Elo TouchSystems 1528L

UserManual:1528L

SW200095RevA,Page4of39

CAUTION-Life Support

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 fail-safe must be available should the touchscreen fail to

operate.

 The touchscreen interface must not be the only means of control of a critical

function.

 An Alternate video monitor should be incorporated into the safety design if used

to monitor a critical function.

 The internal speakers of this touchmonitor 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 reasonably 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.