4
tomonitoracriticalfunction.
♦ The internal speakers of this touchmonitor must not be the sole method of
warningofacriticalfunction.
Criticalfunctionsare:
1. Lifesupportdevicesorsystemsaredevicesorsystemswhich,(a)areintended
for surgical implant into the body, or (b) support
or sustain life, or (c) whose
failuretoperformwhenproperlyusedinaccordancewithinstructionsforuse
provided in the labeling, can be reasonably expected to result in significant
injurytotheuser.
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
thelifesupportdeviceorsystem,ortoaffectitssafetyoreffectiveness.
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INTRODUCTION ................................................................. ..................... ................... 7
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