Abiomed Impella 2.5, Инструкция по эксплуатации

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5.17 Impella
®
System for Use During Cardiogenic Shock 5.17
IMPELLA CP
®
CATHETER INSERTION
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
®
Catheter and during
re-wire through the guidewire access port. The small placement guidewire must be
reliably observed at all times.
Avoid manual compression of the inlet and outlet areas of the cannula assembly.
To prevent malfunction of the locking mechanism of the peel-away introducer,
do NOT hold the hemostatic valve while inserting into the artery.
Do
NOT
kink or clamp the Impella ® Catheter with anything other than a soft jaw
vascular clamp. Do
NOT
kink or clamp the peel-away introducer.
Handle with care. The Impella
®
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 artery.
2.
Insert a 5–8 Fr introducer over the 0.035 guidewire (provided) to pre-dilate the vessel.
3.
Remove the 5–8 Fr introducer over the 0.035 guidewire. Sequentially insert and remove
the 8 Fr, 10 Fr, and 12 Fr dilators and then insert the peel-away introducer with dilator
(see Figure 5.20). While inserting the introducer, hold the shaft of the introducer to
slide it into the artery.
Figure 5.20 Inserting the Peel-Away Introducer
4.
Administer heparin. When the ACT is greater than or equal to 250 seconds, remove the
dilator.
Use Fluoroscopy for
Placement
Impella
®
Catheter
performance will be
compromised if correct
placement cannot be
confirmed. While other
imaging techniques,
such as transesophageal
echocardiography (TEE),
portable C-Arm fluoroscopy,
or chest x-ray can help
confirm the position of
the Impella
® Catheter after
placement, these methods do
not allow visualization of the
entire catheter assembly and
are inadequate for reliably
placing the Impella
®
Catheter
across the aortic valve.
2. 2.
Insert a 5–8 Fr introducer over the 0.035 guidewire (provided) to pre-dilate the vessel.
1. 1.
Obtain access to the femoral artery.
3. 3.
Remove the 5–8 Fr introducer over the 0.035 guidewire. Sequentially insert and remove
the 8 Fr, 10 Fr, and 12 Fr dilators and then insert the peel-away introducer with dilator
(see Figure 5.20). While inserting the introducer, hold the shaft of the introducer to
slide it into the artery.
Keep ACT ≥ 250 Seconds
Achieving an ACT
≥
250
seconds prior to removing
the dilator will help prevent
a thrombus from entering
the catheter and causing a
sudden stop on startup.
Introducer Setup
Refer to the instructions for
use for each introducer for
setup instructions.
When inserting the dilator, be
sure to twist and lock it onto
the hub of the sheath and
twist it off when removing it
from the sheath.
GP IIb-IIIa Inhibitors
If the patient is receiving a
GP IIb-IIIa inhibitor, the dilator
can be removed and the
Impella
®
Catheter inserted
when ACT is 200 or above.
4. 4.
Administer heparin. When the ACT is greater than or equal to 250 seconds, remove the
dilator.
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