Abiomed Impella 5.0 Gebrauchsanweisung Seite 16

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If you observe that the placement waveform has shifted up or down on the display, or the expected flow does not
match the current P-level setting, zero the differential pressure sensor by performing the following steps:
1. Press the MENU key and select "Start Manual Zero."
2. Press OK to adjust flow level.
3.
The controller displays "Wait until new flow level is reached." and then "Offset calculation is in
progress."
4.
Select OK to accept the new setting when the controller displays the "Placement Signal Offset Adjust
finished" message.
5.
The Impella ® will automatically be reset to the previous P-level.
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 triangle
with "Flow Calculation Disabled." The screen displays a yellow question mark over the heart icon and "Placement
Monitoring Suspended."
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
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
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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 and follow the management
strategies.
OPERATING THE IMPELLA
HEPARIN IN THE PURGE SOLUTION
The Impella 5.0 Catheter is designed to be operated with a purge solution that contains heparin. Operation of
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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
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
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
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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 is correctly positioned across the valve. This signal
5.0 CATHETER WITHOUT
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® System without heparin.
® 5.0 Catheter has not been tested
5.0 Catheter motor.
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User Manual