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Once the calibration factor is obtained, the Automated Impella Controller will
continue to calculate the cardiac output, native cardiac output, and cardiac
power output for the next 8 hours using the above equations.
If cardiac power output values are below or equal to 0.6, the value will
display as yellow.
Note: Do not use values as a clinical diagnostic tool, this is for informational
purposes only.
CARDIAC OUTPUT ENTRY REMINDERS
A white reminder to enter the CO will appear every 15 minutes for the last
hour prior to the 8 hour timeout. If a new CO is not entered after 8 hours, the
values will show as dash marks until a new cardiac output is entered.
A white reminder will also be displayed to update the CO if the Automated
Impella Controller detects a significant change in the vascular state. This
notification will be triggered if the average NCO or PP diverges from their
initial values by a significant amount.
PURGE CASSETTE PROCEDURES
When replacing the purge cassette or purge fluid, the replacement
process should be completed within 90 seconds of disconnecting the luer.
The Impella Catheter may be damaged if replacement takes longer than
90 seconds of disconnecting the luer.
There are three procedures for maintaining the Impella Catheter purge
system:
• Change cassette and purge fluid bag
• Change purge fluid bag
• De-Air purge system
Each procedure can be accessed using the PURGE MENU soft button. The
purge cassette procedures are discussed below.
CHANGE CASSETTE AND BAG
The Purge Cassette may need to be replaced for extended use of the Impella
system.
Follow these steps to change both the purge cassette and purge fluid:
1.
Press PURGE MENU and select "Change Cassette and Bag" from the
menu.
2.
Select START to begin the cassette and fluid change process.
3.
When prompted by the controller, disconnect the luer from the Impella
catheter.
4.
Open the purge cassette door by pressing the button on the left side
of the console. Remove and discard the old cassette and purge fluid
bag.
5.
Open the new purge cassette. Spike the new purge fluid bag with the
new purge cassette tubing. Select NEXT to continue.
Note on Connecting Purge Tubing to the Catheter:
If included, disconnect the Y-connector and purge extension line from
the purge tubing and discard.
Impella 5.5
®
with SmartAssist
®
Circulatory Support System
6.
Insert the new purge cassette into the controller. Be sure to slide the
purge disc into place and extend the purge tubing through the gap in
the purge cassette door when you close the door.
7.
Confirm the luer is disconnected. Press NEXT to proceed to prime the
purge cassette.
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.
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