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

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Precautions for operation
・
Adequate heparinization of the blood is required to
prevent blood coagulation in the system.
・
Never clamp the venous line (blue) during circulation.
Otherwise, pressure inside of the pump will turn into
negative, which is a potential hazard of producing gas
bubbles.
・
Always close the branch line of the venous line (blue)
during circulation. Otherwise, pressure in this part will turn
into negative, which is a potential hazard of intermixing
bubbles.
・
DO NOT OBSTRUCT GAS OUTLET PORT.
Avoid build-up of excess pressure in the gas phase to
prevent gaseous emboli entering the blood phase.
・
The oxygenator must be positioned lower than the patient.
Pressure in the blood phase should always be higher than
that in the gas phase to prevent gaseous emboli entering
the blood phase.
・
The gas flow should not exceed 20L/min. Excessive gas
flow will bring about pressure increase in the gas phase,
allowing gaseous emboli to enter the blood phase.
・
Do not exceed a 15
°
C (27
°
F) temperature difference
between blood and water in heat exchanger to prevent gas
dissolved in blood from forming bubbles.
・
This product should be used under monitoring. If
abnormalities such as product-damage and deteriorated
performance are observed, replace the product with a new
one properly after ascertaining the state of patient.
There are possibilities that increasing blood cell damage or
blood coagulation is formed, or the circulation is
obstructed.
PRECAUTIONS
・
This product should be used by a physician or under the
supervision and/or direction of a physician.
・
This product is sterilized by ethylene oxide gas.
・
For single use only. Do not reuse. Do not resterilize. Do not
reprocess. Reprocessing may compromise the sterility,
biocompatibility and functional integrity of the device.
WARNINGS/PRECAUTIONS
WARNINGS