Saturation of peripheral oxygen （SpO2） is one of the most important parameters of vital signs. Pulse oximeter based on near-infrared spectroscopy is commonly used as a non-invasive method to measure SpO2 yl. Current...Saturation of peripheral oxygen （SpO2） is one of the most important parameters of vital signs. Pulse oximeter based on near-infrared spectroscopy is commonly used as a non-invasive method to measure SpO2 yl. Currently, medical device manufacturers as well as metrology measurement agencies in China usually use pulse oximeter simulator as the commonly accepted functional calibration equipment for pulse oximeters. So far, no experimental protocol or devices can be used to test the accuracy and reliability of a pulse oximeter simulator. Therefore, a set of new metrology apparatus with the name of calibration device for pulse oximeter simulator have been designed in order to make a traceable system for the calibration or verification of pulse oximeter simulators. The principles and some research methods of this calibration device for pulse oximeter simulator will be discussed in this paper. Besides that, many experiments have been applied in order to guarantee the accuracy as well as traceability of this set of device.展开更多
Background: Our paper aimed to investigate whether there was a correlation among the pulse oximetry, cerebral oximetry (CO) and MetHb (methemoglobin) values of a patient with congenital methemoglobinemia who underwent...Background: Our paper aimed to investigate whether there was a correlation among the pulse oximetry, cerebral oximetry (CO) and MetHb (methemoglobin) values of a patient with congenital methemoglobinemia who underwent a laparoscopic cholecystectomy operation. Case: The 35-year-old male patient with a weight of 70 kg, body massindex (BMI) of 21, American Society of Anesthesia status-2(ASA-2) category who was planned for laparoscopic cholecystectomy operation was identified to have been diagnosed with congenital methemoglobinemia as per his medical history was methemoglobin levels ranged between 12% and 20% according to the periodical measurements taken for the past 3 years. The patient received standard monitoring during anesthesia and device monitoring with a cerebral oximeter (Invos 5100C somatic/cerebral oximeter, Covidien) and a CO-oximetry (Rad ?87 “Rainbow”, Masimo Inc., Irvine, CA) device to continuously follow up his MetHb values was also added. During the intra-operative follow-up, the patient’s methemoglobin level rose to 16%, his peripheral oxygen saturation levels decreased to 86% and his cerebral oximetry values were identified to have also decreased;therefore, methylene blue (MB) was intravenously administered to the patient. The patient continued to be followed up in the post-operative period and he did not develop any complications. Discussion: Appropriate treatment and monitoring enabled the prevention of potential complications. We believe that monitoring with NIRS and MASIMO CO-oximetry device will enable physicians to perform a safe follow-up and treatment in the intraoperative and postoperative follow-up of methemoglobinemia patients.展开更多
Photoelectric pulse oximeters are widely favored for their non-invasive and continuous monitoring of pulse rate and blood oxygen saturation,which are vital indicators of physiological health.However,traditional pulse ...Photoelectric pulse oximeters are widely favored for their non-invasive and continuous monitoring of pulse rate and blood oxygen saturation,which are vital indicators of physiological health.However,traditional pulse oximeters are frequently hindered by several limitations,such as high-power consumption,instability,and reduced precision.Herein,a WSe_(2)/Si p-n heterojunction photodiode was in-situ fabricated for self-powered high-precision pulse rate and blood oxygen saturation monitoring.Our device demonstrated the excellent broadband photoresponse performance from 265 to 980 nm,covering the biological window,including a high responsivity of 740 mA/W,a fast response time of 7.8/7.1μs and a low detection limit of 25 nW/cm^(2).Leveraging these prominent photoelectrical properties,the WSe_(2)/Si photodiode demonstrates high accuracy and reliability in detecting the physiological signals of heart rate and blood oxygen saturation through a triple-wavelength measurement method,with an error margin of less than 1%,thereby validating its accuracy and reliability for non-invasive health monitoring applications.These achievements provide a new approach for developing low-power,high-sensitivity optoelectronic pulse oximeters.展开更多
A medical device is an instrument that includes components,parts,or accessories to diagnose or treat patients.Since the complexity of medical devices has increased in recent years,functional safety and basic safety ar...A medical device is an instrument that includes components,parts,or accessories to diagnose or treat patients.Since the complexity of medical devices has increased in recent years,functional safety and basic safety are required to ensure the overall device safety.Functional safety is part of the overall safety that relates to the equipment under control(EUC)and to the EUC control system that depends on the correct functionality of the electrical/electronic/programmable electronic(E/E/PE)safety-related systems.This study proposes approach methods to functional safety of medical devices for which it is important to correctly identify the safety functions and the safety integrity level(SIL).The relationship between the functional safety and essential performance is identified focusing on the safety function.The essential performance of E/E/PE systems is defined as the safety function of the functional safety.The target SIL of the essential performance is determined according to the potential risk levels,based on the classification rules of medical devices.This approach is applied to the pulse oximeter as a case study.The target SIL for the functionality of the power-failure alarm condition is determined to be SIL1.The target SILs of other functions are determined as SIL2.展开更多
文摘Saturation of peripheral oxygen （SpO2） is one of the most important parameters of vital signs. Pulse oximeter based on near-infrared spectroscopy is commonly used as a non-invasive method to measure SpO2 yl. Currently, medical device manufacturers as well as metrology measurement agencies in China usually use pulse oximeter simulator as the commonly accepted functional calibration equipment for pulse oximeters. So far, no experimental protocol or devices can be used to test the accuracy and reliability of a pulse oximeter simulator. Therefore, a set of new metrology apparatus with the name of calibration device for pulse oximeter simulator have been designed in order to make a traceable system for the calibration or verification of pulse oximeter simulators. The principles and some research methods of this calibration device for pulse oximeter simulator will be discussed in this paper. Besides that, many experiments have been applied in order to guarantee the accuracy as well as traceability of this set of device.
文摘Background: Our paper aimed to investigate whether there was a correlation among the pulse oximetry, cerebral oximetry (CO) and MetHb (methemoglobin) values of a patient with congenital methemoglobinemia who underwent a laparoscopic cholecystectomy operation. Case: The 35-year-old male patient with a weight of 70 kg, body massindex (BMI) of 21, American Society of Anesthesia status-2(ASA-2) category who was planned for laparoscopic cholecystectomy operation was identified to have been diagnosed with congenital methemoglobinemia as per his medical history was methemoglobin levels ranged between 12% and 20% according to the periodical measurements taken for the past 3 years. The patient received standard monitoring during anesthesia and device monitoring with a cerebral oximeter (Invos 5100C somatic/cerebral oximeter, Covidien) and a CO-oximetry (Rad ?87 “Rainbow”, Masimo Inc., Irvine, CA) device to continuously follow up his MetHb values was also added. During the intra-operative follow-up, the patient’s methemoglobin level rose to 16%, his peripheral oxygen saturation levels decreased to 86% and his cerebral oximetry values were identified to have also decreased;therefore, methylene blue (MB) was intravenously administered to the patient. The patient continued to be followed up in the post-operative period and he did not develop any complications. Discussion: Appropriate treatment and monitoring enabled the prevention of potential complications. We believe that monitoring with NIRS and MASIMO CO-oximetry device will enable physicians to perform a safe follow-up and treatment in the intraoperative and postoperative follow-up of methemoglobinemia patients.
基金financially supported by the National Natural Science Foundation of China(Nos.U22A20138 and 62374149)the Natural Science Foundation of Henan Province(No.252300421059)Henan Province Undergraduate Colleges and Universities Young Key Teachers Development Program(No.2023GGJS007).
文摘Photoelectric pulse oximeters are widely favored for their non-invasive and continuous monitoring of pulse rate and blood oxygen saturation,which are vital indicators of physiological health.However,traditional pulse oximeters are frequently hindered by several limitations,such as high-power consumption,instability,and reduced precision.Herein,a WSe_(2)/Si p-n heterojunction photodiode was in-situ fabricated for self-powered high-precision pulse rate and blood oxygen saturation monitoring.Our device demonstrated the excellent broadband photoresponse performance from 265 to 980 nm,covering the biological window,including a high responsivity of 740 mA/W,a fast response time of 7.8/7.1μs and a low detection limit of 25 nW/cm^(2).Leveraging these prominent photoelectrical properties,the WSe_(2)/Si photodiode demonstrates high accuracy and reliability in detecting the physiological signals of heart rate and blood oxygen saturation through a triple-wavelength measurement method,with an error margin of less than 1%,thereby validating its accuracy and reliability for non-invasive health monitoring applications.These achievements provide a new approach for developing low-power,high-sensitivity optoelectronic pulse oximeters.
文摘A medical device is an instrument that includes components,parts,or accessories to diagnose or treat patients.Since the complexity of medical devices has increased in recent years,functional safety and basic safety are required to ensure the overall device safety.Functional safety is part of the overall safety that relates to the equipment under control(EUC)and to the EUC control system that depends on the correct functionality of the electrical/electronic/programmable electronic(E/E/PE)safety-related systems.This study proposes approach methods to functional safety of medical devices for which it is important to correctly identify the safety functions and the safety integrity level(SIL).The relationship between the functional safety and essential performance is identified focusing on the safety function.The essential performance of E/E/PE systems is defined as the safety function of the functional safety.The target SIL of the essential performance is determined according to the potential risk levels,based on the classification rules of medical devices.This approach is applied to the pulse oximeter as a case study.The target SIL for the functionality of the power-failure alarm condition is determined to be SIL1.The target SILs of other functions are determined as SIL2.
