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BACKGROUND: Blood pressure (BP) naturally undergoes fluctuations and variations, particularly during anesthesia administration during surgery, hemodialysis, upper and lower gastrointestinal endoscopy, exercise testing, arterial and venous catheterization, and rehabilitation. These changes in BP may lead to life-threatening events. OBJECTIVES: The performance of the Omron HBP-M4500 device in monitoring blood pressure (BP) in the upper arm was validated according to the International Organization for Standardization (ISO) 81060-2:2018+amendment (Amd) 1:2020 protocol. METHODS: The device was used to assess 113 participants in the inflation mode, and 107 participants in the deflation mode. All the patients fulfilled the inclusion criteria, including the arm circumference range and systolic and diastolic BP levels, outlined in the protocol. Data validation and analysis were performed according to the manufacturer's instructions. RESULTS: In criterion 1, the mean ± standard deviation (SD) values of the differences between the test device and reference BP were -0.6 ± 5.80/2.8 ± 6.78 mmHg (systolic/diastolic) and -1.0 ± 5.35/3.2 ± 6.52 mmHg for the inflation and deflation modes, respectively. These data fulfilled the ISO81060-2:2018+Amd1:2020 requirements of ⩽ 5 ±â£â©½ 8 mmHg. In criterion 2, the differences were -0.6 ± 4.44/2.8 ± 6.26 and -1.0 ± 3.84/3.2 ± 6.09 mmHg for the inflation and deflation modes, respectively, fulfilling criterion 2 with SD values of ⩽ 6.91 and ⩽ 6.87 for systolic BP and ⩽ 6.34 and ⩽ 6.14 for diastolic BP in the inflation and deflation modes, respectively. These two criteria were fulfilled in both studies. CONCLUSION: The Omron HBP-M4500 device, either in inflation or deflation mode, fulfilled the criteria outlined in the ISO protocol. Therefore, this device is valuable for BP measurement in clinical and hospital settings.

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Purpose: The performance of Omron HEM-1026 (HCR-1901T2 / HCR-1902T2) for monitoring blood pressure (BP) in the upper arm was validated in accordance with the International Organization for Standardization (ISO) 81060-2:2018+amendment (Amd)1:2020 protocol. Methods: The device was assessed in 101 participants who fulfilled the inclusion criteria, including arm circumference range and systolic and diastolic BP provided by the protocol. Data validation and analysis were performed according to the manufacturer's instructions. Results: In the ISO 81060-2:2018+Amd 1:2020 validation procedure (criterion 1), the mean ± standard deviation (SD) of the differences between the test device and reference BP was -2.1 ± 7.24/-0.6 ± 5.63 mmHg (systolic/diastolic). These data fulfilled the ISO81060-2:2018+Amd1:2020 requirement of ≤5±≤8 mmHg. The mean differences between the two observers and Omron HEM-1026 were -2.1 ± 5.71 mmHg for systolic BP and -0.6 ± 4.81 mmHg for diastolic BP, fulfilling criterion 2 with an SD of ≤ 6.62 for systolic BP and ≤ 6.91 for diastolic BP. The two ISO criteria were fulfilled. Conclusion: The Omron HEM-1026 BP monitor fulfilled the requirements of the ISO 81060-2:2018+Amd 1:2020 validation standard and can be recommended for home BP measurements in the general population.

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BACKGROUND: Hypertension is a global public health issue and is closely related to chronic kidney disorder (CKD). In people with CKD, strict monitoring of blood pressure is an important part of therapy. OBJECTIVE: The aim of this research was to validate the iHealth Track blood pressure monitoring device for patients with CKD according to the European Society of Hypertension International Protocol 2010 (ESH-IP2). METHODS: In total, 33 patients who received hemodialysis in Plasencia participated in the study. There were 9 successive measurements made, which conformed to the ESH-IP2. We calculated the differences between the standard reference device (Omron M3 Intellisense) and the test device (iHealth Track) for blood pressure and heart rate values. For 99 total comparisons of paired measurements, we classified differences into various categories (≤5 mmHg, ≤10 mmHg, and ≤15 mmHg for blood pressure; ≤3, ≤5, and ≤8 beats per minute for heart rate). RESULTS: In 90 of 99 systolic blood pressure and 89 of 99 diastolic blood pressure comparisons between the devices, measurement differences were within 5 mmHg. In 81 of 99 heart rate comparisons between the devices, measurement differences were within 3 beats per minute. The mean differences between the test and reference standard measurements were 3.27 (SD 2.99) mmHg for systolic blood pressure, 3.59 (SD 4.55) mmHg for diastolic blood pressure, and 2.18 (SD 2.75) beats per minute for heart rate. We also observed that for both systolic and diastolic blood pressure, 31 of 33 participants had at least two of three comparisons between the devices with measurement differences less than 5 mmHg. For heart rate, 28 of 33 patients had at least two of three comparisons between the devices with measurement differences less than 3 beats per minute. CONCLUSIONS: To our knowledge, this is the first study to show that iHealth Track meets the requirements of the ESH-IP2 in patients with CKD. Therefore, the iHealth Track is suitable for use in renal patients.

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OBJECTIVE: To evaluate the value of blood pressure measurement by the smartphone device iHealth BP5 in pregnant women in a clinical setting, as compared to the Omron M6 Comfort and aneroid manometer. MATERIALS AND METHODS: Women with a gestational age of thirty weeks or more who visited the outpatient clinic for routine visit were eligible for inclusion. For the clinical evaluation we used an adjusted form of the European Society of Hypertension International Protocol. We performed six blood pressure measurements per patient, divided over the iHealth BP5, Omron M6 Comfort and aneroid monitor. Statistical analysis consisted of repeated measurement ANOVA and Bland-Altman plots. RESULTS: We included 45 women. The mean blood pressure differences between all tested devices were less than ±5 mmHg. These differences did not relate to gestational age, BMI or arm circumference. Bland-Altman plots showed good agreement of both iHealth BP5 and Omron M6 Comfort, without any systematic effects, as compared to the aneroid manometer. CONCLUSION: The iHealth BP5 is as good as the frequently used Omron M6 Comfort and can be used for blood pressure measurement during pregnancy. CONDENSED ABSTRACT: In 45 women the mean blood pressure differences between the Omron M6 Comfort, iHealth BP5 and the aneroid manometer were less dan ±5 mmHg. These differences did not relate to gestational age, BMI or arm circumference. Bland-Altman plots showed good agreement of both iHealth BP5 and Omron M6 Comfort, without any systematic effects, as compared to the aneroid manometer. The iHealth BP5 is as good as the frequently used Omron M6 Comfort and can be used for blood pressure measurement during pregnancy.

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OBJECTIVE: The performance of Omron HEM-6232T and Omron HEM-6181 for monitoring blood pressure (BP) at the wrist was validated in accordance with the ANSI/AAMI/ISO 81060-2:2013 protocol (ANSI/AAMI/ISO) and the European Society of Hypertension International Protocol revision 2010 (ESH IP2). METHODS: Three trained medical technologists validated the performance of these devices by comparing data obtained from these devices with those obtained using a standard mercury sphygmomanometer. RESULTS: The mean differences between the devices and mercury readings for SBP and DBP were as follows: HEM-6232T, -0.4±6.7 mmHg and 1.6±5.4 mmHg, respectively; HEM-6181, -0.7±6.2 mmHg and -0.7±5.2 mmHg, respectively, satisfying the ANSI/AAMI/ISO protocol. The mean device-observer measurement difference was -0.9±5.7 mm Hg and 0.2±4.6 mm Hg for SBP and 0.5±4.9 mm Hg and 1.4±3.5 mm Hg for DBP, for HEM-6232T and HEM-6181, respectively, satisfying part 1 of the ESH-IP2. All differences for SBP and DBP in both devices satisfied part 2 of the ESH-IP2. The number of absolute differences in the values obtained using the devices and those measured by the observers fulfilled the requirements of the ANSI/AAMI/ISO and the ESH IP2. CONCLUSION: The Omron HEM-6232T and HEM-6181 devices met all the requirements of the ANSI/AAMI/ISO and the ESH IP2.

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BACKGROUND: Following the European Society of Hypertension International Protocol (ESH-IP) Revision 2010, QardioArm® and Omron M6 Comfort IT® oscillometric devices were evaluated in the general population and in patients with type II diabetes, respectively, for self-blood pressure (BP) measurement. METHODS: Both devices, QardioArm® and Omron M6 Comfort®, measure BP at the brachial level. The ESH-IP Revision 2010 includes a total number of 33 subjects. For each measure, the difference between observer and device BP values was calculated. In all, 99 pairs of BP differences are classified into three categories (≤5, ≤10, and ≤15 mmHg). The protocol procedures were followed precisely. RESULTS: QardioArm® and Omron M6 Comfort® fulfilled the requirements of the ESH-IP and passed the validation process successfully. For QardioArm®, a total of 69 out of 99 comparisons for systolic blood pressure (SBP) showed an absolute difference within 5 mmHg and 82 out of 99 for diastolic blood pressure (DBP). As for Omron M6 Comfort®, a total of 83 out of 99 comparisons for SBP showed an absolute difference within 5 mmHg and 77 out of 99 for DBP. The mean differences between the device and mercury readings were 0.7±5.9 mmHg for SBP and 0.3±4.1 mmHg for DBP for QardioArm® and -1.4±4.7 mmHg for SBP and -2.1±4.3 mmHg for DBP for Omron M6 Comfort®. With regard to part 2 of ESH-IP 2010, 27 out of 33 subjects had a minimum of two out of three measurements within 5 mmHg difference for SBP and 31 out of 33 subjects for DBP for the QardioArm®, and 29 out of 33 patients had a minimum of two out of three measurements within 5 mmHg difference for SBP and 26 out of 33 patients for DBP for Omron M6 Comfort®. CONCLUSION: QardioArm® and Omron M6 Comfort® readings differing from the mercury standard by <5, 10, and 15 mmHg fulfill the ESH-IP Revision 2010 requirements. Consequently, these two devices are suitable for use in the general population and non-insulin-dependent type II diabetic patients, respectively.

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OBJECTIVE: Two oscillometric devices, the Microlife WatchBP O3® and the Omron RS6®, designed for self-blood pressure measurement were evaluated according to the European Society of Hypertension (ESH)-International Protocol (IP) Revision 2010 in the obese population. METHODS: The Microlife WatchBP O3 measures blood pressure (BP) at the brachial level and the Omron RS6 measures BP at the wrist level. The ESH-IP revision 2010 includes a total of 33 subjects. The difference between observers' and device BP values was calculated for each measure. A total of 99 pairs of BP differences were classified into three categories (≤5, ≤10, and ≤15 mmHg). The protocol procedures were followed precisely in each of the two studies. RESULTS: Microlife WatchBP O3 and Omron RS6 failed to fulfill the criteria of the ESH-IP. The mean differences between the device and the mercury readings were: 0.3±7.8 mmHg and -1.9±6.4 mmHg for systolic BP and diastolic BP, respectively, for Microlife WatchBP O3, and 2.7±9.9 mmHg for SBP and 3.5±11.1 mmHg for diastolic BP for Omron RS6. CONCLUSION: Microlife WatchBP O3 and Omron RS6 readings differing from the mercury standard by more than 5, 10, and 15 mmHg failed to fulfill the ESH-IP revision 2010 requirements in obese subjects. Therefore, the two devices cannot be recommended for use in obese subjects.

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BACKGROUND: Four oscillometric devices, including the Omron M6 Comfort, Omron HEM-7420, Withings BP-800, and Polygreen KP-7670, designed for self-blood pressure measurement (SBPM) were evaluated according to the European Society of Hypertension (ESH) International Protocol Revision 2010 in four separate studies. METHODS: The four devices measure brachial blood pressure (BP) using the oscillometric method. The Withings BP-800 has to be connected to an Apple® iOS device such as an iPhone®, iPad®, or iPod®. The ESH International Protocol Revision 2010 includes a total number of 33 subjects. The difference between observer and device BP values was calculated for each measure. Ninety-nine pairs of BP differences were classified into three categories (≤5 mmHg, ≤10 mmHg, ≤15 mmHg). The protocol procedures were followed precisely in each of the four studies. RESULTS: All four tested devices passed the validation process. The mean differences between the device and mercury readings were: -1.8±5.1 mmHg and -0.4±2.8 mmHg for systolic and diastolic BP, respectively, using the Omron M6 Comfort device; 2.5±4.6 mmHg and -1.2±4.3 mmHg for the Omron HEM-7420 device; -0.2±5.0 mmHg and 0.4±4.2 mmHg for the Withings BP-800 device; and 3.0±5.3 mmHg and 0.3±5.2 mmHg for the Polygreen KP-7670 device. CONCLUSION: Omron M6 Comfort, Omron HEM-7420, Withings BP-800, and Polygreen KP-7670 readings differing by less than 5 mmHg, 10 mmHg, and 15 mmHg fulfill the ESH International Protocol Revision 2010 requirements, and therefore are suitable for use by patients for SBPM, if used correctly.

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BACKGROUND: Four oscillometric devices for self-measurement of blood pressure (SBPM) were evaluated according to the European Society of Hypertension (ESH) international protocol and its 2010 revision in four separate studies. The Omron® M2, Omron M3, and Omron M6 measure blood pressure (BP) at the brachial level, while the Omron R2 measures BP at the wrist level. METHODS: The international protocol requires a total number of 33 subjects in which the validation is performed. The Omron M2 and Omron R2 were validated in 2009 according to the ESH international protocol, while the Omron M3 and Omron M6 were validated in 2010-2011 according to the 2010 ESH international protocol revision. The protocol procedures were followed precisely. RESULTS: All four tested devices passed the validation process. The mean differences between the device and mercury readings were 2.7 ± 5.0 and -1.4 ± 3.2 mmHg for systolic and diastolic BP, respectively, using the Omron M2 device, and 1.7 ± 3.2 and -0.9 ± 2.6 mmHg using the Omron M3, 1.6 ± 2.9 and -0.9 ± 2.5 mmHg using the Omron M6, and -1.1 ± 4.8 and -0.9 ± 4.3 mmHg using the Omron R2. CONCLUSION: Readings from the Omron M2, Omron M3, Omron M6, and Omron R2, differing by less than 5, 10, and 15 mmHg, fulfill the ESH international protocol and its 2010 revision requirements. Therefore, each of these four devices can be used by patients for SBPM.

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PURPOSE: To validate the Dinamap ProCare 200 blood pressure (BP) monitor against a mercury sphygmomanometer in children 7 to 18 years old in accordance with the 2010 International Protocol of European Society of Hypertension (ESH-IP2) and the British Hypertension Society (BHS) protocol. METHODS: Forty-five children were recruited for the study. A validation procedure was performed following the protocol based on the ESH-IP2 and BHS protocols for children and adolescents. Each subject underwent 7 sequential BP measurements alternatively with a mercury sphygmomanometer and the test device by trained nurses. The results were analyzed according to the validation criteria of ESH-IP2. RESULTS: The mean (±SD) difference in the absolute BP values between test device and mercury sphygmomanometer readings was 1.85±1.65 mmHg for systolic BP (SBP) and 4.41±3.53 mmHg for diastolic BP (DBP). These results fulfilled the Association for the Advancement of Medical Instrumentation criterion of a mean±SD below 5±8 mmHg for both SBP and DBP. The percentages of test device-observer mercury sphygmomanometer BP differences within 5, 10, and 15 mmHg were 96%, 100%, and 100% for SBP, and 69%, 92%, and 100% for DBP, respectively, in the part 1 analysis; both SBP and DBP passed the part 1 criteria. In the part 2 analysis, SBP passed the criteria but DBP failed. CONCLUSION: Although the Dinamap ProCare 200 BP monitor failed an adapted ESH-IP2, SBP passed. When comparing BP readings measured by oscillometers and mercury sphygmomanometers, one has to consider the differences between them, particularly in DBP, because DBP can be underestimated.

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PURPOSE: To validate the Dinamap ProCare 200 blood pressure (BP) monitor against a mercury sphygmomanometer in children 7 to 18 years old in accordance with the 2010 International Protocol of European Society of Hypertension (ESH-IP2) and the British Hypertension Society (BHS) protocol. METHODS: Forty-five children were recruited for the study. A validation procedure was performed following the protocol based on the ESH-IP2 and BHS protocols for children and adolescents. Each subject underwent 7 sequential BP measurements alternatively with a mercury sphygmomanometer and the test device by trained nurses. The results were analyzed according to the validation criteria of ESH-IP2. RESULTS: The mean (+/-SD) difference in the absolute BP values between test device and mercury sphygmomanometer readings was 1.85+/-1.65 mmHg for systolic BP (SBP) and 4.41+/-3.53 mmHg for diastolic BP (DBP). These results fulfilled the Association for the Advancement of Medical Instrumentation criterion of a mean+/-SD below 5+/-8 mmHg for both SBP and DBP. The percentages of test device-observer mercury sphygmomanometer BP differences within 5, 10, and 15 mmHg were 96%, 100%, and 100% for SBP, and 69%, 92%, and 100% for DBP, respectively, in the part 1 analysis; both SBP and DBP passed the part 1 criteria. In the part 2 analysis, SBP passed the criteria but DBP failed. CONCLUSION: Although the Dinamap ProCare 200 BP monitor failed an adapted ESH-IP2, SBP passed. When comparing BP readings measured by oscillometers and mercury sphygmomanometers, one has to consider the differences between them, particularly in DBP, because DBP can be underestimated.

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PURPOSE: To validate the Dinamap ProCare 200 blood pressure (BP) monitor against a mercury sphygmomanometer in children 7 to 18 years old in accordance with the 2010 International Protocol of European Society of Hypertension (ESH-IP2) and the British Hypertension Society (BHS) protocol. METHODS: Forty-five children were recruited for the study. A validation procedure was performed following the protocol based on the ESH-IP2 and BHS protocols for children and adolescents. Each subject underwent 7 sequential BP measurements alternatively with a mercury sphygmomanometer and the test device by trained nurses. The results were analyzed according to the validation criteria of ESH-IP2. RESULTS: The mean (+/-SD) difference in the absolute BP values between test device and mercury sphygmomanometer readings was 1.85+/-1.65 mmHg for systolic BP (SBP) and 4.41+/-3.53 mmHg for diastolic BP (DBP). These results fulfilled the Association for the Advancement of Medical Instrumentation criterion of a mean+/-SD below 5+/-8 mmHg for both SBP and DBP. The percentages of test device-observer mercury sphygmomanometer BP differences within 5, 10, and 15 mmHg were 96%, 100%, and 100% for SBP, and 69%, 92%, and 100% for DBP, respectively, in the part 1 analysis; both SBP and DBP passed the part 1 criteria. In the part 2 analysis, SBP passed the criteria but DBP failed. CONCLUSION: Although the Dinamap ProCare 200 BP monitor failed an adapted ESH-IP2, SBP passed. When comparing BP readings measured by oscillometers and mercury sphygmomanometers, one has to consider the differences between them, particularly in DBP, because DBP can be underestimated.

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OBJECTIVE: Extensive marketing of devices for self-measurement of blood pressure has created a need for purchasers to be able to satisfy themselves that such devices have been evaluated according to agreed criteria. The Oregon Scientific BPU 330 blood pressure monitor is an electronic device for upper arm measurement. This study assessed the accuracy of the Oregon Scientific BPU 330 blood pressure monitor according to the International Protocol by the Working Group on Blood Pressure Monitoring of the European Society of Hypertension for validation of blood pressure measuring devices. METHOD: 52 participants over 30 years of age were studied in the validation. Nine blood pressure measurements were taken alternately with a mercury sphygmomanometer by two observers, and by the supervisor, using the BPU 330 device. A total of 33 participants were selected for the analysis. The validation was divided into two phases. Phase 1 included 15 participants. If the device passed phase 1, 18 more participants were included. The 99 pairs of measurements were compared according to the International Protocol. The device was given a pass/fail recommendation based on its accuracy compared with the mercury standard (within 5, 10, and 15 mmHg), as well as the number met in the ranges specified by the International Protocol. RESULTS: The mean and standard deviation of the difference between the mean of the observers and the BPU 330 device were 1.7 +/- 4.7 mmHg and 2.8 +/- 3.9 mmHg for systolic blood pressure (SBP) and diastolic blood pressure (DBP), respectively. In phase 1, the device passed with a total of 33, 43, and 44 SBP readings; 38, 44, and 45 DBP readings were within 5, 10, and 15 mmHg, respectively. In phase 2.1, 81, 95, and 96 for SBP, and 83, 95, and 98 for DBP readings fell within the zones of 5, 10, and 15 mmHg, respectively. In phase 2.2, the last phase, 28 participants fell within the zone of two of the three comparisons, lying within 5 mmHg for SBP and 29 participants for DBP. No participants fell within the zone of all three of their comparisons over 5 mmHg apart for both SBP and DBP. CONCLUSION: The BPU 330 can be recommended for self-monitoring of blood pressure in the adult population, according to the International Protocol.

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