Abiomed Impella 2.5, Instructions For Use Manual

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5.48 Instructions for Use & Clinical Reference Manual (US)
TROUBLESHOOTING THE PURGE SYSTEM
LOW PURGE PRESSURE
If at any time during the course of support with the Impella
®
Catheter, the
Automated Impella
®
Controller alarms “Purge Pressure Low,” follow the
instructions below.
1.
Inspect the purge system for leaks.
2.
If there are no leaks, change to a purge fluid with a higher dextrose concentration. To
do this, open the
PURGE SYSTEM
menu and select “Change Purge Fluid.” Follow the
instructions on the screen. (Refer to “Purge Cassette Procedures” earlier in this section
of the manual.)
3.
If the pressure stabilizes, no other action is required.
If the purge pressure is not stable, proceed to Step 4.
4. If the low purge pressure alarm remains unresolved for more than 20 minutes, there
may be a problem with the purge cassette. Replace the purge cassette. (Refer to
“Change Purge Cassette” instructions earlier in this section.)
5.
If the low purge pressure alarm still remains unresolved for more than 20 minutes, this
may be a sign of Impella
®
Catheter damage. Complete the following steps immediately:
a.
Open the
FLOW CONTROL
meter and reduce the P-level to P-2.
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.
PURGE SYSTEM OPEN
If at any time during the course of support with the Impella
®
Catheter, the
Automated Impella ® Controller alarms “Purge System Open,” follow the
instructions below.
1.
Inspect the purge system for leaks.
2.
If no leaks are visible, there may be a problem with the purge cassette. Replace the
purge cassette. (Refer to instructions earlier in this section of the manual.)
3. If the Purge System Open alarm remains unresolved, this may be a sign of Impella
®
Catheter damage. Complete the following steps immediately:
a.
Open the FLOW CONTROL meter and reduce the P-level to P-2.
Purge Pressure
In the initial set-up
configuration, the purge
pressure is set to 600 mmHg,
although it may not
reach 600 mmHg in low
resistance catheters in this
configuration.
In the standard configuration,
optimal purge pressure is
different for every Impella
®
Catheter. Purge pressure
can range from 300 mmHg
to 1100 mmHg. While
purge pressure varies during
operation, the Automated
Impella
®
Controller
automatically maintains purge
pressure within an acceptable
range for each Impella
®
Catheter.
Purge System Open
Alarm
This alarm may occur if
purge pressure is less than
100 mmHg.