User Manual
8.
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.
9.
When Steps 1 through 8 are complete, connect the luer from the new
purge cassette to the Impella catheter.
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.
These are the steps you will follow 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.
Note
: the instructions to disconnect the luer and to automatically
prime the tubing only occurs if the user changed the purge fluid
concentration
a)
To skip the flush select
SKIP PRIME
.
6.
When prompted by the controller, connect the yellow luer from the
purge cassette to the Impella catheter.
DE-AIR PURGE SYSTEM
These are the steps you will follow to de-air the purge system:
1.
Press
PURGE MENU
and select “De-Air Purge System.”
2.
Select
START
to begin the de-air process.
3.
Make sure that the purge fluid bag is NOT empty or inverted and that
the tubing is NOT kinked. Select
NEXT
to continue.
4.
Disconnect the purge tubing from the Impella Catheter.
5.
Confirm that no air remains in the purge tubing. If air remains, press
BACK
to repeat the air removal process.
6.
Connect the purge tubing to the luer on the Impella Catheter to
complete the de-air procedure.
AIR DETECTED ALERT
During any of the purge system processes above, the controller automatically
monitors for air in the system. If air is detected in the system, the controller
provides an alert to disconnect the luer, as shown below. Once the luer is
disconnected, the controller automatically de-airs the purge system.
PATIENT WEANING
Weaning the patient from the Impella Catheter is at the discretion of the
physician. The Impella 5.5
®
with SmartAssist
®
has been approved for ≤ 30
days of use. However, weaning could be delayed beyond the normal use for
temporary support as an unintended consequence of continued instability of
the patient’s hemodynamics. Inability to wean the patient from the device
within a reasonable time frame should result in consideration of a more
durable form of left ventricular support. The LVEDP/CO Trend can be used
while weaning. Refer to the Automated Impella Controller Instructions for Use
document for more information.
The following weaning instructions are provided as guidance only.
R
APID 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, decrease the P-level to
P-1, pull the catheter into the aorta, and stop the motor by decreasing
the P-level to P-0.
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.
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