Abiomed Impella 2.5, Instructions For Use Manual

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5.49 Impella
®
System for Use During Cardiogenic Shock
b. Slowly pull back on the Impella
®
Catheter until it is in the descending aorta
(approximately 20 cm for an average size patient; 1 cm marks are available
on the catheter).
c.
Turn off the Impella
®
Catheter by opening the FLOW CONTROL meter and
reducing the P-level to P-0.
d.
Disconnect the catheter from the Automated Impella
®
Controller.
e.
Remove the Impella ® Catheter with the use of fluoroscopic imaging. If no
fluoroscopy is available, leave the catheter in the descending aorta until fluoroscopy
is available for visual assistance during removal of the Impella
® Catheter.
HIGH PURGE PRESSURE
If the purge pressure exceeds 1100 mmHg, the Automated Impella
®
Controller displays the
“Purge Flow Low” alarm message.
1.
Inspect the purge system and check the Impella
®
Catheter for kinks in the tubing.
2.
If pressure remains high, decrease the concentration of dextrose in the purge solution
(eg, change from 20% dextrose to 10% dextrose).
PURGE SYSTEM BLOCKED
If a “Purge System Blocked” alarm occurs, the purge fluid flow stops.
1.
Check the purge system tubing and the Impella
®
Catheter for kinks or blockages.
2.
Decrease the concentration of dextrose in the purge solution.
3. Replace the purge cassette.
PATIENT WEANING
Weaning the patient from the Impella
®
Catheter is at the discretion of the physician. The Impella
2.5 and CP Systems have been approved for ≤ 4 days and the Impella 5.0 and LD Systems have
been approved for ≤ 6 days of use. However, weaning could be delayed beyond the normal use
for temporary support as an unintended consequence of continued instability of the patient’s
hemodynamics. Inability to wean the patient from the device within a reasonable time frame
should result in consideration of a more durable form of left ventricular support.
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.
De-air Procedure
You may run the de-air
procedure (described earlier
in this section) after changing
the dextrose concentration to
decrease the amount of time
it takes for a change to occur.
Unresolved High Purge
Pressure
/
Purge Flow
Low Alarm
If not resolved by the
recommendations provided,
high purge pressure—which
triggers the “Purge Flow
Low” alarm message—could
be an indication of a kink
in the Impella
® Catheter. In
this case, the motor is no
longer being purged and may
eventually stop. Clinicians
should monitor motor current
and consider replacing the
Impella
® Catheter whenever a
rise in motor current is seen.
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