Abiomed Impella 5.0 Gebrauchsanweisung Seite 12

Use Fluoroscopy for
Placement
Impella 5.0 Catheter
®
performance will be
compromised if correct
placement cannot be confirmed.
While other imaging techniques,
such as transesophageal
echocardiography (TEE), can
help confirm the position of
the Impella 5.0 Catheter after
®
placement, TEE does not allow
visualization of the entire catheter
assembly and is inadequate for
reliably placing the Impella ® 5.0
Catheter across the aortic valve.
Impella 5.0 Use in Open
®
Heart Surgery
If the Impella ® 5.0 Catheter is
used in the OR as part of open
heart surgery, manipulation may
be performed only through the
9 Fr steering catheter. Direct
manipulation of the catheter
through the aorta or ventricle
may result in serious damage to
the Impella 5.0 Catheter and
®
serious injury to the patient.
10
ENTER PURGE FLUID DATA
1.
Enter the purge fluid information.
Impella 5.0 S/N: 123456
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 Automated Impella
remember the purge fluid value entered on the previous Case Start.
3. To change the purge fluid information, press the EDIT soft button, 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 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 (default), or 1000 mL.
• Dextrose concentration can be set to 5% (default), 10%, 20%, 30%, or 40%.
• Heparin concentration can be set to 0 (default), 5, 10, 12.5, 15, 20, 25, or 50 units/mL.
INSERTING THE IMPELLA
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. This describes the femoral
insertion procedure. For using the Axillary Insertion Kit please consult the Axillary insertion Kit
User Manual.
1.
Identify the femoral artery and perform a cut-down of 3 to 5 cm.
2. Expose the femoral artery. Wrap vessel loops, one distal and one proximal to the subsequent point of
incision, one and a half times around the artery. Make the vessel loops as far apart as possible.
Guidewire U-Stitches
Distal Vessel Loop
3.
To prepare the repositioning sheath, remove the luer plug at the end of the sidearm tube and flush the
tube with 0.9% NaCl solution.
Place the luer plug back in the sidearm tube and secure the plug.
4. Make the incision as close as possible to the distal loop. Insert a 6 Fr diagnostic catheter with no side
holes (Abiomed recommends a 6 Fr AL1 or Multipurpose without side holes or 5 Fr pigtail without side
holes) over a diagnostic 0.035 inch or 0.038 inch guidewire into the left ventricle.
5.
Remove the diagnostic guidewire and exchange it for the supplied 0.018 inch placement guidewire.
6. Hold tension on the proximal vessel loop to prevent bleeding. Straighten the blue
pigtail and thread it over the 0.018 inch placement guidewire. Wet the cannula with sterile water and
backload the catheter onto the placement guidewire. One or two people can load the catheter on the
guidewire.
5.0 CATHETER
®
Femoral Artery Proximal Vessel Loop
® Catheter will
User Manual