On-X Ascending Aortic Prosthesis, Instructions For Use Manual

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On-X
®
Ascending Aortic Prosthesis IFU 11
English
CAUTION: 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 surface not seen with the unaided eye that may lead to accel-
erated valve structural dysfunction, leaflet escape, or serve as a nidus for
thrombus formation.
CAUTION: Avoid damaging the prosthesis through the application of
excessive force to the valve orifice or leaflets or to the graft.
Circulating Nurse
1. Check the expiration date on the outer box.
WARNING:
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.
2. Check the labels at each end of the box for integrity.
WARNING: Do not use the On-X
®
Ascending Aortic Prosthesis if either
tamper evident 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 for return of the unused
product through On-X LTI Customer Service (+1 512-339-8000 or
cs@onxlti.com).
3. Open the outer box and remove the protective foil pouch containing
the prosthesis and package inserts. Inspect the foil pouch for damage.
WARNING: 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 for return of the unused product
through On-X LTI Customer Service (+1 512-339-8000 or cs@onxlti.com).
4. Complete electronic implant registration on www.onxlti.com/
implantregistration as completely as local law allows and as soon
as possible. This allows the patient to be entered into the tracking
database, which could be important for future notices regarding the
prosthesis. Give the patient record card to the patient.
5. Open the foil pouch by tearing it at one of the notches on either side of
the indicated tear line. Illustrations for opening the foil pouch, removing
and opening the outer tray, introducing the inner tray into the sterile
field and opening the inner tray are given on the foil pouch.
6. Open the outer tray lid by grasping the pull tab marked on the corner
of the outer lid and pulling the lid in the direction of the arrow. (Refer to
the illustration on the foil pouch.)
7. The inner container can be placed in the sterile field by gently inverting
the outer container slightly above the sterile field and allowing the inner
container to slip out into the sterile field. (Refer to the illustration on the
foil pouch.)