On-X Ascending Aortic Prosthesis, Инструкция по эксплуатации

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On-X
®
Ascending Aortic Prosthesis IFU 5
English
4. WARNINGS AND PRECAUTIONS
4.1 Warnings
USE ONLY AS INDICATED
(see section 2).
FOR SINGLE USE ONLY
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 seals are broken;
• package damage is evident;
• the serial number tag does not match the serial number on the
container label.
DO NOT pass a catheter, surgical instrument, or transvenous pacing lead
through the aortic prosthetic heart valve as this may cause valvular insuf-
ficiency, leaflet damage, leaflet dislodgment, and/or catheter/ instrument/
lead entrapment.
DO NOT re-sterilize the On-X ® Ascending Aortic Prosthesis.
DO NOT use the On-X
®
Ascending Aortic Prosthesis if the expiration date
has elapsed. If a prosthesis is unused, its foil pouch and sealed plastic tray
container is undamaged, and the sterility expiration date has passed, the
prosthesis should be returned to On-X LTI.
DO NOT use the On-X ® Ascending Aortic Prosthesis if either tamper evi-
dent label at each end of the outer box has been broken or is damaged. If
either tamper evident label has been broken or 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 protective foil
pouch is damaged or if the prosthesis has been dropped, damaged, or
mishandled in any way. If any damage is found, use another prosthesis and
arrange to return the unused product to On-X LTI.
DO NOT preclot the Gelweave Valsalva™ Vascular Prosthesis.
DO NOT exert excessive force on the valve components or the graft.
DO NOT attempt to re-insert the holder handle into the prosthesis (valve)
once it has been released from the prosthesis. Doing so could damage the
valve and cause catastrophic failure of the valve or harm to the patient.
DO NOT use the holder handle to rotate the valve once implanted.
DO NOT attempt to disassemble the holder handle. A small spring pro-
tected inside the assembled holder handle could escape and be unnoticed
in the sterile field.
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, steril-
ity 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, arrange return of the prosthesis to
On-X LTI.