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.
DE-AIR PURGE SYSTEM
Perform the following steps to de-air the purge system:
1.
Press PURGE MENU and select "De-Air Purge System."
Note on De-Air Procedure:
You may run the de-air procedure after changing the dextrose
concentration to decrease the amount of time it takes for a change
to occur.
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.
Automated Impella Controller
TROUBLESHOOTING THE PURGE SYSTEM
PURGE PRESSURE LOW
Note on Purge Pressure
The optimal purge pressure is different for every Impella Catheter.
Purge pressure can range from 300 mmHg to 1100 mmHg. While
purge pressure varies during operation, the Automated Impella
Controller automatically maintains purge pressure within an
acceptable range for each Impella Catheter.
Perform the following steps to troubleshoot the Purge Systems
1.
Inspect the purge system for leaks.
2.
If there are no leaks, change to a purge fluid with a higher dextrose
concentration. To do this, open the PURGE MENU and select
"Change Purge Fluid Bag." Follow the instructions on the screen.
(Refer to "Purge Cassette Procedures" earlier in this section of the
manual.)
3.
If the pressure stabilizes, no other action is required.
If the purge pressure is not stable, proceed to Step 4.
4.
If the low purge pressure alarm remains unresolved for more than
20 minutes, there may be a problem with the purge cassette.
Replace the purge cassette. (Refer to the "Change Cassette &
Bag" instructions, earlier in this section.)
PURGE PRESSURE HIGH AND PURGE SYSTEM BLOCKED
If the purge pressure exceeds 1100 mmHg, the Automated Impella
Controller displays the "Purge Pressure High" alarm. If the purge flow stops
completely, the controller displays the "Purge System Blocked" alarm.
For either event, follow these steps:
1.
Inspect the purge system and check the Impella Catheter for kinks
in the tubing.
2.
Check the glucose concentration of the purge fluid. Decrease the
concentration to 5% if current concentration is higher
3.
Replace the purge cassette using the Change Cassette and Bag
procedure shown earlier in this section.
4.
Monitor Motor Current.
Note on Unresolved Purge Pressure High Alarm:
If not resolved by the recommendations provided, high purge
pressure—which triggers the "Purge Pressure High" alarm
message—could be an indication of a kink in the Impella
Catheter. In this case, the motor is no longer being purged and
may eventually stop. Clinicians should monitor motor current and
consider replacing the Impella Catheter whenever a rise in motor
current is seen.
PURGE SYSTEM OPEN
Note on Purge System Open Alarm
This alarm may occur if purge pressure is less than
100 mmHg for 20 seconds or longer.
Perform the following steps to check the Purge System:
1.
Inspect the purge system for leaks.
2.
If no leaks are visible, there may be a problem with the purge
cassette. Replace the purge cassette. (Refer to the "Change
Cassette & Bag" instructions, earlier in this section).
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