Abiomed Automated Impella Controller Manual De Usuario página 35

The electromagnetic field emitted by the Impella Catheter may produce
interference with the magnetic location detection component of the
electroanatomic mapping (EAM) system, particularly when the mapping
catheter is close to the Impella Catheter motor. For example, mapping in
the right or left ventricular outflow tracts places the mapping catheter in
close proximity to the Impella Catheter motor in the ascending aorta.
Electromagnetic interference may appear as:
• Instability in the displayed location of the mapping catheter
• Magnetic interference errors generated by the electroanatomic
mapping system
When operating the Impella Catheter in the presence of an EAM system,
use P-level mode. Operate the Impella Catheter at P-1–P-5 or P-7.
The motor speeds at these P-levels cause the least interference. Best
performance is observed when the Impella Catheter motor is at least 3
cm from the sensors in the mapping catheter. If you suspect interference,
follow the troubleshooting steps in Table 7.
Table 7. Troubleshooting When Operating the Impella Catheter
in the Presence of an EAM System
Observation Actions
Interference with the 1. Check for and address other sources of
magnetic location interference.
detection component of 2. Reposition the Impella Catheter to ensure that
the EAM system the Impella motor is at least 3 cm from the
sensors in the mapping catheter; however do
NOT pull the inlet area out of the left ventricle.
3. Ensure that the Impella Catheter is operating
at P-1–P-5 or P-7, as these P-levels cause the
least interference.
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 Table 8.
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. Table 8 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.
Automated Impella Controller with SmartAssist
Table 8. 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
or 2. If the Impella Catheter does NOT start with the
Impella stops
running
3. Increase the Impella Catheter P-level to P-5 or
4. Place the MNS magnets in the "Navigate" position
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.
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-SmartAssist AIC with
software version 7.0 or higher. 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.
®
and attempt to start the Impella Catheter.
magnets in the "Reduced" position, place the
magnets in the "Stowed" position and start the
Impella Catheter.
higher.
and proceed with magnetic navigation.
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