Mobile Operation - Abiomed Impella Manuel D'utilisation

PLACEMENT SCREEN
The placement screen displays real-time operating data for the system.
The screen displays the placement signal and motor current waveforms
as well as the maximum/minimum and average values for each waveform
in the central display area of the screen. Use the DISPLAY soft button to
navigate to the placement screen.
Placement Signal Waveforms
The placement signal waveform displays a pressure measurement that is
useful for determining the location of the open pressure area (Impella 2.5
and Impella CP ) or differential pressure sensor (Impella 5.0
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LD ® ) of the catheter with respect to the aortic valve. The placement
signal is used to verify whether the Impella Catheter is in the aorta or in
the ventricle by evaluating the current pressure waveform as an aortic or
ventricular waveform (Impella 2.5
differential pressure as pulsatile or flattened (Impella 5.0
LD ). The scale for the placement signal waveform is displayed to the left
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of the waveform. The default scaling is 0–160 mmHg (Impella 2.5, Impella
CP) or -20–60 mmHg (Impella 5.0 and Impella LD). For Impella 2.5 and
Impella CP, it can be adjusted in 20 mmHg increments, with a minimum
upper limit of 100 mmHg and a maximum upper limit of 240 mmHg. For
Impella 5.0 and Impella LD, the maximum display range is -60–100 mmHg.
To the right of the waveforms is a display that labels the waveform,
provides the units of measurement, and shows the maximum and
minimum values and the average value from the samples received. At the
bottom of that window is the time scale, which you can set by pressing the
DISPLAY soft button.
Motor Current Waveform
Motor current is a measure of the energy intake of the Impella Catheter
motor. The energy intake varies with motor speed and the pressure
difference between the inlet and outlet areas of the cannula. Motor current
provides information about the catheter position relative to the aortic
valve. When the Impella Catheter is positioned correctly, with the inlet
area in the ventricle and the outlet area in the aorta, the motor current
is pulsatile because the pressure difference between the inlet and outlet
areas changes with the cardiac cycle. When the inlet and outlet areas are
on the same side of the aortic valve, the motor current will be dampened
or flat because there is little or no pressure difference between the inlet
and outlet areas.
The scale for the motor current waveform is displayed to the left of the
waveform. The default scaling is 0–1000 mA. It is adjustable in 100 mA
increments for the Impella Catheter, with a minimum difference between
upper and lower limits of 200 mA and a maximum difference of 1000 mA.
To the right of the waveform is a display that labels the waveform, provides
the units of measurement, and shows the maximum and minimum values
and the average value from the samples received. You can set the time
scale at the bottom of that window by pressing the DISPLAY soft button.
8
and Impella
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, Impella CP ) or by evaluating the
® ®
® and Impella
PURGE SCREEN
The purge screen displays purge system data. In the central display area
of the screen, the purge flow rate and purge pressure are plotted as a
function of time. To the right of the plots, the current purge flow rate and
purge pressure are displayed. Use the DISPLAY soft button to navigate to
the purge screen.
Purge Flow
The purge flow rate delivered by the purge cassette is displayed in mL/hr.
The standard scale for the purge flow (0–30 mL/hr) is displayed to the left
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of the purge flow plot. The maximum value on this scale can be adjusted
from 20 mL/hr to 200 mL/hr in increments of 10 mL/hr.
To the right of the plot is a display that labels the plot and shows the
most recent value update. You can set the time scale at the bottom of the
window by pressing the DISPLAY soft button.
A purge flow change notification can be enabled to indicate when the
purge flow rate increases or decreases by 2.5 mL/h. The message is
intended to aid patient management by alerting the clinician to changes
in the rates of dextrose and heparin infusion through the purge fluid. The
alarm clears when you press the MUTE ALARM button. This alarm is
disabled by default. To enable this alarm, press MENU, select Settings/
Service, and select Enable Purge Flow Change Notification.
Purge Pressure
The Automated Impella Controller regulates purge pressure, the pressure
of the purge fluid delivered through the catheter to the motor. The purge
pressure generated by the purge cassette is displayed in mmHg. The
standard scale for the purge pressure (0–1500 mmHg) is displayed to the
left of the purge pressure plot. The maximum value on this scale can be
adjusted from 100 mmHg to 2000 mmHg in increments of 100 mmHg. The
purge pressure in the system is set to an ideal pressure between 300-1100
mmHg and the purge flows are between 2-30 mL/hr. An alarm appears if
purge pressure falls below 300 mmHg or exceeds 1100 mmHg.
To the right of the plot is a display that labels the plot and shows the
most recent value update. You can set the time scale at the bottom of the
window by pressing the DISPLAY soft button.
INFUSION HISTORY SCREEN
The infusion history screen displays the infusion volume as well as the
amount of heparin and dextrose infused each hour. The current time
period is displayed at the top of the list. Use the DISPLAY soft button to
navigate to the infusion history screen.

MOBILE OPERATION

The Li-Ion batteries must be charged for 5 hours prior to
system operation in order to meet the runtime requirement
of 1 hour. Failure to do so will yield a shorter runtime. After
being unplugged, the Automated Impella Controller will
operate for at least 60 minutes after the batteries have been
fully charged.
The Automated Impella Controller (AIC) can be operated on internal
battery power when it is not connected to AC power.
1.
Disconnect the AIC from AC power.
2.
The controller beeps once every 5 minutes to alert you that it
is running on battery power and a white advisory notification
appears in the alarms area on the screen. The AC power icon
displays a red X through it.
3.
When the controller is connected back to AC power, the white
advisory notification turns gray and the battery power icon turns
green.
User Manual