Abstract：
OBJECTIVE: To validate the ANDON KD-595 automated upper-arm blood pressure monitor for clinical use and self-measurement blood pressure measurement according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Universal Standard.
METHODS: Same left-arm blood pressure was sequentially measured in 90 qualified adult participants and compared with a standard mercury sphygmomanometer. A total of 270 comparison pairs were obtained and analyzed according to the universal standard.
RESULTS: For the validation Criterion 1 of the universal standard, the mean ± SD of the differences between the test device and reference blood pressure readings was 0.96 ± 5.35 and 0.82 ± 5.08 mmHg for SBP and DBP, respectively. For Criterion 2, the SDs of the averaged blood pressure differences between the test device and reference blood pressure per subject were 4.84 and 4.64 mmHg (with maximum allowed SDs of 6.87 and 6.89 mmHg) for SBP and DBP, respectively.
CONCLUSIONS: The ANDON KD-595 automated upper-arm blood pressure monitor passed all the validation requirements according to the AAMI/ESH/ISO Universal Standard and can be recommended for clinical use and self-measurement blood pressure measurement in the general population.
METHODS: Same left-arm blood pressure was sequentially measured in 90 qualified adult participants and compared with a standard mercury sphygmomanometer. A total of 270 comparison pairs were obtained and analyzed according to the universal standard.
RESULTS: For the validation Criterion 1 of the universal standard, the mean ± SD of the differences between the test device and reference blood pressure readings was 0.96 ± 5.35 and 0.82 ± 5.08 mmHg for SBP and DBP, respectively. For Criterion 2, the SDs of the averaged blood pressure differences between the test device and reference blood pressure per subject were 4.84 and 4.64 mmHg (with maximum allowed SDs of 6.87 and 6.89 mmHg) for SBP and DBP, respectively.
CONCLUSIONS: The ANDON KD-595 automated upper-arm blood pressure monitor passed all the validation requirements according to the AAMI/ESH/ISO Universal Standard and can be recommended for clinical use and self-measurement blood pressure measurement in the general population.
摘要：
目的：根据医疗器械促进协会/欧洲高血压学会/国际标准化组织（AAMI/ESH/ISO）通用标准，验证ANDONKD-595自动上臂血压监测仪的临床用途和自我测量血压。
方法：在90名合格的成年参与者中依次测量相同的左臂血压，并与标准的水银血压计进行比较。根据通用标准共获得并分析了270个比较对。
结果：对于通用标准的验证标准1，对于SBP和DBP，测试设备和参考血压读数之间的差异的平均值±SD为0.96±5.35和0.82±5.08mmHg，分别。对于标准2，SBP和DBP的测试设备和参考血压之间的平均血压差异的SDs为4.84和4.64mmHg（最大允许SDs为6.87和6.89mmHg）。分别。
结论：ANDONKD-595自动上臂血压监测仪通过了AAMI/ESH/ISO通用标准的所有验证要求，可推荐用于临床使用和自我测量一般人群的血压测量。
方法：在90名合格的成年参与者中依次测量相同的左臂血压，并与标准的水银血压计进行比较。根据通用标准共获得并分析了270个比较对。
结果：对于通用标准的验证标准1，对于SBP和DBP，测试设备和参考血压读数之间的差异的平均值±SD为0.96±5.35和0.82±5.08mmHg，分别。对于标准2，SBP和DBP的测试设备和参考血压之间的平均血压差异的SDs为4.84和4.64mmHg（最大允许SDs为6.87和6.89mmHg）。分别。
结论：ANDONKD-595自动上臂血压监测仪通过了AAMI/ESH/ISO通用标准的所有验证要求，可推荐用于临床使用和自我测量一般人群的血压测量。
