(1) Mesulog products are not designed with components and testing for a level of reliability suitable for use in or in connection with surgical implants or as critical components in any life support systems whose failure to perform can reasonably be expected to cause significant injury to a human.
(2) In any application, including the above, reliability of operation of the software products can be impaired by adverse factors, including but not limited to fluctuations in electrical power supply, computer hardware malfunctions, computer operating system software fitness, fitness of compilers and development software used to develop an application, installation errors, software and hardware compatibility problems, malfunctions or failures of electronic monitoring or control devices, transient failures of electronic systems (hardware and/or software), unanticipated uses or misuses, or errors on the part of the user or applications designer (adverse factors such as these are hereafter collectively termed "system failures"). Any application where a system failure would create a risk of harm to property or persons (including the risk of bodily injury and death) should not be reliant solely upon one form of electronic system due to the risk of system failure. To avoid damage, injury, or death, the user or application designer must take reasonably prudent steps to protect against system failures, including but not limited to back-up or shut down mechanisms. Because each end-user system is customized and differs from Mesulog's testing platforms and because a user or application designer may use Mesulog products in combination with other products in a manner not evaluated or contemplated by Mesulog, the user or application designer is ultimately responsible for verifying and validating the suitability of Mesulog products whenever Mesulog products are incorporated in a system or application, including, without limitation, the appropriate design, process and safety level of such system or application.