Institute of Cardiology and Cardiovascular Surgery, 17th street 702 between A and Paseo Avenue, Havana, 10400, Cuba.
Institute of Endocrinology, Zapata street and D street, Havana, 10400, Cuba.
J Hum Hypertens. 2024 Nov;38(11):779-785. doi: 10.1038/s41371-024-00948-9. Epub 2024 Aug 24.
This study evaluates the accuracy of the Hipermax-BF model A7101 (Combiomed, Havana, Cuba) automatic oscillometric upper-arm sphygmomanometer for office and home use in general population as part of the HEARTS in the Americas initiative. The research was developed according to the Universal Standard AAMI/ESH/ISO ISO 81060-2:2018/Amd 1:2020. The subjects were recruited according to the requirements of age, gender, blood pressure values and upper-arm circumference. The same upper-arm sequential blood pressure measurement method was used. For measurements with the device under test, the 2-piece cuff from 22-44 cm limb circumference range was used. 92 subjects were recruited and 85 were analyzed. Mean age was 44.8 ± 14.7 years, mean upper-arm circumference was 32.3 ± 6.2, and 56.5% were female. For Validation Criterion 1, the mean value ± standard deviation of the differences in readings between the device under test and the reference device was 1.2 ± 4.9/0.8 ± 4.9 mmHg (systolic/diastolic). For both pressures, in criterion 1 the standard requires a mean value of the differences ≤ ± 5 mmHg and a standard deviation ≤ ± 8 mmHg. For Validation Criterion 2, the standard deviation of the mean blood pressure differences per subject was 4.2/4.2 mmHg (systolic/diastolic). According to Table 1 of criterion 2, for the mean values of 1.2/0.8 mmHg (systolic/diastolic), the maximum allowable standard deviation had to be < 6.84 for systolic and < 6.89 for diastolic pressure. The Combiomed Hipermax-BF A7101 automatic sphygmomanometer meets the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018/Amd 1:2020) in the general population.
这项研究评估了 Combiomed 公司生产的 Hipermax-BF 模型 A7101 自动上臂血压计（位于古巴哈瓦那）在一般人群中的办公和家庭使用的准确性，该研究是作为美洲心脏倡议（HEARTS in the Americas）的一部分进行的。研究是根据通用标准 AAMI/ESH/ISO ISO 81060-2:2018/Amd 1:2020 进行的。根据年龄、性别、血压值和上臂周长的要求招募受试者。采用相同的上臂连续血压测量方法。对于测试设备的测量，使用了 22-44cm 肢体周长范围的 2 件袖带。共招募了 92 名受试者，其中 85 名进行了分析。平均年龄为 44.8±14.7 岁，平均上臂周长为 32.3±6.2cm，56.5%为女性。对于验证标准 1，测试设备和参考设备读数差异的平均值±标准差为 1.2±4.9/0.8±4.9mmHg（收缩压/舒张压）。对于两种压力，在标准 1 中，要求差异的平均值≤±5mmHg，标准差≤±8mmHg。对于验证标准 2，每个受试者的平均血压差异的标准差为 4.2/4.2mmHg（收缩压/舒张压）。根据标准 2 表 1，对于 1.2/0.8mmHg（收缩压/舒张压）的平均值，收缩压的最大允许标准差必须<6.84，舒张压的最大允许标准差必须<6.89。Combiomed Hipermax-BF A7101 自动血压计符合 AAMI/ESH/ISO 通用标准（ISO 81060-2:2018/Amd 1:2020）的要求。
