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4.1 Affinity CP centrifugal blood pump
• The centrifugal blood pump has not been qualified through in vitro, in vivo, or clinical studies for long-term use (longer than 6 hours)
as a bridge-to-transplant or for pending recovery of the natural heart.
• The Affinity CP centrifugal blood pump and the Affinity CP adapter are not compatible with operation in a pulsatile mode.
• Do not use the centrifugal blood pump with an external drive motor or adapter that it is not compatible with because this may result
in reduced performance, decoupling, or damage.
• Ensure that the centrifugal blood pump and circuit have been debubbled and primed properly before initiating bypass to minimize
the risk of air reaching the patient. The use of an arterial filter is recommended. You must visually confirm that all air has been
removed from the bearing assembly.
• Never clamp or restrict flow proximally to the pump; doing so may result in pump failure. If flow is occluded at the inlet, the pump
may run at high rpms and possibly generate a high vacuum greater than 500 mmHg.
• Do not operate the centrifugal blood pump unprimed; damage to the internal components will occur.
• Massive air entry into the centrifugal blood pump deprimes the pump and stops blood flow. Stop the pump and remove air before
resuming circulation.
• Never operate the pump without fluid.
• Do not operate the centrifugal blood pump at rotational speeds greater than the specified maximum (4000 rpm). Doing so may
result in excessive wear to the pivot bearings.
• Do not expose the centrifugal blood pump to liquid chemical agents, because they may affect the integrity of this device. Anesthetic
liquids, such as isoflurane, are known to degrade polycarbonate plastics. Avoid contact of these solutions with the centrifugal
blood pump.
• To prevent retrograde blood flow when the centrifugal blood pump outlet tubing is open, establish and maintain a minimum pump
speed that overcomes line and patient resistance. If positive flow cannot be maintained, the pump outlet tubing must be clamped
to isolate flow from the patient. Failure to do so could allow retrograde flow and exsanguinate the patient.
• To prevent retrograde flow, arterial lines must always be clamped distally when the centrifugal blood pump is at rest.
• Always have a spare Affinity CP centrifugal blood pump and backup equipment available with appropriate protocol for
replacement. If the centrifugal blood pump needs to be replaced during circulatory support, the potential risk to the patient should
be evaluated before changing the pump.
• Frequent patient and device monitoring is recommended; do not leave the centrifugal blood pump unattended while in use.
Monitor flow rate carefully for signs of occlusion throughout the circuit.
• Do not operate the centrifugal blood pump for more than 30 seconds in the absence of flow. The temperature within the pump could
rise, and increased cellular damage may result.
• The centrifugal blood pump must be handled using aseptic technique.
4.2 Affinity CP adapter
• Always have a spare Affinity CP adapter and backup equipment available with appropriate protocol for replacement. If the adapter
needs to be replaced during circulatory support, the potential risk to the patient should be evaluated before changing the adapter.
• Ensure that the adapter is properly attached to the drive motor. Verify that the adapter is locked onto the drive motor. Improper
attachment may adversely affect pump performance.
• Ensure that the pump is properly attached to the adapter. The pump should be secure under the retaining ledge and the retaining
latch of the adapter. Verify that the pump is locked securely and in close contact with the adapter receptacle. Improper attachment
may adversely affect pump performance.
• The Affinity CP centrifugal blood pump and the Affinity CP adapter are not compatible with operation in a pulsatile mode.
• Do not use the adapter at speeds greater than 3600 rpm. The adapter is not qualified for speeds greater than 3600 rpm.
• Do not sterilize the adapter. Sterilization may damage the adapter.
• The adapter is not serviceable. Do not disassemble the adapter because the performance of the adapter may be adversely
affected. If the adapter has been tampered with, do not use it.
5 Precautions
Caution: This device should only be used by clinicians thoroughly trained in extracorporeal circulation procedures.
5.1 Affinity CP centrifugal blood pump
• Do not forcefully strike or drop the centrifugal blood pump. Shock may cause damage to the device, which may cause the device
to malfunction.
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