Abiomed Impella 2.5, Instructions For Use Manual

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5.27 Impella
®
System for Use During Cardiogenic Shock
10. Loosen the proximal vessel loop and advance the catheter into the vessel. When the
motor housing is entirely past the proximal vessel loop, temporarily tighten the loop to
control bleeding.
To prevent device failure, do not start the Impella ® 5.0 Catheter until the placement
guidewire has been removed.
Do NOT remove the Impella
®
5.0 Catheter over the length of the placement
guidewire.
11.
Advance the repositioning sheath, located on the catheter shaft, through the incision
and into the femoral artery until bleeding is controlled. Secure the sheath outside of the
vessel using the supplied suture loop.
12.
Stabilize the guidewire and repositioning sheath and advance the catheter through the
sheath. Follow the catheter under fluoroscopy as it is advanced into the left ventricle.
(Refer to the following page and to section 7 of this manual for information about
waveforms displayed on the controller during placement.)
13.
When the catheter is correctly positioned, slightly loosen the proximal vessel loop and
remove the 0.018 inch guidewire. Leave at least 2 to 3 cm of the repositioning sheath
inside the vessel.
14.
Tighten the prepared U-stitches to seal the sheath.
15.
Loosen the distal vessel loop. Then loosen the proximal vessel loop.
INSERTION TECHNIQUE USING A SIDEARM GRAFT
1.
After exposing the femoral artery and making the incision as described in the steps
above, prepare a Dacron
® vascular graft (10 mm x 20 cm) by beveling the end of the
graft at a 45 to 60 degree angle.
2.
Tighten the distal and proximal vessel loops to control bleeding.
3.
Attach the vascular graft using the standard end-to-side anastomosis (Figure 5.32).
Figure 5.32 Femoral Artery Insertion of the Impella ® 5.0 Catheter Using a Sidearm Graft
10 10 . . Loosen the proximal vessel loop and advance the catheter into the vessel. When the
motor housing is entirely past the proximal vessel loop, temporarily tighten the loop to
control bleeding.
Do NOT Touch Inlet or
Outlet Areas
While feeding the Impella
®
5.0 Catheter through the
femoral artery, hold the
device at the cannula or
motor housing. Do NOT
touch the inlet area or the
outlet area.
11 11 . .
Advance the repositioning sheath, located on the catheter shaft, through the incision
and into the femoral artery until bleeding is controlled. Secure the sheath outside of the
vessel using the supplied suture loop.
12. 12.
Stabilize the guidewire and repositioning sheath and advance the catheter through the
sheath. Follow the catheter under fluoroscopy as it is advanced into the left ventricle.
(Refer to the following page and to section 7 of this manual for information about
waveforms displayed on the controller during placement.)
13. 13.
When the catheter is correctly positioned, slightly loosen the proximal vessel loop and
remove the 0.018 inch guidewire. Leave at least 2 to 3 cm of the repositioning sheath
inside the vessel.
14. 14.
Tighten the prepared U-stitches to seal the sheath.
15. 15.
Loosen the distal vessel loop. Then loosen the proximal vessel loop.
1 1 . .
After exposing the femoral artery and making the incision as described in the steps
above, prepare a Dacron
® vascular graft (10 mm x 20 cm) by beveling the end of the
graft at a 45 to 60 degree angle.
2. 2.
Tighten the distal and proximal vessel loops to control bleeding.
3. 3.
Attach the vascular graft using the standard end-to-side anastomosis (Figure 5.32).
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