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 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 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 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 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 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.     

Wrist blood pressure-measuring devices: a comparative study of accuracy with a standard auscultatory method using a mercury manometer

BACKGROUND: In this study, we compared two wrist blood pressure-measuring devices, the Omron RX and the Nissei WS-310, against a mercury manometer. METHOD: A total of 152 subjects attending an out-patient hypertensive clinic were recruited from a randomized blood pressure survey, 87 patients (mean 44.4 +/- 14.5 years of age) being selected according to the Association for the Advancement of Medical Instrumentation/British Hypertension Society standards. Device validation was assessed through the use of sequential same-arm readings compared with readings taken using a mercury sphygmomanometer by the two trained observers. RESULTS: There were no differences between the observers and the monitors for diastolic readings (2.8 +/- 4.8 mmHg for the Omron and 4.2 +/- 6.4 mmHg for the Nissei) according to the Association for the Advancement of Medical Instrumentation standards. The largest standard deviations -- 8.3 mmHg for the Omron and 8.8 mmHg for the Nissei, respectively -- were seen for systolic readings recorded by the observers and the monitors. According to the British Hypertension Society standards, the Omron achieved an A grade for diastolic readings and a B grade for systolic readings within 5 and 10 mmHg. The Nissei monitor achieved an A grade for diastolic readings and a B grade for systolic readings within 5 and 10 mmHg. CONCLUSION: Patients found the wrist oscillometric devices that we tested to be comfortable and easy to use. These devices are appropriate for measuring diastolic blood pressure according to the standards, but the reliability of both devices decreased when measuring systolic blood pressure.     

Clinical evaluation of the QuietTrak blood pressure recorder according to the protocol of the British Hypertension Society

METHODS: The QuietTrak ambulatory blood pressure recorder (Tycos-Welch-Allyn, Arden, North Carolina, USA) was evaluated according to the protocol of the British Hypertension Society (BHS). QuietTrak, a lightweight (355 g), automatic, programmable device, uses an auscultatory measuring system. The protocol of the BHS was composed of subsequent phases with QuietTrak and two observers taking simultaneous measurements on the same arm. RESULTS: No interdevice differences were observed at analysis of variance test either before or after a 1-month period of routine clinical use. The average difference between mercury sphygmomanometer and QuietTrak for systolic and diastolic blood pressures was -0.6+/-3.6 and -0.4+/- 3.6 mmHg before and -0.7+/- 3.3 mmHg and 0.6+/- 3.8 mmHg after the 1-month use. At the main static device validation procedure, performed in 85 subjects, the average difference between observers and QuietTrak was -0.3+/- 3.4 and 0.1+/- 3.5 mmHg for systolic and diastolic blood pressures. Eighty-nine per cent and 99% of systolic and 88% and 98% of diastolic QuietTrak readings were within 5 and 10 mmHg of obsevers, determinations (Class A). In children (n = 33) 87% of systolic and 90% of diastolic QuietTrak readings differed by less than 5 mmHg from the observers' readings (average difference -1.1+/-3.9 and 0.1+/- 3.6 mmHg, respectively). In the elderly (n = 30), 95% and 92% of systolic and diastolic readings were within 5 mmHg of mercury column determinations (average difference -0.8+/-3.2 and -0.2+/-4.5 mmHg). In pregnancy (n = 30), 93% of systolic and 100% of diastolic readings were within 5 mmHg of mercury column determination (average difference -0.3+/-3.4 and 0.1+/- 2.9 mmHg). Device reliability was not affected by posture. Ninety-six per cent and 89% of systolic and diastolic readings differed by less than 5 mmHg from the mercury column determinations in the supine position, 90% and 90% in the standing position, and 88% and 90% in the sitting position. During the treadmill exercise (Bruce protocol), 69% and 88% of systolic and 56% and 83% of diastolic QuietTrak readings differed by less than 5 and 10 mmHg from the observers' measurements. CONCLUSION: The QuietTrak achieved A rating for systolic blood pressure and A rating for diastolic blood pressure according to the criteria of the BHS protocol. The device was acceptable to patients because of its small size, light weight and noiseless performance.     

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 the Microlife BP 3BTO-A oscillometric blood pressure monitoring device according to a modified British Hypertension Society protocol

BACKGROUND: The market for devices for the self-measurement of blood pressure is growing, and as accuracy is of prime importance, there is increasing pressure for manufacturers to provide evidence of independent testing. Recent reviews have shown that only five automated upper arm devices for self-measurement of blood pressure have been recommended for use. We tested the Microlife BP 3BTO-A, a lightweight, upper arm, automated oscillometric device, according to a modified version of the British Hypertension Society protocol and also analysed the computer-generated oscillograms for possible causes of inaccuracy. METHODS: One hundred and twenty-six subjects were recruited from general medical and specialist clinics and from amongst the staff at Guy's and St Thomas' Hospital, London, UK. Only 85 of these were included in the final analysis. Nine sequential readings were taken by two trained observers alternating between the mercury sphygmomanometer and the device. The last seven readings were analysed according to the British Hypertension Society protocol. Modifications to the protocol were: (1) the exclusion of patients whose blood pressure varied by more than 15 mmHg between sequential observer readings and (2) limited testing in the low systolic pressure range. RESULTS: The Microlife achieved a grade A for both systolic and diastolic pressure according to the British Hypertension Society protocol. The mean differences (standard deviation) between the observers and the device were -1.6 (7.7) mmHg and -2.1 (6.3) mmHg for systolic and diastolic blood pressure, respectively, therefore also fulfilling the criteria set by the Association for the Advancement of Medical Instrumentation. Sub-analysis for different pressure ranges showed that the device was less accurate in the high-pressure range (>160/100 mmHg). CONCLUSION: The Microlife can be recommended for clinical use in an adult population.     

Evaluation and effects of the Omron 725 CIC device for measuring blood pressure in a hypertension clinic

BACKGROUND: We compared the Omron 725 CIC device (Omron Healthcare Inc., Vernon Hills, Illinois, USA), which is designed to register the blood pressure on the arm, with a mercury sphygmomanometer. In addition, we evaluated the possible impact that this device might have on the decisions made in a hypertension clinic. METHODS: Patients (n=183) older than 18 years (range 18-84 years) with a wide range of systolic (87-197 mmHg) and diastolic (48-108 mmHg) blood pressures were included. Some of the standards of the Association for the Advancement of Medical Instrumentation and of the British Hypertension Society were used to evaluate the results of the automated device in clinical practice. RESULTS: Using Bland-Altman analysis, an underestimation of both measures was observed with the automated Omron 725 CIC device; the systolic pressure was 3.6+/-8.8 mmHg too low with a very wide range of -13.7 to 20.9 and the diastolic pressure was also 4.4+/-6.3 mmHg too low with a range of -8.1 to 16.9. Clinical decisions could have been changed in 24 of the 116 hypertensive patients (20.6%) if the readings of the automated device had been used instead of using the readings of a mercury sphygmomanometer. These could have included modifying the dosage or changing the medicine used. CONCLUSION: The blood pressure measurements by Omron 725 CIC are different from those of blood pressure readings taken with a mercury sphygmomanometer and this could affect clinical decisions in the diagnosis and follow-up of a hypertensive patient in an office environment.     

Performance of the UA-787 oscillometric blood pressure monitor according to the European Society of Hypertension protocol

OBJECTIVE: To determine the accuracy of the UA-787 oscillometric blood pressure monitor developed by the A&D Company. DESIGN: Evaluation of the UA-787 was performed using the new protocol of the European Society of Hypertension. The performance of the monitor was assessed in relation to the subjects' gender, age, skinfold thickness, arm circumference, body mass index and elasticity index of large (C1) and small (C2) arteries. METHODS: The UA-787 monitor was assessed 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. In all subjects (n=33), indices of large-artery elasticity (C1) and small-artery elasticity (C2) were measured with the HDI/Pulsewave CR-2000 Research Cardiovascular Profiling System. RESULTS: The UA-787 passed all three phases of the protocol for both systolic and diastolic blood pressure. The mean blood pressure difference between device and the observers was 1.0+/-5.3 mmHg for systolic pressure, and 0.7+/-5.3 mmHg for diastolic pressure. In univariate analysis, the discrepancy between device and the observers was related to forearm circumference (P=0.02) for systolic pressure. For diastolic blood pressure, a significant relationship was found only for heart rate (P<0.01). However, in a multivariable regression analysis no clinical variable was an independent predictor of device-observer discrepancy. In particular, the performance of the UA-787 appeared to be uniform across the whole range of C1 and C2. CONCLUSIONS: These data show that the A&D UA-787 device satisfies the new recommended European Society of Hypertension accuracy levels for both systolic and diastolic pressure. Its performance is uniform across sub-groups of subjects with different clinical characteristics.     

Evaluation of the Tensioday ambulatory blood pressure monitor according to the protocols of the British Hypertension Society and the Association for the Advancement of Medical Instrumentation

BACKGROUND: The validation of ambulatory blood pressure monitoring devices is necessary to obtain information on their accuracy. The objective of the present study was to evaluate the accuracy of the Tensioday oscillometric ambulatory blood pressure monitor according to the protocols of the British Hypertension Society and the Association for the Advancement of Medical Instrumentation (AAMI). DESIGN: We followed the phases recommended by the British Hypertension Society protocol: before-use calibration, in-use assessment, after-use calibration, static device validation and report of the evaluation. However, we expanded on the protocol to accommodate features required by the AAMI. METHOD: The accuracy of calibration of three Tensioday devices was tested before and after the in-use phase when each of three devices was performing 10 24 h sessions of ambulatory monitoring. As all three devices passed these phases, the accuracy of blood pressure measurement was tested in one arbitrarily selected device on 85 subjects for systolic and 85 for diastolic blood pressure values. This was done by comparing three sequential same-arm blood pressure readings obtained by the device with three readings obtained by two observers using standard mercury sphygmomanometer. The comparisons were carried out while resting in the seated, supine and standing positions for all subjects. The results were used to grade the performance of the device according to the British Hypertension Society protocol and to calculate the mean +/- standard deviation of the difference between the device and the observers, as required by the AAMI. RESULTS: The Tensioday device achieved an overall grade of A for both the systolic and diastolic measurements, and had a mean difference compared with the observer-measured blood pressure of 1.4 +/- 5.3/1.0 +/- 4.7 mmHg, which satisfies the AAMI criteria for accuracy. The British Hypertension Society grading did not change when patients with low, medium, and high blood pressure were analysed separately. The AAMI accuracy criteria were fulfilled in the standing and lying positions as well. CONCLUSION: On the basis of these results, the Tensioday ambulatory blood pressure monitoring device can be recommended for clinical use for ambulatory monitoring. The accuracy of the device needs, however, further testing in special situations, such as in pregnancy, in elderly patients and during exercise.     

Validation of three oscillometric blood pressure devices against auscultatory mercury sphygmomanometer in children

AIM: To validate Welch-Allyn Vital Sign Monitor, Dinamap Procare-120 and Datascope Accutorr Plus against auscultatory mercury sphygmomanometer in children aged 5-15 years old according to the International Protocol of European Society of Hypertension adapted for validation in children. METHOD: One hundred and thirty two children were studied (44 for each device; 67 boys, 65 girls). Each underwent seven sequential BP measurements on the right arm resting in the sitting position, alternately with the mercury sphygmomanometer read simultaneously by two independent, trained observers and the test device by a third observer. RESULTS: For the Welch-Allyn monitor, the mean+/-SD of differences (device minus auscultatory BP) were -4.39+/-4.82 mmHg for systolic blood pressure and -4.1+/-7.07 mmHg for diastolic blood pressure. The device failed phase 2.1 for both systolic blood pressure (55, 91 and 98% were within 5, 10 and 15 mmHg, respectively) and diastolic blood pressure measurements (46, 82 and 95% were within 5, 10 and 15 mmHg, respectively). For the Dinamap device, the mean+/-SD of differences were -3.08+/-5.21 mmHg for systolic blood pressure and -4.61+/-9.35 mmHg for diastolic blood pressure. The device passed phase 2.1 for systolic blood pressure (71, 96 and 98% were within 5, 10 and 15 mmHg, respectively) but failed for diastolic blood pressure (51, 72 and 91% were within 5, 10, and 15 mmHg, respectively). For the Datascope device, mean+/-SD of differences were -0.9+/-4.33 mmHg for systolic blood pressure and -1.20+/-6.48 mmHg for diastolic blood pressure. The device passed phase 2.1 in that 84, 97 and 99% of systolic blood pressure, and 61, 89 and 97% of diastolic blood pressure readings were within 5, 10 and 15 mmHg, respectively. It also passed phase 2.2 for both systolic blood pressure and diastolic blood pressure. CONCLUSION: We performed an independent validation of three oscillometric BP devices in children. Overall Datascope Accutorr Plus passed, whereas Welch-Allyn Vital Sign Monitor and Dinamap Procare-120 failed an adapted IP-ESH.     

Accuracy evaluation of the 'Cardiette BP one' ambulatory blood pressure monitor

OBJECTIVE: Blood pressure (BP) 'Cardiette BP one' system (BP one) is an oscillometric ambulatory BP monitor manufactured in Italy in conformity to current regulations for medical devices. We decided to determine the accuracy of measures made with BP one, using the protocol of the British Hypertension Society published in 1990, and revised in 1993, for evaluating the accuracy of BP measurement devices. METHODS: The evaluation included before-use calibration, in-use assessment, after-use calibration, and static device validation that involved 85 participants. RESULTS: The mean difference between manual readings with sphygmomanometer and automatic ones with the device were -0.36+/-5.74 (mean+/-SD) for systolic values and 2.52+/-4.87 for diastolic values. On the basis of the percentages of measurements differing from the mercury sphygmomanometer standard by 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 Finometer device for measurement of blood pressure in black women

The improved Finapres apparatus, known as the Finometer, measures finger blood pressure noninvasively on a beat-to-beat basis and gives waveform measurements similar to intra-arterial recordings. The Finometer measures brachial pressure and corrects for finger pressure accordingly. It also corrects for the hydrostatic height of the finger with respect to the heart level. The objective was to validate the Finometer according to the revised British Hypertension Society (BHS) protocol and the criteria of the Association for the Advancement of Medical Instrumentation (AAMI). We carried out a main validation test using a subject group of 102 black women, which was also divided into smaller groups, namely 24 hypertensives, 25 obese normotensive and 35 lean normotensive women. Finometer and mercury sphygmomanometer blood pressure (BP) measurements were taken early in the morning before breakfast, after the subjects stayed overnight in a research unit. Within the whole subject group, the Finometer satisfied the AAMI criteria for accuracy and achieved an overall A/B grading according to the BHS criteria. The sphygmomanometer measurements were 128+/-20/78+/-12 mmHg compared to 130+/-20/78+/-11 mmHg for the Finometer. The average differences between the mercury sphygmomanometer and Finometer readings for systolic and diastolic BP were, respectively, -1.83+/-6.8 and 0.88+/-7.5. Systolic readings of the Finometer device differed by less than 5 mmHg for 64%, by less than 10 mmHg for 86% and differed by less than 15 mmHg for 96% of all readings. A total of 63% of all diastolic readings of the Finometer by less than 5 mmHg, 85% by less than 10 mmHg and 94% of all readings differed by less than 15 mmHg. On the basis of these results, the Finometer device satisfied the validation criteria of AAMI and received an A/B grading according to the BHS protocol. It can therefore be recommended for measurements in the clinical set-up and for research purposes.     

Inflationary oscillometric blood pressure monitoring: validation of the OMRON-MIT

BACKGROUND: To evaluate the accuracy of the OMRON-MIT, (an automated inflationary oscillometric blood pressure monitoring device) for use in the general population by direct comparison to standard auscultatory mercury sphygmomanometry. DESIGN: Two trained, blinded observers taking simultaneous blood pressure measurements alternating between a mercury sphygmomanometer and the OMRON-MIT. METHODS: The evaluation was carried out according to the revised British Hypertension Society protocol. The validation data was also classified by the American Association for the Advancement of Medical Instrumentation (AAMI). RESULTS: The OMRON-MIT device achieved a BHS grade A for both systolic blood pressure (SBP) and diastolic blood pressure (DBP). It also met the criteria for the AAMI protocol, the mean difference between the MIT and standard was -2.0 +/- 7 mmHg for SBP and -2.0 +/- 6 mmHg for DBP. CONCLUSIONS: Inflationary oscillometry is a valid technique for the measurement of blood pressure. The OMRON-MIT, which uses this technique, is accurate and can be recommended for clinical use in the adult population.     

Evaluation of the SpaceLabs 90202 non-invasive ambulatory recorder according to the AAMI Standard and BHS criteria

The SpaceLabs 90202, a non-invasive ambulatory blood pressure recorder for the measurement of 24 hr blood pressure, was assessed according to the standard of the Association for the Advancement of Medical Instrumentation (AAMI) and the grading criteria of the British Hypertension Society (BHS) protocol were applied to the results. Two observers measured BP simultaneously in the same arm with the SpaceLabs 90202 and a standard mercury sphygmomanometer at 4 mmHg deflation steps in 85 subjects [age range 22-79 years, BP range 96-212 mmHg (systolic) and 52-134 mmHg (diastolic)]. The mean difference was -2 +/- 5 mmHg (systolic) and -2 +/- 5 mmHg (diastolic). The mean difference (+/- SD) between observers was 1 +/- 3 (systolic) and -2 +/- 3 (diastolic). The SpaceLabs 90202 fulfills the criteria of the AAMI standard (5 +/- 8 mmHg) and a B grading for both systolic and diastolic pressure is achieved with the BHS criteria.     

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.