Abiomed Impella 5.0 Manual Del Usuario página 17

ELECTROANATOMIC MAPPING (EAM) SYSTEMS
The electromagnetic field emitted by the Impella
detection component of the electroanatomic mapping (EAM) system, particularly when the mapping catheter is
close to the Impella ® 5.0 Catheter motor. For example, mapping in the right or left ventricular outflow tracts places
the mapping catheter in close proximity to the Impella
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 below.
Observation
Interference with the magnetic
location detection component of
the EAM system
MAGNETIC NAVIGATION SYSTEMS (MNS)
When initiating Impella 5.0 Catheter support in the presence of a magnetic navigation system (MNS), follow the
®
steps below:
1. Insert the Impella 5.0 Catheter following the steps outlined in section INSERTING THE IMPELLA 5.0
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CATHETER above.
2. Place the MNS magnets in the "Reduced" or "Stowed" position.
3.
Start the Impella ® 5.0 Catheter in the manner described above. Increase performance level to at least
P-5.
4.
Place the MNS magnets in the "Navigate" position and proceed with magnetic navigation.
Keep operating the Impella 5.0 Catheter at a performance level of at least P-3 when the MNS magnets are in
®
the "Navigate" position. If the performance level falls below P-3, the Impella
resume operation, follow the steps in the table below.
During magnetic navigation of the mapping catheter, the motor current of the Impella
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
elevated. To accurately assess the flow rate, note the displayed flow when the magnets are in the "Stowed"
position.
Observation
Unable to start Impella ® 5.0
or
Impella ® 5.0 stops running
MNS magnets: "Navigate"
Displayed flow seems too high
or
MNS magnets: "Stowed"
Displayed flow drops
Impella ® 5.0 Circulatory Support System
® 5.0 Catheter may produce interference with the magnetic location
5.0 Catheter motor in the ascending aorta.
®
Actions
1. Check for and address other sources of interference.
2. Reposition the Impella Catheter to ensure that the Impella
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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.
Actions
1. Place the MNS magnets in the "Reduced" position and attempt to start
the Impella ® 5.0 Catheter.
2. If the Impella 5.0 Catheter does NOT start with the magnets in the
®
"Reduced" position, place the magnets in the "Stowed" position and
start the Impella 5.0 Catheter.
®
3. Increase the Impella ® 5.0 Catheter performance level to P-3 or higher.
4. Place the MNS magnets in the "Navigate" position and proceed with
magnetic navigation.
The Impella 5.0 Catheter displayed flow will be artificially elevated when the
®
MNS magnets are in the "Navigate" position.
The displayed flow will be accurate when the MNS magnets are in the
"Stowed" position.
motor is at least
®
® 5.0 Catheter may stop running. To
5.0 Catheter may
®
5.0 Catheter flow may be artificially
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Examples of EAM Systems
CARTO ® 3 System and
CARTO ® XP Navigation System
(Biosense Webster, Inc.)
®
Example of MNS
Stereotaxis Niobe ® Magnetic
Navigation System (Stereotaxis)
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