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ACCESSORIES
4
The 0.018 inch, 260 cm guidewire is
used for the placement of the Impella 5.5
Catheter. The guidewire has a radiopaque,
shapable tip.
The Impella 5.5 Catheter Set contains a
23 Fr diameter x 6 cm length peel-away
introducer and two (2) graft locks used to
attach a graft onto the introducer.
The kit is packaged with an 8 Fr silicone-
coated lubrication dilator.
The incision template is used to assist
in correct placement of the Impella 5.5
Catheter during direct aortic insertion
by indicating the correct location for the
incision in the ascending aorta.
The two silicone plugs can be placed
around the catheter shaft to help control
bleeding during and after Impella 5.5
Catheter insertion.
Hospital Provided:
Glucose solution, typically 5% glucose
with:
Heparin (25 or 50 IU/mL),
OR sodium hydrogen carbonate (25 or 50
mEq/L) is used as the purge fluid through
the Impella catheter.
Do not add both heparin and sodium
bicarbonate to the glucose solution – only
one should be used.
The Automated Impella Controller cart
holds the Automated Impella Controller.
The cart has wheels for easy transport
of the controller and a storage basket.
(For more information, including assembly
instructions, refer to the Automated Impella
Controller cart instructions for use.)
PRE-SUPPORT EVALUATION
Before initiating the procedure, evaluate the patient for factors that
may prevent successful placement of the Impella Catheter. Use imaging
technology to examine the patient's vasculature access site. An echo
assessment of the left ventricle is also recommended to rule out left
ventricular thrombus, mechanical aortic valves, or severe aortic insufficiency.
Consider inserting a diagnostic Pulmonary Artery (PA) catheter to provide
continuous hemodynamic monitoring, including pulmonary artery and central
venous pressures, measurement of cardiac output, and SvO
STARTUP
SUPPLIES NEEDED
• Automated Impella Controller (Abiomed)
• Impella 5.5
®
with SmartAssist
®
• Hospital Provided:
• Diagnostic catheter (AL1 or MP without side holes or pigtail without
side holes)
• 500 cc bag of glucose solution for purge solution in water
(5% recommended; 5% to 20% acceptable) with heparin (25 or 50 IU/mL)
or sodium hydrogen carbonate (25 or 50 mEq/L)
• 10 mm polyester fiber woven graft proven suitable for this application,
e.g. Hemashield Platinum or Vascutek Gelweave
Note: 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.
CASE START
To avoid fibers drawn into the Impella:
• Keep the Impella Heart Pump in its packaging tray until just before
insertion.
• Do not attempt to run the pump in a basin of saline prior to insertion.
• Do not attempt to rinse and reinsert the device after initial insertion.
• Hold the surgical towel or 4 x 4 gauze pad away from the inflow and
outflow windows, when controlling blood splatter during insertion of the
Impella Heart Pump through the introducer.
If you miss a step in the process of setting up the Impella Catheter, or if
you exceed the amount of time allowed to complete a step, the Automated
Impella Controller will display additional instruction screens for continuing the
setup process for some steps. For the steps discussed below, all shaded steps
require sterile technique.
1.
Press the START NEW CASE soft button from the startup screen or
plug in a new Impella Catheter. "Case Start" can also be selected by
pressing the MENU soft key.
2.
The controller displays the screen shown below
.
2
Set (Abiomed)
User Manual
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