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Functional testers/Simulators

ISO 9919 / draft ISO 80601-2-61
Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use
Functional Testers/Simulators

  • 'A functional tester cannot be used to assess the accuracy of a pulse oximeter probe or a pulse oximeter monitor.'
  • If a particular functional tester has the appropriate r curves it 'can measure the contribution of the monitor to the total error of a monitor/probe system.'
  • Functional testers lack the spectral resolution to check the accuracy of a sensor.