PDF(Pubmed)
Abstract：
OBJECTIVE: To report a validation of the Riester Big Ben Square Desk Aneroid Sphygmomanometer according to the international protocol developed by the Working Group on Blood Pressure Monitoring of the European Society of Hypertension 2002 (ESH-IP 2002) in the interest of transparency. This legacy publication is intended to assure users that the device satisfied the requirements in place at that time.
METHODS: Performance of the device was assessed by participants\' age, sex, arm circumference and entry SBP/DBP. Validation was performed in 33 participants. The sphygmomanometer was assessed according to the ESH-IP, which defines zones of accuracy compared to the mercury standard as ≤5, ≤10, ≤15 mmHg or more.
RESULTS: The mean (± SD) age was 50.5 ± 13.0 years, range 29-71 years, entry SBP 142.6 ± 23.7 mmHg, entry DBP 89.0 ± 17.8 mmHg. The device passed all the requirements listed and the validation protocol. The Riester Big Ben Square Desk aneroid sphygmomanometer slightly underestimated the observer-measured SBP, yet slightly overestimated DBP. The observer-device disagreement was -0.8 ± 6.4 mmHg SBP and +0.6 ± 4.0 mmHg DBP.
CONCLUSIONS: These data show that the Riester Big Ben Square Desk aneroid sphygmomanometer fulfilled the ESH-IP 2002 requirements for the validation of BP monitors. It was on this basis that the British and Irish Hypertension Society recommended it for clinical use in the adult population.
METHODS: Performance of the device was assessed by participants\' age, sex, arm circumference and entry SBP/DBP. Validation was performed in 33 participants. The sphygmomanometer was assessed according to the ESH-IP, which defines zones of accuracy compared to the mercury standard as ≤5, ≤10, ≤15 mmHg or more.
RESULTS: The mean (± SD) age was 50.5 ± 13.0 years, range 29-71 years, entry SBP 142.6 ± 23.7 mmHg, entry DBP 89.0 ± 17.8 mmHg. The device passed all the requirements listed and the validation protocol. The Riester Big Ben Square Desk aneroid sphygmomanometer slightly underestimated the observer-measured SBP, yet slightly overestimated DBP. The observer-device disagreement was -0.8 ± 6.4 mmHg SBP and +0.6 ± 4.0 mmHg DBP.
CONCLUSIONS: These data show that the Riester Big Ben Square Desk aneroid sphygmomanometer fulfilled the ESH-IP 2002 requirements for the validation of BP monitors. It was on this basis that the British and Irish Hypertension Society recommended it for clinical use in the adult population.
摘要：
目的：根据欧洲高血压学会血压监测工作组2002（ESH-IP2002）制定的国际协议，报告对Riester大本钟台式无血血压计的验证。此传统出版物旨在向用户保证该设备满足当时的要求。
方法：根据参与者的年龄，性别,臂围和入口SBP/DBP。对33名参与者进行了验证。根据ESH-IP评估血压计，与汞标准相比，其精度区域定义为≤5、≤10、≤15mmHg或更高。
结果：平均（±SD）年龄为50.5±13.0岁，范围29-71年，输入SBP142.6±23.7mmHg，条目DBP89.0±17.8mmHg。设备通过了列出的所有要求和验证协议。里斯特大本钟方桌无液血压计稍微低估了观察者测量的SBP,但稍微高估了DBP。观察者与装置的分歧为-0.8±6.4mmHgSBP和0.6±4.0mmHgDBP。
结论：这些数据表明，RisterBigBenSquare台式无液血压计符合ESH-IP2002对BP监测仪的验证要求。正是在此基础上，英国和爱尔兰高血压协会建议将其用于成人人群的临床使用。
方法：根据参与者的年龄，性别,臂围和入口SBP/DBP。对33名参与者进行了验证。根据ESH-IP评估血压计，与汞标准相比，其精度区域定义为≤5、≤10、≤15mmHg或更高。
结果：平均（±SD）年龄为50.5±13.0岁，范围29-71年，输入SBP142.6±23.7mmHg，条目DBP89.0±17.8mmHg。设备通过了列出的所有要求和验证协议。里斯特大本钟方桌无液血压计稍微低估了观察者测量的SBP,但稍微高估了DBP。观察者与装置的分歧为-0.8±6.4mmHgSBP和0.6±4.0mmHgDBP。
结论：这些数据表明，RisterBigBenSquare台式无液血压计符合ESH-IP2002对BP监测仪的验证要求。正是在此基础上，英国和爱尔兰高血压协会建议将其用于成人人群的临床使用。
