Abiomed Impella 2.5, Инструкция по эксплуатации

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5.23 Impella
®
System for Use During Cardiogenic Shock
Press the two indicated tabs together
to close the graft lock
Graft lock in fully closed position
Figure 5.28 Closing the Graft Lock
6. Remove the vascular clamp on the graft and insert a 0.035 inch diagnostic guidewire
with a 4–6 Fr diagnostic catheter into the introducer, taking care to center the wire and
catheter in the center of the hemostatic valve. Advance the guidewire and catheter into
the left ventricle.
7.
Remove the diagnostic guidewire and exchange it for a stiff 0.018 inch placement
guidewire. With the 0.018 inch placement guidewire properly positioned in the left
ventricle, remove the diagnostic catheter.
8. Remove the protective sleeve on the provided 8 Fr silicone-coated lubrication dilator,
being careful to avoid getting silicone on your hands. Insert the dilator into the
introducer over the 0.018 inch placement guidewire to coat the hemostatic valve with
silicone oil to facilitate insertion of the Impella
®
Catheter through the hemostatic valve
assembly. Once fully inserted, remove the dilator, keeping the 0.018 inch placement
guidewire in place.
9.
Clamp the graft with a vascular clamp just above the anastomosis to avoid blood loss
through the pump cannula during insertion through the valve.
10. While maintaining guidewire position, backload the Impella
®
Catheter onto the 0.018
inch placement guidewire and advance the catheter over the guidewire through the
introducer into the graft such that the entire pump cannula and motor housing resides
in the graft and only the catheter shaft is seen exiting the valve.
11.
Remove the vascular clamp and continue inserting the Impella
®
Catheter into the aorta.
If inserting an Impella
®
5.0 Catheter, pause to re-zero the pressure sensor (as described
in section 6 of this manual) while the catheter is in the aorta. Continue advancing
across the aortic valve using fluoroscopic imaging to properly position the inlet area in
the left ventricle no more than 3.5 cm below the aortic valve. Remove the placement
guidewire and initiate Impella
®
Catheter support as described later in this section.
12. Clamp the graft adjacent to the axillary artery with a soft jawed vascular clamp or
have an assistant apply digital pressure to control bleeding at the base of the graft so
that the introducer can be removed and the graft shortened. NOTE: To ensure the soft
jaw vascular clamp is completely sealing over the graft and the 9 Fr catheter, open the
sidearm flush valve on the introducer and verify blood is not leaking from the system.
6 6 . . Remove the vascular clamp on the graft and insert a 0.035 inch diagnostic guidewire
with a 4–6 Fr diagnostic catheter into the introducer, taking care to center the wire and
catheter in the center of the hemostatic valve. Advance the guidewire and catheter into
the left ventricle.
7 7 . .
Remove the diagnostic guidewire and exchange it for a stiff 0.018 inch placement
guidewire. With the 0.018 inch placement guidewire properly positioned in the left
ventricle, remove the diagnostic catheter.
9. 9.
Clamp the graft with a vascular clamp just above the anastomosis to avoid blood loss
through the pump cannula during insertion through the valve.
10. 10. While maintaining guidewire position, backload the Impella
®
Catheter onto the 0.018
inch placement guidewire and advance the catheter over the guidewire through the
introducer into the graft such that the entire pump cannula and motor housing resides
in the graft and only the catheter shaft is seen exiting the valve.
11. 11.
Remove the vascular clamp and continue inserting the Impella
®
Catheter into the aorta.
If inserting an Impella
®
5.0 Catheter, pause to re-zero the pressure sensor (as described
in section 6 of this manual) while the catheter is in the aorta. Continue advancing
across the aortic valve using fluoroscopic imaging to properly position the inlet area in
the left ventricle no more than 3.5 cm below the aortic valve. Remove the placement
guidewire and initiate Impella
®
Catheter support as described later in this section.
1 1 2. 2. Clamp the graft adjacent to the axillary artery with a soft jawed vascular clamp or
have an assistant apply digital pressure to control bleeding at the base of the graft so
that the introducer can be removed and the graft shortened. NOTE: To ensure the soft
jaw vascular clamp is completely sealing over the graft and the 9 Fr catheter, open the
sidearm flush valve on the introducer and verify blood is not leaking from the system.
8. 8. Remove the protective sleeve on the provided 8 Fr silicone-coated lubrication dilator,
being careful to avoid getting silicone on your hands. Insert the dilator into the
introducer over the 0.018 inch placement guidewire to coat the hemostatic valve with
silicone oil to facilitate insertion of the Impella
®
Catheter through the hemostatic valve
assembly. Once fully inserted, remove the dilator, keeping the 0.018 inch placement
guidewire in place.
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