On-X®Ascending Aortic Prosthesis IFU9
English
pouch and outer tray are not sterile. Tyvek®seals on the inner and outer
trays must be intact. Any damage to the trays renders the prosthesis non-
sterile. In the event of damage to the primary packaging, the product must
not be used and should be returned to On-X LTI. The packaging consists
of the following items:
• Outer box with labeling
• Plastic prosthesis tray x 2,
inner and outer
• Plastic extended valve holder
with handle
• Prosthesis serial number tag
• Silica gel sachet
• Foil pouch
• May contain Instructions for Use
booklet
• Patient record card
• Instructional card, complete
with Courtesy Labels, used for
accessing: 1) Electronic Implant
Registration and 2) Electronic
Instructions for Use
Instruments for implantation of the On-X®Ascending Aortic Prosthesis are
supplied separately, NON-STERILE, and must be cleaned and sterilized prior
to use as outlined in the Instructions for Use provided with the instruments.
8.4 Storage
The On-X®Ascending Aortic Prosthesis is provided sterile. The sterility
expiration date of the device is recorded on the outer package labeling.
Appropriate inventory control should be maintained so that prostheses
with earlier expiration dates are preferentially implanted and expiration is
avoided. To protect the prosthesis, it should be stored in its outer box until
used. The storage environment should be clean, cool, and dry at a tempera-
ture not less than 0˚C (32˚ F) or higher than 35˚C (95˚ F).
WARNING: Once the foil package containing the sealed plastic tray set and
prosthesis 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 used within 24 hours,
arrange return of the prosthesis.
8.5 Accessories
The On-X®Ascending Aortic Prosthesis (valve) is designed to be used only
with On-X instruments. The instruments, supplied separately, are provided
as a set, which includes sizers, rotators, an instrument handle, and a leaflet
probe. The instruments are reusable. See the On-X Prosthetic Heart Valve
Instruments Instructions for Use for complete descriptions of instruments,
their use and reprocessing.
Replica Sizers
Aortic replica sizers are provided for all aortic valve sizes (Figure 3). They
are used to assure fit of the aortic valve without obstruction of the coronary
arteries. The size 19 through 25 aortic replica sizer shape is intended to
model supra-annular positioning of the valve sewing ring. Size 27/29 aortic
replica sizer is intended to model intra-annular positioning.
Instrument Handle
The instrument handle is comprised of a grip, a bendable stem and a tip
that facilitates holding the rotator during surgery (Figure 4).
