Abstract：
OBJECTIVE: To validate the noninvasive blood pressure monitoring function of the EDAN elite V5 patient monitor with reference invasive blood pressure monitoring equipment for clinical use in adults, adolescents or children according to the International Organization for Standardization (ISO) 81060-2:2018 standard.
METHODS: Patients were recruited, and the ipsilateral sequential method was used for blood pressure measurement according to the standard. The validation results were assessed following the protocol and the Bland-Altman scatterplot was used to show the difference between the test device and reference invasive blood pressure results.
RESULTS: A total of 71 patients were included in the study, with 35 and 36 patients for each iFAST and iCUFS mode, respectively. The validation results showed an average device-reference difference of -3.27 ± 5.60 mmHg for SBP and -0.09 ± 6.10 mmHg for DBP for the iFAST mode, and -2.04 ± 5.55 mmHg for SBP and -0.79 ± 5.86 mmHg for DBP for the iCUFS mode, respectively, which passed the criteria of the ISO 81060-2 : 2018 in adults, adolescents or children population for both SBP and DBP.
CONCLUSIONS: The noninvasive blood pressure monitoring function of the EDAN elite V5 patient monitor passed all the requirements of ISO 81060-2:2018 and can be recommended for clinical use in adults, adolescents, or children.
METHODS: Patients were recruited, and the ipsilateral sequential method was used for blood pressure measurement according to the standard. The validation results were assessed following the protocol and the Bland-Altman scatterplot was used to show the difference between the test device and reference invasive blood pressure results.
RESULTS: A total of 71 patients were included in the study, with 35 and 36 patients for each iFAST and iCUFS mode, respectively. The validation results showed an average device-reference difference of -3.27 ± 5.60 mmHg for SBP and -0.09 ± 6.10 mmHg for DBP for the iFAST mode, and -2.04 ± 5.55 mmHg for SBP and -0.79 ± 5.86 mmHg for DBP for the iCUFS mode, respectively, which passed the criteria of the ISO 81060-2 : 2018 in adults, adolescents or children population for both SBP and DBP.
CONCLUSIONS: The noninvasive blood pressure monitoring function of the EDAN elite V5 patient monitor passed all the requirements of ISO 81060-2:2018 and can be recommended for clinical use in adults, adolescents, or children.
摘要：
目的：通过参考有创血压监测设备，验证EDAN精英V5患者监护仪的无创血压监测功能，以供成人临床使用，根据国际标准化组织（ISO）81060-2：2018标准的青少年或儿童。
方法：招募患者，按标准采用同侧序贯法测定血压。验证结果按照方案进行评估，Bland-Altman散点图用于显示测试设备和参考有创血压结果之间的差异。
结果：本研究共纳入71例患者，每种iFAST和iCUFS模式有35和36名患者，分别。验证结果显示，iFAST模式下SBP和DBP的平均设备参考差异为-3.27±5.60mmHg，为-0.09±6.10mmHg。对于iCUFS模式，SBP为-2.04±5.55mmHg，DBP为-0.79±5.86mmHg，分别,在成年人中通过了ISO81060-2：2018的标准，SBP和DBP的青少年或儿童人群。
结论：EDAN精英V5患者监护仪的无创血压监测功能通过了ISO81060-2：2018的所有要求，可推荐用于成人临床使用，青少年,或孩子。
方法：招募患者，按标准采用同侧序贯法测定血压。验证结果按照方案进行评估，Bland-Altman散点图用于显示测试设备和参考有创血压结果之间的差异。
结果：本研究共纳入71例患者，每种iFAST和iCUFS模式有35和36名患者，分别。验证结果显示，iFAST模式下SBP和DBP的平均设备参考差异为-3.27±5.60mmHg，为-0.09±6.10mmHg。对于iCUFS模式，SBP为-2.04±5.55mmHg，DBP为-0.79±5.86mmHg，分别,在成年人中通过了ISO81060-2：2018的标准，SBP和DBP的青少年或儿童人群。
结论：EDAN精英V5患者监护仪的无创血压监测功能通过了ISO81060-2：2018的所有要求，可推荐用于成人临床使用，青少年,或孩子。
