Upper-arm Blood Pressure Monitor Research Articles

Validation of the Rossmax AC1000f upper-arm blood pressure monitor in adults according to the British Hypertension Society Protocol.

To evaluate the accuracy of the Rossmax AC1000f oscillometric upper-arm blood pressure monitor in adults according to the British Hypertension Society Protocol. Eighty-five subjects (male 42 and female 43) with a mean age of 48.1 years were recruited to fulfill the blood pressure distribution criteria of the British Hypertension Society Protocol in general population using the same arm sequential blood pressure measurement method. For each subject, we sequentially measured blood pressure using a mercury sphygmomanometer (two observers) and the AC1000f device (one supervisor). Data analysis was carried out according to the British Hypertension Society Protocol. A total of 255 comparison pairs were obtained for analysis. The device achieved grade A. The percentage of blood pressure differences within 5, 10 and 15 mmHg was 66.7, 92.2 and 98.0%, respectively, for SBP, and 64.7, 90.2 and 98.4%, respectively, for DBP. The average (±SD) of the device-observer differences was -0.5 ± 6.0 mmHg for SBP and -1.4 ± 5.9 mmHg for DBP, respectively. The automated upper-arm blood pressure monitor Rossmax AC1000f has passed the requirements of the British Hypertension Society Protocol, and hence can be recommended for blood pressure measurement in adults.

Validation of the HL868ED upper-arm blood pressure monitor for clinical use and self-measurement according to the European Society of Hypertension International Protocol revision 2010.

The aim of this study was to evaluate the accuracy of the automated oscillometric upper arm blood pressure monitor HL868ED for clinical use and self-measurement according to the International Protocol of the European Society of Hypertension revision 2010. Systolic and diastolic blood pressure were measured sequentially in 43 adult Chinese (21 women, mean age 51.7 years) using a mercury sphygmomanometer (two observers) and the HL868ED device (one supervisor). A total of 99 pairs of comparisons were obtained from 43 participants for judgements in two parts with three grading phases. The HL868ED device achieved the targets in part 1 of the validation study. The number of absolute differences between device and observers within 5, 10 and 15 mmHg was 68/99, 91/99 and 97/99, respectively, for systolic blood pressure and 85/99, 95/99 and 99/99, respectively, for diastolic blood pressure. The device also fulfilled the criteria in part 2 of the validation study. Twenty-four and 30 participants for systolic and diastolic blood pressure, respectively, had at least two of the three device-observer differences within 5 mmHg (required ≥24). Three participants for systolic and one participant for diastolic blood pressure had all the three device-observer comparisons greater than 5 mmHg. The Health & Life blood pressure monitor HL868ED has passed the requirements of the International Protocol revision 2010 and hence can be recommended for blood pressure measurements in adults.

QardioArm Upper Arm Blood Pressure Monitor Against Omron M3 Upper Arm Blood Pressure Monitor in Patients With Chronic Kidney Disease: A Validation Study According to the European Society of Hypertension International Protocol Revision 2010.

BackgroundHypertension is considered as a main risk factor for chronic kidney disease development and progression. Thus, the control and evaluation of this disease with new software and devices are especially important in patients who suffer from chronic kidney disease.ObjectiveThis study aimed to validate the QardioArm mobile device, which is used for blood pressure (BP) self-measurement in patients who suffer from chronic kidney disease, by following the European Society of Hypertension International Protocol 2 (ESH-IP2) guidelines.MethodsA validation study was carried out by following the ESH-IP2 guidelines. A sample of 33 patients with chronic kidney disease self-measured their BP by using the QardioArm and Omron M3 Intellisense devices. Heart rate (HR), diastolic BP, and systolic BP were measured.ResultsThe QardioArm fulfilled the ESH-IP2 validation criteria in patients who suffered from chronic kidney disease.ConclusionsThus, this study is considered as the first validation using a wireless upper arm oscillometric device connected to an app to measure BP and HR meeting the ESH-IP2 requirements in patients who suffer from chronic kidney disease. New validation studies following the ESH-IP2 guidelines should be carried out using different BP devices in patients with specific diseases.

P60 Invasive Validation of Antares, a New Algorithm to Calculate Central Blood Pressure from Oscillometric Upper Arm Pulse Waves

BackgroundAntares is an algorithm for pulse wave analysis (PWA) by oscillometric blood pressure monitors in order to estimate central (aortic) blood pressure (cBP). Antares aims to enable brachial cuff-based blood pressure (BP) monitors to be type II-devices, determining absolute cBP values independently of potential peripheral BP inaccuracies. The present study is an invasive validation of the Antares algorithm.MethodsWe followed entirely the 2017 ARTERY protocol for validation of non-invasive cBP devices, the 2013 ANSI/AAMI/ ISO 81060-2 and 2018 AAMI/ESH/ISO validation standard protocols. In total, 191 patients undergoing cardiac catheterization were included, of which 145 patients entered analysis. Invasive cBP recordings were prospectively compared to simultaneous non-invasive cBP estimations using Antares, integrated into an oscillometric BP monitor. Antares analyses pulse waves during deflation of the cuff (patent of Redwave Medical GmbH). Generally speaking, pulse waves of a normal oscillometric BP measurement are taken for PWA with no need for altering standard BP pump operation.ResultsMean difference between invasive and non-invasively estimated systolic cBP was 0.71 mmHg with standard deviation of 5.95 mmHg, fulfilling the highest validation criteria. Bland-Altman plot reveals good limits of agreement.ConclusionAntares is the first algorithm for estimation of cBP that entirely fulfills the 2017 ARTERY and AAMI/ESH/ISO validation protocols including criteria for high accuracy devices. The Antares algorithm turns the oscillometric upper arm blood pressure monitor into a type II-device for estimation of true cBP. Integration of Antares into BP monitors could enable the measurement of PWA parameters in virtually every practice in future.Bland altman of estimated vs. invasive central SBP

Validation of the YuWell YE680B upper-arm blood pressure monitor in adults according to the ANSI/AAMI/ISO 81060-2: 2013 standard.

To evaluate the accuracy of the YuWell YE680B oscillometric upper-arm blood pressure monitor for clinic and home blood pressure measurements in adults according to the American National Standards Institute/the Association for the Advancement of Medical Instrumentation/International Organization for Standardization (ANSI/AAMI/ISO) 81060-2:2013 standard. Eighty-five subjects (male 46 and female 39) with a mean age of 44.6 years were recruited to fulfill the age, sex, blood pressure, and cuff distribution criteria of the ANSI/AAMI/ISO standard in the general population using the same arm sequential blood pressure measurement method. Two differently-sized cuffs were used for arm circumferences 22-32 cm (medium) and 22-45 cm (large), respectively, for the test device, and for arm circumferences ≤32 cm (standard) and >32 cm (large), respectively, for the mercury sphygmomanometer. A total of 255 comparison pairs were obtained for analysis. For validation criterion 1, the mean ± SD of the differences between the test device and reference systolic/diastolic blood pressure readings was -2.2 ± 7.2/-3.9 ± 5.2 mmHg. For validation criterion 2, the SD of the averaged systolic/diastolic blood pressure differences between the test device and reference blood pressure per subject was 5.70/4.67 mmHg. The automated upper-arm blood pressure monitor YuWell YE680B has passed the requirements of the ANSI/AAMI/ISO81060-2:2013 standard, and hence can be recommended for blood pressure measurement in the general population.

Validation of Transtek TMB-1776 according to European Society of Hypertension International Protocol revision 2010 in adults

In the present study, accuracy of Transtek TMB-1776 upper-arm blood pressure monitor in adult subjects was determined by comparing with a non-invasive (auscultatory) reference mercury sphygmomanometer, following the European Society of Hypertension International Protocol revision 2010 (ESH-IP 2010). All the validation requirement were reached: 74, 93, and 98 of systolic blood pressure measurements and 86, 97, and 99 of diastolic blood pressure measurements were within 5, 10, and 15 mmHg of absolute difference, respectively. The mean ± SD device-observer difference was -1.2 ± 4.9 mmHg for systolic blood pressure and -0.7 ± 3.5 mmHg for diastolic blood pressure. For systolic blood pressure and diastolic blood pressure, respectively, 25 and 30 of subjects had at least two of their three difference within 5 mmHg, and three and zero subject showed no difference within 5 mmHg. In conclusion, Transtek TMB-1776 has passed all phases of ESH-IP 2010 and is suitable for self/home blood pressure measurement of adults.

Validation of the HL868ED upper-arm blood pressure monitor for clinical use and self-measurement according to the British Hypertension Society Protocol.

The present study aimed to evaluate the accuracy of the Health & Life automated oscillometric upper-arm blood pressure monitor HL868ED for blood pressure monitoring according to the British Hypertension Society Protocol. We recruited individuals until there were 85 eligible participants and their blood pressure could meet the blood pressure distribution requirements specified by the British Hypertension Society Protocol. For each individual, we sequentially measured systolic and diastolic blood pressures using a mercury sphygmomanometer (two observers) and the HL868ED device (one supervisor). Data analysis was carried out according to the British Hypertension Society Protocol. The device achieved grade A. The percentage of blood pressure differences within 5, 10 and 15 mmHg was 68%, 91% and 98%, respectively, for systolic blood pressure, and 79, 96 and 99%, respectively, for diastolic blood pressure. The average (±SD) of the device-observer differences was -1.8 ± 6.0 mmHg for systolic and 0.1 ± 4.7 mmHg for diastolic blood pressures, respectively. The Health & Life automated upper-arm blood pressure monitor HL868ED has passed the requirements of the British Hypertension Society Protocol, and hence can be recommended for blood pressure measurement in adults.

Telemonitoring of 24-Hour Blood Pressure in Local Pharmacies and Blood Pressure Control in the Community: The Templar Project.

The analysis of ambulatory blood pressure monitorings (ABPMs) performed in 639 Italian pharmacies in the context of a telehealth-based service allowed to evaluate the level of blood pressure (BP) control in the community. Twenty-four-hour ABPMs were performed by a clinically validated, automated, upper-arm BP monitor. Recordings were uploaded on a certified web-based telemedicine platform (www.tholomeus.net) and remote medical reporting provided. In each subject, an automatic BP measurement was obtained in the pharmacy and clinical information collected before starting the ABPM. A total of 20,773 subjects (mean age 57 ± 15 years; 54% females; 28% receiving antihypertensive medications, 31% with any cardiovascular [CV] risk factor) provided valid ABPMs. BP control was poor, but better in ambulatory conditions (24-hour BP <130/80 mm Hg 54% vs. pharmacy BP < 140/90 mm Hg 43%; P < 0.0001) and in drug-treated subjects. Sustained normotension was reported in only 28% subjects. Isolated nocturnal hypertension (16%; nighttime BP ≥120/70 mm Hg with normal daytime BP) was more common (P < 0.0001) than isolated daytime hypertension (9%; daytime BP ≥ 135/85 mm Hg with normal nighttime BP). Sustained hypertension (43%) was more common in younger males at the lowest CV risk, with daytime hypertension. White-coat hypertension (14%) was more common in females. Masked hypertension was not uncommon (15%) and more often observed in older males with an elevated nocturnal BP. A telemedicine-based service provided to community pharmacies may facilitate access to ABPM, thus favoring a more accurate hypertension screening and detection. It may also help describe the occurrence of different 24-hour BP phenotypes and personalize the physician's intervention.

Construction of Blood Pressure Monitor Using Photoplethysmography Calibrating with Upper-arm Blood Pressure Monitor

A photoplethysmography (PPG) is one of an alternative technique for monitoring personal health with the advantages of non-invasive, inexpensive, and easy to use. In this work, PPG is used to estimate blood pressure with the aim to construct a prototype of blood pressure monitor by photoplethysmography and calibrate with upper-arm blood pressure monitor. The NIR LED light source and detector is used to obtain PPG signals. The PPG signals from blood pressure prototype are recorded with band pass filter and used for calibration with upper-arm blood pressure monitor in 10 volunteers. It is found that the maximum and minimum values of PPG signals show linear dependence of systolic and diastolic blood pressure from the commercial blood pressure monitor with R2=0.72. The obtained linear relation is applied to calibrate the measured PPG signals and to test with 12 volunteers. From the test, the precision of systolic and diastolic blood pressure from the prototype are 8 mmHg and 6 mmHg respectively and the accuracy is equal to ±10 mmHg compared with that of commercial blood pressure monitor of ±3 mmHg. Thus, the prototype of blood pressure shows less accuracy than that of commercial blood pressure monitor and may not medically use for health monitoring. However, the prototype maybe practically use as a screening tool for monitoring blood pressure due to easy to use and fast measurement.

Validation of the Pangao PG-800B26 upper arm blood pressure monitor in the general population according to the European Society of Hypertension and the British Hypertension Society protocols.

This study aimed to evaluate the accuracy of the automated oscillometric upper arm blood pressure monitor Pangao PG-800B26 for home blood pressure monitoring according to the European Society of Hypertension International Protocol (ESH-IP) revision 2010 and the British Hypertension Society (BHS) protocols. Systolic and diastolic blood pressures were measured sequentially in 33 and 85 adults, respectively, on the basis of the ESH-IP and BHS protocols using a mercury sphygmomanometer (two observers) and the device (one supervisor). The procedures and analysis methods of the protocols were followed precisely. The device fulfilled the criteria of the ESH-IP, with device-observer differences of 1.01±5.16 and -0.58±4.17 mmHg for systolic and diastolic blood pressure, respectively. Furthermore, the A/A grade of the BHS protocol was also achieved for overall grading and for the three pressure levels, with average differences of 0.85±6.35 and -0.15±5.65 mmHg for systolic and diastolic blood pressure, respectively, which also fulfilled the requirements of the Association for the Advancement of Medical Instrumentation. The Pangao PG-800B26 fulfilled the criteria of the ESH-IP 2010 and achieved the A/A grade of the BHS protocol, and hence can be recommended for home use in adults.

Validation of the Microlife BP A3 PC upper arm blood pressure monitor in patients with diabetes mellitus according to the ANSI/AAMI/ISO 81060-2: 2013 protocol.

The aim of the present study was to validate the blood pressure (BP) measurement device, Microlife BP A3 PC, in patients with diabetes mellitus, according to the ANSI/AAMI/ISO 81060-2:2013 protocol. In 85 individuals aged 56-88 years, with predefined criteria for diabetes mellitus, BP measurements on the upper arm were performed alternately using the Microlife BP A3 PC and a standard mercury reference sphygmomanometer. A total of 333 comparisons were included for analysis. The mean difference between the Microlife BP A3 PC and the reference was -1.5±6.3 mmHg for systolic BP (SBP) and -1.3±5.2 mmHg for diastolic BP (DBP) according to criterion 1 of the protocol. For SBP, a total of 209 of the 333 measurements were within the range of 5 mmHg (62.8%), whereas the corresponding numbers for DBP were 232 of 333 (69.7%). For criterion 2, the intraindividual differences for the test device and the reference were -1.50±4.73 mmHg for SBP and -1.30±4.55 mmHg for DBP, thus being within the defined ranges provided by the protocol. The Microlife BP A3 PC fulfilled the requirements of criteria 1 and 2 of the ANSI/AAMI/ISO 81060-2:2013 protocol and can also be recommended for BP measurement in diabetic patients.

Validation of the AVITA BPM64 upper-arm blood pressure monitor for home blood pressure monitoring according to the European Society of Hypertension International Protocol revision 2010.

The aim of this study was to evaluate the accuracy of the automated oscillometric upper arm blood pressure (BP) monitor AVITA BPM64 for home BP monitoring according to the International Protocol of the European Society of Hypertension revision 2010. Systolic and diastolic BPs were measured sequentially in 33 adult Chinese (14 women, mean age 47.0 years) using a mercury sphygmomanometer (two observers) and the AVITA BPM64 device (one supervisor). A total of 99 pairs of comparisons were obtained from 33 participants for judgments in two parts with three grading phases. The AVITA BPM64 device achieved the targets in part 1 of the validation study. The number of absolute differences between device and observers within 5, 10, and 15 mmHg was 91/99, 98/99, and 98/99, respectively, for systolic BP and 92/99, 99/99, and 99/99, respectively, for diastolic BP. The device also fulfilled the criteria in part 2 of the validation study. Thirty-two participants for both systolic and diastolic BP had at least two of the three device-observer differences within 5 mmHg (required ≥24). Only one participant for systolic BP had all three device-observer comparisons greater than 5 mmHg. The AVITA upper arm BP monitor BPM64 has passed the requirements of the International Protocol revision 2010, and hence can be recommended for home use in adults.

Validation of the SEJOY BP-1307 upper-arm blood pressure monitor for home blood pressure monitoring according to the European Society of Hypertension International Protocol revision 2010.

The present study aimed to evaluate the accuracy of the automated oscillometric upper-arm blood pressure monitor SEJOY BP-1307 (also called JOYTECH DBP-1307) for home blood pressure monitoring according to the International Protocol of the European Society of Hypertension revision 2010. Systolic and diastolic blood pressures were sequentially measured in 33 adult Chinese individuals (13 women, 45.1 years of mean age) using a mercury sphygmomanometer (two observers) and the SEJOY BP-1307 device (one supervisor). Ninety-nine pairs of comparisons were obtained from 33 participants for judgments in two parts with three grading phases. The average±SD of the device-observer differences was 0.2±4.1 and -1.7±4.7 mmHg for systolic and diastolic blood pressure, respectively. The SEJOY BP-1307 device achieved the criteria in both part 1 and part 2 of the validation study. The SEJOY upper-arm blood pressure monitor BP-1307 has passed the requirements of the International Protocol revision 2010, and hence can be recommended for home use in adults.

Validation of the YuWell YE690A upper-arm blood pressure monitor, for clinic use and self-measurement, according to the European Society of Hypertension International Protocol revision 2010.

The present study aimed to evaluate the accuracy of the automated oscillometric upper-arm blood pressure monitor YuWell YE690A for blood pressure measurement according to the International Protocol of the European Society of Hypertension revision 2010. Systolic and diastolic blood pressures were measured sequentially in 33 adult Chinese (12 women, 44.2 years of mean age) using a mercury sphygmomanometer (two observers) and the YE690A device (one supervisor). A total of 99 pairs of comparisons were obtained from 33 participants for judgments in two parts with three grading phases. All the blood pressure requirements were fulfilled. The YuWell YE690A device achieved the targets in part 1 of the validation study. The number of absolute differences between device and observers within 5, 10, and 15 mmHg was 79/99, 96/99, and 97/99, respectively, for systolic blood pressure and 72/99, 95/99, and 98/99, respectively, for diastolic blood pressure. The device also fulfilled the criteria in part 2 of the validation study. Thirty-one and 25 participants for systolic and diastolic blood pressure, respectively, had at least two of the three device-observer differences within 5 mmHg (required ≥24). No participant for systolic and two participants for diastolic blood pressure had all the three device-observer comparisons greater than 5 mmHg. The YuWell blood pressure monitor YE690A has passed the requirements of the International Protocol revision 2010 and hence can be recommended for blood pressure measurement in adults.

Validation of the Omron HEM-7320-LA, upper arm blood pressure monitor with Intelli Wrap Technology Cuff HEM-FL1 for self-measurement and clinic use according to the European Society of Hypertension International Protocol revision 2010 in the Mexican population.

ObjectiveThe aim of this study was to determine the accuracy of the Omron HEM-7320-LA with Intelli Wrap technology cuff HEM-FL1 for self-measurement and clinic blood pressure (BP) measurement according to the European Society of Hypertension International Protocol revision 2010.Participants and methodsThe evaluation was performed in 39 individuals. The mean age of the participants was 47.9±14 years; systolic BP was 145.2±24.3 mmHg (range: 97–190), diastolic BP was 90.9±12.9 mmHg (range: 68–120), and arm circumference was 30.8±4 cm (range: 25–38.5).ResultsThe device successfully fulfilled the established criteria of the validation protocol. The device overestimated systolic BP by 0.6±5.7 mmHg and diastolic BP by 2.2±5.1 mmHg. The specially designed cuff HEM-FL1 to cover a broad range of arm circumferences and self-placement fulfilled the requirements of the International Protocol.

Validation of the BPUMP BF1112 upper-arm blood pressure monitor for home blood pressure monitoring according to the European Society of Hypertension International Protocol revision 2010

The present study aimed to evaluate the accuracy of the automated oscillometric upper-arm blood pressure (BP) monitor BPUMP BF1112 for home BP monitoring according to the International Protocol of the European Society of Hypertension revision 2010 (ESH-IP2010). Systolic and diastolic BPs were sequentially measured in 33 adult Chinese (13 women, mean age 46.7 years) using a mercury sphygmomanometer (two observers) and the BF1112 device (one supervisor). A total of 99 pairs of comparisons were obtained from 33 participants for judgments in two parts with three grading phases. The BPUMP BF1112 device achieved the targets in part 1 of the validation study. The number of absolute differences between device and observers within 5, 10, and 15 mmHg was 85/99, 96/99, and 97/99, respectively, for systolic BP, and 83/99, 97/99, and 99/99, respectively, for diastolic BP. The device also fulfilled the criteria in part 2 of the validation study. A total of 31 and 30 participants for systolic and diastolic BP, respectively, had at least two of the three device-observer differences within 5 mmHg (required≥24mmHg). No participant for systolic or diastolic BP had all the three device-observer comparisons greater than 5 mmHg. The BPUMP BP monitor BF1112 has passed the requirements of the ESH-IP2010, and hence can be recommended for home use in adults.

VALIDATION OF THE MECG-DP-NS-01 MONITOR IN OSCILLOMETRY AND AUSCULTATION MODES, ACCORDING TO ESH, BHS AND AAMI PROTOCOLS

Background: Ambulatory blood pressure monitoring is one of the main methods for hypertension diagnosis. According to the recommendations of the Russian Medical Society of Hypertension and the All-Russian Society of Cardiology, only devices that passed all of the international protocols requirements can be recommended for ambulatory blood pressure monitoring. Aim: Validation of the MECG-DP-NS-01 upper arm blood pressure monitor produced by the DMS Advanced Technologies Ltd., in oscillometry and auscultation modes, for ambulatory blood pressure monitoring, in an adult population at rest according to the ESH International Protocol revision 2010 (ESH-IP2), the BHS protocol revision 1993 and the AAMI standard. Materials and methods: A group of 85 people (50 men and 35 female) aged 19 to 86 years (mean age 47.7±18.0 years) was recruited for the validation study. Expert and device blood pressure measurements were taken for each patient according to the international protocols. Results: The MECG-DP-NS-01 upper arm blood pressure monitor produced by the DMS Advanced Technologies Ltd. for ambulatory blood pressure monitoring, was validated in oscillometry and auscultation modes in an adult population at rest according to the BHS protocol revision 1993, the ESH-IP2, and the AAMI standard. The device achieved an A/A grading for the BHS protocol revision 1993 both in the oscillometry and auscultation modes. The device maintained its A/A grading throughout the low-pressure, medium-pressure, and high-pressure ranges. Conclusion: The MECG-DP-NS-01 passed all of the requirements and, fulfilling the standards of the protocols, is recommended for ambulatory blood pressure monitoring according to BHS protocol revision 1993, ESH-IP2, and AAMI standard. According to the Declaration of Blood Pressure Measuring Device Equivalence signed by the manufacturer there are no differences that will affect blood pressure measuring accuracy between the MDP-NS-02s (Voshod) upper arm blood pressure monitor produced by the DMS Advanced Technologies Ltd. and the MECG-DP-NS-01, which passed the ESH-IP2, BHS and AAMI protocols.

Validation of the Andon KD-5965 upper-arm blood pressure monitor for home blood pressure monitoring according to the European Society of Hypertension International Protocol revision 2010

This study aimed to evaluate the accuracy of the Andon KD-5965 upper-arm blood pressure monitor according to the European Society of Hypertension International Protocol revision 2010. Systolic and diastolic blood pressures were sequentially measured in 33 adults, with 20 women using a mercury sphygmomanometer (two observers) and the Andon KD-5965 device (one supervisor). A total of 99 pairs of comparisons were obtained from 33 participants for judgments in two parts with three grading phases. The device achieved the targets in part 1 of the validation study. The number of absolute differences between the device and observers within 5, 10, and 15 mmHg was 70/99, 91/99, and 98/99, respectively, for systolic blood pressure and 81/99, 99/99, and 99/99, respectively, for diastolic blood pressure. The device also fulfilled the criteria in part 2 of the validation study. Twenty-five and 29 participants, for systolic and diastolic blood pressure, respectively, had at least two of the three device-observers differences within 5 mmHg (required≥24). Two and one participants for systolic and diastolic blood pressure, respectively, had all three device-observers comparisons greater than 5 mmHg. According to the validation results, with better performance for diastolic blood pressure than that for systolic blood pressure, the Andon automated oscillometric upper-arm blood pressure monitor KD-5965 fulfilled the requirements of the European Society of Hypertension International Protocol revision 2010, and hence can be recommended for blood pressure measurement in adults.

Validation of the Andon KD-5851 upper arm blood pressure monitor, for self-measurement according to the European Society of Hypertension International Protocol revision 2010.

This study aimed to validate the Andon KD-5851 upper arm blood pressure (BP) monitor according to the European Society of Hypertension International Protocol (ESH-IP) revision 2010. A total of 33 eligible participants were included in the study. Sequential measurements of BPs were performed using a mercury sphygmomanometer and the device, and the data analysis was carried out following precisely the ESH-IP revision 2010. The device had 82, 98, and 99 measurements within 5, 10, and 15 mmHg for systolic blood pressure and 85, 95, and 99 measurements for diastolic blood pressure, respectively. The average device-observer difference was -0.53±4.00 mmHg for systolic blood pressure and -1.15±4.06 mmHg for diastolic blood pressure. The device passed all the criteria according to the ESH-IP revision 2010. According to the validation results on the basis of the ESH-IP revision 2010, the Andon KD-5851 upper arm BP monitor can be recommended for self/home measurement in adults.

Validation of the Rossmax CF175 upper-arm blood pressure monitor for home blood pressure monitoring according to the European Society of Hypertension International Protocol revision 2010.

The present study aimed to evaluate the accuracy of the Rossmax CF175 upper-arm blood pressure monitor for home blood pressure monitoring according to the International Protocol of the European Society of Hypertension revision 2010. Systolic and diastolic blood pressures were sequentially measured in 33 adult Chinese (17 women, mean age 46 years) using a mercury sphygmomanometer (two observers) and the Rossmax CF175 device (one supervisor). A total of 99 pairs of comparisons were obtained from 33 participants for judgments in two parts with three grading phases. All the blood pressure requirements were fulfilled. The Rossmax CF175 device achieved the targets in part 1 of the validation study. The number of absolute differences between the device and observers within 5, 10, and 15 mmHg was 78/99, 94/99, and 98/99, respectively, for systolic blood pressure, and 81/99, 96/99, and 97/99, respectively, for diastolic blood pressure. The device also achieved the criteria in part 2 of the validation study. Twenty-nine participants, for both of systolic and diastolic blood pressure, had at least two of the three device-observers differences within 5 mmHg (required ≥24). Only one participant for diastolic blood pressure had all three device-observers comparisons greater than 5 mmHg. The Rossmax automated oscillometric upper-arm blood pressure monitor CF175 fulfilled the requirements of the International Protocol revision 2010, and hence can be recommended for blood pressure measurement in adults.