Department of Cardiology, Shenzhen Hospital, University of Chinese Academy of Sciences, Guangming District, Shenzhen, Guangdong Province, China.
Blood Press Monit. 2023 Jun 1;28(3):163-166. doi: 10.1097/MBP.0000000000000643. Epub 2023 Mar 7.
To validate the JAMR F1701T (arm type) blood pressure (BP) monitor according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Universal Standard (ISO 81060-2:2018). A total of 90 subjects (male 60 and female 30) were recruited to fulfill the criteria of the AAMI/ESH/ISO Universal Standard (the number, gender, age, limber size, and BP distribution), and sequential measurements of BP, including both SBP and DBP were obtained using the test device and the standard mercury sphygmomanometer. A total of 270 sets of comparison data (three sets of each subject) were obtained and analyzed. According to the validation criterion 1 of ISO 81060-2:2018, the mean ± SD of the differences between the JAMR F1701T and mercury sphygmomanometer BP (systolic/diastolic) readings was 2.06 ± 6.83/-4.84 ± 5.23 mmHg. For criterion 2, the SD of the averaged BP (systolic/diastolic) differences between the JAMR F1701 and reference BP (systolic/diastolic) per participant was 5.62/4.39 mmHg (the requirement was ≤6.43/5.01 mmHg by calculation). The JAMR F1701T met all the requirements of the ISO 81060-2:2018, and can be recommended for clinical and self/home use.
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（ISO 81060-2：2018），对 JAMR F1701T（臂式）血压（BP）监测仪进行验证。
共招募 90 名受试者（男 60 名，女 30 名），满足 AAMI/ESH/ISO 通用标准的标准（人数、性别、年龄、肢体尺寸和 BP 分布），使用测试设备和标准汞柱血压计连续测量 BP，包括 SBP 和 DBP。共获得 270 组比较数据（每组 3 个数据）并进行分析。根据 ISO 81060-2：2018 的验证标准 1，JAMR F1701T 与汞柱血压计 BP（收缩压/舒张压）读数之间的差异平均值±SD 为 2.06±6.83/-4.84±5.23mmHg。对于标准 2，JAMR F1701 和参考 BP（收缩压/舒张压）之间的平均 BP（收缩压/舒张压）差异的 SD 为 5.62/4.39mmHg（计算得出的要求为≤6.43/5.01mmHg）。JAMR F1701T 符合 ISO 81060-2：2018 的所有要求，可推荐用于临床和自我/家庭使用。
