Modes Of Operation - Abiomed Automated Impella Controller Manual Del Usuario

POSITIONING AND STARTING THE
IMPELLA CATHETER
When the Impella Catheter is not correctly placed, there is no effective
unloading of the ventricle. The patient may not be benefiting from the flow
rate shown on the controller.
1. Reconfirm that the placement guidewire has been removed. Also
reconfirm that the controller displays an aortic waveform and the
radiopaque marker band is located at the aortic valve.
2. Press the START IMPELLA soft button. Press the YES soft button
to confirm after wire is removed. The Impella will start in AUTO and
automatically increase the flow rate over 30 seconds.
3. Once the controller has begun to run in AUTO, pressing the FLOW
CONTROL soft button again opens the FLOW CONTROL menu
with options for AUTO, and P-levels ranging from P-0 to P-9.
4.
Wait 30 seconds for flow to reach its maximum value, then confirm
correct and stable placement. Evaluate the catheter position in
the aortic arch and remove any excess slack. The catheter should
align against the lesser curvature of the aorta rather than the
greater curvature. Verify placement with fluoroscopy and with the
placement screen.
5. Reposition the catheter as necessary under fluoroscopy.

MODES OF OPERATION

AUTO
In AUTO, the Automated Impella Controller sets the motor speed of
the Impella Catheter to achieve the maximum possible flow without
causing suction. During AUTO, the highest the p-level the Impella CP
with SmartAssist can run is P-9. After 3 hours of operation, the controller
automatically switches to P-level mode. Upon transfer from AUTO mode
to P-level mode, the controller displays the message shown below and the
AUTO setting is no longer an option.
Figure 1.13 Transfer to P-level Mode
P-LEVEL
In P-LEVEL mode you can select one of ten P-levels (P-0 to P-9) for the
Impella Catheter (see Table below). Select the lowest P-level (P-2 or higher)
that will enable you to achieve the flow rate necessary for patient support.
At P-0, the Impella Catheter motor is stopped. If the Impella Catheter
minimum flow is below 0.1 L/min then the controller will increase the
motor speed to prevent retrograde flow.
Impella CP with SmartAssist
® ®
Table 1.1 P-level Flow Rates for the Impella CP with SmartAssist Catheter
*Flow Rate
P-level (L/min) Revolutions Per Minute (rpm)
P-0 0.0
P-1 0.0 - 0.9
P-2 1.1 - 2.1
P-3 1.6 - 2.3
P-4 2.0 - 2.5
P-5 2.3 - 2.7
P-6 2.5 - 2.9
P-7 2.9 - 3.3
P-8 3.1 - 3.4
P-9** 3.3 - 3.7
*Flow rate can vary due to suction or incorrect positioning.
** The peak flow rate at systole is up to 4.3 L/min at P-9
To operate the Impella Catheter in P-level mode:
1. Press the FLOW CONTROL soft button to open the FLOW
CONTROL menu.
2.
Turn the selector knob to increase or decrease the flow rate.
3.
Press the selector knob to select the new flow rate.
Figure 1.14 Adjusting P-level
ADJUSTING THE LV PLACEMENT SIGNAL
CAUTIONS
The LV placement signal and LV estimates are not displayed when
pumps are running at P-3 or lower. Increase pump speed to P-4 or
higher to re-enable signal
Alarm conditions and low pump speeds may affect the LV placement
signal and estimates
Disruption of the outlet pressure placement signal, including alarms
related to the Ao placement signal, will prevent calculation and display
of an LV estimate. An operational Ao placement signal is required for
the LV estimate
LV placement signal calibration is not available if the P-level is less
than P-4 or if Suction, Placement Signal Not Reliable, or positioning
alarms are active
Abnormal conditions, including cardiac arrhythmia, Ao-LV uncoupling,
or aortic stenosis may limit the utility of the LV adjustment tool
0
23,000
31,000
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46,000
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