On-X Ascending Aortic Prosthesis, Instructions For Use Manual

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On-X
®
Ascending Aortic Prosthesis IFU 16
English
10.2 Returned Goods
Prior authorization from On-X LTI Customer Service is required for the
return of any product. For any questions regarding the valve or for return
authorization, please contact Customer Service at +1 512-339-8000 or
cs@onxlti.com.
Licensed under U.S. Patent Nos. 5,137,532; 5,545,216; 5,772,694; 5,908,452;
5,677,061; 6,096,075; 5,641,324; and foreign counterpart patents.
11. PATIENT INFORMATION
11.1 Patient Registration
In each On-X® Ascending Aortic Prosthesis package, an Instructional
Card, complete with Courtesy Labels, used for accessing the Electronic
Implant Registration and Electronic Instructions for Use is included. On-X
LTI requests that the Electronic Implant Registration be completed imme-
diately.
On-X LTI will use these data for notification purposes and to help with inven-
tory restocking in the hospital. All patient information remains strictly con-
fidential, and the release of patient identifying information can be refused
if allowed by local law.
11.2 Patient Record Card
A Patient Record Card is provided with the prosthesis. The card should
be given to the patient (or placed in the patient record to be given to the
patient). Patients should be encouraged to complete the card and carry it
with them at all times.
12. DISCLAIMER OF WARRANTIES
Because of the complications listed previously that may occur with the use
of any ascending aortic prosthesis and the possibilities of damage, also
noted previously, before, during or after implantation, On-X LTI warrants
only that the product shall conform to On-X LTI’s standard specifications. No
other warranty is made by On-X LTI concerning the function of the product
in use, and On-X LTI assumes no risk whatsoever as to the results of the use
of this product. The entire risk with use of the product is that of the buyer.
On-X LTI disclaims all other warranties, respecting the product, expressed
or implied, including but not limited to those related to the product’s mer-
chantability or fitness for a particular purpose. On-X LTI shall not be liable
for any direct, special, consequential or incidental loss, damage or expense
related to the use of the product. No person has any authority to alter any
of these conditions or to bind On-X LTI to any additional responsibility or
warranty in connection with the use of the product.