English
On-X
®
Prosthetic Heart Valve | Instructions for Use
10
Scrub Nurse/Surgeon:
1. Check the tamper evident seal of the inner container.
WARNING: DO NOT use the On-X Prosthetic Heart
Valve if the tamper evident seal has been broken.
If the tamper evident seal has been broken, use
another valve and arrange for return through On-
XLTI Customer Service.
2. Open the inner container by gently twisting the lid
to break the tamper-proof seals (Figure 9) and then
lifting the lid off the base.
3. Press the instrument handle tip into the slot on the
valve holder until it snaps firmly into position (Figure
10). Gently lift the valve out of the container and slide
the holder plate off the holder.
Carefully grasp the sewing ring with a gloved hand
using a light grip and gently turn the instrument
handle in either direction. The valve should easily
rotate within the sewing ring. Stop rotation testing
with an orientation mark aligned with the pivot axis.
WARNING: DO NOT use the On-X Prosthetic
Heart Valve if the valve does not rotate easily. Use
another valve and arrange for return through On-
XLTI Customer Service.
6. The valve is now ready for implantation. To ease
positioning during implantation, the instrument
handle stem can be bent by grasping the ends of the
handle and the stem, then bending. Avoid grasping
the valve.
WARNING: DO NOT use the valve for leverage in
bending the instrument handle. This could damage
the valve and lead to mechanical failure.
9.4 Device Implantation
WARNING: All accessory instruments must be
cleaned and sterilized prior to use according to the
instrument instructions.
Sizing
Use only On-X Prosthetic Heart Valve sizers when sizing
the annulus. Sizers contain cylindrical, conical, and aortic
replica ends. Refer to Table 2 to facilitate sizer selection.
Cylindrical sizers correspond to the valve sizes 19 mm
through 25 mm. Conical sizers correspond to the valve
size 27/29 mm and 31/33 mm. These types of sizers may
be used for both aortic and mitral valves.
The correct valve size is determined 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.
On-X Mitral Conform-X Prosthetic Heart Valves may be
used when a comfortable fit is at or between size 25 and
size 33.
Aortic replica sizers are provided for all aortic valve sizes.
For size 19 mm through 25 mm aortic valves, the aortic
replica sizers are used to verify that the aortic valve can
be properly seated in the annulus and that the coronary
arteries remain unobstructed. Size 19 mm through 25
mm aortic valves of standard, Conform-X, and Anatomic
sewing ring configurations are designed to fit within the
annulus at implant such that the exposed carbon flare
rests in the annulus and the sewing ring is intrasupra-
annular (Figure 11).
Figure 11. Aortic replica sizers verify the aortic valve
Figure 10. Inserting the
instrument handle
Figure 9. Opening the inner container
4. Check the serial number tag against the label on the
outer container.
WARNING: DO NOT use the On-X Prosthetic Heart
Valve if the serial number tag does not match the
container label. Use another valve and arrange for
a return through On-XLTI Customer Service.
5. Remove the serial number tag by cutting the suture
that holds it on the valve. If desired, the tag can
be used to check for sterility by standard culture
techniques immediately after it is removed.
