Medtronic Affinity Pixie CBP211 Mode D'emploi page 25

■
The use of a blood level sensing mechanism during operation of this device is recommended.
■
Ensure that the venous reservoir outlet is always positioned above the highest point in the membrane
compartment of the oxygenator.
■
CPB must be carefully and constantly monitored.
■
Attach tubing in such a manner as to prevent kinks or restrictions that may alter the blood, water, or gas
flow.
■
Do not allow alcohol, alcohol-based fluid, anesthetic liquids (such as isoflurane), or corrosive solvents (such
as acetone) to come in contact with the device as they may jeopardize the structural integrity.
7. Precautions
■
Each device is sterilized using ethylene oxide.
■
This device was designed for single patient use only. Do not reuse, reprocess, or resterilize this product.
Reuse, reprocessing, or resterilization may compromise the structural integrity of the device or create a risk
of contamination of the device which could result in patient injury, illness, or death.
■
Use aseptic technique in all procedures.
■ Use of a gas scavenging system during transfer of anesthetic gas through the oxygenator should be
considered.
■
Follow a strict anticoagulation protocol and routinely monitor anticoagulation during all procedures.
Adequate anticoagulation should be maintained per institution CPB protocol.
■
It is the responsibility of the user to dispose of the devices in accordance with local regulations and hospital
procedures.
8. Adverse effects
The following known adverse effects are associated with the use of the product: blood loss, coagulopathy,
death, embolism, excessive blood component activation or thrombogenicity, exsanguination, hemolysis,
hemolytic anemia, hypercarbia, hypotension, hypovolemia, hypoxia, infection, ischemia, neurological
dysfunction, and organ dysfunction.
9. Information for products with Cortiva bioactive surface
The primary blood-contacting surfaces of the product are coated with Cortiva bioactive surface. This coated
surface enhances blood compatibility and provides a blood-contacting surface that is thromboresistant. Cortiva
bioactive surface contains nonleaching heparin derived from porcine intestinal mucosa
Caution: Product coated with Cortiva bioactive surface is intended for single use only. Resterilization may
adversely affect the Cortiva bioactive surface.
Caution: Follow a strict anticoagulation protocol and routinely monitor anticoagulation during all procedures.
10. Instructions for use
10.1. System setup
1. Remove the devices from the packaging carefully to ensure sterile fluid pathway.
Warning: Use aseptic technique during all stages of setup and use of this product.
Warning: Before removing the devices from the packaging, inspect the packaging and product for damage.
If the packaging or product is damaged, do not use; sterility may have been compromised or performance
may be affected.
2. If using the Affinity Orbit holder system (sold separately), attach the holder mast clamp to the heart-lung
machine mast at the desired height and tighten the mast clamp knob.
3. Turn the locking lever perpendicular to the holder arm to unlock it.
4. Slide the oxygenator arm onto the post if it is not already in place.
5. Slide the oxygenator holder connector onto the bottom of the oxygenator arm. A click will indicate that the
oxygenator is firmly seated.
Note: To remove the oxygenator, press the holder release tab and pull the oxygenator away from the
connector arm.
6. If using the Affinity Pixie CVR, slide the CVR holder sleeve onto the holder post.
7. Position the oxygenator and CVR as desired for procedure. The oxygenator may be rotated clockwise or
counterclockwise and the oxygenator arm may be moved laterally. The CVR may be rotated clockwise or
counterclockwise.
8. Turn the locking lever parallel to the holder arm to lock components in place.
9. Turn the holder arm knob to lock the holder arm in place. See Figure 4 for final system assembly.
1 Nonleaching is defined as heparin at a level ≤0.1 IU/mL, as measured through clinically relevant extraction conditions.
1
.
Instructions for Use English 23