Emergency Shutdown Procedure - Abiomed Impella Manuel D'utilisation

MAGNETIC NAVIGATION SYSTEMS (MNS)
Example of MNS
Stereotaxis Niobe Magnetic Navigation System (Stereotaxis)
®
When initiating Impella Catheter support in the presence of a magnetic
navigation system (MNS), follow the steps below:
1.
Insert the Impella Catheter following the steps outlined in section
5 of this manual.
2.
Place the MNS magnets in the "Reduced" or "Stowed" position.
3. Start the Impella Catheter in the manner described in section 5 of
this manual. Increase P-level to P-5.
4. Place the MNS magnets in the "Navigate" position and proceed
with magnetic navigation.
Keep operating the Impella Catheter at a P-level of at least P-5 when the
MNS magnets are in the "Navigate" position. If the P-level falls below P-5,
the Impella Catheter may stop running. To resume operation, follow the
steps in the Troubleshooting When Operating the Impella Catheter in the
Presence of a MNS System table.
During magnetic navigation of the mapping catheter, the motor current
of the Impella Catheter may temporarily increase to the point that the
catheter stops running. The table below explains how to resume operation.
When the MNS magnets are in the "Navigate" position, the displayed
Impella Catheter flow may be artificially elevated. To accurately assess the
flow rate, note the displayed flow when the magnets are in the "Stowed"
position.
Troubleshooting When Operating the Impella Catheter in the
Presence of a MNS System
Observation Actions
Unable to start 1. Place the MNS magnets in the "Reduced" position
Impella and attempt to start the Impella Catheter.
or 2. If the Impella Catheter does NOT start with the
Impella stops magnets in the "Reduced" position, place the
running magnets in the "Stowed" position and start the
Impella Catheter.
3. Increase the Impella Catheter P-level to P-5 or
higher.
4. Place the MNS magnets in the "Navigate" position
and proceed with magnetic navigation.
MNS magnets: The Impella Catheter displayed flow will be artificially
"Navigate" elevated when the MNS magnets are in the "Navigate"
Displayed flow position.
seems too high
or MNS magnets: The displayed flow will be accurate when the MNS
"Stowed" magnets are in the "Stowed" position.
Displayed flow
drops
TRANSFERRING FROM THE AUTOMATED
IMPELLA CONTROLLER (AIC) TO A NEW AIC
TRANSFER STEPS
A backup Automated Impella Controller should be available at all times
when a patient is on support. In the event that the controller fails, follow
the steps below to transition the Impella Catheter to the backup controller.
1.
Confirm that the backup controller is powered on and ready.
2. Press PURGE MENU on the original controller, select Change
Purge Fluid Bag.
3. Press the START soft button to initiate the bolus. Note: the
console will read "Please wait" while system completes the bolus.
Do NOT change and spike purge fluid bag prior to next step.
30
4.
Disconnect the yellow luer connector from the Impella Catheter to
release the pressure in the purge cassette.
5.
Transfer the purge cassette and purge solution from the original
controller to the backup controller.
6.
Reconnect the yellow luer connector to the Impella Catheter.
7.
Remove the white connector cable from the original controller
and plug it into the catheter plug on the front of the backup
controller.
8. Once the Impella Catheter is connected to the backup controller,
wait for a message to appear on the screen asking you to confirm
re-starting the Impella Catheter at the previously set P-level.
9. Press OK within 10 seconds to confirm restarting the Impella
Catheter at the previously set P-level.
10. If the message to restart the Impella Catheter does not appear
within 30 seconds, restart the Impella Catheter using the FLOW
CONTROL soft button.
Note: Impella CP with SmartAssist and Impella 5.5 with
SmartAssist Catheters will run on a non-Optical AIC.
Sensor functionality will not work in this case.
CHANGE PURGE FLUID TO OBTAIN ACCURATE PURGE
VALUES
To get accurate purge values after changing to a backup controller,
perform the Change Purge Fluid bag procedure and replace the purge fluid
bag. Go to > MENU , select > Change Purge Fluid, and follow the
instructions given on-screen.
PATIENT MANAGEMENT CHECKLIST
FOLLOWING TRANSFER OF SUPPORT
After transferring patient support to or from the Automated Impella
Controller, perform each of the following patient management checklist
items:
1.
Confirm Impella Catheter placement using echocardiography.
2. Tighten the Tuohy-Borst valve (tighten all the way to the right) on
the Impella Catheter to prevent catheter migration.
3. For the Impella 2.5 and Impella CP Catheters, attach a saline
pressure bag pressurized to 300-350 mmHg to the red sidearm
and complete the "Transfer to Standard Configuration" procedure
under the PURGE MENU option if not already completed.

EMERGENCY SHUTDOWN PROCEDURE

In the unlikely event that the Automated Impella Controller software stops
responding, follow the procedure below to restart the controller.
1. Press and hold the power switch for 30 seconds.
2.
An "Emergency Shutdown Imminent" alarm will sound at 15
seconds.
3.
The controller will shut down after 30 seconds.
4. Restart the controller.
User Manual