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CHANGE PURGE FLUID BAG
Note on Purge Solution Bottles: If the purge solution is supplied in
bottles, open the vent on the purge fluid spike and follow the same procedure
as if supplied in bags.
Perform the following steps to change only the purge fluid.
1.
Press PURGE MENU and select "Change Purge Fluid Bag."
2.
Select START to begin the purge fluid change process.
3.
When prompted by the controller, remove the old purge bag and
replace by spiking the new purge fluid bag. Select NEXT to advance
to the next step.
4.
Update the purge fluid information.
a. To select the default purge fluid values displayed on the
screen, select CONFIRM.
b. To change the purge fluid information, select EDIT. Then use
the soft keys to navigate selections and edit values. Select
DONE to complete editing.
5.
When prompted by the controller, disconnect the luer from the Impella
Catheter. The controller will automatically prime the tubing, which will
flush the fluid from the last bag out of the purge cassette tubing.
a. To skip the flush, select SKIP PRIME.
Note: The instructions to disconnect the luer and to automatically
prime the tubing only occurs if the user changed the purge fluid
dextrose or heparin concentrations.
6.
When prompted by the controller, connect the yellow luer from the
purge cassette to the Impella catheter.
Note on Priming Purge Cassette and Disconnecting Luers:
The system only prompts you to remove luers to prime and flush tubing
if the heparin or dextrose concentrations were changed or air was
detected. You can only select SKIP PRIME if no air was detected.
PATIENT WEANING
Weaning the patient from the Impella 5.0 Catheter is at the discretion of the
physician. Removal of the Impella Catheter must be completed with care to
avoid damage to the catheter assembly. Do NOT attempt to remove the Impella
Catheter through the repositioning sheath. The Impella Catheter will not pass
through the repositioning sheath.
The following weaning protocols are provided as guidance only.
RAPID WEANING
1.
Initiate rapid weaning by decreasing catheter P-level in 2-level steps at
intervals of several minutes (for example, P-6 to P-4 to P-2). Do NOT
decrease P-level to below P-2 until just before removing the catheter
from the ventricle.
2.
When the P-level has been reduced to P-2, maintain the patient on
P-2 support for at least 10 minutes before discontinuing circulatory
support.
3.
If the patient's hemodynamics remain stable, follow the instructions in
the next section for removing the Impella 5.0 catheter.
4.
Explant the catheter.
5.
Follow institutional guidelines for arterial closure.
6.
Disconnect the connector cable from the Automated Impella Controller
and turn the controller off by pressing the power switch on the side of
the controller for 3 seconds.
8
SLOW WEANING
1.
Initiate slow weaning by decreasing catheter P-level in 2-level steps
over time as cardiac function allows (for example, P-6 to P-4 to P-2).
Do NOT decrease P-level to below P-2 until just before removing the
catheter from the ventricle.
2.
When the P-level has been reduced to P-2, maintain the patient on
P-2 support until the patient's hemodynamics remain stable before
discontinuing circulatory support.
3.
If the patient's hemodynamics remain stable, follow the instructions in
the next section for removing the Impella 5.0 catheter.
4.
Explant the catheter.
5.
Follow institutional guidelines for arterial closure.
6.
Disconnect the connector cable from the Automated Impella Controller
and turn the controller off by pressing the power switch on the side of
the controller for 3 seconds.
PRESSURE SENSOR DRIFT AND
PLACEMENT SIGNAL NOT RELIABLE
SENSOR DRIFT AND EFFECTS ON FLOW
The electrical signal produced by the differential pressure sensor may drift
over time. This drifting is normal behavior and is characterized by an upward
or downward shift in the placement signal on the controller display. The
amplitude (peak-to-trough, or maximum to minimum) of the waveform will not
change. In addition, when sensor drifting occurs, the displayed flow rate may
not match the P-level.
P-Level
P-0
P-1
P-2
P-3
P-4
P-5
P-6
P-7
P-8
P-9
*Flow rate can vary due to suction or incorrect positioning.
If you observe that the placement waveform has shifted up or down on the
display, or the expected flow does not match the current P-level setting, zero
the differential pressure sensor by performing the following steps:
1.
Press the MENU key and select "Start Manual Zero."
2.
Press OK to adjust flow level.
3.
The controller displays "Wait until new flow level is reached." and
then "Offset calculation is in progress."
4.
Select OK to accept the new setting when the controller displays the
"Placement Signal Offset Adjust finished" message.
5.
The Impella will automatically be reset to the previous P-level.
*Flow Rate (L/min)
0.0 – 0.0
0.0 – 1.4
0.5 – 2.6
0.5 – 3.1
0.9 – 3.4
1.4 – 3.7
1.8 – 4.0
2.6 – 4.4
3.4 – 4.7
4.2 – 5.3
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