电子血压计与台式水银血压计测量儿童青少年血压的比对研究

目的比较分析电子血压计(示波法)与台式水银血压计(听诊法)对儿童青少年血压的测量结果,对电子血压计测量儿童青少年血压的准确性进行评价。方法 2010年分层整群抽取北京市城、郊3～17岁儿童青少年,各年龄组至少100人,男女各半。问卷调查生活行为信息,测量身高、体质量、腰围,使用电子血压计(欧姆龙HEM-759P)与台式水银血压计分别测量血压两次,交替进行,记录血压及脉搏。比较两法测量结果,Bland-Altman法比较两法测量一致性。结果总计1695名3～17岁儿童青少年参加调查,各年龄组人数基本相同,男女比例0.99。各年龄组电子血压计与台式水银血压计测量结果互有高低,电子血压计测量值高于台式水银血压计居多。两法测量收缩压差值绝对值≤5,≤10和≤15mm Hg所占比例分别为54.2%,82.9%和100%;以台式水银血压计Korotcoff第Ⅳ音(K4)评价舒张压时,两法测量舒张压差值绝对值≤5,≤10和≤15mmHg所占比例分别为42.3%,70.4%和87.2%,以台式水银血压计Korotcoff第Ⅴ音(K5)评价舒张压时,3组比例分别为46.1%,70.6%和84.8%。调整性别、年龄,两法测量收缩压间、电子血压计舒张压与台式水银血压计K4间、电子血压计舒张压与台式水银血压计K5间的偏相关系数分别为0.716、0.448和0.353(P<0.01)。Bland-Altman分析显示两法收缩压差值95%一致性界限为-13.5～19.6mmHg,电子血压计舒张压与台式水银血压计K4差值95%一致性界限为-22.5～15.1mm Hg,电子血压计舒张压与台式水银血压计K5差值95%一致性界限为-20.3～28.4mm Hg。结论电子血压计测量结果高于台式水银血压计,测量结果比较稳定,两方法测量结果一致性好,电子血压计可用于儿童青少年人群血压的现场调查。     

带刻度袖带与有创导管测量粗臂围者血压对比研究

目的探讨专利产品带刻度袖带测量粗臂围者血压的应用价值。方法采用带刻度袖带同时测量65例臂围>26 cm者的血压和臂围者。依据小号袖带高估粗臂围血压的理论进行校正:臂围每增加1 cm将实测收缩压相应减低1 mm Hg、实测舒张压相应减低2/3 mm Hg;其中有48例受试者粗臂围与实测收缩压>140 mm Hg和(或)舒张压>90 mm Hg同时存在,按简化经验公式计算校正。将实测值和校正值与同步有创导管测压相比较。结果 65例受试者臂围在26～38 cm之间,平均(31.9±2.3)cm。校正收缩压和舒张压与导管测压结果接近[(143.5±9.6)mm Hg比(142.7±9.5)mm Hg;(84.6±6.8)mm Hg比(83.9±6.7)mm Hg,均为P>0.05];而实测收缩压和舒张压明显高于导管测压结果[(150.1±10.3)mm Hg比(142.7±9.5)mm Hg;(89.4±7.5)mm Hg比(83.9±6.7)mm Hg,均为P<0.01]。结论带刻度袖带测量粗臂围者血压校正结果更准确,能避免"袖带性高血压"。     

HEM-6000手腕式血压计的可靠性

目的采用美国医疗器械检测协会(AAMI)标准,对HEM-6000手腕式血压计的血压测量精确度进行临床验证研究。方法入选对象为18岁以上成年人,共91人。腕部测压结果与听诊法比较。每位受试者用2种方法同时各进行3次坐位血压测量,对91人的273对血压测量值用以下2种方法进行统计分析:(1)先计算出2种测压方法得到的血压测量值误差,再求得误差的平均值和标准偏差。(2)先计算出每位受试者用2种测压方法得到的血压平均值的差值,再求得该差值的平均值和标准偏差。结果根据方法1得到的收缩压(SBP)和舒张压(DBP)的测量误差分别为(0.5±7.1)mm Hg和(-1.6±6.1)mm Hg;根据方法2得到的结果分别(0.5±6.1)mm Hg和(-1.6±5.3)mm Hg。血压值的水平及手腕周长对测量误差无影响。结论HEM-6000手腕式血压计通过AAMI检验标准,可推荐患者用于家庭自我测压。     

农民健康体检血压测量质量控制研究

目的:观察农民健康体检中血压测量方法存在的缺陷及准确性。方法:对丽水市辖区农民体检点进行随机分群抽样调查,对血压测量环境及测量方法进行评估,使用双听头听诊器评估血压测量读数的准确性,并对所有调查对象(n=2081)再次使用水银汞柱式血压计进行血压测量复核。结果:血压测量存在现场环境较差、测量前未经充分休息、袖带和听诊器位置放置不正确、放气速度过快等问题。乡镇社区医生测量所得血压值高于复核的结果(收缩压(125.28±23.41)mmHg对(124.62±22.39)mmHg,P<0.05;舒张压(77.61±12.51)mmHg对(77.24±11.22)mmHg,P<0.05)。乡镇社区医生测量检出高血压的患病率为35.7%,复核测量检出高血压的患病率为30.75%。使用双头听诊器时乡镇社区医生与现场评估员测量的读数无差异(P>0.05);514例使用电子血压测量结果显著高于水银血压计测量结果(收缩压(133.21±21.62)mmHg对(126.78±21.09)mmHg,P<0.001;舒张压(82.84±12.41)mmHg对(80.15±11.59)mmHg,P<0.001)。结论:当前农民健康体检中血压测量方法存在多种问题,必然影响到测量结果的准确性,应重视对相关人员进行培训。     

宽袖带与常规宽度袖带臂式电子血压计测量血压结果的对比分析

目的 探索宽袖带(宽度为18 cm)与常规宽度袖带(宽度为13 cm)臂式电子血压计在测量血压值的差异.方法 选择2018年5-11月于河北医科大学第二医院心内科住院患者1 155例,其中男性占47％,年龄(59.7±13.2)岁.根据臂围大小将患者分为4组:第1组臂围范围为15～21 cm,第2组为22～26 cm,...     

臂围调查与血压计袖带大小的合理选择

目的调查北京地区成人高血压病患者右上臂臂围的数值,为临床工作中合理选择血压测量袖带提供一定的指导。方法用横断面研究,连续入选了424名成人高血压病患者(其中男性占61.6%),经右上臂的中点测量所有病例的臂围。根据臂围的数值将患者首先分为3组:1组臂围在22~26cm之间(小个成人),2组臂围在27~34cm(标准成人),3组臂围>34cm(大个成人)。再将患者分为两组:A组臂围<32cm,B组臂围≥32cm。结果在全部入选高血压病患者中,臂围均值为(29.6±2.6)cm。82.8%的患者右臂臂围在27~34cm之间,只有8.96%的患者臂围在22~26cm之间。无论男性和女性患者,其臂围和体质量指数(BMI)与腰围(WC)都呈显著相关性(BMI:r=0.810,WC:r=0.725,P均<0.01)。与A组比较,B组患者的血清肌酐、尿酸和三酰甘油都显著高于A组,而高密度脂蛋白胆固醇却显著低于A组。结论在当前临床实践中,需尽早采用气囊尺寸为13cm×30cm的袖带进行血压测量。另外,臂围增加可能与本地区高血压病患者代谢指标的紊乱相关。     

电子血压计与汞柱血压计测量结果对比观察

<正>血压测量是临床工作中一项重要的操作,可以协助诊断疾病以及评价用药效果。近年来,电子血压计广泛应用于临床,其性能不断提升。本院在临床上发现袖带式电子血压计对年龄较大或是臂围较细的患者进行血压测量时,其测量结果较汞柱血压计的测量值有不同程度的差异。本文通过对比两种血压计的测量结果以观察电子血压计在血压测量中的准确性。1资料与方法1.1一般资料:选取2014年3月至5月我院住院患     

血压测量

血压测量是重要临床诊断技术之一,已经历数百年的发展.其测量方式有诊室血压测量、家庭自测、动态血压监测;测量方法有直接测量和间接测量,间接测量又分听诊法、示波法等,各有一定适用范围,以水银柱血压计袖带听诊法应用最为广泛.袖带臂围匹配对血压测值有一定的影响,小袖带测值要高,而大袖带的测值要低.在临床工作中应注意袖带与臂围匹配,诊室应配备各种型号的袖带,适合各类人群的需要,以减少高血压的误诊和漏诊.     

血压测量

血压测量是重要临床诊断技术之一,已经历数百年的发展。其测量方式有诊室血压测量、家庭自测、动态血压监测;测量方法有直接测量和间接测量,间接测量又分听诊法、示波法等,各有一定适用范围,以水银柱血压计袖带听诊法应用最为广泛。袖带臂围匹配对血压测值有一定的影响,小袖带测值要高,而大袖带的测值要低。在临床工作中应注意袖带与臂围匹配,诊室应配备各种型号的袖带,适合各类人群的需要,以减少高血压的误诊和漏诊。     

HEM-6000手腕式血压计的可靠性

目的 采用美国医疗器械检测协会(AAMI)标准,对HEM-6000手腕式血压计的血压测量精确度进行临床验证研究.方法 入选对象为18岁以上成年人,共91人.腕部测压结果与听诊法比较.每位受试者用2种方法同时各进行3次坐位血压测量,对91人的273对血压测量值用以下2种方法进行统计分析:(1)先计算出2种测压方法得到的血压测量值误差,再求得误差的平均值和标准偏差.(2)先计算出每位受试者用2种测压方法得到的血压平均值的差值,再求得该差值的平均值和标准偏差.结果 根据方法1得到的收缩压(SBP)和舒张压(DBP)的测量误差分别为(0.5±7.1)mm Hg和(-1.6±6.1)mm Hg;根据方法2得到的结果分别(0.5±6.1)mm Hg和(-1.6±5.3)mm Hg.血压值的水平及手腕周长对测量误差无影响.结论 HEM-6000手腕式血压计通过AAMI检验标准,可推荐患者用于家庭自我测压.     

Accuracy of the Omron RX-M, an automated blood pressure measuring device, measuring blood pressure at the wrist, according to a modified British Hypertension Society protocol

OBJECTIVE: To determine the accuracy of the Omron RX-M, a device measuring blood pressure oscillometrically at the wrist. METHODS: In 89 subjects (mean age 55+/-14 years) blood pressure measurements at the wrist with the Omron RX-M were compared to sequential blood pressure measurements with a mercury sphygmomanometer at the (same) upper-arm and to simultaneous measurements with the Omron HEM-705 CP at the opposite arm.Measurements with analyzed according to the British Hypertension Society (BHS) - protocol 1993, to the protocol of the Association for the Advancement of Medical Instrumentation (AAMI) and (retrospectively) to the new 'International Protocol'. RESULTS: Mean differences (+/-SD) between the measurements with the mercury sphygmomanometer and the Omron RX-M were -7.5+/-8.4 mmHg for diastolic blood pressure (DBP) and -2.5+/-12.2 mmHg for systolic blood pressure (SBP), thus not fulfilling the AAMI-criteria (< or =5+/-8). According to the BHS-criteria a grade D was achieved for both DBP and SBP. Compared to the Omron HEM 705 CP results were -6.3+/-7.1 for DBP (grade D) and -4.1+/-12.7 for SBP (grade D). The Omron RX-M also failed to pass the new 'International Protocol' in phase 1. CONCLUSION: Although easy to use, based on this study the Omron RX-M can not be recommended to determine blood pressure accurately.     

Validation of the Omron M6 (HEM-7001-E) upper arm blood pressure measuring device according to the International Protocol in elderly patients

OBJECTIVE: Despite the widespread use of automated self-measurement monitors, there is limited published evidence on their accuracy and reliability on different patient groups. The objective of this study was to evaluate the accuracy and reliability of the Omron M6 (HEM-7001-E) upper-arm blood pressure (BP) device against mercury sphygmomanometer on elderly patients according to the criteria of the International Protocol. DESIGNS AND METHODS: Thirty-three patients above 65 years of age, who were classified based on the BP categories of the International Protocol, were recruited for the study. BP measurements at the upper arm with the Omron M6 were compared with the results obtained by two trained observers using a mercury sphygmomanometer. Nine sequential BP measurements were taken. During the validation study, 99 measurements were obtained from 33 patients for comparison. The first phase was carried out on 15 patients and if the device passed this phase, 18 more patients were selected. RESULTS: Mean discrepancies and standard deviations of the device sphygmomanometer were 1.4+/-5.3 mmHg for systolic BP (SBP) and -1.4+/-4.5 mmHg for diastolic BP (DBP) in the study group. The device passed phase 1 in 15 patients. In phase 2.1, from the total 99 comparisons, 76, 92, and 97 for SBP and 77, 94, and 99 for DBP were less than 5, 10, and 15 mmHg, respectively. The Omron M6 passed phases 2.1 and 2.2 in the elderly group of patients. CONCLUSION: The Omron M6 (HEM-7001-E) upper-arm BP monitor passed according to the International Protocol criteria and can be recommended for use in elderly patients.     

Validation of the Omron HEM-907 device for blood pressure measurement

BACKGROUND: The aim of this study was to validate the Omron HEM-907 blood pressure (BP) measuring device according to the international validation protocol. DESIGN: The international validation protocol is divided into two phases: the first phase is performed on 15 selected subjects and if the device passes this phase, 18 more subjects are selected making a total number of 33 subjects on which the final validation is performed. METHODS: For each subject, BP measurements were performed simultaneously by two trained observers using mercury sphygmomanometers alternately with the Omron HEM-907 device. In all, 99 measurements were obtained for comparison. The difference between the BP value given by the device and that obtained by the two observers (mean of the two observers) was calculated for each measure. RESULTS: The difference between the two observers was -1 +/- 2 mmHg for the systolic BP (SBP) and for the diastolic BP (DBP). The Omron HEM-907 passed the first phase of the validation process. For the second phase, the average differences between the device and mercury sphygmomanometer readings were -1 +/- 7 and -5 +/- 6 mmHg for SBP and DBP respectively. Readings for the HEM-907 device differed by less than 5 mmHg for 61 of the systolic readings and 52 of the diastolic readings; by less than 10 mmHg for 85 of the systolic readings and 85 of the diastolic readings; and by less than 15 mmHg for 94 of the systolic readings and 96 of the diastolic readings. CONCLUSIONS: The Omron HEM-907 device passes the two phases of the international validation protocol.     

Validation of two devices for self-measurement of blood pressure by elderly patients according to the revised British Hypertension Society protocol: the Omron HEM-722C and HEM-735C.

BACKGROUND: The validation of self-measurement devices for clinical use by elderly patients has been recommended. The Omron HEM-722C device has recently been validated according to the British Hypertension Society (BHS) protocol for use for general populations and the Omron HEM-735C is a new fully automatic device with a high capacity for storage of measurements that is integrated with a personal computer. OBJECTIVE: To perform a clinical validation for use by elderly people of the Omron HEM-722C and HEM-735C devices according to the revised protocol of the BHS and the criteria of the Association for the Advancement of Medical Instrumentation (AAMI). METHODS: We carried out a main validation test according to the revised BHS protocol for validation procedures for special groups on two groups of 30 subjects aged more than 65 years (29 men and 31 women), 11 of 30 with systolic blood pressures (SBP) <110mmHg, 10 of 30 with SBP >200 mmHg, 15 of 30 with diastolic blood pressures (DBP( <70 mmHg and 10 of 30 with DBP >110 mmHg. The results were graded according to the BHS system from A to D. RESULTS: The Omron HEM 722C achieved an overall A/A grading and satisfied the AAMI criteria for accuracy whereas the Omron HEM-735C achieved an overall B/A grading and satisfied the AAMI criteria for accuracy. The sphygmomanometer measurements were 147 +/- 31/79 +/- 15 and 144 +/- 30/78 +/- 15 mmHg (means+/-SD) respectively, for the models 722C and 735C. The average differences between mercury sphygmomanometer and HEM-722C readings for SBP and DBP were, respectively, 0.76+/-5 and 0.41+/-8 mmHg; those for HEM-735C were, respectively, 0.24+/-8 and 0.9+/-8 mmHg. Readings of the HEM-722C device differed by less than 5 mmHg for 76% of systolic readings and 96% of the readings differed by less than 10 mmHg. Diastolic measurements differed by less than 5 mmHg for 71% and less than 10 mmHg for 71 and 87% of all readings. Readings of the HEM-735C device differed by less than 5 mmHg for 68% of systolic readings and 74% of the readings differed by less than 10 mmHg. Diastolic measurements differed by less than 5 mmHg in 74% and less than 10 mmHg in 88 and 87% of all readings. CONCLUSIONS: On the basis of these results, for elderly subjects both self-measurement devices (Omron HEM-722C and HEM-735C) satisfied the validation criteria of the BHS and therefore can be recommended for the clinical measurement of blood pressure in elderly patients.     

Validation of the Omron M5-I, R5-I and HEM-907 automated blood pressure monitors in elderly individuals according to the International Protocol of the European Society of Hypertension

OBJECTIVE: This study aimed at verifying the accuracy of three automated electronic oscillometric blood pressure measuring devices, namely Omron M5-I (home use upper arm monitor), R5-I (home use wrist monitor) and HEM-907 (professional use upper arm monitor) according to the European Society of Hypertension International Protocol in elderly individuals. METHODS: Sequential measurements of systolic and diastolic blood pressure were obtained in 33 participants (aged >or=75 years) using the mercury sphygmomanometer (two observers) and each of the tested devices (one supervisor). A standard adult cuff was always employed during the study because all participants had an arm circumference compatible with such a cuff. According to the European Society of Hypertension validation protocol 99 couples (three pairs per patient) of test device and reference blood pressure measurements were obtained during phase 1 (15 participants studied) and phase 2 (a further 18 participants) for each electronic monitor. RESULTS: All devices successfully passed the validation study with a mean (+/-SD) device-observer difference for systolic and diastolic blood pressure of 0.2+/-3.6/0.2+/-3.9 mmHg (Omron M5-I), -1.5+/-6.2/-0.7+/-3.7 mmHg (Omron R5-I), and 0.1+/-5.1/-1.9+/-4.2 mmHg (Omron HEM-907). SD of the mean difference was lower and thus the precision was better for diastolic than for systolic blood pressure, and for the Omron M5-I than for the other two devices. CONCLUSIONS: According to the results of the validation study based on the European Society of Hypertension International Protocol the Omron M5-I, R5-I, and HEM-907 may be recommended for clinical use in elderly individuals, without atrial fibrillation or frequent ectopic beats.     

Validation of the Omron M6 (HEM-7001-E) upper-arm blood pressure measuring device according to the International Protocol in adults and obese adults

BACKGROUND: Electronic blood pressure (BP) measurement devices are the preferred choice of patients owing to their user-friendly nature; however, there is a requirement to investigate the accuracy and reliability of these devices. The objective of this study is to evaluate the accuracy of the Omron M6 upper-arm BP device against the mercury sphygmomanometer in adults and obese adults according to the International Protocol criteria. METHODS: One hundred and twenty-one patients, older than 30 years of age, were studied and classified on the basis of the range of the International Protocol. BP measurements at the upper arm with the Omron M6 were compared with the results obtained by two trained observers using a mercury sphygmomanometer. Nine sequential BP measurements were taken. A total of 33 participants were selected for each validation study. During the validation study, 99 measurements were performed on 33 participants for comparison. The first phase was performed on 15 participants, and if the device passed this phase, 18 more participants were selected. Having a two-fold purpose, this study was conducted on both adult and obese adult patients. RESULTS: Mean discrepancies and standard deviations of the monitor-mercury sphygmomanometer were 1.1+/-4.0 mmHg for systolic BP (SBP) and -0.5+/-3.5 mmHg for diastolic BP (DBP) in the adult group. The device passed phase 1 in 15 participants. In phase 2.1, out of a total of 99 comparisons, 88, 96, and 97 for SBP, and 88, 98, and 99 for DBP were <5, <10, and <15 mmHg, respectively. Mean discrepancies and standard deviations of the monitor-mercury sphygmomanometer were 1.7+/-4.8 mmHg for SBP and -0.8+/-4.3 mmHg for DBP in the obese adult group. The device passed phase 1 in 15 participants. In phase 2.1, out of a total of 99 comparisons, 82, 90, and 97 for SBP, and 80, 97, and 99 for DBP were <5, <10, and <15 mmHg, respectively. It was found that the Omron M6 automatic monitor, which measures BP at the upper arm, produced results in accordance with the criteria of phases 2.1 and 2.2 in both SBP and DBP, when applied to adults and to obese adults. CONCLUSION: It was concluded that the Omron M6 device, which measures BP at the upper arm, was deemed to be in accordance with the International Protocol criteria and can be recommended for use by adults and obese adults.     

Validation of the Omron 637IT wrist blood pressure measuring device with a position sensor according to the International Protocol in the elderly

OBJECTIVE: The market for wrist devices for self-measurement is growing and these devices are becoming popular among the patients. Despite widespread use of these devices, there is limited published evidence for their accuracy and reliability in the different patient groups. The objective of this study was to evaluate the accuracy of the Omron 637IT (Omron Healthcare Europe B.V, Hoofddorp, Netherlands) wrist blood pressure device against the mercury sphygmomanometer in the elderly according to the International Protocol criteria. METHODS: Seventy-six patients older than 65 years of age were studied and classified on the basis of the range of the International Protocol. Blood pressure measurements at the wrist with the Omron 637IT were compared with the results obtained by two trained observers using a mercury sphygmomanometer. Nine sequential blood pressure measurements were taken. A total of 33 participants with arm circumference distributed randomly were selected for the validation study. During the validation study, 99 measurements were obtained for comparison in the 33 participants. The first phase was performed on 15 participants, and if the device passed this phase, 18 more participants were selected. RESULTS: Mean discrepancies and standard deviations of the sphygmomanometer device were -0.3+/-6.5 mmHg for systolic blood pressure and 2.8+/-4.8 mmHg for diastolic blood pressure in the study group. The device passed phase 1 in 15 participants. In phase 2.1, from the total 99 comparisons, 66, 87, and 95 for systolic blood pressure and 69, 92, and 97 for diastolic blood pressure were <5, <10, and <15 mmHg, respectively. In phase 2.2, 24 participants had at least two of the differences within 5 mmHg and three participants had no differences within 5 mmHg for systolic blood pressure. For diastolic blood pressure, 24 participants had at least two of the differences within 5 mmHg and three participants had no differences within 5 mmHg. The Omron 637 IT passed the phase 2.1 and 2.2 in the elderly group. CONCLUSION: The Omron 637IT wrist blood pressure device passed according to the International Protocol criteria and can be recommended for use in the elderly.     

Validation of the OMRON M7 (HEM-780-E) blood pressure measuring device in a population requiring large cuff use according to the International Protocol of the European Society of Hypertension

BACKGROUND: A high percentage of hypertensive patients present an arm circumference of over 32 cm; the use of a large cuff is therefore recommended. Validation studies are usually performed in the general population using a standard-size cuff. The aim of this study was to assess the accuracy of the Omron M7 device in a population with an arm circumference ranging from 32 to 42 cm. DESIGN: A validation study was performed according to the International Protocol of the European Society of Hypertension. This protocol is divided into two phases: the first phase is performed on 15 selected participants (45 pairs of blood-pressure measurements); if the device passes this phase, 18 supplementary participants are included (54 pairs of blood-pressure measurements), making a total number of 33 participants (99 pairs of blood-pressure measurements), on whom the analysis is performed. METHODS: For each participant, four blood-pressure measurements were performed simultaneously by two trained observers, using mercury sphygmomanometers fitted with a Y tube; the measurements alternated with three by the test device. The difference between the blood-pressure value given by the device and that obtained by the two observers (mean of the two observations) was calculated for each measure. The 99 pairs of blood-pressure differences were classified into three categories (相似文献   

Validation of the Omron M7 (HEM-780-E) oscillometric blood pressure monitoring device according to the British Hypertension Society protocol

BACKGROUND: The Omron M7 (HEM-780-E) is an automated oscillometric upper arm blood pressure monitor for the professional and home use markets. The aim of this study was to validate the accuracy of this device according to the British Hypertension Society (BHS) and the Association for the Advancement of Medical Instrumentation (AAMI) SP10 validation criteria. METHODS: Participants were recruited until a total of 85 were obtained that filled the blood pressure ranges specified by the BHS protocol. Recruitment to the study was from the general medical and specialist clinics and from the staff at Guy's and St Thomas' Hospital in London, UK. Nine sequential same-arm blood pressure readings were taken from each participant by two trained observers, alternating between a mercury reference sphygmomanometer and the Omron M7 (HEM-780-E). The differences between the reference and test device readings, for both systolic and diastolic pressures, were compared with BHS and AAMI criteria to determine the outcome of the study. RESULTS: The Omron M7 (HEM-780-E) is graded 'A' for systolic and 'A' for diastolic blood pressures according to the BHS criteria. The mean (standard deviation) of the difference between the observer and the device measurements was 0.75+/-6.5) mmHg for systolic and 1.33+/-5 mmHg for diastolic pressures. The device, therefore, also satisfies the AAMI SP10 standard for the study population, which requires differences of <+/-5 (8) mmHg. CONCLUSION: The Omron M7 (HEM-780-E) achieved an 'A/A' performance classification under the BHS criteria and passed the AAMI requirements for the study population. It can be recommended for professional and home-use in this population.     

Validation of the Omron 637IT wrist blood pressure measuring device with a position sensor according to the International Protocol in adults and obese adults

OBJECTIVE: Wrist blood pressure devices are becoming popular for the self-measurement of blood pressure. Despite widespread use of these devices, there is limited published evidence for their accuracy and reliability. In this study, we assessed the accuracy of the Omron 637IT wrist blood pressure device against the mercury sphygmomanometer in adults and obese adults according to the International Protocol criteria. METHODS: A hundred and thirty-one participants were studied and classified on the basis of the International Protocol range. Blood pressure measurements at the wrist using the Omron 637IT were compared with the results obtained by two trained observers using a mercury sphygmomanometer. Nine sequential blood pressure measurements were taken. Initially, 33 participants with random arm circumferences were selected for the first validation study. Then, the device was evaluated in adults with arm circumferences equal to or higher than 34 cm. During each validation study, 99 measurements were obtained for comparison from the 33 participants. The first phase was performed on 15 participants, and, if the device passed this phase, 18 more participants were selected. RESULTS: Mean discrepancies and standard deviations of the sphygmomanometer device were 0.5+/-6.2 mmHg for systolic blood pressure and 0.1+/-3.7 mmHg for diastolic blood pressure in the adult group. The device passed phases 1 and 2 in 33 participants. Mean discrepancies and standard deviations of the sphygmomanometer device were 1.8+/-6.6 mmHg for systolic blood pressure and 1.6+/-4.7 mmHg for diastolic blood pressure in the obese adult group. The device passed phases 1 and 2 in 33 participants in this group. CONCLUSION: The Omron 637IT passed according to the International Protocol criteria and can be recommended for use in adults and obese adults.