Rotators; Leaflet Probe; Instrument Tray; Use Of Instruments - On-X ONXI2 Modo De Empleo

Rotators - The valve rotator (Figure 3) is
used for reorienting an in situ valve and
may be used to verify leaflet mobility. The
valve rotator consists of a plastic head with

Leaflet Probe

a centrally located leaflet mobility probe
and an attached handle. The valve rotator is
properly oriented for insertion into the valve
Cross Bar
when the cross-bar on the head is aligned
with the leaflet pivot axis and the probe tip
is inserted into the central orifice between
the leaflets.
Mitral Rotator – The mitral rotator (Figure
Figure 3: Valve Rotator
4) is used for reorienting an in situ valve in
the mitral position only. The mitral rotator
is distinguishable from the valve rotator by
its shorter body and lack of a leaflet probe.
The rotators may be used with or without
the instrument handle attached. To attach a
rotator to the instrument handle, insert the
instrument handle tip directly into the slot
on the end of the rotator handle. The rotator
snaps into place after the application of a
light insertion force. The rotator must be
removed from the handle after use prior to
Figure 4: Mitral Rotator
cleaning. A force greater than the insertion
force is required to remove the rotator from
the instrument handle.
Leaflet Probe - The leaflet probe (Figure
5) is a flexible rod with tapered ends. The
leaflet probe may be used to gently move
the leaflets to verify that they open and
close freely.
Figure 5: Leaflet Probe
Instrument Tray - The instrument tray is optional and may be used for storage and
®
transportation of On-X Valve instruments. The tray can withstand standard and flash steam
sterilization. The instruments may be sterilized while in this tray. WARNING: The tray, by
itself, does not maintain sterility of the instruments after sterilization. To maintain
sterility of instruments, the tray with instruments must be sterilized in conjunction
with a wrapping material that allows steam sterilization and maintains sterility.

USE OF INSTRUMENTS

®
Additional instructions for the use of each instrument are included in the On-X Prosthetic
Heart Valve Instructions for Use book provided with each valve. Those instructions must also
be followed.
The instruments are reusable and must be separately cleaned and sterilized prior to each
use.
The instruments provided are not sterile and must be sterilized before first use. The
instruments must be cleaned and steamed sterilized prior to each reuse. The instruments
have been validated for 100 reprocessing cycles.
4 ON-X LTI INsTrumeNT IFu - eNGLIsH