Abiomed Impella 5.0 Manual Del Usuario página 11

ZEROING THE DIFFERENTIAL PRESSURE SENSOR WHEN THE
IMPELLA 5.0 ® CATHETER IS RUNNING
The controller software contains a data table listing the expected differential
pressure for a given motor current when the motor speed is set to a specific
value. To zero the differential pressure sensor while the Impella 5.0 Catheter
is running, the software sets the motor speed and measures the motor
current. Using the data table, the software determines what the measured
differential pressure should be, then adjusts the signal from the differential
pressure sensor so that it matches the expected value.
PLACEMENT SIGNAL NOT RELIABLE AND EFFECTS ON FLOW
CALCULATIONS
If the pressure sensor fails, the controller can no longer calculate the flow rate.
The controller displays a "Placement Signal Not Reliable" alarm. The placement
screen displays a table with estimated flows and corresponding MAPs in the
bottom-left corner of the display. The Home screen displays a yellow question
mark over the heart icon and "Placement Monitoring Suspended." To silence
this alarm, go to MENU and select SETTINGS/SERVICE.
PLACEMENT SIGNAL NOT RELIABLE AND EFFECTS ON
POSITION CONTROL
If the pressure sensor fails, placement monitoring is switched off because
it is not possible to display the position of the catheter. In this case, the
motor current signal or imaging procedures can be used for position control.
As long as the motor current signal is pulsatile, the Impella 5.0 Catheter is
correctly positioned across the valve. This signal must be monitored closely
because the catheter can become dislodged (displaced) when moving the
patient or changing the patient's position. Therefore, if patient hemodynamics
change—for example, if arterial pressure falls or there are signs of left
ventricular failure—check the correct positioning of the catheter using
imaging procedures (eg, TEE) and the motor current signal.
SUCTION DETECTION DURING SENSOR DRIFT OR
PLACEMENT SIGNAL NOT RELIABLE
If sensor drift occurs or the pressure sensor fails, the controller can no longer
detect suction. The effectiveness of Impella 5.0 Catheter support can only
be assessed by monitoring patient hemodynamics, cardiac imaging, and the
Impella 5.0 Catheter motor current.
Signs of suction include:
• A drop in the patient's arterial pressure
• Decreased output, if a cardiac monitor is in place
• Dampened or flat motor current waveforms
If imaging reveals that the suction is caused by the catheter inlet area in close
proximity to the intraventricular wall, reposition the catheter. If hemodynamic
parameters, such as low aortic pressure or high pulmonary artery pressure,
indicate suction caused by inadequate filling volume, reduce performance level.
Impella 5.0 ® Circulatory Support System
OPERATING THE IMPELLA 5.0
CATHETER WITHOUT HEPARIN IN THE
PURGE SOLUTION
The Impella 5.0 Catheter is designed to be operated with a purge solution
that contains heparin. Operation of the system without heparin in the
purge solution has not been tested. In the event that a patient is intolerant
to heparin, due to heparin-induced thrombocytopenia (HIT) or bleeding,
physicians should use their clinical judgment to assess the risks versus
benefits of operating the Impella System without heparin.
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If it is in the best interest of the patient to operate the system without
heparin, the dextrose solution is still required, and physicians should consider
systemic delivery of an alternative anticoagulant. DO NOT add any alternative
anticoagulant (such as a direct thrombin inhibitor) to the purge fluid. The
Impella 5.0 Catheter has not been tested with any alternative anticoagulants
in the purge solution.
OPERATING THE IMPELLA 5.0 CATHETER
IN ELECTROMAGNETIC FIELDS
The Impella 5.0 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 5.0 Catheter
motor.
ELECTROANATOMIC MAPPING (EAM) SYSTEMS
Examples of EAM Systems
• CARTO ® 3 System and
• CARTO XP Navigation System (Biosense Webster, Inc.)
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The electromagnetic field emitted by the Impella 5.0 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 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 5.0 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
If you suspect interference, follow the troubleshooting steps below.
Observation Actions
Interference with the 1. Check for and address other sources of interference.
magnetic location
2. Reposition the Impella
detection component
Impella ®
of the EAM system
the mapping catheter; however do NOT pull the inlet
area out of the left ventricle.
3. Ensure that the Impella
P-1–P-5 or P-7, as these P-levels cause the least
interference.
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® Catheter to ensure that the
motor is at least 3 cm from the sensors in
Catheter is operating at
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