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Circulating Nurse
1. Check the expiration date on the outer box.
WARNING: DO NOT use the On-X Prosthetic Heart
Valve if the expiration date has elapsed. If a valve
is unused, its plastic container is undamaged, and
the sterility expiration date has passed, the valve
should be returned to On-XLTI.
2. Remove the valve container and package inserts from
the outer box. Inspect the container for damage.
WARNING: DO NOT use the On-X Prosthetic
Heart Valve if the prosthesis has been dropped,
damaged, or mishandled in any way. If any
damage is found, use another valve and arrange
for a return through On-XLTI Customer Service.
3. Fill out the implant registration card as completely
as local law allows and return to On-XLTI as soon as
possible. This allows the patient to be entered into
the tracking database, which could be important for
future notices regarding the valve. Give the patient
record card to the patient or place it in the patient's
records.
4. Open the outer container
Twist-off outer lid package design: Rotate the lid
counter-clockwise until it stops, then lift the lid off off
of the container (Figure 7a).
Twist-off Lid Design
Figure 7a. Twist-off outer lid
Peel-off Lid Design
Figure 8a. Peel-off outer lid
On-X
Prosthetic Heart Valve | Instructions for Use
®
On-X
Prosthetic Heart Valve | Instructions for Use
®
Peel-off Tyvek
tab corner of the lid and pull back towards the center
of the container (Figure 8a). Continue peeling until the
lid is completely removed.
5. The scrub nurse may remove the sterile inner
container from the outer container by gently lifting
the pull tab attached to the top of the inner container
(Figure 7b or Figure 8b). The inner container is then
placed onto the instrument tray. Alternately, the inner
container can be placed on the sterile field by gently
inverting the outer container slightly above the sterile
field (Figure 7c or Figure 8c) and allowing the inner
container to slip out onto the sterile field.
Scrub Nurse/Surgeon:
1. Check the tamper evident seal of the inner container.
WARNING: DO NOT use the On-X Prosthetic Heart
Valve if the tamper evident seal has been broken.
If the tamper evident seal has been broken, use
another valve and arrange for return through On-
XLTI Customer Service.
2. Open the inner container by gently twisting the lid
to break the tamper-proof seals (Figure 9) and then
lifting the lid off the base.
Figure 7b. Remove by pull tab...
Figure 8b. Remove by pull tab...
lid package design: Grasp the peel
®
Figure 7c. ...or invert on sterile field
Figure 8c. ...or invert on sterile field
English
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