On-X Ascending Aortic Prosthesis, Instructions For Use Manual

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On-X
®
Ascending Aortic Prosthesis IFU 12
English
Scrub Nurse/Surgeon:
8. The scrub nurse may open the sterile inner tray by grasping the pull tab
marked on the corner of the inner lid and pulling toward the direction
of the arrow. (Refer to the illustration on the foil pouch.) The prosthesis
inner container is then placed onto the instrument tray.
WARNING: Do not use the On-X ® Ascending Aortic Prosthesis if the
inner tray lid is damaged. If the inner tray lid is damaged, use another
prosthesis and arrange for return of the unused product through
On-X LTI Customer Service (+1 512-339-8000 or cs@onxlti.com).
9. To remove the prosthesis from the inner tray, stabilize the tray on the
sterile field with one hand. With the other hand, insert the fingers
around the holder handle end and gently lift upward with enough force
to release it from the tray (Figure 7, and the illustration on the inner tray
lid).
10. To test rotation, carefully grasp the sewing cuff with a gloved hand
using a light grip and gently turn the top of the holder handle in either
direction. The valve should easily rotate within the sewing cuff.
WARNING: Do not use the On-X ® Ascending Aortic Prosthesis if
the valve does not rotate easily. Use another prosthesis and arrange
for return of the unused product through On-X LTI Customer Service
(+1 512-339-8000 or cs@onxlti.com).
11. Check the serial number tag against the label on the outer tray.
WARNING: Do not use the On-X
®
Ascending Aortic Prosthesis if the
serial number tag does not match the container label. Use another
prosthesis and arrange for return of the unused product through
On-X LTI Customer Service (+1 512-339-8000 or cs@onxlti.com).
12. Remove the serial number tag by cutting the suture that holds it on
the prosthesis. If desired, the tag can be used to check for sterility
by standard culture techniques immediately after it is removed. The
prosthesis is now ready for implant.
9.4 Device Implantation
WARNING:
All accessory instruments must be cleaned and sterilized prior
to use according to the On-X Instrumentation Instructions for Use provided
separately with the instruments.
Sizing
CAUTION: Use only On-X valve sizers when sizing the annulus. Sizers con-
tain cylindrical, conical, and aortic replica ends.
Cylindrical sizers correspond to valve sizes 19 mm through 25 mm. Conical
sizers correspond to valve size 27/29 mm. The correct valve size is deter-
mined by obtaining a comfortable, not tight, fit of the sizer within the
annulus. When a comfortable fit is found, the corresponding valve size is
signified by the identification on the sizer.