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首页> 外文期刊>Blood Pressure Monitoring >Validation of the ROSSMAX blood pressure measuring monitor according to the European Society of Hypertension International Protocol for Validation of Blood Pressure Measuring Devices in Adults.
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Validation of the ROSSMAX blood pressure measuring monitor according to the European Society of Hypertension International Protocol for Validation of Blood Pressure Measuring Devices in Adults.

机译：根据欧洲高血压学会成人血压测量设备验证国际协议，对ROSSMAX血压测量监视器进行验证。

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SUMMARY: BACKGROUND It is now accepted that blood pressure measuring devices should be subjected to an independent evaluation of their accuracy before they are marketed for clinical use. The results of validation of the ROSSMAX Blood Pressure Measuring Monitor for self-measurement according to the European Society of Hypertension International Protocol for Validation of Blood Pressure Measuring Devices in Adults are presented in this paper.POPULATION Thirty-three subjects were recruited from among staff and patients at Beaumont Hospital, Dublin, Ireland.METHODS The ROSSMAX monitor was connected to the Sphygmocorder, an audiovisual system for validation, which records blood pressure on tape and video for later analysis. Nine sequential same-arm measurements between the device and a standard mercury sphygmomanometer were recorded using the Sphygmocorder.RESULTS In phase 1, the ROSSMAX monitor produced 21 measurements within 5 mmHg, 31 within 10 mmHg and 38 within 15 mmHg for systolic blood pressure (SBP), and 36 within 5 mmHg, 43 within 10 mmHg and 45 within 15 mmHg for diastolic blood pressure (DBP). The mean differences were -5.6 (10.2) [mean (SD)] mmHg for SBP and -0.5 (4.5) mmHg for DBP. The ROSSMAX monitor failed to meet any of the criteria for SBP but comfortably passed all of the criteria for DBP. In phase 2.1, the ROSSMAX monitor had 51 measurements within 5 mmHg, 73 within 10 mmHg and 86 within 15 mmHg for SBP, and 71 measurements within 5 mmHg, 93 within 10 mmHg and 98 within 15 mmHg for DBP. The mean differences were -4.5. (9.5) mmHg for SBP and -1.8 (5.0) mmHg for DBP. The ROSSMAX monitor failed to meet any of the criteria for SBP but comfortably passed all of the criteria for DBP. In phase 2.2, 16 subjects had at least two of the differences lying within 5 mmHg and 10 subjects had no differences within 5 mmHg for SBP; 26 subjects had at least two of the differences falling within 5 mmHg and three subjects no differences within 5 mmHg for DBP. The ROSSMAX monitor failed to meet the criteria for SBP but passed the criteria for DBP.CONCLUSIONS The ROSSMAX monitor cannot be recommended for clinical use in an adult population because it records SBP inaccurately.
机译：概述：背景技术现在已经接受的是，在将血压测量设备推向临床使用之前，应对其准确性进行独立评估。本文介绍了根据欧洲高血压学会国际成人血压测量设备验证协议对ROSSMAX血压测量监测仪进行自我测量的验证结果。人口招募了33名受试者，其中包括方法将ROSSMAX监护仪连接到Sphygmocorder，这是一个用于验证的视听系统，该系统将血压记录在磁带和录像带上，以供以后分析。结果在第一阶段，ROSSMAX监护仪在5 mmHg内进行了21次测量，在10 mmHg内进行了31次测量，在15 mmHg内进行了38次在15 mmHg之内的测量。 ）和5 mmHg内的36、10 mmHg内的43和15 mmHg内的45用于舒张压（DBP）。 SBP的平均差异为-5.6（10.2）[平均值（SD）] mmHg，DBP的平均差异为-0.5（4.5）mmHg。 ROSSMAX监视器无法满足SBP的任何标准，但可以轻松地通过DBP的所有标准。在阶段2.1中，对于SBP，ROSSMAX监护仪在5 mmHg内有51个测量值，在10 mmHg内有73个测量值，在15 mmHg内有86个测量值，对于DBP，有71个测量值在5 mmHg内，有93个测量值在10 mmHg内，有98个。平均差异为-4.5。对于SBP为（9.5）mmHg，对于DBP为-1.8（5.0）mmHg。 ROSSMAX监视器无法满足SBP的任何标准，但可以轻松地通过DBP的所有标准。在阶段2.2中，有16名受试者的SBP差异至少在5 mmHg之内，而10名受试者在5 mmHg之内没有差异。 26名受试者的DBP差异至少有2个在5 mmHg内，而3名受试者在5 mmHg内没有差异。 ROSSMAX监护仪未能达到SBP标准，但通过了DBP标准。结论ROSSMAX监护仪由于不准确记录SBP，因此不建议在成人人群中临床使用。

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