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Chapter 4, Safety and Patient Care Precautions
P/N 120745-IE, Manual revision: AA
Haemonetics
®
Cell Saver
®
Elite
®
User Manual
characteristics of the rotary seal may become altered. The increased friction
and excessive heat can make the contents of the bowl unsuitable for reinfusion
to the patient.
The user should also verify that the flow of sterile air to and from the waste bag
is not prevented by either a flow restriction or an air leak.
Inspecting for Twists and Kinks in the Tubing
A careful inspection of the installed harness should be carried out to ensure
that each section is correctly installed on the device and that all tubes are free
of twists or kinks. It is particularly important that no occlusions are present in
the tube between the bowl and the RBC bag when blood is being pumped out
of the bowl. Forcing a pump to work against a severe flow restriction is likely to
result in high levels of hemolysis with high levels of free hemoglobin.
Avoiding
Overheating
Warning: The user must not use any bowl which cannot be properly seated
in the centrifuge chuck. Overheating can occur, which can subsequently lead
to hemolysis and make any blood being processed unsafe for reinfusion.
During operation, the operator should interrupt the procedure if an
abnormality or noise related to the spinning bowl appears.
Warning: If during a procedure it is discovered that any portion of the
equipment within proximity of the blood has been significantly overheated,
the processed RBCs should be regarded as unsafe for reinfusion.
Avoiding Bowl Misalignment
An improperly installed disposable bowl can become misaligned as it spins.
This can create excessive friction and noise and consequently overheat the
bowl contents. The user should verify the alignment of the bowl at the time of
installation.
Avoiding
Continuous
Aspiration
Caution:
Continuous aspiration of profuse bleeding without breaks in suction
can cause electrical interference. If the device is in the Fill phase (pumps
turning) and the entire tubing set is filled with fluid, there is a potential for
electrical interference to be conducted through the fluid and patient to other
systems, such as the ECG. If these conditions exist simultaneously, it is
possible that the Cell Saver Elite can cause an effect on the ECG which looks
like ventricular tachycardia. To eliminate the potential for this to occur, it is
recommended that the user aspirate with intermittent breaks in suction.
Avoiding Red
Blood Cell
Spillage
Under normal conditions the effluent line sensor ensures that there is little or
no RBC spillage. However, there are four conditions that may result in RBCs
spilling over into the waste bag:
1.)
Overfilling of the bowl when Auto-Wash is turned off.