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Care must be taken when this touchmonitor is a critical component of a life support system or device. In case of failure of this touchmonitor, appropriate redundant systems should be incorporated into the system or device to prevent injury to the user or patient.
The following should be an integral part of the safety design of a life support system or device using this touchmonitor for a critical function.
•An alternate interface or
•The touchscreen interface must not be the only means of control of a critical function.
•An alternate video display should be incorporated into the safety design if used to monitor a critical function.
•The internal speakers of this touchscreen monitor must not be the sole method of warning of a critical function.
Critical functions are:
1.Life support devices or systems are devices or systems which, (a) are intended for surgical implant into the body, or (b) support or sustain life, or (c) whose failure to perform when properly used in accordance with instructions for use provided in the labeling, can be reason ably expected to result in significant injury to the user.
2.A critical component is any component of a life support device or system whose failure to perform can be reasonably expected to cause the failure of the life support device or system, or to affect its safety or effectiveness.
Definitions:
“ PATIENT ENVIRONMENT”
any environment in which intentional or unintentional contact can occur between a PATIENT and parts of the ME EQUIPMENT or ME SYSTEM or between a PATIENT and other persons touching parts of the ME EQUIPMENT or ME SYSTEM.
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