Abiomed Impella LD Gebrauchsanweisung Seite 10

7. Confirm the luer is disconnected. Press NEXT to proceed to prime the
purge cassette. Once the priming is complete, you are prompted to
connect the purge tubing to the Impella LD
8.
Update the purge fluid information.
a. To select the default purge fluid values displayed on the
screen, select CONFIRM.
b. To change the purge fluid information, select EDIT. Then use
the soft keys to navigate selections and edit values. Select
DONE to complete editing.
9.
When Steps 1 through 8 are complete, connect the luer from the new
purge cassette to the Impella catheter.
CHANGE PURGE FLUID BAG
Note on Purge Solution Bottles: If the purge solution is supplied in
bottles, open the vent on the purge fluid spike and follow the same procedure
as if supplied in bags.
Perform the following steps to change only the purge fluid.
1. Press PURGE MENU and select "Change Purge Fluid Bag."
2. Select START to begin the purge fluid change process.
3.
When prompted by the controller, remove the old purge bag and
replace by spiking the new purge fluid bag. Select NEXT to advance
to the next step.
4. Update the purge fluid information.
a. To select the default purge fluid values displayed on the
screen, select CONFIRM.
b. To change the purge fluid information, select EDIT. Then use
the soft keys to navigate selections and edit values. Select
DONE to complete editing.
5.
When prompted by the controller, disconnect the luer from the Impella
Catheter. The controller will automatically prime the tubing, which will
flush the fluid from the last bag out of the purge cassette tubing.
a. To skip the flush, select SKIP PRIME.
Note: The instructions to disconnect the luer and to automatically
prime the tubing only occurs if the user changed the purge fluid
dextrose or heparin concentrations.
6. When prompted by the controller, connect the yellow luer from the
purge cassette to the Impella catheter.
Note on Priming Purge Cassette and Disconnecting Luers:
The system only prompts you to remove luers to prime and flush tubing
if the heparin or dextrose concentrations were changed or air was
detected. You can only select SKIP PRIME if no air was detected.
PATIENT WEANING
Weaning the patient from the Impella LD Catheter is at the discretion of the
physician. 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.
The following weaning protocols are provided as guidance only.
RAPID WEANING
1.
Initiate rapid weaning by decreasing catheter P-level in 2-level steps at
intervals of several minutes (for example, P-6 to P-4 to P-2). Do NOT
decrease P-level to below P-2 until just before removing the catheter
from the ventricle.
2. When the P-level has been reduced to P-2, maintain the patient on
P-2 support for at least 10 minutes before discontinuing circulatory
support.
3.
If the patient's hemodynamics remain stable, follow the instructions in
the next section for removing the Impella LD catheter.
8
SLOW WEANING
1.
Catheter.
®
2.
3.
REMOVING THE IMPELLA LD
PREPARATION FOR REMOVAL
1.
2.
3.
4.
5.
6.
PULLING THE IMPELLA LD CATHETER INTO THE ASCENDING
AORTA
Perform the following steps under the guidance of transesophageal
echocardiography (TEE).
1.
2.
3.
4.
5.
VASCULAR GRAFT CLOSURE
When closing the vascular graft, consider individual patient characteristics
and select the strategy most consistent with an optimal clinical result. The
entire vascular graft can be removed if indicated, but it is not mandatory to
do so. Graft closure options include:
Initiate slow weaning by decreasing catheter P-level in 2-level steps
over time as cardiac function allows (for example, P-6 to P-4 to P-2).
Do NOT decrease P-level to below P-2 until just before removing the
catheter from the ventricle.
When the P-level has been reduced to P-2, maintain the patient on
P-2 support until the patient's hemodynamics remain stable before
discontinuing circulatory support.
If the patient's hemodynamics remain stable, follow the instructions in
the next section for removing the Impella LD catheter.
Gain exposure and clear access to the ascending aorta insertion site,
the Dacron ® vascular graft, and the sites at which the silicone plugs
are secured to the graft.
Complete weaning procedure at P-level P-2 as described previously.
Undo the penetrating suture from the front silicone plug and remove
the suture entirely.
Remove the ligature from the rear silicone plug and remove the plug
from the end of the vascular graft.
Maintaining distal control digitally, remove the final circumferential
ligature from the front silicone plug.
Allow controlled bleed-back through the graft to clear any residual
thrombus from the lumen of the graft.
Immediately prior to pulling the Impella LD Catheter across the aortic
valve, reduce the P-level to P-1.
Carefully pull the Impella LD Catheter back through the aortic valve
and into the ascending aorta. Depending on the level of the insertion
site, a portion of the catheter may be pulled through the aortotomy
and into the vascular graft.
Immediately reduce the P-level to P-0 after the Impella LD Catheter
crosses the aortic valve and enters the ascending aorta. The Impella
LD Catheter should only be removed when the P-level is set to P-0.
Gently pull the Impella LD Catheter completely through the aortotomy
and into the vascular graft.
Close the graft.
• Amputating the vascular graft and sewing the small end-to-side
remnant closed by hand
• Using a vascular stapler to close the graft near the surface of the
aorta
• Removing the complete graft with local patch closure, if necessary
CATHETER
®
User Manual