all tubing connections for added protection against disconnection.
■
Ensure that unused ports remain capped to prevent contamination and that the caps are tightened to avoid
leakage.
■
A replacement oxygenator should be readily available during CPB.
■
Do not obstruct the gas outlet vents to prevent gas side pressures from exceeding blood side pressures.
■
Do not occlude or obstruct the vent port of the CVR during operation (except when using VAVD).
■
Gas transfer characteristics of the oxygenator are not significantly affected by concentrations of anesthetic
gas up to 2%. Above 2% anesthetic gas concentrations, adjustments of FiO
needed to achieve desired gas transfer performance.
■
Gas transfer rates may change over time and adjustments of FiO
achieve desired gas transfer performance.
22 Instructions for Use English
<5 mmHg positive / >60 mmHg vacuum
40°C (104°F)
and gas flow rates may be needed to
2
and gas flow rates may be
2