Recommended Priming Procedures - Medtronic BIO-PUMP+ Serie Instrucciones De Uso

Frequent patient and device monitoring is recommended; do not leave device unattended while in use. Monitor
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carefully for signs of occlusion throughout the circuit.
Do not operate the pump for more than thirty (30) seconds in the absence of flow. The temperature within the pump
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will rise and increased cellular damage may result.
The pump must be handled and used in an aseptic manner.
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Do not operate the Bio-Pump+ blood pump with its inlet clamped as a negative pressure would be generated in the
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pump and air bubbles may be formed in the blood.
5 PRECAUTIONS
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
This device should be used only by persons thoroughly trained in extracorporeal circulation procedures.
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Do not hit or strike the Bio-Pump+ blood pump with hands or instruments. Shock may cause damage to the device,
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which may cause device malfunction.
The Bio-Pump+ blood pump is sterile and nonpyrogenic in an unopened and undamaged unit package. Inspect device
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and package carefully prior to use. Do not use if the unit package or the product has been damaged or soiled, or if
caps are not in place.
Each pump is intended for single use only. Do not resterilize. Resterilization by any means may cause severe damage
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to the device or its components. Dispose of safely after single use to avoid risk of infection.
Attach tubing in such a manner as to prevent kinks or any restrictions that may alter flow.
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Do not run the pump unprimed as damage to the internal components may occur.
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Do not use pump if dropped. Dropping or other severe shock may cause damage, which could lead to device
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malfunction.
Do not use excessive force to install tubing on pump as damage to pump may occur.
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Take care to prevent damage to connectors when repositioning or attaching tubing.
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Always have a spare Bio-Pump+ blood pump and backup equipment available with appropriate protocol for change
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out.
Do not place the pump by items adversely affected by magnetic fields.
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A strict anticoagulation protocol should be followed and anticoagulation should be routinely monitored during all
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procedures. The benefits of extracorporeal support must be weighed against the risk of systemic anticoagulation and
must be assessed by the prescribing physician.
Refer to package labeling for storage temperature requirements.
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6 RECOMMENDED PRIMING PROCEDURES

1. With accepted aseptic technique, attach the appropriate tubing to the inlet and outlet of the Bio-Pump+ blood pump.
(Applying a sterile saline solution to the inlet/outlet connectors may aid tubing attachment.)
2. Where practical, flush the circuit and the pump with CO
3. Fill the Bio-Pump+ blood pump with prime, by gravity, to a point beyond the flow probe and clamp. Eliminate air from
the device by "walking" the air out the outlet.
Caution: Do not hit or strike the Bio-Pump+ blood pump with hands or instruments. Shock may cause damage to the
device, which may cause device malfunction.
Warning: Ensure that the pump and circuit have been debubbled and primed properly prior to beginning bypass to
minimize the risk of air reaching the patient. The use of an arterial filter is recommended.
Warning: Massive air entry into the pump will cause the pump to deprime and blood flow to stop. Stop the pump and
remove air prior to resuming circulation.
4. With the outlet clamped, turn the Bio-Console pump speed controller power "ON."
5. Zero (gain and balance) the flow probe according to the Bio-Console Operator and Reference Manual.
6. With the outlet still clamped, turn the RPMs of the Bio-Console pump speed controller to maximum RPM for 30
seconds. This delivers maximum pressure within the pump which aids in assuring its integrity. Observe the pump for
leakage or other anomalies.
Warning: Do not operate the pump for more than thirty (30) seconds in the absence of flow. The temperature within
the pump will rise and increased cellular damage may result.
7. Bring the RPMs to zero and recheck the integrity of the pump.
Warning: If leaks or other anomalies are found, remove the Bio-Pump+ blood pump and replace with a new, sterile
pump, repeating the above steps to prime.
8. If no anomalies are noted, continue the priming of your circuit in the usual fashion.
6 Instructions for Use
(from filter or reservoir bag).
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