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ENTER PURGE FLUID DATA
1.
Enter the purge fluid information.
2.
To select the default values displayed on the screen, press the
ACCEPT soft button. This will select those values and automatically
advance to the next screen. Note: The default purge fluid values will
be the purge fluid values from the last Case Start performed on a
given Automated Impella Controller.
3.
To change the purge fluid information, press the EDIT soft buttons,
scroll to the appropriate item and push the selector knob to select it
or use the white arrow soft buttons. Then scroll through the values
and push the selector knob or press SELECT to make a new selection.
Press the DONE button to finish editing. The controller will use the
default values if no other selections are made.
• Purge fluid can be set to 50 mL, 100 mL, 250 mL, 500 mL, or 1000
mL.
• Glucose (Dextrose) concentration can be set to 5%, 10% or 20%.
• Heparin concentration can be set to 0 IU/ml, 5 IU/ml, 6.25 IU/ml, 10
IU/ml, 12.5 IU/ml, 20 IU/ml, 25 IU/ml, 40 IU/ml, 50 IU/ml.
• Bicarb concentration can be set to 0 mEq/L, 25 mEq/L, or 50 mEq/L.
AXILLARY INSERTION OF THE IMPELLA
5.5
CATHETER
®
NOTE – Proper surgical procedures and techniques are the
responsibility of the medical professional. The described
procedure is furnished for information purposes only. Each
physician must evaluate the appropriateness of the procedure
based on his or her medical training and experience, the type of
procedure, and the type of systems used.
If the Impella Catheter is used in the OR as part of open heart surgery,
manipulation may be performed only at the access site. Direct manipulation
of the catheter assembly through the aorta or ventricle may result in serious
damage to the Impella Catheter and serious injury to the patient.
When using a pigtail diagnostic catheter with side holes, ensure that the
guidewire exits the end of the catheter and not the side hole. To do so,
magnify the area one to two times as the guidewire begins to exit the pigtail.
During placement of the Impella Catheter, take care to avoid damage to the
inlet area while holding the catheter and loading the placement guidewire.
6
The introducer and graft lock are supplied sterile and can be used only if
the packaging is not damaged and the expiration date has not elapsed.
Fluoroscopy is required for the insertion of the Impella guidewire and
Impella Catheter.
During insertion, avoid manual compression of the inlet or outlet areas of
the Impella Catheter or the sensor area of the cannula on the Impella 5.5
with SmartAssist Catheter.
The graft must be affixed to the introducer proximal to the retainers on the
introducer repositioning unit to prevent the introducer from sliding out of the
graft.
When inserting the Impella Catheter through the introducer and into
the graft, be sure to clamp the graft with a vascular clamp just above
the anastomosis to avoid blood loss through the pump cannula during
insertion through the valve.
The Impella Axillary Insertion kit is intended to be used for insertion only.
To provide continued hemostasis, the introducer must be peeled away
and the repositioning unit inserted into the graft.
Do NOT resterilize or reuse any components of the Impella Axillary
Insertion kit. All components are disposable and intended for single use
only. Reuse, reprocessing, or resterilization may compromise performance.
The introducer is designed to be inserted into a graft. It is not intended
for direct insertion into the artery.
A 10 mm polyester graft providing proper fit and hemostasis between the
graft and the introducer must be used. A smaller diameter graft may not
fit over the introducer.
Abiomed recommends the use of an at least 20 cm length graft to allow
enough length to fully insert the Impella Catheter cannula into the graft
prior to releasing vascular clamps at the anastomosis to minimize blood
loss through the cannula.
Do NOT kink or clamp the white portion of the Impella Catheter with cm
markings with anything other than a soft jaw vascular clamp.
Do NOT kink or clamp the peel-away introducer.
Proper positioning of the Impella Catheter is extremely important and it is
worthwhile to take extra time when positioning the catheter.
Take care to insert the guidewire with diagnostic catheter into the middle
of the hemostatic valve of the introducer to avoid tearing the valve.
When inserting the Impella Catheter into the introducer, take care to
insert it straight into the center of the introducer valve.
Be sure that the stopcock on the peel-away introducer is always kept in the
closed position. Significant bleed back can result if the stopcock is open.
The following steps describe the recommended technique for axillary artery
insertion of the Impella 5.5
with SmartAssist
®
1.
Isolate and expose the axillary artery and obtain control via proximal and
distal vessel loops.
2.
Attach a 10 mm diameter vascular graft to the axillary artery using a
standard end-to-side anastomosis. NOTE: Abiomed recommends using
at least a 60 degree bevel on the end of the graft to facilitate passage of
the rigid motor housing into the artery.
3.
Clamp the graft with a vascular clamp just above the anastomosis and
loosen the vessel loops to allow blood to flow into the graft to assess for
hemostasis at the anastomosis.
4.
Insert the introducer into the graft and secure it with a provided graft
lock. To place the graft lock, open it and place it between the retainers
and the hub on the introducer to prevent the introducer from sliding out
of the graft. Correct positioning of the second graft lock is illustrated
below.
Catheter.
®
User Manual
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