Pulse Oximeter Testing Standards
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Questions and Answers

Que é un funcional probador segundo as normativas mencionadas?

  • Un dispositivo para xerar sinais simulados para probas de monitorización de SpO2. (correct)
  • Un software para analizar datos clínicos.
  • Un dispositivo que mide a presión arterial.
  • Un tipo de sensor para medir a temperatura corporal.
  • Os valores de SpO2 obtidos mediante un funcional probador son:

  • Irrelevantes con respecto ao funcionamento do dispositivo real.
  • Sempre precisos e fiables para uso clínico.
  • Sólo indicativos da habilidade do monitor para reproducir a curva de calibración. (correct)
  • Obxectivamente correctos en todos os casos.
  • Para verificar o rendemento dos dispositivos de SpO2, un funcional probador debe usar:

  • Valores de R preestablecidos. (correct)
  • Calibración aleatoria de sinais.
  • Valores de análise de temperatura.
  • Valores de CO-oximetría.
  • Que papel xoga a curva R na avaliación dos dispositivos de SpO2?

    <p>Proporciona unha base para calibrar os dispositivos de SpO2.</p> Signup and view all the answers

    Cal é a función principal do sensor PPG do dispositivo MAXREFDES103?

    <p>Capturar sinais biolóxicos importantes para a saúde.</p> Signup and view all the answers

    O que se necesita para establecer o ambiente de proba para o AECG100?

    <p>Un ordenador e un sistema AECG100 conectado.</p> Signup and view all the answers

    Que tipo de luz usa o dispositivo durante a proba de SpO2?

    <p>Luz vermella e infravermella.</p> Signup and view all the answers

    A que se refire a calibración clínica de dispositivos de SpO2?

    <p>Asegurar a precisión dos resultados a través de métodos específicos.</p> Signup and view all the answers

    Que aspecto non é regulado polas normativas mencionadas sobre os probadores de función?

    <p>Os pasos detallados para a proba.</p> Signup and view all the answers

    Que se busca ao evaluar a capacidade de reprodución do dispositivo de SpO2?

    <p>Obter datos de calibración que se axusten aos estándares esperados.</p> Signup and view all the answers

    Study Notes

    Introduction to Pulse Oximeter Testing

    • Compliance with ISO 80601-2-61:2011 and YY0784_2010 standards for testing pulse oximeter devices using simulation signal generators referred to as functional test instruments.
    • Functional test instruments help determine if pulse oximeters and their probes can perform as designed by manufacturers, but they do not confirm accuracy of performance.
    • Accurate blood oxygen values require clinical calibration using CO-oximeters or recalibrated pulse oximeter devices.

    Functional Test Instruments

    • These instruments provide a preset R value signal, allowing stakeholders to observe the displayed SpO2 values for comparison against expected values for specific pulse oximeter models.
    • If a manufacturer knows the R curve associated with a particular model, they can generate an accurate R value corresponding to specified blood oxygen levels (e.g., 85%).
    • Assessment of a pulse oximeter's ability to reproduce its internal calibration curve is possible.

    Limitations of SpO2 Readings

    • Accurate SpO2 readings from functional test instruments do not guarantee accuracy on human subjects.
    • Function test instruments can only evaluate the reproduction capability of the pulse oximeter’s curve, which may not be accurate.

    Testing Methodology

    • Blood oxygen functional test instruments use a designated R value signal to assess the functions and reproduction abilities of pulse oximeters, referred to as the R curve.
    • ISO 80601-2-61:2011 and YY0784_2010 mainly focus on clinical test methods; specific protocols for testing using blood oxygen functional test instruments are not detailed.
    • The described method for testing reflective SpO2 is based on the principles of transmittance SpO2 testing methods as per the standards.

    AECG100 Functional Test Instrument

    • Introduction of AECG100 as a functional test instrument to evaluate wearable devices with SpO2 measurement capabilities, using Maxim's MAXREFDES103 as a test subject.
    • To set up the testing environment:
      • A PC with AECG100 software installed and connected to the AECG100 test system.
      • The MAXREFDES103 wearable device.
      • A fixture for pairing with MAXREFDES103.

    MAXREFDES103 Device Overview

    • MAXREFDES103 platform features:
      • High-sensitivity green/red/infrared PPG biosensors, power management IC, algorithms in microcontrollers, Bluetooth for wireless communication, and a tri-axis accelerometer.
      • Designed for wrist-worn usage, capturing crucial biometric signals for health care.
      • Algorithms calculate heart health metrics such as heart rate (HR), SpO2, and heart rate variability (HRV).

    Testing Setup for SpO2 Measurement

    • Equipment description:
      • Diagrams illustrate the structure of MAXREFDES103 and the design of a 3D fixture for connecting AECG100 PPG and MAXREFDES103 to test SpO2.
      • The 3D fixture features openings for aligning DUT LED emissions for red/infrared light while blocking green light to facilitate SpO2 testing.
      • Proper alignment ensures that PPG LED and DUT photodiodes (PD) pair effectively for accurate testing results.

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    Description

    Este cuestionario explora os estándares ISO80601-2-61:2011 e YY0784_2010 para a proba de equipos de oxímetro de pulso. A función de probas permite verificar se o equipamento se comporta segundo as especificacións do fabricante, pero a calibración clínica é esencial para obter valores de SpO2 precisos. Avalíase a importancia da comparación entre os valores amosados e os valores esperados.

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