Terumo CAPIOX EBS Circuit with X coating, Instructions For Use Manual

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Precautions
Cautions
(All equipment)
• If the circulation is performed by satisfying all the following settings, do not remove the ABD/Flow Sensor from the
extracorporeal circulation circuit or from the Controller. [The Air Bubble Detected Alarm may be issued and the Fast Clamp
may work unintentionally.]
• Air bubble detection : On
• Fast clamp function: On
• Safety connection of the Air Bubble Detected Alarm: Clamp+Pump stop
• Make sure to use a pressure sensor which conforms to ANSI/AAMI BP22:1994. [If a pressure sensor that does not
conform to the aforementioned standard is used, this may result in decreased performance.]
• Do not operate the centrifugal pump without filling the pump with liquid beforehand. [Damage may occur to the rotary
sliding part.]
• Use this system while paying attention not to let air in the blood circulation circuit. [Health damages may occur to the
patient.]
• When attaching or detaching the centrifugal pump to or from the Drive Motor or Hand Crank, confirm that the Drive Motor
or Hand Crank are stopped. [The centrifugal pump may start or stop its rotation unintentionally.]
• Attach the centrifugal pump while adjusting the Drive Motor position so as not to let the fixed hook and the extracorporeal
circulation circuit connection part interfere. [The fixed hook or centrifugal pump may be damaged.]
• When attaching the centrifugal pump to the Drive Motor or Hand Crank, confirm that the bottom surface of the centrifugal
pump is in close contact with the pump receptacle and that the slide hook is securely in position. [If rotation starts while
the slide hook is not secured due to residue of blood and drug solution, the centrifugal pump may detach from the pump
receptacle.]
• Perform the flow adjustment by changing the motor speed of the centrifugal pump. [If the adjustment is performed by
partially clamping the blood outlet line of the centrifugal pump, damage to the blood may be increased.]
• While circulating, maintain the motor speed at a speed higher than that at which the Low Flow Alarm is issued (the speed
at which back flow does not occur due to the height gradient or the patient ʼ s blood pressure). [Back flow of blood may
occur.]
• When circulating or priming, if a significant amount of air enters the centrifugal pump causing the pump to idle and
circulation to stop, perform the following procedures: After clamping the blood outlet line of the centrifugal pump, stop the
rotation of the pump. Remove the air and release the clamp to restart circulation. [Otherwise, the centrifugal pump may
start idling and circulation may not start.]
• Be cautious in motor speed adjustment when decreasing the motor speed of the centrifugal pump. [Back flow of blood may
occur.]
• Do not rotate the centrifugal pump for a long period of time (multiple hours) while clamping the blood outlet line of the
centrifugal pump. [The priming solution may be denatured due to heating. The blood may be damaged due to heating.]
• When weaning, be sure to clamp the blood line and then stop the rotation of the centrifugal pump. [If the rotation of the
centrifugal pump stops without clamping the blood line, blood may flow back.]
20
Warnings
• When installing the system in an ambulance and transferring a patient in the event of an emergency, make sure the power
supply of the ambulance is always higher than the total consumption power for all electric devices installed. [If the supply
power of the ambulance becomes insufficient, the device shuts down and circulation cannot be maintained.]
(Controller)
• Use the AC power source as the primary power source. [Battery is used as an auxiliary power source when the AC
power source cannot be used sufficiently, such as during transportation, electric failure, etc. If the battery is depleted
and charging is insufficient, the Controller will not be able to operate by the battery during an emergency such as electric
failure.]
• Set the safety connection and record its setting. Confirm that the device is operating as intended by the safety connection.
[If the setting is wrong, the Controller may not operate as intended.]
• Do not attach the Fast Clamp to the blood inlet line of the centrifugal pump. [Air bubbles may occur if the blood inlet line is
clamped, as the inside of the centrifugal pump will be negatively pressurized.]
(ABD/Flow Sensor)
• When attaching the ABD/Flow Sensor, apply enough vaseline to evenly coat the detection window of the clamp-on ABD/
Flow sensor. [If the amount of vaseline applied is insufficient, the Flow Signal Unstable Alarm may be issued and air
bubbles may not be detected.]