5.10
Instructions for Use & Clinical Reference Manual (US)
INSERTING THE IMPELLA
®
RP 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.
Fluoroscopy is required to guide placement of the Impella
®
RP Catheter. The small
placement guidewire must be reliably observed at all times.
Avoid manual compression of the inlet, outlet, or sensor areas of the cannula
assembly.
Do
NOT
kink or clamp any part of the Impella
®
RP Catheter.
Handle with care. The Impella
®
RP Catheter can be damaged during removal from
packaging, preparation, insertion, and removal. Do
NOT
bend, pull, or place excess
pressure on the catheter or mechanical components at any time.
1.
Obtain access to the femoral vein.
2.
Insert a 5–8 Fr introducer over the 0.035 inch guidewire (provided) to pre-dilate the
vessel.
3.
Remove the 5–8 Fr introducer over the 0.035 inch guidewire. Insert the 8 Fr, 12 Fr,
16 Fr, and 20 Fr dilators sequentially, as needed. Remove the 20 Fr dilator and insert
the 23 Fr introducer with dilator. While inserting the 23 Fr introducer, hold the shaft of
the introducer to advance it into the vein.
4.
Administer heparin. When ACT is at least 250 seconds, remove the 23 Fr dilator.
5.
Insert a 5–6 Fr diagnostic catheter or a flow-directed balloon-tipped catheter into
the 23 Fr introducer and advance it over a guidewire into the left (preferred) or right
pulmonary artery.
6.
Remove the 0.035 inch diagnostic guidewire, leaving the diagnostic or balloon-tipped
catheter in the pulmonary artery. Form a curve or bend on the 0.025 inch Platinum Plus
or similar stiff, 260 cm placement guidewire and then insert it.
7.
Advance the placement guidewire into the pulmonary artery, avoiding overinsertion to
the most distal pulmonary artery.
8.
Remove the diagnostic or balloon-tipped catheter.
Shaded Steps
All shaded steps require sterile
technique.
