11
Impella 5.5
®
with SmartAssist
®
Circulatory Support System
A Cardiac Output Confirmation will be displayed if a total Cardiac Output is
entered that is less than or equal to the current Impella Flow. The
CONFIRM
soft button will use the current Impella Flow as the total Cardiac Output entry
and the Native Cardiac Output will not be trended. The
BACK
soft button
will go back to the Enter Cardiac Output screen. The
CANCEL
soft button
will exit the workflow.
CARDIAC OUTPUT, NATIVE CARDIAC OUTPUT & CARDIAC
POWER OUTPUT CALCULATIONS
Once a cardiac output is entered, the Automated Impella Controller can
calculate an initial cardiac power output and native cardiac output using the
following equations:
CPO = (CO x MAP) / 451
NCO = CO - Impella Flow
The Native Cardiac Output estimate is derived from a relationship between
native function and aortic pulse pressure (PP). This relationship is linear and
scaled by a calibration factor, ß which may vary between patients and as an
individual patient’s condition changes. This relationships can be shown by the
following equation:
NCO= ß x PP
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.
Note on Connecting Purge Tubing to the Catheter:
If included, remove and discard the Y-connector and connect the
yellow luer on the purge tubing directly to the yellow check valve on
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.
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.
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