高倍轮盘® standard products are not recommended, authorized or intended for use in lifesaving, life-critical or life-sustaining applications, nor in any other applications where failure or malfunction may result in personal injury or death. Life-critical applications include devices identified by the U.S. Food and Drug Administration as Class III devices and generally equivalent classifications outside of the United States. Unless expressly and specifically approved in writing by two authorized 高倍轮盘 representatives on a case-by-case basis, use of any 高倍轮盘® standard products in such unauthorized applications is not safe and thus is at the user’s sole risk.