Validation of the Omron 705IT (HEM-759-E) oscillometric blood pressure monitoring device according to the British Hypertension Society protocol

BACKGROUND: The Omron 705IT (HEM-759-E, Omron Corporation, Kyoto, Japan) 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 and the Association for the Advancement of Medical Instrumentation SP10 validation criteria. METHODS: Study participants were recruited until a total of 85 were obtained that filled the blood pressure categories specified by the British Hypertension Society protocol. Recruitment to the study was from the general medical and specialist clinics and from the staff at Guy's & St Thomas' Hospital in London, UK. Nine sequential same-arm blood pressure readings were taken from each participant by two trained observers, alternating between mercury reference sphygmomanometers and the Omron 705IT (HEM-759-E). The differences between the reference and test device readings, for both systolic and diastolic pressures, were compared with British Hypertension Society and Association for the Advancement of Medical Instrumentation criteria to determine the outcome of the study. RESULTS: The Omron 705IT (HEM-759-E) is graded 'A' for systolic and 'A' for diastolic blood pressures according to the British Hypertension Society criteria. The mean (standard deviation) of the difference between the observer and the device measurements was 0.60 (6.0) mmHg for systolic and -3.15 (6.6) mmHg for diastolic pressures, respectively. The device, therefore, also satisfies the Association for the Advancement of Medical Instrumentation SP10 standard, that requires differences of less than +/-5 (8) mmHg. CONCLUSIONS: The Omron 705IT (HEM-759-E) achieved an 'A/A' performance classification under the British Hypertension Society criteria and passes the Association for the Advancement of Medical Instrumentation requirements for the study population. It can be recommended for professional and home-use in an adult population.     

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.     

Evaluation of three devices for self-measurement of blood pressure according to the revised British Hypertension Society Protocol: the Omron HEM-705CP, Philips HP5332, and Nissei DS-175

OBJECTIVE: We evaluated three devices for self-measurement of blood pressure - the Omron HEM-705CP, the Philips HP5332 and the Nissei DS-175 - according to the revised protocol of the British Hypertension Society (BHS). The results were also analysed according to the criteria for accuracy of the revised standard of the Association for the Advancement of Medical Instrumentation (AAMI). DESIGN: The revised BHS protocol is divided into two parts. Part I, 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; report of evaluation. METHODS: Three models of each device passed the before-use device calibration test, after which they entered the in-use phase, which involved use of the three recorders for a month; inter-device calibration was assessed again at the end of the month. There was no difference in calibration testing between the three models of each device, and therefore one of each was selected randomly; the main validation test was carried out in 85 subjects with a wide range of pressures, and the results were analysed according to the BHS grading system from A to D. RESULTS: The Omron HEM-705CP achieved an overall B/A grading and fulfilled the AAMI accuracy criteria; the Philips HP5332 achieved an overall C/A grading and failed the AAMI accuracy criteria for measuring systolic pressure; the Nissei DS-175 achieved an overall D/A grading and failed the AAMI accuracy criteria for measuring systolic pressure. When the BHS and AAMI criteria were applied to tertiles of pressure (low-pressure range < 130/80 mmHg; medium-pressure range 130-160/80-100 mmHg; high-pressure range > 160/100 mmHg) all three devices were less accurate in the high-pressure range: the Omron HEM-705CP achieved C/B grading while continuing to fulfil the AAMI criteria; the Philips HP5332 dropped to D grading for systolic pressure and the Nissei DS-175 achieved a lower D grading for systolic pressure. The mean and standard deviation of the first mercury sphygmomanometer measurements were 148+/-35/88+/-22 mmHg. Acceptability by the users was good and the manufacturer's manual was satisfactory for all three devices. CONCLUSIONS: On the basis of these results, the Omron HEM-705CP was the most accurate of the three devices tested, achieving Grade B for systolic and Grade A for diastolic pressure, as well as fulfilling the AAMI criteria for accuracy for both systolic and diastolic pressure. It can therefore be recommended for the clinical measurement of blood pressure and is the first inexpensive device to satisfy the accuracy criteria of these protocols.     

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 two automatic devices for self-measurement of blood pressure according to the International Protocol of the European Society of Hypertension: the Omron M6 (HEM-7001-E) and the Omron R7 (HEM 637-IT)

BACKGROUND: Two electronic devices for self-measurement of blood pressure - a brachial monitor, the Omron M6, and a wrist monitor, the Omron R7 - were evaluated in two separate studies according to the International Protocol of the European Society of Hypertension. DESIGN: The International Validation 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 final validation is performed. METHODS: The same methodology recommended by the European Society of Hypertension protocol was applied for both studies. In each study and for each participant, four blood pressure measurements were taken simultaneously by two trained observers using mercury sphygmomanometers alternately with three measurements taken by the tested device. The difference between the blood pressure value given by the device and that obtained by the two observers (mean of the two observers) was calculated for each measure. The 99 pairs of blood pressure differences were classified into three categories (相似文献   

Evaluation of two devices for self-measurement of blood pressure according to the international protocol: the Omron M5-I and the Omron 705IT

BACKGROUND: Two devices for self-measurement of blood pressure at the brachial artery-the Omron M5-I and the Omron 705IT-were evaluated according to the international protocol of the European Society of Hypertension. DESIGN: The international validation protocol is divided into two phases: the first phase is performed on 15 selected subjects and if the device passes this phase, 18 supplementary subjects are included making a total number of 33 subjects on which the final validation is performed. METHODS: For each subject, four blood pressure (BP) measurements were performed simultaneously by two trained observers using mercury sphygmomanometers alternately with three measurements by the tested device. The difference between the BP value given by the device and that obtained by the two observers (mean of the two observers) was calculated for each measure. The 99 differences were classified into categories (相似文献   

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 Omron HEM-907 device for blood pressure measurement

BACKGROUND: The aim of this study was to validate the Omron HEM-907 blood pressure (BP) measuring device according to the international validation protocol. DESIGN: The international validation protocol is divided into two phases: the first phase is performed on 15 selected subjects and if the device passes this phase, 18 more subjects are selected making a total number of 33 subjects on which the final validation is performed. METHODS: For each subject, BP measurements were performed simultaneously by two trained observers using mercury sphygmomanometers alternately with the Omron HEM-907 device. In all, 99 measurements were obtained for comparison. The difference between the BP value given by the device and that obtained by the two observers (mean of the two observers) was calculated for each measure. RESULTS: The difference between the two observers was -1 +/- 2 mmHg for the systolic BP (SBP) and for the diastolic BP (DBP). The Omron HEM-907 passed the first phase of the validation process. For the second phase, the average differences between the device and mercury sphygmomanometer readings were -1 +/- 7 and -5 +/- 6 mmHg for SBP and DBP respectively. Readings for the HEM-907 device differed by less than 5 mmHg for 61 of the systolic readings and 52 of the diastolic readings; by less than 10 mmHg for 85 of the systolic readings and 85 of the diastolic readings; and by less than 15 mmHg for 94 of the systolic readings and 96 of the diastolic readings. CONCLUSIONS: The Omron HEM-907 device passes the two phases of the international validation protocol.     

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 the Omron M6 (HEM-7001-E) upper arm blood pressure measuring device according to the International Protocol in elderly patients

OBJECTIVE: Despite the widespread use of automated self-measurement monitors, there is limited published evidence on their accuracy and reliability on different patient groups. The objective of this study was to evaluate the accuracy and reliability of the Omron M6 (HEM-7001-E) upper-arm blood pressure (BP) device against mercury sphygmomanometer on elderly patients according to the criteria of the International Protocol. DESIGNS AND METHODS: Thirty-three patients above 65 years of age, who were classified based on the BP categories of the International Protocol, were recruited for the study. BP measurements at the upper arm with the Omron M6 were compared with the results obtained by two trained observers using a mercury sphygmomanometer. Nine sequential BP measurements were taken. During the validation study, 99 measurements were obtained from 33 patients for comparison. The first phase was carried out on 15 patients and if the device passed this phase, 18 more patients were selected. RESULTS: Mean discrepancies and standard deviations of the device sphygmomanometer were 1.4+/-5.3 mmHg for systolic BP (SBP) and -1.4+/-4.5 mmHg for diastolic BP (DBP) in the study group. The device passed phase 1 in 15 patients. In phase 2.1, from the total 99 comparisons, 76, 92, and 97 for SBP and 77, 94, and 99 for DBP were less than 5, 10, and 15 mmHg, respectively. The Omron M6 passed phases 2.1 and 2.2 in the elderly group of patients. CONCLUSION: The Omron M6 (HEM-7001-E) upper-arm BP monitor passed according to the International Protocol criteria and can be recommended for use in elderly patients.     

Omron HEM-711 DLX home Blood pressure monitor passes the European Society of Hypertension International Validation Protocol

The Omron HEM-711 DLX home Blood pressure monitor was tested using the European Society of Hypertension International Protocol in 33 patients. The average error was 0.9+/-5.2 (SD) (range: -12 to 10 mmHg)/-0.8+/-5.6 (-19 to 8). It can be recommended for use by patients. With all automatic devices it is, however, important to validate its accuracy in each individual patient who uses it.     

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.     

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.     

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.     

Evaluation of Meditech ABPM-04 ambulatory blood pressure measuring device according to the British Hypertension Society protocol

BACKGROUND: The use of ambulatory blood pressure measuring devices has become widespread in the diagnosis of hypertension. The accuracy of the device is fundamental for the diagnosis and treatment of the disease. OBJECTIVE: Internationally accepted validation of the newest ambulatory blood pressure measuring device, the ABPM-04 prototype, manufactured by Meditech Ltd. PATIENTS AND METHODS: Validation was carried out by assessing 94 outpatients, according to the British Hypertension Society protocol. RESULTS: The test device achieved grade B on the scale defined in the British Hypertension Society protocol, for both systolic and diastolic blood pressure. The mean and standard deviation of the difference between measurements of the test device and the mercury standard for both systolic and diastolic blood pressure were within the recommendations of the Association for the Advancement of Medical Instrumentation. CONCLUSION: The present study demonstrates that the Meditech ABPM-04 ambulatory blood pressure measuring device complies with the above mentioned requirements, and thus can be recommended for clinical use.     

Trial of validation of two devices for self-measurement of blood pressure according to the European Society of Hypertension International Protocol: the Citizen CH-432B and the Citizen CH-656C

OBJECTIVE: Two devices for self-measurement of blood pressure, one at the upper arm (Citizen CH-432B) and one at the wrist (Citizen CH-656C), were evaluated 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 with five participants in three different blood pressure ranges. If the devices passed this phase, 18 additional participants selected on the basis of the same criteria as in phase 1 were included. METHODS: Two skilled observers performed the following blood pressure measurements: five measurements were performed with the mercury standard alternating with four measurements with each of the test devices per participant. The first measurement result from each device instrument was not included in the analysis. The difference between the blood pressure value given by the devices and that obtained by the two observers (mean of the two observers) was calculated for each pair of measurements and classified into three categories (within 5, 10 and 15 mmHg). The results were compared to the pass criteria established by the European Society of Hypertension. Afterwards the number of measurement differences falling within 5 mmHg was determined for every person. At least 22 of the 33 participants should have two of their three comparisons within 5 mmHg and there should be a maximum of three participants without a measurement difference within the 5 mmHg range. RESULTS: Both tested devices passed the first phase of the validation process by exceeding the required number of comparisons falling within the 5, 10 and 15 mmHg error zones. Even the second phase confirmed the validation criteria with average differences between the device and the mercury sphygmomanometer of 0.7+/-4.4 and -3.6+/-4.0 mmHg for systolic blood pressure and diastolic blood pressure, respectively, for the Citizen CH-432B device and -0.7+/-6.0 and -1.2+/-4.5 mmHg for the Citizen CH-656C device. Phase 2 contains furthermore an individual analysis of the 33 participants, the requirements of which were also fulfilled by both devices. CONCLUSION: The Citizen CH-432B and the Citizen CH-656C devices pass the validation recommendations of the International Protocol. They can be recommended for clinical use.