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Originally Published MD&DI October 2007

VALIDATION

User Tasks

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Manufacturers must demonstrate that their device enables users to perform tasks, such as those listed here, with little or no chance of an error.
  • Turn on the monitor.
  • Configure the monitor to display two ECG waveforms, heart rate, arterial blood pressure, and oxygen saturation.
  • Set the monitor to take a noninvasive blood pressure reading every 15 minutes.
  • Set the heart-rate alarm limits to 150 and 50 bpm.
  • Display an ST segment analysis.
  • Display the heart-rate trend.
  • Print out the ECG-Lead 1 waveform on a paper strip.

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