Validation of the A&D UA-631 (UA-779 Life Source) device for self-measurement of blood pressure and relationship between its performance and large artery compliance

OBJECTIVES: To determine the accuracy of the UA-631 (UA-779 Life Source for the American market) blood pressure monitor developed by the A&D Company (Toshimi-ku, Tokyo, Japan). DESIGN: Device evaluation was performed using a new protocol proposed by the Working Group on blood pressure monitoring of the European Society of Hypertension (ESH). Monitor performance was assessed in relation to subjects' gender, age, skinfold thickness, arm circumference, BMI, and elasticity index of large (C1) and small (C2) arteries. METHODS: The A&D recorder was assessed according to the various phases of the protocol. Sequential readings were taken for the main validation test. Outcome was classified according to the criteria of ESH recommendations, which are based on four zones of accuracy differing from the mercury standard by 5, 10, 15 mmHg, or more. RESULTS: The main validation test was performed in 66 subjects for a total of 198 device measurements. The A&D monitor passed all three phases both for systolic and diastolic blood pressure (SBP and DBP). Mean blood pressure difference between device and observers was 2 +/- 5 mmHg for SBP and 1 +/- 3 mmHg for DBP. The absolute discrepancy between device and observers (4 +/- 4 mmHg for SBP, and 2 +/- 2 mmHg for DBP) was related to age (negatively) and to C1 (positively), but in a multivariable regression analysis only C1 remained a significant independent predictor of the absolute device-observer discrepancy. CONCLUSIONS: These data show that the A&D UA-631 device satisfies the new recommended ESH accuracy levels for both SBP and DBP. Its performance seems to be better in subjects with stiffer arteries.     

Validation of the A&D UA-705 device for self-measurement of blood pressure according to the British Hypertension Society protocol

OBJECTIVES: We tested the accuracy of the UA-705 blood pressure semi-automatic monitor. METHODS: Device evaluation was performed according to the modified British Hypertension Society protocol released in 1993. Eighty-five patients with characteristics outlined in the British Hypertension Society protocol were recruited among those attending our out-patient clinic. Sequential readings were taken for the main validation test. Outcome was classified according to the British Hypertension Society criteria, which are based on four zones of accuracy differing from the mercury standard by 5, 10 and 15 mmHg, or more. RESULTS: The mean blood pressure difference (+ or -1 SD) between device and observers was 0.4 mmHg (SD 7.7) for systolic blood pressure and 0.3 mmHg (SD 8.2) for diastolic blood pressure. Overall, 96% (observer 1) and 95% (observer 2) of readings between device and observers differed by 15 mmHg or less for both systolic and diastolic blood pressure. The device achieved a grade A for both systolic and diastolic blood pressure. CONCLUSIONS: This study shows that the A&D UA-705 device satisfies the British Hypertension Society standard for accuracy by achieving a grade A for both systolic and diastolic blood pressure.     

Validation of the A&D UA-774 (UA-767Plus) device for self-measurement of blood pressure

OBJECTIVES: To determine the accuracy of the UA-774 (UA-767Plus) blood pressure monitor developed by the A&D Company. METHODS: Device evaluation was performed according to the modified British Hypertension Society (BHS) protocol released in 1993. Eighty-five subjects with characteristics outlined in the BHS protocol were recruited among those attending the outpatient clinic of the Department of Cardiovascular Disease, Hospital 'R. Silvestrini', Perugia, Italy. The A&D blood pressure monitor was evaluated according to the various steps of the protocol. Sequential readings were taken for the main validation test. Outcome was classified according to the criteria of BSH recommendations, which are based on four areas of accuracy differing from the mercury standard by 5, 10 and 15 mmHg, or more. RESULTS: The device achieved a grade A for systolic and a grade A for diastolic blood pressure. Mean blood pressure difference (+/-1 SD) between device and observers was -1.01+/-7.14 mmHg for systolic blood pressure and -1.42+/-7.61 mmHg for diastolic blood pressure. There was no systematic change in the device-observed difference over a wide range of blood pressure values CONCLUSIONS: These data show that the A&D UA-774 (UA-767Plus) device satisfies the BSH recommendations for accuracy for systolic and diastolic blood pressure.     

Validation of semi-automatic device UA-704 for self-measurement of blood pressure

OBJECTIVE: To perform a clinical validation for a semi-automatic arm-type device UA-704 (A&D Company, Ltd., Tokyo, Japan) according to the British Hypertension Society protocol. METHODS: Eighty-five study participants (37 men) were included. The mean age was 50.1+/-17.0 years, systolic blood pressure range was 79-212 mmHg and diastolic blood pressure range was 43-118 mmHg. For each participant, three readings of the UA-704 were compared with simultaneous auscultatory measurements by two trained independent observers. The observers used a mercury calibrated sphygmomanometer and a dual stethoscope. The results were graded according to the 1993 British Hypertension Society protocol. RESULTS: The average difference between mercury sphygmomanometer and UA-704 readings was -1.85+/-4.26 mmHg (mean+/-SD) for systolic blood pressure and -1.44+/-3.97 mmHg for diastolic blood pressure. The proportions of values agreeing to within 5, 10 and 15 mmHg were 79.2%, 96.5% and 99.6% for systolic blood pressure and 86.7%, 96.9% and 99.6% for diastolic blood pressure for the observers and device (A/A grade for British Hypertension Society). CONCLUSIONS: For an adult population, the UA-704 device for self-measurement of blood pressure achieved a British Hypertension Society grade A/A and therefore can be recommended for home blood pressure monitoring.     

Validation of Heine Gamma G7 (G5) and XXL-LF aneroid devices for blood pressure measurement

OBJECTIVE: To determine the accuracy of the Gamma G7 (and G5 model) and XXL-LF aneroid sphygmomanometers developed by the Heine Company. DESIGN: Device evaluations were performed using the new protocol of the European Society of Hypertension. Monitor performance was assessed in relation to participants' sex, age, arm circumference, and systolic and diastolic blood pressures. METHODS: The two sphygmomanometers were assessed in two different samples according to European Society of Hypertension requirements, which are based on four zones of accuracy differing from the mercury standard by 5, 10, 15 mmHg, or more. RESULTS: Both sphygmomanometers passed all three phases of the protocol for systolic blood pressure and diastolic blood pressure. Mean blood pressure difference between Gamma G7 sphygmomanometer and observers was -0.4+/-3.3 mmHg for systolic blood pressure and -0.5+/-2.6 mmHg for diastolic blood pressure. Mean differences for the Gamma XXL-LF sphygmomanometer were -0.3+/-3.7 and -1.0+/-2.6 mmHg, respectively. In multivariable analyses, the SBP discrepancies between both aneroid sphygmomanometers and observers were unrelated to age, sex, arm circumference and systolic blood pressure. For diastolic blood pressure, a borderline relationship was found only for arm circumference (P=0.057) with the Gamma G7 device. CONCLUSIONS: These data show that the Heine Gamma G7 and Gamma XXL-LF aneroid sphygmomanometers satisfy the new recommended ESH accuracy levels for both SBP and DBP. Their performance is uniform across subgroups of participants with different clinical characteristics.     

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 A&D UA-767 device for the self-measurement of blood pressure

BACKGROUND: The validation of self-measurement devices has been recommended. Automatic monitor A&D UA-767 (A&D Company, Ltd, Tokyo, Japan) is well known and widely used, but not tested according to the Association for Advancement of Medical Instrumentation (AAMI) and British Hypertension Society (BHS) recommendations. OBJECTIVE: To perform a clinical validation for use by adults of the A&D UA-767 device according to the criteria of the AAMI and a modified BHS protocol. METHODS: The test concerned 101 subjects (57 men and 44 women) aged 15-85 years with arm circumferences of 22-39 cm, a systolic blood pressure (SBP) range of 89-206 mmHg, and a diastolic blood pressure (DBP) range of 53-122 mmHg. For each subject, three readings of the UA-767 were compared with simultaneous auscultatory measurements by two trained independent observers who used a mercury manometer and dual stethoscope. The results were graded according to the BHS (1990 and 1993) and AAMI recommendations. RESULTS: Observers showed close agreement, with mean differences of 1.1+/-2.4 mmHg for SBP and -0.7+/-2.0 mmHg for DBP. The proportion of values agreeing to within 5, 10 and 15 mmHg were 93, 100, and 100% for SBP and 97, 100, and 100% for DBP for the two observers. The sphygmomanometer measurements were 132+/-24/79+/-14 mmHg (mean+/-SD). The average difference between the mercury sphygmomanometer and A&D UA-767 readings for SBP and DBP were, respectively, -0.4+/-5.4 and -0.4+/-4. 8 mmHg. The proportion of values agreeing to within 5,10, and 15 mmHg were 82, 94, and 98% for SBP and 80, 95, and 98% for DBP for the observers and device (A/A grade for BHS). CONCLUSIONS: For an adult population, the A&D UA-767 device for the self-measurement of blood pressure satisfied the AAMI criteria, achieved a BHS grade of A/A and can therefore be recommended for monitoring blood pressure in home and clinical conditions by patients with mild-to-moderate arterial hypertension.     

Validation of the A&D wrist-cuff UB-511 (UB-512) device for self-measurement of blood pressure

OBJECTIVES: To determine the accuracy of the A&D UB-511 (UB-512) oscillometric wrist-cuff device for self-measurement of blood pressure, the only difference between the two devices being the size of storage memory. METHODS: Device evaluation was performed according to the modified British Hypertension Society protocol released in 1993. Eighty-five study participants with characteristics outlined in the British Hypertension Society protocol were recruited among those attending our out-patient clinic. The device was evaluated according to the various steps of the protocol. The non-dominant arm was used for blood pressure measurement. To maintain the wrist at cardiac level during validation, the arm was kept horizontal at the mid-sternum level and supported by a soft table. The wrist was kept extended. Sequential readings were taken for the main validation test. Outcome was classified according to the criteria of the British Hypertension Society recommendations, which are based on four strata of accuracy differing from the mercury standard by 5, 10 and 15 mmHg, or more. RESULTS: The device achieved a British Hypertension Society grade B for systolic and a grade B for diastolic blood pressure. The device tended to overestimate arm blood pressure, the mean difference (+/-1 SD) between device and observers being 4.3+/-8.7 mmHg for systolic blood pressure and 3.7+/-8.1 mmHg for diastolic blood pressure for observer 2, and 4.4+/-8.6 mmHg for systolic blood pressure and 3.8+/-7.9 mmHg for diastolic blood pressure for observer 1. In a logistic regression analysis, age was the sole predictor of an achieved difference between device and mercury column by 5 mmHg or less (hazard ratio 1.020; 95% confidence interval 1.003-1.04; P=0.024). CONCLUSIONS: These data show that the A&D UB-511 (UB-512) device satisfies the British Hypertension Society recommendations with a grade B/B. The device tends to overestimate cuff blood pressure and its accuracy increases with age.     

Validation of TM-2655 oscillometric device for blood pressure measurement

OBJECTIVE: To perform validation for an arm-type oscillometric TM-2655 device (A&D Company Ltd, Tokyo, Japan) for blood pressure measurement according to the British Hypertension Society protocol. METHODS: Eighty-five study participants (33 men and 52 women) were included in the study. Mean age was 52.9+/-15.0 years, systolic blood pressure range was 84-208 mmHg and diastolic blood pressure range was 48-120 mmHg. For each participant, three readings of TM-2655 were compared with sequential auscultatory measurements by two trained independent observers. The observers used a calibrated mercury sphygmomanometer and dual stethoscope. The results were graded according to the British Hypertension Society protocol 1993. RESULTS: The average difference between mercury sphygmomanometer and TM-2655 readings for systolic blood pressure was -1.0+5.2 mmHg (mean+/-SD) and for diastolic blood pressure -0.9+/-4.7 mmHg. The proportions of values agreeing to within 5, 10 and 15 mmHg were 72.5, 93.7 and 99.6% for systolic blood pressure and 78.8, 96.9 and 100% for diastolic blood pressure between the observers and the device (A/A British Hypertension Society grade). CONCLUSIONS: The TM-2655 device achieved British Hypertension Society grade A/A and therefore can be recommended for blood pressure measurement in an adult population.     

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 a non-mercury digital auscultatory device with manual pressure registration (PMS Mandaus)

OBJECTIVE: To assess the clinical accuracy of a non-mercury digital auscultatory device (PMS Mandaus) with manual pressure registration in an adult population. METHODS: The accuracy of the device was assessed by predefined criteria (European Society of Hypertension protocol) in 33 study participants recruited from among patients and staff in a teaching hospital. A series of same-arm sequential blood pressure measurements were taken: first, two observers taking simultaneous mercury readings, followed by a reading with the device. A total of seven readings were taken from each participant in the sitting position. The data were then analysed according to the European Society of Hypertension protocol and the criteria of the Association for the Advancement of Medical Instrumentation. RESULTS: The device fulfilled the criteria of the European Society of Hypertension protocol, achieving a pass for both systolic and diastolic pressure. The device also passed the Association for the Advancement of Medical Instrumentation standard (the mean to be within 5+/-8 mmHg) with the mean differences being -3.2+/-3.8 mmHg for systolic blood pressure and -1.8+/-2.9 mmHg for diastolic blood pressure. CONCLUSION: The device performed in a satisfactory manner according to the European Society of Hypertension and the Association for the Advancement of Medical Instrumentation criteria. The systematic under-recording related to the delay of manual pressure registration is not sufficient to preclude clinical use.     

Validation of the Microlife BP W200-1 wrist device for blood pressure measurement

OBJECTIVE: The objective of the study was to determine the accuracy of the BP W200-1 device for blood pressure measurement at the wrist developed by the Microlife Company. The BP W200-1 model features a 'Microlife Average Mode', which uses a 'weighted' average of a minimum of three consecutive blood pressure (BP) readings taken 15 s apart. METHOD: Device evaluation was carried out using the International Protocol of the European Society of Hypertension. Monitor performance was assessed in relation to patients' sex, age, wrist circumference, and systolic (SBP) and diastolic blood pressures (DBP). RESULTS: The BP W200-1 comfortably passed all three phases of the protocol for SBP and DBP. The device performed well in all ranges of SBP and DBP. Mean blood pressure differences for the BP W200-1 monitor were -1.2+/-4.5 mmHg for SBP and -0.2+/-3.1 mmHg for DBP. In multivariable analyses, the SBP and DBP discrepancies between device and observer were unrelated to age, sex, wrist circumference, and blood pressure level. CONCLUSION: These data show that the Microlife BP W200-1 wrist monitor satisfies the recommended European Society of Hypertension accuracy levels for SBP and DBP and therefore can be recommended for clinical use in the adult population. Its performance is uniform across subgroups of patients with different clinical characteristics.     

Validation of an oscillometric home blood pressure monitor in an end-stage renal disease population and the effect of arterial stiffness on its accuracy

OBJECTIVES: Increased arterial stiffness, common in end-stage renal disease patients, has been shown to affect the correspondence between oscillometric and mercury sphygmomanometer blood pressure readings. The purpose of this study was to validate an oscillometric home blood pressure monitor in an end-stage renal disease population and to determine the effect of arterial stiffness on its accuracy. METHODS: Blood pressure measurements were taken with the Microlife 3AC1-1PC (Microlife; Taipei, Taiwan), an oscillometric home blood pressure monitor, and a mercury sphygmomanometer in 33 patients as specified by the European Society of Hypertension Validation Protocol. Radial pulse wave analyses were also performed. RESULTS: On the basis of European Society of Hypertension criteria, the Microlife 3AC1-1PC received a passing score for systolic and diastolic blood pressures. On average, the oscillometric monitor overestimated diastolic blood pressure by 2.4 mmHg (P=0.005, SD=4.5 mmHg) and there was a trend towards overestimation of systolic blood pressure as well (1.3 mmHg, P=0.09, SD=4.4 mmHg). A positive correlation was found between arterial stiffness, as assessed by augmentation index and pulse pressure, and the diastolic blood pressure difference between the device and the mercury sphygmomanometer (r=0.54, P=0.003; and r=0.65, P=0.001, respectively). Diastolic blood pressure was negatively correlated with the diastolic blood pressure difference (r=-0.49, P=0.003). No significant relationship was found between the systolic blood pressure difference and augmentation index, pulse pressure or systolic blood pressure. CONCLUSION: The Microlife 3AC1-1PC was shown to accurately measure blood pressure in patients with end-stage renal disease. As arterial stiffness increased and diastolic blood pressure fell, diastolic blood pressure was increasingly overestimated.     

Accuracy of the Microlife large-extra large-sized cuff (32-52 cm) coupled to an automatic oscillometric device

To determine the accuracy of the large-extra large-sized (L-XL) cuff (32-52 cm) coupled to a Microlife WatchBP Office ABI blood pressure measuring device tested according to the requirements of the International Protocol of the European Society of Hypertension. The L-XL cuff tested in this study is designed to provide accurate blood pressure measurements in patients with large arms (arm circumference≥32 cm) over a wide range of arm circumferences using a single 145±1×320±1 mm bladder. The evaluation was made in 33 patients with a mean±standard deviation age of 53±17 years (range: 30-96 years). Their systolic blood pressure (SBP) was 142±21 mmHg (range: 110-180 mmHg), diastolic blood pressure (DBP) was 87±14 mmHg (range: 62-106 mmHg) and arm circumference was 36±5 cm (range: 32-50 cm). Blood pressure measurements were made in the sitting position. The L-XL cuff coupled to the WatchBP Office ABI passed all three phases of the European Society of Hypertension protocol for SBP and DBP. Mean blood pressure differences between device and observer were -1.3±5.1 mmHg for SBP and -1.8±5.8 mmHg for DBP. Similar device-observer differences were observed in patients divided into two subgroups according to whether their arm circumference was above or below the median in the group. These results indicate that the L-XL cuff coupled to the WatchBP Office ABI monitor provides accurate blood pressure readings in patients with large arms over a wide range of arm circumferences.     

Validation of the HEM-780REL with easy wrap cuff for self-measurement of blood pressure according to the European Society of Hypertension International Protocol

OBJECTIVE: We tested the accuracy of the HEM-780REL automatic blood pressure monitor with Easy Wrap Cuff. METHODS: We used the International Protocol for validation of blood pressure measuring devices developed by the Working Group on Blood Pressure Monitoring of the European Society of Hypertension. Thirty-three adults over the age of 30 years participated to have 11 total participants in each of the three required blood pressure ranges for systolic and diastolic blood pressure. Sequential blood pressure readings were taken independently by trained observers using a mercury standard with appropriate size cuff. A third observer performed measurements with the test device. Analyses were performed according to International Protocol specifications for the 99 pairs of measurements. The device was given a pass/fail recommendation based on bands of accuracy compared with the mercury standard (within 5, 10, or 15 mmHg), as well as number of readings per participant within 5 mmHg. RESULTS: The mean blood pressure difference was 0.52+/-7.7 mmHg for systolic blood pressure and 0.39+/-4.7 mmHg for diastolic blood pressure. Twenty-four out of 33 participants had two out of three readings within 5 mmHg of the mercury standard for systolic blood pressure. Twenty-seven out of 33 participants had two out of three readings within 5 mmHg of the mercury standard for diastolic blood pressure. The device received a passing grade both for accuracy of individual measurements and for accuracy for individuals. CONCLUSION: The HEM-780REL with Easy Wrap Cuff performs accurately according to the standards of the International Protocol.     

Validation of the Oscar 2 oscillometric 24-h ambulatory blood pressure monitor according to the British Hypertension Society protocol

OBJECTIVES: Accuracy of blood pressure measuring devices is of prime importance and should be validated before devices are used clinically. We carried out an independent evaluation of the Oscar 2 oscillometric ambulatory blood pressure monitor (SunTech Medical, Model 222) according to the British Hypertension Society (BHS) Protocol. METHODS: Validation of the Oscar 2 was carried out in accordance with Part 1 of the British Hypertension Society protocol. Having successfully completed the first three phases, in the static validation phase blood pressure measurements were made on 114 participants simultaneously by two observers blinded from each other's readings and those of the device, giving 255 data pairs for systolic and diastolic blood pressure. Readings were made using simultaneous same-arm measurement, each observer using a dual-head binaural stethoscope and a calibrated mercury sphygmomanometer. Data were recorded independently, to the nearest 2 mmHg and were checked by the supervisor who operated the device. RESULTS: The device mean and observer means (and standard deviations) were exceptionally close across a high range of pressures, with a mean difference for the better observer of 0+/-7 mmHg and -1+/-6 mmHg for systolic and diastolic blood pressure, respectively. With 62% of all systolic blood pressure standard vs. device differences equal or less than 5 mmHg, and 70% of all similar differences for diastolic blood pressure equal to or less than 5 mmHg, the device was categorized as Grade A for systolic and diastolic blood pressure. CONCLUSION: The Oscar 2 was graded A for both systolic and diastolic blood pressure by the British Hypertension Society protocol and can be recommended for clinical use in an adult population.     

Validation of the Oregon scientific BPW810 blood pressure monitor according to the European Society of Hypertension Protocol

OBJECTIVE: To determine the accuracy of the BPW810 blood pressure monitor developed by IDT Technology Limited, according to the international protocol of the European Society of Hypertension. DESIGN: The international protocol is divided into two phases: the first phase is performed on 15 selected participants and, if the device passes this phase, 18 more participants are included making a total of 33 participants on whom the final validation is performed. METHOD: According to the European Society of Hypertension requirements, for each of the 33 participants, four blood pressure measurements were taken simultaneously by two trained observers, using mercury sphygmomanometers alternately with three measurements by the test device. The difference between the blood pressure value given by the device and mean of the two observers' readings was calculated for each measurement. The 99 differences were classified into zones (< or =5, < or =10, and < or =15 mmHg). The number of differences in each zone was compared with the number required by the international protocol. Furthermore, an individual analysis was then done to determine for each participant the number of comparisons < or =5 mmHg, which requires that at least 22 of the 33 participants should have two of three comparisons < or =5 mmHg. RESULTS: The BPW810 passed the first phase of the validation process for systolic and diastolic blood pressure. For the second phase, the difference between the device and mean of two observers was -2.2+/-4.8 mmHg for systolic blood pressure and -0.5+/-3.7 mmHg for diastolic blood pressure. In the last phase, 26 participants fell in the zone of two of the three comparisons lying within 5 mmHg and none of the participants fell in the zone of all three of the comparisons over 5 mmHg apart. CONCLUSION: The BPW810 passed all the phases of the international protocol for both systolic and diastolic blood pressure.     

Validation of the TM-2564G device for in-hospital blood pressure measurement

OBJECTIVE: To perform clinical validation of the TM-2564G device for in-hospital blood pressure measurement according to the British Hypertension Society protocol. METHODS: The tests were carried out on 85 patients aged 19-82 years (41 male patients, mean age 50+/-19 years) with systolic blood pressure 75-219 mmHg and diastolic blood pressure 43-117 mmHg (mean 142+/-33/85+/-20 mmHg). For each patient, three readings of the TM-2564G device were compared with simultaneous auscultatory measurements by two trained independent observers. The observers used a mercury-calibrated sphygmomanometer and dual stethoscope. The results were graded according to the British Hypertension Society protocol 1993. RESULTS: The average difference was -1.85 mmHg for systolic blood pressure and -1.20 mmHg for diastolic blood pressure. The standard deviation of the difference between TM-2564G and the observers' results was 4.85 and 4.16 mmHg for systolic and diastolic blood pressures, respectively. Systolic blood pressure percentage of readings agreeing to within 5 mmHg was 75.7%, 10 mmHg 95.36% and 15 mmHg 99.6%, and for DBP 82.7, 97.6 and 99.8%, respectively. CONCLUSIONS: The TM-2564G device achieved A/A British Hypertension Society grade and can be recommended for in-hospital measurement of blood pressure.     

Validation of the Health & Life HL868BA blood pressure monitor for home blood pressure monitoring according to the European Society of Hypertension International Protocol

OBJECTIVE: This study aimed to evaluate the accuracy of the automated Health & Life oscillometric upper arm blood pressure monitor HL868BA for home blood pressure monitoring according to the European Society of Hypertension International Protocol for blood pressure measuring devices in adults. METHOD: Systolic and diastolic blood pressures were sequentially measured in 33 adult Chinese using a mercury sphygmomanometer (two observers) and the HL868BA device (one supervisor). Ninety-nine pairs of comparisons were obtained from 15 participants in phase 1 and further 18 participants in phase 2 of the validation study. Data analysis was performed using the ESHIP Analyzer. RESULTS: The HL868BA device successfully passed phase 1 of the validation study with a number of absolute differences between device and observers within 5, 10, and 15 mmHg for at least 31/45, 42/45, and 44/45 measurements (required 25, 35, and 40, respectively), respectively. The device also achieved the targets for phase 2.1, with 68/99, 91/99, and 95/99 differences within 5, 10, and 15 mmHg, respectively, for systolic blood pressure, and with 71/99, 88/99, and 94/99 within 5, 10, and 15 mmHg, respectively, for diastolic blood pressure. In phase 2.2, 22 and 28 participants had at least two of the three device-observers differences within 5 mmHg (required >/=22) for systolic and diastolic blood pressure, respectively. CONCLUSION: The Health & Life upper arm blood pressure monitor HL868BA can be recommended for home use in adults.     

Evaluation of the A&D UA-767 and Welch Allyn Spot Vital Signs noninvasive blood pressure monitors using a blood pressure simulator

The performance of five units of the A&D UA-767 NIBP monitor and five units of the Welch Allyn Spot Vital Signs noninvasive blood pressure monitor was evaluated with the Biotek BP Pump blood pressure simulator under a variety of conditions. Using the simulator to provide a normal blood pressure waveform at 80 bpm over a range of pressures, it was found that the mean bias for the combined results from the A&D monitors was 1.9+/-2.8 mmHg and from the Welch Allyn monitors was 0.7+/-2.4 mmHg. No individual measurement showed a bias greater than 10 mmHg. A bias of greater than 5 mmHg was present in 28 out of 150 measurements for the A&D monitor and 10 out of 150 measurements for the Welch Allyn monitor. These results are comparable with ratings achieved by the instruments when tested previously according to the British Hypertension Society protocol, but testing with a simulator allowed assessment of aspects of performance which were not included in the British Hypertension Society protocol.