Medtronic Affinity CP BBAP40 Gebrauchsanweisung Seite 19

Warning: 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.
3. To rotate the pump to the desired location, press the retaining latch, turn the pump, and release the retaining latch. Adjust the
pump until the retaining latch locks into place.
Caution: Prime the pump before starting circulation. Operate the pump, coupled to the drive motor with the adapter, at
maximum RPM to check for vibration, unusual noises, lack of flow, and other anomalies. If an anomaly is noted, refer
to Section 9.
4. Proceed with extracorporeal circulation. Refer to the instructions for use supplied with each device.
Warning: Always have a spare Affinity CP adapter and backup equipment available with the appropriate protocol for
replacement. If the adapter needs to be replaced during circulatory support, the potential risk to the patient should be evaluated
prior to changing the adapter.
Warning: The Affinity CP centrifugal blood pump and the Affinity CP adapter are not compatible with operation in a pulsatile
mode.
Warning: Do not use the adapter at speeds greater than 3600 rpm. The adapter is not qualified for speeds greater than
3600 rpm.
8.7. Priming the Affinity™ CP Centrifugal Blood Pump Circuit
1. Using accepted aseptic technique to maintain a sterile fluid pathway, attach the appropriate tubing to the inlet and outlet ports
of the centrifugal blood pump.
2. If possible, flush the circuit and the pump with carbon dioxide (CO
3. Using gravity, fill the centrifugal blood pump with priming solution to a point beyond the pump outlet port and clamp. Remove
air from the outlet tubing.
Warning: Ensure that the centrifugal blood pump and circuit have been debubbled and primed properly prior to initiating
bypass to minimize the risk of air reaching the patient. The use of an arterial filter is recommended.
Warning: Massive air entry into the centrifugal blood pump may cause the pump to deprime and blood flow to stop. Stop the
pump and remove air prior to resuming circulation.
Caution: Do not strike the centrifugal blood pump with instruments. Shock may cause damage to the device, which may cause
device malfunction.
4. With the outlet tubing clamped, turn the Medtronic controller power on.
5. Connect the flow probe to the circuit tubing according to the appropriate compatible system operator's manual. If using a
Medtronic controller, zero the flow probe according to the appropriate Medtronic controller operator's manual.
6. With the outlet tubing still clamped, turn the rpm knob of the Medtronic controller to the desired level to adequately prime and
debubble the circuit. Observe the pump for leakage or other anomalies.
Warning: 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.
7. Set the rpm knob to zero and recheck the integrity of the centrifugal blood pump.
Warning: If leaks are found, remove the centrifugal blood pump and replace with a new, sterile pump. If other anomalies are
found, refer to Section 9. Repeat steps 1 to 7 to prime.
8. If no anomalies are noted, continue priming the circuit.
9. Verify all connections and the integrity and flow of the circuit prior to use.
Warning: Do not operate the centrifugal blood pump with its inlet tubing clamped, as negative pressure would be generated
in the pump and air bubbles may be formed in the blood.
8.8. Affinity™ CP Centrifugal Blood Pump Checklist
Follow the protocol specified by your clinical team. Information from this blood pump bypass checklist can be used to revise,
upgrade, or expand existing checklists appropriately.
1. EQUIPMENT ASSEMBLY
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Mount external drive motor model 560A or drive unit from a compatible system.
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Instructions for Use English 17