Validation of the A&D UM-212BLE monitor according to ISO 81060-2, 2018: a device with clinically important programmability.

IF 1.2 4区医学 Q4 PERIPHERAL VASCULAR DISEASE

Blood Pressure Monitoring Pub Date : 2023-04-01 Epub Date: 2023-02-13 DOI:10.1097/MBP.0000000000000636

Bruce S Alpert

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引用次数: 1

Abstract

Objective: The objective of this report was to describe the validation of the A&D UM-212BLE automated oscillometric sphygmomanometer to the ISO 81060-2, 2018 protocol. The device is specifically designed for enhanced office and out-of-office programmability.

Methods: A combined pediatric ( n = 35) and adult ( n = 50) population was studied at Clinmark LLC in Louisville, Colorado, USA. Same-arm sequential testing was performed following the ISO 81060-2, 2018 requirements. Five cuffs were tested with a total arm circumference range from 12 to 50 cm. Reference readings were done by two blinded observers performing simultaneous auscultation.

Results: For validation of Criterion 1 the mean ± SD (mmHg) of the device minus the reference differences were 3.94 ± 6.89 for SBP and 2.09 ± 6.68 for DBP. Both passed the Standard limits for Criterion 2; the systolic(S)SD achieved was 5.56 (5.70 permitted) and the diastolic(D)SD was 6.01 (6.62 permitted). All other Standard requirements were met.

Conclusions: The UM-212BLE passed all requirements. The features that make this device clinically superior include settings for automated office BP, variable pressure inflation, dual measurement modes (oscillometry, auscultation), the wide range of cuffs tested, automated irregular heartbeat detection, and full validation in a pediatric population. The inclusion of all of these features makes the UM-212BLE a highly attractive device for both office and out-of-office BP estimation.

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根据ISO 81060-22018验证A&D UM-212BLE监护仪：一种具有临床重要可编程性的设备。

目的：本报告的目的是描述A&D UM-212BLE自动示波血压计是否符合ISO 81060-22018协议。该设备专为增强办公室和办公室外的可编程性而设计。方法：一组儿童（n = 35）和成人（n = 50）群体在美国科罗拉多州路易斯维尔的Clinmark LLC进行了研究。根据ISO 81060-22018的要求进行了相同臂序列测试。测试了五个袖口，总臂围在12到50之间参考读数由两名同时听诊的盲法观察者完成。结果：对于标准1的验证，平均值 ± 装置的SD（mmHg）减去参考差异为3.94 ± 收缩压为6.89，收缩压为2.09 ± DBP为6.68。两者均通过了标准2的标准限值；收缩（S）SD为5.56（允许5.70），舒张（D）SD为6.01（允许6.62）。符合所有其他标准要求。结论：UM-212BLE通过了所有要求。使该设备具有临床优势的功能包括自动办公室血压设置、可变压力充气、双重测量模式（示波法、听诊）、广泛的袖带测试、自动不规则心跳检测以及在儿科人群中的全面验证。所有这些功能的包含使UM-212BLE成为办公室和办公室外BP估计的极具吸引力的设备。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Blood Pressure Monitoring 医学-外周血管病

CiteScore

2.00

自引率

7.70%

发文量

110

审稿时长

>12 weeks

期刊介绍： Blood Pressure Monitoring is devoted to original research in blood pressure measurement and blood pressure variability. It includes device technology, analytical methodology of blood pressure over time and its variability, clinical trials - including, but not limited to, pharmacology - involving blood pressure monitoring, blood pressure reactivity, patient evaluation, and outcomes and effectiveness research. This innovative journal contains papers dealing with all aspects of manual, automated, and ambulatory monitoring. Basic and clinical science papers are considered although the emphasis is on clinical medicine. Submitted articles undergo a preliminary review by the editor. Some articles may be returned to authors without further consideration. Those being considered for publication will undergo further assessment and peer-review by the editors and those invited to do so from a reviewer pool.