Abiomed Impella 5.5 Manuel Utilisateur page 18

REMOVING THE IMPELLA 5.5
SMARTASSIST CATHETER
®
The Impella Catheter can be removed after weaning when the introducer is
still in place or when the catheter is secured with the repositioning sheath.
REMOVING THE IMPELLA CATHETER WITH THE INTRODUCER
IN PLACE
1.
Remove the Impella Catheter through the introducer.
2. Wait until ACT drops below 150 seconds.
3.
When ACT is below 150 seconds, remove the introducer.
REMOVING THE IMPELLA CATHETER SECURED WITH THE
REPOSITIONING UNIT
1.
When ACT is below 150 seconds, remove the Impella Catheter and
repositioning unit together (the catheter will not come through the
repositioning unit).
VASCULAR GRAFT CLOSURE
When closing the vascular graft, consider individual patient characteristics
and select the strategy most consistent with an optimal clinical result. The
entire vascular graft can be removed if indicated, but it is not mandatory to
do so. Graft closure options include:
• Amputating the vascular graft and sewing the small end-to-side
remnant closed by hand
• Using a vascular stapler to close the graft near the surface of the
aorta
• Removing the complete graft with local patch closure, if necessary
OPERATING THE IMPELLA 5.5 WITH
SMARTASSIST CATHETER WITHOUT
HEPARIN IN THE PURGE SOLUTION
The Impella Catheter is designed to be operated with a purge solution that
contains heparin or sodium hydrogen carbonate to maintain the patency of
the Impella catheter's purge system.
The Impella Catheter has not been tested with any alternative anticoagulants,
such as direct thrombin inhibitors, in the purge solution. Use of alternative
anticoagulants may reduce the longevity or performance of the Impella
catheter.
OPERATING THE IMPELLA 5.5
WITH SMARTASSIST CATHETER IN
ELECTROMAGNETIC FIELDS
The Impella Catheter contains a permanent magnet motor that emits an
electromagnetic field. This field may produce electromagnetic interference
with other equipment. In addition, other equipment that emits a strong
electromagnetic field may affect the operation of the Impella Catheter motor.
ELECTROANATOMIC MAPPING (EAM) SYSTEMS
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.
14
WITH
®
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
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 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 this manual.
2. Place the MNS magnets in the "Reduced" or "Stowed" position.
3.
Start the Impella Catheter in the manner described in this manual.
Increase P-level to at least 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 below.
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.
Observation
Unable to start
Impella
or
Impella stops
running
MNS magnets:
"Navigate"
Displayed flow
seems too high
or
MNS magnets:
"Stowed"
Displayed flow
drops
Catheter in the presence of an EAM system, use
®
Actions
1. Check for and address other sources of interference.
2. Reposition the Impella Catheter to ensure that 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.
Actions
1. Place the MNS magnets in the "Reduced" position and
attempt to start the Impella Catheter.
2. If the Impella Catheter does NOT start with the magnets
in the "Reduced" position, place the 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.
The Impella 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.
User Manual