On-X Ascending Aortic Prosthesis, Инструкция по эксплуатации

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On-X
®
Ascending Aortic Prosthesis IFU 10
English
Rotator
The valve rotator (Figure 5) is used for reorienting an in situ valve after
the conduit is cut to length. The rotator consists of a plastic head with a
centrally located leaflet probe and a slot for connection to the instrument
handle. To attach the 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.
Leaflet Probe
The leaflet probe (Figure 6) 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.
9. DIRECTIONS FOR USE
WARNING:
Do not use the On-X
®
Ascending Aortic Prosthesis if:
• the prosthesis has been dropped, damaged, or mishandled in
any way;
• the expiration date has elapsed;
• the tamper evident seal is broken;
• package damage is evident;
• the serial number tag does not match the serial number on the
container label.
9.1 Physician Training
The techniques for implanting the On-X ® Ascending Aortic Prosthesis are
similar to those used for any ascending aortic prosthesis. Trained cardiovas-
cular surgeons will be familiar with these techniques.
9.2 Sterilization and Re-sterilization
The On-X
®
Ascending Aortic Prosthesis is provided sterile. If the sterility
expiration date has passed, or if upon removal from the outer box, the
foil pouch is punctured or the sterility barriers of the sealed plastic trays
inside the foil pouch are compromised, do not use the prosthesis, contact
On-X LTI Customer Service (+1 512-339-8000 or cs@onxlti.com) to arrange
return of the prosthesis.
WARNING: Once the foil package is opened, the prosthesis must be
implanted within 24 hours. If the plastic trays with sealed Tyvek ® lids are
not damaged, sterility of the prosthesis is maintained and the sealed tray
set can remain out of the foil pouch for up to 24 hours. If the prosthesis is
not implanted within 24 hours of opening the foil pouch, contact On-X LTI
Customer Service (+1 512-339-8000 or cs@onxlti.com) to arrange return of
the prosthesis.
WARNING: Do not re-sterilize the On-X
®
Ascending Aortic Prosthesis.
9.3 Handling and Preparation Instructions
CAUTON:
Handle the prosthesis only with On-X LTI Instruments. Only On-X
valve sizers should be used during the selection of the prosthesis size; other
sizers may result in improper prosthesis selection.