On-X Ascending Aortic Prosthesis, Инструкция по эксплуатации

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On-X
®
Ascending Aortic Prosthesis IFU 6
English
TEST the leaflet mobility only with the On-X leaflet probe.
All accessory instruments must be cleaned and sterilized prior to use
according to the instructions provided separately with the instruments.
USE ONLY
the On-X rotator to rotate the valve in situ. Use only the cor-
respondingly sized rotator. Use of the wrong size rotator could damage
the valve.
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 to return the unused product to On-X LTI
DO NOT use the On-X
®
Ascending Aortic Prosthesis if the valve does not
rotate easily. Use another prosthesis and arrange to return the unused
product to On-X LTI.
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
to return the unused product to On-X LTI.
DO NOT size the sewing cuff of the size 19 mm through 25 mm aortic valve
to fit within the annulus. Size 27/29 mm aortic valves are designed to be
placed in an intra-annular position and have a replica sizer to mimic this
placement.
4.2 Precautions
CAUTION:
Federal (USA) law restricts this device to sale, distribution and
use by or on the order of a physician.
Handle the prosthesis with On-X Valve Instruments and the provided prod-
uct handle. Only On-X valve sizers should be used during the selection of
the prosthesis size; other sizers may result in improper prosthesis selection.
Avoid contacting the carbon surfaces of the valve with gloved fingers or any
metallic or abrasive instruments as they may cause damage to the valve sur-
face not seen with the unaided eye that may lead to accelerated valve struc-
tural dysfunction, leaflet escape, or serve as a nidus for thrombus formation.
No resistance should be experienced when inserting the rotator. If resis-
tance is encountered, stop, remove, and realign the rotator before attempt-
ing to insert the rotator again. Retest leaflet motion after rotation. If free
leaflet motion cannot be achieved, remove the prosthesis.
Clamping may damage any vascular graft. Handling of the graft must be
gentle and minimized in order to prevent loss of gelatin coating.
Excessive tension on the graft should be avoided.
The use of round taper point needles minimizes graft damage. When de-
airing through the graft, a 19-gauge needle is usually sufficient. Cutting
point needles should be avoided to prevent damage.
Gelweave Valsalva™ Vascular Prosthesis has a woven structure and there-
fore should be cut with a cautery to minimize fraying. Use of the cautery for
any sealed graft can cause burning. Immersion of the graft in saline prior to
use of the cautery will prevent focal burning. Immersion of the ascending
aortic prosthesis should be no longer than 5 minutes. The prosthesis should
not be allowed to dry out after soaking.