A validation of the Mobil O Graph (version 12) ambulatory blood pressure monitor

OBJECTIVE: To assess the clinical accuracy of the Mobil O Graph (version 12) ambulatory blood pressure monitor in an adult population. METHODS: The accuracy of the device was assessed by predefined criteria (British Hypertension Society, BHS) in 85 subjects recruited from the 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 Mobil O Graph ambulatory monitor. A total of seven readings were taken from each subject in the sitting position. The data were then analysed according to the BHS protocol and the criteria of the Association for the Advancement of Medical Instrumentation (AAMI). RESULTS: The Mobil O Graph ambulatory monitor fulfilled the criteria of the BHS protocol, achieving a grade B for systolic blood pressure (SBP) and a grade A for diastolic blood pressure (DBP). The mean differences were -2+/-8 mmHg for SBP and -2+/-7 mmHg for DBP. The device therefore also passed the AAMI standard (the mean to be within 5+/-8 mmHg). CONCLUSION: The Mobil O Graph ambulatory monitor performed in a satisfactory manner according to the BHS and the AAMI criteria and can therefore be recommended for clinical use in the general population.     

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 SAA-102 home blood pressure monitor according to the protocols of the European Society of Hypertension, the Association for the Advancement of Medical Instrumentation and the British Society of Hypertension

OBJECTIVE: To determine the accuracy of a new oscillometric home blood pressure (BP) monitor for arm BP measurement, the SAA-102, developed by the Sensacare Company. DESIGN: Evaluation of the SAA-102 was performed using validation protocols of the European Society of Hypertension (ESH), the Association for the Advancement of Medical Instrumentation (AAMI), and the British Hypertension Society (BHS). METHODS: The SAA-102 monitor was assessed on 33 participants according to ESH requirements, which are based on four zones of accuracy differing from the mercury standard by 5, 10, 15 mmHg or more. Then the oscillometric monitor was tested on 85 participants according to AAMI criteria which require a mean device-observers discrepancy within 5+/-8 mmHg. Finally, the electronic device was evaluated on 93 participants according to BHS requirements, which are based on five phases: before-use calibration, in-use assessment, after-use calibration, static device validation and report of the results. RESULTS: The SAA-102 passed all phases of the ESH international protocol for both systolic and diastolic blood pressure (SBP and DBP). The SAA-102 passed also AAMI criteria for SBP and DBP. The mean discrepancy between the SAA-102 and observers was 0.1+/-4.6 and -2.7+/-5.2 mmHg, for SBP and DBP, respectively. According to BHS protocol, the oscillometric monitor achieved final grading of A/A for SBP and DBP, respectively. CONCLUSION: These data show that the SAA-102 device satisfies ESH, AAMI, and BHS protocols for both SBP and DBP and may be recommended for everyday use for BP monitoring at home and in clinical practice.     

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

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

Accuracy and applicability of the Terumo ES-H55 double-cuff sphygmomanometer for hospital use

BACKGROUND: We have developed a new blood pressure (BP)-measuring device with a double-cuff, and evaluated its accuracy and applicability for practical use. DESIGN: The double-cuff method features a small cuff placed in the centre of the compression cuff to detect the oscillation of arterial pulsation, by which algorithms for the determination of systolic BP (SBP) and diastolic BP (DBP) were rendered more objective than with the conventional oscillometric method. Algorithms for automatic BP determination were developed from the oscillation data taken with the small cuff from 217 men and 256 women, and then installed in the Terumo ES-H55 device (length: 17 cm, weight: 120 g). This ES-H55 device was tested on 87 subjects (65 hypertensives and 22 normotensives) to compare its accuracy with that of the auscultatory method according to the AAMI SP-10 protocol. RESULTS: Using Bland and Altman scatter plots, the difference in SBP between the ES-H55 device and the auscultatory method was within +/- 5 mmHg in 88% of subjects, and within +/- 10 mmHg in 97% (mean difference +/- SD: 0.2 +/- 3.9 mmHg). The difference in DBP was within +/- 5 mmHg in 80%, and within +/- 10 mmHg in 97% (difference: -0.1 +/- 4.6 mmHg). These results satisfied AAMI guidelines, and this device was easy to use. CONCLUSIONS: The ES-H55 device is compact and light, with clear algorithms for the determination of BP, and satisfies AAMI criteria, so that it is considered a useful BP-measuring device that could be used instead of a mercury sphygmomanometer by nurses and doctors in hospital wards.     

Validation of the FM-800 ambulatory blood pressure monitor according to the Association for the Advancement of Medical Instrumentation criteria and the International Protocol

To validate the FM-800 device (Fukuda Denshi Co., Ltd., Tokyo, Japan) for ambulatory blood pressure monitoring (ABPM), this validation study was performed based on the European Society of Hypertension (ESH) protocol and the Association for the Advancement of Medical Instrumentation (AAMI) criteria. Thirty-three participants were included (15 in phase 1 and an additional 18 in phase 2) in the ESH protocol. The device was tested on 85 participants according to the AAMI criteria, which require a mean device-observers discrepancy within 5 ± 8 mmHg. The tested device passed all the criteria for both systolic blood pressure (SBP) and diastolic blood pressure (DBP), and for the Korotkoff and oscillometric methods according to the ESH protocol. The test device also fulfilled the AAMI accuracy criteria for the 85 participants; the mean ± SD of the SBP/DBP differences between the tested device and the mean of the observer readings were -1.1 ± 4.2/-0.8 ± 4.2 mmHg for the Korotkoff method and 2.3 ± 3.9/-2.3 ± 3.9 mmHg for the oscillometric method. The FM-800 device for ABPM passed all the validation criteria of the ESH and AAMI and can, therefore, be recommended for clinical use in an adult population.     

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

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

Evaluation of the ambulatory blood pressure monitor SAVE 33 model 2]

This work tests a new ambulatory blood pressure device: Save 33 II. The evaluation is conducted according to the phases II and IV of the British Hypertension Society (BHS) protocol: the phases I and III (before and after use) are not performed as this device has received the European quality label 'CE' that guarantees a +/- 3 mmHg accuracy before and after 10,000 simulated cycles. Two trained observers (hearing test and certification done according to the BHS recommendations) have performed 7 sequential BP measurements with conventional and automatic method, at the same arm, among 85 patients. The ranges of mean blood pressure are 78-203 mmHg, for SBP and 53-130 mmHg for DBP. RESULTS: The Save 33 II monitor satisfies the grade B of BHS evaluation for both systolic and diastolic pressures. This device also satisfies the Association for the Advancement of Medical Instrumentation (AAMI) protocol: mean difference between methods and standard deviation less than 5 +/- 8 mmHg: -2.7 +/- 6.8 mmHg for SBP and -0.86 +/- 6.6 mmHg for DBP. The in-use assessment is conform to BHS criteria for 20 recordings (less than 20% invalid values during day and night); the 5 other recordings have not enough night values, due to batteries failure (2 cases), sleeping discomfort (2 cases) and a cuff withdraw. CONCLUSION: This device, in the tested configuration, agrees the B grade of BHS and can be recommended for ambulatory blood pressure measurement.     

Validation of the FM-800 Ambulatory Blood Pressure Monitor According to the Association for the Advancement of Medical Instrumentation Criteria and the International Protocol

To validate the FM-800 device (Fukuda Denshi Co., Ltd., Tokyo, Japan) for ambulatory blood pressure monitoring (ABPM), this validation study was performed based on the European Society of Hypertension (ESH) protocol and the Association for the Advancement of Medical Instrumentation (AAMI) criteria. Thirty-three participants were included (15 in phase 1 and an additional 18 in phase 2) in the ESH protocol. The device was tested on 85 participants according to the AAMI criteria, which require a mean device-observers discrepancy within 5 ± 8 mmHg. The tested device passed all the criteria for both systolic blood pressure (SBP) and diastolic blood pressure (DBP), and for the Korotkoff and oscillometric methods according to the ESH protocol. The test device also fulfilled the AAMI accuracy criteria for the 85 participants; the mean ± SD of the SBP//DBP differences between the tested device and the mean of the observer readings were –1.1 ± 4.2//–0.8 ± 4.2 mmHg for the Korotkoff method and 2.3 ± 3.9//–2.3 ± 3.9 mmHg for the oscillometric method. The FM-800 device for ABPM passed all the validation criteria of the ESH and AAMI and can, therefore, be recommended for clinical use in an adult population.     

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 Microlife Watch BP Office professional device for office blood pressure measurement according to the International protocol

OBJECTIVE: To assess the accuracy of oscillometric and auscultatory blood pressure (BP) measurement taken using the professional electronic device Microlife Watch BP Office according to the European Society of Hypertension International Protocol. METHODS: Thirty-three participants were included for the assessment of each measurement mode (oscillometric and auscultatory). Simultaneous BP measurements were taken by two observers (mercury sphygmomanometers) four times, sequentially with three measurements taken using the tested device. Absolute observer device BP differences were calculated. For each participant the number of measurements with a difference within 5 mmHg was calculated. RESULTS: In phase 1 the device produced 32, 40 and 40 oscillometric systolic BP (SBP) measurements within 5, 10 and 15 mmHg, respectively and diastolic BP (DBP) 30, 40 and 43 (for auscultatory SBP 29, 42, 45 and DBP 33, 43, 45). In phase 2.1 the device produced 71, 90 and 96 SBP measurements within 5, 10 and 15 mmHg, respectively and DBP 71, 88 and 97 (for auscultatory SBP 72, 96, 99 and DBP 83, 96, 99). Twenty-four participants had at least two of their SBP differences within 5 mmHg and one participant had no difference within 5 mmHg, and DBP 23 and three participants, respectively (for auscultatory SBP 29 and 0 and DBP 29 and 1). Mean SBP difference was -1.4+/-6.3 mmHg and DBP -0.8+/-6.0 mmHg (auscultatory SBP -1.8+/-4.5 and DBP -0.4+/-4.0). CONCLUSION: The Microlife Watch BP Office device used in the oscillometric or the auscultatory mode fulfills the validation criteria of the International protocol and therefore can be recommended for clinical use.     

海尔BP3BG1-A全自动上臂电子血压计准确性的临床评价

目的:按照《欧洲高血压协会国际质量控制方案2010修正版（ESH-IP 2010）》,评估海尔BP3BG1-A全自动上臂电子血压计临床应用的准确性。方法: 测量者采用水银血压计和受试血压计先后测量33名被试者同一左侧上臂收缩压和舒张压。根据ESH-IP 2010,每位被试者测量3对血压,共收集99例次受试血压计与水银血压计的测值。结果: 受试血压计测得73次（74%）收缩压与水银血压计测值差在5 mmHg以内,98次（99%）在10 mmHg以内,99次（100%）在15 mmHg以内;86次（87%）舒张压与水银血压计测值差5 mmHg以内,98次（99%）差10 mmHg。受试血压计测得收缩压与水银血压计测值差为（3.1±3.7） mmHg;舒张压测值差为（-0.9±3.7） mmHg。采用受试血压计与水银血压计的测值2~3次的差别都在5 mmHg以内的受试者数目分别为26名（79%）和29名（88%）。结论: 受试血压计对临床成人患者血压测量的准确性达到《 ESH-IP 2010》的验证标准。     

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

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

Validation of the SpaceLabs 90207 ambulatory blood pressure device for hemodialysis patients.

BACKGROUND: Background Ambulatory blood pressure monitoring (ABPM) has been used increasingly in assessing dialysis patients. However, devices have not been validated formally for this population. Formal device validation is important in order to guarantee adequate performance for populations with special characteristics, such as patients undergoing hemodialysis. OBJECTIVE: To achieve formal validation of the SpaceLabs 90207 ambulatory blood pressure device (SLD) using a modified British Hypertension Society protocol. METHODS: Eighty-five hemodialysis patients were studied, generating 255 readings. Readings were obtained with patients supine (in a dialysis chair) over 5-10 min during hemodialysis. Simultaneous, same-arm readings were obtained through the use of a T connector to a calibrated mercury manometer. The mean differences between readings obtained by observers and those obtained by the device were calculated. Limits of agreement between observers and SLD were determined and plotted according to the method of Bland and Altman. For grading of performance, we determined the number of readings for which the readings obtained by the device were within 5, 10, and 15mmHg of manometer readings. Final gradings were ascribed according to British Hypertension Society criteria. RESULTS: The mean blood pressure (+/-SD) was 141/76+/-31/15mmHg (observers) and 141/77+/-27/15mmHg (SLD), and the mean (+/-SD) difference between observers and device (observer-device) was -0.5+/-7.5mmHg for systolic blood pressure (SBP) and -0.2+/-5.2mmHg for diastolic blood pressure (DBP). The device was less accurate in extreme ranges of SBP. In fact, there was a positive correlation between average [(observer+device)/2] and difference (observer-device) for SBP (r =0. 54, P <0.0001), showing that underestimation in higher ranges, and overestimation in lower ranges of blood pressure occurred for SBP. For SBP, 53% of readings were within 5mmHg of those obtained by the observers, 85% were within 10mmHg, and 97% within 15mmHg. For DBP, 78% were within 5mmHg, 96% within 10mmHg, and 98% within 15mmHg. These observations conferred on the device grade C for SBP and grade B for DBP. The type of vascular access and the presence of non-functioning arteriovenous grafts and fistulas in the ipsilateral arm did not alter these results significantly. CONCLUSIONS: These data validate the use of this device for hemodialysis patients. However, caution should be exercised in the evaluation of upper and lower ranges of SBP.     

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 the A&D UM-101 professional hybrid device for office blood pressure measurement according to the International Protocol

OBJECTIVE: Assessment of the accuracy of the A&D UM-101 mercury-free professional device for auscultatory blood pressure (BP) measurement according to the European Society of Hypertension International Protocol. Further to auscultation, the device has a button to mark readings during deflation. METHODS: Fifteen adults were included in phase 1 and another 18 in phase 2. Simultaneous BP measurements were taken by two observers (connected mercury sphygmomanometers) four times, sequentially with three measurements using the tested device (two connected tested devices, one used with and the other without the mark button). RESULTS: In phase 1, the device produced 44/45/45 measurements within 5/10/15 mmHg, respectively, for systolic BP (SBP) and 39/43/45 for diastolic (DBP). In phase 2.1, 87/97/99 measurements within 5/10/15 mmHg, respectively, for SBP, and 91/97/99 for DBP (using the mark button 65/93/98 for SBP and 76/96/99 for DBP). In phase 2.2, 29 participants had at least two of their SBP differences within 5 mmHg and none had any differences within 5 mmHg, whereas 32 and none, respectively, for DBP (with mark 24/4 participants for SBP; 29/1 for DBP). Mean SBP differences were -1.5+/-3.5 mmHg and DBP -1.3+/-3.0 (with mark -3.6+/-4.2 and -2.8+/-3.7). The difference in SBP measured by the tested device with versus without using the mark button was 3.0+/-3.3 mmHg (P<0.001) and DBP 1.9+/-2.5 mmHg (P<0.001). CONCLUSION: The device comfortably passed the validation protocol requirements. Using the mark button, the device, however, failed to meet the validation criteria. Therefore, it is recommended for clinical use without using the mark button.     

Comparison of a radial artery compression device with invasive radial artery blood pressure monitoring

OBJECTIVE: The goal of this study was to validate the accuracy of the Primo radial artery compression device (RACD) according to the guidelines recommended by the American National Standards Institute/Association for the Advancement of Medical Instrumentation (AAMI) SP10-2002 Standards for Electronic or Automated Sphygmomanometers. METHODS: A prospective, nonblind, convenience sample trial at a level 1 trauma center (annual emergency department census 70,000) enrolled 17 adult patients with preexisting radial artery line catheters (RAL). Each patient had 10 blood pressure measurements giving an n=170. This number is consistent with calculations on the basis of the American National Standards Institute/AAMI guidelines. RESULTS: The mean arterial pressures (MAPs), systolic blood pressures (SBPs), and diastolic blood pressures (DBPs) measured by both the RACD and the RAL were compared. The R for the RAL/RACD were 0.94, 0.96, and 0.85 for MAP, SBP, and DBP, respectively (P<0.05). The mean difference between the RAL MAP and the RACD MAP was +1.0 mmHg (95% confidence interval, -1.69 to -0.33). The mean SBP difference was -2.8 mmHg (SD 6.4 mmHg) and the mean DBP difference was +2.6 mmHg (SD 5.7 mmHg). CONCLUSION: The RACD meets the guidelines for automated blood pressure monitors set by the AAMI SP10-2002 Standards for Electronic or Automated Sphygmomanometers with an accuracy of +/- 5 mmHg and SD of 8 mmHg or less for both SBP and DBP measurements.     

Validation of the SpaceLabs 90207 automatic non-invasive blood pressure monitor in elderly subjects

OBJECTIVE: To validate the SpaceLabs 90207 ambulatory blood pressure monitor in the elderly. METHODS: Eighty-five subjects aged 60-90 years were recruited from hospital inpatients. Using the same-arm sequential measurement technique two observers recorded blood pressure with a mercury sphygmomanometer first and then by using the SpaceLabs 90207 ambulatory monitor. This set of blood pressure readings was performed three times with all 85 subjects supine, sitting and standing. Data were analysed according to the British Hypertension Society protocol. RESULTS: Over the blood pressure range tested the SpaceLabs 90207 device recorded diastolic blood pressure (DBP) satisfactorily, achieving grade A in all body postures, but not systolic blood pressure (SBP; supine D, standing C, sitting C). However, at SBP 相似文献   

Accuracy of home blood pressure readings: monitors and operators

OBJECTIVE: To evaluate the accuracy of automated digital blood pressure monitoring devices and operators in the community. Also, we tested the effects of a simple education program, and looked for arm-arm differences. DESIGN: Subjects who had bought their own automated digital blood pressure monitor were recruited via an advertisement in the local newspaper. On arrival, they were asked to record their blood pressure exactly as they would at home. The investigator noted any technique deficiencies then corrected them. Blood pressures were then recorded by the investigator and the subject, on opposite arms, simultaneously, and repeated with the arms switched. Finally, subjects recorded their blood pressure again. The subjects' readings were compared to the average of monitor and mercury readings using Bland-Altman methods. RESULTS: A total of 80 subjects were tested. Before educating, subjects' systolic blood pressure (SBP) readings were +5.8+/-6.4 (standard deviation) mmHg greater than the mean of all readings, and diastolic blood pressure (DBP) were +1.3+/-4.0 mmHg; after educating they were +1.3+/-4.0 and -1.3+/-2.7 respectively. The monitors, as a group, were accurate, and met British Hypertension Society and AAMI highest standards. We found no differences among monitors that had been validated (n=26) and those that had not. There were differences between the arms: 5.3+/-5.2 mmHg for SBP and 3.4+/-3.3 mmHg for DBP. Most patients had never been informed by anyone of proper blood pressure measuring techniques. CONCLUSIONS: We conclude that home blood pressure measurement, as practiced in our community, is prone to error, mostly due to mistakes by the operator. These can easily be corrected, so that readings become more accurate. Attention should be paid to arm-arm differences.     

Evaluation of the Schiller BR-102 ambulatory blood pressure system according to the protocols of the British Hypertension Society and the Association for the Advancement of Medical Instrumentation.

OBJECTIVE: To evaluate the Schiller BR-102 monitor for ambulatory blood pressure measurement according to the protocols of the British Hypertension Society (BHS) and the Association for the Advancement of Medical Instrumentation (AAMI). DESIGN: The BHS protocol is divided into two parts. Part I, which is the part applicable to this study, comprises the main validation procedure and has five phases: before-use device calibration; in-use (field) phase; after-use device calibration; static device validation; and report of evaluation. METHOD: Three Schiller BR-102 recorders passed the before-use device calibration test, after which they entered the in-use (field) assessment phase during which the three recorders were each worn by 10 subjects for 24 h, after which calibration was again assessed. Because there was no difference in results of calibration testing among the three devices, one was selected randomly and the main validation test was carried out on 85 subjects with a wide range of blood pressures both for the auscultatory mode and for the oscillometric mode using the Sphygmocorder. The results were analysed according to the BHS grading system from A to D. The data were also analysed according to the standard of the Association for the Advancement of Medical Instrumentation (AAMI), which stipulates that the mean difference between the test device and the standard shall be 160/100 mmHg) the Schiller BR-102 was less accurate in the high pressure range for diastolic blood pressure but more accurate for systolic blood pressure, achieving A/C grading, while satisfying the AAMI criteria both for systolic and for diastolic blood pressure in the auscultatory mode. In the oscillometric mode the device performed less accurately in the high-pressure range, achieving grade D/C, while failing to satisfy the AAMI criteria both for systolic and for diastolic blood pressure. The means+/-SD of the first mercury sphygmomanometer measurements were 143+/-32 mmHg for systolic blood pressure and 88+/-21 mmHg for diastolic blood pressure. Acceptability to subjects was good and the manufacturer's manual was satisfactory. CONCLUSION: On the basis of these results, the Schiller BR-102 can be recommended for ambulatory blood pressure measurement in clinical practice using the auscultatory mode, but the oscillometric mode, which operates only if the device fails in the auscultatory mode, does not provide accurate measurements.