Indications, Contraindications, Warnings
General warning
Vitatron implantable leads are implanted in the extremely hostile environment of the human body. Leads are necessarily very small in diameter and must still be very flexible, which unavoidably reduces their potential performance or longevity. Leads may fail to function for a variety of causes, including, but not limited to: medical complications, body rejection phenomena, allergic reaction, fibrotic tissue, or failure of leads by breakage or by breach of their insulation covering. In addition, despite the exercise of all due care in design, component selection, manufacture, and testing prior to sale, leads may be easily damaged before, during, or after insertion by improper handling or other intervening acts. Consequently, no representation or warranty is made that failure or cessation of function of leads will not occur or that the body will not react adversely to the implantation of leads or that medical complications (including perforation of the heart) will not follow the implantation of leads or that the lead will, in all cases, restore adequate cardiac function.
Disclaimer of warranty
Although the Vitatron Implantable Lead, hereafter referred to as 'Product' has been carefully designed, manufactured and tested prior to sale, the Product may fail to perform its intended function satisfactorily for a variety of reasons. Warnings contained in the Product labeling provide more detailed information and are considered an integral part of this DISCLAIMER OF WARRANTY. Vitatron, therefore, disclaims all warranties, both express and implied, with respect to the Product. Vitatron shall not be liable for any incidental or consequential damages caused by any use, defect or failure of the Product, whether the claim is based on warranty, contract, tort or otherwise.
The exclusions and limitations set out above are not intended to, and should not be construed so as to, contravene mandatory provisions of applicable law. If any part or term of this DISCLAIMER OF WARRANTY is held by any court of competent jurisdiction to be illegal, unenforceable or in conflict with applicable law, the validity of the remaining portion of the DISCLAIMER OF WARRANTY shall not be affected, and all rights and obligations shall be construed and enforced as if this DISCLAIMER OF WARRANTY did not contain the particular part or term held to be invalid.
Service
Vitatron employs highly trained representatives and engineers located throughout the world to serve you and, upon request, to provide training to qualified hospital personnel in the use of Vitatron products. In addition, Vitatron maintains a professional staff of consultants to provide technical and medical consultation to product
users. For supplemental information, contact your local Vitatron representative, or call or write Vitatron at the appropriate address or telephone number listed on the back cover.