Abiomed Automated Impella Controller Manual Del Usuario página 11

CARDIAC OUTPUT, NATIVE CARDIAC OUTPUT & CARDIAC
POWER OUTPUT CALCULATIONS
Once a cardiac output is entered, the Automated Impella Controller can
calculate an initial cardiac power output and native cardiac output using
the following equations:
CPO = (CO x MAP) / 451
NCO = CO - Impella Flow
The Native Cardiac Output estimate is derived from a relationship between
native function and aortic pulse pressure (PP). This relationship is linear
and scaled by a calibration factor, ß which may vary between patients
and as an individual patient's condition changes. This relationships can be
shown by the following equation:
NCO= ß x PP
Once the calibration factor is obtained, the Automated Impella Controller
will continue to calculate the cardiac output, native cardiac output, and
cardiac power output for the next 8 hours using the above equations.
If cardiac power output values are below or equal to 0.6, the value will
display as yellow.
Note: Do not use values as a clinical diagnostic tool, this is for
informational purposes only.
CARDIAC OUTPUT ENTRY REMINDERS
A white reminder to enter the CO will appear every 15 minutes for the last
hour prior to the 8 hour timeout. If a new CO is not entered after 8 hours,
the values will show as dash marks until a new cardiac output is entered.
A white reminder will also be displayed to update the CO if the Automated
Impella Controller detects a significant change in the vascular state. This
notification will be triggered if the average NCO or PP diverges from their
initial values by a significant amount.
USE OF THE REPOSITIONING SHEATH
AND THE PEEL-AWAY INTRODUCER
1. Slide the repositioning sheath back to the red Impella plug.
Note: For the 14 Fr x 25cm peel-away introducer, it may be
necessary to pull the introducer over the repositioning sheath
to remove the peel-away completely from the artery
2. Remove the peel-away introducer completely from
the artery over the catheter shaft to prevent trauma and
significant bleeding and apply manual pressure above the puncture
site.
3.
Grasp the two "wings" and bend back until the valve
assembly comes apart. Continue to peel the two wings until
the introducer is completely separated from the catheter shaft.
4.
Slide the repositioning sheath over the catheter shaft and advance
it into the artery to the blue suture pads.
5. Secure the repositioning unit to the patient with the blue
suture pads or a StatLock
®
6.
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 signal.
7.
Attach the anticontamination sleeve to the blue section of the
repositioning sheath. Lock the anchoring ring in place by
turning it clockwise. Secure the catheter shaft in place by tightening
the connected anchoring ring.
8.
Carefully extend the anticontamination sleeve to maximum length
and secure the end closest to the red Impella plug by tightening the
anchoring ring.
Impella CP with SmartAssist
®
stabilization device.
®
PATIENT WEANING
Weaning the patient from the Impella Catheter is at the discretion of the
physician. The LVEDP/CO Trend can be used while weaning. Refer to the
Automated Impella Controller Instructions for Use document for more
information.
The following weaning instructions are provided as guidance
only.
1. To initiate weaning, press FLOW CONTROL and reduce P-level by
2 level increments over time intervals as cardiac function allows.
2. Keep Impella Catheter P-level at P-2 or above until the catheter is
ready to be explanted from the left ventricle.
3.
When the patient's hemodynamics are stable, reduce the P-level to
P-2 and pull the Impella Catheter back across the aortic valve into the
aorta.
4. If the patient's hemodynamics remain stable, follow instructions in
the next section for removing the Impella Catheter.
REMOVING THE IMPELLA 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.
Removal of the Impella Catheter must be completed with care to avoid
damage to the catheter assembly. Do NOT attempt to remove the Impella
Catheter through the repositioning sheath. The Impella Catheter will not
pass through the repositioning sheath.
REMOVING THE IMPELLA CATHETER WITH THE
INTRODUCER IN PLACE
1. Reduce the P-level to P-0.
2.
Remove the Impella Catheter through the introducer.
3. Wait until ACT drops below 150 seconds.
4.
When ACT is below 150 seconds, remove the introducer.
5. Disconnect the connector cable from the Automated Impella
Controller and turn the controller off by pressing the power switch
on the side of the controller for 3 seconds.
6.
Apply manual compression for 40 minutes or per hospital
protocol.
REMOVING THE IMPELLA CATHETER SECURED WITH THE
REPOSITIONING SHEATH
1. When ACT is below 150 seconds, press FLOW CONTROL and
reduce the P-level to P-0.
2.
Remove the Impella Catheter and repositioning sheath together (the
catheter will not come through the repositioning sheath).
3. Disconnect the connector cable from the Automated Impella
Controller and turn the controller off by pressing the power switch
on the side of the controller for 3 seconds.
4.
Apply manual compression for 40 minutes or per hospital
protocol.
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