Questions and Answers
Que é un funcional probador segundo as normativas mencionadas?
Os valores de SpO2 obtidos mediante un funcional probador son:
Para verificar o rendemento dos dispositivos de SpO2, un funcional probador debe usar:
Que papel xoga a curva R na avaliación dos dispositivos de SpO2?
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Cal é a función principal do sensor PPG do dispositivo MAXREFDES103?
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O que se necesita para establecer o ambiente de proba para o AECG100?
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Que tipo de luz usa o dispositivo durante a proba de SpO2?
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A que se refire a calibración clínica de dispositivos de SpO2?
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Que aspecto non é regulado polas normativas mencionadas sobre os probadores de función?
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Que se busca ao evaluar a capacidade de reprodución do dispositivo de SpO2?
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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.
